Part VII - UNITAR · 2005. 9. 13. · federal register 58665 Friday October 29, l999 Part VII Environmental Protection Agency 40 CFR Part 372 Persistent Bioaccumulative Toxic (PBT)

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Part VII

EnvironmentalProtection Agency40 CFR Part 372Persistent Bioaccumulative Toxic (PBT)Chemicals; Final Rule

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58666 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Part 372

[OPPTS–400132C; FRL–6389–11]

RIN 2070–AD09

Persistent Bioaccumulative Toxic(PBT) Chemicals; Lowering ofReporting Thresholds for Certain PBTChemicals; Addition of Certain PBTChemicals; Community Right-to-KnowToxic Chemical Reporting

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Final rule.

SUMMARY: EPA is lowering the reportingthresholds for certain persistentbioaccumulative toxic (PBT) chemicalsthat are subject to reporting undersection 313 of the Emergency Planningand Community Right-to-Know Act of1986 (EPCRA) and section 6607 of thePollution Prevention Act of 1990 (PPA).EPA is also adding a category of dioxinand dioxin-like compounds to theEPCRA section 313 list of toxicchemicals and establishing a 0.1 gramreporting threshold for the category. Inaddition, EPA is adding certain otherPBT chemicals to the EPCRA section313 list of toxic chemicals andestablishing lower reporting thresholdsfor these chemicals. EPA is removingthe fume or dust qualifier fromvanadium and adding all forms ofvanadium with the exception of

vanadium when contained in alloys.EPA is also adding vanadiumcompounds to the EPCRA section 313list of toxic chemicals. However, EPA isnot lowering the reporting thresholdsfor either vanadium or vanadiumcompounds. EPA is taking these actionspursuant to its authority under EPCRAsection 313(f)(2) to revise reportingthresholds and pursuant to its authorityto add chemicals and chemicalcategories that meet the EPCRA section313(d)(2) toxicity criteria. The additionsof these chemicals are based on theircarcinogenicity or other chronic humanhealth effects and/or their significantadverse effects on the environment.Today’s actions also includemodifications to certain reportingexemptions and requirements for thosetoxic chemicals that are subject to thelower reporting thresholds. Thisdocument also announces the effectivedate of § 372.27 of the Code of FederalRegulations, which containedinformation collection requirements andwhich was originally published in theFederal Register on November 30, 1994.DATES: 40 CFR 372.27 became effectiveon March 17, 1995, when the Office ofManagement and Budget approved itsinformation collection requirements.This rule shall take effect on December31, 1999. For purposes of EPCRAsection 313(d)(4), the chemicaladditions shall be considered made as ofNovember 30, 1999, and shall apply forthe reporting year beginning January 1,2000.

FOR FURTHER INFORMATION CONTACT: Fortechnical information on this final rulecontact: Daniel R. Bushman, PetitionsCoordinator, Environmental ProtectionAgency, Mail Code 7408, 401 M St.,SW., Washington, DC 20460; telephonenumber 202–260–3882, e-mail address:[email protected]. For generalinformation on EPCRA section 313,contact the Emergency Planning andCommunity Right-to-Know Hotline,Environmental Protection Agency, MailCode 5101, 401 M St., SW., Washington,DC 20460, Toll free: 1–800–535–0202,in Virginia and Alaska: 703–412–9877or Toll free TDD: 1–800–553–7672.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action ifyou manufacture, process, or otherwiseuse aldrin, chlordane, dioxin andcertain dioxin-like compounds,heptachlor, hexachlorobenzene, isodrin,mercury, mercury compounds,methoxychlor, octachlorostyrene,pendimethalin, pentachlorobenzene,polychlorinated biphenyls, certainpolycyclic aromatic compounds,tetrabromobisphenol A, toxaphene,trifluralin, and vanadium (except alloys)or vanadium compounds. See Table 1 inUnit V.C. for a more detailed listing.Potentially affected categories andentities may include, but are not limitedto:

Category Examples of Potentially Affected Entities

Industry SIC major group codes 10 (except 1011, 1081, and 1094), 12 (except 1241), or 20 through 39; industry codes4911 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution incommerce); 4931 (limited to facilities that combust coal and/or oil for the purpose of generating power fordistribution in commerce); or 4939 (limited to facilities that combust coal and/or oil for the purpose of gener-ating power for distribution in commerce); or 4953 (limited to facilities regulated under the Resource Con-servation and Recovery Act, subtitle C, 42 U.S.C. section 6921 et seq.), or 5169, or 5171, or 7389 (limitedto facilities primarily engaged in solvent recovery services on a contract or fee basis)

Federal Government Federal facilities

This table is not intended to beexhaustive, but rather provides a guidefor readers regarding entities likely to beaffected by this action. Other types ofentities not listed in the table could alsobe affected. To determine whether yourfacility would be affected by this action,you should carefully examine theapplicability criteria in part 372, subpartB of Title 40 of the Code of FederalRegulations. If you have questionsregarding the applicability of this actionto a particular entity, consult the person

listed in the ‘‘FOR FURTHERINFORMATION CONTACT’’ section.

B. How Can I Get AdditionalInformation or Copies of this Documentor Other Support Documents?

1. Electronically. You may obtainelectronic copies of this document fromthe EPA Internet Home Page at http://www.epa.gov/. On the Home Page select‘‘Laws and Regulations’’ and then lookup the entry for this document underthe ‘‘Federal Register--EnvironmentalDocuments.’’ You can also go directly to

the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency hasestablished an official record for thisaction under docket control numberOPPTS–400132. The official recordconsists of the documents specificallyreferenced in this action, any publiccomments received during an applicablecomment period, and any otherinformation related to this action,including any information claimed asconfidential business information (CBI).This official record includes the


58667Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations

documents that are physically located inthe docket, as well as the documentsthat are referenced in those documents.The public version of the official recorddoes not include any informationclaimed as CBI. The public version ofthe official record, which includesprinted, paper versions of any electroniccomments submitted during anapplicable comment period, is availablefor inspection in the TSCANonconfidential Information Center,North East Mall Rm. B–607, WatersideMall, 401 M St., SW., Washington, DC.The Center is open from noon to 4 p.m.,Monday through Friday, excluding legalholidays. The telephone number for theCenter is (202) 260–7099.

II. Statutory AuthorityEPA is finalizing these actions under

sections 313(d)(1) and (2), 313(f)(2),313(g), 313(h), and 328 of EPCRA, 42U.S.C. 11023(d)(1)-(2), 11023(f)(2),11023(g), 11023(h) and 11048; PPAsection 6607, 42 U.S.C. 13106.

Section 313 of EPCRA requires certainfacilities manufacturing, processing, orotherwise using a listed toxic chemicalin amounts above reporting thresholdlevels, to report certain facility specificinformation about such chemicals,including the annual quantity enteringeach environmental medium. Thesereports must be filed by July 1 of eachyear for the previous calendar year.Such facilities also must reportpollution prevention and recycling datafor these chemicals, pursuant to section6607 of PPA.

A. What is the Authority for theAddition of Chemicals?

Section 313 established an initial listof toxic chemicals comprised of morethan 300 chemicals and 20 chemicalcategories. Section 313(d) authorizesEPA to add or delete chemicals from thelist, and sets forth criteria for theseactions. EPA has added and deletedchemicals from the original statutory liston the basis of the criteria insubparagraph (A), (B) and/or (C) ofsubsection (d)(2) of EPCRA section 313.Under section 313(e)(1), any person maypetition EPA to add chemicals to, ordelete chemicals from, the list on thegrounds that it does or does not meetthe criteria at 313(d)(2)(A) or (B).Pursuant to EPCRA section 313(e)(1),EPA must respond to petitions within180 days, either by initiating arulemaking or by publishing anexplanation of why the petition isdenied. EPCRA section 313(d)(2) statesthat a chemical may be added to the listif any of the three listing criteria setforth there are met. Therefore, in orderto add a chemical, EPA must find that

at least one criterion is met, but does notneed to examine whether all othercriteria are also met. EPA has publisheda statement elaborating its interpretationof the section 313(d)(2) and (3) criteriafor adding and deleting chemicals fromthe section 313 list (at 59 FR 61432,November 30, 1994) (FRL–4922–2).

B. What is the Authority for theLowering of Reporting Thresholds?

EPA is finalizing these actionspursuant to its authority under EPCRAsection 313(f)(2) to revise reportingthresholds. EPCRA section 313establishes default reporting thresholds,which are set forth in section 313(f)(1).Section 313(f)(2), however, providesthat EPA:

may establish a threshold amount for atoxic chemical different from the amountestablished by paragraph (1). Such revisedthreshold shall obtain reporting on asubstantial majority of total releases of thechemical at all facilities subject to therequirements of this section. The amountsestablished by EPA may, at theAdministrator’s discretion, be based onclasses of chemicals or categories of facilities.

This provision provides EPA withbroad, but not unlimited, authority toestablish thresholds for particularchemicals, classes of chemicals, orcategories of facilities, and commits toEPA’s discretion the determination thata different threshold is warranted.Congress also committed thedetermination of the levels at which toestablish any alternate thresholds toEPA’s discretion, requiring only thatany ‘‘revised threshold shall obtainreporting on a substantial majority oftotal releases of the chemical at allfacilities subject to the requirements’’ ofsection 313. 42 U.S.C. 11023(f)(2).

For purposes of determining whatconstitutes a ‘‘substantial majority oftotal releases,’’ EPA interprets thelanguage in section 313(f)(2), ‘‘facilitiessubject to the requirements of [section313],’’ to refer to those facilities that fallwithin the category of facilitiesdescribed by sections 313(a) and (b), i.e.,the facilities currently reporting.Subsection (a) lays out the generalrequirement that ‘‘the owner or operatorof facilities subject to the requirementsof this section shall’’ file a report underEPCRA section 313. Subsection (b) thendefines the facilities subject to therequirements of this section:

[t]he requirements of this section shallapply to owners and operators of facilitiesthat have 10 or more full-time employees andthat are in Standard Industrial ClassificationCodes 20-39, . . . and that manufactured,processed, or otherwise used a toxicchemical listed under subsection (c) of thissection in excess of the quantity of that toxic

chemical established under subsection (f) ofthis section during the calendar year forwhich a toxic chemical release form isrequired under this section.

Thus, in revising the reportingthresholds, EPA must ensure that, underthe new thresholds, a substantialmajority of releases currently beingreported will continue to be reported.No further prerequisites for exercisingthis authority appears in the statute.

C. What is the Authority forModifications to Other EPCRA Section313 Reporting Requirements?

Today’s actions also includemodifications to certain reportingexemptions and requirements for thosetoxic chemicals that are subject to thelower reporting thresholds. Congressgranted EPA rulemaking authority toallow the Agency to fully implement thestatute. EPCRA section 328 providesthat the ‘‘Administrator may prescribesuch regulations as may be necessary tocarry out this chapter’’ (28 U.S.C.11048).

III. Background Information

A. What is the General Background forthis Action?

Under EPCRA section 313, Congressset the initial parameters of the ToxicRelease Inventory, but also gave EPAclear authority to modify reporting invarious ways, including authority tochange the toxic chemicals subject toreporting, the facilities required toreport, and the threshold quantities thattrigger reporting. By providing thisauthority, Congress recognized that theTRI program would need to evolve tomeet the needs of a better informedpublic and to refine existinginformation. EPA has, therefore,undertaken a number of actions toexpand and enhance TRI. These actionsinclude expanding the number ofreportable toxic chemicals by adding286 toxic chemicals and chemicalcategories to the EPCRA section 313 listin 1994. Further, a new category offacilities was added to EPCRA section313 on August 3, 1993, throughExecutive Order 12856, which requiresFederal facilities meeting thresholdrequirements to file annual EPCRAsection 313 reports. In addition, in 1997EPA expanded the number of privatesector facilities that are required toreport under EPCRA section 313 byadding seven new industrial groups tothe list of covered facilities. At the sametime, EPA has sought to reduce theburden of EPCRA section 313 reportingby actions such as delisting chemicals ithas determined do not meet thestatutory listing criteria and establishing



an alternate reporting threshold of 1million pounds for facilities with 500pounds or less of production-relatedreleases and other wastes. Facilitiesmeeting the requirements of thisalternate threshold may file acertification statement (Form A) insteadof reporting on the standard EPCRAsection 313 form, the Form R.

In today’s actions, EPA is finalizingenhanced reporting requirements thatfocus on a unique group of toxicchemicals. These toxic chemicals whichpersist and bioaccumulate in theenvironment are commonly referred toas persistent bioaccumulative toxicchemicals or PBT chemicals. To date,with the exception of the alternatethreshold certification on Form A, EPAhas not altered the statutory reportingthreshold for any listed chemicals.However, as the TRI program hasevolved over time and as communitiesidentify areas of special concern,thresholds and other aspects of theEPCRA section 313 reportingrequirements may need to be modifiedto assure the collection anddissemination of relevant, topicalinformation and data. Towards that end,EPA is increasing the utility of TRI tothe public by adding a number ofchemicals to the section 313 list of toxicchemicals that persist andbioaccumulate in the environment andby lowering the reporting thresholds fora number of toxic chemicals that havethese properties. Toxic chemicals thatpersist and bioaccumulate are ofparticular concern because they remainin the environment for significantperiods of time and concentrate in theorganisms exposed to them. EPAbelieves that the public understandsthat these PBT chemicals have thepotential to cause serious human healthand environmental effects resultingfrom low levels of release and exposure(Refs. 75 and 76). Lowering thereporting thresholds for PBT chemicalswill ensure that the public hasimportant information on the quantitiesof these chemicals released or otherwisemanaged as waste, that would not bereported under the 10,000 and 25,000pound/year thresholds that apply toother toxic chemicals.

B. What Outreach Has EPA Conducted?EPA has engaged in a comprehensive

outreach effort. This outreach served toinform interested parties, includingindustry groups affected by the rule,state regulatory officials, environmentalorganizations, labor unions, communitygroups, and the general public of EPA’sintention to add certain PBT chemicalsto the list of toxic chemicals underEPCRA section 313 and lower the

applicable reporting thresholds for asubset of PBT chemicals. For allinterested parties, EPA held three publicmeetings (in Chicago, IL (February 23,1999); San Francisco, CA (March 5,1999); and Washington, DC (February16, 1999)) during the comment periodfor the proposal. Participants included arange of industry representatives, tradeassociations (representing both smalland large businesses), law firmsrepresenting industry groups,environmental groups, the generalpublic, plus other groups andorganizations. For state and tribalgovernments, EPA attended theregularly-held public meetings of theForum on State and Tribal ToxicsAction (FOSTTA) to discuss the PBTproposal. EPA also received substantialpublic comment on this proposal, towhich EPA is responding in this FinalRule and the Response to Commentsdocument (Ref. 69). In response to thestrong interest by the public, and toallow more individuals and groups tosubmit their comments, EPA extendedthe public comment period to April 7,1999 (at 64 FR 9957, March 1, 1999)(FRL–6066–1). Additional informationregarding EPA’s outreach may be foundin supporting documents included inthe public version of the official record.

IV. Summary of Proposal

A. What Chemicals Did EPA Propose toAdd to the EPCRA Section 313 List ofToxic Chemicals?

In an initial screening of PBTchemicals that appear on the list ofchemicals of concern in the variouschemical initiatives, EPA identifiedseven chemicals and one category ofchemicals that persist andbioaccumulate in the environment butthat were not on the list of EPCRAsection 313 toxic chemicals. Althoughidentification of these chemicals forinitial consideration prior to thisrulemaking was based on their status asPBT chemicals, their proposed additionin this rulemaking was based solely onthe determination that they meet theEPCRA section 313(d)(2) listing criteria.All of the chemicals proposed foraddition were found to be reasonablyanticipated to cause serious orirreversible chronic human healtheffects at relatively low doses orecotoxicity at relatively lowconcentrations, and thus are consideredto have moderately high to high chronictoxicity or high ecotoxicity. Thechemicals and chemicals categories EPAproposed to add to the list of EPCRAsection 313 toxic chemicals include:Dioxin and dioxin-like compoundscategory, benzo(g,h,i)perylene,

benzo(j,k)fluorene (fluoranthene), 3-methylcholanthrene, octachlorostyrene,pentachlorobenzene,tetrabromobisphenol A (TBBPA),vanadium (except alloys) and vanadiumcompounds.

B. What Persistence andBioaccumulation Issues Did EPAConsider?

As noted above, for purposes of theproposed rule, EPA conducted its first,limited review of chemicals for theirpersistence and bioaccumulationproperties under EPCRA section 313.EPA first established criteria to be usedunder section 313 for determining if achemical persists or bioaccumulates inthe environment. These criteria werethen applied to determine whether thechemicals included in the review havethe potential to persist andbioaccumulate in the environment. Theinitial group of chemicals reviewedwere the result of EPA’s screeningassessment of two lists of persistent andbioaccumulative chemicals: (1) TheGreat Lakes Binational Level 1 list (Ref.24); and (2) chemicals that received highscores for persistence andbioaccumulation in the initial version ofthe Waste Minimization PrioritizationTool (WMPT) developed by EPA’sOffice of Solid Waste (Ref. 74). Finally,included in this initial review were thechemicals included in the dioxin anddioxin-like compounds category thatEPA had proposed for addition to thesection 313 list in 1997 (at 62 FR 24887,May 7, 1997) (FRL–5590–1).

1. Persistence. A chemical’spersistence refers to the length of timethe chemical can exist in theenvironment before being destroyed(i.e., transformed) by natural processes.The proposal discussed those aspects ofpersistence that are important toconsider in determining a chemical’spersistence in the environment and setforth the criteria that EPA used fordetermining whether a chemical ispersistent for purposes of reportingunder EPCRA section 313. Numerousorganizations and internationallynegotiated agreements have setnumerical criteria for environmentalpersistence, many of which have beendeveloped through consensus processes(Ref. 68). Of those reviewed, the criteriafor persistence in water, soil, andsediment tend to cluster around twohalf-lifes, 1 to 2 months and 6 monthswhile the persistence criterion for airwas either a half-life of 2 or 5 days. Ahalf-life of 6 months for water, soil, andsediment and half-lifes of either 2 or 5days for air were chosen by theinternational organizations as criteriafor chemicals that are being banned or



severely restricted. However, EPCRAsection 313 is an information collectionand dissemination program. EPAbelieves that persistence criteriaconsistent with the criteria applied tochemicals that are of global or regional(e.g., Europe and the Great Lakes)concern and that are targeted for ban,restriction, or phase-out areinappropriate for such a program.Chemicals that meet the persistencecriteria used in the internationalagreements are the extremely persistentchemicals. Applying these strict criteriato EPCRA section 313 would result in avery narrow list of chemicals that wouldfocus on only extremely persistentchemicals. This is inconsistent with oneof the fundamental tenets of right-to-know which is to provide the publicwith information on toxic chemicalsthat have the potential to cause adverseeffects in their community. Further,persistence criteria of half-lifes of 6months and 5 days have not been usedto establish whether a chemical is a PBTchemical but rather whether a chemicalshould have restrictions on its uses. TheAgency stated in the proposal its beliefthat half-life criteria of 2 months forwater, sediment, and soil and 2 days forair will include a better representativesample of chemicals that persist in theenvironment. Therefore, EPA used ahalf-life criterion of 2 months for water,sediment, and soil and a half-life of 2days for air for the purposes ofdetermining under EPCRA section 313whether a toxic chemical is persistent inthe environment. Under these criteria, ifa toxic chemical meets any one of themedia-specific criteria, it is consideredto be persistent.

2. Bioaccumulation. Bioaccumulationis a general term that is used to describethe process by which organisms mayaccumulate chemical substances in theirbodies. The term refers to both uptakeof chemicals from water(bioconcentration) and from ingestedfood and sediment residues. Thediscussions and data onbioaccumulation in the proposed ruledealt strictly with aquatic organismsbecause most of the bioaccumulationdata are from aquatic studies. Theproposal also discussed, in detail, thoseaspects of determining bioaccumulationthat are important to consider inassessing whether a particular chemicalwill bioaccumulate in the environment.

A chemical’s potential tobioaccumulate can be quantified bymeasuring or predicting a chemical’sbioaccumulation factor (BAF) or achemical’s bioconcentration factor(BCF). Sources of BAF and BCF data forthe chemicals included in the proposedrule included a mixture of both

predicted and measured BAF and BCFvalues. The record for the proposed ruleincludes a document that explains theorigin of the BAF or BCF value selectedfor each PBT chemical (Ref. 71). Mostdata were retrieved from the U.S. EPA’sAQUIRE data base (Ref. 58) and theJapanese Chemicals Inspection andTesting Institute (CITI) data base (Ref.18a).

As with persistence, a number oforganizations and internationallynegotiated agreements have setnumerical criteria for bioaccumulation,many of which have been developedthrough a consensus processes. Of thosereviewed, the criteria used forbioaccumulation was a BAF/BCFnumerical value of either 5,000 or 1,000or, in some cases, 500. Thebioaccumulation criteria chosen by theinternational organizations as criteriafor chemicals that are being banned orseverely restricted was 5,000. However,for the same reasons discussed in UnitIV.B.1., EPA stated that the criteria usedby the international organizationswould not be appropriate for purposesof EPCRA section 313. Therefore, EPAused a BAF/BCF numerical criterion of1,000 for determining if a chemical isbioaccumulative for purposes of EPCRAsection 313.

3. Persistence and bioaccumulationdata. In the proposal, EPA presented thebioaccumulation and persistence datafor the PBT chemicals being considered.More detailed discussions of the sourcesof these data are provided in the supportdocuments (Refs. 7 and 71). Whenconsidering the bioaccumulation andpersistence potential of chemicalcategories, EPA reviewed the individualbioaccumulation and persistence datafor the category members anddetermined in which tier the entirechemical category should be placed. Forchemicals that had half-life ranges thatbracketed the persistence tiers, EPAconsidered the types of studiessupporting the half-life ranges anddetermined the most appropriate tier foreach chemical.

C. How Did EPA Propose to AddressDioxin and Dioxin-Like Compounds?

In response to a petition fromCommunities For A Better Environment,EPA issued a proposed rule (at 62 FR24887) to add a category of dioxin anddioxin-like compounds to the EPCRAsection 313 list of toxic chemicals. Aspart of that action, EPA proposed tomove 11 co-planar polychlorinatedbiphenyls (PCBs) from their listingunder Chemicals Abstract ServiceRegistry (CAS) Number 1336–36–3 tothe dioxin and dioxin-like compoundscategory. However, since PCBs persist

and bioaccumulate, EPA stated its beliefin the proposed rule that PCBs shouldbe subject to lower reporting thresholds.Thus EPA believed there was no needto move the 11 co-planar PCBs to theproposed dioxin and dioxin-likecompounds category. Therefore, EPAwithdrew its original proposal to modifythe listing for PCBs and insteadproposed to lower the reportingthresholds for the current PCB listingwhich covers all PCBs (at 64 FR 710).Because of this change, the proposeddioxin and dioxin-like compoundscategory included only the 7polychlorinated dibenzo-p-dioxins andthe 10 polychlorinated dibenzofuransidentified in the proposed rule. In orderto focus reporting on those facilities thatactually add to the environmentalloading of the dioxin and dioxin-likecompounds and to reduce reportingburden, EPA proposed to add theactivity qualifier ‘‘manufacture only’’ tothe category. This qualifier would havelimited reporting to those dioxin anddioxin-like compounds that aremanufactured at the facility, includingthose coincidentally manufactured.

D. What Proposed Changes to ReportingRequirements for PBT Chemicals DidEPA Consider?

1. Changes to reporting thresholds. Inevaluating potential lower reportingthresholds for PBT chemicals, EPAconsidered not only their persistenceand bioaccumulation and the purposesof EPCRA section 313, but also thepotential burden that might be imposedon the regulated community. Becauseall PBT chemicals persist andbioaccumulate in the environment, theyhave the potential to pose greaterexposure to humans and theenvironment over a longer period oftime (Refs. 75 and 76). The nature ofPBT chemicals indicates that smallquantities of such chemicals are ofconcern, which provides strong supportfor setting lower reporting thresholdsthan the current section 313 thresholdsof 10,000 and 25,000 pounds. Fordetermining the levels at whichreporting thresholds should be set forthese chemicals, EPA adopted a two-tiered approach. EPA made a distinctionbetween persistent bioaccumulativetoxic chemicals and highly persistent,highly bioaccumulative toxic chemicalsby proposing to set lower reportingthresholds based on two levels ofpersistence and bioaccumulationpotential. EPA proposed to set amanufacture, process and otherwise usethreshold of 100 pounds for PBTchemicals and a threshold of 10 poundsfor that subset of PBT chemicals that arehighly persistent and highly



bioaccumulative toxic chemicals. Oneexception to this is the reportingthreshold for the dioxin and dioxin-likecompounds category, see the discussionin Unit IV.D.2.

In determining the appropriatereporting thresholds to propose for PBTchemicals, EPA started with the premisethat low or very low reportingthresholds may be appropriate for thesechemicals based on their persistenceand bioaccumulation potentials only.EPA then considered the burden thatwould be imposed by lower reportingthresholds and the distribution ofreporting across covered facilities.Considering the factors described above,in addition to the purposes of EPCRAsection 313, EPA proposed to lower themanufacture, process, and otherwise usethresholds to 100 pounds for PBTchemicals and to 10 pounds for thatsubset of PBT chemicals that are highlypersistent and highly bioaccumulative.EPA presented the proposed section 313reporting thresholds for each of the PBTchemicals considered. For purposes ofsection 313 reporting, thresholddeterminations for chemical categoriesare based on the total of all toxicchemicals in the category (see 40 CFR372.25(d)).

2. Special reporting threshold fordioxin and dioxin-like compounds. Thecategory of dioxin and dioxin-likecompounds are highly persistent andhighly bioaccumulative toxic chemicals.However, this category of chemicalsposes unique problems with regard tosetting section 313 reporting thresholdsbecause these chemicals are generallyproduced in extremely small amountscompared to other section 313chemicals. In response to EPA’s originalproposal to add dioxin and dioxin-likecompounds, EPA received numerouscomments suggesting that the reportingthreshold for this category be set at zero.EPA stated its belief that rather thansetting a zero reporting threshold itwould be better to set a very lowthreshold that provides facilities with aclear indicator of when they arerequired to report. EPA proposed amanufacture threshold of 0.1 gram forthe category. EPA expressed its intent todevelop reporting guidance forindustries that may fall within thisreporting category. In addition to theproposed lower reporting threshold forthe dioxin and dioxin-like compoundscategory, EPA requested comment on analternative way of reporting release andother waste management data for thiscategory. This alternative includedreporting release and other wastemanagement data for the dioxin anddioxin-like compounds category in

terms of grams of toxicity equivalents(TEQs).

E. What Other Reporting Issues Did EPAConsider for PBT Chemicals?

1. De minimis exemption. In 1988,EPA promulgated the de minimisexemption because: (1) The Agencybelieved that facilities newly covered byEPCRA section 313 would have limitedaccess to information regarding lowconcentrations of toxic chemicals inmixtures that are imported, processed,otherwise used or manufactured asimpurities; (2) the Agency did notbelieve that these low concentrationswould result in quantities that wouldsignificantly contribute to thresholddeterminations and release calculationsat the facility (53 FR 4509, February 16,1988); and (3) the exemption wasconsistent with information collected bythe Occupational Safety and HealthAdministration’s (OSHA) HazardCommunication Standard (HCS).However, given that: (1) Coveredfacilities currently have several sourcesof information available to themregarding the concentration of PBTchemicals in mixtures; (2) even minimalreleases of persistent bioaccumulativechemicals may result in significantadverse effects and can reasonably beexpected to significantly contribute toexceeding the proposed lowerthresholds; and (3) the concentrationlevels chosen, in part, to be consistentwith the OSHA HCS are inappropriatelyhigh for PBT chemicals, EPA’s originalrationale for the de minimis exemptiondoes not apply to PBT chemicals. EPAtherefore proposed to eliminate the deminimis exemption for PBT chemicals.EPA did not propose, however, tomodify the applicability of the deminimis exemption to the suppliernotification requirements (40 CFR372.45(d)(1)) because the Agencybelieved there was sufficientinformation available.

2. Use of the alternative threshold andForm A. EPA stated its belief that use ofthe existing alternate threshold andreportable quantity for Form A would beinconsistent with the intent of expandedPBT chemical reporting. The generalinformation provided in the Form A onthe quantities of the chemical that thefacility manages as waste is insufficientfor conducting analyses on PBTchemicals and would be virtuallyuseless for communities interested inassessing risk from releases and otherwaste management of PBT chemicals.EPA, therefore, proposed excluding allPBT chemicals from the alternatethreshold of 1 million pounds.

3. Proposed changes to the use ofrange reporting. EPA stated its belief

that use of ranges could misrepresentdata accuracy for PBT chemicalsbecause the low or the high end rangenumbers may not really be that close tothe estimated value, even taking intoaccount its inherent error (i.e., errors inmeasurements and developingestimates). EPA believed thisuncertainty would severely limit theapplicability of release informationwhere the majority of releases,particularly for PBT chemicals, areexpected to be within the amountseligible for range reporting. Given EPA’sbelief that the large uncertainty thatwould be part of these data wouldseverely limit their utility, EPAproposed to eliminate range reportingfor PBT chemicals.

4. Proposed changes to the use of thehalf-pound rule and whole numbers.EPA currently allows facilities to reportwhole numbers and to round releases of0.5 pound or less to zero. EPA explainedits concern that the combination ofrequiring the reporting of wholenumbers and allowing rounding to zerowould result in a significant number offacilities reporting their releases of somePBT chemicals as zero. EPA, therefore,proposed that all releases or other wastemanagement quantities greater than 1⁄10

of a pound of PBT chemicals (exceptdioxins) be reported, provided that theappropriate activity threshold has beenexceeded. For the category of dioxin anddioxin-like compounds, which have aproposed reporting threshold of 0.1gram, EPA proposed that facilitiesreport all releases and other wastemanagement activities greater than 100micrograms (ug) (i.e., 0.0001 gram).

5. Proposed changes to other EPCRAsection 313 reporting requirements. Thealkyl lead compounds tetraethyl lead(CAS No. 78–00–2) and tetramethyl lead(CAS No. 75–74–1) are currentlyreportable under the EPCRA section 313category listing for lead compounds.However, these two chemicalsspecifically appear on the BinationalLevel 1 list of chemicals that have beenidentified for virtual elimination fromthe Great Lakes and thus are of specialconcern. EPA, therefore, proposed thatseparate reports be filed for these twomembers of the lead compoundscategory, which would allow bettertracking of these specific leadcompounds. In addition, EPA proposedto list ‘‘vanadium’’ and ‘‘vanadiumcompounds’’ and delete the EPCRAsection 313 listing for ‘‘vanadium (fumeor dust).’’ Since vanadium without thefume or dust qualifier would be a newsection 313 listing, EPA did not proposeto include additional reporting on alloyscontaining vanadium. In the proposal,EPA deferred making a final decision on



vanadium contained in alloys until theAgency could complete a scientificreview of issues pertinent to somealloys. EPA proposed to include thequalifier ‘‘except when contained in analloy’’ in the vanadium listing. EPA alsorequested comment on the adequacy ofexisting studies for determining thebioaccumulation potential of cobalt andcobalt compounds.

V. Summary of the Final Rule

A. Which Chemicals is EPA Adding tothe List of Toxic Chemicals UnderEPCRA Section 313?

In this action, EPA is adding sevenchemicals and two chemical compoundcategories to the list of toxic chemicalssubject to reporting under EPCRAsection 313. These chemicals include:benzo(g,h,i)perylene, benzo(j,k)fluorene(fluoranthene), 3-methylcholanthrene,octochlorostyrene, pentachlorobenzene,TBBPA, vanadium (except when in analloy), vanadium compounds, and acategory consisting of 17 specifieddioxin and dioxin-like compounds. EPAhas determined that each of these

chemicals and chemical compoundcategories meets the listing criteriaunder EPCRA section 313(d)(2). Two ofthese chemicals, 3-methylchloanthreneand benzo(j,k)fluorene (fluoranthene),are being added as members of thepolycyclic aromatic compounds (PACs)category. Vanadium, with the qualifier‘‘fume or dust,’’ has been on the list oftoxic chemicals since the program’sinception in 1987. In today’s action,however, the Agency is removing the‘‘fume or dust’’ qualifier from thevanadium listing. However, EPA is notincluding reporting on vanadium whencontained in alloys. EPA is finalizingthe proposed qualifier ‘‘except whencontained in an alloy’’ to the vanadiumlisting. Therefore all elementalvanadium, unless it is in an alloy, isnow reportable under EPCRA section313. In addition to modifying thequalifier, EPA is also adding a newvanadium compounds category. Thus,all chemical compounds that containvanadium are reportable under thislisting. Further, EPA is finalizing itsproposal (62 FR 24887) to add dioxinsand 16 dioxin-like compounds.

However, the Agency is modifying thequalifier that it originally included withthis listing. In the PBT proposed rule,EPA proposed to add the dioxin anddioxin-like compounds category withthe qualifier ‘‘manufacturing only.’’However, based on comments theAgency received, EPA is changing thisqualifier to include: Manufacturing; andthe processing or otherwise use ofdioxin and dioxin-like compounds if thedioxin and dioxin-like compounds arepresent as contaminants in a chemicaland if they were created during themanufacturing of that chemical.

B. Which Chemicals is EPA Including asPBT Chemicals Under EPCRA Section313?

EPA has made the final determinationthat 18 of the chemicals and chemicalcategories proposed meet the EPCRAsection 313 criteria for persistence andbioaccumulation. Thus EPA is loweringthe reporting threshold for all of thesetoxic chemicals. These chemicals andtheir final thresholds are listed in Table1 below:

Table 1.—Reporting Thresholds for EPCRA Section 313 Listed PBT Chemicals

Chemical Name or Chemical Category Name CASRNSection 313 Reporting Threshold(in pounds unless noted other-

wise)

Aldrin 309-00-2 100

Benzo(g,h,i)perylene 191-24-2 10

Chlordane 57-74-9 10

Dioxin and dioxin-like compounds category (manufacturing; and theprocessing or otherwise use of dioxin and dioxin-like compounds ifthe dioxin and dioxin-like compounds are present as contaminantsin a chemical and if they were created during the manufacturing ofthat chemical)

NA 0.1 grams

Heptachlor 76-44-8 10

Hexachlorobenzene 118-74-1 10

Isodrin 465-73-6 10

Methoxychlor 72-43-5 100

Octachlorostyrene 29082-74-4 10

Pendimethalin 40487-42-1 100

Pentachlorobenzene 608-93-5 10

Polycyclic aromatic compounds category NA 100

Polychlorinated biphenyl (PCBs) 1336-36-3 10

Tetrabromobisphenol A 79-94-7 100

Toxaphene 8001-35-2 10

Trifluralin 1582-09-8 100

Mercury 7439-97-6 10



Table 1.—Reporting Thresholds for EPCRA Section 313 Listed PBT Chemicals—Continued

Chemical Name or Chemical Category Name CASRNSection 313 Reporting Threshold(in pounds unless noted other-

wise)

Mercury compounds NA 10

EPA is deferring its decision for twochemicals and one chemical category.Specifically, EPA is deferring adetermination on dicofol while theAgency continues to review theavailable persistence data. EPA is alsodeferring its decision on cobalt andcobalt compounds because it needs tofurther investigate the bioaccumulativepotential of these chemicals.

C. What Thresholds Has EPAEstablished for PBT chemicals?

EPA is finalizing the thresholds itproposed for PBT chemicals in theJanuary 5, 1999 (64 FR 688) FederalRegister. Specifically, EPA is finalizingtwo thresholds based on the chemicals’potential to persist and bioaccumulatein the environment. The two levelsinclude setting section 313 manufacture,process, and otherwise use thresholds at100 pounds for PBT chemicals and at 10pounds for that subset of PBT chemicalsthat are highly persistent and highlybioaccumulative. One exception is thedioxin and dioxin-like compoundscategory. The dioxin and dioxin-likecompounds category thresholddetermination required specialconsideration because these highlypersistent and highly bioaccumulativecompounds are manufactured inextremely small amounts compared toother section 313 chemicals. In order tocapture release and other wastemanagement data, EPA is setting thethreshold for the dioxin and dioxin-likecompound category at 0.1 gram.

D. What Exemptions and OtherReporting Issues is EPA Addressing?

EPA is eliminating the de minimisexemption for the PBT chemicalsincluded in today’s final rule. However,this action will not affect theapplicability of the de minimisexemption to the supplier notificationrequirements (40 CFR 372.45(d)(1)).During the inter-agency review process,it was suggested that EPA considerconstructing an exemption for facilitiesin SIC code 5171, i.e., Petroleum BulkPlants and Terminals. Specifically, itwas suggested that EPA exempt theprocessing of PBT chemicals inpetroleum products. Before EPA canconsider this exemption, EPA mustdetermine that these facilities processand release and otherwise manage as

waste very small aggregate quantities ofPBT chemicals. The Agency is solicitingcomments and information on thissuggestion, particularly any informationthat could provide a factual basis forsuch an exemption. Please send yourcomments to the person listed in the‘‘FOR FURTHER INFORMATIONCONTACT’’ section within the next 60days. EPA will evaluate this suggestion,and provide a response withinapproximately 180 days.

In today’s action, EPA is alsoexcluding all PBT chemicals fromeligibility for the alternate threshold of1 million pounds and eliminating forPBT chemicals range reporting for on-site releases and transfers off-site forfurther waste management. This will notaffect the applicability of the rangereporting of the maximum amount on-site as required by EPCRA section313(g). EPA is addressing the alkyl leadcompounds, tetraethyl lead (CAS No.78–00–2), and tetramethyl lead (CASNo. 75–74–1), in a separate rulemakingfor lead and lead compounds (64 FR42222, August 3, 1999) (FRL–6081–4).Therefore, EPA is not finalizing anyaction with respect to these two leadcompounds in today’s action.

EPA proposed to require reporting ofall releases and other wastemanagement quantities greater than 1⁄10

of a pound of PBT chemicals (exceptdioxin), provided that the accuracy inthe underlying data on which theestimate is based supports this level ofprecision. Also, EPA stated that releasesand other waste management quantitieswould continue to be reported to twosignificant digits. In addition, EPAstated that for quantities of 10 poundsor greater, only whole numbers wouldbe required to be reported. For thecategory of dioxin and dioxin-likecompounds, which have a proposedreporting threshold of 0.1 gram, EPAproposed that facilities report allreleases and other waste managementactivities greater than 100 µg (i.e.,0.0001 gram). After reviewing all thecomments on this issue, EPA isproviding additional guidance on thelevel of precision at which facilitiesshould report their releases and otherwaste management quantities of PBTchemicals. Facilities should still reportreleases and other waste managementquantities greater than 0.1 pound

(except dioxins) provided the accuracyand the underlying data on which theestimate is based supports this level ofprecision. Rather than reporting inwhole numbers and to two significantdigits, if a facility’s release or otherwaste management estimates supportreporting an amount that is more precisethan whole numbers and two significantdigits, then the facility should reportthat more precise amount. The Agencybelieves that, particularly for PBTchemicals, facilities may be able tocalculate their estimates of releases andother waste management quantities to1⁄10 of a pound and believes that suchguidance is consistent with thereporting requirements of sections313(g) and (h).

E. What is the Relationship BetweenThis Rule and the Clean Air ActMercury Information CollectionRequest?

Throughout calendar year 1999, EPAhas been using authority under section114 of the Clean Air Act to require allcoal-fired power plants over 25 megawatts to submit to EPA the results ofanalyses of the mercury content of theircoal. A representative sample of theseplants, stratified by type of plant andtype of coal burned, have been requiredto perform stack testing to determine theamount (and species) of mercuryemitted. The stack testing will allowEPA to develop a set of emissionsfactors that can be applied to themercury in coal analysis to generatemercury emissions estimates for eachcoal-fired plant. EPA does not intend tocontinue to require plants to submiteither the coal analysis or the stacktesting beyond the current requirement.Therefore for the purpose of reportingmercury releases to the TRI, EPAexpects coal-fired power plants that donot have monitoring or stack test datafor the reporting year to use theemissions factors that EPA will developand make available to the public in thesummer of 2000.



VI. Summary of Public Comments andEPA Responses

A. What Comments Did EPA Receive onits Statutory Authority to AddChemicals and Lower the ReportingThreshold and What is EPA’s Response?

Several commenters assert thatEPCRA section 313(f)(2) only grantsEPA the authority to raise the statutorythresholds, but not to lower them. Theyagree that the substantial majority test ismet ‘‘as a matter of logical necessity’’when EPA lowers the reportingthreshold, and argue that this makes the‘‘substantial majority’’ test essentiallymeaningless when thresholds arelowered. They argue that thisdemonstrates that Congress did notintend for EPA to lower reportingthresholds, only to raise them.

These commenters also rely on thelanguage of other provisions of EPCRAsection 313 to support their argumentthat Congress did not grant EPAauthority to lower thresholds. They relyon the fact that section 313(f)(2) doesnot provide that EPA can ‘‘raise orlower’’ thresholds, unlike section313(d), under which EPA can ‘‘add ordelete’’ chemicals from the list, andsection 313(b), under which EPA can‘‘add or delete’’ industry sectors. Inaddition, the commenters argue thatsection 313(f)(2) is analogous to section313(l), where, despite the use of theotherwise neutral term ‘‘modify,’’Congress clearly meant for EPA only tomake the reporting requirements lessfrequent (i.e., less stringent). Based onthese provisions, they also argue that,where Congress intended EPA to havethe authority to both expand and restrictreporting, the statute explicitly providesthe authority, but where Congress onlyintended to authorize EPA to reduce thereporting burden, it provided a neutralterm, and then restricted it. Thecommenters argue that in section313(f)(2), Congress qualified EPA’sauthority with a substantial majorityrestriction that only makes sense if EPAraises the thresholds.

EPA disagrees with the commenters’interpretations. Section 313(f)(2) clearlyauthorizes EPA to lower thresholds, aswell as to raise them. The plainlanguage of this provision provides that‘‘the Administrator may establish athreshold different from the amountestablished by paragraph (1).’’ It clearlydoes not state that the Administratormay only establish a higher thresholdthan the amount established byparagraph (1), which appears to be thecommenters’ interpretation. Moreover,in the House debate on the conferencereport, Representative Edgar, one ofEPCRA’s sponsors, noted:

The EPA is authorized to revise thesethresholds, but only if such revisedthresholds obtain reporting on a substantialmajority of total releases, especially if suchrevised thresholds raise the statutory levels,.. . (A Legislative History of the SuperfundAmendments and Reauthorization Act of1986, Committee Print, vol. 6, 5315)(emphasis added).

The clear implication of this statementis that Congress intended EPA to havethe authority to lower, as well as toraise, the statutory thresholds.

The commenters’ interpretation thatEPA lacks the authority to lower thethresholds conflicts with Congressionalintent in other ways. During debate onthe Conference Report, RepresentativeEdgar noted that ‘‘This act is intendedto provide a comprehensive view oftoxic chemical exposure and, hopefully,provide a basis for more sensible andeffective local, State, and nationalpolicies.’’ Legislative History at 5316.See, also, Legislative History at 5313 and5338. And yet without the authority tolower the thresholds, EPA cannotensure that this objective is achieved.For example, Congress included PCBson the original list of EPCRA section313 chemicals, thereby indicating anintent to provide the public with a‘‘comprehensive view of exposure’’ toPCBs; but under the original reportingrequirements, EPA only received 6reports. Under no interpretation can sixreports be characterized as obtaining ‘‘acomprehensive view of toxic chemicalexposure.’’ Legislative History at 5315.

EPA also disagrees with the commentthat the Agency’s interpretation hasrendered this provision meaningless.This argument is based on a logicalfallacy; a standard need not constrainagency action to the same degree in allcircumstances to be meaningful.Congress may impose a standard thatconstrains actions to varying degrees indifferent circumstances. In this case, theCongressional debate on this provisionindicates that Congress was mostconcerned with the loss of publiclyavailable information that may resultfrom raising the thresholds. See, e.g.,Legislative History at 5315-16. It istherefore reasonable to assume thatCongress chose to impose a standardthat presented a greater constraint onthe Agency’s ability to raise thresholds,and therefore created a ceiling beyondwhich the Agency was not authorized tomodify thresholds.

Further, notwithstanding the fact thatunder EPA’s interpretation of section313(f)(2), the Agency can meet thestatutory standard without the need forquantitative support when it lowers thethreshold, EPA does not believe thatCongress has granted it unfettered

discretion to establish a differentthreshold. As discussed at length inUnit VI.E., Congress providedsignificant guidance in other provisionsof the statute and the legislative history,to guide the Agency’s exercise ofdiscretion under this provision.Moreover, as noted above, thesubstantial majority requirementestablishes a ceiling beyond which theAgency is not authorized to modifythresholds.

EPA also disagrees with thecommenters’ interpretation of otherprovisions of EPCRA section 313. Ingeneral, Congress established the basicframework of right-to-know reporting inEPCRA section 313, and selectivelygranted EPA carefully qualifiedauthority to adjust individualparameters as appropriate. For example,EPA is authorized to modify thechemicals on the EPCRA section 313list, the SIC codes and facilities coveredby section 313, the reporting frequency,and the reporting thresholds, but eachgrant of authority is constrained tovarying degrees by the standardscontained in each respective provision.As the commenters have correctlynoted, where Congress intended torestrict the Agency’s authority to modifythe original requirements, it did soexplicitly. For example section 313(l)specifically limits EPA’s authority tomodify the reporting frequency: ‘‘. . .butthe Administrator may not modify thefrequency to be any more often thanannually.’’ Similarly Congress includedno provision authorizing anyamendments to the generally applicableemployee threshold. It is thereforereasonable to assume that had Congressintended to only permit EPA to raise thethresholds, they would have includedsuch an explicit restriction in theprovision. Moreover, as noted earlier inthis unit, the little legislative historythat exists on this provision indicatesthat Congress intended EPA to have thediscretion to both raise and lower thereporting thresholds. Further, EPAdisagrees with the commenters’interpretation that Congress relied ondifferent statutory construction toindicate its decision not to grant theAgency authority to decrease reportingthresholds, rather than relying on anexplicit restriction in the plain languageof the statute. EPA is aware of noindication of such Congressional intentin the legislative history, nor have thecommenters cited to any. More to thepoint, the commenters’ interpretation isclearly refuted by the inclusion insection 313(l) of an explicit restriction,demonstrating that where Congress



intended to restrict EPA’s authority, itdid so explicitly.

One commenter argues that EPA lacksauthority to lower the thresholds basedon a comparison of the language inEPCRA sections 311 and 312authorizing EPA to revise the section311 and section 312 thresholds, with thelanguage of section 313(f)(2). Thecommenter states that Congress couldhave used this same broad and simplelanguage in section 313, and argues thatbecause it did not, but instead chose toimpose the ‘‘substantial majority’’requirement, this demonstrates thatCongress did not intend EPA to have theauthority to lower the thresholds.Instead, the commenter argues, Congresswas concerned with reporting burdenwhen it crafted section 313, and sodeclined to grant EPA authority to lowerthe thresholds.

EPA disagrees. There is no significantdifference between the language insections 311, 312, and 313 that supportsthe commenter’s interpretation. Unlikesection 313, Congress did not establishthresholds in sections 311 and 312, butgranted the Administrator broaddiscretion to determine whether athreshold was even appropriate; at whatlevel to establish the threshold; and tomodify it as appropriate. The languagewith which Congress conferred thisauthority provides that ‘‘theAdministrator may establish thresholdquantities. . . .’’ This is almost identicalto the language of section 313(f)(2),which simply provides that ‘‘theAdministrator may establish a thresholdamount for a toxic chemical differentfrom the amount established byparagraph (1).’’ The commenter’sargument turns wholly on the inclusionof the ‘‘substantial majority’’requirement, and as explained above,EPA does not believe that this standardeither precludes EPA from loweringthresholds or demonstratesCongressional intent to do so.

Several commenters challenged EPA’sfinding that its alternate thresholdswould capture a substantial majority oftotal releases, contending that theAgency had impermissibly relied on anincrease in the number of reportssubmitted. The commenters assert thatEPA is required to estimate releases atthese facilities and determine, on apercentage basis, whether a ‘‘substantialmajority’’ of all releases of eachchemical, from all facilities subject toEPCRA section 313, will be captured.One commenter noted that, even iflowering the threshold for an EPCRAsection 313 chemical results in anincrease in the number of reports on thechemical, this does not necessarilymean that the additional reports will

capture a substantial majority of thetotal releases from all facilities subjectto EPCRA section 313 reporting. Inorder for the lower threshold to meet thestatutory test, the threshold must resultin capturing at least two thirds of allreleases of the chemical at coveredfacilities. The commenter contendedthat the number of reports is irrelevantto the percentage of releases captured bythe reports. If a certain chemical werepresent at only one facility in thecountry subject to EPCRA section 313,the submission of one report on thechemical accounting for at least 66% ofthe releases from that facility wouldsatisfy the ‘‘substantial majority’’ test.By contrast, if a lower thresholdgenerated 1,000 new reports on aEPCRA section 313 chemical, the‘‘substantial majority’’ test would not bemet if those reports did not account forat least 66% of the total releases from allfacilities subject to EPCRA section 313.This may be the case, for example, if alarge percentage of releases of theEPCRA section 313 chemical occurredat facilities otherwise subject to EPCRAsection 313 that do not meet thethreshold for that particular chemicalthat triggers the obligation to report thereleases.

EPA disagrees with the commenter’sinterpretation. As noted in the proposedrule, EPA interprets the language in313(f)(2), ‘‘facilities subject to therequirements of [section 313],’’ to referto those facilities that fall within thecategory of facilities described bysections 313(a) and (b). Subsection (a)lays out the general requirement that‘‘the owner or operator of facilitiessubject to the requirements of thissection’’ file an EPCRA section 313report. Subsection (b) then furtherdefines the facilities subject to therequirements of this section:

[t]he requirements of this section shallapply to owners and operators of facilitiesthat have 10 or more full-time employees andthat are in Standard Industrial ClassificationCodes 20-39, . . . and that manufactured,processed, or otherwise used a toxicchemical listed under subsection (c) of thissection in excess of the quantity of that toxicchemical established under subsection (f) ofthis section during the calendar year forwhich a toxic chemical release form isrequired under this section.

Thus, to be subject to the requirements,a facility must meet all three of therequirements laid out in subsection (b).This means that the class of facilitiessubject to reporting under section 313will vary according to the individualchemical. Moreover, facilities that havenot exceeded a threshold for a particularchemical are not ‘‘subject to the

requirements’’ of EPCRA section 313 forthat chemical.

To determine whether a particularthreshold, either higher or lower, for anindividual chemical meets thesubstantial majority test, one wouldcompare the total national aggregate ofreleases of the chemical by coveredfacilities at the existing thresholds withthe estimated total national aggregate ofreleases at the proposed alternatethreshold, and determine whether asubstantial majority of releases reportedunder the original thresholds would bereported. Logically, the universe offacilities subject to the requirementsunder a lower threshold will always beeither equivalent to, or greater, than theuniverse of facilities that are subject tothe requirements under the existingthresholds. Moreover, because facilitiessubject to the requirements of section313 must report ‘‘the annual quantity ofthe toxic chemical entering eachenvironmental medium,’’ EPA can meetthe substantial majority standard whenlowering the thresholds, without theneed for quantitative support; i.e.,facilities that report, must report theirreleases and other waste managementquantities. In this instance, the numberof reports serves as an adequatesurrogate for releases becauseessentially all releases (and other wastemanagement quantities) will be reportedby facilities subject to the requirementsof this section.

In other words, facilities ‘‘subject tothe requirements of this section’’ arethose that must file EPCRA section 313reports. Thus, the baseline againstwhich the ‘‘substantial majority of totalreleases’’ is measured is the category offacilities that currently submit reports.Consequently, if quantitative support forits finding were necessary, EPA wouldbe justified in relying on the number ofreports to make its finding.

By contrast, although it is not clearexactly how the commenters interpretthe phrase ‘‘facilities subject to therequirements of this section,’’ it is clearthat they do so without reference to allof the requirements in subsections (a)and (b). And essentially, anyinterpretation that ignores any portionof subsection (b), results in aninterpretation of EPCRA section313(f)(2) as ‘‘facilities otherwise orpotentially subject to the requirementsof this section.’’ This is inconsistentwith the plain language of section313(f)(2). The commenters can onlysupport their argument that EPA has notmet the ‘‘substantial majority’’ test byassuming that all facilities, irrespectiveof whether they are in a covered SICcode or they exceed the existingthresholds, are subject to EPCRA section



313, and that EPA must ensure that itcaptures a substantial majority ofreleases from the universe of thosefacilities. If this were correct, theaddition of certain SIC codes could bea prerequisite to lowering thresholds forcertain chemicals. Such a requirement isnot currently included in section 313.The commenters have provided nosupport in either the statute orlegislative history for theseinterpretations. Nor have thecommenters provided any support forthe interpretation that ‘‘substantialmajority’’ equates to a particularpercentage, such as 66%.

Finally, EPA notes, as it noted in theproposed rule, that, for several reasons,it does not believe that it has thenecessary information to develop evenreasonably accurate estimates of thepotential releases that would bereported at an average facility at each ofthe identified options for a loweredthreshold. Specifically, EPA believesthat: (1) Sufficient information is notcurrently available for these chemicals,and (2) there is insufficient informationon the numerous processes employed byall the sectors involved to calculate acomprehensive release estimate for eachsector. While there are some dataavailable, comprehensive data are notavailable for all sectors and chemicals.EPA further notes that none of thecommenters provided either anyinformation or methodology to addressthis issue, notwithstanding EPA’sspecific request.

Two commenters rely on excerptsfrom the debate on the ConferenceReport with respect to section 313(f)(2)to argue that EPA is only authorized torevise the thresholds if EPA presents aconvincing analysis that revisions to thethreshold will capture a substantialmajority of the releases while alsoensuring that it is not placing undueburdens on facilities which contributelittle to such releases. The commentersargue that EPA has not satisfied thesubstantial majority requirement, and todo so, must conduct a more thoroughassessment of the burden imposed onindustry focused on the volume ofreleases that will be captured, not thenumber of reports. Another commentercompares the legislative history ofsections 311 and 312 with 313, andconcludes that Congress clearlyintended EPA to factor burden intosection 313 threshold questions.

EPA disagrees. Ultimately, EPA mustcomply with the statutory language, andsection 313(f)(2) does not impose anyrequirement on the Agency to rely onthe type of analyses described by thecommenter. In addition, thecommenters’ reliance on the statements

made during the Conference Reportdebate are misplaced. The commenteronly quotes part of RepresentativeEdgar’s statement; the full quotationindicates only that EPA must present aconvincing case, ‘‘based on verifiable,historical data’’ that the statutorythresholds warrant revision. Asdiscussed below in Unit VI.E., EPAbelieves it has presented a convincingcase that the thresholds should belowered for PBT chemicals. Thecommenter also failed to include theportion of Representative Edgar’sstatement explaining that a convincingcase was particularly necessary if theeffect of the modification was to raisethe thresholds. See, Legislative Historyat 5315.

Nonetheless, as discussed in greaterdetail in Unit VI.E., EPA considered theburden that lower thresholds wouldimpose on industry in selecting the PBTthresholds. EPA believes that the levelsit has adopted will capture significantlymore information about PBT chemicalsthan current thresholds, but will not beunduly burdensome on industry. Inaddition, as discussed in the Responseto Comments document (Ref. 69), EPAbelieves that the number of reports filedis a more accurate measure of burdenthan the volume of releases.

A commenter alleges that EPA’sinterpretation of section 313(f)(2)contradicts its prior statementsregarding threshold changes. Thecommenterstates that EPA was clear inthe original EPCRA section 313rulemaking that the statute requires asubstantial majority finding supportedby actual data. For example, in the June1987 proposed rule, EPA stated: ‘‘TheAgency is interested in data that wouldsupport the necessary finding that amodified threshold would still generatereporting on a substantial majority oftotal releases, as the statute requires.’’And in the February 16, 1988 final rulepromulgating EPCRA section 313requirements, EPA stated

. . .the first few years’ data should beevaluated to determine whethermodifications of the threshold would meetthe statutory test of obtaining reporting on asubstantial majority of the releases (i.e.,pounds released per year) of each chemicalfrom subject facilities. EPA may considerchanging the reporting thresholds based onseveral years of data collection.

The commenter also notes that inneither the proposed nor final ruleestablishing EPCRA section 313requirements did EPA specifically assertthat it had the authority to lowerthresholds.

EPA disagrees that its statements inthis rulemaking contradict its priorstatements in the 1988 rulemaking. As

a preliminary matter, EPA has neverdenied that the requirement that arevised threshold obtain reporting on asubstantial majority of total releasesapplies to any action lowering thereporting thresholds. Specifically, EPA’sdiscussion in the 1987 proposed rulewas in the context of a response toproposals from the Small BusinessAdministration (SBA) that the Agencyraise the thresholds to capture onlylarger facilities. EPA’s statements in the1988 final rule also need to be evaluatedwith SBA’s proposals in mind.Moreover, while it is true that thediscussion to which the commentercited did not distinguish betweenlowering and raising the thresholds (itwas intended as a response to commentson both sides of the issue), EPA notesthat the majority of the commentsummary focuses on requests to raisethe thresholds. Finally, while it is truethat EPA did not specifically assert itsauthority to lower the thresholds ineither rule, neither did EPA deny thatEPCRA section 313(f)(2) grants it thisauthority. However, it is worth notingthat in the final rule, EPA responded tocomments from environmental andpublic interest groups requesting thatthe Agency lower the thresholds, andthat EPA never stated or implied that itlacked the authority to lower thresholds.

One commenter states that EPA’sauthority to lower reporting thresholdsis not limitless. The commenter arguesthat a decision to lower the thresholdsmust be tied to the overall purpose ofthe Act, namely, to inform the public ofpotential health risks posed by thepresence of toxic chemicals released tothe environment in their communities.A regulatory decision to capture morereports under EPCRA section 313 mustbe based on the need to inform thepublic of health risks associated withthe releases captured in those reports.Otherwise, the usefulness of the TRIdata base begins to diminish. EPA needsto demonstrate that the releases of thePBTs at such small amounts pose ameaningful risk to the public health.Another commenter asserts that EPA isrelying on the purposes of EPCRA tosupport its interpretation of section313(f), and argues that, although section313(h) does describe intended uses forTRI data, section 313(h) itself does notdescribe the purposes or intention ofsection 313. The commenter insteadrelies on several provisions of section313 and argues that the purpose andintention of Congress to makeinformation available to the public wasbalanced by concerns about thepotential burden of the TRI program.The commenter also states that the uses



Congress anticipated for TRI data do notoutweigh the balance that Congressintended between generatinginformation and minimizing burden,and do not grant EPA blanket authorityto expand the reporting requirements.

EPA agrees with the commenter thatits authority to lower reportingthresholds is not limitless, and that itsdecision to lower the thresholds must betied to EPCRA’s overall purposes.However, EPA believes that Congressgranted the Agency broad, but notunfettered, discretion to determinewhen it is appropriate to lowerthresholds, and to determine thespecific thresholds that are appropriate.As discussed in greater detail in UnitVI.E., EPA believes that its decision tolower the thresholds, and the thresholdsit has chosen, reflect these principles.

However, EPA generally disagreeswith the remainder of the commenter’sconclusions. As discussed in moredetail in Unit VI.F., EPA is not requiredto base its decisions under EPCRAsection 313 on the need to inform thepublic of health risks associated withreported releases and other wastemanagement quantities. And asdiscussed elsewhere in this preambleand the Response to Commentsdocument (Ref. 69), EPA believes thatthe information that will be reported asa result of this rulemaking will provideuseful information to the public.

In large measure, the issues raised inthe second comment closely relate tothe specific thresholds and EPA’srationale for choosing them, and thisissue is discussed in more detail in UnitVI.E. However, to the extent it relates toEPA’s interpretation of section 313(f)(2),some response is also provided here.

As a preliminary matter, while it istrue that EPCRA section 313 does notexplicitly identify the purposes of thesection, the Conference Report makesclear that subsection (h) of section 313:

Describes the intended uses of the toxicchemical release forms required to besubmitted by this section and expresses thepurposes of this section. The informationcollected under this section is intended toinform the general public and thecommunities surrounding covered facilitiesabout releases of toxic chemicals, to assist inresearch, to aid in development ofregulations, guidelines, and standards, andfor other similar purposes. (ConferenceReport at 299).

Contrary to the commenter’sassertion, the Agency never indicatedthat it was relying on section 313(h) toexpand its authority under section313(f)(2). Rather, EPA noted that it wasrelying on the purposes of section 313as an additional source of Congressionaldirection to guide the Agency’s exercise

of discretion under this provision. EPArelied on section 313(h), in part, becausethe Agency believes that itsimplementation of EPCRA generallyshould be guided by EPCRA section313’s purposes. In addition, section313(h) shares certain elements with theCongressional guidance on section313(f)(2) in the legislative history. Asdiscussed in greater detail in Unit VI.E.,EPA has distilled those commonelements, and relied on them to guideits discretion in establishing the specificthresholds under section 313(f)(2).

EPA also disagrees with thecommenter’s assertion that the purposeof EPCRA is to achieve a balancebetween the public’s right toinformation about their potentialexposures to toxic chemicals and thereporting burden imposed on industry.EPCRA section 313(f)(2) does notrequire EPA to consider burden inestablishing revised thresholds.Although EPA has included thereporting burdens imposed on industryas one consideration in determining theappropriate thresholds, the Agency isalso mindful that the authors of EPCRA,while sensitive to the burdens EPCRAsection 313 reporting placed onindustry, never intended thisconsideration to outweigh the public’sneed for access to informationconcerning release and wastemanagement, and thus their potentialexposure to toxic chemicals. See, e.g.,Legislative History at 5315–16 and5338–39. And with respect to theassertion that the general purposes ofsection 313 are to balance the public’sright-to-know about toxic chemicalreleases and other waste management intheir communities against the reportingburdens EPCRA section 313 imposes,EPA notes that reporting burden is notincluded anywhere in section 313(h).Nor does the strong policy directiveunderlying EPA’s overallimplementation of EPCRA section 313support such an interpretation.Representative Edgar, one of the bill’sprimary architects noted:

The heart of the Federal Right-to-KnowProgram is its reporting requirements, whichare intended to provide a comprehensivepicture of the community’s and the Nation’sexposure to toxic chemicals. As theEnvironmental Protection Agency, the States,and localities implement this program, theyshould be guided by several generalprinciples.

First, Congress recognizes a compellingneed for more information about the Nation’sexposure to toxic chemicals. Until now, thesuccess of such regulatory programs such asthe Clean Air Act, the Resource Conservationand Recovery Act, and the Clean Water Acthas been impossible to measure because nobroad-based national information has been

compiled to indicate increases or decreasesin the amounts of toxic pollutants enteringour environment. As a result, the reportingprovision in this legislation should beconstrued expansively to require thecollection of the most information permittedunder the statutory language. Any discretionto limit the amount of information reportedshould be exercised only for compellingreasons. . . . Legislative History at 5313.

Significantly, Representative Edgar didnot include reporting burden as one ofthe general principles that should guidethe Agency’s implementation of EPCRAsection 313. Rather, he stated:

This is a new Federal initiative, and Irecognize the desire of some of my colleaguesto move ahead cautiously to ensure thatburdens imposed on industry are notexcessive. Frankly, my concerns rest with thefamilies that live in the shadows of thesechemical and manufacturing plants. I haveput myself in their shoes and have fought fora program that looks after their needs. Thislegislation gets us well on the path to the fulldisclosure they deserve. Id at 5316.

Nonetheless, EPA has considered thelegislative history on section 313(f)(2),including the excerpts cited by thecommenter, and determined it would bereasonable to include someconsideration of the reporting burdensin selecting its revised thresholds. Thedegree to which EPA included burdenin its selection of the thresholdsestablished in this rulemaking isdiscussed at length in Unit VI.E. and theResponse to Comments document (Ref.69).

EPA agrees that section 313(h) doesnot grant EPA unfettered discretion toexpand EPCRA’s reportingrequirements; as noted in a previousresponse, Congress established the basicparameters of the EPCRA section 313reporting requirements, and selectivelygranted EPA carefully qualifiedauthority to modify certain of them. Inthis action, for example, EPA is onlyaffecting the activity thresholds, butCongress established other limitationsthat govern whether a facility is subjectto reporting. For example, facilities withfewer than 10 employees are not subjectto reporting under subsection 313(b)(1).

B. What Comments Did EPA Receive onPersistence Criteria, BioaccumulationCriteria, and Toxicity Criteria, and WhatAre EPA’s Responses?

1. Comments on EPA’s generalapproach. Several commenters contendthat only chemicals which are globallyrecognized as persistentbioaccumulative toxic chemicals shouldform the foundation of the EPCRAsection 313 PBT chemical list andcriteria. The application of the criteriain this manner is consistent with severalexisting international agreements and



programs, such as the Great LakesBinational Strategy, the North AmericanCommission on EnvironmentalCooperation (NACEC), the UnitedNations Economic Commission forEurope’s (UNECE) agreement to addresspersistent organic pollutants (POPs),and the United Nations EnvironmentalProgramme (UNEP). These programshave prompted widely acceptednumerical values for persistence andbioaccumulation and definedparameters for assessing toxicity. Thesecriteria have also been adopted withU.S. support and leadership and thecommenters contend that it is not clearwhy EPA is now taking a vastlydifferent approach to identifying PBTcriteria in the proposed rule. Thecommenters suggest that EPA conformthe criteria for PBT chemicals onEPCRA section 313 with the criteria andchemicals that are part of the programsbeing implemented by the NACEC,UNECE, and UNEP. By doing so, EPAwould harmonize the U.S. program withsimilar international programs thatfocus on a narrow set of PBT chemicals.

EPA believes that it would beinappropriate to merely adopt thecriteria and list of chemicals managedunder the international programs citedbecause the purposes of the TRIprogram are different than the purposesof the cited international programs. TheTRI was established by Congress underEPCRA section 313 in response topublic demand for information on toxicchemicals being released in theircommunities. The TRI program isnational in scope, but a significant partof its overriding goal is to provideinformation on releases to localcommunities so that they can determineif the releases result in potential risks.The entire concept of TRI, and indeedother, similar Pollutant Release andTransfer Registries (PRTRs) sinceestablished in several nations, isfounded on the belief that the public hasthe right to know about chemical use,release, and other waste management inthe areas in which they live, as well asthe hazards associated with thesechemicals. This emphasis isfundamentally different from the globalfocus of the UNEP negotiation and itsconcept of residual risk. It is EPA’sposition that the domestic, community-based purposes of EPCRA section 313have important implications with regardto the criteria used to identify toxicchemicals as persistent and/orbioaccumulative, as well as the methodsand models used to evaluate persistenceand/or bioaccumulation.

EPCRA section 313 charges EPA withcollecting and disseminatinginformation on releases, among other

waste management data, so thatcommunities can estimate localexposure and local risks. One intent ofEPCRA section 313 is to provideinformation to the public so that theycan take an active role in determiningwhat risks resulting from toxic chemicalreleases in their community areacceptable. This basic localempowerment is a cornerstone of theright-to-know program.

EPCRA section 313(h) states that:The release forms required under this

section are intended to provide informationto the Federal, State, and local governmentsand the public, including citizens ofcommunities surrounding covered facilities.The release form shall be available,consistent with section 11044(a) of this title,to inform persons about releases of toxicchemicals to the environment; to assistgovernmental agencies, researchers, andother persons in the conduct of research anddata gathering; to aid in the development ofappropriate regulations, guidelines, andstandards; and for other similar purposes.

EPCRA section 313 establishes aninformation collection anddissemination program. EPA interpretsEPCRA section 313(g)(2) to requirefacilities to use readily availableinformation to prepare each chemical-specific EPCRA section 313 report. Thestatute does not require that the facilityconduct additional monitoring oremissions measurements to determinethese quantities. A facility must onlyuse readily available data or reasonableestimation methods in preparing thequantitative information it reports.

The purpose of EPCRA section 313 isnot to ban the manufacture or use of achemical, to restrict releases of thechemical, or to dictate how it should beused or released. As a result, the burdenand control EPCRA section 313 imposesis significantly less than that imposedby a statute that controls themanufacture, use, and/or release of achemical. The focus of EPCRA section313 is not equivalent to the focus of astatute or international agreements inwhich chemicals are to be banned,phased-out, or restricted.

In contrast, the internationalagreements cited by the commenters areintended to ban, restrict, or phase-outthe manufacture, use and/or release of alimited set of persistent organicpollutants and certain heavy metals thatare highly persistent and highlybioaccumulative. Descriptions of thepurposes of the Protocol on PersistentOrganic Pollutants (POPs); Conventionon Long-Range Transboundary AirPollution (LRTAP), UNECE, UNEP onPOPs, North American Commission forEnvironmental Cooperation’s SoundManagement of Chemicals (NACEC

SMOC), as well as the InternationalCouncil of Chemical Associations’(ICCA) position on POPs are presentedbelow. The following quotes clearlyillustrate that the intent of theinternational agreements is to narrowlyfocus on that subset of toxic chemicalswhich are of regional (e.g., NorthAmerica and Europe) or global concern.UNECE LRTAP

The ultimate objective is to eliminate anydischarges, emissions and losses of POPs.The Protocol bans the production and use ofsome products outright (aldrin, chlordane,chlordecone, dieldrin, endrin,hexabromobiphenyl, mirex and toxaphene).Others are scheduled for elimination at alater stage (DDT, heptachlor,hexachlorobenzene, PCBs). Finally, theProtocol severely restricts the use of DDT,HCH (including lindane) and PCBs. TheProtocol includes provisions for dealing withthe wastes of products that will be banned.(The 1998 Aarhus Protocol on PersistentOrganic Pollutants (POPs); Convention onLong-Range Transboundary Air Pollution,United Nations Economic Commission forEurope (UNECE) at http://www.unece.org/env/lrtap) (Ref. 54)

UNEP

International action to protect health andthe environment through measures whichwill reduce and/or eliminate emissions anddischarges of persistent organic pollutants,including the development of aninternational legally binding instrument.(Governing Council Decisions 20/24, 1999;United Nations Environmental Programme athttp://irptc.unep.ch/pops/newlayout/negotiations.htm) (Ref. 57)

NACEC SMOC

NACEC SMOC has developed action plansfor PCBs, DDT, chlordane, and mercury. Theaction plans include 1) for PCBs ‘‘worktoward the virtual elimination of PCBs in theenvironment, which the task force isinterpreting as no measurable release to theenvironment’’, 2) for DDT ‘‘gradual reductionof DDT use for malaria control’’ and‘‘additional reductions,’’ 3) for chlordane‘‘phase-out of chlordane use’’, and 4) formercury ‘‘reduce sources of anthropogenicmercury pollution.’’ The longer-term goal ofthe plan is to reduce the presence of mercuryin the environment to achieve naturallyoccurring levels.’’ (North AmericanCooperation for the Sound Management ofChemicals (June 1998); North AmericanCommission for Environmental Cooperationat http://www.cec.org/english/profile/coop/Pollute—f.cfm?format=1) (Ref. 40)

ICCA

ICCA Position: ICCA member associationshave demonstrated their commitment tosound chemicals management, and to thegoal of reducing the potential human healthand environmental risks that may beassociated with POPs. Many POPs arealready subject to considerable voluntary riskmanagement by chemical companies, and theuses of most substances identified as POPshas been discontinued or extremely limited



by chemical companies within the countriesrepresented by ICCA member associations.(International Council of ChemicalAssociations (ICCA) Briefing Note onPersistent Organic Pollutants (POPs) (April21, 1998) at http://www.icca-chem.org/issues.htm) (Ref. 26)

In addition, as directed under EPCRAsection 313(h), EPA makes the TRI dataavailable to various groups, includinginternational organizations, that, inturn, use the information to decidewhether to ban, restrict, or phase-outchemicals.

For the same reasons, EPA alsodisagrees that only substances globallyrecognized as POPs should provide thebasis of persistence criteria for thisrulemaking. POPs are organic chemicalswhose characteristics of persistence inthe environment, accumulation inbiological organisms and toxicity makethem priority pollutants that causesignificant environmental risks tohumans and ecosystems. The substancesor substance categories being consideredfor implementation of global controlsthrough the UNEP negotiations (UNEP/

GC.18/32, 1995: aldrin, chlordane, DDT,dieldrin, endrin, heptachlor, mirex,toxaphene, hexachlorobenzene, PCBs,polychlorinated dibenzo-p-dioxins andfurans) (Refs. 44 and 45) were selectedlargely because they or their degradationproducts pose risks that may occur farfrom their sites of initial entry into theenvironment. The UNEP action is theglobal counterpart to similar, regionalnegotiations, most notably the UNECEConvention on Long-RangeTransboundary Air Pollution (LRTAP)(Ref. 54); the North American FreeTrade Agreement (NAFTA) CECInitiative on the Sound Management ofChemicals (Ref. 39); and the bilateralUS/Canada agreement to controldischarge or release of POPs in the GreatLakes basin (Ref. 23). A central theme ofthe UNEP action, consistent with itsglobal scope, is the notion of residualrisk, meaning specifically that to besubject to the negotiations, it is notsufficient for a substance to pose riskswithin a nation or regionally, rather itmust pose risks to populations andnations distant from release sites.

2. Comments on EPA’s individualcriteria. The same commenters state thatEPA should use the internationalcriteria being applied by UNEP, UNECELRTAP, NACEC SMOC, for persistence,bioaccumulation, and toxicity. Some ofthese commenters also include thecriteria developed by CMA (CMA, PTBPolicy Implementation Guidance:Product Risk Management Guidance forPTBs (February 1996)). One commenterincludes the criteria developed by theICCA for POPs. Another commenterstates that there is no reason to adoptcriteria that are significantly morestringent than those used in otherprograms. One commenter states thatEPA should consider the degree oftoxicity and focus on the most toxicchemicals. Some commenters state thatEPA should couple the persistence andbioaccumulation criteria to each other.They believe that these criteria shouldnot be considered independently. Thenumerical criteria presented by some ofthe commenters are provided below:

Table 2.—Numerical Persistence and Bioaccumulation Criteria Suggested by Commenters

CMA PTB Policy NACEC SMOC UNECE (LRTAP)POPs

UNEP POPs/CEGFRAMEWORK

Environment Can-ada Toxic Sub-

stances Manage-ment Policy (June

1995)

ICCA

Persistence Half-life = 6months in wateror 1 year in soil

Half-life > = 2days air; 6months water/soil; or 1 yearsediment

Half-life> 2months water or6 months soils/sediment; orotherwise suffi-ciently per-sistent to be ofconcern

Half-life > [2 or 6]months soil/sediment; orother evidencethat substanceis sufficientlypersistent to beof concern

Half-life > = 2days air; 6months water/soil; 1 yearsediment

Half-life = 6months water, 1year soil sedi-ments, or 5days air

Bioaccumulation BAF/BCF > =5,000 or esti-mation tech-niques

BAF/BCF >=5,000 or LogKow > = 5

BAF/BCF > 5,000or Log Kow > 5or factors suchas high toxicity

BCF/BAF > 5,000or Log Kow> [4or 5]; evidencethat substancewith significantlylower BCF/BAFis of concern,e.g., due tohigh toxicity/ecotoxicity; ormonitoring datain biota indi-cating sufficientbioaccumulationto be of con-cern

Half-life > 2months wateror 6 monthssoils/sediment(or otherwisesufficiently per-sistent to be ofconcern)

BCF > 5,000 orlog Log Kow > 5and <7.5,MW<700 andsubstance isnot metabolized



Table 2.—Numerical Persistence and Bioaccumulation Criteria Suggested by Commenters—Continued

CMA PTB Policy NACEC SMOC UNECE (LRTAP)POPs

UNEP POPs/CEGFRAMEWORK

Environment Can-ada Toxic Sub-

stances Manage-ment Policy (June

1995)

ICCA

Toxicity Professional judg-ment in evalua-tion of aquatictoxicity, wildlifetoxicity, oral/dermal/inhala-tion toxicity(mammals andbirds), repro-ductive toxicity,neurologicaltoxicity; carcino-genicity, muta-genicity, and/orteratogenicity

Acute and chronic(including tox-icity of break-down products,if appropriate)

Potential to affecthuman healthand/or the envi-ronment ad-versely

Evidence that(chronic) toxicityor ecotoxicitydata indicate apotential fordamage tohuman healthor the environ-ment caused bythe substanceresulting or an-ticipated fromlong-rangetransport

CEPA - toxic Expert judgmentthat acuteaquatic lethality,subchronic andchronic aquatictoxicity, acutewildlife toxicity,oral/dermal/in-halation toxicityin mammalsand birds, car-cinogenicity,mutagenicity,teratogenicity,reproductivetoxicity, neuro-logical toxicity,and immunesystem effectsmust be dem-onstrated or ex-pected to occurat the con-centrations ob-served in theenvironment

EPA is establishing criteria in thisrulemaking for the TRI program forpersistence and bioaccumulation.EPCRA section 313(d)(2) alreadyprovides toxicity criteria for the TRIprogram. While EPA chose in thisrulemaking to focus on chemicals thatare toxic and persistent andbioaccumulative, EPA did not state thatthe persistence criterion could only beapplied in conjunction with thebioaccumulation criterion and viceversa. EPA has not tied the criteriatogether because there is no scientificrationale to define persistence criteria interms of both bioaccumulation andpersistence and to definebioaccumulation both in terms ofpersistence and bioaccumulation. Asillustrated by the descriptions ofpersistence and bioaccumulationprovided in the proposed rule,persistence and bioaccumulation areseparate chemical and/or biologicalprocesses. They are not by definitiondependent upon the other.

A chemical’s persistence refers to thelength of time the chemical can exist in theenvironment before being destroyed. (at 64FR 698)

andBioaccumulation is a general term that is

used to describe the process by whichorganisms may accumulate chemicalsubstances in their bodies. (at 64 FR 703)

A chemical is not considered to bepersistent if it is only bioaccumulative.For example, a chemical may beextremely persistent and yet notbioaccumulate appreciably. Forexample, metals cannot be destroyed inthe environment and thus are extremelypersistent. Some metals bioaccumulateappreciably while others do not.However, the degree to which a metalcan bioaccumulate does not affect themetal’s persistence in the environment.The connection suggested by thecommenters is not scientificallyjustified. Thus, EPA does not believethat persistence criteria can be appliedonly in conjunction with thebioaccumulation criteria. EPA reiteratesthat in this rulemaking the Agencychose to focus on those toxic chemicalsthat meet both the persistence andbioaccumulation criteria proposed forEPCRA section 313. In the future, theAgency may focus on toxic chemicalsthat are either persistent orbioaccumulative.

A discussion of the individual criteriais presented in the remainder of thisunit.

a. Persistence. EPA proposedpersistence criteria for the TRI programof half-lifes of 2 months in water, soil,and sediment and 2 days in air. Asdiscussed in Unit VI.B.1., EPA disagrees

that it must choose persistence criteriafor EPCRA section 313, an informationcollection and dissemination program,consistent with the international criteriabeing applied to chemicals that are ofglobal or regional (e.g., Europe and theGreat Lakes) concern and that are beingtargeted for ban, restriction, or phase-out. Chemicals that meet the persistencecriteria used in the internationalagreements are extremely persistentchemicals. Applying these criteria toEPCRA section 313 would result in avery narrow list of chemicals that wouldfocus on only extremely persistentchemicals. This is inconsistent withboth the purposes of EPCRA section 313and with EPA’s technical judgment.There is no ‘‘bright line’’ that separateswhat is persistent from what is notpersistent. The degree of persistence isa continuum. Chemicals with a half-lifeof 2 to 6 months are not non-persistent.They are less than chemicals with ahalf-life of greater than 6 months. Thedegree of persistence that should beused as criteria is not an absolutescientific determination. Rather it is acombination of science and policy. Asdiscussed in the proposed rule and theremainder of this section, organizationshave generally used as persistencecriteria half-lifes of 2 months and/or 6months for water, soil, and sediment.



The determination of which set ofnumerical criteria to apply will dependon the final intent: for example,providing communities withinformation on persistent chemicals thatcan build up in their environmentversus banning the manufacture and useand eliminating releases of a chemicalthat has global impacts. For EPCRAsection 313, which provides informationon toxic chemicals to communities,researchers, and governments, thecriteria should be in keeping with bothscience and the intent of the statute.

Long-range transport (LRT) andresidual risk are relevant domestically,since chemical substances may betransported regionally andtranscontinentally, resulting inexposures at sites distant from releasesbut still within U.S. borders.Nevertheless, as a general rule, thecloser the sources and receptor are, themore likely it is that released materialwill reach that receptor. The 12 UNEPPOPs or their degradation products allmeet or exceed the half-life criterion of6 months for soil, water, or sediment,often by large margins (Refs. 44 and 45),and the 6 months criterion thus acts toisolate these substances for internationalattention aimed at limiting LRT. But ashorter half-life criterion is necessary toprotect communities frombioaccumulative toxicants derived fromsources closer to home, since, all otherthings being equal, a pollutant reachesnearby populations in less time thandistant ones.

An article by Wania and Mackay (Ref.81) is often cited in discussions of‘‘global distillation’’ of relatively mobilePOPs such as hexachlorobenzene andlindane, which tend to have invertedconcentration profiles such thatconcentrations increase with distancefrom the source (i.e., from temperate topolar regions) rather than the reverse.What may be less obvious is that theconverse is also true; namely, that lessvolatile substances show no significantlatitudinal dependence; that low-mobility POPs such as mirex and themore highly chlorinated PCBs tend toundergo rapid deposition and retentionclose to their sources; and that all buthigh or relatively high mobilitychemicals are expected to show‘‘normal’’ concentration profiles, suchthat concentrations decline withdistance from warmer sources to colderremote regions (Ref. 81). A recent studyof organochlorine contaminants in seaotters illustrates this point. Althoughthe levels of total DDTs observed werenot considered toxicologicallysignificant, Bacon et al. (Ref. 8) foundthe highest levels in California sea otters(ca. 850 micrograms per kilogram (µg/

kg)) but much lower levels in Aleutianotters (40 µg/kg) and southeast Alaskaotters (1 µg/kg), and attributed thehigher levels in the California otters toextensive DDT use and production inthis region from the 1950s to the 1970s.Even UNEP’s Criteria Expert Group(CEG), which is charged withdeveloping criteria and procedures foraddition of substances beyond theoriginal 12 POPs, has highlighted theimportance of ‘‘near-field’’ exposures:

In warmer climates exposures may occurcloser to the source; e.g., occupationalexposure during use, or local exposurecaused by runoff from use or leaking fromstockpiles. Food, such as fish, may be a majorroute of intake also in warmer climates [incontrast to Arctic and sub-Arctic regions] andPOPs may accumulate in the food chain andreach high levels in predatory species inthese conditions. (UNEP/POPS/INC/CEG/1/2:1998) (Ref. 56)

An additional factor that argues foradopting the more protectivepersistence criterion is the need forcommunities with vulnerablepopulations to have access to data onrelease and other waste managementquantities. Examples of suchpopulations include toddlers who playin contaminated soil, local farmers whoconsume their own produce, andsubsistence as well as sport fishers, whooften consume large quantities of whatthey catch. The relative importance ofany of these pathways depends on theproperties of the substance, rates andmedia of release and other factors, butingestion of bioaccumulating substancesmay occur by all of these routes. TheOrganization for Economic Cooperationand Development (OECD) guidance onthe assessment of indirect humanexposure to chemical toxicants isconsistent with EPA policy, and statesthat in the case of local, site-specificemissions, one or more of thesesubgroups may be particularlyendangered (Ref. 53).

From a scientific perspective there isno one best persistence criterion.However, it is simply not accurate tostate that there is no precedent or basisfor using a persistence criterion of 2months. As outlined in the proposedrule (64 FR 701), similar values havebeen proposed by several authorities,including the Ontario, Canada Ministryof Environment and Energy (MOEE) forits Candidate Substances List for Bansor Phaseouts (Ref. 36); the Canadianinitiative for Accelerated Reduction/Elimination of Toxics (ARET) (Refs. 1and 2); the International JointCommission’s (IJC) Great Lakes WaterQuality Agreement (GLWQA) (Ref. 27);and the UNECE’s LRTAP Convention,which did adopt 2 months as the

persistence criterion of record for water(Ref. 54). In each of these programs thefocus was on persistent,bioaccumulative and toxic substances,and it is noteworthy that all are nationalor regional, not global, in scope. Thus,a trend exists in which authorities withdomestic or regional mandates to takeaction to reduce risks from indirectexposure to PBT chemicals haverecommended half-life criteriasubstantially lower than 6 months.

EPA’s Office of Water maintains aListing of Fish and Wildlife Advisories(LFWA) for the U.S. and territories,which listed 2,299 advisories in 1997(Ref. 29). U.S. states and territories andNative American tribes have primaryresponsibility for issuing advisories forthe general population, which includerecommendations to limit or avoidconsumption of certain fish and wildlifefrom specific water bodies. Theoverwhelming majority of the advisoriesare for well recognized PBT chemicals(chlordane, mercury, PCBs, etc.), butmany less familiar substances are alsorepresented. The number and content ofadvisories in LFWA clearly indicate thattoxicologically significant levels ofchemical contaminants, specificallyPBT chemicals, are often found in fishand wildlife that are caughtnoncommercially and consumed by theU.S. population. It is generallyimpossible to determine the exactsource(s) of exposure for the species andlocations included in any givenadvisory, but it seems highly unlikelythat the majority of listed contaminantsin U.S. waters could be derived fromnon-U.S. (i.e., geographically distant)sources. The LFWA thus lends furthersupport to the contention that concernfor exposure to PBT chemicals is notlimited to situations where the exposureresults primarily from LRT. It should benoted that the fact that no advisorieshave been issued for a particularchemical does not mean that it does notpersist. Not all species of aquaticorganisms are tested nor are all waterbodies, in addition, each statedetermines what it will use as the levelof concern for issuing an advisory.

A series of Toxic Substances ControlAct (TSCA) section 5 PremanufactureNotifications (PMNs) submitted to EPAin 1990 also illustrates that exposure toPBT chemicals is not limited to LRT(Refs. 37 and 38), and alsodemonstrates: (i) Why EPA believes thatthe persistence criterion forbioaccumulating substances in soil,water, or sediment should be setsubstantially lower than 6 months; and(ii) that for purposes of EPCRA section313, concern for potential exposures topersistent and bioaccumulative toxics



must extend beyond the UNEP’s 12widely acknowledged POPs. Thesubstances in question were alkylateddiphenyls for use as solvents, and forwhich EPA expected discharge toreceiving streams and rivers. Thesubmitter supplied data on use anddisposal, aquatic toxicity, andbiodegradability. The submittedenvironmental fate data and EPAestimates of biodegradability based onstructural analogs suggested that half-lifes in water would be well below 6months, but not necessarily lower than2 months. As a result of concernsexpressed by EPA, use was limited tosites where resulting waterconcentrations could be limited to 1microgram per liter (µg/L) or less;concomitantly, the submitter was alsoinformed of EPA’s belief that a potentialfor long-term risk existed, but that EPAcould not quantify this risk sinceassessments typically evaluated releasesover only 1 year. In 1998, results ofmonitoring were announced by the StateEPA and revealed that the alkylatedbiphenyls had been found in fish filletsand sediment samples from thereceiving stream.

One commenter contends that thepersistence criteria of half-lifes of 2months for water, soil, and sedimentand 2 days for air may not besufficiently protective (i.e., the criteriamay be too high).

EPA disagrees with the comment.EPA believes that it should adoptcriteria that focus on toxic chemicalsthat will build up in the environment,while at the same time not limiting thelist of persistent toxic chemicals to onlythose that are of global concern. Asdiscussed earlier in this section, EPAbelieves that 2 months is a reasonablehalf-life criterion given the purposes ofEPCRA section 313. EPA believes thatapplication of lower criteria wouldinclude so many substances as to beimpractical. Further, given theuncertainties that often exist regardingphysical properties and environmentalbehavior of chemicals, caution isespecially appropriate for substanceswith shorter half-lifes, since they are (allother things being equal) less likely tobuild up in the environment than morepersistent substances. EPA believes thatthe adoption of criteria of half-lifes of 2months in water, soil, and sediment anda half-life of 2 days in air allows EPAto balance the need to providecommunities and other data users withinformation on toxic chemicals thatpersist in their environment withoutbeing overly inclusive or restrictive.

One commenter contends that a half-life criterion for air of 2 days should be

considered sufficient in and of itself fordesignating substances as persistent.

EPA agrees with the comment. EPAmade the following statements in theproposed rule regarding the 2–day airhalf-life criterion and its use in thedetermination as to whether a chemicalwas a PBT under EPCRA section 313:

For the purposes of determining whether atoxic chemical is persistent in theenvironment under section 313, EPA used ahalf-life criterion of 2 months for water/sediment and soil and a half-life of 2 days forair. Given the above discussions, EPAbelieves that, for purposes of reporting undersection 313, these values are appropriate fordetermining whether a toxic chemical ispersistent in the environment and willpersist long enough in the environment tobioaccumulate or be transported to remotelocations. Under these criteria, if a toxicchemical meets any one of the media specificcriteria, then it is considered to be persistent.Thus if a toxic chemical’s half-life in wateror sediment or soil is equal to or greater than2 months or greater than 2 days for air thenthe toxic chemical is considered to bepersistent for purposes of section 313. Notethat when considering persistence inconnection with the potential for a toxicchemical to bioaccumulate, meeting the airhalf-life criteria alone would not besufficient, since a chemical’s potential tobioaccumulate is usually dependent on itbeing persistent in either water, sediment, orsoil. In determining whether the chemicals inthis proposal were persistent, EPA did notrely solely on the persistence in air. (at 64 FR702)

It is clear from the discussion above thatEPA agrees with the commenter thatwhen considering persistence alone anair half-life of 2 days would beconsidered sufficient to classify achemical as persistent under EPCRAsection 313. However, for the reasonsexplained above, if a chemical onlymeets the 2–day air half-life persistencecriteria, EPA does not believe thatwould be sufficient for classifying achemical as a PBT under EPCRA section313.

Some commenters contend that EPA’stwo-tiered approach to the persistencecriteria is confusing.

EPA notes that it proposed only oneset of persistence criteria for EPCRAsection 313, half-lifes of 2 months orgreater in water, soil, and sediment and2 days in air. The Agency did notpropose to use half-lifes of 6 months orgreater in water, soil, and sediment and2 days in air as a second set ofpersistence criteria for EPCRA section313. However, for purposes of settingreporting thresholds in this rulemaking,the Agency did choose to focus on thesubset of PBT chemicals that have half-lifes of 6 months or greater in water,soil, or sediment (and BCF/BAFs greater

than 5,000) by proposing a 10 poundreporting threshold.

For the reasons given above, EPAreaffirms its intention to use a half-lifeof 2 months as the criterion forpersistence in water, soil, and sedimentand a half-life of 2 days as the criterionfor air when characterizing a chemicalas persistent for purposes of EPCRAsection 313.

b. Bioaccumulation. EPA proposed asbioaccumulation criteria for the TRIprogram bioaccumulation/bioconcentration factors of 1,000. Asdiscussed in Unit VI.B.1., EPA disagreesthat it must choose for EPCRA section313, bioaccumulation criteria consistentwith the international criteria. Applyingthese strict criteria to EPCRA section313 would result in a very narrow listof chemicals that would focus on onlyextremely bioaccumulative chemicals.This is inconsistent with the purposesof EPCRA section 313 and with EPA’stechnical judgment. There is no ‘‘brightline’’ that separates what isbioaccumulative from what is notbioaccumulative. The degree ofbioaccumulation is a continuum.Chemicals with BCFs or BAFs of 1,000to 5,000 are not non-bioaccumulative.They are less bioaccumulative thanchemicals with BCFs or BAFs greaterthan 5,000. The degree ofbioaccumulation that should be used asa criterion is not an absolute scientificdetermination. Rather it is acombination of science and policy. Asdiscussed in the proposed rule andbelow, organizations have generallyused as bioaccumulation criteria BAFs/BCFs of 1,000 and 5,000. Thedetermination of which numericalcriterion to apply will depend on thefinal intent: for example, providingcommunities with information onbioaccumulative chemicals that canaccumulate in organisms versus banningthe manufacture and use andeliminating releases of a chemical thathas global impacts. For EPCRA section313 which provides information ontoxic chemicals to communities,researchers, and governments, thecriteria should be in keeping with boththe Agency’s scientific judgment andthe intent of the statute.

From a scientific perspective there isno one bioaccumulation criterion.However, it is simply not accurate tostate that there is no precedent or basisfor using a bioaccumulation criterion of1,000. As noted in the proposed rule, fora number of years EPA scientists andprograms have used a BCF of 1,000 ormore to indicate a high level of concernfor bioaccumulation. In addition, thisvalue has been used in some Canadianprojects, many dealing with the Great



Lakes basin. Also, Germany proposed aBAF/BCF criterion of 1,000 duringnegotiation of the LRTAP Protocol.Support for a BAF criterion of 1,000 alsocomes from the Final Water QualityGuidance for the Great Lakes System(FWQGGLS) (60 FR 15366, March 23,1995) (FRL–5173–7). In this document,EPA stated that bioaccumulation ofpersistent pollutants is a seriousenvironmental threat to the Great LakesBasin Ecosystem and that chemicalsidentified as bioaccumulative chemicalsof concern (BCCs) (i.e., with BAF valuesgreater than 1,000) would receiveincreased attention and more stringentcontrols. The final guidance designatedas BCCs those chemicals with humanhealth BAFs greater than 1,000 thatwere derived from certain field-measured BAFs. One commenterbelieved that the BAF criteria used inthe FWQGGLS did not provide supportfor the use of a BAF of 1,000 since amore strenuous methodology takingmore factors into account was used.However, EPA believes that this doesprovide support for the criteriaestablished for the purposes of EPCRAsection 313 because, although theunderlying technical assessments maybe more stringent, the bioaccumulationlevel of concern is still a BAF of 1,000.Also, as noted by some commenters,EPA has proposed to use a BCF/BAF of1,000 to trigger testing under TSCAsection 5(e) (63 FR 53417). Specifically,for chemicals subject to TSCA section 5that have a BAF of 1,000 or greater andthat meet certain toxicity andpersistence criteria (similar to theEPCRA section 313 persistence criteria)testing would be ‘‘triggered’’ by specificproduction limits. While themanufacturer of the chemical would beallowed to commercialize the substance,certain controls could be stipulated,including specific limits on exposures,releases, or uses. EPA notes that in thesame Federal Register document, theAgency has proposed that chemicalsthat have a bioaccumulation factor of5,000 and that meet certain toxicity andpersistence criteria (e.g., half-life of 6months or greater in soil) be placed ina ‘‘Ban Pending Testing,’’ bin.Chemicals meeting these criteria couldbe subject to more stringent control upto a ban on commercial production.

Not only is there precedent for the usea BCF/BAF of 1,000, but EPA believesthat the purposes of the statute argue forthe use of the more expansive criterion.Data on PBT chemicals are the type ofinformation that will be of particularuse to specific communities such asthose that consist of subsistence fishers.Subsistence fishers (as well as sports

fishers) are more highly exposed to PBTchemicals than the general population.Subsistence fishers consume largequantities of what they catch. Inaddition, children are affected by lowerdoses of certain PBTs than are adults.Children of both subsistence fishers andsport fishers will consume largerquantities of lake food and seafood thanchildren in other communities. Asdiscussed in Unit VI.B.2., EPA’s Officeof Water maintains a Listing of Fish andWildlife Advisories (LFWA) for the U.S.and its territories, which listed 2,299advisories in 1997 (Ref. 29). Theoverwhelming majority of the advisoriesare for well-recognized PBT chemicals(chlordane, mercury, PCBs, etc.), butmany less familiar substances are alsorepresented. The number and content ofadvisories in LFWA clearly indicate thattoxicologically significant levels ofchemical contaminants, specificallyPBTs, are often found in fish andwildlife that are caughtnoncommercially and consumed by theU.S. population. It should be noted thatthe fact that no advisories have beenissued for a particular chemical does notmean that the chemical does notbioaccumulate. Not all species ofaquatic organisms are tested nor are allwater bodies. In addition, each statedetermines what it will use as the levelof concern for issuing an advisory. EPAbelieves that it would be inconsistentwith the intent of EPCRA section 313 tolimit the information onbioaccumulative toxic chemicals to onlyinformation for the mostbioaccumulative.

One commenter contends that EPAdid not provide scientific justificationfor its choice of the bioaccumulationcriterion of a BCF/BAF of 1,000. Thecommenter states the EPA’s discussionof the origin of the 1,000 BCF/BAFvalue at a 1976 meeting sponsored bythe American Society of Testing andMaterials, and its reaffirmation in 1995in a research article by two of theoriginal authors, the use of the value byscientists in EPA’s Office of Researchand Development’s Duluth Laboratories,by EPA’s Office of Pollution Preventionand Toxics in the review of chemicalsunder TSCA sections 4 and 5, by EPA’sOffice of Water in the Final WaterQuality Guidance for the Great LakesSystem, and the use by otherauthorities, such as the Germangovernment, to identify chemicals ofhigh concern for bioaccumulation donot provide a technical basis forchoosing a value of 1,000 as a criterionfor bioaccumulation. The commentercontends that a criterion of 5,000 isscientifically supportable because

chemicals with a BCF/BAF of 5,000have a high potential to biomagnify.

As discussed above, there is noscientifically ‘‘best’’ bioaccumulationcriterion. The degree ofbioaccumulation is a continuum. Achemical does not bioaccumulate only ifit has a BCF that is 5,000 or greater. Achemical that has a BCF of 1,000 willbioaccumulate, specifically thechemical will be present in an organismat a concentration that is 1,000 timesgreater than its concentration in thesurrounding aqueous environment.Rather the choice of a value along thebioaccumulation spectrum is based to alarge degree on how the criterion is tobe used, e.g., to track chemicals enteringa particular environment, or to restrictthe use of chemicals, etc. As such thechoice of a bioaccumulation criterion isa combination of science and policy.

The commenter did not providesupport for the contention that 5,000was scientifically the ‘‘best’’bioaccumulation criterion. Specifically,the commenter did not indicate why asa scientific matter a BCF of 5,000 waspreferable to a BCF of, for example4,000 or a BCF of 15,500. While thecommenter did note that chemicals thathave a BCF of 5,000 tend to have a highpotential to biomagnify, the commenterdid not indicate in what way thisfactored into his determination that aBCF of 5,000 is the scientifically ‘‘best’’bioaccumulation criterion. In addition,EPA does not agree that a BAF or BCFof 5,000 indicates that a chemical willbe more likely to biomagnify sincebiomagnification is a much morecomplex process. Biomagnification isnot a separate process frombioaccumulation or bioconcentration,but is instead a specific example orsubset of both. Biomagnification hasbeen defined as: The result of theprocesses of bioconcentration andbioaccumulation by which tissueconcentrations of bioaccumulatedchemicals increase as the chemicalpasses up through two or more trophiclevels (Ref. 43). The difference betweenbioaccumulation and biomagnificationis that for a chemical to biomagnify itslevel of bioaccumulation must increaseas it moves up the food chain. Thewhole concept of biomagnification canbe viewed as controversial (Ref. 9) andbiomagnification has been studied foronly a few chemicals. Most importantly,biomagnification is not required inorder to have a concern for chemicalsthat bioaccumulate. This is becausebioaccumulation in even one speciescan have a serious impact on thatspecies or any other species that feedson it. For example, if a chemical onlybioaccumulates in fish then the fish will



be exposed to higher concentrations ofthe chemical as will anything that eatsthe fish. Therefore, EPA believes thatthere is no reason to establishbiomagnification as a criterion for PBTchemicals since bioaccumulation is ofmore than sufficient concern in and ofitself.

None of the other commenters whobelieve that the bioaccumulationcriterion of 1,000 is too expansivesuggested that EPA adopt another value,other than the 5,000 value used ininternational agreements, addressed inprevious responses in this unit. At most,several commenters took issue with thefact that the EPCRA section 313bioaccumulation criterion (BCF/BAF of1,000) is 5 fold less than theinternational bioaccumulation criterionof a BCF/BAF or 5,000. Given that foreach of these programs the focus was onPBT chemicals that are of globalconcern, EPA believes that as a matterof public policy, it is more appropriatefor a reporting program to use a moreprotective criterion than that used ininternational agreements that seek toban or severely restrict the use and/orrelease of chemicals.

One commenter believes that EPAshould not adopt a bioaccumulationcriterion (BCF/BAF of 1,000) for EPCRAsection 313 that is more stringent thanthe criterion for a Great Lakes BCCs (ahuman health BAF of 1,000). EPA notesthat BCCs will receive stringent controlswhich is not the case for toxic chemicalsidentified as bioaccumulative (andpersistent) under EPCRA section 313.

Many commenters supported theproposed bioaccumulation criterion of aBCF/BAF or 1,000. However, one ofthese commenters believes that 1,000should be the criterion only if the BCFor BAF is a measured value. If the BCFis an estimated value, then the criterionshould be 500.

EPA believes that such a two-tieredapproach will add confusion. Further,estimated or predicted BCFs are oftenbased on measured data and equationsthat have been found to correlate wellwith measured data. In addition, EPAbelieves that a BCF of 500 is overlyexpansive. EPA believes that expandingthe criteria to include estimated BCFs of500 would label so many chemicals asbioaccumulative as to be impractical.EPA believes that the adoption of thecriterion of BCF/BAF of 1,000 allowsEPA to balance the need to providecommunities with information on toxicchemicals that bioaccumulate withoutbeing overly inclusive or restrictive.

Some commenters contend that EPA’stwo-tiered approach to thebioaccumulation criteria is confusing.EPA notes that it proposed only one

bioaccumulation criterion for EPCRAsection 313, a BCF/BAF of 1,000. TheAgency did not propose to use a BCF/BAF of greater 5,000 as a secondbioaccumulation criterion for EPCRAsection 313. However, for purposes ofsetting reporting thresholds in thisrulemaking, the Agency did choose tofocus on the subset of PBT chemicalsthat have a BCF/BAF greater than 5,000(and half-lifes greater than 6 months) byproposing an even lower reportingthreshold.

For the reasons given above, EPAreaffirms its intention to use a BCF/BAFof 1,000 as the criterion forcharacterizing a chemical asbioaccumulative under EPCRA section313.

c. Toxicity. A number of commenterscontend that EPA should set a separatetoxicity criteria for PBT chemicals. EPAdisagrees. EPCRA section 313 providestoxicity criteria at section 313(d)(2) to beused in adding a chemical to or deletinga chemical from the EPCRA section 313list of toxic chemicals. These criteriaare:

(A) The chemical is known to cause or canreasonably be anticipated to cause significantadverse acute human health effects atconcentration levels that are reasonablylikely to exist beyond facility site boundariesas a result of continuous, or frequentlyrecurring, releases.

(B) The chemical is known to cause or canreasonably be anticipated to cause inhumans-

(i) cancer or teratogenic effects, or(ii) serious or irreversible-(I) reproductive dysfunctions,(II) neurological disorders,(III) heritable genetic mutations, or(IV) other chronic health effects.(C) The chemical is known to cause or can

reasonably be anticipated to cause, becauseof-

(i) its toxicity,(ii) its toxicity and persistence in the

environment, or(iii) its toxicity and tendency to

bioaccumulate in the environment, asignificant adverse effect on the environmentof sufficient seriousness, in the judgment ofthe Administrator, to warrant reporting underthis section.

Given that Congress has provided EPAwith specific toxicity criteria, and thatlisted chemicals are statutorily definedas ‘‘toxic chemicals,’’ the Agency doesnot believe that additional ‘‘toxicity’’criteria would be appropriate. Onereason is that the Agency is concernedthat this would imply that TRI data onthe toxic chemicals that meet thestatutory toxicity criteria are of lessvalue than TRI data that meet both thestatutory toxicity criteria and someadditional toxicity criteria that would bedeveloped by EPA. EPA believes thatbifurcating the list with an additional,

non-statutory toxicity criteria would beinconsistent with the intent of Congress.In addition, it is worth noting that someof the toxicity criteria presented by thecommenters are fundamentallyconsistent with the toxicity criteriaoutlined in the statute. However, EPAnotes that some of the criteria providedby the commenters are risk criteriarather than hazard criteria. For example,see ICCA Briefing Note on POPs (April21, 1998) (Ref. 26). As discussed atlength in the final rule adding 286chemicals to the EPCRA section 313 list(59 FR 61432), the EPCRA section313(d)(2)(B) toxicity criteria (chronictoxicity) are hazard criteria, not riskcriteria. The EPCRA section 313(d)(2)(C)criteria are primarily hazard based withonly a limited exposure component. Toimpose additional toxicity criteria forpurposes of defining a PBT or a PT orBT chemical based on risk rather thanhazard would be inconsistent withEPCRA section 313. See, e.g., LegislativeHistory at 5186. Risk assessment may beappropriate for use under statutes thatcontrol the manufacture, use and/orrelease of a chemical. However, EPCRAsection 313 is an information collectionprovision that is fundamentallydifferent from other environmentalstatutes that control or restrict chemicalactivities. For these reasons, EPAbelieves that it is inappropriate to addtoxicity criteria, beyond the criteriaprovided by Congress at EPCRA section313(d)(2).

3. Persistence and bioaccumulationconsideration under EPCRA section313(d)(2)(C)(ii) and (iii). The criteria thatEPA has laid out in this rule fordetermining if a chemical is a persistentand/or bioaccumulative chemical arenot the same criteria EPA uses whenconducting assessments for listingchemicals pursuant to EPCRA section313(d)(2)(C)(ii) and (iii). These sectionsof EPCRA allow EPA to considerwhether a chemical meets the listingcriteria based on ‘‘its toxicity andpersistence in the environment’’ or ‘‘itstoxicity and tendency to bioaccumulatein the environment.’’ Includingconsideration of persistence and/orbioaccumulation modifies the way inwhich EPA assesses a chemical’stoxicity for purposes of listing. EPAinterprets the results of the toxicity datain light of a chemical’s persistence and/or bioaccumulation, and adjusts itsconcerns for the chemical’s toxicity inaccordance with the degree to which achemical persists or bioaccumulates.For example, standard aquatic toxicitytests provide toxicity results in timeframes that range from hours to a fewweeks. For aquatic toxicity that results



from such short exposure times, achemical with a persistence half-life ofeven 2 weeks will result in a greaterpotential for exposure and thereforeincreased concern for the concentrationat which toxicity is expressed. In thiscase, EPA would be concerned about thechemical’s persistence at levels wellbelow a half-life of 2 months or more.Because EPA’s concern under theseprovisions is with the interrelationshipbetween two chemical properties andhow that affects whether the chemicalcan reasonably be anticipated to causea significant adverse effect on theenvironment, EPA believes that it needsto be able to consider a broader range ofvalues. By contrast, the persistence andbioaccumulation criteria established intoday’s rulemaking serve a differentpurpose; they are intended to operateindependent of a chemical’s toxicity, toidentify a fixed class of chemicals. EPAhas provided this explanation to clarifythe different purposes of the persistenceand bioaccumulation criteriaestablished in this rule, and the use ofpersistence and bioaccumulation inassessments pursuant to EPCRA section313(d)(2)(C)(ii) and (iii).

C. Criteria as they Apply to MetalsMany commenters contend that the

persistence criteria proposed by EPAwere developed for organic chemicalsand cannot be applied to metals, or ifapplied, are not useful in screening forhazard. The critical parameter indetermining risk is bioavailability, notpersistence. This has been recognizedby international organizations of whichEPA is a member, so it is unclear whyit is now necessary for EPA to deviatefrom these policies. Metals are notharmful if they are not in a bioavailableform. Moreover, metals are naturalcomponents of the earth’s crust andmany are accumulated by livingorganisms because they are essentialnutrients. Two of the commenters statethat because persistence is defined as‘‘the failure of a substance to readilybiodegrade,’’ this concept has norelevance for metals.

EPA disagrees. The scientificliterature contains many definitions ofpersistence which vary in detail, butcenter on a common theme: persistenceis the ability of a chemical substance toremain in a particular environment inan unchanged form. This definitionmakes no mention whatsoever of anyspecific processes that may impact asubstance’s environmental fate, such asbiodegradation. According to thisdefinition, specific metal compoundsmay or may not be persistent dependingon the form of the metal andenvironmental conditions, but the

elemental metal itself obviously meetsthe definition, and this wasacknowledged in the majority ofcomments received.

That elemental metals are persistentby definition is widely accepted. Whilethey may take different oxidation statesthat can be interconverted, theelemental metal itself cannot bedestroyed. For example, chromium (VI)may convert to chromium (III). Both aresimply different forms of chromium. Allelemental metals therefore meet the 2months half-life criterion automatically.Given this, it is obviously false to assert,as did the majority of commenters onthis issue, that EPA’s proposedpersistence criteria cannot be applied tometals. The position of manycommenters was that in determiningwhether a metal or metal compoundmay actually pose a risk if released tothe environment, bioavailability ismuch more important than the fact thata substance meets the formal‘‘definition’’ of persistence. EPA agreesthat bioavailability is important indetermining the potential for the metalto be accumulated in organisms, butparent metals do have the potential tobecome available from metalcompounds under commonenvironmental conditions. Availabilityof the metal ion may be the result ofbiotic or abiotic processes. There are anumber of environmental factors whichEPA considers in determining theavailability of the metal ion. Theseinclude hydrolysis, pH effects onsolubility, photolysis, aerobic andanaerobic transformations, and in vivotransformations. As outlined in theremainder of this section, it is realisticto expect that, in general, metals whenreleased into the environment canencounter conditions in which they areavailable at levels sufficient to exerttoxicity and bioaccumulate.

EPA also disagrees with thecommenters’ claims, direct or implied,that metals released to the environmentas a result of human activity must be ofnegligible concern because they:

• Cannot be converted to bioavailableforms; or even if initially bioavailableare rapidly sequestered in such a waythat subsequent exposure is impossible;or

• If bioavailable, are naturallywholesome and good because organismsneed them to function.EPA disagrees with this simplistic view.Metals can enter the environment inbioavailable forms or can be convertedin the environment into bioavailableforms. As shown below, metals andmetal compounds may be available tobioaccumulate under many realistic andcommon environmental conditions.

The commenters are correct in statingthat metals released to the environmentfrom anthropogenic sources are affectedby prevailing environmental conditions,meaning broadly the wide variety ofphysical, chemical and biologicalprocesses that act upon them, and thesecollectively determine the form inwhich the metal ultimately exists.

According to Klein (Ref. 28),interconversion of inorganic metalcompounds can be quite rapid,especially for ionic forms, and as aresult the chemical form in which anelemental metal is released may not bethe predominant form post-release.Generally, the ionic forms of inorganicmetals are the most available.Availability is affected by many factorsand its determination is complex. Formetals environmental conditions canaffect their availability. A detailedscientific discussion of theenvironmental fate of lead, which isrepresentative of other metals, and thatis illustrative of many of the moreimportant environmental variables thataffect availability is provided in Refs.14, 28, 30, 50, 66a, 72, and 84. See alsothe preamble to EPA’s recent proposalto lower the EPCRA section 313reporting thresholds for lead and leadcompounds (64 FR 42222). The samebasic chemical properties andenvironmental variables will affect thedegree of availability of a metal in theenvironment regardless of the specificmetal. There is no metal that isunavailable under all conditions.

EPA recognizes that lead and leadcompounds are the subject of an EPAproposal under EPCRA section 313 (64FR 42222). The inclusion of thediscussion of the environmental fate oflead and lead compounds does notpredetermine EPA’s decision on theappropriate thresholds that should beset for lead and lead compounds. Thatdetermination will be based on anumber of factors, including thebioaccumulation of lead.

Microbial transformations in soil,water, and sediment are often importantin determining the overall fate of metalsand metal compounds, and therefore thepotential for formation of bioavailableforms. Metals known to undergomicrobial oxidation/reduction processesinclude, antimony, arsenic, iron,mercury, selenium, and tellurium (Ref.11). Arsenic microbiology illustrates theimportance of environmental conditionsin the interconversion of inorganicforms of arsenic. Microbial populationsin activated sludge can oxidize arseniteto arsenate under aerobic conditions,but under anaerobic conditions such asoften predominate in sediments,arsenate can be reduced to arsenite and



beyond. Both arsenites and arsenatescan be available in the environment(Ref. 11). Microorganisms can reducemercury in the form of mercuricchloride to elemental mercury, and arealso capable of producing elementalmercury from organomercurials such asphenylmercuric acetate andmethylmercuric chloride. Although thereduction of Hg2∂ to elemental mercurycan be regarded as decreasingavailability, the elemental mercuryformed is volatile and more likely toenter the global atmospheric circulation.

Mercury is perhaps better known forits potential to be biomethylated bybacteria in the environment (Ref. 11).Mercury has very high stabilityconstants with organic ligands and canform true organometallic compounds(Ref. 6). As indicated by Stumm andMorgan (Ref. 49), metals and metalloidsthat form stable alkyl compounds are ofspecial concern because they may bevolatile; may accumulate in cells; andare toxic to the central nervous systemof higher organisms. Methylmercury ishighly bioaccumulative and is by far thebest studied example of microbialbioalkylation. However, methylation ofarsenic is also fairly well-characterized,involves the replacement of substituentoxygen atoms by methyl groups (e.g.,arsenate is biomethylated to formdimethylarsine), and is important in thetransfer of arsenic from sediment to theatmosphere (Ref. 11). Lead, germanium,selenium, tellurium, tin, and severalother metals can also be biomethylated(Ref. 49).

Many of the commenters noted thatcertain metals are indeed micronutrients(e.g., cobalt, copper, and iron), and areaccumulated precisely because they arerequired for certain cellular functions. Itdoes not follow, however, that anyamount of the same metal is acceptableor desirable. Accumulation of essentialelements is usually governed byhomeostatic mechanisms that controluptake (Ref. 28), but excessive uptake ispossible and can be toxic to anorganism. For example, selenium whichis a micronutrient can cause selenosis atdoses as low as 0.023 milligrams perkilogram per day (mg/kg/day). Clinicalsigns of selenosis include thecharacteristic ‘‘garlic odor’’ of excessselenium excretion in the breath andurine, thickened and brittle nails, hairand nail loss, lowered hemoglobinlevels, mottled teeth, skin lesions, andcentral nervous system (CNS)abnormalities (peripheral anesthesia,acroparesthesia, and pain in theextremities) (Ref. 61). Similarly, copper,which is an essential nutrient, at highdoses can cause vascular injury andhemolytic anemia. It should also be

noted that copper exhibits high acuteand chronic toxicity to aquaticorganisms that results in the death ofthe organism (61 FR 54381, October 18,1996) (FRL–5396–9), and inhalation ofhexavalent chromium is known to causecancer in humans (Ref. 60), even thoughchromium in very small oral doses is amicronutrient (Ref. 25). Moreover, thecommenters freely cite Allen (Ref. 4),Chapman (Ref. 18) and other authors tothe effect that metals are accumulated‘‘deliberately’’ depending on thephysiological needs of the organism, butit is clear that this applies only to metalsthat are essential nutrients. Metals aregenerally taken into cells by nutrientmetal transport systems, and these arenot sufficiently specific to completelyexclude nonessential metals, some ofwhich may be toxic and/orbioaccumulative. In this situationnutrient metals can be displaced fromtheir binding sites by undesirable, toxicmetals, which then gain access to thecell interior with concomitant exclusionof the essential metal (Ref. 49). Toxicmetal ions are then free to react withcritical enzymes or otherwise disruptcellular functions if they reach certainlevels. Often this toxicity occurs atrelatively low doses. For example,inorganic arsenic is a known humancarcinogen and causes chronic toxicityat doses as low as 0.014 mg/kg/day (Ref.59). Lead has no known biologicalfunction in humans but is readilyabsorbed and has been shown to causevarious toxic effects. For example,children can suffer permanent damagefrom lead poisoning, resulting inlowered intelligence, learningdisabilities, hearing loss, reducedattention span, and behavioralabnormalities (Ref. 66).

EPA concludes that under manyenvironmental conditions, metals andmetal compounds may be available toexpress toxicity and to bioaccumulate,and that these effects are not necessarilylimited to metals that are not essentialnutrients. It is appropriate, therefore, tobe concerned about the potentialadverse effects, and one step in thisdirection is to more accurately assessemissions from anthropogenic activities.EPCRA section 313 provides thatopportunity. Precedent for this concernexists at the international level in theform of a protocol for heavy metalsunder the UNECE LRTAP, which iscurrently being negotiated. The draftprotocol expresses concern ‘‘. . .thatemissions of certain heavy metals aretransported across national boundariesand may cause damage to ecosystems. ..and may have harmful effects onhuman health. . .,’’ and specifically

advocates assessing and controllingemissions caused by human activities(Ref. 54).

Several commenters raised the issueof EPA participation in variousinternational organizations, claimingthat any attempt to apply EPA’sproposed persistence andbioaccumulation criteria and/orassessment approach to metals wouldviolate the policies of theseorganizations, whose positions EPA haspreviously endorsed. These claims arefalse because the commenters eithermisunderstand or misstate theaforementioned policies. The mainfocus of the commenter’s attention istwo documents, the OECD’sHarmonized Integrated HazardClassification System for Human Healthand Environmental Effects of ChemicalSubstances (Ref. 41), and the NorthAmerican Agreement on EnvironmentalCooperation (NAAEC)’s Process forIdentifying Candidate Substances forRegional Action under the SoundManagement of Chemicals Initiative(Ref. 39). A report from a joint Canada/European Union Technical Workshopon metals (Ref. 17) was also cited bycommenters and reached similarconclusions.

The OECD document’spronouncements on metals arecontained in paragraphs 22 and 23 ofthat document. Paragraph 22 reads asfollows:

For inorganic compounds and metals, theconcept of degradability as applied to organiccompounds has limited or no meaning.Rather the substance may be transformed bynormal environmental processes to eitherincrease or decrease the bioavailability of thetoxic species. Equally, the use ofbioaccumulation data should be treated withcare. Specific guidance will be [but has notyet been] provided on how these data forsuch materials may be used in meeting therequirements of the classification criteria.(Ref. 41)

By ‘‘degradability as applied to organiccompounds’’ OECD means moleculardegradation, most often by microbialdegradation and/or hydrolysis or otherabiotic processes, to progressivelysimpler organic chemical structures,leading eventually to inorganicsubstances like carbon dioxide andwater. But, note, paragraph 22 does notin any way suggest that metals are notpersistent. Moreover, it does not suggestthat OECD hazard classification criteriacannot be applied, only that ‘‘care’’ (i.e.,professional judgment) is required inthe interpretation of data relative to theclassification criteria. In fact, EPAagrees that bioavailability is importantin determining the potential for themetal to be accumulated in organisms.



The Agency has analyzed informationon the environmental fate of metals,and, as noted above, asserts itsprofessional judgment that the parentmetals do have the potential to becomeavailable from metal compounds undercommonly encountered environmentalconditions. Therefore, the Agency’streatment of metals is consistent withthe OECD’s intent.

The same holds with respect toNAAEC’s pronouncements under theSMOC (Ref. 39). The focus of NAAEC/SMOC (Ref. 39) is the development ofNorth American Regional Action Plans(NARAPs) for substances that posesignificant risk to human health and theenvironment in all three membercountries (namely, Mexico, Canada, andthe United States). To date, NARAPshave been established for DDT/chlordane, PCBs, and mercury (note: ametal). NAAEC/SMOC (Ref. 39)acknowledges the persistence of metals,but highlights the role of expertjudgment in assessing potentialbioavailability of metals and metalcompounds:

For naturally occurring substances such asmetals and minerals, the Task Forceunderstands that the direct application of thepersistence and bioaccumulation criteriaproves very difficult.....Organometals canbehave like other persistent organicpollutants in their metallic form, and ascertain compounds, metals tend to beinfinitely persistent though not necessarily ina form that is bioavailable, and in some cases,they naturally bioaccumulate for beneficialpurposes in organisms (i.e., essentialelements). Expert judgment is essential for ameaningful evaluation of these substances.

Further, an earlier section of thedocument (Ref. 39) states,

It is understood that expert scientificjudgment plays a significant role inacknowledging and addressing thedifficulties posed by quantitative criteria forpersistence and bioaccumulation,particularly in relation to naturally-occurringsubstances like metals and minerals wherethe potential for transformation to complexesor metallic species which are more or lessbioavailable, are emerging as importantconsiderations.

It is difficult to read into thepreceding any intention to excludemetals and metal compounds fromconsideration, as many commentersimply, and more specifically, to declarethat these substances have no potentialto pose risk because they are neverreleased in bioavailable forms; cannotbe converted to bioavailable formsunder any foreseeable circumstances,etc. On the contrary, it is clear from thepreceding language as well as theinclusion of mercury among theNARAPs developed to date that anysubstance judged to be potentially

bioavailable and that otherwise meetsthe SMOC criteria, whether organic orinorganic, should not be excluded as acandidate for action. As outlined above,it is realistic to expect that, in general,released metals can encounterconditions in which they are availableat levels sufficient to exert toxicity andbioaccumulate. Therefore, the Agency’streatment of metals is consistent withinternational policy under NAAEC/SMOC (Ref. 39).

Finally, EPA reminds commentersthat a mechanism already exists toaddress concerns for any metalcompound for which the data show thatthe metal cannot become available. Theissue of bioavailability was addressedpreviously for EPCRA section 313chemical assessments through EPA’spolicy and guidance concerningpetitions to delist individual membersof the metal compound categories listedunder EPCRA section 313 (56 FR 23703,May 23, 1991). This policy states that ifthe metal in a metal compound cannotbecome available as a result of biotic orabiotic processes, then the metal willnot be available to express its toxicity,and by extension, to bioaccumulate. Ifthe intact metal compound is not toxicand the metal is not available from themetal compound, then such a chemicalis a potential candidate for delisting.EPA has received fewer than 10petitions to delete individual metalcompounds because the petitionercontended that the metal portion of themetal compound would not be availableunder environmental conditions or invivo.

D. Multimedia ModelingOne commenter contends that EPA

should clarify how and whenmultimedia models will be used in theevaluation of PBT chemicals. EPAshould not use the EQC model or othermultimedia models as the soledeterminant of potential risk. Ifexposure and use information isavailable, a detailed technicalevaluation based on these data ispreferred over modeling based onhypothetical exposure and loadingscenarios.

The purpose of this rulemaking is tolower reporting thresholds for certainEPCRA section 313 substances that arebeing designated as persistent andbioaccumulative, and to list severaladditional substances that meet EPCRAsection 313 listing criteria and are alsopersistent and bioaccumulative.Although neither quantitative risk norexposure assessments have beenperformed, nor are they required underEPCRA, designation as a PBT doesimply the existence of potential risk.

However, contrary to the comment, EPAhas not proposed that multimediamodels be used as the sole factor indetermining persistence. As clearlystated in the proposed rule, EPA intendsto use such modeling ‘‘as an additionalfactor, in conjunction with reaction half-lifes for individual media,bioaccumulation/bioconcentrationfactors, etc., in justifying [the] actionsproposed.’’

In the proposed rule EPA did explainin a general way (at 64 FR 703) howmodels would be used in PBTevaluation, and stated that results ofmultimedia modeling may be used tooverride compartment (medium)-specific degradation half-lifes, but onlyif all model inputs are judgedsufficiently accurate. This leavesunspecified what specific value(s) mightbe used for overall environmentalpersistence criteria (expressed either asan overall residence time or overall half-life). To date no international scientificor regulatory authority has proposedany such criterion for POPs/PBTchemicals, and the complex relationshipbetween compartment-specific andoverall persistence criteria is in fact amajor topic of current research.

One commenter raises concernsregarding the modification EPA made tothe EQC III model that deleted advectivelosses and sediment burial.

EPA modified the model to excludeadvective losses and sediment burialbecause if these processes are includedthe persistence based on destructionwill be underestimated. In multimediamodeling, advection can be viewed asthe flow into or out of the evaluativeenvironment or ‘‘box.’’ These includeprocesses such as downstream flow insurface waters, dispersion downwind inair, and burial in sediments. The modelconsiders these non-destructiveprocesses to result in loss from theevaluative environment in the same waythat destruction does. However, theseprocesses simply result in the transportof a chemical to another part of theenvironment downwind or downstreamfrom where it is released, or itsdeposition into sediments, but not thedestruction of the chemical.

The persistence of a chemicalcalculated when the model is runconsidering advective losses includenon-destructive transport processeswhich remove the chemical from theevaluative environment. For example,the environmental persistence of achemical released to water which doesnot significantly partition to sediments,degrade, or volatilize will reflect the rateat which the water to which it isreleased flows out of the evaluativeenvironment. In this example, the



relative rate of non-destructive transportout of the evaluative environment maybe more rapid than the processes whichresult in the destruction of the chemical.Thus, the persistence calculated by themodel will be less than if advectivetransport from the evaluativeenvironment was not considered.

EPA used the model to evaluatepersistence based on destruction in amultimedia environment. This isconsistent with EPCRA section 313persistence criteria in that the criteriaare based on destruction, not transportof the chemical. The Level III (non-equilibrium partitioning, steady statemass balance) models are preferred fordeveloping qualitative and quantitativepredictions of chemical distribution,pathways, and relative concentrations(Ref. 16). Level III models can also beused to assess persistence (Ref. 33). Atsteady state (level III) conditions theamount of chemical is unchanging withtime and the input and output rates fora compartment are equal. The overallresidence time of the chemical is themass of the chemical in thecompartment divided by the input oroutput rates. This represents the averagetime the chemical will reside in thecompartment. Output may be byreactions that result in the destructionof the chemical or by advective flow(non-destructive) usually in air or water.When the model is modified toeliminate advective flow, thepersistence of a chemical based on therates of reactions that result in thedestruction of the chemical can beassessed. Webster et al (Ref. 82) usedthis approach in evaluating theenvironmental persistence of chemicalsusing a multimedia fate model andnoted that if advective loss is included,the residence time is reduced and cangive a misleading impression of a shortpersistence. It was also noted that theseadvective losses ‘‘. . .merely relocate thechemical; they do not destroy it.’’ EPAalso used a modified version of the EQClevel III model as a tool to assist on thecharacterization of the persistence of thechemicals subject to this rule. In thisversion of the model only irreversibletransformation contributes to net loss ofa chemical. In other words, the modelwas modified to represent a ‘‘closedbox’’ in which the effect of processesthat serve only to move the chemicalfrom within the evaluative environmentto outside of it, primarily in air andwater (advective losses) were nullified.Sediment processes responsible fortransport of the chemical from theevaluative environment such assediment burial were similarly treated.The intent of this modification was to

make sure that only processesresponsible for the destruction of thechemical were considered in evaluatingits persistence in a multimediaenvironment. EPA supports the use oflevel III multimedia models modified, asdescribed, for their ability tosimultaneously consider reaction ratesand partitioning so as to give areasonable assessment of the persistenceof chemicals in the multimediaenvironment.

However, EPA notes that its relianceon the multimedia modeling waslimited. As discussed in the proposedrule (at 64 FR 703) and in Unit VI.B.2.,EPA primarily considered media-specific data and made a case-by-casedetermination about the persistence ofeach chemical.

E. ThresholdsThe issue most frequently raised by

commenters was the Agency’s choice ofthresholds and the factors that EPAconsidered in lowering the thresholds.Many commenters contended that EPAshould not consider burden in choosingthresholds. They believe that EPAshould set a threshold of 10 pounds forPBT chemicals and 1 pound for thatsubset of PBT chemicals that are bothhighly persistent and highlybioaccumulative. Some commentersbelieve that EPA should set a thresholdof 1 pound for all chemicals that arePBT chemicals. Numerous commentersbelieve that the threshold for reportingshould be zero. Other commentersbelieve that burden should have been agreater consideration in EPA’s choice ofreporting thresholds. Many of thesecommenters believe that EPA should setthresholds based on some percentage ofreleases that would be reported.

EPA disagrees with thesecommenters. As explained in theproposal, the Agency considered anumber of factors to determine theappropriate thresholds that should beestablished for these chemicals. EPArelied on the language of EPCRAsections 313(f)(2) and (h), and thelegislative history to elicit the followingprinciples to guide its exercise ofdiscretion in lowering the thresholds,and in selecting the specific thresholdsfor PBT chemicals: (1) The purposes ofEPCRA section 313; (2) the ‘‘verifiable,historical data’’ that convinces EPA ofthe need to lower the thresholds; (3) thechemical properties shared by themembers of the class of toxic chemicalsfor which EPA is lowering thethresholds i.e., the degree of persistenceand bioaccumulation; and (4) thereporting burden imposed by revisedthresholds to the extent that suchconsideration would not deny the

public significant information from arange of covered industry sectors.Further, EPA believes that in thelanguage of EPCRA section 313, and itslegislative history, Congress provideddirection on the appropriate weight toallocate to each of these considerationsin implementing EPCRA section313(f)(2). These considerations underlaythe entire process by which EPAdetermined the appropriate thresholds.But, as noted below, the Agency’schoice of revised thresholds wasgoverned, and ultimately constrained,by EPCRA section 313’s overridingpurpose, which is to providegovernment agencies, researchers, andlocal communities, with acomprehensive picture of toxicchemical releases and potentialexposures to humans and ecosystems.

In general, EPA’s implementation ofEPCRA section 313 is guided by thestatutory purposes described by EPCRAsection 313(h), which provides:

The release forms required under thissection are intended to provide informationto the Federal, State, and local governmentsand the public, including citizens ofcommunities surrounding covered facilities.The release form shall be available. . .toinform persons about releases of toxicchemicals to the environment; to assistgovernmental agencies, researchers, andother persons in the conduct of research anddata gathering; to aid in the development ofappropriate regulations, guidelines, andstandards; and for other similar purposes.

In addition to section 313(h), EPA wasalso guided by several statements on theprinciples intended to guide EPA’simplementation of EPCRA section 313made by Representative Edgar, one ofEPCRA section 313’s principalarchitects, during debate on theConference Report. See, LegislativeHistory at 5313–16. In the course of hisstatement, Representative Edgar alsoarticulated EPCRA section 313’soverriding purpose, which is:

to provide a comprehensive view of toxicchemical exposure and, hopefully, provide abasis for more sensible and effective local,State, and national policies. LegislativeHistory at 5316 (emphasis added).

Based on the existing reportingrequirements, the Agency believes thatthere are still significant gaps in thepicture the TRI data provides localcommunities, government agencies, andresearchers. One of the most significantof these gaps is a comprehensive pictureof the releases and potential exposure ofPBT chemicals to humans and theenvironment. Currently, only a verylimited picture of releases and otherwaste management of PBT chemicals isavailable from the TRI data, in part, asa result of the current thresholds. For



example, under the current reportingthresholds, in 1997, EPA received only29 reports on mercury and mercurycompounds, and 6 reports on PCBs.This does not present a ‘‘comprehensiveview of toxic chemical exposure.’’ Inaddition, information on the releasesand other waste management of PBTchemicals is particularly significantbecause these chemicals both persistand bioaccumulate. Individually, eachof these attributes has the potential topose increased exposures to humansand the environment. Toxic chemicalspossessing both attributes have thepotential to pose significant exposuresto humans and ecosystems over a longerperiod of time; even small amounts ofPBT chemicals that enter theenvironment can accumulate to elevatedconcentrations in the environment andin organisms, and therefore have agreater potential to result in adverseeffects on human health and theenvironment.

As a first step in addressing thesignificant gap of information on PBTchemical releases and wastemanagement, EPA considered whetherto lower the reporting thresholds forPBT chemicals. EPA then looked tosection 313(f)(2) for further guidance onhow to proceed. Since lowering thethresholds ensures that ‘‘all facilitiessubject to the requirements of [section313]’’ will continue to report, therequirement in section 313(f)(2) that arevised threshold obtain a ‘‘substantialmajority of total releases of eachchemical at all facilities subject to therequirements of this section’’ can be metwithout the need for quantitativesupport. Consequently, EPA looked toother sources of Congressional directionin the statute and legislative history toguide its exercise of discretion inestablishing revised thresholds.

Given that there is no guidance onimplementing section 313(f)(2) in theConference Report, EPA looked to thedebate on the Conference Report. In thiscontext, Representative Edgar, stated:

It is also important to clarify the intent ofCongress in establishing thresholds forreporting under this section. . . .Thesethresholds were designed to obtain reportingon both a substantial majority of the Nation’stoxic chemical releases and to obtainreporting from a large number of firms. Thesethresholds reflect Congress’ judgement thatsuch thresholds appropriately balance theneed for information against the burden onfacilities required to provide suchinformation. The EPA is authorized to revisethese thresholds, but only if such revisedthresholds continue to obtain reporting on asubstantial majority of total releases. Anydetermination by the EPA regarding theability of revised thresholds to obtainreporting on a substantial majority of

releases, especially if such revised thresholdsraise the statutory levels, must be based onverifiable, historical data which presents aconvincing case that the statutory levels mustbe revised. Legislative History at 5313(emphasis added).

And during the House debate,Representative Swift noted that anyrevised threshold ‘‘should be designedto improve the usefulness of the reports.It must be structured to obtain reportingon a substantial majority of the totalnationwide releases of the toxicchemical at all facilities covered bysection 313.’’ Id. at 5338 (emphasisadded).

In determining how to structure itsthreshold revisions, and particularlyhow it would improve the usefulness ofthe reports, EPA also consultedEPCRA’s purposes, laid out insubsection (h). In this context, EPA alsoconsidered the statements made bySenator Stafford during debate on theConference Report:

This section also requires theAdministrator to computerize the datareported on the required forms and to makethese data public by various means.Successful implementation of thisrequirement is vital to the basic purpose ofthe program. The data should be managed inthe computer in such a way as to allow awide variety of analyses. For example, itshould be possible to retrieve data, not onlyabout individual facilities, but also aggregatedata organized by type of chemical, type ofeffect, geographic location, company name,etc. as well as combinations of theseparameters. . . . Legislative History at 5186(emphasis added).

Based on this Congressional guidance,EPA reached several conclusions. First,ample ‘‘verifiable, historical data’’ existsto support EPA’s conclusions that PBTchemicals persist for long periods oftime in the environment andbioaccumulate in organisms, includinghumans; that this persistence andbioaccumulation can result in higherexposures to humans and theenvironment; and that to ‘‘obtain asubstantial majority of the Nation’s toxicchemical releases,’’ lower thresholds forPBT chemicals are warranted. Forexample, PCBs have been foundthroughout the Great Lakes insediments, water, and aquaticorganisms. Multimedia analysesindicate that the majority (80–90%) ofhuman exposure to chlorinated organiccompounds, such as PCBs comes fromthe food pathway, a lesser amount (5–10%) from air, and minute amounts(less than 1%) from water. Most of thedata available on human exposure toPCBs in the Great Lakes come from theanalyses of contaminant levels indrinking water and sport fish. The

consumption of contaminated sport fishand wildlife can significantly increasehuman exposure to the Great Lakescritical pollutants, such as PCBs. Thesport fish are exposed to PCBs byconsumption of sediments and throughwater (Ref. 76). See also Refs. 75 and 77.

Further, EPA strongly believes thatincreased reporting on PBT chemicalswill improve the usefulness of the dataon these chemicals. There are currentlyvery few reports for some of the PBTchemicals, such as mercury, mercurycompounds and PCBs. The currentlyavailable data provide a distortedpicture of potential exposures tohumans and the environment, becauseat the current thresholds only a fractionof the releases from facilities otherwisesubject to EPCRA section 313 arereported. This limited reporting resultsin a significant underestimation of thereleases from the industry sectorscovered by EPCRA section 313. As such,the current data are of limited use forevaluating the potential exposures tohumans and the environment of toxicchemicals that persist andbioaccumulate. Expanding the picture ofreleases, and therefore potentialexposures, will increase the utility of allthe TRI data on these chemicals. See,e.g., Economic Analysis, Chapter 6.4(Ref. 67).

On these bases, EPA determined thatrevising the thresholds would be animportant first step in closing theinformation gap on PBT chemicals. TheAgency then began the process ofdetermining the appropriate levels atwhich to establish the revisedthresholds. For a number of technicaland policy reasons, EPA chose anapproach focused on two classes of PBTchemicals: (1) Toxic chemicals thatmeet the EPCRA section 313 persistenceand bioaccumulation criteria discussedin Unit VI.B., i.e., those toxic chemicalsthat have half-lifes of 2 months orgreater in water/sediment or soil andthat have bioaccumulation orbioconcentration factors of 1,000 and (2)the subset of PBT chemicals that arehighly persistent and highlybioaccumulative, i.e., those toxicchemicals that have half-lifes of 6months or greater in water/sediment orsoil and that have bioaccumulation orbioconcentration factors of 5,000 orgreater.

First, for the most persistent andbioaccumulative toxic chemicals anyrelease will lead to elevatedconcentrations in the environment andin organisms. EPA believes that suchhighly persistent and highlybioaccumulative toxic chemicals are ofinternational, as well as nationalconcern, because of the extent of their



persistence and bioaccumulation. Asdiscussed elsewhere in this preamble,these facts have been widely recognized;there are a number of internationalagreements that ban, restrict, or phaseout the manufacture, use and/or releaseof highly persistent and highlybioaccumulative toxic chemicals.

Similarly, toxic chemicals that arepersistent and bioaccumulative are ofnational, regional, and local concern. Asdiscussed elsewhere in this preamble,toxic chemicals that are persistent andbioaccumulative present a significantconcern to many local communities dueto the proximity of the communities toindustrial sources. All other thingsbeing equal, a pollutant reaches nearbypopulations in less time than distantones. Thus, toxic chemicals that persistand bioaccumulate can pose significantexposures to communities andecosystems that immediately surroundindustrial sources as well as thosecommunities that are subject to regionaltransport.

Given the international support forthe extreme limitations on the use andrelease of toxic chemicals that arehighly persistent and highlybioaccumulative, and the significantexposures that persistent andbioaccumulative toxic chemicals canpose to both local communities andbroader regions of the United States andNorth America, EPA believes that it isappropriate to lower the reportingthresholds for both (1) Persistent andbioaccumulative toxic chemicals and (2)for highly persistent and highlybioaccumulative toxic chemicals. Inaddition, EPA believes this informationis important to the public, governmentagencies, and researchers; for example,the information reported by facilitiesunder the lower thresholds will helpthese groups assess the loading of thePBT chemicals in both local andregional ecosystems, e.g., a small lake orriver or a larger ecosystem such as theGreat Lakes or the Chesapeake Bay. Seealso, Economic Analysis at Chapter 6,pages 32–50 for examples of other usesof TRI data (Ref. 67).

Second, EPA considered how therevised thresholds would provide theinformation on PBT chemicals neededto assist the public to obtain ‘‘acomprehensive view of toxic chemicalexposure,’’ as well as to assistgovernment agencies, researchers, andother persons to conduct research and toestablish appropriate regulations,guidelines and standards, in accordancewith the directives laid out insubsection (h). EPA determined thatproviding greater information on twoidentifiable classes of chemicals bestachieved these ends. It is consistent

with the actions of a significant numberof the groups that would use thisinformation; for example, as discussedin Unit VI.B., UNEP is in the process ofnegotiating an international agreementon the class of persistent organicpollutants with half-lifes of 6 monthsand BCF/BAF values of 5,000. See alsoEconomic Analysis at Chapter 6, pages46–48 for examples of how TRI data willbe used (Ref. 67). Moreover, EPAdetermined that data on memberswithin the same class are more easilycomparable; the members of the classesEPA established in this rulemakingshare a qualitatively comparable level ofconcern based on their potential forincreased exposure. The Agencybelieved that creating two distinctclasses of comparable chemicals wouldsignificantly enhance the ability ofresearchers, government agencies, andother similar persons, to use the reports.Establishing distinct classes ofcomparable chemicals normalizes thesubsequent years’ data, providing abaseline against which data users canascertain trends over time.Consequently researchers can moreeasily distinguish, and therefore track,the releases and other wastemanagement of highly PBT chemicals,to evaluate the efficacy and progress ofthe policy strategies intended to addressthe risks of PBT chemicals, such as theBinational Great Lakes Water QualityInitiative. Finally, administrativeconvenience argued for establishing alimited number of alternate thresholds.As a practical matter, it would beburdensome for both the Agency andthe regulated community to track avariety of individual thresholds forseparate chemicals. In addition, becausethis was only the Agency’s initialrulemaking to lower thresholds forcertain PBT chemicals, EPA intendedthat the revised thresholds establish aset of categories that would be generallyapplicable to future designated PBTchemicals. All of these considerationsled the Agency to conclude that itshould establish two sets of revisedthresholds based on two classes of PBTchemicals.

Thus, having concluded it wasappropriate to focus the rulemaking ontwo classes of chemicals, persistent andbioaccumulative toxic chemicals andthat subset of PBT chemicals that arehighly persistent and highlybioaccumulative, EPA began the processof determining the specific thresholdsthat would achieve the purposes ofsubsections (f)(2) and (h). The intrinsicproperties of PBT chemicals argue forvery low thresholds. The subset of PBTchemicals that are highly persistent and

highly bioaccumulative warrant, in theabsence of other considerations, athreshold approaching zero. Any releaseof these toxic chemicals is of globalconcern because they can persist forlong periods of time, can maintain theiridentity even after undergoing longrange transport, and can bioaccumulateto a significant degree. As discussedabove, and at length in Unit VI.B., thepotential impacts that can result fromany release of toxic chemicals that arehighly persistent and highlybioaccumulative have been widelyrecognized. There are a number ofinternational agreements that ban,restrict, or phase out the manufacture,use and/or release of the most persistentand bioaccumulative toxic chemicals.

However, EPA believes that a zerothreshold would be impractical.Attempting to require facilities todetermine if they manufacture, process,or otherwise use any amountwhatsoever of these chemicals would beextremely burdensome and perhapstechnically impossible. Without anactual numerical threshold, manyfacilities might report some amount ofthese chemicals in a misguided attemptto assure compliance. This could lead tomisleading and inaccurate data on theactual sources of these chemicals. EPAbelieves that rather than setting a zeroreporting threshold it would be better toset a very low threshold that providesfacilities with a clear indicator of whenthey are required to report. In generalfor purposes of EPCRA section 313, 1pound is the practical equivalent of zerofor these chemicals. EPA explainedthese considerations in the proposedrule (64 FR 712) and has received noinformation from commenters thatconvinces the Agency to pursue adifferent approach.

EPA then considered the relativedegree of persistence andbioaccumulation between the twoclasses of chemicals. EPA wanted toestablish two sets of revised thresholdswith the same approximate relationshipto each other, as the relative exposurepotentials of PBT chemicals to thatsubset of highly persistent and highlybioaccumulative PBT chemicals. Simplystated, chemicals with half-lifes of 6months or greater and a BAF/BCF of5,000 or greater have a higher exposurepotential than chemicals with half-lifesof 2 months or greater and a BAF/BCFof 1,000 or greater. However, although,as discussed below, EPA could establisha qualitative relationship, the Agencycould not reliably quantify the relativeexposure potential across the board forall of the members of both classes.Therefore, in attempting to translate thequalitative exposure potential of PBT



chemicals to that subset of PBTchemicals that are highly persistent andhighly bioaccumulative into aqualitative threshold relationship, EPAconsidered both the attributes of thesechemicals and factors specific tothresholds.

The manufacture, process, andotherwise use thresholds are notequivalent to release thresholdsalthough, in many cases, the quantitymanufactured or otherwise used will bevery similar to the quantity released.Thus, even if EPA were able to quantifythe relative exposure potential of PBTchemicals and that subset of PBTchemicals that are highly persistent andhighly bioaccumulative, based on theirdegrees of persistence andbioaccumulation, and theirinterrelationship, the Agency would notrely solely on this to select aquantitative threshold relationshipbetween these two classes of chemicalsbecause: (1) The manufacturing,processing, and otherwise usethresholds are not equivalent to releasethresholds, and (2) the quantityreleased, not the quantity manufactured,processed or otherwise used, is a criticalfactor in determining exposure.

Nonetheless, EPA believes that therelative reporting thresholds should bebased to some extent upon thequalitative differential between thepotential exposures that may result fromreleases of PBT chemicals and thatsubset of PBT chemicals that are highlypersistent and highly bioaccumulative.

There is not a direct quantifiablerelationship between the potentialexposures that can result fromequivalent releases of a toxic chemicalthat persists in the environment with ahalf-life of 6 months and that has abioaccumulation factor of 5,000 andreleases of a toxic chemical that persistsin the environment with a half-life of 2months and that has a bioaccumulationfactor of 1,000. The potential exposureto humans and the environment willdepend upon a number of factors,including release patterns, environmentvariables such as soil type, surface waterchemistry, the types and distribution offlora and fauna, and fish consumptionpatterns. However, EPA did considerthe relative differences in the potentialexposures between these two classes.For example, after 1 year, there will bemore than 15 times as much of a highlypersistent chemical that remains in theenvironment than of a persistentchemical, all other things being equal.Similarly, fish will accumulate morethan 5 times as much of the highlybioaccumulative chemical than of thebioaccumulative chemical, all otherthings being equal. While EPA believes

that it can qualitatively describe therelative relationship of highly persistentchemicals to persistent chemicals andthe relative relationship of highlybioaccumulative chemicals tobioaccumulative chemicals, the Agencycannot at the present time, define therelative relationship of persistence andbioaccumulation between the twoclasses of chemicals. This is in largepart due to the many variables that mustbe considered in determining thepotential exposures both due to theinteraction of these chemical attributesand the large number of environmentalfactors that must be considered whenevaluating persistence andbioaccumulation together.

Although EPA could not develop anexact quantitative threshold relationshipbetween the two classes of chemicals,the Agency did consider the factorsdiscussed above and did rely to someextent on the numerical relationshipsbetween the highly persistent andpersistent chemicals and the highlybioaccumulative and bioaccumulativechemicals. Therefore, given that: (1)Highly bioaccumulative toxic chemicalswill accumulate approximately 5 timesgreater than bioaccumulative toxicchemicals, (2) highly persistent toxicchemicals will remain in theenvironment after 1 year, at a levelabout 15 times greater than persistenttoxic chemicals, (3) the fact that theEPCRA section 313 reporting thresholdsare not release thresholds but that insome instances the quantitiesmanufactured or otherwise used will bevery similar to the quantity released,and (4) toxic chemicals that persist inthe environment with half-lifes of 2months and bioaccumulation factors of1,000 or greater can be of both local andregional concern, EPA believes that thethreshold for PBT chemicals should bea factor of 10 greater than the thresholdfor that subset of PBT chemicals that arehighly persistent and highlybioaccumulative. EPA believes that thisratio balances the uncertainties andfactors, including numerical factors, thatthe Agency considered. Therefore, basedon the chemicals’ intrinsiccharacteristics, EPA would establishthresholds of 1 pound for that subset ofPBT chemicals that are highly persistentand highly bioaccumulative and 10pounds for PBT chemicals.

However, the legislative history ofsection 313(f)(2) indicates that inestablishing the original thresholds,Congress recognized the burdenimposed on the regulated community.Lowering thresholds necessarily willincrease that burden. Therefore, EPAdetermined it would be reasonable toinclude some consideration of reporting

burden in selecting thresholds for PBTchemicals. But EPA accorded lessweight to burden than to the otherconsiderations discussed above. First,neither section 313(f)(2), section 313(h),nor any other provision of EPCRArequires EPA to consider burden.Second, EPA was mindful of the factthat in several places in the legislativehistory Congress made clear it neverintended impacts on reporting facilitiesto outweigh the public’s right-to-knowabout their potential exposures to toxicchemicals. For example, althoughRepresentative Edgar recognized thatCongress had considered burden inestablishing the statutory thresholds, hedid not include reporting burden as oneof the general principles that shouldguide the Agency’s implementation ofEPCRA section 313 as a whole. Rather,he stated:

This is a new Federal initiative, and Irecognize the desire of some of my colleaguesto move ahead cautiously to ensure thatburdens imposed on industry are notexcessive. Frankly, my concern rest with thefamilies that live in the shadows of thesechemical and manufacturing plants. I haveput myself in their shoes and have fought fora program that looks after their needs. Thislegislation gets us well on the path to the fulldisclosure they deserve. Legislative History at5316. See also, Legislative History at 5185–86(Senate debate on the Conference Report).

As noted in Unit VI.A, one of themajor pieces of Congressional guidanceon the establishment of alternatethresholds was to obtain acomprehensive picture of ‘‘totalnationwide releases of the toxicchemical at all facilities covered bysection 313.’’ This language, plus otherCongressional directives onimplementing section 313 generally,such as section 313(h), reflect aninterest in obtaining information from abroadly representative range of sources.Consequently, EPA determined that theAgency should consider burden only tothe extent that it would not deny thepublic significant information from arange of covered industry sectors.

Therefore, EPA estimated the numberof reports that would be submitted byeach industry sector for four groups ofthresholds, 1 and 10 pounds, 10 and 100pounds, 100 and 1,000 pounds, and1,000 pounds for both classes ofchemicals. These options were selectedfor the following reasons. EPA needed areasonable but finite number of optionsto evaluate, and the options describedabove represent a reasonable picture ofthe entire range of potential revisedthresholds. Data limitations on themanufacturing, processing, andotherwise use of PBT chemicals in thenumerous industries, processes, anduses covered by EPCRA section 313



constrained EPA’s ability to makemeaningful and reliable distinctionsbetween threshold options that are lessthan an order of magnitude apart. Forexample, while EPA believes it canreliably estimate the difference in thenumber of reports from a 10 poundreporting threshold and a 100 poundreporting threshold, EPA believes thatthe data are insufficient to allow it tomake a meaningful and reliabledistinction in estimates of options thatare closer than an order of magnitudesuch as 35 pounds and 50 pounds. EPAexplained its data limitations in theproposal, and commenters provided noinformation that would allow theAgency to increase the resolution of itsanalysis. Consequently, for the finalrule, EPA analyzed options that wereorders of magnitude apart from the twothresholds identified through itstechnical review: 1 pound for highlypersistent and highly bioaccumulativechemicals, and 10 pounds for persistentand bioaccumulative chemicals.

Based on information provided in theeconomic analysis for this rulemaking,at the technical reporting thresholdsEPA would obtain information from abroad range of facilities (Ref. 67a). Theanalysis showed that at a threshold of 1pound, the public would obtaininformation from all industry sectorsthat are currently subject to EPCRAsection 313, and that have beenidentified as manufacturing, processing,or otherwise using those highlypersistent highly bioaccumulative toxicchemicals that are part of thisrulemaking (except dioxin and dioxin-like compounds which are discussedbelow). At a threshold of 10 pounds, thepublic would obtain information fromall industry sectors that are currentlysubject to EPCRA section 313, and thathave been identified as manufacturing,processing, or otherwise using thosePBT chemicals that are part of thisrulemaking. At the technical reportingthresholds, the estimated costs of theadditional reports filed would havetotaled $355 million in the first year,and $193 million in subsequent years(Ref. 67). EPA considered these costs,even though it cannot quantify the valueof the information obtained or lost at thevarious thresholds, and cannot quantifythe relationship between the reportingcosts and the value of the informationreported, or lost, at a particularthreshold.

At thresholds of 10 pounds for highlypersistent and highly bioaccumulativechemicals and 100 pounds for persistentand bioaccumulative chemicals, EPA isstill able to obtain a significant amountof information on both classes of PBTchemicals from a wide range of industry

sectors and sources. For example, noreporting on TBBPA would be lost fromany sources or industry sectors at 100pounds, and some information onoctachlorostyrene would be potentiallylost from only one industry sector,pesticide manufacturing facilities. Atthese thresholds, EPA does, however,lose information significant to localcommunities; for example, EPA losesconsiderable reporting on mercury andmercury compounds at 10 pounds, butthe loss of information is localized in alimited number of industry sectors, andthe public will still obtain somereporting from all of the currentlycovered industry sectors (Ref. 67a). Forthis threshold option, EPA estimated thetotal burden at these thresholds to be$191 million for the first year, and $105million for subsequent years (Ref. 67).

At thresholds of 100 and 1,000pounds and higher, EPA’s analysisindicated that the public, governmentagencies, and researchers would loseinformation on many of the PBTchemicals from certain industry sectorsand sources. For example, at a thresholdof 100 pounds for toxic chemicals thatare highly persistent and highlybioaccumulative, the Agency would notobtain reporting on mercury andmercury compounds generated inboilers in the manufacturing sector orinformation on octachlorostyrene fromthe primary metal industries (Ref. 67a).However, at these thresholds, EPAestimated the total first year costs to be$99 million and $55 million insubsequent years (Ref. 67).

These analyses led EPA to severalconclusions. First, thresholds of 10pounds for highly persistent and highlybioaccumulative chemicals and 100pounds for persistent andbioaccumulative chemicals, achieve asignificant reduction in reportingburden. Second, at these thresholds EPAobtains information from a broaddistribution of industry sectors.Although EPA also loses informationsignificant to local communities at thesethresholds, it maintains the overalldistribution of reporting from a broadrange of industry sectors nationally.EPA could have attempted tocompensate for the community-levelloss of information on individualmembers of the classes of PBTchemicals (i.e., by establishing separatethresholds of 1 pound or 10 pounds forindividual chemicals), but only byfailing to take reporting burden intoaccount for those individual chemicals.As explained previously, the availabilityof the data limited EPA’s ability todistinguish meaningfully betweenthresholds separated by less than anorder of magnitude. In addition,

establishing separate thresholds wouldsacrifice many of the benefits ofreceiving information from comparablefacilities using comparable chemicals,discussed earlier in this unit. Thusgreater information for localcommunities would be achieved at theexpense of the increased utility of thereports for other purposes establishedunder EPCRA section 313(h)--e.g.,assisting governmental agencies,researchers, agencies and other personsin the conduct of research and datagathering; and aiding in thedevelopment of appropriate regulations,guidelines, and standards. EPA believesthat, to be consistent with the overridingpolicy directive in subsection (h), itmust achieve a balance betweenimproving the utility of the reports forall of the groups that rely on TRI data.Finally, as noted earlier in this Unit,administrative convenience arguesagainst the establishment of individualthresholds. Among other issues, itwould be burdensome on both EPA andthe regulated community to track avariety of separate thresholds.Moreover, EPA intends the revisedthresholds established in thisrulemaking for the two classes of PBTchemicals to be generally applicable tofuture members of the two classes;absent a strong technical or policyconcern to the contrary, it wouldultimately be inconsistent with thepurposes of EPCRA section 313 forchemicals that share such commoncharacteristics to have vastly differentthresholds.

Therefore, EPA believes its selectionof thresholds of 100 pounds for PBTchemicals and 10 pounds for that subsetof PBT chemicals that are highlypersistent and highly bioaccumulative,balances the purposes of EPCRA section313 and the Agency’s desire to providea comprehensive picture on releases andpotential exposures of PBT chemicals,while factoring in an appropriate degreeof the consequent impact on theregulated community.

Dioxin and dioxin-like compoundsare highly persistent and highlybioaccumulative toxic chemicals. Asdiscussed above, toxic chemicals thatare highly persistent and highlybioaccumulative warrant, in the absenceof other considerations, a thresholdapproaching zero. But, for the reasonsdiscussed previously in this section,EPA does not believe that a zerothreshold would be practical. However,because the dioxin and dioxin-likecompounds are manufactured inextremely small amounts, EPA neededto select a threshold lower than that forthe other highly persistent and highly



bioaccumulative chemicals in order toobtain any reporting.

In choosing reporting thresholds forthese chemicals, the Agency consideredthe extent of the information on dioxinand dioxin-like compounds that wouldbe made available to the public,government agencies and researchers.EPA considered whether this level ofinformation would provide them with‘‘a comprehensive view of toxicchemical exposure,’’ given the attributesof dioxin and dioxin-like compounds,and with ‘‘broad-based nationalinformation.’’ At a threshold of 0.1gram, the public would obtaininformation from all industry sectorsthat are subject to EPCRA section 313and that have been identified in theInventory of Sources of Dioxin in theUnited States (Ref. 3). EPA does notbelieve that a higher threshold, i.e., 1.0grams, would provide the public withbroad-based national informationbecause there would be no informationon the manufacture and release andother waste management of certainsectors. For example, at a higherthreshold, EPA anticipates that therewould be no reporting from hazardouswaste incinerators, pulp mills, non highferrous foundry industries, andsecondary lead smelters (Ref. 67a). Atthresholds lower than 0.1 gram, there isgreater coverage within certain industrysectors, with a concomitant significantincrease in burden. EPA believes itsselection of a threshold of 0.1 gram fordioxin and dioxin-like compoundsbalances the purposes of EPCRA section313 and the Agency’s desire to providea comprehensive picture on releases andexposures of dioxin and dioxin-likecompounds while factoring in anappropriate degree of the resultantimpact on the regulated community.

F. What Comments Did EPA Receive onExposure and Risk Considerations andWhat Are EPA’s Responses?

One of the most significant issuesraised by commenters relates to theAgency’s lack of consideration ofquantitative risk in modifying thesection 313(f) reporting thresholds.Specifically, a number of commentersbelieve that EPA should use quantitativerisk as a criterion in determiningwhether to lower the reportingthresholds and in choosing a particularreporting threshold for each PBTchemical. The commenters contend thatEPA should conduct risk assessmentsand make a formal determination that ata particular threshold releases of thePBT chemical pose a risk beforelowering the reporting threshold. Whilethe majority of commenters whocommented on the issue believe that

EPA should make a risk determinationbefore modifying the reportingthresholds, the rationale for theirconclusions varied. Some commentersstate that a risk determination isrequired by EPCRA because the intent ofEPCRA is to provide information to thepublic of potential risks posed by thepresence of toxic chemicals released tothe environment in their communities.Some commenters state that in additionto addressing the substantial majoritytest, EPCRA section 313(f)(2) requiresEPA to use the degree of risk thatreleases will pose to communities as adeterminant in choosing newthresholds. Other commenters state thatconsideration of risk is a requiredcomponent of any action under EPCRAsection 313. In support of this position,one of the commenters cites two D.C.Circuit Court decisions. Othercommenters contend that it would begood public policy to choose a thresholdbased on risks. Some commenterscontend that EPA should lower thereporting thresholds only for thosechemicals that present the highest risksto the public. One commenter, however,believes that the Agency should notconsider the degree of risk in making adetermination to lower the reportingthresholds for PBT chemicals becausethe consideration of risk in past actionstaken by EPA under otherenvironmental statutes have notresulted in a decrease of human healthor environmental risks due to PBTchemicals. The commenter states thatthe increasing number of fish advisoriesand the lingering and, in some cases,increasing levels of PBT chemicals inthe environment and in fish, wildlife,and human tissue demonstrates themagnitude of the failure of the ‘‘riskmanagement strategy.’’

EPA disagrees with the commenters’assertion that evidence of risk isrequired prior to lowering the thresholdfor any EPCRA section 313 chemical.Section 313(f)(2) addresses revisions tothe reporting thresholds. It does notrequire EPA to establish, prior to thelowering of reporting thresholds, thatreleases at a particular threshold willresult in specific quantitative risks. Thatsection expressly provides that theAdministrator may establish a thresholdamount for a toxic chemical differentfrom the 25,000 pound threshold formanufacturing and processing activitiesand the 10,000 pound threshold forotherwise use activities. The onlyprerequisite for revising the reportingthreshold for a toxic chemical is that therevised threshold obtain reporting on asubstantial majority of total releases ofthe chemical at all facilities subject to

the requirements of EPCRA section 313.As discussed in Units II.B. and VI.A.,EPA believes that it has satisfied therequirements of EPCRA section 313(f)(2)without the need for quantitativesupport.

EPA believes that the commentersattribute a purpose to EPCRA that isinconsistent with that clearly intendedby Congress. Specifically, Congressstated in EPCRA section 313(h) that:

The release forms required under thissection are intended to provide informationto the Federal, State, and local governmentsand the public, including citizens ofcommunities surrounding covered facilities.The release form shall be available,. . .toinform persons about releases of toxicchemicals to the environment; to assistgovernment agencies, researchers, and otherpersons in the conduct of research and datagathering; to aid in the development ofappropriate regulations, guidelines, andstandards; and for other similar purposes. 42U.S.C. section 11023(h).

Neither EPCRA section 313(h) nor itslegislative history directs EPA to limitthe collection of information on releasesto those releases that, from the Federalgovernment’s perspective, posesignificant local human andenvironmental exposure and humanhealth and environmental risks. See,e.g., Legislative History at 5186.

Federal and local perspectives onwhat may be an acceptable risk arelikely to be very different. The roles oflocal government and the Federalgovernment differ significantly in termsof ensuring environmental quality. Inpassing EPCRA, Congress determinedthat it is for the public to take theinformation reported on the use andreleases and other waste management oftoxic chemicals, and to determinewhether these releases result inpotential risks that the communitydetermines warrant further action givenother factors, such as economic andenvironmental conditions, orparticularly vulnerable human orecological populations. Congress did notintend the Federal government toconsider these specific local factorsprior to determining whether certaininformation should be made public orprior to determining whether a differentthreshold should be established for oneor more toxic chemicals.

The intent of EPCRA section 313 is tomove the determination of what risksare acceptable from EPA to thecommunities in which the releasesoccur. This basic local empowerment isa cornerstone of the right-to-knowprogram. EPCRA section 313 establishesan information collection anddissemination program. The burden itimposes is significantly less than the



burden imposed by a statute whichcontrols the manufacture, use, and/ordisposal of a chemical. EPCRA section313 requires that a facility use readilyavailable data, or if such data are notavailable, reasonable estimates toprepare each chemical-specific report.The statute does not require that thefacility conduct monitoring or emissionsmeasurements to determine thesequantities. This is in contrast to otherenvironmental statutes that may requirea facility to monitor releases, change itsmanufacturing process, install a specificwaste treatment technology, or disposeof wastes in a certain manner. As such,the Agency believes that as a matter ofpolicy the standard that must be met torequire information pursuant to EPCRAsection 313 is less than that required toregulate a chemical under a statute suchas the Clean Air Act. See, e.g.,Legislative History at 5186.

Further, contrary to assertions bysome commenters, EPCRA section 313does not require the collection ofquantitative risk data nor does thestatute require that risk data bedisseminated to the public. Rather TRIdata provide communities withinformation on releases and other wastemanagement quantities. TRI datacannot, in themselves, provideinformation on quantitative risks toindividual communities. Adetermination of the potential risk thata chemical release may pose isdependent upon a number of factors,including the toxicity of the chemical,the physical chemical properties of thechemical, the specific media to whichthe chemical is released, and site-specific information that will determinethe estimated exposures. While TRI dataare not in themselves measures of risk,they are an important input that localcommunities can use along with thefactors described in this section todetermine potential risks to themselves,their children, their communities, andtheir environment that may result fromreleases of toxic chemicals.

EPA’s decision to lower the reportingthreshold for PBT chemicals isrationally related to the EPCRA section313 goals of informing communities,assisting research and data gathering,and aiding the development ofregulations and guidelines. Because PBTchemicals persist in the environment fora significant period of time andbioaccumulate in animal tissues, PBTchemicals have the potential to bepervasive in the environment, in thefood chain, and often in humans. Inshort, for PBT chemicals, releases andother waste management activities forrelatively small amounts of PBTchemicals are of concern. Accordingly,

pursuant to the intended purposes ofEPCRA, even relatively small releasesand other waste management activitiesfor PBT chemicals need to be reportedin order to inform communities, assistthose engaged in research and datagathering, and to aid the development ofregulations and guidelines. Loweredreporting thresholds for PBT chemicalsare needed to obtain reporting on theserelatively small releases and other wastemanagement activities for PBTchemicals. Consequently, EPA believesthat including consideration of thequantitative risk in establishing thethresholds would be poor public policythat would be inconsistent with theoverall principles of EPCRA.

Finally, the reference by one of thecommenters to two D.C. Circuit Courtdecisions is misplaced. In support of itsposition that EPA must undertake a riskassessment of any toxic chemical it isconsidering for lower reportingthresholds, the commenter citesAmerican Petroleum Institute v. Costle,665 F.2d 1176, 1187 (D.C. Cir. 1981),cert. denied, 455 U.S. 1034 (1982), andMilwaukee Metropolitan SewerageDistrict v. EPA, 40 F.3d 392 (D.C. Cir.1994). Neither case cited by thecommenter addresses EPCRA. Nor dothese cases establish a generallyapplicable principle of law that riskassessments are required prior to anygovernment action. In MilwaukeeMetropolitan Sewerage the courtreviewed standards adopted by EPA ina Clean Water Act regulation. InAmerican Petroleum Institute the courtreviewed the primary and secondarynational ambient air quality standardsfor ozone promulgated by EPA underthe Clean Air Act. Both the Clean AirAct and the Clean Water Act have nobearing on EPCRA section 313. Unlikethe statutes at issue in the cases cited bythe commenter, consideration of risk isnot a requirement of section 313(f)(2) formodifying the reporting thresholds forEPCRA section 313 listed chemicals,and, in fact, the consideration of risk isgenerally not required for anyrulemaking under section 313. TroyCorporation v. EPA, 120 F.3d 277 (D.C.Cir. 1997).

Some commenters further state that inproposing to change EPCRA section 313reporting thresholds, EPA has notaddressed any of the factors the Agencymentioned when it originallypromulgated EPCRA section 313regulations. In the February 16, 1988final rule, EPA stated:

EPA may consider a number of factors forthreshold modification including exposurefactors such as population density, thedistance of population from coveredfacilities, and the types of releases. Threshold

modifications could also take into accountthe relative potency of the chemical or classof chemicals and effects of concern. (53 FR4508).

In this statement, the commenterscontend that EPA correctly mentionsfactors that relate to risk (i.e., exposureand relative toxicity). The currentproposal to change reporting thresholdsunder EPCRA section 313 fails toaddress these factors.

As is clearly evident in the quote fromthe February 16, 1988 final rule, EPAstated that these were things that it‘‘may consider’’ or that could be takeninto account. These statements do notrequire that the possible factorsmentioned above be a basis for anychange in the reporting thresholds nordo they preclude the consideration offactors such as the persistence and/orbioaccumulation of toxic chemicals inmodifying the reporting thresholds. Thisstatement was not a commitment thatEPA would consider risk in anydecision to modify reporting thresholds.It merely provided examples of thingsthat the Agency may consider.

As explained in previous responses,EPA does not believe that it would begood public policy to consider factorsrelated to quantitative risk with respectto establishing thresholds for PBTchemicals. Given the degree ofpersistence and bioaccumulation thatthese toxic chemicals exhibit, EPAbelieves that the value of thisinformation to the public outweighs thepolicy considerations presented in favorof considering risk factors inestablishing revised thresholds. Anyother decision would be inconsistentwith the legislative intent underlyingEPCRA section 313.

Finally, EPA notes that this decisionis consistent with the approach adoptedin modifying the thresholds to establisha 1 million pound manufacture, process,or otherwise use threshold for facilitiesthat have 500 pounds or less ofproduction-related waste (59 FR 61488,November 30, 1994) (FRL–4920–5). Anydecision to include risk considerationsin establishing modified thresholdsunder section 313(f)(2) would compelthe Agency to re-examine the thresholdsestablished for facilities with less than500 pounds of production-related waste.

Several commenters contend that achemical’s degree of persistence andbioaccumulation are unrelated to thechemical’s exposure potential. Theydisagree that persistence andbioaccumulation are necessarilyindicators of exposure or exposurepotential. As an example, thecommenter states that many of thecompounds EPA is targeting are highlylipophilic, non-water soluble



compounds, and the greatest potentialfor bioaccumulative effects is throughuptake from the water column. EPAshould evaluate how these compoundspartition in the environment. Those thatare not bioavailable have limitedexposure potential, and thereforelimited risk. Thus, the commenterbelieves that EPA must considerexposure in conjunction withpersistence and bioaccumulation.

EPA disagrees with the commenters.All other things being equal, thechemical with a higher degree ofpersistence and bioaccumulation willhave a greater exposure potential thanthe chemical with a lower degree ofpersistence and bioaccumulation. Forexample, all other things being equal, achemical that has a half-life in water of4 months will have a higher exposurepotential to aquatic organisms than achemical with a half-life in water of 1month. Fifty percent of the firstchemical will remain in the water after4 months while only 12.5% of thesecond chemical will remain in thewater after 4 months. After 4 months,aquatic organisms will be exposed to 4times more of the first chemical than thesecond chemical. Clearly the chemicalwith the greater persistence has thehigher exposure potential.

EPA does not believe that thecommenter’s example supports theircontention that persistence andbioaccumulation are unrelated toexposure potential. As EPA understandsthe commenter’s example, chemicalsthat have the greatest bioaccumulationpotential will not be bioavailable inwater because they are highly lipophilicand non-water soluble. Thus, becausethey are not bioavailable in water, theycannot bioaccumulate in aquaticorganisms. A well-studied example thatclearly contradicts the commenter’sclaim is the bioaccumulation ofpolychorinated biphenyls (PCBs) in theGreat Lakes. PCBs have BAFs as high as141,000,000 (Table 1, at 64 FR 707–8)and very, very low water solubility.PCBs have been found throughout theGreat Lakes in sediments, water, andaquatic organisms. Multimedia analysesindicate that the majority (80–90%) ofhuman exposure to chlorinated organiccompounds, such as PCBs comes fromthe food pathway, a lesser amount (5–10%) from air, and minute amounts(less than 1%) from water. Most of thedata available on human exposure totoxic substances in the Great Lakescome from the analyses of contaminantlevels in drinking water and sport fish.The consumption of contaminated sportfish and wildlife can significantlyincrease human exposure to the GreatLakes critical pollutants. The sport fish

are exposed to PCBs by consumption ofsediments and in water, from whichthey bioaccumulate the PCBs (Ref. 62).

Some commenters contend thatEPCRA requires that EPA consider therisks that a chemical may pose whenmaking determinations to add achemical to the EPCRA section 313 listof toxic chemicals. In support of thisposition, one commenter cites two D.C.Circuit Court decisions.

As discussed in detail in the final ruleadding 286 chemicals to EPCRA section313 (59 FR 61432), EPA disagrees withcommenters that the Agency mustinclude a risk assessment component toEPCRA section 313 determinations.While the Agency believes that there arelimited circumstances where it may beappropriate to consider risk in makinglisting determinations, e.g., acutehuman health effects, EPA does notbelieve that the intent of EPCRA, theEPCRA section 313 toxicity criteria, orthe legislative history support thecontention that risk assessment is arequired component of all EPCRAsection 313 listing determinations.

The EPCRA section 313 toxicitycriteria require that exposure and riskfactors be considered only whendetermining if the toxic chemicalshould be listed on EPCRA section 313based on its acute human health effects,but even then in only a very limitedmanner. The statute mandates that EPAconsider whether ‘‘a chemical is knownto cause or can reasonably beanticipated to cause significant adverseacute human health effects atconcentration levels that are reasonablylikely to exist beyond facility siteboundaries.’’ EPA has, and willcontinue to look at exposuresreasonably likely to exist beyond facilitysite boundaries when making a listingdetermination pursuant to EPCRAsection 313(d)(2)(A). However, EPAnotes that none of the toxic chemicalsadded in today’s action were addedpursuant to paragraph (A) of thatsection.

The statute is silent on the issue ofexposure considerations for the section313(d)(2)(B) and (C) criteria. Thelanguage of section 313 does notprohibit EPA from considering exposurefactors when making a finding undereither section 313(d)(2)(B) or section313(d)(2)(C). However, the language ofsections 313(d)(2)(B) and (C) does notrequire the type of exposure assessmentand/or risk assessment argued by thecommenters. EPA believes that it hasthe discretion under both section313(d)(2)(B) and section 313(d)(2)(C) toconsider, where appropriate, thoseexposure factors that may call intoquestion the validity of listing of any

specific chemical on EPCRA section313.

EPA believes that its positionregarding the limited use of risk inlisting decisions is consistent with thepurpose and legislative history ofEPCRA section 313, as illustrated in thefollowing passage from the Conferencereport:

The Administrator, in determining to list achemical under any of the above criteria,may, but is not required to, conduct newstudies or risk assessments or perform site-specific analyses to establish actual ambientconcentrations or to document adverseeffects at any particular location. (H. Rep. 99-962, 99th Cong., 2nd Sess., p. 295 (October3, 1986)). See also Legislative History at 5186.

This passage indicates that Congress didnot intend to require EPA to conductnew studies, such as exposure studies,or to perform risk assessments.Therefore, Congress did not considerthese activities to be mandatorycomponents of all section 313 decisions.EPA believes that this statementcombined with the plain language of thestatutory criteria clearly indicate thatCongress intended that the decision ofwhether and how to consider exposureunder EPCRA section 313(d)(2)(B) and(C) should be left to the Agency’sdiscretion. EPA has carefully consideredwhen and how to use exposure to fullyimplement the right-to-know provisionsof EPCRA. The Agency believes thatexposure should be considered only invery limited circumstances whenadding a chemical to EPCRA section313(d)(2)(B) or (C). The Agency’sinterpretation of the section 313(d)(2)and (d)(3) criteria for modifying thesection 313 list of toxic chemicals isdiscussed in the final rule adding 286chemicals to EPCRA section 313 (at 59FR 61440–2). And in fact, EPA’sinterpretation was upheld by the D.C.Circuit in Troy v. EPA, 120 F.3d 277.The addition of chemicals pursuant toEPCRA section 313(d)(2)(B) and (C) intoday’s rulemaking is consistent withthis interpretation.

The intent of EPCRA section 313 is tomove the determination of which risksare acceptable from EPA to thecommunities in which the releasesoccur. This basic, local empowerment isa cornerstone of the right-to-knowprogram. EPCRA section 313 establishesan information collection anddissemination program. It provides thepublic with information that can beused with other site-specific factors todetermine if releases into theircommunities result in risks that thecommunity determines warrant furtheraction given other factors, such aseconomic and environmental



conditions, or particularly vulnerablehuman or ecological populations.

In addition, the reference by one ofthe commenters to two D.C. CircuitCourt decisions is misplaced. In supportof its position that EPA must undertakea risk assessment of any toxic chemicalit is considering to add to EPCRAsection 313, the commenter citesAmerican Petroleum Institute v. Costle,665 F.2d 1176, 1187 (D.C. Cir, 1981),cert. denied, 455 U.S. 1034 (1982), andMilwaukee Metropolitan SewerageDistrict v. EPA, 40 F.3d 392 (D.C. Cir.1994). As discussed in a previousresponse in this unit, neither case citedby the commenter addresses EPCRA. Inaddition, since both cases were decidedprior to Troy, by the same court, thatdecided the specific issue raised by thecommenter, nothing in the two earliercases cited by the commenter canoverrule that decision.

G. Which Chemicals is EPA Adding tothe List of EPCRA Section 313 ToxicChemicals?

EPA is adding the followingchemicals to the EPCRA section 313 listof toxic chemicals: dioxin and dioxin-like compounds, benzo(g,h,i)perylene,benzo(j,k)fluorene (fluoranthene), 3-methylcholanthrene, octachlorostyrene,pentachlorobenzene,tetrabromobisphenol A, vanadium(except alloys) and vanadiumcompounds. EPA conducted a hazardassessment on each chemical beingadded to the EPCRA section 313 list oftoxic chemicals today. This assessmentwas separate and independent from thereview conducted to determine eachchemical’s persistence andbioaccumulation potential, althoughEPA considered some of the same datain certain of its hazard assessments.EPA finds that each chemical beingadded today meets the criteria forchronic human toxicity and/orenvironmental toxicity, as set forth atEPCRA sections 313(d)(2)(B) and (C). Asummary discussion of the basis forlisting each of these chemicals as wellas other related issue are presented inthe remainder of this unit. A moreextensive discussion of these issues isincluded in the Response to Commentsdocument (Ref. 69) and supportingdocuments.

1. Dioxin and dioxin-like compoundscategory. There were a number ofcomments received on the addition ofthe dioxin and dioxin-like compoundscategory and these are addressed indetail in the Response to Commentsdocument (Ref. 69). Most of thecomments on the toxicity data that EPApresented in support of the addition ofthe category concern the dioxin-like

compounds since most commentersseemed to agree that 2,3,7,8-tetrachlorodibenzo-p-dioxin (dioxin or2,3,7,8-TCDD) meets the criteria forlisting under EPCRA section313(d)(2)(B). A number of commentersdid not believe that there was sufficientinformation to add any of the dioxin-like compounds while severalcommenters argue that the data on theocta- and heptachlorodibenzo-p-dioxinsin particular were not sufficient.Commenters also argue that reliance onestablished toxicity equivalence factors(TEFs) does not provide sufficientsupport for determining that the dioxin-like compounds meet the EPCRAsection 313(d)(2)(B) criteria.

EPA disagrees with the commentersthat contend that there are not sufficientdata to add the dioxin-like compoundspursuant to EPCRA section 313(d)(2)(B).2,3,7,8-TCDD is generally recognized asone of the most studied toxiccompounds found in the environment.To require the degree of documentationsupporting toxicological classification of2,3,7,8 -TCDD as a necessary criterionfor determining that other dioxin-likecompounds exhibit dioxin-like toxicityor for listing under EPCRA section 313is an arbitrary and unrealistic criteria.As discussed in more detail in theResponse to Comments document (Ref.69), a more scientifically supportable setof criteria for determining if compoundsexhibit dioxin-like toxicity wasproposed by the World HealthOrganization European Centre forEnvironmental Health (WHO-ECEH) andthe International Programme onChemical Safety (IPCS) consultationgroup. These criteria include: (1) Acompound must show a structuralrelationship to TCDD; (2) a compoundmust bind to the Ah receptor; (3) acompound must elicit Ah receptor-mediated biochemical and toxicresponses; and (4) a compound must bepersistent and accumulate in the foodchain. Each of the 2,3,7,8 substitutedioxins and furans included in thedioxin TEQ approach meet these criteria(Ref. 3).

The commenters often quoted fromthe EPA Science Advisory Board (SAB)review of EPA’s draft dioxinreassessment, to help support the claimthat dioxin-like compounds other than2,3,7,8-TCDD should not be included inthe toxic release inventory. The SABreport is a complex documentcontaining a number of contrastingobservations. Care must be taken toaccurately capture the SAB’s concerns.For example, in their ExecutiveSummary, the SAB concluded that,‘‘The use of the TEFs as a basis fordeveloping an overall index of public

health risk is clearly justified’’; theycaution, however, ‘‘that practicalapplication depends on the reliability ofthe TEFs and the availability ofrepresentative and reliable data.’’ Intheir summary conclusions, the SABstated:

The document (EPA Draft Reassessment)represents a departure from the earlier EPArisk assessment for dioxin, which dealtprimarily with 2,3,7,8-TCDD. In addressing abroad range of dioxin-like compounds havingthe common property of binding to the Ahreceptor and producing related responses incells and whole animals, it createsopportunities for a holistic assessment of thecumulative impacts of these broadlydistributed anthropogenic pollutants. Thus,while the environmental concentrations ofeach compound alone may be too low toproduce effects of concern, the combinedexposure may be producing effects thatwarrant concern. The use of the concept ofTEFs and the concentrations of thecompounds in foods and environmentalmedia to produce an overall index of publichealth risk is clearly justifiable.

The character and thrust of thesestatements made by the SAB aresignificantly different from thoseselectively chosen by many of thecommenters opposing the addition ofsome or all of the dioxin-likecompounds. The apparent contradictionbetween these broad concludingstatements by the SAB and those citedby several commenters is due, in part,to commenters confusing the SABcriticisms of the text of the draftreassessment with statements about thegeneral state of scientific knowledge.The SAB clearly felt that EPA needed todo a more rigorous job of discriminatingbetween the inferences it drew about thetoxicity of 2,3,7,8-TCDD, other 2,3,7,8substitute dioxins and furans, anddioxin-like PCBs. Many of thecomments cited were intended to helpEPA generate a more rigorous scientificdiscussion in its final reassessmentdocument rather than to representsubstantive conclusions reached by theSAB on the nature of dioxin toxicology.Fully taking these concerns intoconsideration it was still the SAB’soverall judgment, as stated above, that‘‘the use of the TEFs as a basis fordeveloping an overall index of publichealth risk is clearly justified.’’

Some commenters argue that there arequalitative differences in the toxicity ofthe different 2,3,7,8-substituted isomersof polychlorinated dioxins (PCDDs) andfurans (PCDFs). Specifically, there arestructural differences between the moretoxic, lower chlorinated isomeric PCDDsand PCDFs and the higher chlorinatedcogeners to the extent that the octa- andhepta-PCDDs and PCDFs should not beadded to the list of EPCRA section 313



toxic chemicals. These arguments arenot valid for several reasons. First, thereare data from subchronic studies forboth octa- and hepta-PCDDS and PCDFswhich demonstrate dioxin-like effects(Refs. 19, 21, 79, and 80). The new WHOTEFs are based on these subchronicstudies (Ref. 78). While short-termstudies indicate limited dioxin-likeeffects of these chemicals, thesecontrasting results are readily explainedby the structural differences betweenthe octa- and hepta-PCDDS and PCDFscompared to the lower chlorinatedPCDDs and PCDFs. The relative potencyof the dioxin-like compounds is relatedto both their ability to bind to the Ahreceptor and their pharmacokineticproperties (Ref. 20). The water solubilityof PCDDs and PCDFs decrease withincreasing chlorine substitution. Hencethe octa- and hepta-PCDDS and PCDFsare significantly less soluble in aqueoussolutions compared to the lowerchlorinated PCDDs and PCDFs. Thesesolubility problems limit the amount ofchemical that can be absorbed in highdose acute toxicity studies. The lack ofeffect observed in the high dose acutestudies is consistent with the limitedaqueous solubility of these compounds.However, low dose subchronic studiesallow the chemicals to be betterabsorbed and bioaccumulate toconcentrations which producebiochemical and toxic effects (Refs. 19,21, 79, and 80). Once again this isconsistent with the evidence of dioxin-like effects of these chemicals observedin the low-dose subchronic studies.Although not legally required todetermine that a chemical meets thelisting criteria under EPCRA section313(d)(2)(B), it should be noted thathuman exposure to octa- and hepta-PCDDs and PCDFs are subchronic lowdose exposures, similar to theexperimental studies whichdemonstrate dioxin-like effects of thesechemicals (Refs. 19, 21, 79, and 80).

While there are structural differencesbetween the octa- and hepta- PCDDs andPCDFs compared to the lowerchlorinated PCDDs and PCDFs, thesedifferences result in quantitative notqualitative differences in the toxicity ofthese chemicals. The quantitativedifferences are demonstrated by thelower potency of the octa- and hepta-congeners compared to TCDD. Inaddition, the TEFs reflect thesequantitative differences by assigninglower TEF values to the octa- and hepta-PCDDS and PCDFs. While there islimited evidence that the shape of thedose-response curve for induction ofCYP1A1 activity in vitro foroctachlorodibenzo-p-dioxin (OCDD) is

different from TCDD, in vivo evidenceindicates that the dose response forCYP1A1 induction byoctachlorodibenzofuran (OCDF) in threetissues is equivalent to TCDD (Ref. 20).However, it should be noted that theseare quantitative not qualitativedifferences.

Commenters also argue that octa- andhepta-PCDDs and PCDFs should not belisted because ‘‘there is a growingconsensus in the scientific communitythat the potential risks posed by dioxinsare largely driven by a limited numberof dioxin and dioxin-like compounds(tetra-, penta-, and hexa-PCDDs andPCDFs and certain coplanar PCBs).’’ It isimportant to remember that, asdiscussed in Unit VI.F., EPCRA section313 is primarily a hazard-based ratherthan a risk-based statute. The ‘‘growingconsensus’’ on dioxin toxicity isprobably best captured by the revisedTEFs recently established by the WHO(Ref. 78). In this review the scientificevidence for ascribing values of relativetoxicity to octa- and hepta-PCDDs andPCDFs was specifically reviewed, asevidenced by the lowering of the TEFfor OCDD and OCDF by a factor of 10.In the course of the deliberations by theWHO panel of internationallydistinguished scientists, there was theopportunity to remove both octa- andhepta-PCDDs and PCDFs from the TEFlistings. However, the WHO panelconcluded that the best scientificinterpretation of the data available wasto leave hepta-PCDDs and PCDFsunchanged and reduce but not eliminateOCDD from TEQ calculations. Evenwith this reduced toxicity, OCDD andOCDF clearly meet the listing criteria ofEPCRA section 313(d)(2)(B).

EPA disagrees with the commentersthat contend that TEFs are not adequatesupport for listing chemicals underEPCRA section 313. The development ofTEFs has been a rigorous scientific effortinvolving a number of internationalpanels of scientific experts and hasinvolved the careful review of allrelevant scientific literature. EPAbelieves that the development andreview processes used for the generationof the TEFs was sound and representsa reasoned and reliable judgment on thedioxin toxicity of each of the 17 dioxinand dioxin-like compounds. TheResponse to Comments document (Ref.69) includes an extensive discussion ofthe history of the development of dioxinTEFs which demonstrates why EPAbelieves that the TEFs are wellsupported scientifically andconsequently have been openly adoptedby the international scientific andregulatory community. In addition, asEPA has previously explained (59 FR

61432), the Agency believes that EPCRAsection 313 allows a chemical categoryto be added to the list, where EPAidentifies the toxic effects of concern forat least one member of the category andthen shows why those effects canreasonably be expected to be caused byall other members of the category. Here,individual toxicity data are not availablefor all members of the category;however, there is sufficient informationto conclude based on generally acceptedscientific principles, that all of thesechemicals are highly toxic based onstructural and physical/chemicalproperty similarities to those membersof the category for which data areavailable.

Thus, EPA reaffirms that there issufficient evidence for adding dioxinand dioxin-like compounds on EPCRAsection 313 pursuant to EPCRA section313(d)(2)(B) based on the availablecancer and other serious chronic healtheffects data for these compounds.Therefore, EPA is finalizing the listingof dioxin and dioxin-like compounds onthe EPCRA section 313 list.

a. Manufacturing only qualifier fordioxins and dioxin-like compoundcategory. Comments were mixed withregard to EPA’s proposal to add amanufacture only qualifier to the dioxinand dioxin-like compounds category.Some commenters agree with EPA’sstatements in the proposed ruleconcerning the burden reductionaspects of the qualifier and the fact thatas a result, the dioxin reporting wouldfocus on facilities that manufacturedioxin and dioxin-like compoundsrather than those that process orotherwise use raw materials containingdioxin and dioxin-like compounds thathave accumulated in those rawmaterials. Some commenters state thatthe qualifier would avoid duplicativetesting and administrative costs amongmany processing and using industrieswhich do not necessarily dischargedioxins or furans into the environment.Some commenters state that all releasesof dioxin and dioxin-like compoundsmust be reported, not just thoseresulting from the manufacture of thesechemicals. Other commenters note thata significant gap is created by themanufacture only qualifier because itwould exclude the processing andotherwise use of chemicals than containdioxin and dioxin-like compounds as aresult of the processes used tomanufacture them. Commentersspecifically cite pentachlorophenol asan example of a chemical that iscontaminated with dioxin and dioxin-like compounds from its manufacturingprocess. Commenters state that theprocessing and use of such chemicals



result in the release of dioxin anddioxin-like compounds that would gounreported under the manufacture onlyqualifier. One commenter states that ifthe qualifier is finalized the commenterwould like to see language that requiresfacilities to report if the backgroundlevels of dioxin are modified,concentrated, or somehow added to inthe manufacturing process. Anothercommenter states that if the Agencywants to exempt animal sources ofdioxin, such as dioxin contained inmeat and other animal products, itshould craft the rule to do so and notcut out other significant sources ofdioxin in the environment by exemptingall facilities that process materialcontaining dioxin.

EPA believes that in order to obtainany reporting on dioxin and dioxin-likecompounds a very low threshold isrequired, which is several orders ofmagnitude lower than the thresholds forother PBT chemicals. At such a lowreporting threshold it is estimated thatthousands of reports could potentiallybe filed by facilities, mainly foodprocessing facilities, due to the amountof dioxins in the raw materials theyprocess. The dioxins found in the meatand dairy products that food processorshandle have been previously released,circulated in the environment, andbioaccumulated in animals; thus theseare not additional loadings to theenvironment but loadings that havealready occurred and cycled through theenvironment due to the persistence andbioaccumulative properties of thesecompounds. The unique combination ofvery low thresholds, the number of foodprocessors that would be required tofile, and the fact that they would befiling because of the bioaccumulation ofpreviously released material, led EPA toadd the manufacture only qualifier tothe dioxins category. The qualifier wasadded in response to the unique set ofconditions that apply to the reporting ofdioxin and dioxin-like compounds. Themanufacture only qualifier was added toreduce reporting burden on facilities,mainly in the food processing industry,that results from the uniquecombination of circumstances related tothe reporting for these chemicals and tofocus on those activities that add to theloading of dioxins in the environmentrather than on activities dealing withpreviously released and bioaccumulatedchemicals.

However, EPA acknowledges that thecommenters who noted that theprocessing and otherwise use ofchemicals contaminated with dioxinand dioxin-like compounds as a resultof their manufacturing process, arecorrect that these would be newly

created and thus any releases of dioxinand dioxin-like compounds that are dueto the processing and otherwise use ofsuch chemicals would be new loadingson the environment. In addition, EPAagrees, and has never stated otherwise,that the processing or use of chemicalscontaminated with dioxin and dioxin-like compounds could result in therelease of these chemicals to theenvironment. Given the fact that themanufacture of certain chemicals alsoresults in the manufacture of dioxin anddioxin-like compounds that remain withthose chemicals as impurities, EPAbelieves that releases and other wastemanagement quantities for the dioxinand dioxin-like compounds found asimpurities with those chemicals shouldbe reported under the dioxin anddioxin-like compounds category. Thus,EPA’s original proposal would havecreated an exemption that was toobroad. Consequently, EPA is modifyingthe qualifier to read as follows:

Dioxin and dioxin-like compounds(Manufacturing; and the processing orotherwise use of dioxin and dioxin-likecompounds if the dioxin and dioxin-likecompounds are present as contaminants in achemical and if they were created during themanufacturing of that chemical)

EPA believes that narrowing itsproposal in this fashion is consistentwith EPA’s intention to focus on newloadings to the environment for dioxinand dioxin-like compounds.

One commenter states that the activityqualifier for dioxin and dioxin-likecompounds is intended to minimize theburden of reporting on naturally-occurring constituents of raw materialsand that this qualifier would beconsistent with the PBT criteria set forthby Canada’s Department of theEnvironment in their Toxic SubstancesManagement Policy. The commenterstates that the Canadian policy requiresa chemical to be ‘‘predominantlyanthropogenic’’ to be considered a PBTchemical. The commenter states thatEPA’s assumption that thesecompounds are ubiquitous in rawmaterials may be incorrect. Thecommenter further states that thesecompounds may be formed incombustion processes due to theubiquitous presence of precursorchemicals in coal, such as naturalhydrocarbons and chlorine. Thecommenter argues that it is notreasonable to expect the hydrocarbonnor the chlorine to be removed from theraw material prior to combustion. Thus,the ‘‘incidental manufacture’’ ofextremely minute amounts of thesechemicals may be unavoidable.

EPA disagrees that the sole basis forits qualifier was to minimize the burden

of reporting. The qualifier was added inresponse to the unique set of conditionsthat apply to the reporting of dioxin anddioxin-like compounds. As noted above,EPA was, and remains, concerned that,because dioxin is ubiquitous in theenvironment, the reporting be focusedon those facilities that actually add tothe environmental loading of thesechemicals. EPA did not state that dioxinand dioxin-like compounds would beubiquitous in all raw material and didnot intend to imply that all rawmaterials contain these compounds.EPA stated that these compounds areubiquitous in the environment and,thus, facilities that process rawmaterials containing these compoundsmight have to report because of the verylow reporting threshold necessary toobtain reports from any sources,including those facilities thatcoincidentally manufacture them. Inaddition, although the qualifier may beconsistent with Canada’s ToxicSubstances Management Policy, EPAhas not proposed any requirement thata chemical must be ‘‘predominantlyanthropogenic’’ to be considered a PBTchemical under EPCRA section 313. Thecommenter is correct that dioxin anddioxin-like compounds may bemanufactured in combustion processesdue to the ‘‘ubiquitous presence ofprecursor chemicals’’ and that such‘‘incidental manufacture’’ may beunavoidable. However, the merepresence of the dioxin precursors willnot guarantee dioxin production. Thereare well documented conditions thatfavor the formation of dioxins duringcombustion, and in some cases it maybe possible to stringently control fuelcomposition, flow times, temperature,and other conditions in order tosubstantially reduce or even eliminatethe incidental manufacture of dioxinsduring combustion processes.

b. Withdrawal of the proposal toinclude dioxin-like PCBs in the dioxincategory. Several commenters supportEPA’s decision to withdraw theproposal to modify the current PCBlisting and move the 11 co-planar PCBsto the proposed dioxin and dioxin-likecompounds category and retain the co-planar PCBs as part of the current PCBlisting. Two commenters support EPA’sdecision to leave co-planar PCBs out ofthe dioxin and dioxin-like compoundscategory since the structure,metabolism, gene regulation, andtoxicities of PCBs are substantiallydifferent from those of 2,3,7,8-tetrachlorodibenzo-p-dioxin. Onecommenter takes exception to the use ofthe term ‘‘dioxin-like’’ as a way ofdescribing PCBs and other chlorinated



compounds and agrees that the PCBsshould be kept out of the ‘‘dioxin-like’’class. Other commenters also argue thatPCBs are more appropriately classifiedas PCBs, not dioxin-like compounds.

One commenter contends that sincethese chemicals are no longer allowed tobe distributed in commerce,maintaining a separate EPCRA section313 chemical category for thesechemicals will streamline datamanagement. This approach will alsoenable EPCRA section 313 reporting forthis category of chemicals to be moreconsistent with existing data alreadycollected for the purposes of complyingwith TSCA. Further the commenterasserts that approach is also consistentwith EPA’s Reinvention Policy and willenable ‘‘one-stop’’ reporting.

Another commenter asserts that it isunclear just how many grams of dioxin-like compounds would be excludedfrom this reporting since there areconflicting Agency proposals at work:the first is a much lower threshold fordioxins. The second includes onlydioxins manufactured on site. SincePCBs are not generally manufactured onsite, these 11 dioxin-like compoundswould not be reported under theproposal if they were included asdioxins. On the other hand, if alldioxins (manufactured, processed, andotherwise used) are included in theEPCRA section 313 thresholddetermination, these 11 PCBs couldmake the difference between a facility’sreporting or not reporting dioxins. If thedioxin threshold remains as proposed,then the 11 PCBs should remain withthe PCB category. Further thecommenter argues that if the thresholdis expanded to include sources otherthan those that manufacture dioxin on-site, then the PCBs should be part of thedioxin-like compounds category. If EPAdoes not modify the dioxin threshold toinclude all dioxin uses, the 11 dioxin-like PCBs should remain with the PCBcategory.

While EPA agrees with thecommenters that the co-planar PCBsshould remain as part of the currentPCB listing, the Agency does not agreewith all of the reasons the commentershave presented. As EPA stated in theproposed rule:

. . .EPA has determined that all PCBspersist and bioaccumulate. Since PCBspersist and bioaccumulate, EPA believes thatthey should be subject to lower reportingthresholds, and thus there is no need to movethe 11 co-planar PCBs to the proposed dioxinand dioxin-like compounds category.Therefore, EPA has decided to withdraw itsproposal to modify the current listing forPCBs and instead proposes to lower thereporting thresholds for the current PCB

listing which covers all PCBs. EPA believesthat, since all PCBs persist andbioaccumulate, it is appropriate to lower thereporting threshold for this class of chemicalsand that this proposal is less burdensomethan requiring separate reporting on thedioxin-like PCBs as part of the proposeddioxin and dioxin-like compounds category(at 64 FR 710).

EPA did not base its decision on adetermination that co-planar PCBs werenot ‘‘dioxin-like’’ and keeping themunder the current PCB listing should notbe interpreted as such a determination.Also, since EPA is not expanding thequalifier for the dioxin and dioxin-likecompounds category to include allprocessing and otherwise use activities,the amounts of co-planar PCBs thatmight be reportable under the categorywould not be expected to contributesignificantly to thresholddeterminations for the category at mostfacilities.

Four commenters specifically do notsupport EPA’s decision to withdraw theproposal to modify the current PCBlisting. Commenters assert that theaggregation of dioxin-like PCBs togetherwith other PCBs will fail to providereporting of useful information ondioxin-like PCBs. The commenterseither contend that the PCBs should beincluded in the dioxin-like compoundscategory or the PCBs and all dioxin-likecompounds should be reportedseparately. One commenter argues thatthe aggregate reporting of dioxin-likePCBs and other PCBs fails to provideany information on the release ofdioxin-like PCBs to meet the research,regulatory, or public information goalsof EPA’s proposal. This commenterraises several points. The commentercontends that specifically, even if somefacilities releasing dioxin-like PCBsreported these releases as a portion oftheir total PCBs production of 10pounds annually or greater, informationon dioxin-like PCBs releases would stillbe unobtainable. The commenter assertsthat aside from the food chain, wheresome dioxin-like PCBs tend toconcentrate disproportionately,available measurements indicate thatthese dioxin compounds are only asmall portion of the mass of all PCBcompounds. The commenter furtherargues that some of these dioxincompounds such as PCB-126 are farmore toxic than other dioxin-like andnon dioxin-like PCBs. Thus, thecommenter asserts that in addition to allof the problems of dioxin-like chemicalaggregate reporting, one would notknow what, if any, portion of the totalPCBs reported were dioxin-like. Thecommenter contends that the dioxin-like co-planar PCBs also should be

reported individually so that a TEQ forall 28 dioxin and dioxin-likecompounds can be calculated. Anothercommenter argues that based oninformation about current body burdensof co-planar PCBs, they compose asmuch or an even greater percentage ofone’s overall exposure than the 17dioxin and dioxin-like compounds. Thiscommenter cites an EPA document thatstated that: ‘‘[e]stimates of exposure todioxin-like CDDs and CDFs based ondietary intake are in the range of 1-3 pgTEQ/kg/day. Estimates based on thecontribution of dioxin-like PCBs totoxicity equivalents raise the total to 3-6 pg TEQ/kg/day.’’ Some commenterscontend that reporting the co-planarPCBs differently from the 17 dioxin anddioxin-like compounds would make anyassessment of the overall release andpotential health impact of these types ofcompounds difficult. One commenterargues that PCBs are currentlycontaminating sediments and industrialsites nationally and have ruined fish asa natural resource for humanconsumption across the nation and thatthe distinction between dioxin-likePCBs and dioxin-like compounds madeunder this rule is a distinction withouta difference. This commenter urges EPAto include all dioxin-like compounds,including PCBs, in the dioxin-likecompounds category and to requirestrict accounting from all sources whichrelease these compounds and whichmanufacture them, incidentally or bydesign.

One commenter contends that thefailure to report dioxin-like PCBs as adistinct entity separate from other PBTchemicals may hold back informationon a significant portion of the totaldioxin-like hazard from releases byfacilities that report under EPCRAsection 313, even if all dioxin and furanreleases were reported. The commenterargues that environmental exposuremeasurements, such as those from fishin San Francisco Bay and from humantissues nationally, indicate that dioxin-like PCBs contribute a very significantportion of the total toxicity hazard fromexposure to all dioxin-like chemicals.The commenter also asserts that PCBreleases might in some cases representan inadequately measured yetsignificant portion of the ongoing dioxinrelease hazard. If, for example, PCB-126comprises even 1⁄10 of the PCBs releasemeasured from San Francisco Bay Areasources, it would contributesubstantially to total dioxin-like toxicityemission from some of these facilities.The commenter contends that thefailure to provide release information ondioxin-like PCBs under EPA’s proposal



may result in failure to inform thepublic about a significant portion of thetotal dioxin toxicity that is still released.

EPA agrees that PCBs are toxicchemicals of concern that have causedsignificant contamination of theenvironment and that co-planar PCBsmay have dioxin-like health effects.However, this does not, in itself, createa requirement that the co-planar PCBsmust be moved from their current PCBlisting to the dioxin and dioxin-likecompounds category. EPA does notbelieve that the co-planar PCBs must bereported separately from the non co-planar PCBs because they may be moretoxic than other PCBs. In general,chemical categories consist of chemicalsthat vary in their level of toxicity butthis variability alone does not mean thatrelease information must be reportedseparately for each chemical in thecategory. EPA believes that all PCBs areof concern and that leaving the co-planar PCBs under the current PCBlisting will still provide the public withuseful and important information. Indeciding not to move the co-planarPCBs to the dioxin category, EPA alsoconsidered any potential additionalburden associated with splitting thereporting for PCBs into two differentlistings, as well as the fact that facilitiesare not likely to be able to determinequantities of the specific co-planar PCBsin question. Specifically, EPAconsidered the lack of readily availableestimation techniques for determiningquantities of co-planar PCBs, as opposedto other PBT chemicals and the PCBlisting as a whole (co-planar PCBs willbe included in the estimation of PCBs).EPA determined that since all PCBs areof concern and since the reportingthreshold for all of the PCBs under thePCB listing would be loweredsubstantially, that requiring separatereporting on the co-planar PCBs was notwarranted.

One commenter contends that thefailure to report dioxin-like PCBs wouldfail to provide information on thatsubgroup of dioxin-like compounds forwhich there is the greatest need foradditional information. The commenterargues that EPA’s evaluation of theemission of dioxin-like chemicalsnationwide shows that there is lessinformation on releases of dioxin-likePCBs than there is for other dioxincompounds. The commenter asserts thatsimilarly, their survey of sourceinformation in the San Francisco BayArea shows that, despite manymeasurements of dioxin and furanreleases, and despite a handful of sourcemeasurements confirming PCBs, thereare few or no source measurements fordioxin-like PCBs. The commenter

argues that the information on releasesfrom facilities is even less available forthe dioxin-like PCBs than it is for theother dioxin-like chemicals and thatEPA’s analysis in the proposed rule failsto consider adequately this extremeneed for source release information.

EPA agrees that there is far lessinformation available on co-planar PCBsthan for dioxin and other dioxin-likecompounds. Much less testing andanalysis has been conducted for thesechemicals. This would pose anadditional problem for reporting on theco-planar PCBs separately from theother PCBs. EPA considered the abilityto estimate quantities of specific co-planar PCBs and determined that thereis a lack of readily available estimationtechniques for co-planar PCBs. In fact, atthis time, the Agency would not be ableto provide guidance for making areasonable estimate of quantities of co-planar PCBs that may be manufacturedin certain processes. In addition, EPCRAsection 313 does not require anyadditional monitoring beyond thatrequired by other provisions of law solisting the co-planar PCBs separatelywould not mean that additional sourcemeasurements would be developed.Thus, listing under EPCRA section 313will not require the development ofadditional monitoring data that could beused to make reasonable estimations ofthresholds or releases and other wastemanagement quantities. Given the lackof information available for estimatingquantities of co-planar PCBs and thepotential additional burden associatedwith splitting the reporting for PCBsinto two different listings, EPA decidedto leave the co-planar PCBs under thecurrent PCB listing.

One commenter asserts that theburden on industrial producers ofdioxin-like PCBs is not an appropriatereason for excluding dioxin-like PCBsfrom the dioxin and dioxin-likecompounds category because this willnot meet EPCRA’s right-to-know goal fordioxin-like PCBs. The commentercontends that EPA’s cost analysis doesnot address dioxin-like PCBsspecifically and thus, EPA’s rationale inUnit VI. of the preamble of the proposedrule (64 FR 688) that ‘‘this proposal isless burdensome than requiring separatereporting on the dioxin-like PCBs’’ isnot based on any cost analysis in EPA’sproposal. The commenter argues furtherthat in any case, aggregate reporting ofdioxin-like PCBs with a 10 poundthreshold will fail to obtain the requiredreporting on a substantial majority ofdioxin-like PCBs or to provide neededinformation about dioxin-like PCBreleases and therefore, EPA’sperceptions regarding reporting burden

cannot properly outweigh the public’sneed for the information which isdenied under EPA’s new proposal. Thecommenter refers to the proposal toretain dioxin-like PCBs under the PCBlisting as the ‘‘less than 10 poundsexemption.’’ The commenter asserts thatexisting evidence demonstrates thatmany dioxin producing processes suchas waste incinerators, oil-fired boilers,and other processes also producepotentially significant amounts of PCBswhich are released to the environmentfrom these facilities. The commenterargues that this evidence suggests that atleast some facilities reporting underEPCRA section 313 are likely to bereleasing dioxin-like PCBs as a portionof these PCB releases. The commentercontends that the evidence also suggeststhat most or all releases of dioxin-likePCBs at these facilities may beassociated with total annual PCBproduction of less than 10 pounds perfacility and thus, EPA may not meet therequirement that a substantial majorityof dioxin-like PCBs be reported underthis exemption.

Reporting burden was not the sole oreven most important factor in EPA’sdecision not to move the co-planar PCBsto the dioxin and dioxin-likecompounds category. In reaching itsfinal decision, EPA considered the factthat additional information would becollected on all PCBs by lowering thethreshold for the PCB listing and thatthe additional information that wouldbe collected was sufficient for EPCRAsection 313 purposes, as well as lessburdensome. Even in its proposal EPAdid not conclude that reporting burdenalone outweighed the public’s right-to-know about chemical releases. As statedin other responses to this issue, EPA isalso concerned about the ability toestimate quantities of specific co-planarPCBs since there is a lack of readilyavailable estimation techniques for co-planar PCBs. It is correct that EPA didnot attempt to quantify the reduction inburden that would result from notincluding the co-planar PCBs in thedioxin and dioxin-like compoundscategory. However, EPA believes that itwould be inherently less burdensomesince facilities would not have toattempt to determine if they canestimate co-planar PCBs separately andfiling one form would obviously beeasier and less confusing thanattempting to track and adjust theamounts that must be applied to twodifferent listings and filing two reports.With regard to the issue of obtainingreporting on a substantial majority of‘‘dioxin-like PCB’’ releases, as stated inEPCRA section 313(f)(2), the



determination of whether a revisedthreshold meets the ‘‘substantialmajority’’ standard is measured againstthe ‘‘total releases of the chemical at allfacilities subject to the requirements ofthis section.’’ As EPA stated in theproposed rule:

For purposes of determining whatconstitutes a ‘‘substantial majority of totalreleases’’, EPA interprets ‘‘facilities subject tothe requirements’’ of section 313 as thefacilities currently reporting, ... (at 64 FR689).

Currently, facilities required to reporton PCBs must report on all PCBs, notjust the co-planar PCBs or any otherindividual PCBs. The current listingincludes all PCBs. Consequently EPAdoes not believe that the requirementsof section 313(f)(2) function as animpediment to its decision to withdrawits proposal to include the co-planarPCBs in the dioxin and dioxin-likecompounds category. As discussed inUnits II.B. and VI.A., EPA believes thatit has satisfied the requirements ofEPCRA section 313(f)(2), without theneed for quantitative support.

c. Listing dioxin and dioxin-likecompounds as a category versusindividual listing of each chemical.Some commenters contend thatreporting dioxin and dioxin-likecompounds as one category would notprovide useful information and askedthat the individual compounds bereported. One commenter recommendsthat reporting on individual chemicalspecies should be required when theinformation is available. Onecommenter who supports the individualreporting of all of the dioxin and dioxin-like compounds, states that the amountsof individual dioxin compoundsreleased from facilities is part of theimportant public information needed toassist research and policy development.The commenter claims that reporting asa category will not provide the publicwith the information to assess therelative hazards of releases since onedioxin-like compound can have arelative hazard several orders ofmagnitude less than 2,3,7,8-tetrachlorodibenzo-p-dioxin. Thiscommenter also states that differentsources often emit a different mix ofdioxin compounds and that thisinformation is widely used to tracedioxin contamination to specific rootcauses. The commenter states that therelative amounts of the many differentdioxin-like chemicals in a sample arecompared to create a ‘‘profile’’ whichmight match the profile created byemission from a particular source. Thecommenter did not support thereporting of the category based on toxic

equivalents (TEQs) but thought itimportant for the users of the data to beable to determine TEQs. Some othercommenters make the same generalargument that individual isomerreporting is needed to facilitate riskcharacterization including transport andfate of the different isomers.

Some commenters contend thatcertain dioxin-like compounds such asoctachlorodibenzo-p-dioxin andoctachlorodibenzofuran should not bereported since they are ubiquitous in theenvironment and are the least toxicunder the toxic equivalent factors(TEFs). One commenter states that EPAshould require reporting only for themost toxic congeners: the tetra-, penta-, and hexa-congeners and not the hepta-and octa-congeners which are less toxicand less relevant from a risk standpoint.Other commenters state that only2,3,7,8-tetrachlorodibenzo-p-dioxinshould be reported. Some commenterscontend that reporting for thesecompounds should not be required atthe same reporting threshold as theother dioxin and dioxin-likecompounds. Most commenters whowould like to exclude certain dioxin-like compounds did not indicate thatthey wanted individual reporting of theremaining compounds. Somecommenters support the reporting ofdioxin and dioxin-like compounds as acategory, as EPA proposed. Onecommenter states that if reporting is notlimited to just 2,3,7,8-tetrachlorodibenzo-p-dioxin, then thecommeter supports EPA’s proposal tolimit the category to only the 7 dioxinsand 10 furans listed in the proposedrule.

After consideration of all of thecomments on this issue, EPA hasdecided that the best way to report ondioxin and dioxin-like compounds is toreport them as a category. This isconsistent with the way EPA hasaddressed other groups of chemicalsthat share the same toxic effect and inthis case are also generated as complexmixtures. As discussed in UnitsVI.G.1.d. and e., reporting as a categoryand based on TEQs would not provideusers of the data with information onwhich compounds contribute the mostto the TEQ total. In addition, requiringfacilities to report each compoundindividually would impose anadditional burden on the industries thatwill be required to report. However,EPA agrees that being able to determinethe amounts of the individual dioxinand dioxin-like compounds would makethe data more useful. Therefore EPAwill add a section to the Form R thatwill require the reporting facility toprovide the distribution of dioxin and

each dioxin-like compound for the totalquantity that the facility is reporting. Ifa facility has information on thedistribution of the dioxin and dioxin-like compounds, the facility must reporteither the distribution that bestrepresents the distribution of the totalquantity of dioxin and dioxin-likecompounds released to all media fromthe facility; or its one best media-specific distribution. This information isonly required if it is available from thedata used to calculate thresholds,releases, and other waste managementquantities, no additional analysis isrequired. As with all other reportingunder EPCRA section 313, thisinformation will only be required if thefacility has information that can be usedto make a reasonable estimate of thedistribution from the available data.With the distribution of congenersreported on each Form R, the user of thedata can determine the grams of dioxinand each individual dioxin-likecompound that makes up the totalquantity reported on the Form R. Underthis reporting mechanism, all of theinformation that the commenters havestated is important to determining thesignificance of quantities reported underthis category will be provided to thepublic but the reporting facilities willstill only have to file one report. Any ofthe other possible options, such asreporting in terms of TEQs or reportingeach individual compound separately,either do not provide all of theinformation the commenters would liketo have, or impose too great anadditional reporting burden withoutproviding the public with significantadditional information.

d. Using mass versus TEQs forreporting releases and other wastemanagement quantities. Most of thecommenters on this issue suggest thatEPA should require that release andother waste management data for thedioxin and dioxin-like compoundscategory be reported in terms of TEQsrather than in terms of absolute grams.The following list is a summary of thevarious reasons provided by thecommenters in support of reportingdioxin and dioxin-like compounds interms of TEQs: (1) All dioxin datareported under other EPA programs aswell as other Federal and stateregulatory programs are reported interms of toxicity equivalents; (2) thepublic is familiar with dioxin datareported in terms of TEQs and reportingin other units would cause confusionand be misleading; (3) TEQs providemore meaningful information than totalweights since they take into account therelative toxicities of the various dioxin-



like compounds; (4) facilities that reportunder other regulatory programs arelikely to rely upon TEQ data that theyalready have; (5) use of absolute massmay cause misleading comparisonsbetween grams and grams TEQ; (6)releases reported in absolute mass makeit difficult to assess the impacts thesecompounds may have on theenvironment due to the differences intheir toxicities; and (7) reports based onTEQs would provide far more usefulinformation about potential communityrisks than reports based on the totalmass of compounds in the categorysince more risk information would beprovided.

One commenter argues that EPA’sjustification for adding the category isbased on assumptions about the toxicityof the other dioxin-like compoundsrelative to dioxin itself and that giventhese assumptions the reporting of TEQsmakes sense. The commenter states thatunder current TEQ schemes, thesedioxin-like compounds are all less toxicthan dioxin, as much as 1,000 timesless, and that facilities should notsimply sum emissions on the Form R forcompounds with such drasticallydifferent toxicities. One commentersuggests that EPA require the reportingof both grams and TEQs and if not both,then just grams. This commenter assertsthat if only grams are reported, the datawill be somewhat difficult to interpretwithout any further information, but ifonly TEQs are required to be reported,then there are uncertainties about whatand how much is discharged.

Another commenter states that if EPAis going to require dioxin reporting as agroup and not by specific chemicals,TEQ reporting is an unnecessarycomplication. The commenter statesthat the TEFs used to formulate theTEQs are constantly reviewed andchanged, which would necessitate EPAreview and possible reissuance of newTEFs each year. The commenter arguesthat this would make previous years’TRI data impossible to compare oncethe changes were made.

While EPA recognizes that TEQs area common way of expressing quantitiesof dioxin-like compounds, EPA does notbelieve that reporting in these unitswould be the best or most appropriateway to report for the dioxin and dioxin-like compounds category under EPCRAsection 313. Although some commentersbelieve that TEQ reporting should beused since not all of the dioxin-likecompounds are as toxic as dioxin itself,EPA has determined that all of thedioxin-like compounds meet the listingcriteria of EPCRA section 313. Since allof these compounds meet the listingcriteria, the actual mass of each member

of the category should be reported. Todo otherwise would deny the publicinformation on the actual quantities oftoxic chemicals entering theenvironment. It would also beinconsistent with all other reporting ofEPCRA section 313 toxic chemicalssince none of them are reported basedon relative toxicities. In addition, thiswould be inconsistent with EPCRAsection 313(g)(1)(C)(iv) which requiresthat ‘‘the annual quantity of the toxicchemical entering each environmentalmedium’’ be reported.

Some of the commenters state thatTEQs should be used because theyprovide more risk information to thepublic than just reporting mass. WhileTEQs do provide information on relativetoxicity, EPA does not believe thatincreasing the amount of riskinformation is a basis for changing theEPCRA section 313 method for reportingfrom mass-based to relative toxicity-based. As discussed in Unit VI.F.,EPCRA section 313 is not a risk-basedprogram, and reporting is not intendedto communicate information aboutrelative risks. Rather it provides localcommunities with data on release andother waste management quantities onlisted toxic chemicals, so that they mayuse the data in conjunction withinformation on chemical properties(e.g., persistence and bioaccumulation)and site-specific information todetermine if releases present a potentialrisk. It is also not clear, as somecommenters state, that the public ismore familiar with dioxin data reportedin terms of TEQs or that they willunderstand TEQs any better than grams.

EPA does not believe that the fact thatother programs require reporting inTEQs and that facilities will alreadyhave TEQ information is a significantreason to require TEQ reporting underEPCRA section 313. Since the first pieceof information that is required todetermine TEQs is the grams of dioxinand each dioxin-like compound, thesefacilities should already have the gram-based information they would need. Inaddition, as stated above, EPCRAsection 313 reporting serves thepurposes of EPCRA section 313; otherprograms, e.g., the CWA, are risk-basedcommand and control programs.

Several commenters also disagreewith the concerns that EPA raised in theproposed rule, which were:

. . .there are three significant disadvantagesto reporting in TEQs. First, revisions in TEFfactors for individual dioxin-like compoundsin future years would require changes to thecalculations in the reported release and otherwaste management quantities, thus makingyear to year comparisons more difficult,unless the particular dioxin-like compounds

are identified. Second, some facilities maynot be able to report in TEQs, since, althoughthey may be able to estimate a mass quantityfor the category as a whole, they may nothave enough information to estimate therelative distribution of all category members.Third, TEQ reporting would be different fromall other TRI reporting, which is mass-based,and may cause additional confusion. (at 64FR 712-713)

Some commenters contend that EPA’sfirst concern is not valid since theEPCRA section 313 reportingrequirements have been changed severaltimes in the past in spite of difficultiesin comparing future reports to pastperformance. Two commenters statethat this same logic could be applied tothe use of AP–42 factors which EPAacknowledges have been revised andrefined over the years, and that this alsodiminishes the value of year-to-yearreporting comparisons. One commentersuggests that EPA could minimize anyconfusion that might be caused by asubsequent change in one or more TEFsby each year specifically publishing orcross referencing the TEFs that must beused for that reporting period.

One commenter contends that EPA’ssecond and third concerns appearedweak in light of the much greater riskinformation provided by a TEQapproach. Some commenters contendthat EPA’s third concern is not validsince the reporting requirement beingproposed for dioxin and dioxin-likecompounds is different whether TEQsare used or not. One commenter statesthat the third concern is clearly dwarfedby the confusion that would ensue if alldioxin-like compounds were reported asequivalent, when the hazards vary by afactor of 500. One commenter states thatreporting dioxin on a TEQ basis willcause more rather than less confusion ifthe public mistakenly compares data ingrams with data presented in gramsTEQ. Some commenters agreed with theconcerns EPA expressed in thepreamble. One commenter states that itagreed with these concerns but that theconcern about year-to-year comparisonsbeing more difficult also applies to thereporting of a single mass value for theentire category. The commentercontends that since the amounts of theindividual dioxin-like compoundswould not be known, if TEFs change,one cannot adjust previously reportedvalues to reflect the changes in TEFs.This commenter suggests that in orderto make the information reported ofgreatest use, the mass of dioxin andeach of the dioxin-like compoundsshould be reported once a TEQthreshold is exceeded.

One commenter argues that whileTEQs are a valid and scientifically



sound metric for reporting the likelyhealth hazard of a compound, that wasnot the intended purpose of the EPCRAsection 313 reporting requirement. Thecommenter claims that reporting dioxinand dioxin-like compounds in TEQswill cause confusion, since all otherreporting under EPCRA is done in termsof mass and does not take toxicity intoaccount.

EPA believes, as do some of thecommenters, that the concerns that wereexpressed in the proposed rule forreporting dioxin and dioxin-likecompounds in terms of TEQs underEPCRA section 313 are valid. EPAdisagrees with those commenters whoclaim that since other changes inreporting have occurred, such asrevisions to AP-42 emission factors,there should be no concern for thechanges that might occur in TEFs andthe resulting TEQs. The fact that certainchanges have occurred in reportingrequirements or methods of estimationand that those changes may makecertain year-to-year comparisons moredifficult does not reduce the concern forknowingly selecting reporting units,based on relative toxicity as opposed toemission factors, that have changed inthe past and may well change in thefuture. Also, EPA would be required tochoose a particular set of TEFs (i.e., asof 1999) and would need to amend themby rulemaking each time the TEFs wererevised. Changes in TEFs and theresulting TEQs would be unlike any ofthe past changes in EPCRA section 313reporting since none of these reportingchanges were related to the relativetoxicity of chemicals that meet thelisting criteria of EPCRA section 313.The cross referencing or publishing ofthe TEFs that must be used for eachreporting period would still not allowyear-to-year comparisons since withoutknowing a facility’s distribution of eachof the category members the TEQ cannotbe recalculated. EPA’s concerns thatsome facilities may not be able to reportin terms of TEQs are also valid.Although most facilities that will beable to make reasonable estimations forthe dioxin and dioxin-like compoundscategory should be able to report interms of TEQs, there may be some thatcan only report in actual mass units andthey should not be exempt fromreporting. EPA is also still concernedthat TEQs would be different than otherEPCRA section 313 reporting units,since they are not based on absolutemass, and that this could causeconfusion. EPA does not agree with thecommenters that state that this does notmatter since the reporting for the dioxinand dioxin-like compounds category is

going to be different anyway. The onlyreal reporting difference for the dioxinand dioxin-like compounds category isthat the reporting units are in gramsrather than pounds. To determine theamounts in pounds all that one wouldhave to do is multiply the grams by0.002204. However, TEQ reportingwould be much different since in orderto understand the reported value onewould need to understand the basis forTEFs, what they are, how they relate todioxin, and how TEQs are calculatedfrom the individual TEFs. Thisobviously requires more knowledge onthe part of the data user than simplyunderstanding different units of massand does have the potential to causesome confusion.

One commenter contends that neithertotal mass nor TEQ reporting providessufficient information on reduction inpotential exposure and risk. Thecommenter asserts that it is possible thata facility could reduce its dioxin TEQwhile releasing a greater mass of dioxin-like compounds, but neither total massnor TEQ reporting would really providea good picture of what a facility wasdoing. The commenter suggests that ifEPA wants to provide TEQ informationto the public, it should also requirefacilities to report dioxins by individualchemical, rather than as a group.

Another commenter that favors thereporting of dioxin and dioxin-likecompounds as individual chemicalsclaims that reporting as a category butin TEQs would still fail to reveal theamounts of individual dioxincompounds released. The commenterargues that this alternative wouldprovide no information on individualcompounds for use in tracing dioxinsource profiles. The commentercontends that reporting in TEQs wouldprovide better information on therelative toxicity hazard based upontoday’s toxicity information but thatinformation on the relative toxicity ofthe many dioxin-like chemicals isimproving and thus toxicity factors forsome of these compounds will changein the future. The commenter claimsthat in future years the Inventory wouldhave to choose between keeping the oldtoxicity calculation (and becomingirrelevant in comparison with otherresearch data), or changing the toxicitycalculation (and becoming irrelevant fortracking changes in dioxin release ratesover time). The commenter contendsthat the need to aid research and policydevelopment based on current scienceand the need to track release rates overtime are fundamental to the Inventory’spurpose and that this alternative mustbe rejected as just another ill-advisedaggregate reporting scheme. The

commenter recommends that EPArequire the reporting of dioxin anddioxin-like compounds in the way thesecompounds are measured and analyzedby scientists and government agencies,as individual chemicals, and consideran additional service by EPA tocalculate and report dioxin toxicity asTEQ for the year-to-year data using themost recent toxicity information whichbecomes available.

Several commenters make the pointthat for dioxin and dioxin-likecompounds neither reporting total massnor reporting in terms of TEQs providessufficient information on potentialexposures and risks, and that neitherwould allow for the tracing of dioxinsource profiles. EPA agrees that neitherapproach would provide all of the datathat the commenters would like to havereported and that being able todetermine TEQs would provideadditional useful information. Acommon solution to the TEQ issue thatthe commenters suggest, was to reportdioxin and each individual dioxin-likecompound separately rather than as acategory. However, EPA believes thatthis approach would be overlyburdensome and unnecessary to get thekind of data that would be the mostuseful. As discussed in the previoussection of this unit, many othercommenters requested that dioxin anddioxin-like compounds be reportedseparately rather than as a category.After consideration of all of thecomments on this issue, EPA hasdetermined that the best way to reportfor the dioxin and dioxin-likecompounds category is to report interms of absolute grams for the entirecategory. This is consistent with allother reporting under EPCRA section313 and will provide the mostconsistent information from year-to-year. However, EPA agrees with most ofthe commenters that being able todetermine TEQs from the reported dataand being able to determine whichindividual chemicals are include in afacilities report would make the datamore useful to the public. Therefore, asdiscussed in the previous section of thisunit, EPA will add a section to the FormR that will require the reporting facilityto provide the distribution of dioxin andeach dioxin-like compound for the totalquantity that the facility is reporting. Ifa facility has information on thedistribution of the dioxin and dioxin-like compounds, the facility must reporteither the distribution that bestrepresents the distribution of the totalquantity of dioxin and dioxin-likecompounds released to all media fromthe facility; or its one best media-



specific distribution. This information isonly required if it is available from thedata used to calculate thresholds,releases, and other waste managementquantities, no additional analysis isrequired. As with all other reportingunder EPCRA section 313, thisinformation will only be required if thefacility has information that can be usedto make a reasonable estimate of thedistribution from the available data.With the distribution of the individualmembers of the category reported oneach Form R, the user of the data candetermine the grams TEQ thatcorrespond to the absolute gramsreported and can adjust the grams TEQas TEF values change over time. Underthis reporting mechanism, all of theinformation that the commenters state isimportant to determining thesignificance of quantities reported forthis category will be provided to thepublic on one Form R. This way allparties can express the data inwhichever format they believe is best,and since the first thing that must bedetermined under any reporting methodis the mass of each member of thecategory, there should be little, if any,additional burden associated withincluding the distribution.

e. Using TEQs as the basis forreporting thresholds. All of thecommenters on this issue requested thatthe reporting threshold for the dioxinand dioxin-like compounds be set interms of TEQs. Most of the commentersindicate that the reasons they support aTEQ-based threshold were the same asthe reasons they support reportingrelease and other waste managementquantities in terms of TEQs (see the firstparagraph of the preceding section ofthis unit). Two commenters argue thatsince EPA proposed to use TEQs forreporting release and other wastemanagement quantities, that not basingthe reporting threshold on TEQs wouldbe inconsistent. The commenterscontend that a facility may triggerreporting by having emissions thatexceed the threshold (in terms ofabsolute weight) but have no significantreporting quantity (in terms of TEQequivalent weight) and, therefore, nosignificant health risk. The commentersrecommend the use of a consistentapproach where TEQs are used for boththreshold determinations and releaseand other waste management quantities.The commenters state that such anapproach would be consistent with thehealth risk rationale for EPCRAreporting, yet not rely on site-specificrisk approaches that may evolve overtime. Another commenter had similarconcerns suggesting that it would be

extremely burdensome andunnecessarily complex to havethresholds based on absolute grams andrelease and other waste managementquantities reported in TEQs andrecommends that EPA should use TEQsfor both.

One commenter claims that it mayease the reporting burden somewhat tobase the EPCRA section 313 reportingthreshold on a TEQ basis rather thanattempting to develop mass-basedestimates. Another commenter contendsthat in order to determine the sum of themass of the 17 dioxin and dioxin-likecompounds, one already will havedetermined the mass of each compoundindividually and that with data reportedby compound, a TEQ can easily becalculated. The commenter also suggeststhat there are short-term screeningbioassays for determining the TEQ of asample that are less expensive, moresensitive, and can be done more rapidlythan traditional analytical chemistrymethods. The commenter states thatrather than facilities trying to guesswhat their releases may be, in anattempt to avoid spending money onexpensive analytical chemistrymethods, if the reporting threshold werebased on TEQs, a facility can readilyand more inexpensively screen itsreleases. The commenter argues thathaving a reporting threshold based onTEQ is more representative of potentialhealth risks and recommends that EPAconsider using some amount of TEQs asthe reporting threshold. Anothercommenter suggests that one optionwould be to report releases of eachdioxin-like compound if the total, inTEQ, exceeds some chosen threshold.

One commenter that suggests thatTEQs should be used for thresholds,notes that reporting dioxin on a massbasis is quite different from reporting ona TEQ basis. The commenter asserts thatsince some of the dioxin-likecompounds have TEFs of 0.001 then the0.1 gram threshold could requirefacilities that produce 0.0001 gram TEQof dioxin to report. The commenterclaims that when compared to theestimate that there are 2,973 grams TEQof U.S. dioxin emissions such amountsare insignificant and meaningless. Thecommenter maintains that using TEQsinstead of the mass of each compoundfor determining whether an EPCRAreporting threshold for dioxin anddioxin-like compounds is exceededwould not deprive EPA or the public ofinformation regarding meaningfulreleases of dioxin. The commenter alsorecommends that whatever units EPAdecides to use should be the same forthresholds and for release and otherwaste management quantities.

One commenter suggests that EPAshould require sources to use toxicityfactors in calculating the manufacturingthreshold for dioxin and dioxin-likecompounds to avoid triggering thethreshold based solely on non-detection.The commenter states that the 17dioxin-like compounds to which the 0.1gram proposed reporting thresholdwould apply vary in toxicity by a factorof 1,000 but that EPA does not take thisvariation in toxicity into considerationfor the purpose of determining themanufacturing threshold.

EPA did not propose to use TEQs asthe units of measurement for the EPCRAsection 313 reporting threshold fordioxin and dioxin-like compounds. EPAhas the same concerns for using TEQsfor EPCRA section 313 thresholds as itdoes for reporting releases and otherwaste management quantities in termsof TEQs, and most of the issues raisedhere have been addressed in thepreceding section of this unit. Mostimportantly, since EPA has determinedthat each of the dioxin-like compoundsmeets the listing criteria of EPCRAsection 313, the actual mass of eachmember of the category should beincluded in threshold determinations.Also, the fact that the TEFs and thus theTEQs can change over time, is evenmore important for thresholds since TEFchanges would in effect change thethreshold, because for example, thesame mass quantity that would haveexceeded the threshold before thechange may not exceed the thresholdafter the change.

As one of the commenters pointedout, using TEQs as the units for thereporting threshold is much differentthan using actual mass. The commentershowed how a 0.1 gram threshold for adioxin-like compound with a TEF of0.001 would be equivalent to a 0.0001gram TEQ threshold. The opposite ofthis is that if the 0.1 gram thresholdwere in units of TEQ, then for dioxin-like compounds with a 0.001 TEF, itwould take 100 grams to reach thereporting threshold. Using TEQs as theunits for the reporting threshold wouldthus be equivalent to establishingseparate thresholds for each member ofthe dioxin and dioxin-like compoundscategory based on their relative toxicity.EPA does not believe that any of thereporting requirements of EPCRAsection 313 should be based on relativetoxicities since, as discussed in UnitVI.F., EPCRA section 313 is not a risk-based program and reporting is notintended to communicate informationabout the Federal government’s riskdeterminations for individualchemicals. Rather it provides localcommunities with data on release and



other waste management quantities onlisted toxic chemicals, so that they mayuse the data in conjunction withinformation on chemical properties (e.g.persistence and bioaccumulation) andsite-specific information to determine ifreleases present a potential risk.

Several commenters express concernabout consistency between the units ofmeasurement for the threshold for thedioxin and dioxin-like compoundscategory and the units of measurementused to report releases and other wastemanagement quantities. While EPA isnot adopting the use of TEQ as somecommenters requested, EPA is beingconsistent since absolute gramquantities will be used for boththresholds and the reporting of releasesand other waste management quantities.

EPA does not agree with thosecommenters who state that theinformation collected under a 0.1 gramthreshold would, in some cases,represent such a small portion of theestimated national amount of dioxinTEQs that the data would not be useful.On a facility-by-facility basis, theamounts reported may be a smallpercentage of the national total, but thatdoes not mean that it will not be usefulor meaningful to the public. One of thepurposes of EPCRA section 313 is toprovide information to communitiesabout releases into their community. Asmall percentage of national releasesmay pose potential risks to localcommunities. Further, even informationthat shows little or no releases helpscommunities to understand what risksmay be or may not be present in theircommunities and helps governmentagencies to target resources. In addition,since not all of the sources of dioxin anddioxin-like compounds will be reportingunder EPCRA section 313, the amountreported will be a larger portion of thetotal amount reported under EPCRAsection 313 than it will be on a nationalbasis. The issue of how many sources ofdioxin and dioxin-like compounds arecaptured by EPCRA section 313 areaddressed in the Response to Commentsdocument (Ref. 69) for this rulemaking.

EPA does not agree that reporting interms of TEQs would necessarily be lessburdensome. As one commenter states,in order to determine the sum of themass of the 17 dioxin and dioxin-likecompounds, one already will havedetermined the mass of eachcompounds individually and that withdata reported by compound, a TEQ caneasily be calculated. Since the TEQs arecalculated from the relative amounts ofdioxin and each dioxin-like compoundthat is present, it is an additional stepto present the data in terms of TEQs and

therefore it should not be lessburdensome.

f. Reporting guidance for dioxin anddioxin-like compounds. A number ofcommenters requested that EPA developreporting guidance for the dioxin anddioxin-like compounds category.

EPA agrees that guidance should beprovided to assist facilities indetermining threshold and releasequantities for the dioxin and dioxin-likecompounds category. As EPA stated inthe proposed rule:

EPA intends to develop reporting guidancefor industries that may fall within thisreporting category. The guidance developedwill be consistent with the methods andprocedures that EPA has developed fordetermining if dioxin and dioxin-likecompounds are present in various industrialprocesses, including Method 23 (Ref. 77)developed for electric utilities. In developingthe reporting guidance for the dioxin anddioxin-like compounds category EPA willwork with interested parties to provide thebest possible guidance for reporting facilities(at 64 FR 712).

EPA will provide a guidance documentto assist certain facilities in makingthresholds and release determinationsfor the dioxin and dioxin-likecompounds category. The guidancedocument will be consistent with EPAestablished methods of measuring orestimating quantities of dioxin anddioxin-like compounds, includingMethod 23.

2. Benzo(g,h,i)perylene (CAS No. 191-24-2) (Ref. 70). EPA proposed to addbenzo(g,h,i)perylene to EPCRA section313 pursuant to EPCRA section 313(d)(2)(C). One commenter states thatEPA should not addbenzo(g,h,i)perylene to the EPCRAsection 313 list of toxic chemicalsbecause there are insufficient data tosupport the EPCRA section 313(d)(2)(C)determination. The commenter statesthat EPA used predicted aquatic toxicityvalues based on quantitative structureactivity relationship (QSAR) analysisbut did not provide any toxicity data.The commenter contends that EPA didnot provide any evidence to support thestatement that aquatic QSAR equationsshow a high correlation betweenpredicted and measured toxicity values,and did not provide any otherinformation to support use of QSAR forthis type of chemical.

EPA disagrees with the commenter’sstatements. EPA provided the followingdiscussion in the proposed rule:

Three of the chemicals being proposed forlisting (benzo(g,h,i)perylene, 3-methylcholanthene, and octachlorostyrene)have been found to meet the EPCRA section313(d)(2)(C) criteria for ecotoxicity based onpredicted aquatic toxicity values generated

from quantitative structure activityrelationship (QSAR) equations and otherpredictive techniques. As previously stated(58 FR 63500, December 1, 1993), EPAbelieves that, where no or insufficient actualmeasured aquatic toxicity data exist uponwhich to base a decision, toxicity predictionsgenerated by QSARs and other predictivetechniques may constitute sufficientevidence that a chemical meets the section313 listing criteria. EPA’s authority to usesuch predictive techniques derives fromsection 313(d)(2) of the statute, which statesthat EPA shall base its listing determinationson, inter alia, ‘‘generally accepted scientificprinciples.’’ EPA believes that the aquaticQSAR equations that are in widespread useand show a high correlation betweenpredicted and measured aquatic toxicityvalues can be considered to be ’’generallyaccepted scientific principles’’ and canappropriately form the basis of a listingdetermination (Ref. 70). (at 64 FR 693)

EPA believes that QSAR data is validpredicted aquatic toxicity data and thefact that no actual toxicity studies wereprovided does not mean that theavailable data were insufficient todetermine that benzo(g,h,i)perylene metthe listing criteria of EPCRA section313(d)(2)(C). In addition, EPA didprovide support for the statement thataquatic QSAR equations are inwidespread use and show a highcorrelation between predicted andmeasured aquatic toxicity values. Thedocket for the proposed rule containeda document titled ‘‘SAR/QSAR in theOffice of Pollution Prevention andToxics’’ In: Environmental Toxicologyand Risk Assessment: 2nd Volume, STP1216. One of the articles in thisreference was titled Validation ofStructure Activity Relationships UsedBy the USEPA’s Office of PollutionPrevention and Toxics for theEnvironmental Hazard Assessment ofIndustrial Chemical. This includes themethods of SAR for the class of neutralorganic chemicals which, as discussedin the support document, was used forbenzo(g,h,i)perylene since it is a neutralorganic chemical. Thus, EPA didprovide support for its conclusionsabout QSAR analysis and for the use ofQSAR for benzo(g,h,i)perylene.

This commenter also states that EPAuses an estimated Log Kow in its aquatictoxicity prediction and argues that LogKow is an inaccurate predictor for manychemicals particularly if it is estimatedrather than measured. The commentercontends that EPA’s basis for the listingof benzo(g,h,i)perylene is a predictionbased upon a prediction, with no actualdata and that this is not a sufficientbasis for listing under EPCRA section313 and it does not meet the statutoryrequirements for listing that a chemicalis ‘‘known to cause or can reasonably be



anticipated to cause’’ a significantadverse effect.

EPA disagrees with the commenter’sconclusions. The majority of the SARcalculations in the ECOSAR ClassProgram are based upon the octanol/water partition coefficient (Kow or Log P)since there is a correlation between LogP and toxicity. Using the measuredaquatic toxicity values and estimatedLog P values, regression equations canbe developed for a class of chemicals.Toxicity values for a chemical withinthat class may then be calculated byinserting the estimated Kow into theclass regression equation and correctingthe resultant value for the molecularweight of the compound. The ecologicalassessment guidelines for predicting thetoxicity of chemicals with limitedmeasured aquatic toxicity data havebeen used for over a decade (Ref. 35).The commenter has not provided theAgency with any concrete informationor data indicating that this approacheither is not a generally acceptedscientific approach or is unreliable, andthe Agency finds no reasonable basis tochange these techniques at this time. Inaddition, the commenter did notprovide any data to indicate that thepredicted Log Kow forbenzo(g,h,i)perylene was inaccurate.

This commenter also contends thatEPA’s failure to consider exposure inthis proposed rule is particularlyimportant for benzo(g,h,i)perylene. Thecommenter argues that given theproperties of benzo(g,h,i)perylene, anyrelease into water will result in the vastmajority (more than 99%) of thecompound being partitioned tosediment or adsorbed onto suspendedparticulates and organics in the watercolumn and thus the potential for thischemical to be in a toxic form and poserisk in natural systems is low.

EPA disagrees with the commenters’contention that EPA should considerexposure in its determination thatbenzo(g,h,i)perylene meets the EPCRAsection 313(d)(2)(C) listing criteria. Asdiscussed in Unit VI.F., EPA is onlyrequired to consider exposure under alimited set of circumstances. In the finalchemical expansion rule (59 FR 61432),EPA further explained its policy on theuse of exposure considerations underEPCRA section 313(d)(2)(C) and the factthat the Agency does not considerexposure for chemicals that are highlyecotoxic. As EPA explained in the finalrule:

The Agency believes that exposureconsiderations are not appropriate in makingdeterminations (1) under section 313(d)(2)(B)for chemicals that exhibit moderately high tohigh human toxicity (These terms, which donot directly correlate to the numerical

screening values reflected in the Draft HazardAssessment Guidelines, are defined in unitII.) based on a hazard assessment, and (2)under section 313(d)(2)(C) for chemicals thatare highly ecotoxic or induce well-established adverse environmental effects (at59 FR 61441).

Although EPA does not believe that itwould be appropriate to considerexposure, EPA also disagrees with thecommenter’s characterization of the fateof benzo(g,h,i) perylene. Environmentalfate models show that the chemical willonly partition about 60% to thesediment. Also, the Agency cannot relyon the environment to serve as a sink forthis chemical. Other environmentalconditions such as turbidity, biologicalactivity, or the chemical activity inwater could cause redistribution of thechemical into the water column again.

Based upon QSAR equations andother predictive techniques, EPA hasconcluded that benzo(g,h,i)perylene istoxic. It has the potential to kill fish,daphnia, and algae, among otheradverse effects, based on chemical and/or biological interactions.Benzo(g,h,i)perylene can cause thesetoxic effects at relatively lowconcentrations. The predicted aquatictoxicity values for benzo(g,h,i)perylene,based upon QSAR analysis using theequation for neutral organics and anestimated Log Kow of 6.7, includedcalculated values of 0.030 milligramsper liter (mg/L) for the fish 96–hourLC50 (i.e., the concentration that is lethalto 50% of test organisms) and 0.0002mg/L for fish chronic toxicity; 0.012 mg/L for daphnia 48–hour LC50 and 0.027mg/L for the daphnid 16–day chronicLC50; and 0.03 mg/L for the algae 96–hour EC50 (i.e., the concentration that iseffective in producing a sublethalresponse in 50% of tests organisms)with an algal chronic toxicity of 0.012mg/L.

Benzo(g,h,i)perylene can cause itstoxic effects at relatively lowconcentrations, therefore EPA considersit to be highly toxic. Since benzo(g,h,i)perylene is toxic at relatively lowconcentrations EPA believes that itcauses or can reasonably be anticipatedto cause a significant adverse effect onthe environment. In addition, because ofthe nature of the potential significantadverse effects, e.g., fish, daphnia, andalgae kills, and the impacts such effectscan have on ecological communities andecosystems, EPA has determined thatthey are of sufficient seriousness towarrant reporting.

EPA reaffirms that there is sufficientevidence for listing benzo(g,h,i)peryleneon the EPCRA section 313 list of toxicchemicals pursuant to EPCRA section313(d)(2)(C)(i) based on the available

ecotoxicity information for thischemical. Therefore, EPA is finalizingthe addition of benzo(g,h,i)perylene onthe EPCRA section 313 list.

3. Benzo(j,k)fluorene (fluoranthene)(CAS No. 206–44–0) (Ref 70). EPAproposed to add fluoranthene to EPCRAsection 313 pursuant to EPCRA sections313 (d)(2)(B) and (C). EPA received nocomments specific to thecarcinogenicity data that EPA presentedin the proposed rule in support of theaddition of fluoranthene to the EPCRAsection 313 list of toxic chemicals.Thus, EPA reaffirms that there issufficient evidence for addingfluoranthene to this list of EPCRAsection 313 toxic chemicals pursuant toEPCRA section 313(d)(2)(B) based onthe available carcinogenicity data forthis chemical.

One commenter argues that EPAshould refrain from listing fluoranthenepending additional assessment of thedata. The commenter contends thatEPA’s reported toxicity values forfluoranthene span a range of about twoorders of magnitude and that for such awide range, it is necessary to evaluatepotential exposure to determine whichscenarios, and therefore which types ofdata, are most relevant to thiscompound following a release. Thecommenter argues that fluoranthene is ahighly lipophilic compound that willbind primarily to sediment andsuspended organics, so it is not clearwhether the reported toxicity values onwhich EPA relies for the listing areapplicable to this compound in theenvironment. EPA assumes thecommenter was referring to data used tosupport EPA’s proposal to listfluoranthene pursuant to EPCRA section313(d)(2)(C).

As discussed in Unit VI.F., EPA doesnot believe that it is appropriate toconsider exposure for chemicals that arehighly ecotoxic as the data forfluoranthene clearly shows it is.However, even if EPA were to considerexposure, the commenter provided nodata to support the assumption thatfluoranthene will bind primarily tosediments and suspended organics, andEPA believes that fluoranthene willpartition to water as well as sediment.While the ecotoxicity data forfluoranthene does range over about twoorders of magnitude that does not, initself, form a basis for conducting anexposure assessment. There are datathat clearly show that fluoranthene ishighly ecotoxic. Thus, an exposureassessment is not required. While itdoes not impact EPA’s assessment, EPAnotes that of the ecotoxicity valuespresented in the proposed rule, 9 werewithin the same order of magnitude, 4



were one order of magnitude higher,and 2 were two orders of magnitudehigher. Thus, 60% are within the sameorder of magnitude and 87% are withinone order of magnitude. EPA does notbelieve that this represents a very widedistribution as the commenter implies.

Based on the available toxicity data,EPA has concluded that fluoranthene istoxic. It has the potential to kill mysidshrimp, a variety of freshwater benthicspecies and various saltwater speciesand it can also cause other adverseeffects on fish and mysids, based onchemical and/or biological interactions.Fluoranthene can cause these toxiceffects at relatively low concentrations.Ecotoxicity values for fluorantheneinclude a calculated 96–hour LC50 of0.04 mg/L for mysid shrimp. Usingstandard acute toxicity tests,fluoranthene has been tested in 12freshwater species from 11 genera. Forfreshwater benthic species, the acute96–hour LC50 calculated values are0.032 mg/L for an amphipod(Gammarus minus), 0.070 mg/L for ahydra (Hydra americana), 0.17 mg/L foran annelid (Lumbriculus variegatus),and 0.17 mg/L for a snail (Physellavirgata). For saltwater species, the 96–hour LC50 values are 0.051 mg/L for amysid (Mysidopsis bahia), 0.066 mg/Lfor an amphipod (Ampelisca abdita),0.14 mg/L for a grass shrimp(Palaemonetes pugio), and 0.50 mg/L foran annelid (Neanthes arenaceodentata).Fathead minnows exposed tofluoranthene at a concentration of0.0217 mg/L for 28 days in a chronicearly life-stage test showed a reductionof 67% in survival and a 50.2%reduction in growth relative to thecontrols. In a 28–day chronic study,mysids exposed to 0.021 mg/L offluoranthene showed a 26.7% reductionin survival and a 91.7% reduction inreproduction; at 0.043 mg/L all mysidsdied. In a 31–day study, mysids showeda reduction of 30% in survival, 12% ingrowth, and 100% in reproductionrelative to controls at a concentration of0.018 mg/L of fluoranthene.

Fluoranthene can cause its toxiceffects at these relatively lowconcentrations, therefore EPA considersit to be highly toxic. Since fluorantheneis toxic at relatively low concentrations,EPA believes that it causes or canreasonably be anticipated to cause asignificant adverse effect on theenvironment. In addition, because of thenature of the potential significantadverse effects, e.g., kills of mysidshrimp, a variety of freshwater benthicspecies, and various saltwater species,and the impacts such effects can haveon ecological communities andecosystems, EPA has determined that

they are of sufficient seriousness towarrant reporting.

Thus, EPA reaffirms that there issufficient evidence for addingfluoranthene on the EPCRA section 313list of toxic chemicals pursuant toEPCRA section 313(d)(2)(C)(i) based onthe available ecotoxicity information forthis chemical.

Therefore, EPA is finalizing the listingof fluoranthene on the EPCRA section313 list.

4. 3-Methylcholanthrene (CAS No. 56–49–5) (Ref. 70). EPA proposed to add 3-methylcholanthrene to EPCRA section313 pursuant to EPCRA sections313(d)(2)(B) and (C). EPA received nocomments on the carcinogenicity datathat EPA presented in the proposed rulein support of the addition of 3-methylcholanthrene to the EPCRAsection 313 list of toxic chemicals.Thus, EPA reaffirms that there issufficient evidence for adding 3-methylcholanthrene to the list of EPCRAsection 313 toxic chemicals pursuant toEPCRA section 313(d)(2)(B) based onthe available carcinogenicity data forthis chemical.

No comments were receivedconcerning the ecotoxicity data thatEPA presented for 3-methylcholanthrene in the proposedrule. Based upon quantitative structureactivity relationship (QSAR) equationsand other predictive techniques, EPAhas concluded that 3-methylcholanthrene is toxic. It has thepotential to kill fish and daphnia as wellas cause other adverse effects on fish,daphnia, and algae based on chemicaland/or biological interactions. 3-Methylcholanthrene can cause thesetoxic effects at relatively lowconcentrations. The predicted aquatictoxicity values for 3-methylcholanthrene, based on QSARanalysis using the equation for neutralorganics and an estimated Log Kow of7.05, include a calculated fish 96–hourLC50 of 0.009 mg/L and a chronic fishtoxicity value of 0.003 mg/L, a daphnia48–hour LC50 of 0.005 mg/L and a 16–day chronic LC50 of 0.015 mg/L, and analgae 96–hour EC50 of 0.0105 mg/L witha calculated chronic toxicity value of0.014 mg/L.

3-Methylcholanthrene can cause itstoxic effects at these relatively lowconcentrations; therefore, EPA considersit to be highly toxic. Since 3-methylcholanthrene is toxic at relativelylow concentrations, EPA believes that itcauses or can reasonably be anticipatedto cause a significant adverse effect onthe environment. In addition, because ofthe nature of the potential significantadverse effects, e.g., fish and daphniakills, and the impacts such effects can

have on ecological communities andecosystems, EPA has determined thatthey are of sufficient seriousness towarrant reporting.

Thus, EPA reaffirms that there issufficient evidence for listing 3-methylcholanthrene on the EPCRAsection 313 list of toxic chemicalspursuant to EPCRA section313(d)(2)(C)(i) based on the availableecotoxicity information for thischemical.

Therefore, EPA is finalizing the listingof 3-methylcholanthrene on the EPCRAsection 313 list.

5. Octachlorostyrene (CAS No. 29082–74–4) (Ref. 70). EPA proposed to addoctachlorostyrene to EPCRA section 313pursuant to EPCRA sections 313(d)(2)(B)and (C). One commenter argues thatoctachlorostyrene (OCS) should not beincluded in the EPCRA section 313 PBTchemicals list. The commenter contendsthat OCS was included as a PBTchemical simply because it appears onseveral lists of persistent andbioaccumulative chemicals and notbased on a thorough evaluation of itstoxicity. The commenter argues thatthere is limited toxicity data for OCSand cited two statements that were inEPA’s support document for theaddition of OCS and the other chemicalsbeing added in this rulemaking. The twostatements the commenter cited were:

The health hazard data which support TRIlisting are very limited. Human health datawere not located. (Ref. 70 p. 48)

EPA disagrees with the commenters’conclusions. The commenter did notcomment on the actual toxicity data thatEPA provided as the basis for listingOCS pursuant to EPCRA section313(d)(2)(B). Rather the commentertakes two statements that werecontained in the support document outof context to support their apparentcontention that there are insufficientdata to list OCS under EPCRA section313(d)(2)(B). The fact that thecommenter has taken these statementsout of context is demonstrated by thecontent of the rest of the paragraph thatcontained the statements the commentercited:

Laboratory studies on rats suggest OCSmay have acute and chronic effects on theliver, kidneys, and thyroid. In a long-termstudy (one year) of rats a LOAEL of 0.31 mg/kg/day was determined based on significanthistological effects on these organs. (Ref. 70)

The statements the commenter citedonly acknowledged that there was not avast amount of toxicity data for OCS andspecifically, that there were no humanstudies; they do not support thecommenters’ conclusion that OCS doesnot meet listing criteria of EPCRA



section 313(d)(2)(B). In addition, thesestatements were from the summarysection of the discussion on OCS, moredetailed discussion of the toxicity datafor OCS was contained in the othersections on OCS toxicity but thecommenter provided no comments onthis information.

EPA reaffirms that there is sufficientevidence for adding OCS to the EPCRAsection 313 list of toxic chemicalspursuant to EPCRA section 313(d)(2)(B)based on the available hepatic, nephric,and thyroid toxicity data for thischemical.

The same commenter also claims thatthe toxicity comparisons tohexachlorobenzene are not supportedand that no references or rationale areprovided to support basing the aquatictoxicity of OCS on that ofhexachlorobenzene. As with the humanhealth data, the commenter argues thatthere are limited environmental toxicitydata for OCS and cited some statementsthat were in EPA’s support document.The statements the commenter citedwere:

So far as is known, after a search of formerEEB chemical files, the ecological hazard ofOCS has never been formally reviewed underTSCA section 4 or in the OPPT RiskManagement (RM) process. OCS was brieflyreviewed for aquatic toxicity in August 1986,as part of an OTS (now OPPT) chemicalscoring project. Thus, available informationon OCS is very limited. (Ref. 70, p. 52)

EPA disagrees with the commenter’sconclusions. The commenter has notcommented on the actual toxicity databut rather states that the data are limitedand that hexachlorobenzene is not anappropriate analogue for predicting theaquatic toxicity data for OCS. Thestatements the commenter cited onlyacknowledged that there was not a vastamount of toxicity data for OCS, they donot support the commenter’s conclusionthat OCS does not meet the listingcriteria of EPCRA section 313(d)(2)(C).Contrary to the commenter’s statement,EPA did provide a reference to the useof hexachlorobenzene as an appropriateanalogue for OCS. As EPA stated in thesame section of the support documentthe commenter cited:

OCS is one of 7 compounds in thischemical class (chlorinated styrenes) withthe generic formula C8H8-xClx, where x equals8 for OCS. This class is analogous to thechlorinated benzenes; for examplehexachlorobenzene (HCB), is considered tobe an appropriate analogue chemical for OCS(2). (Ref. 70, page 52).

The reference EPA cited is a previousEPA analysis of this class of chemicalsthat also used hexachlorobenzene as anappropriate analogue for OCS. EPAbelieves that since OCS and

hexachlorobenzene are both highlychlorinated derivatives of benzene theycan reasonably be anticipated to havesimilar toxicities. However, in additionto aquatic toxicity data onhexachlorobenzene, EPA provided theresults of a QSAR analysis of OCS, usinga measured Log Kow of 7.7, that gave apredicted 14–day LC50 value of 6 µg/Lfor guppies.

Based upon QSAR equations andanalogue data, EPA has concluded thatOCS is toxic. It has the potential to killfish and inhibit photosynthesis in algae,among other adverse effects, based onchemical and/or biological interactions.OCS can cause these toxic effects atrelatively low concentrations. Thepredicted aquatic toxicity value forOCS, based upon QSAR analysis usinga measured Log Kow of 7.7, is anestimated 14–day LC50 of 6 µg/L forguppies. Based on the chemicalanalogue hexachlorobenzene, OCS canreasonably be anticipated to inhibitphotosynthesis in algae at aconcentration of 30 µg/L and have acalculated subchronic EC50 value of 16µg/L for daphnids.

OCS can cause its toxic effects atthese relatively low concentrations;therefore, EPA considers it to be highlytoxic. Since OCS is toxic at relativelylow concentrations, EPA believes that itcauses or can reasonably be anticipatedto cause a significant adverse effect onthe environment. In addition, because ofthe nature of the potential significantadverse effects, e.g., fish kills, andinhibition of photosynthesis in algaeand the impacts such effects can haveon ecological communities andecosystems, EPA has determined thatthey are of sufficient seriousness towarrant reporting.

EPA reaffirms that there is sufficientevidence for listing OCS on the EPCRAsection 313 list of toxic chemicalspursuant to EPCRA section313(d)(2)(C)(i) based on the availableecotoxicity information for thischemical.

Therefore, EPA is finalizing theaddition of OCS on the EPCRA section313 list.

6. Pentachlorobenzene (CAS No. 609–93–5) (Ref. 70). EPA proposed to addpentachlorobenzene to EPCRA section313 pursuant to EPCRA sections313(d)(2)(B) and (C). No comments werereceived concerning the human healthtoxicity data that EPA presented in theproposed rule. Thus, EPA reaffirms thatthere is sufficient evidence for addingpentachlorobenzene on EPCRA section313 pursuant to EPCRA section313(d)(2)(B) based on the availablehepatic, nephric, hematological, and

developmental toxicity data for thischemical.

No comments were receivedconcerning the ecotoxicity data thatEPA presented for pentachlorobenzenein the proposed rule. Based on theavailable toxicity data, EPA hasconcluded that pentachlorobenzene istoxic. It has the potential to kill fish andmysid shrimp as well as cause otheradverse effects on algae and daphnia,based on chemical and/or biologicalinteractions. Pentachlorobenzene cancause these toxic effects at relativelylow concentrations. Aquatic acutetoxicity calculated values forpentachlorobenzene include asheepshead minnow 96–hour LC50 of0.83 mg/L, bluegill sunfish 96–hourLC50s of 0.25 mg/L and 0.3 mg/L, aguppy 96–hour LC50 of 0.54 mg/L, anda mysid shrimp 96–hour LC50 of 0.16mg/L. Because pentachlorobenzene cancause these toxic effects at theserelatively low concentrations, EPAconsiders it to be highly toxic.Additional acute toxicity calculatedvalues include algae 96–hour EC50s of1.98 mg/L and 6.78 mg/L, and daphnia48–hour EC50s of 1.3 mg/L and 5.28 mg/L. Considering pentachlorobenzene’spersistence and bioaccumulationpotential pentachlorobenzene isconsidered highly toxic to aquaticorganism at these higher concentrations.

As discussed above,pentachlorobenzene is highly toxic.Because pentachlorobenzene is highlytoxic at relatively low concentrations,EPA believes that it causes or canreasonably be anticipated to cause asignificant adverse effect on theenvironment. In addition, because of thenature of the potential significantadverse effects, e.g., fish and mysidshrimp kills as well as other adverseeffects on algae and daphnia, and theimpacts such effects can have onecological communities and ecosystems,EPA has determined that they are ofsufficient seriousness to warrantreporting.

Thus, EPA reaffirms that there issufficient evidence for addingpentachlorobenzene on the EPCRAsection 313 list of toxic chemicalspursuant to EPCRA section313(d)(2)(C)(i), (ii), and (iii) based on theavailable ecotoxicity information forthis chemical.

Therefore, EPA is finalizing the listingof pentachlorobenzene on the EPCRAsection 313 list.

7. Tetrabromobisphenol A (CAS No.79–94–7) (Ref. 70). EPA proposed to addTBBPA to EPCRA section 313 pursuantto EPCRA sections 313(d)(2)(B) and (C).One commenter claims that the studycited by EPA in support of its



conclusion that TBBPA meets theEPCRA section 313(d)(2)(B) criteria forlisting based on developmental toxicitywas not a study on TBBPA. The studyin question was submitted to EPA by ICIAmericas Inc. with a cover letteridentifying Saytex 111, the producttested, as being TBBPA. The productwas identified as TBBPA by both nameand CAS number.

EPA has determined that the producttested was not TBBPA as claimed by thesubmitter but has been unable todetermine why it was misidentified bythe submitter. ICI Americas is nowZeneca at the Delaware location thatsubmitted the study. A Zeneca staffmember researched the submission andfound that the report was originallyfrom Ethyl Corporation and that noother report on TBBPA was submitted toEPA on that date. Without themisidentified developmental study, noadequate toxicology studies or otherdata were located by EPA that supportthe addition of TBBPA pursuant toEPCRA section 313(d)(2)(B). Thus, EPAis not adding TBBPA based on concernsfor developmental toxicity or any otherhuman health effects.

The same commenter providescomments on the persistence andbioaccumulation of TBBPA andcontends that there are insufficient datato conclude that TBBPA meets thelisting criteria of EPCRA section313(d)(2)(C)(ii) and 313(d)(2)(C)(iii).These two sections deal with EPA’sauthority to add a chemical based on its‘‘toxicity and persistence in theenvironment’’ and its ‘‘toxicity andtendency to bioaccumulate in theenvironment’’ respectively. However,the commenter does not contend thatTBBPA does not meet the listing criteriaof EPCRA section 313(d)(2)(C)(i) whichaddresses EPA’s authority to add achemical based on its ‘‘toxicity’’ withoutconsideration of persistence andbioaccumulation. EPA believes thatTBBPA is persistent andbioaccumulative as discussed in UnitVI.H. However, EPA did not propose toadd TBBPA to the EPCRA section 313list of toxic chemicals based on itspersistence or bioaccumulation data,and neither of these properties werementioned in the toxicity discussion ofTBBPA in the proposed rule. Rather,EPA based its listing decision on theecotoxicity data alone which indicatedthat TBBPA was highly toxic evenwithout consideration of persistence orbioaccumulation.

Based the available toxicity data, EPAhas concluded that TBBPA is toxic. Ithas the potential to kill fish, daphnid,and mysid shrimp, among other adverseeffects, based on chemical and/or

biological interactions. TBBPA cancause these toxic effects at relativelylow concentrations. Aquatic acutetoxicity calculated values for TBBPAinclude a fathead minnow 96–hour LC50

of 0.54 mg/L, a rainbow trout 96–hourLC50 of 0.40 mg/L, a bluegill sunfish 96–hour LC50 of 0.51 mg/L, and a daphnid48–hour LC50 of 0.96 mg/L; mysidshrimp 96–hour LC50 values rangedfrom 0.86 to 1.2 mg/L depending on theage of the shrimp. Aquatic chronictoxicity calculated values from adaphnia 21–day study resulted in aMaximum Acceptable ToxicantConcentration (MATC) that wasbetween 0.30 and 0.98 mg/L (geometricmean 0.54 mg/L) based on a significantreduction in reproduction rates; afathead minnow 35–day study resultedin a MATC that was calculated to bebetween 0.16 and 0.31 mg/L (geometricmean 0.22 mg/L) based on adverseeffects on embryo and larval survival.

TBBPA can cause its toxic effects atthese relatively low concentrations;therefore, EPA considers it to be highlytoxic. Since TBBPA is toxic at relativelylow concentrations, EPA believes that itcauses or can reasonably be anticipatedto cause a significant adverse effect onthe environment. In addition, because ofthe nature of the potential significantadverse effects, e.g., fish, daphnid, andmysid shrimp kills, and the impactssuch effects can have on ecologicalcommunities and ecosystems, EPA hasdetermined that they are of sufficientseriousness to warrant reporting.

EPA reaffirms that there is sufficientevidence for listing TBBPA on theEPCRA section 313 list of toxicchemicals pursuant to EPCRA section313(d)(2)(C)(i) based on the availableecotoxicity information for thischemical. Therefore, EPA is finalizingthe addition of TBBPA on the EPCRAsection 313 list.

8. Vanadium and vanadiumcompounds. EPA proposed to addvanadium and vanadium compounds toEPCRA section 313 pursuant to EPCRAsections 313(d)(2)(C). One commentercited the following statement from theproposed rule, ‘‘However, very fewtoxicity tests have been conducted withinvertebrates.’’ The commenter arguesthat, beyond vanadium pentoxide, theAgency appears to have very littletoxicity data on vanadium compounds.The commenter contends that thepaucity of toxicity data on manydifferent forms of vanadium compoundsin the proposal, as well as in theliterature, does not appear to supportthe Agency’s belief that ‘‘the evidence issufficient to list vanadium andvanadium compounds on EPCRAsection 313 pursuant to EPCRA section

313(d)(2)(C) based on the availableecotoxicity information on vanadiumand vanadium compounds’’ (at 64 FR698).

EPA disagrees with the commenters’conclusions. Although there is limitedinformation on vanadium’s toxicity oninvertebrates, data that were availablefor invertebrates shows that vanadium istoxic to these species. Furthermore,EPA’s assessment of vanadium’s toxicityincluded algae and vertebrates, andshowed that the chemical is highly toxicto aquatic organisms. The data onvanadium are not limited to vanadiumpentoxide, the ecological data providedin the proposed rule for vanadiumevaluates vanadium toxicity based ondata for other vanadium compoundsincluding: sodium metavanadate,sodium orthovanadate, vanadyl sulfate,and ammonium vanadate. In assessingthe ecological toxicity of vanadium andvanadium compounds, EPA evaluatedthe parent metal (vanadium) anddetermined that it is highly toxic tosome aquatic species and anticipated tocause a significant adverse effect on theenvironment of sufficient seriousness towarrant reporting. Thus, vanadium, theparent metal in vanadium compounds,is the concern, not the othercomponents of each vanadiumcompound. Many metals are tested inthe salt form because these forms arereadily soluble in aqueous solutions.The toxicity data for vanadium showsthat the metal is highly toxic (aquatictoxicity < 1 mg/L) to the most sensitivespecies. This evaluation of vanadium’stoxicity is acceptable according totraditional guidelines for the assessmentof toxic substances as conducted by theAgency for over 2 decades. In addition,when consideration is given tovanadium’s persistence it is alsoconsidered highly toxic at higherconcentrations.

Three commenters contend that sincemost vanadium compounds arepractically insoluble, they consequentlyhave very low bioavailability, and thusit is likely that they could qualify fordelisting. The commenters argue thatthe delisting process is extremelycumbersome, time-consuming andcostly. One of these commenterscontends that it is inappropriate to listall of vanadium compounds based onaquatic toxicity of the few compoundscited in the proposed rule. Thebioavailability of metals such asvanadium was also raised as an issue atthe public meetings held for thisrulemaking. It was suggested that theparent metal will not be bioavailablefrom certain metal compounds that maybe released into the environment andthat therefore the compounds cannot be



properly characterized as a PBTchemicals.

EPA disagrees with these comments.First, it should be noted that EPA hasnot addressed whether vanadium andvanadium compounds can properly beclassified as PBT chemicals in thisrulemaking. The sole issue, therefore, iswhether vanadium and vanadiumcompounds meet the EPCRA section313(d)(2)(C) listing criteria. EPA’sanalysis of the environmental fate ofvanadium and vanadium compoundsshows that under many environmentalconditions vanadium will be availableand thus is able to express its toxicity.The commenters have not provided EPAwith any data or acceptable scientificstudies indicating that vanadium in anyparticular compound will not becomeavailable in the environment. In fact, atleast one commenter appears to indicatethat these vanadium compounds maymerely have low solubility. In thesecompounds, the parent metal vanadiumcan become available. While watersoluble vanadium compounds wouldobviously provide vanadium in animmediately bioavailable form,solubility is not the only factor toconsider in determining thebioavailability of vanadium from avanadium compound. In addition tosolubility, processes such as: hydrolysisat various pHs; solubilization in theenvironment at various pHs; photolysis;aerobic transformations (both abioticand biotic); anaerobic transformation(both abiotic and biotic); andbioavailability when the compounds areingested (solubilization in and/orabsorption from the gastrointestinaltract and solubilization in variousorgans) need to be considered. In UnitVI.C., EPA discusses in detail thepersistence and bioavailability of metalsin general.

The issue of bioavailability has beenaddressed for EPCRA section 313chemical assessments through EPA’spolicy and guidance concerningpetitions to delist individual membersof the metal compound categories on theEPCRA section 313 toxic chemical list(56 FR 23703). This policy states that ifthe metal in a metal compound cannotbecome available as a result of biotic orabiotic processes then the metal will notbe available to express its toxicity. If theintact metal compound is not toxic andthe metal is not available from the metalcompound then such a chemical is apotential candidate for delisting.

One commenter argued that thelowest toxicity value cited by EPA for amarine algal species was for Dunaliellamarina with a 9–day LC50 of 0.5 mg/Lbut that EPA omitted a study whichtested the same species and reported no

significant adverse effects at aconcentration of 50 mg/L.

EPA believes that the study thatreported the 9–day LC50 of 0.5 parts permillion (ppm) on Dunaliella marina, isaccurate and was acceptably conductedwithin the guidelines for ecologicalassessments of hazardous chemicals.This study shows the most sensitivespecies’ response to the chemical. Thereare differences in the two studies thatcould explain the range of toxicitybetween the two. They are: (1)Differences in the exposure times, (2)the species used in the experiments, and(3) the form of vanadium that wasexposed to the organisms. The exposuretime in the study EPA cited reported a9–day LC50 of 0.5 mg/L. However, thestudy the commenter cites did notreport an LC50 duration. Also, thespecies for the study EPA cited reportedthe test species to be Dunaliella marina(salina), but the study the commentercited only reported the genus name forthis organism. Furthermore, the studyEPA cited reported the form ofvanadium as sodium vanadate, but thestudy the commenter cites only reportedusing the vanadium compound withoutreporting the specific salt form. It isclear that any one of the three factorsmentioned, or some combination ofthese factors, likely accounts for thevariation in toxicity between the twostudies.

One commenter argues that a study,omitted in EPA’s review of vanadiumtoxicity, on nine algal species showedno significant reduction in productivity(as measured by chlorophyll synthesis)at vanadium concentrations in excess of10 mg/L. The commenter also contendsthat the authors of the study alsodemonstrated that phosphateconcentrations were critical in thetoxicity of vanadium to algae.

The Agency has not neglected toreview the study cited by thecommenter. However, EPA interpretsthe study cited by the commenter asdescribing the competition uptakebetween vanadium and phosphorus inan algal medium containing twodifferent kinds of phosphorusconcentrations (i.e., phosphorusdeficient and phosphorus sufficient).Also, this study was performed only onfreshwater algae and one form ofvanadium (orthovanadate) which onlyexists in a pH range of 3 to 6. This studydid report a moderately high toxicityvalue for Scenedesmus acutus between5 and 177 M, which continues tosupport EPA’s findings that vanadium istoxic to algae. Furthermore, EPA isaware that there are studies that werenot included in the assessment thatshowed that the chemical was more

toxic than the values reported in EPA’sassessment. However, each study wascarefully reviewed based on EPA’sextensive evaluation process whichreviews studies for conformance withgenerally accepted scientific standardsand tests. The studies that were reportedin EPA’s assessment used generallyaccepted, validated scientific methodsfor evaluating aquatic toxicity. Thetoxicity values that were reported in theecological assessment of vanadiumtoxicity were from well-conductedstudies.

One commenter argues that it appearsfrom a review of the data that thecontention that vanadium is highlytoxic to algae has no basis. Thecommenter contends that with theexception of one study on a singlespecies, Ceratium hirundinella, none ofthe studies on freshwater algae showedsignificant toxicity at concentrationsbelow 10 mg/L. The commenter statesthat the lowest level of toxicity reportedfor a marine species (Dunaliella marina)was an LC50 of 0.5 mg/L, but that thereis conflicting evidence that thethreshold of toxicity for this speciesmay be higher than 50 mg/L. Thecommenter concludes that there appearsto be little evidence that vanadium is ahighly toxic agent to algae. Thecommenter also argues that evaluatingthe toxicity of a compound based on theresponse of individual algal species canbe misleading. The commenter contendsthat algae never exist within eithermarine or freshwater environments asmonocultures, but rather as dynamicmixed populations. The commenterconcludes that unless a compound canbe shown to have a broad effect over anentire assemblage or over numerousspecies of either freshwater or marinespecies, it is not likely to have asignificant effect within the naturalenvironment.

EPA’s assessment on algae toxicityshows that vanadium is highly toxicbased on the most sensitive species’response to the chemical. There is noconflict in the threshold of toxicity ofDunaliella marina. As stated above,there are three factors that mostprobably account for the differencesbetween the study EPA cited and thestudy the commenter cites. After carefulreview of the available data, it is EPA’sprofessional judgment that the studyEPA cited provides accurate and validdata.

Algae studies have been included inecological risk assessments for over 2decades. Several guidelines on differentspecies have been written to show thatthese genera are important in theenvironment and show sensitivity inhow chemicals affect the biota. EPA



agrees that algae usually do not exist inmonocultures in the marine orfreshwater environment. However,testing monocultures species is the mostaccurate method to determine whether achemical is directly harmful to thatspecies. Therefore, if a compound ishighly toxic to a particular species ofalgae or any species, its effects can beextrapolated to represent other speciesexposed to that chemical. Thisevaluation process has been used by theAgency and accepted by OECD for overtwo decades, and used on thousands ofchemicals. Vanadium’s toxicity rangesfrom highly toxic to moderately toxic foralgae in EPA’s assessment. It isreasonable from the evidence in EPA’sassessment of vanadium that the speciesthat is the most sensitive to thechemical can represent the toxicity forall other species based on this narrowrange. EPA’s final evaluation of anychemical’s toxicity is based on the mostsensitive species’ response.

One commenter contends that thestudy EPA cited that reported the 144–hour LC50 of 0.4 and 0.5 mg/L forvanadyl sulfate (VOSO4) andammonium metavanadate (NH4VO3),respectively, were actually values forVOSO4 and sodium metavanadate(NaVO3) respectively. The commentercontends that the 144–hour LC50 forNH4VO3 was l.5 mg/L. The commenteralso argues that EPA neglected to reportfrom the same study a 144–hour LC50 of1.1 mg/L for vanadate pentoxide (V2O5)for this species. The commenter alsocontends that the findings of 144–hourLC50s of 2.5 to 8.1 mg/L in goldfish(Carassius auratus) for the same fourvanadium species were also omitted.

The comment concerning thevanadium compounds for the 144–hourLC50s of 0.4 and 0.5 mg/L is correct.EPA inadvertently cited to the incorrectcompound in the study. The correctvanadium compounds will be reflectedin an update to the support document.However, sodium metavanadate, is stilla vanadium compound and the studytherefore continues to support EPA’sfindings that vanadium is highly toxicto fish. The other values of 2.5 and 8.1mg/L merely provide further support forEPA’s finding that the vanadium ismoderately toxic to fish. However,considering vanadium’s persistence inthe environment, EPA believes that it ishighly toxic at concentrations between 1and 10 mg/L. Thus the goldfish valuesprovide further support to EPA’s findingthat vanadium is highly toxic to someaquatic organisms.

One commenter contends that inassessing the toxicity of vanadium tofish, EPA neglected to review thefollowing studies: (1) Hamilton and

Buhl (1997), who reported a 96–hourLC50 for the flannelmouth sucker(Catostomus latipinnis) of 11.7 mg/L; (2)Taylor et al. (1985), who reported a 96–hour LC50 for English sole (Limandalimanda) of 26.8 mg/L; (3) Ernst andGarside (1987), who reported a 96–hourLC50 for the brook trout (Salvelinusfontinaliis) alevins of 24 mg/L and foryearlings of 7–15 mg/L (the authors alsoreported that the method by which stocksolutions are formulated could have adramatic effect on the toxicity ofvanadium through its effects on thepolymeric form of the metal in the teststudy); and (4) Hamilton and Buhl(1990), who reported a 96–hour LC50 forchinook salmon (Oncorhynchustshawytscha) fry of 16.5 mg/L.

EPA undertook an exhaustive reviewof vanadium toxicity. The studies thecommenter has listed show thatvanadium compounds are moderatelytoxic to fish, which further supportEPA’s findings on the toxicity ofvanadium. EPA’s review of the studiescited in the proposed rule are notcontradicted or undermined by thestudies provided by the commenter, andcontinue to support the Agency’sconclusion that vanadium andvanadium compounds are highly toxicto some aquatic species.

One commenter states that thebackground document to support EPA’sproposal to list vanadium and vanadiumcompounds indicates that the proposedlisting is based on data for fivevanadium compounds: vanadiumpentoxide, sodium metavanadate,sodium orthovanadate, vanadyl sulfate,and ammonium vanadate. Thecommenter contends that EPA mayconsider listing under EPCRA section313 for the individual compounds forwhich the Agency has data, but EPA isnot justified in listing a broad‘‘vanadium and vanadium compounds’’category based on data for only fivecompounds. The commenter suggeststhat EPA consider individual listings forthese compounds, or a categoryconsisting only of the compounds forwhich the Agency has data.

EPA disagrees with the commenter’scharacterization of the Agency’sassessment of vanadium and vanadiumcompounds. In assessing the ecologicaltoxicity of vanadium and vanadiumcompounds, EPA evaluated the parentmetal (vanadium) and determined that itis highly toxic to some aquaticorganisms and can reasonably beanticipated to cause a significantadverse effect on the environment ofsufficient seriousness to warrantreporting pursuant to EPCRA section313(d)(2)(C). Thus, vanadium, theparent metal in vanadium compounds,

is the concern, not the othercomponents of each compound. Manymetals are tested in the salt formbecause they are readily soluble inaqueous solutions. The toxicity data forvanadium shows that the metal is highlytoxic (aquatic toxicity < 1 mg/L) to themost sensitive species. In addition,because vanadium is persistent, EPAconsiders any toxicity values between 1and 10 mg/L as indicating highecotoxicity. This evaluation ofvanadium’s toxicity is acceptableaccording to traditional guidelines forthe assessment of toxic substancesconducted by the Agency for over twodecades.

EPA has also provided sufficient basisfor the inclusion of all vanadiumcompounds in the category. As EPAstated in the 1994 chemical expansionfinal rule:

The Agency believes it satisfies thestatutory criteria to add a category to the listby identifying the toxic effect of concern forat least one member of the category and thenshowing why that effect may reasonably beexpected to be caused by all other membersof the category. (at 59 FR 61442) See also,Troy, supra at 277.

EPA developed a hazard assessment forvanadium which reviewed the toxicitydata for several vanadium compounds.The assessment indicated that thevanadium from these compounds ishighly toxic to aquatic organisms. Sinceit is the vanadium from thesecompounds that is highly toxic ratherthan the intact chemical compound,EPA believes that all chemicals that area source of vanadium meet the EPCRAsection 313(d)(2)(C) listing criteria.Thus, EPA has established the toxiceffect of concern, the chemical speciesthat causes the effect, and the basis forwhy it may reasonably be expected thatall members of the vanadiumcompounds category can cause theeffects of concern.

Based on the available toxicity data,EPA has concluded that vanadium andvanadium compounds are toxic. Theyhave the potential to kill fish, algae, andinvertebrates as well as causing a rangeof other adverse effects on fish, algae,and invertebrates, based on chemicaland/or biological interactions.Vanadium and vanadium compoundscan cause these toxic effects at relativelylow concentrations. Toxicity data forvanadium and vanadium compoundsinclude for algae, a 9–day LC50 of 0.5mg/L, a 15–day LC50 of 0.5 mg/L,inhibition of growth at 0.1 ppm, adverseeffects on cell division at 3 ppb, 20 ppb,and 0.5 ppm; and for fish, a 96–hourLC50 of 0.62 ppm, and growth andsurvival depression of larvae at 0.17ppm. Because vanadium and vanadium



compounds can cause these toxic effectsat these relatively low concentrations,EPA considers these chemicals to behighly toxic. Additional toxicity valuesinclude for algae, 9–day LC50s of 2 and3 ppm, and a 15–day LC50 of 2 mg/L; forinvertebrates, a 9–day LC50 of 10 ppm;and for fish, 96–hour LC50s of 6.4 ppm,10 ppm, and 7 mg/L, an LC50 of 5.6 mg/L, an 11–day LC50 of 1.99 mg/L, 14–dayLC50s from 1.95 to 4.34 mg/L, and 7–dayLC50s from 1.9 to 6.0 ppm. Consideringvanadium’s persistence, vanadium andvanadium compounds are consideredhighly toxic to aquatic organism at thesehigher concentrations.

As discussed above, vanadium andvanadium compounds are highly toxic.Because vanadium and vanadiumcompounds are toxic at relatively lowconcentrations, EPA believes that theycause or can reasonably be anticipatedto cause a significant adverse effect onthe environment. In addition, because ofthe nature of the potential significantadverse effects, e.g., fish, algae, andinvertebrate kills as well as a range ofother adverse effects on fish, algae, andinvertebrates, and the impacts sucheffects can have on ecologicalcommunities and ecosystems, EPA hasdetermined that they are of sufficientseriousness to warrant reporting.

Thus, EPA reaffirms that there issufficient evidence for adding vanadiumand vanadium compounds on theEPCRA section 313 list of toxicchemicals pursuant to EPCRA section313(d)(2)(C)(i) and (ii), based on theavailable ecotoxicity information forvanadium and vanadium compounds.

Therefore, EPA is finalizing the listingof vanadium and vanadium compoundson the EPCRA section 313 list.

a. Reporting limitation of alloys. Anumber of commenters support EPA’sproposed determination to defer thereporting of vanadium when containedin alloys (64 FR 717). Many commentersalso suggest that the Agency adopt areporting limitation for the other metalssuch as chromium, copper, manganese,and nickel which are commonly foundin alloys. The commenters assert thatalloys have significantly differentbioavailability, bioaccumulation, andtoxicity characteristics than other formsof metals, and thus should be treatedseparately. The commenters argue thatalloys are inherently more stable thanunalloyed materials, do not enter theenvironment as readily as unalloyedmaterials and hence do not interact asgreatly with organisms, and should beconsidered safer from an environmentaland human health perspective. Thecommenters suggested that alloysshould be treated separately not only forthreshold changes, but also for EPCRA

section 313 listings in general andrecommend excluding alloys fromgeneral EPCRA section 313 listings formetals.

One commenter states in regard to thereporting of metals in alloys that itmakes little or no sense to require thereporting of such ‘‘useless’’ information,since the information does not serve thepurpose of informing the community.The commenter contends that notadding vanadium when contained inalloys would help to achieve EPCRAsection 313’s underlying purpose, i.e., toprovide the public with meaningfulinformation, while at the same timereducing the burden on reportingfacilities. Another commenter arguesthat the proposed alloys exemptioncorrectly recognizes that metals inalloys are not generally available forexposure or for toxic effects. Thecommenter argues that expansion of theexemption would improve the TRI database by reporting only releases that maypose risks to human health and theenvironment, thereby providing thepublic with more meaningful data.

Two commenters state that thedefinition of vanadium alloys shouldinclude ‘‘fused alloy slag’’ in thequalifier as well. The commenterscontend that the state of the vanadiumin a ferroalloy form is one of intimatechemical combination on the atomiclevel, not a simple mixture of individualcomponents and it is inherently stableand cannot be dissociated by ordinarymeans. The commenters argue thatlikewise, the fused alloy slag formedrepresents an intimate chemicalcombination of materials as a result ofthe smelting operation. The commentersassert that these elemental materialsmay include various components suchas gangue or ore, ash of fuel, refractorylining, or other stable oxides with theultimate characterization resting uponthe chemical stability of the resultantfused alloy bearing slag. Thus, thecommenters argue, vanadium containedin either alloy or alloy slag form is fusedin a stable compound and therefore, noreleases of vanadium into theenvironment would occur from eithersubstance. The commenters state thatthe true environmental issue to considerin the formulation of an activityqualifier is the leachability of thematerial in that state, and since in bothof the aforementioned cases thevanadium is in a stable compound,leaching would not be expected. Thecommenters assert that withoutallowing an exemption for fused alloyslag, large volumes of steelmaking andferroalloy slag will unnecessarily fallunder this reporting requirement. Thecommenters request that EPA reconsider

its position and expand the definition ofalloy to include both vanadium alloysand vanadium alloy slags.

EPA agrees with those commentersthat support EPA’s belief that it wouldbe inappropriate, at this time, to changethe status quo regarding reportingvanadium when contained in an alloy.As EPA stated in the proposed rule, theAgency is reviewing the issue ofwhether there should be any changes tothe reporting requirements for metalscontained in alloys.

In the proposed rule, EPA did notstate, and did not intend to imply, thatEPA considers alloys to be ‘‘safe,’’ or assome commenters suggested, that EPAhad ‘‘correctly’’ recognized that metalsin alloys are not generally available forexposure or to express their toxiceffects. EPA has not completed itsreview of the alloys issue and has madeno conclusions regarding whether thereshould or should not be any type oflimitation or exemption for any metalscontained in alloys. EPA’s proposalmerely recognized that while this issuewas under review, it would not beappropriate to add alloy forms ofvanadium.

The commenters contend that alloyshave significantly differentbioavailability, bioaccumulation,toxicity characteristics than other formsof metals and are inherently more stablethan unalloyed materials and do notenter the environment as readily asunalloyed materials. EPA believes thatthe issue with alloys is primarilybioavailability, i.e., do the metalscontained in alloys become available.This issue is the focus of EPA’s currentreview. At this point in time, while EPAis in the process of a scientific reviewof the issues pertinent to alloys, theAgency is not prepared to make a finaldetermination on whether vanadium invanadium alloys meet the EPCRAsection 313(d)(2) toxicity criteria.

The commenters did not provide anydata to support their contention. TheAgency does not believe that a metalcompound in a slag necessarily will beenvironmentally unavailable; rather, theAgency’s experience with a previousEPCRA section 313(d) review ofmanganese slags, indicates that at leastin some cases the metal will be available(60 FR 44000, August 24, 1995) (FRL–4954–6).

Some commenters suggested that EPAcreate an alloys reporting limitation forall metals contained in alloys. However,as EPA has stated, the review of whetherany kind of exemption or reportinglimitation should be granted for certainmetals in alloys is still under reviewand until the Agency has thoroughlyreviewed the available data, EPA is not



prepared to extend the reportinglimitation to any other metals. Forexample, EPA is not lowering thereporting threshold for cobalt and cobaltcompounds, and therefore the Agency istaking no action with respect to areporting limitation for cobalt whencontained in alloys.

One commenter asserts that forreasons of consistency--which helpsensure data quality--with existingEPCRA section 313 metal compoundcategories, they oppose adding thequalifier ‘‘except when contained in analloy’’ in any new listing for vanadium.

EPA has not completed its review ofthe alloys issue and has made no

conclusions regarding whether thereshould be any type of general limitationor exemption for any metals containedin alloys. EPA merely recognized thatwhile this issue was under review itwould not be appropriate to increase thereporting requirements for thosefacilities that would otherwise submitreports for vanadium contained inalloys. Therefore, as discussed earlier inthis section, EPA has expanded theEPCRA section 313 listing for vanadiumby removing the ‘‘fume or dust’’qualifier for vanadium, but has notadded the alloy forms of vanadium.Until EPA has the opportunity to fully

evaluate the available data, the Agencyis not prepared to make a finaldetermination whether vanadiumcontained in alloys meets the EPCRAsection 313(d)(2) listing criteria andshould therefore be added. EPA believesthat consistency, in this context, doesnot provide a sufficient basis to requirereporting of vanadium contained inalloys.

H. Persistence and Bioaccumulation

The persistence and bioaccumulationdata for the PBT chemicals covered bythis final rule are listed in Table 3. Adiscussion of these data follows Table 3.

Table 3.—Persistence and Bioaccumulation Data

Chemical Category/Chemical Name CASRN BCF BAF Air Half-lifeSurface

Water Half-life

Soil Half-life

Dioxin/Dioxin-Like CompoundsPolychlorinated dibenzo-p-dioxins

1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin 35822–46–9 1,466 12.2–4.2 hrs ∼20 yrs1,2,3,4,7,8-hexachlorodibenzo-p-dioxin 39227–28–6 5,176 12.4–2.7 hrs ∼20 yrs1,2,3,6,7,8-hexachlorodibenzo-p-dioxin 57653–85–7 3,981 12.4–2.7 hrs ∼20 yrs1,2,3,7,8,9-hexachlorodibenzo-p-dioxin 19408–74–3 1,426 12.4–2.7 hrs ∼20 yrs1,2,3,4,6,7,8,9-octachlorodibenzo-p-dioxin 3268–87–9 2,239 20.4–4.8 hrs ∼20 yrs1,2,3,7,8-pentachlorodibenzo-p-dioxin 40321–76–4 10,890 14.8–2.0 hrs ∼20 yrs2,3,7,8-tetrachlorodibenzo-p-dioxin 1746–01–6 5,755 9.6–1.2 hrs 20–1.5 yrs

Polychlorinated dibenzofurans1,2,3,4,6,7,8-heptachlorodibenzofuran 67562–39–4 3,545 25.0–4.3 hrs ∼20 yrs1,2,3,4,7,8,9-heptachlorodibenzofuran 55673–89–7 3,545 25.0–4.3 hrs ∼20 yrs1,2,3,4,7,8-hexachlorodibenzofuran 70648–26–9 3,586 13.3–3 hrs ∼20 yrs1,2,3,6,7,8-hexachlorodibenzofuran 57117–44–9 3,586 13.3–3 hrs ∼20 yrs1,2,3,7,8,9-hexachlorodibenzofuran 72918–21–9 10,300 13.3–3 hrs ∼20 yrs2,3,4,6,7,8-hexachlorodibenzofuran 60851–34–5 3,586 13.3–3 hrs ∼20 yrs1,2,3,4,6,7,8,9-octachlorodibenzofuran 39001–02–0 1,259 29.4–13.7

hrs∼20 yrs

1,2,3,7,8-pentachlorodibenzofuran 57117–41–6 33,750 11.6–1.2 hrs ∼20 yrs2,3,4,7,8-pentachlorodibenzofuran 57117–31–4 42,500 11.6–1.2 hrs ∼20 yrs2,3,7,8-tetrachlorodibenzofuran 51207–31–9 2,042 11.5–2.1 hrs ∼20 yrs

PesticidesAldrin 309–00–2 3,715 10 hrs–1 hr 24 days1 9 yrs–291

days

Chlordane 57–74–9 11,050 >6,000,0002 5 days–12hrs

239 days 8-0.4 yrs

Heptachlor 76–44–8 19,953 10.5 hrs–1hr

129.4–23.1hrs

4 yrs–8 days

Isodrin 465–73–6 20,180 10 hrs–1 hr 5 yrs–180days

Methoxychlor 72–43–5 8,128 12 hrs–1 hr 15.2–5days

136–81 days

Pendimethalin 40487–42–1 1,944 21–2 hrs 1300–54days

Toxaphene 8001–35–2 34,050 16 days–19hrs

5 yrs–1 yr 11–1 yrs

Trifluralin 1582–09–8 5,674 3.2–0.42 hrs 36.5–4.5days1

394–99 days

Polycyclic Aromatic Compounds



Table 3.—Persistence and Bioaccumulation Data—Continued


Water Half-life

Soil Half-life

Benzo(a)pyrene 50–32–8 912 2.4 hrs 17.3–5.4yrs

14.6 yrs–151days

Benzo(b)fluoranthene 205–99–2 5,631 1.4 days–3.4hrs

≥100 days 14.2 yrs–87days

Benzo(r,s,t)pentaphene 189–55–9 26,280 13 hrs–1 hr 371–232days

Benzo(a)anthracene 56–55–3 800 13 hrs–1 hr 3-1.2 yrs 2.0 yrs–240days

7,12-Dimethylbenz(a)anthracene 57–97–6 5,834 4–0.4 hrs 6 yrs–1 yr 28–20 days

Dibenzo(a,h)anthracene 53–70–3 31,440 13 hrs–1 hr ≥100 days 2 yrs–240days

3-Methylcholanthrene 56–49–5 17,510 3–0.3 hrs 3.8–1.7 yrs

7H-Dibenzo(c,g)carbazole 194–59–2 16,900 23–2 hrs >160 days

Benzo(k)fluoranthene 207–08–9 10,090 12 hrs–1 hr 11 yrs–139days

Benzo(j)fluoranthene 205–82–3 10,090 12 hrs–1 hr 10.5 yrs

Dibenzo(a,e)pyrene 192–65–4 6,875 13 hrs–1 hr 371–232days

Dibenzo(a,h)pyrene 189–64–4 26,280 13 hrs–1 hr 371–232days

Indeno(1,2,3-cd)pyrene 193–39–5 28,620 7.6–0.34 hrs 730–58 days

Dibenz(a,h)acridine 226–36–8 3,500 13 hrs–1 hr >160 days

Dibenz(a,j)acridine 224–42–0 18,470 23–2 hrs >160 days

Benzo(g,h,i)perylene 191–24–2 25,420 10.0–0.31hrs

≥100 days 1.8 yrs–173days

Dibenzo(a,e)fluoranthene 5385–75–1 26,280 10 hrs–1 hr 371–232days3

5-Methylchrysene 3697–24–3 9,388 5–0.5 hrs 3.8 yrs–79days4

2.7 yrs–255days4

Dibenzo(a,l)pyrene 191–30–0 6,875 13 hrs–1 hr 371–232days

Benzo(a)phenanthrene 218–01–9 800 13 hrs–1 hr 3.8 yrs–79days

2.7 yrs–255days

1-Nitropyrene 5522–43–0 908 4 days–10hrs

44 yrs–16yrs

Benzo(j,k)fluorene (fluoranthene) 206–44–0 5,100 20–2 hrs 13 yrs–110days

Metals/Metal CompoundsMercury5 and Mercury compounds 7439–97–6 7,000-36,000 see footnote

5see foot-

note 5see footnote

5

Polychlorinated Biphenyl (PCBs) 1336–36–3 >200,0002,6

2,3,3′,4,4′,5,5′-heptachlorobiphenyl 39635–31–9 4,922 191–19 days >56 days >5–3.92 yrs

2,3,3′,4,4′,5-hexachlorobiphenyl 38380–08–4 37,590 127–13 days >56 days >5–3.42 yrs

2,3,3′,4,4′,5′-hexachlorobiphenyl 69782–90–7 37,590 114–11 days >56 days >5–3.42 yrs



Table 3.—Persistence and Bioaccumulation Data—Continued


Water Half-life

Soil Half-life

2,3′,4,4′,5,5′-hexachlorobiphenyl 52663–72–6 37,590 114–11 days >56 days >5–3.42 yrs

3,3′,4,4′,5,5′-hexachlorobiphenyl 32774–16–6 73,840 88–9 days >56 days >5–3.42 yrs

2,3,3′,4,4′-pentachlorobiphenyl 32598–14–4 196,900 >134,000,0002 80-8 days >56 days 7.25–0.91yrs

2,3,4,4′,5-pentachlorobiphenyl 74472–37–0 196,900 67–7 days >56 days 7.25–0.91yrs

2,3′,4,4′,5-pentachlorobiphenyl 31508–00–6 184,300 >141,000,0002 80–8 days >56 days 7.25–0.91yrs

2′,3,4,4′,5-pentachlorobiphenyl 65510–44–3 196,900 50–5 days >56 days 7.25–0.91yrs

3,3′,4,4′,5-pentachlorobiphenyl 57465–28–8 196,900 57–6 days >56 days 7.25–0.91yrs

3,3′,4,4′-tetrachlorobiphenyl 32598–13–3 105,900 37–4 days >98 days 4.83–0.91yrs

Other ChemicalsHexachlorobenzene 118–74–1 29,600-66,000 >2,500,0002 1,582–158

days5.7–2.7 yrs

Octachlorostyrene 29082–74–4 33,113 >117,000,0002 10 hrs–1 hr 5.7–2.7 yrs7

Pentachlorobenzene 608–93–5 8,318 >640,0002 460–46 days 194 days–>22 yrs

Tetrabromobisphenol A 79–94–7 780; 1,200;3,200

9 days–1day

84–48 days 44–179 days

1The reported half-life data for water are suspected to include significant removal from the medium by processes other than degradation (e.g.,volatilization).

2Values are for Piscivorous Fish.3Since data could not be found for this chemical, the data for the dibenzopyrenes (192–65–4; 189–64–0; 191–30–0), which are structural ana-

logues, was used.4Since data could not be found for this chemical, the data for benzo(a)phenanthrene (218–01–9), a structural analogue was used.5The bioaccumulation potential for the parent metals is assumed to be equivalent to the associated metal compounds since in the environment

the parent metals may be converted to a metal compound. Since metals are not destroyed in the environment they persist longer than 6 months.6Lowest value reported for a dichlorinated PCB.7Since no data could be found for this chemical, the data for the structural analogues hexachlorobenzene (118–74–1) and pentachlorobenzene

(608–93–5) was used.

1. Persistence—a. Dioxin and dioxin-like compounds. In the proposal, EPApreliminarily determined that dioxinand dioxin-like compounds havepersistence half-life values in soil thatranged from 1.5 years to more than 20with all but one chemical having a soilhalf-life of more than 20 years. EPA hasreviewed information and all commentsreceived on dioxin and dioxin-likecompounds’ persistence characteristics.Taking into account this information, asindicated in Table 3, EPA finds thatdioxin and dioxin-like compoundspersist in the environment with half-lives of 2 months or greater andtherefore meet the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical category can be foundin EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)

and/or in EPA’s support documents forthis rulemaking (Ref. 7). In addition,dioxin and dioxin-like compoundspersist in the environment with a half-life of greater than 6 months making ithighly persistent. This, plus otherfactors, supports EPA’s decision tolower the threshold to 0.1 gram.

b. Aldrin. In the proposal, EPApreliminarily determined that aldrin haspersistence half-life values in soil of 291days to 9 years and a persistence half-life value in water of 24 days. EPA hasreviewed information and all commentsreceived on aldrin’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that aldrin persists in theenvironment with a half-life of 2 monthsor greater and therefore meets thepersistence criterion established in thisrulemaking. A complete discussion of

EPA’s findings on this chemical can befound in EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking (Ref. 7).

c. Chlordane. In the proposal, EPApreliminarily determined that chlordanehas persistence half-life values in soil of0.4–8 years and a persistence half-lifevalue in water of 239 days. EPA hasreviewed information and all commentsreceived on chlordane’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that chlordane persists in theenvironment with a half-life of 2 monthsor greater and therefore meets thepersistence criterion established in thisrulemaking. A complete discussion ofEPA’s findings on this chemical can befound in EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)



and/or in EPA’s support documents forthis rulemaking (Ref. 7). In addition,chlordane persists in the environmentwith a half-life of greater than 6 monthswhich supports EPA’s decision to lowerthe threshold to 10 pounds.

d. Heptachlor. In the proposal, EPApreliminarily determined thatheptachlor has persistence half-lifevalues in soil of 8 days to 4 years anda persistence half-life value in water of23.1–129.4 hours. EPA has reviewedinformation and all comments receivedon heptachlor’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that heptachlor persists in theenvironment with a half-life of 2 monthsor greater and therefore meets thepersistence criterion established in thisrulemaking. A complete discussion ofEPA’s findings on this chemical can befound in EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking (Ref. 7). In addition,heptachlor persists in the environmentwith a half-life of greater than 6 monthswhich supports EPA’s decision to lowerthe threshold to 10 pounds.

e. Isodrin. In the proposal, EPApreliminarily determined that isodrinhas persistence half-life values in soil of180 days to 5 years. EPA has reviewedinformation and all comments receivedon isodrin’s persistence characteristics.Taking into account this information, asindicated in Table 3, EPA finds thatisodrin persists in the environment witha half-life of 2 months or greater andtherefore meets the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 7). In addition, isodrinpersists in the environment with a half-life of greater than 6 months whichsupports EPA’s decision to lower thethreshold to 10 pounds.

f. Methoxychlor. In the proposal, EPApreliminarily determined thatmethoxychlor has persistence half-lifevalues in soil of 81 to 136 days and apersistence half-life value in water of 5to 15.2 days. EPA has reviewedinformation and all comments receivedon methoxychlor’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that methoxychlor persists inthe environment with a half-life of 2months or greater and therefore meetsthe persistence criterion established inthis rulemaking. A complete discussionof EPA’s findings on this chemical canbe found in EPA’s Response to

Comments document for thisrulemaking (Ref. 69) and/or in EPA’ssupport documents for this rulemaking(Ref. 7).

g. Pendimethalin. In the proposal,EPA preliminarily determined thatpendimethalin has a persistence half-life value in soil of 54 to 1,300 days.EPA received several significantcomments addressing pendimethalin’spersistence potential which areaddressed below. EPA has reviewedinformation and all comments receivedon pendimethalin’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that pendimethalin persistsin the environment with a half-life of 2months or greater and therefore meetsthe persistence criterion established inthis rulemaking. A complete discussionof EPA’s findings on this chemical canbe found in EPA’s Response toComments document for thisrulemaking (Ref. 69) and/or in EPA’ssupport documents for this rulemaking(Ref. 7).

One commenter contends that EPAhas miscategorized pendimethalin as aPBT chemical based on limitedscreening data which conflicts withconclusions reached by EPA in its riskassessment under the FederalInsecticide, Fungicide, and RodenticideAct (FIFRA). The commenter believesthat the characterization ofpendimethalin is inaccurate and willlead to misplaced effort and misplacedfocus on listed chemicals, and that therewill be no benefit to the public or theenvironment in lowering the reportingthreshold for pendimethalin.

EPA disagrees with the commenter.EPA did not base its determination thatpendimethalin meets the EPCRA section313 persistence criteria, nor thatpendimethalin is highly persistent on‘‘screening’’ data. EPA’s conclusion thatpendimethalin persists with a half-lifegreater than 6 months is based on awell-conducted study in whichpendimethalin degrades in soil with ahalf-life of 1,322 days. Further, even ifthese data were discounted, there arenumerous data submitted in support ofreregistration of pendimethalin underFIFRA that provide strong evidence thatpendimethalin meets the EPCRA section313 persistence criteria, i.e., a half-lifegreater than 2 months. A more detaileddiscussion of these data is presented inthe following responses. Contrary to theassertion by the commenter, thecategorization of pendimethalin as aPBT chemical as described in theproposed rule is not in conflict with theconclusions reached by EPA during theFIFRA assessment. In addition, EPAdisagrees that there will be no benefits

to the public or the environment fromlowering the thresholds forpendimethalin. EPA believes thatpendimethalin, like all PBT chemicals,is of special concern because it has thepotential to cause adverse effects evenwhen released to the environment insmall quantities because it canbioaccumulate in organisms to levelsmuch greater than those present in theenvironment. EPA believes thatlowering the reporting threshold forpendimethalin will provide informationto the public that will increase theirawareness of low levels of releases tothe environment which have thepotential to concentrate in organismsand cause adverse effects, which is fullyconsistent with the purposes of EPCRAsection 313.

The commenter states that EPA hasignored bioavailability in designatingpendimethalin as a PBT chemical andargues that the true bioaccumulationpotential for pendimethalin is greatlyoverestimated based on the results ofthe standard laboratory fishbioconcentration study. The commenterasserts that when data onbioavailability, degradation, anddepuration are all considered, the ‘‘realworld’’ bioconcentration potential forpendimethalin is low and, thereforependimethalin should not bemischaracterized as a PBT chemical.

The bioavailability data thecommenter refers to was not specificallyidentified. Bioavailability of a chemicalwill vary from environment toenvironment and soil type to soil type.Caution must be taken, however, not todraw the erroneous conclusion thatbecause a chemical has been shown tohave a high affinity to sorb to sedimentsin aquatic environments that it will notbe available for uptake by aquaticorganisms. Examples like the PCBs (seeUnit VI.F. for a further discussion onthis issue) indicate that although someof these compounds have sorptioncoefficients much greater thanpendimethalin, they are still widelyfound in the tissues of aquaticorganisms in contaminated waters.Further, it would be erroneous to statethat pendimethalin is not bioavailablebecause if it were not bioavailable itcould not function as an herbicide.

The commenter claims that usingEPA’s own criteria (half-lifes longerthan 2 months in water, sediment, orsoil, or a half-life longer than 2 days inair) pendimethalin cannot be classifiedas persistent. Rather the commentercontends that pendimethalin has ‘‘low’’or ‘‘low to moderate’’ persistence.

The commenter is incorrect. TheAgency has set persistence criteria ofhalf-lifes for soil, sediment, and water



greater than 2 months and a half-life inair of greater than 2 days. Chemicalsmeeting these criteria are consideredpersistent for purposes of EPCRAsection 313. There are, in fact, noqualifiers such as ‘‘low,’’ ‘‘moderate,’’ or‘‘high’’ associated with the persistencecriteria. The commenter’scharacterization of the persistence ofpendimethalin as ‘‘low’’ or ‘‘low tomoderate’’ is thus not particularlyrelevant. It appears, based on thecomments, that the commenter defineslow to moderate persistence as a half-life of greater than 2 days in air andgreater than 2 months in soil, sediment,or water. If this is the case, then thecommenter in fact concurs with EPA’sassessment of pendimethalin aspersistent (half-life greater than 2months in soil or water and greater than2 days in air).

If the commenter, instead, meant thatpendimethalin has half-lifes of less than2 months in soil or water, and 2 daysin air, EPA notes that the commenterhas failed to provide data to supportthat assertion, and that EPA’s review ofthe data support the Agency’sconclusion.

A commenter cites numerouslaboratory and field dissipation studiesin support of the claim thatpendimethalin does not meet thepersistence criteria.

EPA disagrees that the degree ofpersistence of pendimethalin can becharacterized by the field dissipationstudies cited by the commenter. Fielddissipation studies are not equivalent tothe studies which measure the half-lifefor destruction of a chemical in aspecific medium (i.e., soil, water, or air).Field dissipation studies are designed tomeasure the rate or extent of chemicalloss from the medium after applicationof the chemical. The processes by whichthe chemical is lost may include notonly those that result in destruction ofthe chemical, but those which onlytransport the chemical from onemedium to another such asvolatilization. The studies cited by thecommenter measure the dissipation ofpendimethalin from soil. For a relativelyvolatile chemical such aspendimethalin, field dissipation studiesare of limited use in assessingpersistence because an unknownamount of pendimethalin will betransported from soil to air, resulting ina measured loss from that medium, butnot destruction. Thus, the fielddissipation studies cited by thecommenter will underestimate thepersistence of pendimethalin in soil.

The commenter cites severallaboratory experiments on thedegradation of pendimethalin in soil to

support the argument thatpendimethalin does not meet thepersistence criteria. For example, theystate that laboratory aerobic soildegradation studies have beenconducted in which pendimethalin wasapplied to soil grab samples andincubated under controlled conditions.Pendimethalin degraded in laboratorysoil studies with half-lifes ranging from31 to 1,322 days. In the ReregistrationEligibility Decision (RED) forPendimethalin (Ref 63) document, EPAexplained that 172 days was usedinstead of 1,322 days because:

The half-lifes for aerobic soil metabolismranged from 42-563 days in the literaturestudies referenced below with a guidelinestudy reporting a half-life of 1,322 days fora total of 27 total observations. Because of therange of half-life values, statistical analysesof the available data were performed. Themean, median, and modal half-lifes are 126,122, and 122 days, respectively, with astandard deviation of 66 days (n=24). Thehalf-life values of 409, 563, and 1,322 dayswere not included in the final statisticalanalyses because they were greater than threestandard deviations from the mean. Based onsoils and crops that are normally treated withpendimethalin, the reviewer assumed thattemperatures would likely range from 20–30°C and soil moisture contents from 50-75%Field Capacity (FC). The range of observedhalf-lifes in the above experimentalconditions was 72–172 days.

The commenter contends that the1,322–day half-life value is assumed tobe an outlier (Ref. 5), the range was 31to 172 days. Thus, it is claimed thatlaboratory studies also indicate thatpendimethalin has a low to moderatepersistence according to the EPCRAsection 313 persistence criteria.

EPA believes that the guideline studythat reported a half-life of 1,322 daysrepresents an accurate andrepresentative value for the assessmentof the persistence of pendimethalin inthe environment. In situations wheremultiple values for half-lifes aresubmitted under FIFRA to EPA’s Officeof Pesticide Program (OPP), statisticalanalysis may be conducted to determinemean values and standard deviations.The analysis permits the use of a valuefor exposure assessment modeling thattakes into account the variability indata, and allows the exclusion of valuesmore than three standard deviationsoutside the mean as ‘‘outliers.’’ Thedesignation as an outlier does notinvalidate the study, and in fact, EPAmaintains that even a study designatedas an ‘‘outlier,’’ if valid, gives usefulhalf-life information.

In their assessment of the persistenceof chemicals in soils, OPP focuses onstudies using soil types, soil moisturecontents, and temperatures consistent

with the field application of thechemical in its intended use. In the OPPreview of the studies, the reviewerassumed that in the field application ofthe chemical, temperatures would likelyrange from 20-30 °C and that soilmoisture would range from 50 to 75%field capacity. The consideration of datafrom studies conducted under theseconditions resulted in a half-life rangeof 72 to 172 days for pendimethalin. Itshould be noted that even after theelimination of outliers andconsideration of studies relevant tonormal field application, the entire half-life range is above 2 months, clearlymeeting the criteria for persistence insoil, i.e., a half-life of 2 months.

The releases of pendimethalin subjectto EPCRA section 313 reporting, inmany cases, will not be to agriculturalsoils under typical applicationscenarios. EPA, therefore, contends thateven though some soil half-life valueswere not considered by OPP, eitherbecause they were derived using studiesthat did not represent the desired fieldconditions, or because they were labeledas statistical outliers, the studyconditions still represent realisticscenarios for releases reported underEPCRA section 313 and are valid for usein the determination of persistence.

The commenter cites studiesconducted using flooded soils tosupport the argument thatpendimethalin does not meet thepersistence criteria. The commenterasserts that the studies involved the useof pendimethalin spiked into soil grabsamples covered with a shallow layer ofwater and incubated in the laboratoryunder controlled conditions. Inlaboratory flooded soil studies,pendimethalin degradation half-lifesranged from seven to 104 days with themajority of studies giving half-lifes ofless than 2 months. Degradation ofpendimethalin was more rapid inflooded soils than in nonflooded soils inmost instances. The commenter assertsthat these results demonstrate thatpendimethalin has a low to moderatepersistence in flooded soils according tothe EPCRA section 313 persistencecriteria.

EPA agrees that the reporteddegradation half-lifes in laboratoryflooded soils studies range from 7 to 104days. The studies were reviewed forquality and preferred methodologies. Ofthe studies that are of acceptablequality, EPA chose the highest value(most protective) of the range todetermine if the chemical meets theEPCRA section 313 persistence criteria.In this case, the value of 104 days wouldbe used to characterize pendimethalinas persistent in flooded soils. However,



there is not a separate persistencecriterion for flooded soils, nor are dataon flooded soils preferable to other soildata. EPA notes that other soil studies,as discussed above in this section,indicate a half-life of 1,322 days in soils.

The commenter states that whilependimethalin is stable to hydrolysis, itwill degrade in natural water and water/sediment systems under laboratoryconditions with degradation half-lifesranging from 4 to 22 days.Photodegradation is also rapid withhalf-lifes of approximately 3.5 days. Thecommenter concludes that these resultsindicate that pendimethalin has a lowpersistence in both water and itsunderlying sediment according to theEPCRA section 313 persistence criteria.

Two of the aerobic aquaticdegradation studies cited by thecommenter were not provided to theAgency or are not publicly available,(i.e., they are internal AmericanCyanamid studies). It is unclear fromthe summary provided whether thecited studies measured destruction ofpendimethalin or its loss from themedium by non-destructive water to airtransport processes. If the latter is thecase, the ‘‘dissipation half-lifes’’ citedcannot be used to characterizepersistence. EPA agrees that if the half-lifes reported for aerobic aquaticdegradation represent half-lifes fordestruction of the chemical, they do notmeet the criteria for persistence inwater. However, as noted, the fullstudies were not available for reviewand as such, EPA cannot assume thatthe studies followed destruction ofpendimethalin, or that the studies meetthe quality criteria outlined in this rule.

The commenter cites a half-life rangeof 6 to 22 days derived from ananaerobic aquatic degradation study tosupport the argument thatpendimethalin has a low persistence inboth water and its underlying sedimentaccording to the EPCRA section 313persistence criteria. EPA agrees that thepersistence half-life values cited by thecommenter do not meet the EPCRAsection 313 persistence criteria, butpoints out that additional datasubmitted in support of thereregistration of pendimethalinindicated that half-lifes in aquaticenvironments could be longer. OPPused flooded soil degradation studies toassess the persistence of pendimethalinunder anaerobic aquatic conditions.Half-lifes in these studies ranged from 6to 105 days. In its discussion of thepotential impact of pendimethalin onwater resources, OPP in the RED notesthat pendimethalin has an anaerobicaquatic metabolism half-life of 60 days.EPA believes that after review of the

available data on its persistence in waterpendimethalin meets the EPCRA section313 persistence criteria.

EPA agrees that rapid aqueousphotodegradation under laboratorystudies has been reported forpendimethalin. However, the photolysisscreening tests used are designed toallow the determination of rates ofphotolysis at shallow depths in purewater as a function of lattitude andseason. EPA believes that theenvironmental relevence of these testsshould be considered in their use todetermine persistence, and that theresults are most applicable to shallow,clear waters. EPA believes that theapplication of the results beyond theseenvironments is tenuous due to theattenuation of light by suspended matterand increasing depth in the aquaticenvironment. EPA believes thatpendimethalin’s tendency to sorb to soiland sediments may result, under somecircumstances, in its deposition inbenthic environments beyond the effectsof aqueous photolysis. Therefore, EPAdoes not believe that the half-life forpendimethalin in water should be basedon aqueous photolysis.

The commenter claims pendimethalinwill not persist in air according to theEPCRA section 313 persistence criteriafor air since it has a half-life of less than2 days. The commenter discusses theestimation of pendimethalin’satmospheric half-life and a study on itsphotodegradation in air. The commentercites the results of a calculationaccording to the method of Atkinsonperformed to determine the rateconstant for reaction of pendimethalinwith OH radicals in the gas phase (Ref42). A tropospheric half-life of 3.4 hourswas calculated using the method. Thephotolysis of pendimethalin wasinvestigated by Bossan, et al., 1995 (Ref.15), who reported on the photoreactivityof pendimethalin on airborne fly ashand kaolin using simulated sunlight.Approximately 70% of appliedpendimethalin degraded within 30minutes when adsorbed to fly ash butlittle degradation was observed after 100minutes when pendimethalin wasbound to kaolin.

EPA agrees that pendimethalin doesnot meet the persistence half-life criteriafor air of greater than 2 days, butbecause it meets the persistence criteriafor soil and water, this does not affectEPA’s conclusion. As noted in theproposed final rule (at 64 FR 702), achemical need only meet one of themedia-specific criteria to be consideredpersistent.

The commenter cites EPA’spendimethalin RED document and citesits conclusion in support of the

argument that pendimethalin does notmeet the persistence criteria. Thecommenter describes the REDconclusions as follows:

Pendimethalin dissipates in theenvironment by binding to soil, microbially-mediated metabolism and volatilization. It isessentially immobile in soil.

Based on laboratory studies and limitedfield study information, pendimethalin isslightly to moderately persistent in aerobicsoil environments. Persistence decreaseswith increased temperature, increasedmoisture and decreased soil organic carbon.

EPA disagrees with the commenters’suggestion that the OPP RED forpendimethalin concludes that it doesnot meet the EPCRA 313 persistencecriteria. As stated in an earlier response,‘‘moderate’’ persistence has norelevance in the context of the proposedrule. A chemical is consideredpersistent if it has half-lifes of 2 days inair or 2 months in soil, sediment, orwater, respectively.

The commenter implies that OPP hasconcluded that pendimethalin does notmeet the persistence criteria byselectively citing the OPP RED whilefailing to acknowledge otherinformation OPP discussed in thedocument confirming the persistence ofpendimethalin. OPP did not make anyformal summary conclusions regardingthe overall environmental persistence ofpendimethalin. The commenter hasselectively cited from the RED by takinga few comments out of context whileignoring additional findings whichdemonstrate that pendimethalin meetsthe persistence criteria.

The first statement cited by thecommenter addresses dissipation in theenvironment. Two of the three processes(soil binding and volatilization)responsible for dissipation do not resultin the destruction of the chemical andcannot be directly related to persistence.Volatilization results in the relocation ofthe chemical to the atmosphere. Bindingto soil does not destroy pendimethalinand under some soil conditions hasbeen shown to increase persistence.While microbial metabolism ofpendimethalin can result in itsdestruction, it has been shown to be aslow process under manyenvironmental conditions.

The commenter cites OPP’squalitative description of thepersistence of pendimethalin in aerobicsoil environments as slight to moderate.This does not serve as, nor did OPPintend for this statement to represent, aquantitative description ofpendimethalin’s persistence in soil. OPPdoes not attempt to relate thischaracterization to a numeric range ofpersistence values in the RED, and the



commenter does not provide a rationalefor concluding that OPP’s languageindicates that pendimethalin does notmeet the EPCRA section 313 persistencecriteria.

The final sentence of the citationpoints out factors that decreasepersistence, but a more detailed readingof the RED on the subject ofpendimethalin persistence in aerobicsoils reveals that its persistenceincreases as temperature and soilmoisture decrease, and soil organiccarbon increase.

The commenter performed a Level IIIEQC Multimedia Modeling assessmentfor pendimethalin assuming ‘‘best case,reasonable case, and worst case’’scenarios. The calculated overallenvironmental persistence wasdetermined for pendimethalin to be 5days, 58 days, and 142 days under the‘‘best, reasonable, and worst case’’scenarios, respectively. The results ofthe multimedia model indicated thatpendimethalin will have a persistencein the environment of less than 2months, assuming a reasonable casescenario. The commenter claims thatmultimedia modeling results indicatethat pendimethalin will not bepersistent according to the EPCRAsection 313 persistence criteria.

The commenter notes that the valuesit calculated using the EQC model aremuch lower than the 30 days and 487days calculated for EPA (Ref. 51)assuming best case and worst casescenarios. The commenter alleges thatEPA assumed that half-lifes in soil,sediment and water were identical, 54days and 1,322 days, respectively (Ref.7). The data presented above, however,indicate that these were erroneousassumptions. The half-lifes forpendimethalin dissipation in water,soil, and sediment are not identical, andthe 1,322 day half-life is an outlier.

The commenter concludes thatpendimethalin will have a low tomoderate persistence whether found inthe air, water, soil, or sedimentcompartments of the environment. Thecommenter asserts that this is supportedby field and laboratory degradationstudies, multimedia modeling, andEPA’s FIFRA registration environmentalassessment of pendimethalin. Therefore,pendimethalin should not be classifiedas persistent for purposes of inclusionon the EPCRA section 313 list of PBTchemicals.

EPA disagrees that pendimethalinwill have low persistence in theenvironment whether laboratory andfield studies or multimedia modelingare considered. Multimedia massbalance models offer the mostconvenient means to estimate overall

environmental persistence frominformation on sources and loadings,chemical properties and transformationprocesses, and intermedia partitioning.For the chemicals included in theproposed rule, EPA used a modifiedversion of the EQC model (Ref. 33) toestimate overall environmentalpersistence. Overall persistenceestimated in this way is used as anadditional factor, in conjunction withreaction half-lifes for individual media,bioaccumulation/bioconcentrationfactors, in justifying the determinationmade by EPA in this rule.

The EQC model is based on thefugacity approach first delineated byMackay (Ref. 31) and subsequentlyapplied to numerous environmentalprocesses (Ref. 32). It uses an‘‘evaluative environment’’ in whichenvironmental parameters such as bulkcompartment dimensions and volumes(e.g., total area, volume of soil andsediment, etc.) are standardized, so thatoverall persistence for chemicals withdifferent properties and rates oftransformation may be compared on anequal basis (Ref. 15). EPA used a versionof the EQC level III model (Ref. 33)which was modified to focus on netlosses by deleting model terms foradvective losses (movement out of theevaluative environment of air and waterpotentially containing a chemical) andsediment burial (Ref. 82). In this versionof the model only irreversibletransformation contributes to net loss ofa chemical.

The overall persistence obtained fromthis model is calculated as the totalamount in the evaluative environmentwhen steady state is achieved, dividedby the total loss rate. The results thusobtained are neither an overallenvironmental half-life nor acompartment (or transformation)-specific half-life; rather they areequivalent to an environmentalresidence time. When only irreversibletransformation contributes to net loss--i.e., under the conditions of this versionof the EQC model--overallenvironmental persistence times can beconverted to half-lifes by multiplyingthe former by ln 2 (i.e., 0.693). Theoverall half-life calculated in this way isfor dissipation in the environment as awhole and cannot be related directly toany individual compartment.

The commenter selected media-specific environmental half-lifes for useas input to the EQC model. The valueswere characterized as ‘‘best,’’‘‘reasonable’’ and ‘‘worst’’ case. Nojustification was given for thisclassification. It appeared that theshortest half-lives were categorized as‘‘best case.’’ Based on the information

provided by the commenter, it was notalways possible to determine whetherthe half-lifes for soil or water selectedby the commenter for use as input to theEQC model were for destruction ofchemical, or its dissipation from themedium. As noted previously,dissipation half-lifes do not necessarilyrepresent destruction of the chemicalsince non-destructive transportprocesses such as volatilization can beresponsible for loss from the medium.Their use in multimedia modeling couldpotentially underestimate overallenvironmental persistence. This isparticularly important since themodified EQC model predicted thatgreater than 90% of the pendimethalinwould partition to soil at steady state. Ifa soil half-life based on loss from soil bynondestructive processes was usedrather than one based on the destructionof pendimethalin, its persistence wouldhave been underestimated.

In its modeling of the overallenvironmental persistence ofpendimethalin EPA used the highest,lowest and mean values for the rangesof media-specific half-lifes from validstudies as inputs to the modified EQCmodel, not the highest and lowest asstated by the commenter. Theseincluded a half-life for pendimethalin insoil of 1,322 days. EPA determined thatthe study was properly conducted andchose the half-life value of 1,322 daysfor soil because it represented the mostenvironmentally protective half-lifederived from a valid study. Thecalculated overall environmentalpersistence half-lifes were 1 month, 8months, and 16 months based on thehighest, mean, and lowest half-lifes,respectively. For chemicals in thisrulemaking, EPA considered the multi-media modeling EQC results incharacterizing persistence in the overallenvironment. EPA only intended to usemultimedia modeling results to overridethe medium-specific persistence data inlimited circumstances, e.g., only if allmodel inputs are judged to be accurate(and, as noted above, the commenter’sinputs cannot be determined to beaccurate). But even if EPA were to usethe EQC model to assess persistence,pendimethalin would be consideredpersistent because, with the EPA inputsdescribed above, EQC overallenvironmental persistence half-lifeswere calculated to be greater than 6months using the mean and maximumair, soil, and water half-lifes calculated.

In response to this comment (eventhough it was unclear whether thecommenter was basing its assertion ondegradation data or dissipation data),EPA conducted a new EQC assessmentfor pendimethalin using the same half-



life inputs selected by the commenter.The calculated overall environmentalpersistence half-life was greater than 2months using the longest half-lifesprovided by the commenter for air, soil,water, and sediment. These resultssupport EPA’s assertion that thepersistence of pendimethalin in theenvironment meets the EPCRA section313 persistence criteria.

The commenter argues that thescientifically-based risk assessmentsconducted on pendimethalin as a part ofthe pesticide registration process shouldnot be ignored, and that EPA shouldreview pesticide PBT chemicalclassifications with EPA registrationinformation to ensure an accurateanalysis has been performed.

The commenter notes that EPA hasdetermined through the review of acomplete set of studies that this materialused at an approximate rate of 1.0 to 2.0pounds of active ingredient per acredoes not present an unreasonable risk tohuman health or the environment, thatlow levels of pendimethalin inmanufacturing wastewater releases donot pose an unacceptable risk to theenvironment, and that reported EPCRAsection 313 air releases do not pose asignificant risk to human health or theenvironment.

The commenter concludes that basedon the weight of evidence it is clear thatreleases of pendimethalin frommanufacturing do not pose a significantthreat to human health and theenvironment and that pendimethalinshould not be branded as having a highpotential for harm as indicated by theproposed listing as a PBT chemical andlowering of the reporting threshold.

EPA disagrees that the riskassessments cited by the commenter arerelevant to the characterization ofpendimethalin as a PBT chemical. Thecharacterization of chemicals as PBTchemicals for the purpose of this ruleare based on intrinsic physical-chemicalproperties. Risk is not an intrinsicproperty of a substance, but rather theresult of the combination of intrinsichazard (toxicity) a substance possessesand the exposure to a target organismunder a defined set of circumstances. Itis possible for a substance to present arisk under one set of exposureconditions, but not another. In contrast,a substance characterized as a PBTchemical will remain a PBT chemical,regardless of the exposure to it or itslevels in the environment. (See UnitVI.C.)

Toxic chemicals that persist andbioaccumulate are of particular concernbecause they remain in the environmentfor significant periods of time andconcentrate in the organisms exposed to

them. Furthermore, these PBTchemicals can have serious humanhealth and environmental effectsresulting from low levels of release andexposure.

EPA believes that the substancessubject to this rule have beencharacterized as PBT chemicals usingscientifically sound indicators based onthe intrinsic properties of thesubstances. The PBT characterization isindependent of the risk the substancemay pose under a given set ofcircumstances. These substances havebeen characterized as persistent,bioaccumulative and toxic and,therefore, meet the criteria for loweredreporting thresholds.

Further, FIFRA requires the Agency todetermine that pesticidal uses of achemical do not cause ‘‘unreasonableadverse effects on the environment,’’which is defined in FIFRA section 2(bb)as ‘‘any unreasonable risk to man or theenvironment taking into account theeconomic, social, and environmentalcosts and benefits of the use ofpesticides’’ (7 U.S.C. section 136(bb)).FIFRA is a regulatory statute, and theimpacts of regulation can be immediateand direct (e.g., banning of a chemical),and as such EPA examines not only thehazards presented by the chemical, butalso the specific exposure scenarios, andweighs the risks against the benefits ofthe chemical. The ‘‘unreasonableadverse effects’’ determination underFIFRA is specific to the intentional useof the chemical as a pesticide and doesnot address other uses or releases of thechemical that may result frommanufacture, processing, or other use.Furthermore, a determination underFIFRA that the use of a chemical willnot result in an ‘‘unreasonable adverseeffect’’ is not a determination that thechemical is not hazardous or persistentor that the use of the chemical iswithout risk, but merely that thebenefits of agricultural use as a pesticideoutweigh its risks as an agriculturalpesticide or that the pesticide chemicalresidues on food or feed meet thestandards of section 408 of the FederalFood, Drug, and Cosmetic Act. EPCRAsection 313 was not enacted to serve thesame purpose as FIFRA. Listing onEPCRA section 313 providescommunities with some of theinformation required to determine whatrisks may result from the manufacture,processing, and use of a chemical, andto allow local communities to determinefor themselves whether such risks areacceptable, information not providedunder FIFRA.

h. Toxaphene. In the proposal, EPApreliminarily determined thattoxaphene has persistence half-life

values in soil of 1 to 11 years and apersistence half-life value in water of 1to 5 years. EPA has reviewedinformation and all comments receivedon toxaphene’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that toxaphene persists in theenvironment with a half-life of 2 monthsor greater and therefore meets thepersistence criterion established in thisrulemaking. A complete discussion ofEPA’s findings on this chemical can befound in EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking. (Ref. 7). In addition,toxaphene persists in the environmentwith a half-life of greater than 6 monthswhich supports EPA’s decision to lowerthe threshold to 10 pounds.

i. Trifluralin. In the proposal, EPApreliminarily determined that trifluralinhas persistence half-life values in soil of99 to 394 days and a persistence half-life value in water of 5 to 37 days. EPAhas reviewed information and allcomments received on trifluralin’spersistence characteristics. Taking intoaccount this information, as indicated inTable 3, EPA finds that trifluralinpersists in the environment with a half-life of 2 months or greater and thereforemeets the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 7).

j. Polycyclic aromatic compounds. Inthe proposal, EPA preliminarilydetermined that PACs have persistencehalf-life values in soil that ranged from20 days to 13 years. All but a few hadhalf-lifes well in excess of 6 months.These chemicals had persistence half-life values in water that ranged from 79days to 44 years. EPA received onesignificant comment addressing thepersistence potential of PACs, which isdiscussed below. EPA has reviewedinformation and all comments receivedon PACs’ persistence characteristics.Taking into account this information, asindicated in Table 3, EPA finds thatPACs persist in the environment withhalf-lives of 2 months or greater andtherefore meet the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical category can be foundin EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking (Ref. 7).

One commenter contends that EPAhas incorrectly ignored biotreatment



studies in evaluating persistence forPACs. EPA has also ignored a large bodyof recent research on sequestration andother phenomena that collectively act toreduce the bioavailability of soilcontaminants, such as PACs.

Biotreatment studies includeactivated sludge or other wastewatertreatment studies. As EPA stated in theproposed rule (at 64 FR 700), the reasonfor excluding such studies is thatwastewater treatment in general andactivated sludge in particular representconditions that are far removed fromambient (surface) waters, soils, andsediments. Data on environmental fateand persistence of substances inwastewater and activated sludgenormally cannot be extrapolated to theother conditions. The commenter seemsmost concerned about land biotreatment(bioremediation) studies, but in factgoes well beyond the concept oftreatability, appearing to infer that EPAhas ignored all biodegradation studies ofPACs. However, this is incorrectbecause all mixed-culturebiodegradation studies other thanactivated sludge tests--i.e., field tests aswell as lab studies that used authenticsoil, water and/or sediment grabsamples--were considered indetermining persistence for all of thelisted substances.

The commenter also discusses recentresearch indicating that bioavailabilityof a substance may decline with time ofincubation in soil, and suggests thatEPA should include ‘‘reasonablebioavailability factors’’ in itsdetermination of persistence. As anexample of why this is relevant, therehas been a concern that Superfund siteremediation actions may be mistargetedif they are based on residues releasedfrom the soils by vigorous extractionprocedures, since chemical substancesin soil may become nonbioavailable yetstill be extractable for analyticalpurposes. Additionally, bioremediationmay fail to destroy all of a substancethat such analysis shows is present, ifsome portion is sequestered in a non-bioavailable state. Further, thecommenter contends that chemicals(including many PACs) are notbioavailable if the bioavailability isconsiderably less than 100%. Thecommenter does further specify anumerical bioavailability criteria.

The commenter over-generalizes fromthe research findings, using selectivecitation and quotation from theliterature to give the impression that allis now known and any substancereleased to soil is as good as gonetoxicologically speaking. Other reportscan be quoted to the effect that the manyfactors determining bioavailability,

sequestration, etc. are far fromcompletely resolved, and deserve muchfurther research. Moreover,sequestration does not necessarily implynon-bioavailability. For example, in astudy of PAC sequestration andbioremediation, Tang et al. (Ref. 51a)state that:

The results of the present study suggestthat extensive biodegradation bymicroorganisms does not necessarily removeall of the fraction of an aged compound thatis bioavailable since some uptake by wormsoccurred even after the laboratory-scalebioremediation. . . .it is also possible that aportion of a compound that is sequestered isavailable to different degrees to dissimilarorganisms. . . .It may be that the mass ofmaterial that becomes sequestered should beconsidered as existing in two forms. Oneform may be unavailable to all organismsbecause it is physically remote and thusinaccessible. The second form may bedifferentially available, and its assimilation,toxicity, and/or biodegradation may dependon the properties of the species and its abilityto mobilize the molecules from this non-remote location.

[There is] danger if it is assumed that thedisappearance of lethality denotes theabsence of bioavailability....The point isreinforced by the case of DDT, which issequestered in soil (13) and whose lethalityto insects totally disappears as a result ofsuch sequestration (5), yet a portion of thatinsecticide was still assimilated byearthworms introduced into soil that wastreated in the field with DDT more than 40years before the bioassay was performed. . ..(emphasis added)

And in a similar paper on DDT anddieldrin, Robertson and Alexander (Ref.43a) state that:

The significance of soil properties incontrolling sequestration is evident in theearly observation that the degree ofsequestration of lindane after 22 months wasgreatest in a muck, intermediate in extent ina loam, and least in a sandy loam (11). Thus,soil properties must be considered inattempting to predict the bioavailability ofpersistent compounds. It is also evident fromthe data presented herein that thebioavailability of a sequestered toxicantvaries with the exposed species. Thus, thedeclines in toxicity of aged DDT and dieldrinto the three test insects were quite different;whereas the lethality of the sequesteredcompound to one species had almostdisappeared, it still was effective against asecond. (emphasis added)

The conclusion is manifest: it is thatalthough chemical substances releasedto soil may become sequestered overtime, it cannot be assumed that thisprocess necessarily leads tononbioavailability even when the timehorizon is years. Site- and species-specific factors, as well as substanceproperties, are important in determiningbioavailability. Therefore, it isappropriate to be concerned about the

bioavailability in soil and sediment ofPACs and other substances that meet thePBT criteria established for thisrulemaking.

Further, there is no scientific reasonwhy a chemical can only be consideredbioavailable if its bioavailabilityapproaches 100%. The degree ofbioavailability will vary dependingupon the environmental conditions. Inaddition, as noted above the degree ofbioavailability will also be speciesdependent. Therefore, EPA believes thatthe commenter’s approach is overlysimplistic.

k. Benzo(g,h,i)perylene. In theproposal, EPA preliminarily determinedthat benzo(g,h,i)perylene haspersistence half-life values in soil of 173days to 1.8 years and persistence half-life values in water of greater than 100days. EPA has reviewed informationand all comments received onbenzo(g,h,i)perylene’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that benzo(g,h,i)perylenepersists in the environment with a half-life of 2 months or greater and thereforemeets the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking. (Ref. 7). In addition,benzo(g,h,i)perylene persists in theenvironment with a half-life of greaterthan 6 months which supports EPA’sdecision to lower the threshold to 10pounds.

1. Mercury and mercury compounds.Because metals may convert to differentoxidation states but can never bedestroyed, all metals meet the 6 monthshalf-life criterion automatically. EPAreceived a few significant commentsaddressing mercury and mercurycompounds’ persistence. These arediscussed below. EPA has reviewedinformation and all comments receivedon mercury and mercury compounds’persistence characteristics. Taking intoaccount this information, as indicated inTable 3, EPA finds that mercury andmercury compounds persist in theenvironment with half-lives of 2 monthsor greater and therefore meet thepersistence criterion established in thisrulemaking. A complete discussion ofEPA’s findings on this chemicalcategory can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and in EPA’ssupport documents for this rulemaking(Ref. 7). In addition, mercury andmercury compounds persist in theenvironment with a half-life of greater



than 6 months which supports EPA’sdecision to lower the threshold to 10pounds.

One commenter asserts that EPAshould not classify all forms of mercuryas persistent. The commenter agrees thatHg (0) is properly characterized aspersistent. However, the commentercontends that EPA is incorrect incharacterizing Hg (II) as persistentbecause it is removed rapidly from theatmosphere via wet and dry deposition.

EPA believes that the commenterconfuses residence time with half-life;these terms do not represent equivalentprocesses. There is a distinctionbetween atmospheric ‘‘half-life,’’ whichis the amount of time necessary for halfof the chemical present to be destroyedin the medium, and atmospheric‘‘residence time’’ which is the length oftime a chemical resides in a particularenvironmental medium. For thepurposes of this rule ‘‘half-life’’ includesonly irreversible chemicaltransformations resulting in thedestruction of chemical whereas‘‘residence time’’ includes factors suchas transport of the substance to anothermedium, for example, wet and drydeposition, sorption, complexation orsequestration; and reversible changes inspeciation (i.e., oxidation reductionreactions). EPA agrees that Hg (0) has anaverage ‘‘residence time’’ in theatmosphere of about 1 year and that Hg(II) may be deposited relatively quicklyby wet and dry deposition processes,leading to a ‘‘residence time’’ of hoursto months (Ref. 42a). But the shorterresidence times noted for Hg (II) are dueto physical transport from the medium,rather than irreversible transformationsresulting in the destruction of chemical.Hg (0) released to the atmosphere israpidly converted to Hg (II) throughozone-mediated oxidation. However,this is not an irreversible reaction, nordoes it result in the destruction of thesubstance since the Hg (II) producedfrom oxidation of Hg (0) by ozone canbe reduced back to Hg (0) by sulfite (Ref.28a). The persistence of mercury willnot be mitigated simply by redoxreactions of Hg (0) to and from Hg (II).Whether as Hg (0) or as Hg (II), mercurypersists in the environment.Environmental processes may cause it tochange oxidation states or to betransported from one environmentalmedium to another; however, theseprocesses will not destroy it.

EPA agrees that the report citedprovides reasonable estimates of thefraction of mercury emissions from eachsource category that is likely to be in theform of Hg (II) versus the fraction as Hg(0). However, this information is notrelevant to the assessment of the

persistence of mercury and mercurycompounds because persistenceconsiders destruction only.

m. Polychlorinated biphenyls. In theproposal, EPA preliminarily determinedthat polychlorinated biphenyls (PCBs)have persistence half-life values in soilthat ranged from 1 to 7 years andpersistence half-life values in water thatranged from 56 to 98 days. EPA hasreviewed information and all commentsreceived on PCBs’ persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that PCBs persist in theenvironment with half-lifes of 2 monthsor greater and therefore meet thepersistence criterion established in thisrulemaking. A complete discussion ofEPA’s findings on this chemical listingcan be found in EPA’s Response toComments document for thisrulemaking (Ref. 69) and/or in EPA’ssupport documents for this rulemaking(Ref. 7). In addition, all of the PCBspersist in the environment with a half-life of greater than 6 months whichsupports EPA’s decision to lower thethreshold to 10 pounds.

n. Hexachlorobenzene. In theproposal, EPA preliminarily determinedthat hexachlorobenzene has persistencehalf-life values in soil of 3 to 6 years.EPA has reviewed information and allcomments received onhexachlorobenzene’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that hexachlorobenzenepersists in the environment with a half-life of 2 months or greater and thereforemeets the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and in EPA’ssupport documents for this rulemaking(Ref. 7). In addition, hexachlorobenzenepersists in the environment with a half-life of greater than 6 months whichsupports EPA’s decision to lower thethreshold to 10 pounds.

o. Octachlorostyrene. In the proposal,EPA preliminarily determined that OCShas persistence half-life values in soil of3 to 6 years. EPA received onesignificant comment addressing OCS’spersistence potential which is discussedbelow. EPA has reviewed informationand all comments received on OCS’spersistence characteristics. Taking intoaccount this information, as indicated inTable 3, EPA finds that OCS persists inthe environment with a half-life of 2months or greater and therefore meetsthe persistence criterion established inthis rulemaking. A complete discussionof EPA’s findings on this chemical can

be found in EPA’s Response toComments document for thisrulemaking (Ref. 69) and/or in EPA’ssupport documents for this rulemaking(Ref. 7). In addition, OCS persists in theenvironment with a half-life of greaterthan 6 months which supports EPA’sdecision to lower the threshold to 10pounds.

One commenter believes that OCSshould not be considered to be a PBTchemical. The commenter admits thatOCS has the potential to bioaccumulateand may theoretically persist in theenvironment, but cites fallingenvironmental levels of OCS and thelack of evidence of human andenvironmental toxicity as justificationfor why OCS should not be consideredto be a persistent, bioaccumulative andtoxic chemical. The commenterscontend that pentachlorobenzene andhexachlorobenzene are not good analogsfor OCS.

EPA disagrees. As discussed in UnitVI.G., EPA believes that OCS meets theEPCRA section 313 toxicity criteria.Further, EPA believes that OCS is highlypersistent. No measured half-life datafor soil or water that met the standardsfor data acceptability could be locatedfor octachlorostyrene (CAS No. 29082–74–4). Therefore, EPA used half-lifes forthe structural analogspentachlorobenzene (CAS No. 608–93–5) and hexachlorobenzene (CAS No.118–74–1) for estimating half-lifes forOCS. EPA believes thatpentachlorobenzene andhexachlorobenzene are good analogs forOCS because they, like OCS, are highlychlorinated benzene derivatives, whichare structurally very similar. By analogy,OCS is expected to have a half-life insoil of greater than 6 months and greaterthan 2 days in air (Ref. 7). These half-lifes are sufficient to designate OCS aspersistent using the criteria described inthe proposed rule. EPA believes that itsuse of analog data is scientificallysupportable because like OCS bothanalogs are highly chlorinatedmonocyclic aromatics.

EPA believes that the degree oftoxicity as well as the degree ofpersistence and bioaccumulation areinherent to a chemical. The absolutelevel of a chemical in the environmentdoes not affect its degree of persistence,bioaccumulation, or whether or not ithas been shown to cause adverse effectsto aquatic organisms. The absolute levelin the environment is a factor of bothhow much is entering the environmentand the persistence of the chemical inthe environment. The degree to which achemical is present in aquatic organismsis not only a measure of the BAF, butalso inputs into the environment and



persistence. The assertions made by thecommenter do not support theircontentions concerning the toxicity,persistence, or bioaccumulation of OCS.

p. Pentachlorobenzene. In theproposal, EPA preliminarily determinedthat pentachlorobenzene has persistencehalf-life values in soil of 194 days tomore than 22 years. EPA received nosignificant comments addressingpentachlorobenzene’s persistencepotential. EPA has reviewedinformation and all comments onpentachlorobenzene’s persistencecharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that pentachlorobenzenepersists in the environment with a half-life of 2 months or greater and thereforemeets the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 7). In addition,pentachlorobenzene persist in theenvironment with a half-life of greaterthan 6 months which supports EPA’sdecision to lower the threshold to 10pounds.

q. Tetrabromobisphenol A. In theproposal, EPA preliminarily determinedthat TBBPA has persistence half-lifevalues in soil of 44 to 179 days andpersistence half-life values in water of48 to 84 days. EPA received severalsignificant comments addressingTBBPA’s persistence and discussesthem below. EPA has reviewedinformation and all comments receivedon TBBPA’s persistence characteristics.Taking into account this information, asindicated in Table 3, EPA finds thatTBBPA persists in the environment witha half-life of 2 months or greater andtherefore meets the persistence criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 7).

One commenter states that EPA’sdetermination that TBBPA is persistentin the environment appears to be basedupon a model which uses default data,that it is difficult to interpret EPA’smethodology for applying its EQCModel Output for Toxics ReleaseInventory PBT Rule Chemicals, and ittherefore is not clear how EPA arrivedat the conclusion that TBBPA ispersistent.

EPA disagrees that it is unclear howthe EQC model was used in theassessment of chemical persistence and

that EPA used only default data. EPAprovided discussion on the conduct ofthe multimedia modeling in thedocument titled EQC Model Output forToxics Release Inventory PBT RuleChemicals (Ref. 33). EPA used chemical-specific input data (i.e., half-lifes in air,soil, water, and sediment and chemicalproperties) where available in allmultimedia modeling runs. No defaultdata were used in lieu of chemical-specific inputs. All chemical-specificinputs for each chemical were listed inthis document. Further, EPA explainedits use of the modified EQC model notonly in the support document identifiedearlier, but also in the preamble to theproposed rule. In its description of themodeling EPA stated:

Multimedia mass balance models offer themost convenient means to estimate overallenvironmental persistence from informationon sources and loadings, chemical propertiesand transformation processes, and intermediapartitioning. For the chemicals included inthis proposed rule EPA used the [modified]EQC model. . .to estimate overallenvironmental persistence. Overallpersistence estimated in this way is used asan additional factor, in conjunction withreaction half-lifes for individual media,bioaccumulation/ bioconcentration factors,etc., in justifying actions proposed in thisrule.

The EQC model is based on thefugacity approach first delineated byMackay (Ref. 31) and subsequentlyapplied to numerous environmentalprocesses (Ref. 32). It uses an‘‘evaluative environment’’ in whichenvironmental parameters such as bulkcompartment dimensions and volumes(e.g., total area, volume of soil andsediment) are standardized, so thatoverall persistence for chemicals withdifferent properties and rates oftransformation may be compared on anequal basis (Ref. 15). EPA used a versionof the EQC level III model (Ref. 33)which was modified to focus on netlosses by deleting model terms foradvective losses (movement out of theevaluative environment of air and waterpotentially containing a chemical) andsediment burial (Ref. 82). In this versionof the model only irreversibletransformation contributes to net loss ofa chemical.

The overall persistence obtained fromthis model is calculated as the totalamount in the evaluative environmentwhen steady state is achieved, dividedby the total loss rate. The results thusobtained are neither an overallenvironmental half-life nor acompartment (or transformation)-specific half-life; rather they areequivalent to an environmentalresidence time. When only irreversible

transformation contributes to net loss--i.e., under the conditions of this versionof the EQC model--overallenvironmental persistence times can beconverted to half-lifes by multiplyingthe former by ln 2 (i.e., 0.693). Theoverall half-life calculated in this way isfor dissipation in the environment as awhole and cannot be related directly toany individual compartment.

In the analysis EPA used the highest,lowest and mean values for the rangesof half-lifes for soil, air, and water asinputs to the model. These half-lifeswere collected from the literature fromscientifically sound studies and weresubject to data quality standards. Theoverall environmental persistence half-life for TBBPA calculated based on theEQC model was greater than 2 monthsbut less than 6 months using the longesthalf-lifes for air, soil, water, andsediment. These results support EPA’sassertion that the persistence of TBBPAin the environment will meet theEPCRA section 313 persistence criteria.

The commenter believes that TBBPAdoes not meet the persistence criteria forair. To support this contention thecommenter refers to a study cited in aWorld Health Organization (WHO)document (Ref. 83). Specifically thecommenter cites photodegradationstudies that demonstrated that the half-life of TBBPA absorbed onto silica gelexposed to ultraviolet (UV) radiationwas 0.12 day in air. In addition, thecommenter contends that studies of thephotolysis of TBBPA in the presence ofUV light and hydroxyl radicals showthat TBBPA was totally degraded within5 to 6 days with an estimated 33–hourhalf-life. The commenter did notprovide these studies or providereferences to the original studies.

Further, the same commenter citesWHO EHC 172 (Ref. 83) for data onphotodegradation to support the claimthat TBBPA does not meet thepersistence criteria for air. A review ofthe citation provided by the commenterreveals that it is a secondary referencetaken from unpublished data from Bayer(Ref. 10). EPA was unable to review thefull unpublished study to determine thequality of the data, only the summaryfound in the WHO document wasavailable. In the WHO summary of theBayer study TBBPA adsorbed onto silicagel and was exposed to ultravioletirradiation at the 254 nanometer (nm)wavelength. Eight metabolites weredetected and a half-life value of 0.12days obtained. WHO noted that ‘‘[i]t isdifficult to derive environmentalconclusions from the results of theseexperiments.’’

EPA believes that the environmentalrelevance of the test results is doubtful.



While the experiment may demonstratethe potential for TBBPA to undergophotodegradation under laboratoryconditions, the experimental conditions,to the extent they could be determinedfrom the short summary provided, werenot environmentally relevant.

In order for a molecule to undergophotochemical change it must absorblight. It is well known that only thetransitions corresponding to ultraviolet/visible light absorption are inherentlyenergetic enough to lead to chemicalreactions. The wavelengths ofimportance for photochemicaltransformations is thus ultraviolet/visible light with a wavelength of 110 -750 nm. When environmentalphotochemistry at or near the earth’ssurface is considered, the wavelengthsof light of importance are furthernarrowed because the stratosphericozone layer effectively prevents UVirradiation of less than 290 nm fromreaching the earth’s surface. Thus, onlythe light of the 290-750 nm wavelengthabsorbed by a molecule can potentiallylead to photochemical changes of thatmolecule in the environment near theearth’s surface. EPA believes thatbecause the subject study utilized UVirradiation at the 254 nm wavelength, awavelength that does not reach theearth’s surface due to mitigation bystratospheric ozone, the half-life derivedis not relevant and, therefore, cannot beused to determine the persistence ofTBBPA in air.

The commenter also refers to studiesof the photolysis of TBBPA in thepresence of UV light and hydroxylradicals in which TBBPA was shown tototally degrade within 5 to 6 days withan estimated 33–hour half-life. Noadditional information or referenceswere provided to enable EPA to evaluatethese findings for use in thecharacterization of the atmospheric half-life TBBPA.

The commenter contends thatTBBPA’s molecular structure makes itinherently biodegradable. The hydroxylmoiety on the TBBPA molecule can bereadily transformed by organisms in theenvironment. The parent TBBPAmolecule is no longer present once thisbiotransformation takes place.Therefore, based on TBBPA’s structurealone, the Agency should considerTBBPA as unlikely to beenvironmentally persistent.

EPA disagrees with the statement thatbased on structure alone, the Agencyshould consider TBBPA as unlikely tobe environmentally persistent. WhileEPA generally believes that measuredvalues from well conducted studies arepreferable to structure activityrelationships (SAR) as an indicator of

persistence, the Agency believes that itis possible to make some generalstatements about the biodegradability ofTBBPA based on its structure.

Current knowledge of structurebiodegradability relationships suggeststhat the presence of multiple bromineson an aromatic molecule adverselyeffects biodegradation. In fact, when thebiodegradability of TBBPA is assessedwith EPA structure activity relationshiptools for predicting biodegradation fromstructure (Refs. 46 and 47), the presenceof multiple aromatic bromines, a carbonwith four single bonds, and themolecular weight of TBBPA are allstructural features that reducebiodegradability. Therefore, even if EPAwere to base its assessment of thepersistence of TBBPA on its molecularstructure, the Agency would concludethat it is not readily biodegradable.

The commenter contends that TBBPAwill not meet the persistence criteria forwater, soil, and sediment becauseTBBPA will biodegrade in these media.The commenter cites the results ofseveral biodegradation studies asdemonstrating that TBBPA is notpersistent in these media. Thecommenter states that even thoughdegradation studies have shown thatTBBPA is not ‘‘readily biodegradable’’(i.e., TBBPA is not mineralized to asignificant extent by sewage sludgewithin 28 days) there are studies thatindicate it is not persistent. Specifically,in studies submitted to EPA in 1989,TBBPA has been shown to be subject tobiodegradation both in soil andsediment under aerobic or anaerobicconditions; TBBPA’s estimated half-lifederived from these studies is 50 days. Instudies submitted by the BrominatedFlame Retardants Industry Panel toEPA, TBBPA also was shown to undergodegradation in a sediment/water systemwith an estimated half-life of 48 to 84days. (These data were reported underthe Agency’s TSCA Section 4 test rule.)The commenter argues that these datademonstrate that TBBPA does not meetmost widely (and internationally)accepted criteria for persistence in soilor sediments (See Unit VI.B.) Therefore,TBBPA should not be considered to bepersistent for purposes of EPCRASection 313.

The commenter cites additionalresearch conducted on thebiodegradation of TBBPA under aerobicand anaerobic conditions in soil (Refs.47) and asserts that the data indicatethat ‘‘TBBPA does not meet the mostwidely and internationally acceptedcriteria.’’ EPA discusses its assessmentof the Springborn soil biodegradationstudies elsewhere in the Response toComments document (Ref. 69). As

explained earlier, the internationalpersistence criteria are not relevant tothe classification of persistence underthe criteria adopted by the Agency, andEPA disagrees that TBBPA should notbe considered persistent because it doesnot meet the ‘‘most widely (andinternationally) accepted’’ criteria. (SeeUnit VI.B.)

The commenter makes the argumentthat TBBPA has been shown to besubject to biodegradation in soil andsediment under aerobic and anaerobicconditions with ‘‘estimated’’ half-lifes of50 days. Although the commenterderived a biodegradation half-life, themethod used to do so and the validityof the value could not be determinedbecause no supporting information wasprovided. EPA questions the validity ofthe 50–day half-lifes estimated by thecommenter on those grounds.

The commenter refers to two soil grabsample studies and a sediment/watermicrobial system study. These studiesinvestigated the biodegradation ofTBBPA in three different soil types inthe presence (aerobic) and absence(anaerobic) of oxygen, and thebiodegradation of TBBPA in a systemcontaining sediment and river water inthe presence of oxygen. In the aerobicsoil studies less than 6% ultimatebiodegradation (completebiodegradation to CO2) was observedover the 64–day test period. The majorportion of TBBPA remained in the soil.Analysis showed after 64 days 74 to82% TBBPA remained in aMassachusetts sandy loam soil, 36 to40% remained in an Arkansas silt loam,and 41 to 43% remained in a Californiaclay loam soil. Over the course of theexperiments, TBBPA either remained insoil undegraded, underwent minorstructural changes (primarybiodegradation), or to a very smallextent (<6%), underwent completebiodegradation to CO2. Individualvalues for evolved CO2 in each soil typeover time were not reported andbiodegradation half-life values were notcalculated. If it is assumed in theabsence of values for CO2 evolution atsampling times spaced evenly over thetest period reported data, that TBBPAunderwent a steady rate of degradationover the duration of the experiments,approximate half-lifes of 44 to 179 dayscan be estimated (Ref. 7).

Biodegradation half-lifes from theaerobic soil biodegradation experimentscan be approximated. The half-life isdefined as the amount of time necessaryfor the destruction of half of thechemical present in the medium. Giventhat the duration of the soilbiodegradation test is 64 days(equivalent to greater than 2 months), a



chemical that undergoes less than 50%biodegradation by the end of the testperiod would have a half-life of greaterthan 2 months and meet the EPCRA 313persistence criteria for soil. In one of thesoils in which TBBPA was tested (aMassachusetts sandy loam soil) 74 to82% of the original TBBPA appliedremained in the soil unchanged at theend of the 64–day test period. Thus, inthis study, TBBPA was shown to havea half-life in soil of greater than 2months since less than 50% degradationof TBBPA occurred in 64 days.

The biodegradation of TBBPA in thesame three soils as above underanaerobic conditions in a 64–day testhas also been studied. The resultsshowed that 44 to 57% of the TBBPAapplied to soil remained undegraded inthe Massachusetts sandy loam soil aftera 64–day test period, 53–65% in anArkansas silt loam soil, and 90% in aCalifornia clay loam soil. Less than 50%destruction of the test chemicaloccurred over a 64–day (> 2 month) testperiod in all soils tested. Thus, in thisstudy, TBBPA was shown to have a half-life in soil of greater than 2 monthssince less than 50% degradation ofTBBPA occurred in 64 days.

Aerobic sediment water microbial testsystems containing natural sedimentsand river water were used to measuredegradation half-lifes for TBBPA in 56–day experiments. Half-lifes calculatedfor the biodegradation of TBBPA rangedfrom 48 to 84 days. Researchers foundan apparent correlation between half-lifes and TBBPA concentration, andhalf-lifes and microbial concentrations.Thus, in this study, TBBPA was shownto have a half-life in sediment watersystems of greater than 2 months wheneither the larger value or the mean of thetwo values is considered.

Further, the commenter claims thatabiotic degradation of TBBPA in wateralso is expected. The calculated half-lifeof decomposition of TBBPA by UVradiation in water was 10.2 days inspring, 6.6 in summer, 25.9 in autumn,and 80.7 days in winter. Therefore,TBBPA is not expected to be persistentin water. No other information wasprovided.

The commenter cites WHO EHC 172(Ref. 83) for data on photodegradation tosupport the claim that TBBPA does notmeet the persistence criteria for water.In its review of the literature to evaluatethe persistence of TBBPA, EPA foundno information on its photodegradationin water. A review of the citationprovided by the commenter reveals thatit is a secondary reference taken from anunpublished study from Bayer (Ref. 10).EPA was unable to review the fullunpublished study to determine the

quality of the data. Only the summaryfound in the WHO document wasavailable. The Bayer study onphotodegradation in water yieldedcalculated half-lifes ranging from 6.6days to 80.7 days with the longest half-life calculated during the winter, whensolar irradiation is least intense and theshortest half-life occurring in thesummer, when the solar irradiation ismost intense. The commenter did notinclude the fact that the effect of cloudcover lengthened the calculated half-lifeby a factor of 2. Water depth was alsofound to influence the directphotodegradation of TBBPA. At thesurface of a water body, solar irradiationis fairly uniform; however, as depthincreases, both the water itself andmaterials in it can attenuate thetransmission of solar energy through thewater column. Irradiance has beenshown to decrease by greater than 90%for both ultraviolet and visible light ata depth of 5 meters in a eutrophic lake(Ref. 52). EPA disagrees with thecommenter’s conclusion that TBBPAphotodegradation in water will besufficiently rapid that it will not meetthe persistence criteria. Based on thestudy cited by the commenter whichincludes an 80–day ( > 2 month) half-life for photodegradation of TBBPA inwinter, and the mitigating effects ofwater depth and cloud cover on rates ofphotodegradation, EPA believes that ahalf-life of greater than 2 months inwater is supported. EPA, thereforeasserts that based on these findings,TBBPA meets the EPCRA section 313persistence criteria of greater than 2months in soil and water.

2. Bioaccumulation—a. Dioxin anddioxin-like compounds. In the proposal,EPA preliminarily determined thatdioxin and dioxin-like compounds haveBCF values that range from 1,259–42,500 with 6 chemicals over 5,000 and6 chemicals between 3,500 and 5,000.EPA has reviewed information and allcomments received on dioxin anddioxin-like compounds’bioaccumulation characteristics. Asindicated in Table 3, EPA finds thatdioxin and dioxin-like compoundsbioaccumulate in the environment withBAF/BCF values greater than 1,000 andtherefore meet the bioaccumulationcriterion established in this rulemaking.A complete discussion of EPA’s findingson this chemical category can be foundin EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking (Ref. 71). In addition,most of the members of the dioxin anddioxin-like compounds categorybioaccumulate in the environment with

a value close to, or well above, 5,000,which supports EPA’s decision to lowerthe threshold to 0.1 gram.

b. Aldrin. In the proposal, EPApreliminarily determined that aldrin hasa BCF value of 3,715. EPA has reviewedinformation and all comments receivedon aldrin’s bioaccumulationcharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that aldrin bioaccumulates inthe environment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71).

c. Chlordane. In the proposal, EPApreliminarily determined that chlordanehas a BCF value of 11,050. EPA hasreviewed information and all commentsreceived on chlordane’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatchlordane bioaccumulates in theenvironment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition,chlordane bioaccumulates in theenvironment with a BCF value greaterthan 5,000 which supports EPA’sdecision to lower the threshold to 10pounds.

d. Heptachlor. In the proposal, EPApreliminarily determined thatheptachlor has a BCF value of 19,953.EPA has reviewed information and allcomments received on heptachlor’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatheptachlor bioaccumulates in theenvironment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and in EPA’ssupport documents for this rulemaking(Ref. 71). In addition, heptachlorbioaccumulates in the environment witha BAF/BCF value greater than 5,000which supports EPA’s decision to lowerthe threshold to 10 pounds.



e. Isodrin. In the proposal, EPApreliminarily determined that isodrinhas a BCF value of 20,180. EPA hasreviewed information and all commentsreceived on isodrin’s bioaccumulationcharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that isodrin bioaccumulatesin the environment with a BAF/BCFvalue greater than1,000 and thereforemeets the bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition,isodrin bioaccumulates in theenvironment with a BAF/BCF valuegreater than 5,000 which supports EPA’sdecision to lower the threshold to 10pounds.

f. Methoxychlor. In the proposal, EPApreliminarily determined thatmethoxychlor has a BCF value of 8,128.EPA has reviewed information and allcomments received on methoxychlor’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatmethoxychlor bioaccumulates in theenvironment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71).

g. Pendimethalin. In the proposal,EPA preliminarily determined thatpendimethalin has a BCF value of 1,944.EPA has reviewed information and allcomments received on pendimethalin’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatpendimethalin bioaccumulates in theenvironment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71).

h. Toxaphene. In the proposal, EPApreliminarily determined thattoxaphene has a BCF value of 34,050.EPA has reviewed information and allcomments received on toxaphene’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds that

toxaphene bioaccumulates in theenvironment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition,toxaphene bioaccumulates in theenvironment with a BAF/BCF valuegreater than 5,000 which supports EPA’sdecision to lower the threshold to 10pounds.

i. Trifluralin. In the proposal, EPApreliminarily determined that trifluralinhas a BCF value of 5,674. EPA hasreviewed information and all commentsreceived on trifluralin’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thattrifluralin bioaccumulates in theenvironment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterion. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71).

j. Polycyclic aromatic compounds. Inthe proposal, EPA preliminarilydetermined that PACs have BCF valuesthat ranged from 800 to 31,440 with 16of the 21 members of the categoryhaving BCF values greater than 5,000.EPA received several commentsconcerning the PACs category listingand the bioaccumulation data which areaddressed below. EPA has reviewedinformation and all comments receivedon PACs’ bioaccumulationcharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that PACs bioaccumulate inthe environment with BAF/BCF valuesgreater than 1,000 and therefore meetthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical category can be foundin EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking (Ref. 71).

Three of the commenters support theretention of a single PACs categorywhile one commenter believes thatsplitting the category into two categorieswould be the most appropriate option.Additional specific comments were asfollows. One commenter stated thatPACs are typically found as mixtures inincoming natural organic raw materials,such as coal and that it would be

difficult to separate information intotwo reporting categories. Anothercommenter stated that reporting as onecategory is also more consistent with theGreat Lakes Binational Toxics StrategyLevel 2 listing for these chemicals. Acommenter stated that the alternateproposal to create two PAC categorieswould be unnecessarily burdensome forthe regulated community sincereporting facilities would be required tospeciate their PAC releases, and, ifchemicals from both categoriesexceeded reporting thresholds, file twoForm R reports, instead of one. Onecommenter stated that use of a singlePACs category will simplify thereporting requirements; thus, it willreduce reporting burden. Severalcommenters stated that according to theproposed rule, 16 of the 21 members ofthe category had BCF values greaterthan 5,000 and that one proposal wouldregard the entire PACs category to behighly persistent and bioaccumulative,regardless of each individual PAC’sactual persistence and bioaccumulativeproperties. Several commenters statedthat they believed that splitting thecategory into two categories would bethe most appropriate course. Anothercommenter stated that no chemicalshould be added to the highlypersistent/bioaccumulative categorywhen it does not fit the criteria and thatin order to gain the most accurateinformation, two separate categorieswould be the superior solution. Thecommenter stated that lowering thereporting threshold for the PACscategory to 10 pounds is unjustifiedconsidering that, according to EPA data,many of the individual PACs within thecategory do not meet the PBT criteria.

EPA considered splitting the PACscategory into two or three categories orlistings, but EPA believes, as do most ofthe commenters, that the mostappropriate option is to retain a singlePACs category. The PACs category wascreated because the members of thecategory are chemically and structurallyvery similar, share the sametoxicological effect (carcinogenicity),and typically are produced, released,and otherwise managed as waste ascomplex mixtures rather thanindividual chemicals. As such it wouldbe more difficult to estimate releases ifthe category were split into two or threecategories based on the currentlyavailable bioaccumulation data. Thesereasons support retaining a single PACscategory. EPA agrees with thosecommenters that stated that theretention of a single PACs categorywould be the simpler and lessburdensome option. EPA also



recognizes that, based on currentlyavailable information, not all membersof the PACs category meet the highlypersistence and highly bioaccumulativecriteria. Of the 21 chemicals in the PACscategory proposed for a lower threshold,5 have BCF values that nominally donot meet the highly bioaccumulativecriteria, while the rest exceed the highlybioaccumulative criteria. Given thestructural similarities of the members ofthis category and the higherbioaccumulation values for 16 of the 21PACs, the 5 BCF values below 5,000may underestimate, to some extent, thebioaccumulation potential of thesecompounds. For purposes of thisrulemaking, EPA is classifying the PACscategory as persistent andbioaccumulative rather than highlypersistent and highly bioaccumulative.Thus, the PACs category will have areporting threshold of 100 pounds.However, the Agency will continue toassess the bioaccumulation potential ofthis category and specifically whetherthe lower bioaccumulation values for 5members of the category areappropriate.

k. Benzo(g,h,i)perylene. In theproposal, EPA preliminarily determinedthat benzo(g,h,i)perylene has a BCFvalue of 25,420. EPA has reviewedinformation and all comments receivedon benzo(g,h,i)perylene’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatbenzo(g,h,i)perylene bioaccumulates inthe environment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition,benzo(g,h,i)perylene bioaccumulates inthe environment with a BCF valuegreater than 5,000 which supports EPA’sdecision to lower the threshold to 10pounds.

l. Mercury and mercury compounds.In the proposal, EPA preliminarilydetermined that mercury and mercurycompounds have BCF values thatranged from 7,000 to 36,000. EPA hasreviewed information and all commentsreceived on mercury and mercurycompounds’ bioaccumulationcharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that mercury and mercurycompounds bioaccumulate in theenvironment with BAF/BCF valuesgreater than 1,000 and therefore meetthe bioaccumulation criterion

established in this rulemaking. Acomplete discussion of EPA’s findingson this chemical category can be foundin EPA’s Response to Commentsdocument for this rulemaking (Ref. 69)and/or in EPA’s support documents forthis rulemaking (Ref. 71). In addition,mercury and mercury compoundsbioaccumulate in the environment witha value above 5,000, which supportsEPA’s decision to lower the threshold to10 pounds.

m. Polychlorinated biphenyls. In theproposal, EPA preliminarily determinedthat PCBs have BCF values that rangedfrom 4,922 to 196,900. All of the PCBs,except one, had BCF values farexceeding 5,000. The one exception,2,3,3’,4,4’,5,5’ heptachlorobiphenyl, hada BCF value of 4,922. EPA has reviewedinformation and all comments receivedon PCBs’ bioaccumulationcharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that PCBs bioaccumulate inthe environment with BAF/BCF valuesgreater than 1,000 and therefore meetthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical listing can be found inEPA’s Response to Comments documentfor this rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition, withone exception, all of the PCBs listedbioaccumulate in the environment witha value far exceeding 5,000, whichsupports EPA’s decision to lower thethreshold to 10 pounds.

n. Hexachlorobenzene. In theproposal, EPA preliminarily determinedthat hexachlorobenzene has a BCF valueof 29,600 to 66,000. EPA has reviewedinformation and all comments receivedon hexachlorobenzene’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thathexachlorobenzene bioaccumulates inthe environment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition,hexachlorobenzene bioaccumulates inthe environment with a BAF/BCF valuegreater than 5,000 which supports EPA’sdecision to lower the threshold to 10pounds.

o. Octochlorostyrene. In the proposal,EPA preliminarily determined that OCShas a BCF value of 33,113. EPA receivedone significant comment addressing

OCS’s bioaccumulation potential whichis discussed below. EPA has reviewedthis comment and information on OCS’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatOCS bioaccumulates in the environmentwith a BAF/BCF value greater than1,000 and therefore meets thebioaccumulation criterion established inthis rulemaking. A complete discussionof EPA’s findings on this chemical canbe found in EPA’s Response toComments document for thisrulemaking (Ref. 69) and/or in EPA’ssupport documents for this rulemaking.(Ref. 71). In addition, OCSbioaccumulates in the environment witha BAF/BCF value greater than 5,000which supports EPA’s decision to lowerthe threshold to 10 pounds.

One commenter argued that OCSshould not be included in the EPCRAsection 313 PBT chemicals list. Thecommenter contends that OCS wasincluded as a PBT chemical simplybecause it appears on several lists ofpersistent and bioaccumulativechemicals and not based on a thoroughevaluation of its bioaccumulation. Thecommenter states that OCS has thepotential to bioaccumulate, butnonetheless, OCS levels in fish andaquatic species in the Great Lakescontinue to decline. The commenterprovides a report on the Great Lakesregion and argues that OCS should notbe considered a PBT chemical sinceenvironmental concentration data showOCS levels in the environment aredecreasing at a rate of 8% to 30% peryear.

EPA disagrees with the commenter’sconclusions. The commenter does notdispute the bioaccumulation values EPApresented in the proposed rule. Ratherthe commenter agrees that OCS has thepotential to bioaccumulate but contendsthat since environmental concentrationsare declining in the Great Lakes regionOCS should not be considered a PBTchemical. The fact that OCS levels inthe Great Lakes region may be decliningis not a basis for concluding that OCSis not a PBT chemical or that it cannotbioaccumulate. There are a number ofreasons that could explain a decrease inenvironmental concentrations of OCSbut they do not change the fact that OCShas been shown to be highlybioaccumulative. OCS was included asa PBT chemical because it meets theEPCRA section 313 criterion forbioaccumulation laid out in theproposed rule, not simply because it hasappeared on several other lists of PBTchemicals.

p. Pentachlorobenzene. In theproposal, EPA preliminarily determined



that pentachlorobenzene has a BCFvalue of 8,318. EPA has reviewedinformation and all comments receivedon pentachlorobenzene’sbioaccumulation characteristics. Takinginto account this information, asindicated in Table 3, EPA finds thatpentachlorobenzene bioaccumulates inthe environment with a BAF/BCF valuegreater than 1,000 and therefore meetsthe bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71). In addition,pentachlorobenzene bioaccumulates inthe environment with a BAF/BCF valuegreater than 5,000 which supports EPA’sdecision to lower the threshold to 10pounds.

q. Tetrabromobisphenol A. In theproposal, EPA preliminarily determinedthat TBBPA was found to have BCFvalues of 780; 1,200; and 3,200. EPAreceived one significant commentaddressing TBBPA’s bioaccumulationwhich is discussed below. EPA hasreviewed the comments and informationon TBBPA’s bioaccumulationcharacteristics. Taking into account thisinformation, as indicated in Table 3,EPA finds that TBBPA bioaccumulatesin the environment with a BAF/BCFvalue greater than 1,000 and thereforemeets the bioaccumulation criterionestablished in this rulemaking. Acomplete discussion of EPA’s findingson this chemical can be found in EPA’sResponse to Comments document forthis rulemaking (Ref. 69) and/or inEPA’s support documents for thisrulemaking (Ref. 71).

One commenter contends that theavailable data on TBBPA do not supportits classification as a PBT chemical. Thecommenter argues that the oyster BCFvalue of 780 does not support theproposed criterion of 1,000. Thecommenter also notes that EPA fails toconsider that TBBPA is not retained inthe body once dosing stops in a BCF testand that TBBPA is rapidly eliminated.The commenter states that rapidelimination limits any potential forbiomagnification. The commenter notesthat only the highest chironomid BCFvalue (3,200) was cited by EPA and notthe fact that this is from a range of 650–3,200.

EPA believes that the available datado support classification of TBBPA as aPBT chemical. Measured BCF values of780, 1,200, and 3,200 were obtainedfrom TSCA section 4 tests with oysters,fish and chironomids, respectively. Themeasured BCF values of 1,200 and 3,200

for fish and chironomids respectively,clearly satisfy the EPCRA section 313bioaccumulatioin criterion of 1,000.EPA is aware that TBBPA will beeliminated from the body eventuallyonce exposure to the chemical is halted;however, continuous or intermittentexposures of TBBPA to organisms mayresult in significant tissue residuesdepending on the exposure or releasescenarios. The issue of biomagnificationof TBBPA is not relevant to determiningif TBBPA is a PBT chemical. Asdiscussed in Unit VI.B.3.,biomagnification is not required inorder to have a concern for chemicalsthat bioaccumulate. The highestchironomid BCF value was listedbecause it is considered as a worst caseindication of bioaccumulation insediment-dwelling invertebrates.

I. Exemptions and Other ReportingRequirements

1. De minimis exemption. Many of thecommenters assert that the initialreasons for adopting the de minimisexemption are still valid and that thisexemption should be maintained forPBT chemicals. Specifically, severalcommenters contend that the deminimis exemption was initiallyadopted to alleviate undue burden onreporting facilities and that theelimination of this exemption for PBTchemicals will significantly increase thereporting burden for this rulemaking.

EPA disagrees with the commenters’contention that the initial reasons foradopting the de minimis exemption arevalid for PBT chemicals. As originallyexplained in the 1988 final ruleimplementing the reporting provisionsof EPCRA section 313, reiterated in the1997 final rule adding seven newindustry sectors, and discussed in theproposal to this final rule, EPApromulgated the de minimis exemptionfor several reasons, of which burdenwas only one. In addition to burdenreduction, EPA promulgated the deminimis exemption because: (1) TheAgency believed that facilities newlycovered by EPCRA section 313 wouldhave limited access to informationregarding low concentrations of toxicchemicals in mixtures that are imported,processed, otherwise used ormanufactured as impurities; (2) theAgency did not believe that these lowconcentrations would result inquantities that would significantlycontribute to threshold determinationsand release calculations at the facility(53 FR 4509); and (3) the exemption wasconsistent with information collectedunder the Occupational Safety andHealth Administration’s (OSHA) HazardCommunication Standard (HCS). If EPA

had adopted the exemption only toreduce burden, the exemption wouldhave covered all uses of de minimisquantities of the toxic chemical inmixtures. The exemption, however,includes only limited uses of the toxicchemical in mixtures (i.e., importing,processing, otherwise use, andmanufacturing impurities) that wereroughly tailored to whether EPAexpected that facilities were reasonablylikely to have information that wouldallow them to determine thresholds andmake release calculations.

The purpose of the PBT rulemaking,however, is different from pastrulemakings in that it is intended tocapture information on significantlysmaller quantities of releases and otherwaste management associated withthese chemicals. Most of the PBTchemicals addressed in this rule havebeen shown to cause adverse effects atconcentrations far less than the deminimis levels. For example, dioxinshave been shown to cause adverseeffects at levels in the parts per trillion.In addition, after 10 years of experiencewith the program, the Agency believesthere are many sources of information inaddition to material safety data sheets(MSDSs), readily available to reportersto use in making EPCRA section 313determinations. Some of these sourcesof information include EPA guidancedocuments (e.g., EPCRA Section 313Industry Guidance: ElectricityGenerating Facilities (EPA 745–B–99–003)) and trade association guidancedocuments (e.g., National Council of thePaper Industry for Air and StreamImprovement (NCASI) TechnicalBulletins and NCASI’s Handbook ofChemical Specific Information forSARA Title III Section 313 Form RReporting). In addition, relevantinformation has become much moreaccessible to covered facilities over thepast 10 years. For example, although theUnited States Geological Survey’s U.S.Coal Quality Database has been inexistence since the mid 1970s, onlymore recently has it been madeavailable on the Internet. (http://energy.er.usgs.gov/products/databases/UScoal/index.htm). Further, the Agencybelieves that it underestimated howmuch information covered facilities hadavailable to them in 1988 regardingsmall concentrations of toxic chemicalsin mixtures. Therefore, given that: (1)Covered facilities have several sourcesof information available to themregarding the concentration of PBTchemicals in mixtures; (2) even minimalreleases of persistent bioaccumulativechemicals may result in significantadverse effects and these small



quantities can reasonably be expected tosignificantly contribute to the lowerthresholds; and (3) the concentrationlevels originally chosen, in part, to beconsistent with the OSHA HCS areinappropriately high for PBT chemicals,EPA believes that the reasons for the deminimis exemption that the Agencyheld for previous rulemakings do notapply to PBT chemicals.

A few commenters assert thatreviewing each MSDS, when a facilitymay have many MSDSs for mixturesused on-site, to see if it includes tracequantities of PBT chemicals will be verytime consuming. They contend that theydo not have the manpower to trackproducts on an individual basis lookingfor trace quantities of PBT chemicalsand that these activities will be veryburdensome.

EPA disagrees that eliminating the deminimis exemption for PBT chemicalswill greatly increase burden underEPCRA section 313. Covered facilitiesare not required to report on toxicchemicals in mixtures and trade nameproducts for which they have noconcentration information or suchinformation that is not reasonablyknown. However, if facilities do haveinformation concerning theconcentration of PBT chemicals inmixtures, such as on MSDSs, EPA doesnot believe it is more burdensome forfacilities to identify and evaluateprocess streams containing relativelysmall quantities of PBT chemicals thanfor larger quantities of chemicals.Although some burden is associatedwith the identification and evaluation ofprocess streams, EPA disagrees that theelimination of the de minimisexemption would vastly increase theextent of this required effort. Coveredfacilities will need to identify andevaluate process streams whenconsidering a PBT chemical inconcentrations below the de minimislevel in the same manner they alreadydo for toxic chemicals found in processstreams in concentrations above the deminimis level. The additional burdencan be attributed to resources spentconsidering and reporting oninformation they currently are allowedto disregard. Further, as explainedabove, EPA adopted the de minimisexemption for several reasons, of whichburden reduction was only one, andEPA does not believe that these originalreasons apply to this PBT rulemaking.

Some commenters assert that it isunrealistic for EPA to assume thatindustry will report only on what theyknow without making an effort to fillthe data gaps and that enforcementactions could arise from reports basedon only what is known to a facility.

EPA disagrees, however, becausecovered facilities are expected to havereasonable knowledge of the toxicchemicals present at their site and needonly document their considerationsconcerning threshold determinationsand release and other wastemanagement calculations. As stated inEPCRA section 313(g)(2):

[i]n order to provide the informationrequired under this section, the owner oroperator of a facility may use readilyavailable data (including monitoring data)collected pursuant to other provisions of law,or, where such data are not readily available,reasonable estimates of the amountsinvolved. Nothing in this section requires themonitoring or measurement of the quantities,concentration, or frequency of any toxicchemical released into the environmentbeyond that monitoring and measurementrequired under other provisions of law orregulation. . . . (emphasis added)

Further, as stated previously, coveredfacilities are not required to report ontoxic chemicals in mixtures and tradename products for which they have noconcentration information, or for whichsuch information is not readilyavailable. Therefore, it is unlikely thatfacilities will have additionalenforcement concerns.

Several commenters argue that theneed to be consistent with the OSHAHCS that EPA cited in the 1988 finalrule continues to be relevant withregards to collecting information onvery small quantities.

EPA disagrees that the need to beconsistent with OSHA to reduce burdenis sufficient to justify retaining the deminimis exemption for PBT chemicals.EPA is not required to be consistentwith the OSHA HCS. In 1988, EPAchose to be consistent with the OSHAHCS as part of its rationale for theexemption, because the Agencyexpected facilities to be familiar withthese levels and thought that coveredfacilities might only have access toMSDSs for information on the contentand percentage composition of toxicchemicals in mixtures. (See 53 FR 4509)However, EPA has never instructedfacilities to stop looking if informationconcerning a toxic chemical is not on anMSDS. Rather, EPA has consistentlyinstructed facilities to use their bestreadily available data in determiningcompliance with EPCRA section 313. AsEPA explained earlier, given 10 years ofexperience with the program, theAgency believes that facilities may haveother sources of information, in additionto MSDSs, available to them. Therefore,if a facility has better informationregarding the concentration of a toxicchemical in a mixture, for example, thatthe chemical is above the de minimis

level, the facility should be using thatinformation to comply with EPCRAsection 313. Further, EPA is consistentin some respects because under theOSHA HCS, if an employer has reasonto believe that a permissible exposurelimit for a component may be exceededunder the mixture’s normalcircumstances of use, the HCS alsorequires employers to list chemicals thatare below the 1.0% and 0.1%thresholds. Therefore, OSHA adoptedexceptions to the 1.0% and 0.1% limitsunder the HCS. Similarly, PBTchemicals are different from other toxicchemicals in that they may pose a moresignificant concern to the environmentin much smaller quantities than othertoxic chemicals. Furthermore, asexplained in other responses in thisunit, EPA believes the remainder of itsrationale for the de minimis exemptionis not applicable to PBT chemicals. Forexample, contrary to the commenter’sstatement, the small concentrationssubject to the de minimis exemption arenot necessarily small quantities andmay contribute significantly toexceeding the lowered reportingthresholds.

Some commenters argue that theAgency has not justified why theexemption will result in increasedhealth risk to the public or theenvironment. One commenterspecifically argues that given theextremely low levels of these PBTchemicals in coal, the risk to the generalpublic from these releases, which theybelieve is the original purpose of thelegislation, is not apparent. Anothercommenter asserts that EPA mustdemonstrate that the removal of theexemption for specific PBT chemicalswill have a public health orenvironmental benefit. Yet anothercommenter argues that theconcentration of toxic chemicalscontained in mixtures is irrelevant topublic health concerns when thecompounds of concern remainchemically bound within benigncompounds.

EPA strongly disagrees with thosecommenters who indicated that EPAmust consider risk to the general publicwhen determining whether to eliminatethe de minimis exemption. A primarypurpose of the TRI program is toprovide data on the releases (and otherwaste management activities) of listedtoxic chemicals to communities so thatthey may use these data in conjunctionwith toxicity information for thechemical and site-specific informationto determine if releases present apotential risk. They can also use TRIdata in other ways. For example, anindividual can use TRI data as a factor



in choosing a neighborhood in which tolive. The purpose of TRI, however, isnot to make a national determination ofrisk, nor did EPA consider risk in itsoriginal adoption of the de minimisexemption under EPCRA section 313.

Moreover, as previously explained,EPA originally promulgated the deminimis exemption based on severalconsiderations that are inapplicable toPBT chemicals. Where, as here, therationale and factual bases underlyingan exemption no longer exist withrespect to a particular class, the Agencybelieves it cannot justify retaining theexemption for that class. Further, theAgency has received no informationfrom any commenters that contradictsthe Agency’s factual and legalconclusions, or that would otherwisepresent a basis for retention of the deminimis exemption.

EPA also disagrees with the commentthat because there are very low levels ofPBT chemicals (e.g., mercury) in coalthat the risk to the general public is notapparent. EPA believes that thecommenter misunderstands the conceptof risk. Because a chemical is in a lowconcentration in coal does not in itselfcontrol the level of risk that can resultwhen coal is combusted. For example,mercury compounds are found in verylow concentrations in coal. When coalis combusted, mercury compounds areeither converted into mercury chlorideor reduced to elemental mercury. Someof the mercury/mercury chloride isreleased to air and some remains in thebottom ash. The concentration of themercury/mercury chloride in the airwastestream will not be the same as theconcentration originally present in thecoal. Once the mercury/mercurychloride is released, it will be carriedvarying distances before it is deposited.Mercury can be transported over largedistances, while mercury chloride maybe deposited relatively rapidly by wetand dry deposition processes. Theamount of mercury in a community orecosystem will depend upon sourcesboth local and distant. Once mercuryhas been deposited, it willbioaccumulate in organisms and willalso persist in the environment as a sinkfor exposure and bioaccumulation. Theamount of mercury that a human,animal, or plant will be exposed to isrelated more closely to exposurepathways and the quantity that ispresent in an ecosystem rather than theconcentration in the coal that iscombusted. Thus, EPA believes that thecommenter is incorrect.

One commenter asserts that theelimination of the de minimisthresholds would not yield meaningfuladditional information. The commenter

argues that the proposed rule vastlyoverstates the significance of TRI dataand therefore incorrectly concludes thatthe de minimis thresholds would‘‘deprive communities of importantinformation on PBT chemicals’’ (at 64FR 714). Instead, the commentercontends, TRI data only provide asnapshot view of releases from thechemical industry and the few otherindustry sectors subject to TRI reportingand that many potential release sourcesare not subject to TRI reporting. Thecommenter argues that these sourcesoverwhelm the limited additionalinformation that will be reported byeliminating the de minimis exemption.

EPA disagrees that the proposed rulevastly overstates the significance of theTRI data. The public, all levels ofgovernment, and the regulatedcommunity have come to rely on TRIdata in improving decision-making,measuring pollution prevention, andunderstanding the environmental andhealth consequences of toxic chemicalreleases and other waste managementactivities. Although the Toxics ReleaseInventory does not contain a completeinventory of every release, EPA believesit does provide one of the mostcomprehensive and accessible sourcesof release and other waste managementinformation available. EPA alsodisagrees with the commenter’sassertion that the data base onlycontains information from the chemicalindustry and a few others. In fact, all 20manufacturing industry groups as wellas an additional 7 other industriesincluding metal and coal miningfacilities and hazardous wastemanagement facilities are subject toEPCRA section 313. Further, with theaddition of these 7 newly coveredindustries, EPA expects over 27,500facilities to submit over 110,000 reportson more than 630 toxic chemicals to theTRI for the 1998 reporting year.Currently no other sources ofinformation can provide releases andinformation on other waste managementquantities and qualitative sourcereduction data with the scope, level ofdetail, and chemical coverage as datacurrently included in TRI.

Further, as EPA has previouslyexplained, PBT chemicals can remain inthe environment for a significantamount of time and can bioaccumulatein animal tissues. Even relatively smallreleases of such chemicals have thepotential to accumulate over time andcause significant adverse impacts onhuman health and the environment.Therefore, EPA believes it is particularlyimportant to gather and disseminate tothe public relevant information on evenrelatively small amounts of releases and

other waste management of PBTchemicals. Under the 10,000 and 25,000pound/year reporting thresholds, asignificant amount of the releases andother waste management activitiesinvolving PBT chemicals are not beingcaptured and thus the public does nothave the information needed todetermine if these chemicals are presentin their communities at levels that maypose a significant risk.

Several commenters argue that the deminimis exemption already does notapply to the manufacture of a toxicchemical unless the toxic chemical ismanufactured as an impurity or isimported. Therefore, any incidentalmanufacturing of a PBT chemical as aby-product would not be eligible for thede minimis exemption and would besubject to reporting. Thus, they argue,the elimination of the exemption willprovide little additional informationand will not provide added value.

The commenters are correct in statingthat there are instances where PBTchemicals are manufactured as by-products and would, therefore, not beaffected by the elimination of the deminimis exemption. However, as EPAexplained in the PBT proposal, there arealso many instances where a PBTchemical may exist in a mixture or tradename product at a concentration belowthe 1% or 0.1% de minimis limit butwhere the processing or otherwise useof the PBT chemical in that mixturewould otherwise contributesignificantly to or in itself exceed thereporting thresholds (at 64 FR 714). Forexample, mercury can be found at verylow concentrations in steel. Aresmelting facility could process andrelease more than 100 pounds ofmercury a year from its resmeltingactivities. However, although this totalquantity is greater than the 10 poundproposed threshold for mercury, if theconcentration of mercury in the steel isless than the de minimis limit, none ofthe mercury would be reportable if thede minimis level is retained for PBTchemicals. Releases and other wastemanagement associated with theseexempt activities would be absent fromthe TRI data base. Because evenminimal releases of PBT chemicals mayresult in elevated concentrations in theenvironment or in an organism and canhave the potential to cause an adverseeffect, EPA believes that all releases ofthese chemicals are of concern and thatsuch information is significant and ofvalue to the public.

a. Readily available data. Somecommenters assert that the eliminationof the de minimis exemption willconflict with the condition thatreporters obtain data from readily



available sources. They argue thatbecause concentrations below 1% (and0.1% for carcinogens) are not requiredon MSDSs, reporters will no longer beable to use MSDSs to screen forproducts containing PBT chemicalsbelow these concentrations. Theyfurther contend that AP-42 guidance,Air CHIEF CD-ROM, TANKS,CHEMDAT8 and WATER8 wouldprovide additional assistance inestimating the amount of a PBTcoincidentally manufactured inwastestreams or released; however,these tools will not help quantify theamount of chemical in materials whichare distributed in commerce or used asfeedstock. They assert that there are noother consistent sources of informationon whether a product contains a PBTchemical below de minimis levels. Theyalso assert that the elimination of the deminimis exemption will causeadditional burden for the regulatedcommunity because covered facilitieswill struggle with how to comply in theabsence of information.

The Agency believes that sincereporting first began in 1988, newsources of information have becomeavailable to covered facilities to use todetermine concentrations of toxicchemicals in mixtures. In addition tothe data bases and information sourcescited by the commenter, EPA believesthere are other sources of data that canand should be used in making thresholddeterminations and release and otherwaste management calculations for PBTchemicals. Examples of these sources ofinformation include EPA guidancedocuments (e.g., EPCRA Section 313Industry Guidance: ElectricityGenerating Facilities (EPA 745–B–99–003)) and trade association guidancedocuments (e.g., National Council of thePaper Industry for Air and StreamImprovement (NCASI) TechnicalBulletins and NCASI’s Handbook ofChemical Specific Information forSARA Title III Section 313 Form RReporting). In addition, relevantinformation has become much moreaccessible to covered facilities over thepast 10 years. For example, the UnitedStates Geological Survey’s U.S. CoalQuality Database has been in existencesince the mid 1970s, but only morerecently has it been made available onthe Internet. (http://energy.er.usgs.gov/products/databases/UScoal/index.htm)EPA believes that these tools, inaddition to the ones cited by thecommenter, will help covered facilitiesquantify the amount of chemical inmaterials which are distributed incommerce or used as feedstock and willallow covered facilities to make

reasonable calculations to comply withEPCRA section 313. Further, the Agencybelieves that it underestimated howmuch information covered facilities hadavailable to them in 1988 regardingsmall concentrations of toxic chemicalsin mixtures. Therefore, EPA believesthat facilities have sufficientinformation to make thresholddeterminations and release and otherwaste management calculations for PBTchemicals below de minimisconcentrations. However, as EPAexplained above, if a covered facilityhas no information, including noreasonable estimates or other reasonablyknown information, on theconcentration of the toxic chemical inthe mixture, they need not consider thechemical in that mixture for thresholddeterminations and release and otherwaste management calculations (at 53FR 4511). Therefore if the only sourceof information on a toxic chemical in amixture is from an MSDS, and theMSDS does not indicate if the chemicalis contained in the mixture, the facilityis not required to consider the toxicchemical towards thresholddeterminations or release and otherwaste management calculations.

Because some facilities covered underEPCRA section 313 have more extensiveinformation available to them than theydid in 1988, or EPA underestimatedhow much information they hadavailable in 1988, and because thesefacilities are not required to report ifthey have no information on theconcentration of the toxic chemical, theAgency believes that in these casesretention of the de minimis exemptionwould allow facilities to avoid reportingwhen information is available to themthat would otherwise permit them toreport.

Some commenters assert that facilitieswill have to begin monitoring for tracequantities of chemicals in mixtures ifthe de minimis exemption is eliminatedfor PBT chemicals. One commenterargues that the only way facilities wouldbe able to estimate the levels of dioxinin combustion products and wastewatertreatment ‘‘would be to undertake thecostly burden of monitoring what comesoff at a series of concentrations andtemperatures.’’ Another commenterasserts that if the de minimis level iseliminated, industry would be subject toincreased enforcement action becauseexhaustive testing may be insufficient todetect the chemicals.

EPA disagrees with the commentersbecause, as stated previously, EPCRAsection 313(g)(2) limits monitoringrequirements under EPCRA section 313.Under this section, facilities are notrequired to perform any additional

monitoring or analysis of production,process or use other than that alreadycollected under other requirements.However, if a facility is required tomonitor toxic chemicals under anotherstatute, this data must be considered indetermining thresholds and release andother waste management calculationsunder EPCRA section 313. EPCRAsection 313(g)(2) requires that facilitiesuse readily available data, or in absenceof such data, facilities are required touse reasonable estimates. If nomonitoring data are available, thefacility should use other readilyavailable information in makingthreshold determinations and releaseand other waste managementcalculations. Further, if the facilitybelieves that it has other, morerepresentative data than its monitoringdata, the facility should use thatinformation instead.

As to specifically tracking PBTchemicals in wastewater, thecommenter does not specify whether thetoxic chemicals discussed in thecomment are manufactured as by-products, are processed, or otherwiseused. As discussed above, the deminimis exemption does not apply totoxic chemicals manufactured as by-products. Therefore, if PBT chemicalsare coincidentally manufactured duringon-site wastewater treatment, coveredfacilities would be required to considerthose PBT toxic chemicals for thresholddeterminations and release and otherwaste management calculations even ifthe de minimis exemption were retainedfor PBT chemicals. Similarly, PBTchemicals manufactured as a result ofburning fuel would not be exempt evenif the de minimis exemption wereretained because manufactured by-products are not eligible for thisexemption. PBT chemicals in below deminimis concentrations in mixtures thatare imported, processed, or otherwiseused will be affected by the eliminationof the de minimis exemption. Coveredfacilities will need to consider thesequantities towards thresholddeterminations and release and otherwaste management calculations. Thesecalculations would include the amountscontained in combustion by-productsand wastewater treatment units.Additional monitoring of thesequantities, however, would not berequired under EPCRA section 313.Finally, EPA has limited the dioxinlisting with the qualifier‘‘manufacturing; and the processing orotherwise use of dioxin and dioxin-likecompounds if the dioxin and dioxin-likecompounds are present as contaminantsin a chemical and if they were created



during the manufacturing of thatchemical.’’ Therefore, not all processingor otherwise use activities of the dioxinand dioxin-like compounds categorymust be considered towards a facility’sthreshold determinations.

Some commenters assert that EPAshould maintain the de minimisexemption for PBT chemicals present asimpurities. They argue that informationon PBT chemicals present as impuritiesis not readily available and thatobtaining the relevant data, conductingthe initial reviews to determine whatinformation is available, and identifyingdata gaps would impose a huge burdenon industry. They argue that evendeveloping estimates with any accuracyentails a significant amount of time. Inthe instance of impurities, they assertthat the absence of data and thedifficulty in developing estimates willresult in a heavy burden with littleinformation of value being reported.These commenters believe that theelimination of the de minimis level is arequirement to provide new data whenutilizing the de minimis exemption.

EPA disagrees with thesecommenters. Although there areburdens associated with obtainingrelevant data, determining availableinformation and identifying data gaps,EPA disagrees that the elimination ofthe de minimis exemption for PBTchemicals present as impurities wouldvastly increase the extent of thisrequired effort. From the comment, it isunclear why requiring facilities toidentify and evaluate process streamscontaining small quantities of PBTchemicals as impurities is moreburdensome than for larger quantities ofthese chemicals manufactured,processed, or otherwise used at acovered facility in excess of the activitythresholds. For example, a facilitymonitors for chemical A at aconcentration of greater than 0.001%and monitors for chemical B at aconcentration of greater than 1.5%. Themonitoring is done for the samewastestream and the same frequency.There is no differential in effort orburden. Currently, the only difference isthat facilities can ignore available datawhen utilizing the de minimisexemption.

One commenter asserts that the deminimis exemption should be retainedfor PBT chemicals present at miningfacilities. The commenter argues thatthe burden upon the mining industry iseven greater in the context of the lowthresholds proposed for PBT chemicals.Further, the commenter asserts thatalthough EPCRA does not requirecovered facilities to conduct testsconcerning the amount of listed

chemicals processed, most reporters relyupon their knowledge of theirmanufacturing processes and rawmaterials to produce meaningful datafor EPCRA section 313 reportingpurposes. The commenter contends thatthis is not true of the mining industry.Due to the volume of materials movedin the extraction process and theheterogeneous nature of the materialsmined, process knowledge often isinadequate to produce a meaningfulpicture of the minute levels of PBTchemicals that may be present in miningoperations. The commenter asserts thatinadequate process knowledgecombined with the enormous expense ofconstantly testing the processedmaterials makes the elimination of thede minimis exemption for PBTchemicals unworkable as applied tomining operations.

EPA disagrees with the commenter.As the commenter points out, underEPCRA section 313(g)(2), facilities arenot required to perform any additionalmonitoring or analysis of production,process, or use other than that alreadycollected under other statutory orregulatory requirements. Therefore,there should be no added cost due totesting to comply with EPCRA section313. However, EPA believes that inmany cases mining facilities have theinformation needed to make reasonableestimates regarding smallconcentrations of PBT chemicals in theores mined. In addition, as EPAexplained in the 1988 final rule, if acovered facility has no information onthe concentration of the toxic chemicalin the mixture, including no reasonableestimates, the facility need not considerthe chemical in that mixture forthreshold determinations and releaseand other waste managementcalculations. If a mining facility doeshave information regarding theconcentration of a toxic chemical in amixture or trade name product, thefacility must consider all non-exemptedsources of the chemical for thresholddeterminations. If an activity thresholdis exceeded for the chemical, the facilitymust then calculate release and otherwaste management quantities. Coveredmining facilities will need to identifyand evaluate process streams whenconsidering a PBT chemical inconcentrations below the de minimislevel just as they already do for toxicchemicals found in process streams inconcentrations above the de minimislevel. Therefore, given that coveredfacilities: (1) Are not required toperform additional monitoring; (2) arenot required to consider concentrationsof toxic chemicals for which they have

no information; and (3) need onlyconsider readily available data, EPAdisagrees that identifying and evaluatingmining activities involving mixturescontaining less than 1.0% or 0.1%concentrations of PBT chemicals will bemore burdensome than for largerquantities of these chemicalsmanufactured, processed, or otherwiseused at a mining facility in excess of theactivity thresholds.

b. Alternate de minimis level. Severalcommenters argue that in lieu ofeliminating the de minimis exemptionfor PBT chemicals, it would make moresense to change the level for the deminimis exemption for these chemicals.Some commenters argue that a moreappropriate approach would be tocompare the current thresholds and thecurrent de minimis levels and use thesame ratio to create a new de minimislevel for the lowered PBT chemicalthresholds. Therefore, they argue, theexisting level is 1% for a threshold of10,000 pounds, so an analogousreduction of the de minimis level wouldbe 0.01% for the new proposedthreshold of 100 pounds and 0.001% forthe new proposed threshold of 10pounds per year and 1 ppb for dioxins.One commenter argues that the currentde minimis level of 0.1% for known orsuspected carcinogens is notappropriate for dioxins. They suggestthat EPA lower the de minimisexemption for dioxins proportionally tothe lower reporting threshold EPA setsin the final rule. They assert that areporting threshold for dioxins of 0.002pound TEQ (not the threshold in thePBT proposal nor the one that EPA isfinalizing today), is approximatelyseven orders of magnitude less than thecurrent 10,000 pound threshold.Therefore, they argue, the 0.1% deminimis exemption should be loweredproportionally to 1 x 10-8%. Thistranslates to a concentration of 100 partsper trillion.

EPA disagrees with thesecommenters. As explained previously,EPA adopted the de minimis exemptionfor several reasons including the desireto be consistent with informationmandated by the OSHA HCS. ThisOSHA standard requires the listing ofhazardous chemicals on MSDSs butallows chemical suppliers to omit fromthe MSDSs hazardous chemicals that arebelow certain concentrations:Specifically, levels of 0.1% for OSHAcarcinogens and 1.0% for otherhazardous chemicals. However, therationale for the OSHA HCS de minimisexemption is not relevant to PBTchemicals and therefore, is insufficientby itself to support an alternative deminimis exemption for PBT chemicals.



As explained in the 1983 final rule,OSHA chose the 1.0% concentrationlimit based on comments that this levelseemed to be sufficiently protective ofworkers and was considered to bereasonable by a number of commenters(48 FR 53280, at 53290, November 25,1983). OSHA was also persuaded bycomments that in some instances the1.0% cut-off levels may not beprotective enough with respect tocertain health hazards and adopted the0.1% level for carcinogens (at 48 FR53292). Specifically, PBT chemicals areof concern because they persist andbioaccumulate in the environment.Persistence and bioaccumulation werenot considered as a part of the OSHArulemaking. In addition, as explained inother responses in this unit, EPA’soriginal rationale for this exemption isinapplicable to PBT chemials, and thecommenters have provided no alternaterationale to support an exemption basedon extrapolating new de minimis levelsfrom the proposed thresholds.Therefore, given the different intentsbetween the OSHA HCS and EPCRAsection 313, EPA does not believe thatcreating alternative de minimis levelsfor PBT chemicals based on a ratiobetween the lowered threshold and theOSHA HCS levels is appropriate.

Several commenters support EPA’selimination of the de minimisexemption for PBT chemicals. Theyassert that retention of the de minimisexemption would undermine thechanges to the reporting threshold andwould allow an unnecessary loopholefrom reporting. They assert that the ruledoes not require any additional testingfor impurities and that the onlyadditional reporting would be for thosefacilities that use sufficient quantities ofmixtures or trade name productscontaining PBT chemicals as impurities.One commenter asserts that one of theoriginal reasons for the de minimisexemption levels, that it was based onOSHA HCS thresholds of 1.0% forhazardous chemicals in mixtures and0.1% for carcinogens in mixtures, doesnot apply to raw materials that are notmanufactured chemicals, such as crudeoil, coal, and mining inputs.

EPA agrees with these commentersand is eliminating the de minimisexemption for PBT chemicals addressedin today’s rule. As discussed above, thereasons EPA indicated for originallyadopting the de minimis exemption arenot applicable to PBT chemicals. Inaddition, EPA has received nocompelling arguments from commentersto extend the de minimis exemption toPBT chemicals. Because the purpose oftoday’s rulemaking is different from pastrulemakings in that it is intended to

capture information on significantlysmaller quantities of releases and otherwaste management associated withthese chemicals, the de minimisexemption could significantly limit theamount of reporting on PBT chemicals.Therefore, given that: (1) Coveredfacilities have several sources ofinformation available to them regardingthe concentration of PBT chemicals inmixtures; (2) even minimal releases ofpersistent bioaccumulative chemicalsmay result in significant adverse effectsand can reasonably be expected tosignificantly contribute to the proposedlower thresholds; and (3) theconcentration levels chosen, in part, tobe consistent with the OSHA HCS areinappropriately high for PBT chemicals,EPA believes that the reasons for the deminimis exemption that the Agencyheld for previous rulemakings do notapply to PBT chemicals. EPA istherefore eliminating the de minimisexemption for PBT chemicals.

c. Supplier notification. Severalcommenters were confused by EPA’sfailure to modify the de minimisexemption for PBT chemicals under thesupplier notification requirements. Asexplained in the PBT proposal, theAgency believes that covered facilitieshave sufficient information available tothem on PBT chemicals. Therequirement of additional informationunder the supplier notificationrequirements would result inredundancies. Commenters thatcorrectly understood EPA’s inaction onthis topic support the retention of the deminimis exemption for purposes ofSubpart C Supplier NotificationRequirements under 40 CFR372.45(d)(1). EPA agrees with thesecommenters and has therefore taken noaction on the supplier notificationrequirements for PBT chemicals.

2. Other exemptions. Although theAgency received several commentsregarding the existing exemptions, EPAis not modifying any of theseexemptions in this rule. Any changes tothese exemptions would requireadditional rulemaking, and anycomments submitted to EPA during thisrulemaking will be considered as part ofEPA’s evaluation of these exemptions.

3. Use of alternate threshold andForm A. One issue that commentersraise relates to EPA’s proposal toexclude all PBT chemicals from thealternate threshold of 1 million poundsfor PBT chemicals. Several commentersargue that EPA should retain thealternate threshold of 1 million poundsfor PBT chemicals. EPA disagrees. Asstated in detail in the proposal, EPAbelieves that use of the existing alternatethreshold and reportable quantity for

Form A would be inconsistent with theintent of expanded PBT chemicalreporting. The general informationprovided on the Form A, on thequantities of the chemical that thefacility manages as waste is insufficientfor conducting meaningful analyses onPBT chemicals.

A commenter states that becausePACs in fuel are destroyed duringcombustion, EPA should retain thealternate threshold or provide a newalternate threshold. First, thecommenter did not provide anyinformation to support the contentionthat PACs in fuel are destroyed duringcombustion. And, to the contrary, EPAbelieves that, even if some or all of thePACs in fuel are destroyed duringcombustion, additional PACs may becreated during the combustion process.Consequently, absent any information tosupport the basis for such an option, orthe need for an alternate threshold, EPAdoes not believe it would be appropriateat this time to provide a new alternateForm A threshold. Although EPAsolicited comments on this issue in theproposal, at this time, the Agencybelieves that it is appropriate to collectand analyze several years worth of dataat the lowered thresholds before EPAconsiders developing a new alternatethreshold and reportable quantityappropriate for PBT chemicals.

In addition, the commenter alsoappears to be raising a broader issuethan just the destruction of PACs duringcombustion. The commenter impliesthat when a facility estimates itsreleases to be zero, the facility should beeligible to use the Form A. However, thecommenter appears to misunderstandhow to calculate the amounts requiredto determine eligibility for the Form A.Facilities may use the Form A providedthat they do not exceed 500 pounds forthe total annual reportable amount for achemical, and that their amountsmanufactured or processed or otherwiseused do not exceed 1 million pounds.The annual reportable amount is equalto the combined total quantities releasedat the facility, treated at the facility,recovered at the facility as a result ofrecycle operations, combusted for thepurpose of energy recovery at thefacility, and amounts transferred fromthe facility to off-site locations for thepurpose of recycle, energy recovery,treatment, and/or disposal. Thecommenter only appears to considertheir releases as reportable amounts anddoes not appear to consider quantitiesgenerated from their other wastemanagement activities as reportableamounts. This additional wastemanagement information on PBTchemicals is very important to



communities because it helps themunderstand the quantities of EPCRAsection 313 chemicals that are beingtransported through their communities,the destination of these EPCRA section313 chemicals, as well as the reportedwaste management activity at thereceiving facility. In conclusion, EPAhas not proposed to disregard this wastemanagement information in calculatingthe annual reportable amount, thereforethe commenter’s approach is notconsistent with current reporting underForm A or appropriate as an approachfor reporting on PBT chemicals.

The commenter also states that thealternate threshold should be retainedin order to ensure that only meaningfulamounts of substances are reportedunder EPCRA section 313. EPAdisagrees that retention of the alternatethreshold would ensure that onlymeaningful information is reportedunder EPCRA section 313. The 500pound waste eligibility could beinterpreted by some data users, as aworst case, to mean that greater than500 pounds of the chemical has beenreleased into the environment (i.e., 500pounds of production-related waste asrelease and some quantity ofcatastrophic release). Other data usersmay assume that the facility had nocatastrophic releases and all of the toxicchemical in waste was managed in amanner other than as a release, e.g., thetoxic chemical in waste was recycled.For PBT chemicals where any release isa concern, an uncertainty level of 500pounds may result in data that isvirtually unusable. As a result, EPAdoes not agree with the commenter thatthe alternate threshold will ensure thatonly meaningful amounts of substanceswill be reported under EPCRA section313.

In addition, the commenter argueselimination of the alternate thresholdfor PBT chemicals will cause reportingburdens to increase while failing toprovide for the collection of substantialadditional release information. EPA’seconomic analysis used reporting costsfor the Form R to estimate the costs tothose facilities that would not be able touse the alternate threshold. Theeconomic analysis also evaluated thebenefits of the collection of additionalrelease and other waste management ofPBT chemicals (Ref. 67). Thecommenter does not dispute thoseestimates. As a result, EPA sees nocompelling argument to revise itsdecision to exclude all PBT chemicalsfrom the alternate threshold of 1 millionpounds.

A number of commenters argue thatEPA should eliminate the alternatethreshold of 1 million pounds for all

PBT chemicals on the EPCRA section313 list. One commenter asserts that inlight of the relatively small quantities ofconcern for PBT chemicals, particularlythose with no deliberate commercialmanufacture, it makes little sense toretain the Form A. The commenterfurther states that it believes that amodified Form A would beinappropriate due to the concern overreleases of these chemicals at low levels.Another commenter adds that the FormA is clearly inappropriate for chemicalsthat will now have thresholdssignificantly lower than the 500 poundwaste generation level. The commenterfurther contends that it is notappropriate for EPA to set a new FormA threshold for PBT chemicals, giventhe need to collect more information onthese substances.

EPA agrees with the commenters thatall PBT chemicals should be excludedfrom the alternate threshold of 1 millionpounds. As stated in detail in theproposal, EPA believes that use of theexisting alternate threshold andreportable quantity for Form A would beinconsistent with the intent of expandedPBT chemical reporting (at 64 FR 715–716). The general information providedin the Form A on the quantities of thechemical that the facility manages aswaste is insufficient for conductingmeaningful analyses on PBT chemicals.

EPA also agrees that a new alternatethreshold for PBT chemicals would beinappropriate due to the concern overreleases and other waste management ofthese chemicals at low levels. As statedin the proposal, even small quantities ofpersistent bioaccumulative chemicalsmay cause elevated concentrations inthe environment and organisms thatmay cause significant adverse effects.Given the persistent andbioaccumulative nature of thesechemicals and the need for the public tohave information about smaller amountsof these PBT chemicals, EPA believes itwould be inappropriate at this time toallow an option that would excludesignificant information on some releasesand other waste management of thesechemicals.

In response to EPA’s proposal toexclude all PBT chemicals from thealternate threshold of 1 million pounds,one commenter argues that EPA shouldconsider establishing a new alternatereporting threshold for these chemicals.The commenter states that, at aminimum, an alternate reportingthreshold of 10 to 100 pounds would beconsistent with the throughput-reporting threshold proposed for all PBTchemicals except dioxins. Thecommenter further states that the SBA’sanalysis suggests significant reductions

in burden associated with alternatereporting thresholds of 50 pounds forPBT chemicals. The commenter statesthat, based on an SBA studycommissioned of petroleum bulk plants,which it estimates will be the largestgroup of reporters under this proposal,it finds that most of the reports avoidedby this alternate threshold would reflectzero releases.

EPA disagrees with the commentsuggesting that a new alternatethreshold be established for PBTchemicals. As stated in the proposal,even small quantities of persistentbioaccumulative chemicals may causeelevated concentrations in theenvironment and organisms that maycause significant adverse effects. Giventhe persistent and bioaccumulativenature of these chemicals and the needfor the public to have information aboutsmaller amounts of these PBTchemicals, EPA believes it would beinappropriate at this time to allow anoption that would exclude significantinformation on some releases and otherwaste management of these chemicals.The general information provided in theForm A on the quantities of thechemical that the facility manages aswaste is insufficient for conductingmeaningful analyses on PBT chemicals.Therefore, EPA does not agree that anew alternate threshold for PBTchemicals should be established.

The commenter also suggests thatreporting burdens will increase whilefailing to provide for the collection ofsubstantial additional releaseinformation. EPA’s economic analysisused reporting costs for the Form R toestimate the costs to those facilities thatwould not be able to use the alternatethreshold. The economic analysis alsoevaluated the benefits of the collectionof additional release and other wastemanagement of PBT chemicals (Ref. 67).The commenter does not dispute thoseestimates. As a result, EPA sees nocompelling argument to revise itsdecision to exclude all PBT chemicalsfrom the alternate threshold of 1 millionpounds.

4. Data precision issues—a. Use ofsignificant digits, half pound and wholenumbers. EPA proposed to requirereporting of all releases and other wastemanagement quantities of PBTchemicals (except dioxin) that aregreater than 1⁄10 of a pound, providedthat the accuracy in the underlying dataon which the estimate is based supportsthis level of precision. EPA furtherstated that releases and other wastemanagement quantities would continueto be reported to two significant digits.In addition, EPA stated that forquantities of 10 pounds or greater, only



whole numbers would be required to bereported. For the category of dioxin anddioxin-like compounds, which have aproposed reporting threshold of 0.1gram, EPA proposed that facilitiesreport all releases and other wastemanagement activities greater than 100µg (i.e., 0.0001 gram).

After reviewing all comments on thisissue, EPA is providing the followingguidance on the level of precisioncovered facilities should use to reporttheir releases and other wastemanagement quantities of PBTchemicals. Facilities should continue toreport releases and other wastemanagement amounts greater than 1⁄10 ofa pound (except dioxin), at a level ofprecision supported by the accuracy ofthe underlying data and the estimationtechniques on which the estimate isbased.

This approach is consistent with thestatutory reporting requirements whenestimating reportable amounts. Thestatute requires facilities to, amongother things, report ‘‘[t]he annualquantity of the toxic chemical enteringeach environmental medium.’’ (42U.S.C. 11023(g)(1)(C)(iv)). To determinethis ‘‘annual quantity,’’ the statutedirects facilities to use readily availabledata (including monitoring data). Whensuch data are not readily available, thestatute directs facilities to usereasonable estimates. (42 U.S.C.11023(g)(2)). However, while the statuteallows for some level of imprecisionregarding reportable amounts, it doesnot create an exemption or exceptionthat would allow facilities to report lessprecisely than provided for by their dataor estimation techniques. Therefore,facilities should report PBT chemicalsas precisely as their estimationtechniques or readily available dataallow. If a facility’s release or othermanagement calculations supportreporting an amount that is more precisethan two significant digits, then thefacility should report that more preciseamount.

b. Use of range reporting. In thepreamble to the proposed rule, EPArequested comments on its proposal toeliminate the use of range reporting inForm Rs for PBT chemicals.Commenters disagree with the proposalfor a number of reasons outlined below.

Commenters argue that applyingdifferent reporting conventions for PBTchemicals would complicate EPCRAsection 313 reporting, cause compliancedifficulty, and introduce datainconsistencies (i.e., ranges for somechemicals but not for others).Commenters also argue that eliminatingthe use of range reporting for PBTchemicals has the potential to mislead

the public and divert attention fromactual risks.

EPA disagrees that the elimination ofthe use of range reporting for PBTchemicals will cause insurmountableobstacles to EPCRA section 313reporting and cause compliancedifficulties and data inconsistencies.There are already many differentindustries that report to EPA for 643chemicals. EPA provides numerousguidance documents and trainingopportunities to reporting industries.With the finalization of the PBT rule,EPA will provide updated guidancedocuments, will prepare and provide, inthose cases where it is appropriate,chemical-specific guidance documents,and will continue to offer training inorder to assist facilities in reportingunder EPCRA section 313. EPA alsobelieves that the Agency will be able toadequately explain to the public thedifferent reporting requirements for PBTchemicals so that they are put in contextof other TRI data. EPA currently doesthis for other types of chemicals on theEPCRA section 313 list such as metalsand pesticides.

Additionally, EPA believes that theelimination of range reporting is acritical part of this rulemaking, of whichthe ultimate intent is to provide usefulinformation on PBT chemicals to assistcommunities in determining if PBTchemicals are present in theircommunities at levels that may pose anunacceptable risk. This information onPBT chemicals can also be used bygovernment agencies and others toidentify problems, set priorities, andtake appropriate steps to reduce anypotential risks to human health and theenvironment. Consequently, theinformation collected about these PBTchemicals will inform the public ratherthan mislead the public and willactually assist the public in determiningthe risk of PBT chemicals in theircommunities.

Commenters also argue that reportingnumerical values for PBT chemicalsassumes a level of accuracy thatgenerally does not exist in themeasurement of releases. In addition,commenters state that estimatingnumerical values would require the useof material balances, which are difficultto apply and essentially inaccurate forchemicals used in low concentrations.Commenters contend that, especiallywhere reports are estimates, ranges mayin fact provide more information thanpoint estimates. Commenters argue that,for these reasons, elimination of rangereporting will result in inaccurateestimates. Commenters also state thateliminating the use of range reportingfor PBT chemicals would give the false

impression of precise data, whereuncertainty inherently exists.

As stated in the proposal, EPAbelieves that the use of ranges couldmisrepresent data accuracy because thelow or the high end range numbers maynot really be that close to the estimatedvalue, even taking into account itsinherent error (i.e., error inmeasurements and developingestimates) (at 64 FR 716). The user ofthe data must make a determination onwhether to use the low end of the range,the mid-point, or the upper end. Forexample, a release of 501 pounds couldbe misinterpreted as 999 pounds ifreported as a range of 500–999. Thisrepresents nearly a 100% error. Thisuncertainty severely limits theapplicability of release informationwhere the majority of releases,particularly for PBT chemicals, areexpected to be within the amountseligible for range reporting. The utilityof these data would be severely limitedgiven the uncertainty associated withdata reported using ranges. Therefore,due to this uncertainty, EPA believesthat facilities should report numericalvalues, not ranges, for PBT chemicals.

In addition, EPA believes that theinformation available to the typicalEPCRA section 313 reporter is generallygreater and/or more accessible than itwas 10 years ago. Because of thisimproved information availability, EPAbelieves that many facilities will be ableto accurately estimate releases and off-site transfers for further wastemanagement of PBT chemicals inquantities of less than 1,000 poundswithout the use of range codes.Although it may be true that somefacilities will be better able to makethose estimates than others, EPA doesnot believe this justifies not collectingthe more specific and usefulinformation from those facilities thatcan provide it.

Further, the Form R and Instructionsand annual TRI data release provideinformation on the methods used togenerate information reported andcharacterize many of the limitations thatmay apply to the data. This aids the datauser in understanding the overall natureof the information available underEPCRA section 313. Facilities arerequired, for each release or transferamount, to indicate on the the principalmethod used to determine the amountof release reported. There are codeswhich allow the facility to indicatewhether the estimate is based onmonitoring data, mass balancecalculations, published emissionfactors, or other approaches such asengineering calculations or bestengineering judgment. By looking at the



information provided through the use ofthese codes, users of the data can gainan understanding of the degree ofaccuracy or uncertainty in anyparticular number reported by a facility.Thus, EPA believes that falseimpressions will not be communicatedto the data user about the accuracy ofthe information filed.

Finally, EPCRA permits facilities touse reasonable estimates in the absenceof readily available data to calculatereportable amounts. Compliance withEPCRA section 313 does not require thatadditional monitoring or sampling bedone. Thus, the statute contemplatessome level of imprecision in the datathat may be filed, yet, by authorizingreporting based on reasonable estimates,affirms the community right-to-knowpurposes relative to information basedon such reasonable estimates. Reportingreleases of low volumes of PBTchemicals based on such reasonableestimates is no different than reportingon other toxic chemicals based on thesame kind of information. The TRI datathat has been reported since 1987 is ablend of estimates based on monitoringdata, mass balance calculations,published emissions factors, andengineering calculations or engineeringjudgment.

The commenters contend thateliminating the use of range reportingfor PBT chemicals would be extremelyburdensome to facilities. EPA explainedin the proposal that the original intentof providing the range reporting optionwas primarily as a burden reducingmeasure focused on small businesses. Inpast expansion activities, EPA has triedto retain burden reducing optionswherever feasible. However, EPA doesnot expect the elimination of rangereporting to significantly affect the unitcost of reporting because many facilitiesthat could use range reporting are notchoosing to do so. An analysis of the1997 data reported under EPCRAsection 313 reveals that the number ofinstances in which a range code wasused for reporting quantities in sections5 and 6 of the Form R was 37,168. These37,168 instances included 7,605,305pounds of releases and transfers usingthe median of the range code reported.However, there were 66,842 instances inwhich range reporting could have beenused (i.e., the amounts reported wherebelow 1,000 pounds), but the reportingfacility chose instead to report a numberrather than a range. These 66,842instances included 13,662,758 poundsof releases and transfers. Thus, in 64%of the instances where range reportingcould have been used facilities reporteda number instead. The fact that in amajority of the instances in which range

reporting could have been used facilitiesopted to report specific numbers wouldappear to indicate that the eliminationof range reporting for PBT chemicals isunlikely to impose any significantadditional burden on facilities.Therefore, EPA does not expect theelimination of range reporting to haveany significant effect on unit reportingcosts.

Commenters also argue that theelimination of the use of range reportingfor PBT chemicals could result in anincrease in the threat to confidentialinformation and a possible increase intrade secret claims. Commentersmaintain that Congress considered theneed to protect trade secret informationin the discussion of reporting chemicaluse and presence in ranges for EPCRAsection 313:

The conference substitute provides forreporting categories of use and ranges ofchemicals present because the exact use of anidentified chemical at a facility or the exactamount present may disclose secretprocesses. In some circumstances, thisinformation may need to be reported in termsof broad 43 categories of use or amountranges. . . . (H.R. Report No. 99–962, 298)

However, EPA believes that theconference report language cited by thecommenter clearly refers only to the useof range reporting for the data elemententitled ‘‘maximum amount of the toxicchemical on-site at any time during thecalendar year.’’ EPA is not precludingrange reporting for maximum amountson-site. Contrary to the notion expressedby the commenter, Congress did notexpressly direct EPA to allow rangereporting for the reporting of releasesand transfers off-site for further wastemanagement. Additionally, in thestatute, Congress provided the onlymeans and mechanism for facilities toprotect confidential businessinformation (CBI) through the statute’strade secret provisions. If thecommenter believes that any report filedmight reveal confidential information asto the identity of the chemical, thecommenter may choose to file a CBIclaim by following the procedures asoutlined in 40 CFR part 350. Inaddition, the statute is clear that tradesecret claims may only be made for theidentity of the chemical. Therefore, EPAbelieves that Congress adequatelyprovided procedures for the protectionof CBI and that a possible increase inCBI claims does not outweigh the needfor increased information on releasesand other waste management of PBTchemicals. See, Legislative History at5185.

Commenters also argue thateliminating the use of range reportingfor PBT chemicals will not result in the

collection of substantial additionalrelease information. EPA disagrees. Theissue of range reporting is closely tiedto the lowering of the reportingthresholds for PBT chemicals. As EPAnoted in the proposal,

Since PBT chemicals can remain in theenvironment for a significant amount of timeand can bioaccumulate in animal tissues,even relatively small releases of suchchemicals from individual facilities have thepotential to accumulate over time to higherlevels and cause significant adverse impactson human health and the environment.

EPA also noted in the proposal that,Under current reporting thresholds, a

significant amount of the releases and otherwaste management activities involving PBTchemicals are not being captured and thusthe public does not have the informationneeded to determine if PBT chemicals arepresent in their communities and at levelsthat may pose a significant risk.

Therefore, by the lowering of reportingthresholds, EPA will receive importantinformation on the quantities of PBTchemicals being released or otherwisemanaged as waste. Given the loweringof the reporting thresholds, continueduse of ranges could misrepresent dataaccuracy because the low or the highend range numbers may not really bethat close to the estimated value, eventaking into account any inherent error(i.e., errors in measurements anddeveloping estimates). The user of thedata must make a determination onwhether to use the low end of the range,the mid-point, or the upper end. Forexample, a release of 501 pounds couldbe misinterpreted as 999 pounds ifreported as a range of 500–999. Thisrepresents a nearly 100% error. Thisuncertainty severely limits theapplicability of release informationwhere the majority of releases,particularly for PBT chemicals, areexpected to be within the amountseligible for range reporting. Given thatthe large uncertainty would be part ofthese data and would severely limittheir utility, EPA has concluded thatfacilities must report numerical values,not ranges, for PBT chemicals.

In addition to the above comments,several commenters recommend the useof multiple ranges rather than totalelimination of ranges just for PBTchemicals. One commenter generallyagrees with EPA’s position thatreporting ranges ‘‘B’’ (11 to 499 pounds)and ‘‘C’’ (500 to 999 pounds), as theycurrently exist, may be too broad toprovide meaningful information for PBTchemicals. Because the proposal doesnot impose any new obligation tomeasure or test beyond what iscurrently required, however, thecommenter believes it is still



appropriate to retain the ‘‘A’’ reportingrange of 1 to 10 pounds for PBTchemicals. The commenter contendsthat the use of a specific numberconveys a sense of precision that maynot actually exist. The commenterargues that the retention of the ‘‘A’’reporting range in its current form,coupled with the new reporting range of‘‘greater than zero, but less than 1pound,’’ will provide meaningful andvaluable information to the public onPBT chemical transfers or releases.

Another commenter agrees with thepurpose underlying the EPA’s proposalto prohibit the use of range reporting forPBT chemicals and believes the rangesauthorized under the current rules aretoo broad to be useful for PBTchemicals. However, the commenterbelieves that EPA should recognize thatreporting in ranges is often necessarybecause uncertainty makes the selectionof a single number arbitrary.

Another commenter argues that EPAshould retain range reporting for PBTchemicals, even if the ranges are lowerthan those allowed for non-PBTchemicals. The commenter furthercontends that they believe that rangereporting helps to correct some of theerror introduced to EPCRA section 313reporting through the use of estimates.

EPA disagrees that the Agency shouldretain the ‘‘A’’ reporting range of 1 to 10pounds for PBT chemicals or that theAgency should retain some form ofrange reporting for PBT chemicals. Asstated in the proposal, EPA believes thatthe use of ranges could misrepresentdata accuracy because the low or thehigh end range numbers may not reallybe that close to the estimated value,even taking into account its inherenterror (i.e., error in measurements anddeveloping estimates). The user of thedata must make a determination onwhether to use the low end of the range,the mid-point, or the upper end. Forexample, a release of 501 pounds couldbe misinterpreted as 999 pounds ifreported as a range of 500–999. Thisrepresents a nearly 100% error. Evenwith a lower range such as 1 to 10pounds, the uncertainty associated withrange reporting could severely limit theapplicability of release information forPBT chemicals. Numerical values areparticularly important since PBTchemicals can remain in theenvironment for a significant amount oftime and can bioaccumulate in animaltissues. This means that even relativelysmall releases of such chemicals fromindividual facilities have the potentialto accumulate over time to higher levelsand cause adverse impacts on theenvironment and organisms. The utilityof these data would be limited given the

uncertainty associated with datareported using ranges. Therefore, due tothis uncertainty, EPA is requiring thatfacilities report numerical values, notranges, for PBT chemicals.

In addition, EPA believes that theinformation available to the typicalEPCRA section 313 reporter is generallygreater and more accessible than it was10 years ago. Because of this improvedinformation availability, EPA believesthat facilities will be able to accuratelyestimate releases and off-site transfersfor further waste management of PBTchemicals in quantities of less than1,000 pounds without the use of rangecodes. Although it may be true thatsome facilities will be better able tomake those estimates than others, EPAdoes not believe this justifies notcollecting the more specific and usefulinformation from those facilities thatcan provide it. Further, in the Form R,facilities are required, for each release ortransfer amount, to indicate theprincipal method used to determine theamount of release reported. There arecodes which allow the facility toindicate whether the estimate is basedon monitoring data, mass balancecalculations, published emissionfactors, or other approaches such asengineering calculations or bestengineering judgment. By looking at theinformation provided through the use ofthese codes, users of the data can gainan understanding of the degree ofaccuracy or uncertainty in anyparticular number reported by a facility.Thus, EPA does not believe that falseimpressions will be communicated tothe data user about the accuracy of theinformation filed.

Finally, as noted earlier EPCRApermits facilities to use reasonableestimates in the absence of readilyavailable data to calculate reportableamounts. EPCRA does not require thatadditional monitoring or sampling bedone in order to report. Thus, the statutecontemplates some level of imprecisionin the data that may be filed, yet, byauthorizing reporting based onreasonable estimates, affirms thecommunity right-to-know purposesrelative to information based on suchreasonable estimates.

A number of commenters agreed withEPA’s proposal that range reporting beeliminated for all PBT chemicals on theEPCRA section 313 list. Thecommenters agreed with EPA’s beliefthat the use of ranges couldmisrepresent data accuracy andsignificantly impact the usefulness ofthe data.

J. Other Issues1. Placing reported data into context.

Several commenters make the samegeneral comment that EPCRA section313 does not capture all sources of PBTchemical releases and therefore will notprovide a complete or accurate pictureof the releases of these chemicals.Commenters criticize the proposal fornot putting the PBT releases fromEPCRA section 313 covered facilitiesinto context, in terms of either risk orthe amount of PBT releases expectedfrom non-covered facilities or sources.EPA disagrees with the implication byseveral commenters that simply becauseEPCRA section 313 may not capture allthe sources of releases of PBT chemicalsEPA should not attempt to capture moreinformation from the facilities that doreport under EPCRA section 313. Thiscomment has been voiced in everymajor rulemaking under EPCRA section313 but, as EPA has stated in the past,this is not an argument that EPAbelieves should restrict any efforts tocollect additional data under EPCRAsection 313. The mere fact that for somechemicals significant release sources arenot captured does not in any waydiminish the importance of theinformation that can be provided bythose facilities that are required toreport under EPCRA section 313. Thereis currently no one single reportingrequirement that captures all of thereleases of PBT chemicals and makesthat information available to the public.For those chemicals that do have largerelease sources not captured underEPCRA section 313, EPA will use allavailable data to aid its actions andthose of other international and nationalorganizations and the public in efforts toaddress concerns on PBT chemicals. Forexample, all data will be considered toaid EPA’s PBT strategy or other EPAPBT related programs; EPA will not relysolely on the data collected underEPCRA section 313. In addition, if thereare significant sources of PBT chemicalsthat are not reported under EPCRAsection 313, EPA will attempt to let thepublic know that some sources are notcaptured. In fact, in the most recent TRIdata release documents, EPA has beenproviding information to the pubic onother sources of releases for certainEPCRA section 313 chemicals. Inaddition, EPA will continue to improveand augment public informationmaterials so that users of the data willhave information available to put incontext the releases and other wastemanagement of PBT chemicals byindustries reporting under EPCRAsection 313 versus those industries thatdo not report under EPCRA section 313.



In fact, rather than an argument againstlowering the reporting thresholds forPBT chemicals, EPA believes that theargument the commenters are making isone that supports expanding the typesof facilities that should be required toreport under EPCRA section 313 and notan argument that supports denying thepublic the right-to-know about PBTchemical releases from EPCRA section313 covered facilities.

Some commenters stated that sinceEPA did not use exposure or riskconsiderations, the data on PBTchemical releases will be misleading tothe public by indicating risks wherenone exist. EPCRA section 313 is not arisk-based reporting system, and, asdiscussed in Unit VI.F., EPA believesthat a risk-based approach to EPCRAsection 313 reporting is at odds with theoverriding policy of EPCRA section 313,which is to get information about theuse, disposition, and management oftoxic chemicals into the public domain,enabling the users of this information toevaluate the information and draw theirown conclusions about risk. The intentof EPCRA section 313 is to move thedetermination of which risks areacceptable from EPA to thecommunities in which the releasesoccur. This basic, local empowerment isa cornerstone of the right-to-knowprogram. In addition, EPA will continueto improve its annual public datarelease as well as its outreach andeducation efforts to assist users inunderstanding the data. Consequently,EPA disagrees with the commenters thatthe information reported on releases andother waste management of PBTchemicals will be misleading to thepublic.

Another commenter states that thequantities of PBT chemicals reported inthe TRI will be far smaller than thequantities of other chemicals whichpose far less significant health risks. Thecommenter is concerned that the smallquantities could lead members of thepublic to overlook the data on PBTchemicals. Therefore, the commenterargues that EPA should present PBTdata in a way that draws the public’sattention to it. The commenter statesthat it sees a danger that withoutsufficient education and guidance, thepublic may either overestimate orunderestimate the health risks from PBTchemicals. The commenter believes thatEPA should make a commitment toensuring that the public is given thenecessary education and guidance. EPAunderstands that the quantities of PBTchemicals may be reported in smallerquantities than other chemicals underEPCRA section 313 and that thesequantities have the potential to be

overlooked. EPA is also sensitive to theissue that data on PBT chemicals mustbe presented clearly to assist data usersin understanding how the informationon PBT chemicals is different from thatreported on other chemicals underEPCRA section 313. EPA will continueto improve its annual public datarelease as well as its outreach andeducation efforts to assist users inunderstanding the data. Despite theconcerns voiced by the commenters,EPA still believes that it is important tocollect and disseminate this informationso that communities can use theinformation with other site-specificfactors to determine if releases into theircommunities result in risks that thecommunity determines warrant furtheraction given other factors, such aseconomic and environmentalconditions, or particularly vulnerablehuman or ecological populations.

Another commenter expressesconcern that release numbers for PBTchemical will not be comparable tothose for other chemicals with higherreporting thresholds or to releases of thePBT chemical in previous years. Thecommenter adds that the lowerthresholds may mislead the public intothinking that releases are rising or thata new chemical has been introduced ata facility. EPA understands thecommenter’s concern but does notbelieve this is a justification for notcollecting additional information aboutPBT chemicals. EPA believes that it willbe able to adequately explain to thepublic the different reportingrequirements for PBT chemicals so thatthey are put in context of other TRI data.EPA will make clear which PBTchemicals were reportable prior to thefinalization of this rule and what thereporting threshold was for thesechemicals. Finally, EPA will continue toimprove its annual public data releaseas well as its outreach and educationefforts to assist users in understandingthe data.

2. Manufacture only qualifier forchemicals other than dioxin. Manycommenters request that EPA add a‘‘manufacture only’’ qualifier to all PBTchemicals, not just the dioxin anddioxin-like compounds category. Thecommenters assert that the addition ofthe manufacture only qualifier to allPBT chemicals would greatly reduce theburden of the rule. Some commenterssuggest that at a minimum themanufacture only qualifier should applyto polychlorinated biphenyls (PCBs),since EPA’s rationale for applying thequalifier to dioxin and dioxin-likecompounds is equally applicable toPCBs. One commenter contends thatEPA’s statement that the manufacture

qualifier is appropriate for chemicalsthat are ‘‘ubiquitous in theenvironment’’ because otherwise manyfacilities would be required to reportsimply due to background levels in rawmaterials applies to PCBs as well. Somecommenters suggest thatunintentionally manufactured by-products such as hexachlorobenzeneand octachlorostyrene should also havethe manufacture only qualifier. Somecommenters argue that the burden of therule could be significantly reduced ifEPA focused the reporting effort on themanufacturing sector, which shouldhelp concentrate EPA’s pollutionprevention efforts on the sector mostlikely to be able to make reductions.Some commenters contend that theprimary source for PBT chemicalswithin the EPCRA section 313 reportingsectors is from manufacturing, and theseare the sources that should be focusedon for tracking PBT chemicals. Somecommenters assert that EPA hasacknowledged that many chemicalsidentified as persistent andbioaccumulative are not imported,processed, or otherwise used, but aremanufactured as by-products (at 64 FR715). Some commenters assert that theyagree that manufacturing is the primarysource for environmental loading of PBTchemicals from EPCRA section 313facilities, and thus the effort forreporting should be concentrated on thesources where PBT chemicals aregenerated and data can be gathered.Some commenters argue thatconcentration on the manufacturing ofPBT chemicals provides an efficientfocus for meaningful pollutionprevention efforts. Some commentersassert that they are concerned that datafrom importing, processing, orotherwise use of PBT chemicals will beinaccurate and misleading sinceprocessors and users may not have theresources to conduct the analysesrequired to provide accurate estimates.One commenter contends that the fearof enforcement might motivate thoseimporting, processing, or otherwiseusing PBT chemicals to report ‘‘someamount’’ and that such information islikely to be inaccurate, and will notaccurately reflect the true level ofconcern. Some commenters assert thatinstead of requiring reports from themany sources where effective emissionsreductions may not be possible, that theaddition of a manufacture only activityqualifier for all PBT chemicals willprovide the public with the mostaccurate information on PBT chemicalemissions and the best opportunity tomonitor EPCRA section 313-related



environmental loading of thesechemicals.

EPA believes that in order to obtainany reporting on dioxin and dioxin-likecompounds a very low threshold isrequired, which is several orders ofmagnitude lower than the thresholds forother PBT chemicals. At such a lowreporting threshold it is estimated thatthousands of reports could potentiallybe filed by facilities, mainly foodprocessing facilities, due to the amountof dioxins in the raw materials theyprocess. The dioxins found in the meatand dairy products that food processorshandle have been previously released,circulated in the environment, andbioaccumulated in animals, thus theseare not additional loadings to theenvironment but loadings that havealready occurred and cycled through theenvironment due to the persistence andbioaccumulative properties of thesecompounds. The unique combination ofvery low thresholds, the number of foodprocessors that would be required tofile, and the fact that they would befiling because of the bioaccumulation ofpreviously released material led EPA topropose to add only dioxin and dioxin-like compounds that are manufactured.EPA is finalizing the addition of dioxinwith a revised qualifier in response tothe unique set of conditions that applyto the reporting of dioxin and dioxin-like compounds. EPA proposed and isfinalizing the addition of dioxin with aqualifier to reduce reporting burden onfacilities, mainly in the food processingindustry, that results from the uniquecombination of circumstances related tothe reporting for these chemicals and tofocus on those activities that add to theloading of dioxins in the environmentrather than on activities dealing withpreviously released and bioaccumulatedchemicals.

EPA did not conclude and does notbelieve that the manufacturing activityis the only important source of PBTchemical releases to the environmentand believes that other activities such asprocessing or use can result insignificant releases of PBT chemicals,including chemicals released to theenvironment for the first time. Asdiscussed in Unit VI.G., EPA hasmodified the dioxin qualifier to reflectthis. The unique combination ofcircumstances that exists for dioxin anddioxin-like compounds does not existsfor any of the other PBT chemicals beingadded by this rule. EPA did notconclude that the manufacture qualifieris generally appropriate for otherchemicals that are being added and thatare ‘‘ubiquitous in the environment.’’The full statement in the proposal was‘‘These dioxin and dioxin-like

compounds are ubiquitous in theenvironment and thus under the verylow reporting thresholds necessary toget reports from any sources (seediscussion in Unit VII.A.2.), facilitiesthat process raw materials would berequired to report simply because theraw material contains background levelsof these chemicals’’ (at 64 FR 710).Clearly EPA made this statement in thecontext of the ‘‘very low reportingthresholds necessary to get reports [forthe dioxin and dioxin-like compoundscategory] from any sources.’’ Thisstatement is consistent with the uniquecombination of circumstances thatexists for dioxin and dioxin-likecompounds and was not intended toapply to all PBT chemicals.

Neither did EPA conclude that themanufacturing activity is the activity forwhich facilities would be most likely tobe able to make reductions or that EPA’spollution prevention efforts shouldfocus solely on the manufacturing ofPBT chemicals. Commenters providedno basis for such a conclusion and EPAbelieves that processors and users ofPBT chemicals also have theopportunity to make effective emissionsreductions by using less of a PBTchemical, by not using materials thatcontain PBT chemicals as contaminants,etc. In addition, the purposes ofreporting under EPCRA section 313 arenot limited to the collection ofinformation from sources whereeffective reductions in release and otherwaste management quantities arepossible. Data collected under EPCRAsection 313 can serve a variety ofinformation purposes that do notdepend on how easy it is for the sourceto achieve reduction in releases andother waste management. Thecommenter statement that EPA hasacknowledged that many chemicalsidentified as persistent andbioaccumulative are not imported,processed, or otherwise used, but aremanufactured as by-products, isincorrect. The actual statement was:‘‘[m]any of the chemicals identified aspersistent and bioaccumulative intoday’s action are not imported,processed, or otherwise used but aremanufactured as by-products’’ (at 64 FR715). As the words ‘‘today’s action’’clearly demonstrate, this statement wasnot a broad statement about all PBTchemicals but simply anacknowledgment that many of the PBTchemicals in the proposed rule were by-products. In addition, this statementwas made in the context of thediscussion on the de minimis exemptionabout how removing the exemption forPBT chemicals would affect the

chemicals in the proposed rule; it wasnot a statement made in connectionwith the discussion on the manufactureonly qualifier. EPA also did not statethat manufacturing is the primarysource for environmental loading of PBTchemicals from facilities covered underEPCRA section 313. The discussion onthe loading of chemicals in theenvironment from manufacturing was inrelation to the reporting of dioxinwhich, as discussed above, presents aunique combination of circumstancesthat EPA considered to determine howto focus its listing decision and does notapply to all PBT chemicals. EPAdisagrees with the statements that datafrom facilities that import, process, orotherwise use PBT chemicals will beinaccurate and misleading or that suchfacilities will report some quantity outof fear of enforcement and that suchinformation is likely to be inaccurate,and will not accurately reflect the truelevel of concern. EPA believes thatfacilities that import, process, orotherwise use PBT chemicals will bejust as able to report as facilities thatmanufacture PBT chemicals. It is nomore difficult to do calculationsregarding small numbers than it is to docalculations on larger numbers, so if afacility that imports, processes, orotherwise uses PBT chemicals hasinformation that allows them to make areasonable estimation of quantities thenthey should be just as able to report asany manufacturing facility would beable to report on small quantitiesmanufactured as by-products. Iffacilities that import, process, orotherwise use PBT chemicals do nothave data available that allows them tomake a reasonable estimation ofquantities then they are not required toreport. As for fear of enforcement, EPAcan take enforcement actions both forunder reporting and over reporting sofacilities should not report an amount ofa PBT chemical in order to avoid anenforcement action.

EPA does not believe that the uniquecombination of circumstances thatexists for dioxin and dioxin-likecompounds exists for any of the otherPBT chemicals being added by this rulenor does EPA believe that reducedburden or any of the other reasonssuggested by the commenters provide asufficient reason to focus onmanufacturing activity only for theother PBT chemicals in this rule.Therefore, EPA does not believe that itis appropriate to add a manufactureonly qualifier to any of the other PBTchemicals in this rule.

3. Waste management issues. Somecommenters contend that becauseactivities such as recycling, approved



waste disposal, and treatment areincorporated into reported volumes, theEPCRA section 313 reported releaseswill be substantial overestimates of theactual quantities released to the ambientenvironment. They further argue thatalthough this information may be usefulto source reduction efforts, merging ofreporting requirements under section313 of EPCRA and section 6607 of PPAhas resulted in information which ismisleading to the public’s desire toknow the actual exposures that areoccurring. Another commenter assertsthat by requiring electricity generatingfacilities to report transfers off-site fortreatment and disposal of PCBs fromtransformers, EPA has established adisincentive to properly dispose of PCBtransformers and remove them from usebecause most PCB wastes transferred tooff-site facilities are destroyed inregulated units which destroy at least99.9999% of the PCBs. They areconcerned that because the casualreader may conclude additional releasesof PCBs to the environment haveoccurred, companies would have adisincentive to voluntarily removePCBs.

The commenters are incorrect instating that EPCRA section 313 releasequantities include recycling andtreatment amounts. Under EPCRAsection 313, if a chemical activitythreshold is met for the chemical,covered facilities are required to reportthe quantity of the toxic chemicalentering each environmental medium;this includes ‘‘releases.’’ The definitionof release pursuant to EPCRA section329(8) means:

any spilling, leaking, pumping, pouring,emitting, emptying, discharging, injecting,escaping, leaching, dumping, or disposinginto the environment (including theabandonment or discarding of barrels,containers, and other closed receptacles) ofany hazardous chemical, extremelyhazardous substance, or toxic chemical.

There is no language in this definition,any other provision of EPCRA, or in theregulations promulgated pursuant toEPCRA section 313, that limit thisdefinition to ambient releases to theenvironment which may result in publicexposure. In fact the definitionspecifically includes disposing of toxicchemicals as well as the abandonmentof closed receptacles. In addition,neither the statute nor the regulationslimit this definition to on-site releases.Therefore, the statutory definition ofrelease under EPCRA section 313 issignificantly broader than thecommenter seems to believe.

In addition to release reporting, undersection 6607(b)(1) of the PPA, if acovered facility meets the reporting

thresholds under EPCRA section 313,the facility is required to report the‘‘quantity of the chemical entering anywastestream (or otherwise released tothe environment). . . .’’ This quantityincludes amounts of the toxic chemicalreleased, treated, and recycled.However, this quantity does notinclude:

[t]he amount of any toxic chemicalreleased into the environment whichresulted from a catastrophic event,remedial action, or other one time event,and is not associated with productionprocesses during the reporting year.(PPA 6607 (b)(7)) (emphasis added)Therefore, the quantity of the toxicchemical entering the wastestream ascollected under section 6607(b)(1) of thePPA, is the amount of the toxicchemical in production related waste.Covered facilities currently report theamount of the toxic chemical inproduction related waste as quantities ofthe toxic chemical released, treated,combusted for energy recovery andrecycled. These quantities are collectedas separate data elements in section 8 ofthe Form R. Further, facilities report theultimate disposition of toxic chemicalsin waste such that these quantities (i.e.,amounts released, treated, combustedfor energy recovery, and recycled) aremutually exclusive. Collectively, then,these quantities are the amount enteringthe waste stream or the quantity of thetoxic chemical in production relatedwaste. For example, a covered facilitytransfers 1,000,000 pounds of PCBs toan incinerator for treatment. Thecovered facility knows that 999,999pounds are destroyed in the incineratorand the remaining 1 pound is disposedin a landfill. The facility reports 999,999pounds as transferred off-site fortreatment and 1 pound as transferredoff-site for disposal. These twoquantities are reported as separate dataelements on the Form R. The quantityreported as disposed off-site isconsidered released because, asexplained previously, disposal is a typeof release. The entire quantity(1,000,000 pounds) is the amount ofproduction related waste.

Once collected, EPA presents the TRIdata to the public in a number offormats. In its annual data releasedocuments, EPA highlights differentaspects of the quantities of toxicchemicals released and otherwisemanaged as waste. For example, EPApresents total on-site releases and, assubsets, presents the quantities releasedto air, surface water, undergroundinjection and on-site land releases. (See1997 Toxics Release Inventory (EPA745–R–99–003) Figure 2-3 ‘‘TRI On-site

Releases’’) EPA also presents thequantity of total releases in the publicdata release. As discussed earlier, underEPCRA section 313, release quantitiesare not limited to quantities released tothe ambient environment. Therefore,total releases, as presented in the publicdata release include both on and off-sitereleases as well as a variety of disposalmethods. For example, in Table 2-20Aof the 1997 public data release, EPApresents TRI on-site and off-site releasesby chemical and type of release (e.g., airemissions, underground injection, etc.)(1997 Toxics Release Inventory; EPA745–R–99–003).

In addition to TRI release data, EPApresents production related wastequantities in the public data release.Because production related wasteincludes releases, EPA includes releasequantities with other waste managementquantities. However, in this document,the Agency generally distinguishesquantities of the toxic chemical releasedfrom other types of waste management.EPA does not count the quantities oftoxic chemicals treated, combusted forenergy recovery or recycled asquantities released. (See, for example,1997 Toxics Release Inventory (EPA745-R-99-003) Table 2-20A ‘‘TRI On-siteand Off-site Releases, by Chemical,1997’’ and Table 2-20B ‘‘TRI Chemicalsin Waste, by Chemical, 1997’’)

Further, EPA does not believe that theTRI program provides a disincentive forthe proper and safe handling of PCBs intransformers managed as waste. Asexplained earlier, covered facilities arerequired under EPCRA section 313 andsection 6607 of the PPA to reportquantities of toxic chemicals released orotherwise managed as waste if theymeet a chemical activity threshold.Quantities of toxic chemicals sent off-site for treatment are described as such.These transfers are not included asreleases. In addition, EPA disagrees thatquantities of PCBs sent off-site fortreatment will be misunderstood by thepublic because these quantities areaccurately represented in the TRI database and in the public data release as aseparate type of waste management.

Another commenter asserts that theproposed rule will not encourage wasteminimization because facilities will notbe able to modify process designs toaccomodate such minimization simplyon the basis of data generated fromguidance documents or reasonableestimates. The commenter asserts thatalthough industry has made substantialminimization gains, the technology isnot available to treat or removechemicals of concern frommanufactured products or waste (priorto generation) at such low



concentrations and that any futureimprovements will be enormouslyexpensive due to the low concentrationsthat would likely be involved.

EPA disagrees with the commenter. Inthe preamble to the proposed rule, EPAdid not assert that covered facilities willbegin performing waste minimizationactivities as a direct result of thisrulemaking. Rather, the Agency statedthat the PBT chemical rulemaking willprovide data on PBT chemicals to EPA,industry, and the public. For example,several EPA offices have ongoingprojects and programs that deal withissues concerning PBT chemicals. EPAhas established the PBT planning groupwhich is a coordinating body consistingof representatives from various programoffices throughout EPA that are dealingwith PBT chemicals. This group hasdeveloped a strategy to reduce pollutionfrom PBT chemicals through theapplication of regulatory andnonregulatory authorities, with a strongemphasis on pollution prevention. Theavailability of that data, in turn, canallow all parties to identify and trackreleases of PBT chemicals and monitorthe progress of the programs designed toreduce the amount of PBT chemicalsentering the environment. The data willalso allow EPA and others to designprevention strategies that are focusedand effective.

In addition, EPA disagrees with thecommenter’s last assertion concerningthe available technology and its costs.Although there are some processes thatmight not, at present, be amenable tosource reduction in terms of PBTchemicals, some processes may be. Forexample, it may be possible tostringently control fuel composition,flow times, temperature, and otherconditions in order to substantiallyreduce or even eliminate the incidentalmanufacture of dioxins duringcombustion processes. Therefore, EPAcontinues to believe that in some cases,opportunities for pollution preventionwill present themselves resulting frominformation reported under EPCRAsection 313 and section 6607 of thePPA.

4. Modulated reporting thresholds.The majority of commenters contendthat modulating thresholds for reportingso that lower reporting thresholds areused every other year (with currentthresholds used in alternate years)would introduce confusion for theregulated community and data usersand would not significantly reduceburden. Further it could discouragefacilities from establishing commonstandard procedures for data collection.Modulation will also result in data gaps,undermining data consistency and

tracking. Many commenters believe thatannual reporting is a fundamentalattribute of TRI.

EPA agrees that modulating thereporting thresholds would introduceconfusion for both the regulatedcommunity and data users. For datausers, EPA believes that modulating thereporting thresholds would limit theusefulness of the TRI data because therewould be poor data consistency andpoorer data quality. For the regulatedcommunity, EPA believes that theburden reduction would not besignificant and would possibly be offsetby the confusion that would beintroduced by different thresholds inalternate years.

VII. What Were the Results of EPA’sEconomic Analysis?

EPA has prepared an economicanalysis of the impact of this action,which is contained in a documententitled Economic Analysis of the FinalRule to Modify Reporting of PersistentBioaccumulative Toxic Chemicals underEPCRA Section 313 (Ref. 67). Thisdocument is available in the publicdocket for this rulemaking. The analysisassesses the costs, benefits, andassociated impacts of the rule, includingpotential effects on small entities. Themajor findings of the analysis are brieflysummarized here.

A. What is the Need for the Rule?Federal regulations exist, in part, to

address significant market failures.Markets fail to achieve socially efficientoutcomes when differences existbetween market values and socialvalues. Two causes of market failure areexternalities and informationasymmetries. In the case of negativeexternalities, the actions of oneeconomic entity impose costs on partiesthat are ‘‘external’’ to any markettransaction. For example, a facility mayrelease toxic chemicals withoutaccounting for the consequences toother parties, such as the surroundingcommunity, and the prices of thatfacility’s goods or services thus will failto reflect those costs. The market mayalso fail to efficiently allocate resourcesin cases where consumers lackinformation. For example, whereinformation is insufficient regardingtoxic releases, individuals’ choicesregarding where to live and work maynot be the same as if they had morecomplete information. Since firmsordinarily have little or no incentive toprovide information on their releasesand other waste management activitiesinvolving toxic chemicals, the marketfails to allocate society’s resources inthe most efficient manner.

This rule is intended to address themarket failures arising from privatechoices about PBT chemicals that havesocietal costs, and the market failurescreated by the limited informationavailable to the public about the releaseand other waste management activitiesinvolving PBT chemicals. Through thecollection and distribution of facility-specific data on toxic chemicals, TRIovercomes firms’ lack of incentive toprovide certain information, andthereby serves to inform the public ofreleases and other waste management ofPBT chemicals. This informationenables individuals to make choices thatenhance their overall well-being.Choices made by a more informedpublic, including consumers, corporatelenders, and communities, may leadfirms to internalize into their businessdecisions at least some of the costs tosociety relating to their releases andother waste management activitiesinvolving PBT chemicals. In addition,by helping to identify areas of concern,set priorities and monitor trends, TRIdata can also be used to make moreinformed decisions regarding the designof more efficient regulations andvoluntary programs, which also movessociety towards an optimal allocation ofresources.

If EPA were not to take this actionadding certain PBT chemicals to EPCRAsection 313 and lowering reportingthresholds, the market failure (and theassociated social costs) resulting fromthe limited information on the releaseand other waste management of PBTchemicals would continue. EPAbelieves that today’s action will improvethe scope of multi-media data on therelease and other waste management ofPBT chemicals. This, in turn, willprovide information to the public,empower communities to play ameaningful role in environmentaldecision-making, and improve thequality of environmental decision-making by government officials. Inaddition, this action will serve togenerate information that reportingfacilities themselves may find useful insuch areas as highlighting opportunitiesto reduce chemical use or release orother waste management and therebylower costs of production and/or wastemanagement. EPA believes that theseare sound rationales for addingchemicals to the EPCRA section 313 listof toxic chemicals and loweringreporting thresholds for PBT chemicals.

B. What Are the Costs Associated WithThis Rule?

This action will result in theexpenditure of resources that, in theabsence of the regulation, could be used



for other purposes. The cost of the ruleis the value of these resources in theirbest alternative use. Most of the costs ofthe rule result from requirements on

industry. Approximately 11,300facilities are expected to submitapproximately 20,000 additional Form Rreports annually. The estimated

composition of this reporting, bychemical, is shown in Table 4.

Table 4.—Summary of Chemical Reporting as Estimated for Proposed and Final Rules

Chemical or Chemical CategoryEstimated Number of Reports (Annual)

Proposed Rule Final Rule

Alkyl lead (tetraethyl lead and tetramethyl lead) 134 N/A

Benzo(g,h,i)perylene 353 909

Dioxin and dioxin-like compounds category 1,863 1,475

Hexachlorobenzene 778 778

Mercury; mercury compounds category 5,230 5,346

Octachlorostyrene 230 230

Pentachlorobenzene 707 707

Pesticides (aldrin, chlordane, heptachlor, isodrin, methoxychlor,pendimethalin, toxaphene, trifluralin)

264 264

Polycyclic aromatic compounds (PACs) category 4,699 7,166

Polychlorinated biphenyls (PCBs) 2,267 2,310

Tetrabromobisphenol A 150 150

Vanadium; vanadium compounds category 654 655

Total 17,329 19,990

Table 5 displays the industry costs forthis action based on the estimatednumber of facilities affected and theestimated number of additional reports.Aggregate industry costs in the first yearfor the rule are estimated to be $145

million; in subsequent years they areestimated to be $80 million per year.Industry costs are lower after the firstyear because facilities will be familiarwith the reporting requirements, andmany will be able to update or modify

information from the previous year’sreport. EPA is expected to expend $2.0million in the first year, and $1.6million in subsequent years as a resultof the rule.

Table 5.—Summary of Reporting and Associated Costs as Estimated for Proposed and Final Rules

Proposed Rule Final Rule

Number of new facilities 2,600 3,114

Total number of facilities 9,515 11,257

Number of Form Rs submitted 17,329 19,990

First year industry costs $126 million $145 million

Subsequent year industry costs $70 million $80 million

EPA costs $1.4 million $1.6 million

The estimated cost of the final rulediffers from the estimated cost of theproposed rule as shown in Table 5.There are six major reasons for thischange. First, EPA received new dataduring the comment period on theconcentrations of PACs andbenzo(g,h,i)perylene in distillate fueloil. Since approximately 18,000manufacturing facilities subject to

EPCRA 313 reporting use distillate fueloil, this change had a significantpositive effect on the estimated numberof reports for PACs andbenzo(g,h,i)perylene as shown in Table4. Second, the methodology forestimating reporting from facilities inSIC 5171 (Bulk Petroleum Stations andTerminals) was revised to account forthe mix of products containing PBT

chemicals that are processed at thesefacilities. This revision also had apositive effect on the estimated numberof reports. Third, because facility-leveldioxin emission factors for coal- and oil-burning manufacturing facilities havenot been developed, the estimatednumber of reporting facilities wasreduced. Fourth, the reporting qualifierfor dioxin was changed from



‘‘manufacture only’’ to ‘‘manufacturing;and the processing or otherwise use ofdioxin and dioxin-like compounds if thedioxin and dioxin-like compounds arepresent as contaminants in a chemicaland if they were created during themanufacturing of that chemical’’ in thefinal rule. This resulted in additionalexpected reporting from facilities thatprocess or otherwise use chemicals withdioxin impurities. Fifth, the Agency isnot lowering EPCRA section 313reporting thresholds for alkyl leads aspart of this rulemaking. Therefore, noadditional EPCRA section 313 reportingon alkyl leads is expected at this time.Sixth, the threshold for the PACscategory was changed from 10 poundsin the proposed rule to 100 pounds inthe final rule.

C. What Are the Benefits of This Rule?In enacting EPCRA and PPA, Congress

recognized the significant benefits ofproviding the public with informationon toxic chemical releases and otherwaste management practices. EPCRAsection 313 has empowered the Federalgovernment, State governments,industry, environmental groups, and thegeneral public to fully participate in aninformed dialogue about theenvironmental impacts of toxicchemicals in the United States. EPCRAsection 313’s publicly available database provides quantitative informationon toxic chemical releases and otherwaste management practices. Since theTRI program’s inception in 1987, thepublic, government, and the regulatedcommunity have had the ability tounderstand the magnitude of chemicalreleases in the United States, and toassess the need to reduce the uses,releases and other waste management oftoxic chemicals. TRI enables allinterested parties to establish crediblebaselines, to set realistic goals forenvironmental progress over time, andto measure progress in meeting thesegoals over time. The TRI program is aneutral yardstick by which progress canbe measured by all stakeholders.

The information reported underEPCRA section 313 increases knowledgeof the amount of toxic chemicalsreleased and waste managementpractices, and thus aids in theevaluation of the potential pathways ofexposure, improves scientificunderstanding of the health andenvironmental risks of toxic chemicals;allows the public to make informeddecisions on where to work and live;enhances the ability of corporate leadersand purchasers to more accurately gaugea facility’s potential environmentalliabilities; provides reporting facilitieswith information that can be used to

save money as well as reduce emissions;and assists Federal, State, and localauthorities in making better decisionson acceptable levels of toxic chemicalsin the environment.

There are two types of benefitsassociated with EPCRA section 313reporting, those resulting from theactions required by the rule (such asreporting and recordkeeping), and thosederived from follow-on activities thatare not required by the rule. Benefits ofactivities required by the rule includethe value of improved knowledge aboutthe release and waste management oftoxic chemicals, which leads toimprovements in understanding,awareness, and decision-making. It isexpected that this rule will generatesuch benefits by providing readilyaccessible information that otherwisewould not be available to the public.The rule will benefit ongoing researchefforts to understand the risks posed byPBT chemicals and to evaluate policystrategies that address the risks.

The second type of benefits derivefrom changes in behavior that mayresult from the information reportedunder EPCRA section 313. Thesechanges in behavior, includingreductions in releases of and changes inthe waste management practices fortoxic chemicals may yield health andenvironmental benefits. These changesin behavior come at some cost, and thenet benefits of the follow-on activitiesare the difference between the benefitsof decreased chemical releases andtransfers and the costs of the actionsneeded to achieve the decreases.

Because the state of knowledge aboutthe economics of information is nothighly developed, EPA has notattempted to quantify the benefits ofadding chemicals to EPCRA section 313or changing reporting thresholds.Furthermore, because of the inherentuncertainty in the subsequent chain ofevents, EPA has also not attempted topredict the changes in behavior thatresult from the information, or theresultant net benefits (i.e., the differencebetween benefits and costs). EPA doesnot believe that there are adequatemethodologies to make reasonablemonetary estimates of either the benefitsof the activities required by the rule, orthe follow-on activities. The economicanalysis of the rule, however, doesprovide illustrative examples of how therule will improve the availability ofinformation on PBT chemicals (Ref. 67).

A number of commenters assertedthat information on the magnitude ofPBT chemical releases that would bereported as a result of this rule isrequired for EPA and commenters toevaluate the benefit of EPA’s proposed

alternatives. EPA disagrees with thesecommenters for the following reasons.

Existing data do not support estimatesof releases to multiple environmentalmedia from the full range of facilitiesthat may be affected by the rule becausemost of the data required for theanalysis would only be available afterthe rule is in place. For most PBTchemicals and industry sectors, up-to-date multi-media release and otherwaste management estimates foraffected facilities do not exist. Evenwhere release estimates are available foran industry sector, most are derivedfrom national activity levels rather thanfrom facility-level information. To theextent that release estimates areavailable, they tend to cover only asingle medium such as air. EPA doesnot believe that there is sufficientinformation to make reasonablepredictions of the multi-media releasesand other waste managementinformation that will be reported as aresult of EPCRA section 313rulemakings.

Some commenters note that EPA hasestimated releases of certain PBTchemicals in recent reports such as theMercury Study Report to Congress (Ref.65) and the Inventory of Source ofDioxin in the United States (Ref. 73). Infact, EPA reported the results of thesereports in its economic analysis for thisproposal. These studies do not providecommunity- or facility-level releaseestimates. The estimates in these studiesare derived using a ‘‘top-down’’methodology in which emission factorsare applied to activity levels for entireindustries. While having an estimate ofmulti-media PBT releases for a specificindustry sector is a first step, otherinformation would also be required toestimate the releases that would bereported as a result of each proposedalternative. Assuming that multi-mediarelease estimates were available for anentire industry sector, these releaseswould still have to be divided amongindividual facilities according to somecurrently unknown distribution. Inaddition, there is the complication thatEPCRA section 313 reporting thresholdsare based on chemical throughput(manufacture, process, or use) ratherthan chemical release. The relationshipbetween a chemical throughput thattriggers the submission of a report, andthe releases reported will vary in somecurrently unknown manner amongindustries, as well as among facilitieswithin an industry.

Therefore, EPA does not believe thatthere is sufficient information to makereliable release estimates for this rule,when considering all the affectedchemicals and industries. The



uncertainties in the estimated valuesthat go into such a calculation makepredictions of facility level reportingextremely imprecise. Historical attemptsto estimate the releases expected to bereported under EPCRA section 313would have been imprecise to the pointof being misleading, particularly inrespect to estimates of releases perreport or per facility (which somecommenters have suggested that EPAshould make). Further information onthe feasibility of ex ante releaseestimates is available in the Response toComments document (Ref. 69).

Aside from the general issue ofuncertainty in the estimates of aggregatereleases, predictions of releases perfacility or per report (or dollars ofreporting cost per pound of releasesreported) are likely to be misleading dueto the biases built into the estimates.The predicted number of reports (andthus costs) is generally an overestimate,since EPA’s economic analyses useconservative estimates to avoidunderestimating true costs. On the otherhand, predictions of releases will tendto underestimate emissions, becausewhile there may be informationavailable on releases of some chemicalsfrom some sectors, such estimates willnot include other sources where releasesare not identified until more detaileddata (such as TRI data) are collected.Combining the two sets of estimatescompounds the problem. Sinceestimated pounds of releases areunderestimated and reports areoverestimated, pounds per report wouldbe biased significantly downward.Likewise, estimates of dollars ofreporting cost per pound of releases(which varies as the inverse of poundsper report) would be biased significantlyupward.

EPA notes that there were variousreports and studies about air emissionsof toxic chemicals prior to EPCRAsection 313, but the collection offacility-level data provided significantnew information on releases as well asother waste management. EPA cannotpredict, at this stage, the quantity ofreleases and other waste managementthat will be reported as the result of thisaction any more accurately than it couldhave predicted when it proposed theoriginal EPCRA section 313 rule.

Aside from the issue of whether EPAcan predict releases and other wastemanagement quantities prior to TRIreporting, EPA notes that pounds ofreleases (even if known) are not areasonable proxy for the benefits of theinformation being provided. This isbecause the benefits of an informationalregulation are not a linear function ofthe magnitude of the information being

reported. EPA disagrees with theimplicit assumption by commenters thatthe benefits of information fromdifferent facilities is strictly andsystematically related to the quantityreported as being released. Calculationssuch as the commenters have suggestedpresume that the benefit to the public ofknowing about a release of 20,000pounds is twice as large as the benefitof knowing about a release of 10,000pounds; and that the benefit of knowingabout a 40,000 pound release is twicethe benefit of knowing about a 20,000pound release and four times the benefitof knowing about a 10,000 poundrelease. EPA does not believe thischaracterization to be accurate.

One of the central purposes of TRIdata is to inform the public aboutreleases and other waste management ofEPCRA section 313 listed toxicchemicals in their community so thatthe public can form its own conclusionsabout risks. The amount of releases andwaste management quantities that acommunity may find relevant or usefulwill vary depending on numerousfactors specific to that community, suchas the toxicity of the various chemicals,potential exposure to these toxicchemicals, and the number of otherfacilities in the area that release EPCRAsection 313 listed toxic chemicals.Section 313(h) of EPCRA states that thedata are ‘‘to inform persons aboutreleases of toxic chemicals to theenvironment; to assist governmentalagencies, researchers, and other personsin the conduct of research and datagathering; to aid in the development ofappropriate regulations, guidelines, andstandards; and for other similarpurposes’’ (See Unit VI.E. for a moredetailed discussion on the purposes ofEPCRA section 313). Pounds of releasesreported does not measure how the dataperform these functions, and thus is nota measure of benefits.

Finally, EPA notes that commenterson this rule did not provide informationon approaches or methodologies forestimating releases and/or throughput,or on estimating releases fromthroughput data, for the spectrum ofindustries, chemicals, and facilitiescovered by the rule. Instead, somecommenters submitted data from EPAstudies (that EPA had already reviewedin the context of this rule and used asreferences for the economic analysis ofthe proposed rule) for very narrow slicesof the regulated universe (for example,estimated mercury releases from electricutilities or estimated dioxin releasesfrom the vinyl industry). EPAconsidered these data and determinedthat they are not sufficient to predict thereleases and/or throughput that will be

reported as a result of this rule. Othercommenters simply stated that EPAshould consider releases withoutreferencing any data. None of thecommenters suggested newmethodologies or approaches, orprovided information from any sourcesthat EPA had not already reviewed andconsidered. As a result, EPA continuesto conclude that while there are dataavailable to estimate national releasesfor some chemicals for some sectors,comprehensive, reliable data for allsectors and chemicals are unavailable,resulting in an incomplete data set.Furthermore, as stated previously, thequantity of releases reported are not ameasure of the benefits of the rule. EPAdoes not believe that inaccurate orincomplete estimates of releases wouldaid the decision-making process for therule. Therefore, EPA has not estimatedthe releases that would be reported as aresult of the rule.

D. What are the Potential Impacts onSmall Entities?

In accordance with the RegulatoryFlexibility Act (RFA) and the Agency’slongstanding policy of alwaysconsidering whether there may be apotential for adverse impacts on smallentities, the Agency has evaluated thepotential impacts of this rule on smallentities. The Agency’s analysis ofpotentially adverse economic impacts isincluded in the Economic Analysis forthis rule (Ref. 67). The following is abrief overview of EPA’s findings.

1. Overall methodology. This rule mayaffect both small businesses and smallgovernments. For the purpose of itsanalysis for the rule, EPA defined asmall business using the small businesssize standards established by the SmallBusiness Administration (SBA) at 13CFR part 121. EPA defined smallgovernments using the RFA definitionof jurisdictions with a population of lessthan 50,000. No small organizations areexpected to be affected by the rule.

Only those small entities that areexpected to submit at least one reportare considered to be affected for thepurpose of the small entity analysis,although EPA recognizes that othersmall entities will conduct compliancedeterminations under lower thresholds.The number of affected entities will besmaller than the number of affectedfacilities, because many entities operatemore than one facility. Impacts werecalculated for both the first year ofreporting and subsequent years. Firstyear costs are typically higher thancontinuing costs because firms mustfamiliarize themselves with therequirements. Once firms have becomefamiliar with how the reporting



requirements apply to their operations,costs fall. EPA believes that subsequentyear impacts present the best measure tojudge the impact on small entitiesbecause these continuing costs are morerepresentative of the costs firms face tocomply with the rule.

EPA analyzed the potential costimpact of the rule on small businessesand governments for the manufacturingsector and in each of the recently addedindustry sectors separately in order toobtain the most accurate assessment foreach. EPA then aggregated the analysesfor the purpose of determining whetherit could certify that the rule will not, ifpromulgated, have a ‘‘significanteconomic impact on a substantialnumber of small entities.’’ RFA section605(b) provides an exemption from therequirement to prepare a regulatoryflexibility analysis for a rule where anagency makes and supports thecertification statement quoted above.EPA believes that the statutory test forcertifying a rule and the statutoryconsequences of not certifying a rule allindicate that certificationdeterminations may be based on anaggregated analysis of the rule’s impacton all of the small entities subject to it.

2. Small businesses. EPA used annualcompliance costs as a percentage ofannual company sales to assess thepotential impacts on small businesses ofthis rule. EPA believes that this is agood measure of a firm’s ability to affordthe costs attributable to a regulatoryrequirement, because comparingcompliance costs to revenues provides areasonable indication of the magnitudeof the regulatory burden relative to acommonly available measure of acompany’s business volume. Whereregulatory costs represent a smallfraction of a typical firm’s revenue (forexample, less than 1%, but not greaterthan 3%), EPA believes that thefinancial impacts of the regulation maybe considered not significant. Asdiscussed above, EPA also believes thatit is appropriate to apply this measureto subsequent year impacts.

Based on its estimates of additionalreporting as a result of the rule, theAgency estimates that approximately6,300 businesses will be affected by therule, and that approximately 4,400 ofthese businesses are classified as smallbased on the applicable SBA sizestandards. For the first reporting year,EPA estimates that approximately 17small businesses may bear compliancecosts between 1% and 3% of revenues,and that no small businesses will bearcosts greater than 3%. In subsequentyears, EPA estimates that approximately5 small businesses may bear compliancecosts between 1% and 3% of revenues,

and that no small businesses will bearcosts greater than 3%. As stated above,EPA believes that subsequent-yearimpacts are the appropriate measure ofsmall business impacts.

3. Small governments. To assess thepotential impacts on small governments,EPA used annual compliance costs as apercentage of annual governmentrevenues to measure potential impacts.Similar to the methodology for smallbusinesses, this measure was usedbecause EPA believes it provides areasonable indication of the magnitudeof the regulatory burden relative to agovernment’s ability to pay for the costs,and is based on readily available data.

EPA estimates that 39 municipalitiesoperate 49 publicly owned electricutility facilities. Of these facilities, 44are expected to file additional reports asa result of this action. Of these affectedfacilities, 15 are operated by 15 smallgovernments (i.e., those withpopulations under 50,000). It isestimated that none of these smallgovernments will bear annual costsgreater than 1% of annual governmentrevenues.

4. All small entities. As discussedabove, approximately 5 small businessesare expected to bear annual costsbetween 1% and 3% of annual revenuesafter the first year of reporting. None ofthe affected small governments areestimated to bear annual costs greaterthan 1% of annual revenues. No smallorganizations are expected to be affectedby the rule. Thus, the total number ofsmall entities with impacts above 1% ofrevenues does not change when theresults are aggregated for all smallentities (i.e., small businesses, smallgovernments, and small organizations).

VIII. What are the References for thisAction?

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6. Andreae, M.O. 1986. ChemicalSpecies in Seawater and MarineParticulates. In Bernhard M, FEBrinkman and PJ Sadler (Eds.), TheImportance of Chemical ‘‘Speciation’’ inEnvironmental Processes. DahlemKonferenzen, Berlin: Springer-Verlag,pp 301-335.

7. Aronson, D. et.al., 1998. ChemicalFate Half-Lives and PersistenceEvaluation for Toxics Release InventoryPBT Rule Chemicals. Prepared bySyracuse Research Corp. for Robert S.Boethling, USEPA Office of PollutionPrevention and Toxics, Washington, DC.Contract Number 68D50012 Task 451 .

8. Bacon, C.E., W.M. Jarman, J.A.Estes, M Simon and R.J. Norstrom. 1999.Comparison of OrganochlorineContaminants among Sea Otter(Enhydra Lutris) Populations inCalifornia and Alaska. Environ. Toxicol.Chem. 18: 452-458.

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21. DeVito, M.J., Diliberto, J.J., Ross,D.G., Menache, M.G., Birnbaum, L.S.December 1997. Dose-responserelationships for polyhalogenateddioxins and dibenzofurans followingsubchronic treatment in mice. I.CYP1A1 and CYP1A2 enzyme activityin liver, lung, and skin. Toxicol. Appl.Pharmacol. ;147(2):267-80

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37. Moss, K.T. and R.S. Boethling.March 1999. USEPA New ChemicalsProgram Pbt Chemical Category.Presented at the National Meeting of theAmerican Chemical Society (ACS),Anaheim, CA.

38. Nabholz, J.V., M. Zeeman and D.Rodier. 1998. Case study #1: Assessingthe Ecological Risks of a New Chemicalin Chapter 5. Case studies illustratingthe current state-of-the practice, pp.205–225 in Warren-Hicks, W.J. andMoore, D.R.J. (eds.). UncertaintyAnalysis in Ecological Risk Assessment.SETAC Special Publications Series.Proceedings of the Pellston Workshopon Uncertainty Analysis in EcologicalRisk Assessment, 23–28 August 1995,Pellston, Michigan. Pensacola, Fl:Society of Environmental Toxicologyand Chemistry.

39. North American Agreement forEnvironmental Cooperation-Commission for EnvironmentalCooperation (NAAEC-CEC). 1997. DraftProcess for Identifying CandidateSubstances for Regional Action underthe Sound Management of ChemicalsInitiative. Report to the North AmericanWorking Group on the SoundManagement of Chemicals by the TaskForce on Criteria, under the NorthAmerican Agreement on EnvironmentalCooperation (NAAEC). Internet site:http://www.cec.org.

40. North American Agreement forEnvironmental Cooperation-Commission for EnvironmentalCooperation (NAAEC-CEC). 1997.Process for Identifying CandidateSubstance for Regional Action under theSound Management of ChemicalsInitiative.

Report to the North AmericanWorking Group on the SoundManagement of Chemicals by the TaskForce on Criteria. CEC, Montreal,Quebec, Canada. Draft, July 1997.

41. OECD Environment Directorate.1998. Harmonized Integrated HazardClassification System for Human Healthand Environmental Effects of ChemicalSubstances. As endorsed by the 28thJoint Meeting of the ChemicalsCommittee and the Working Party on



Chemicals in November 1998. Paris:Organization for Economic Cooperationand Development. Internet site: http://www.oecd.org.

42. Palm, W.U., and Zetch, C. 1992.‘‘Estimated Rate Constant for theReaction of Pendimethalin with OHRadicals at Room Temperature in theGas Phase According to the Method ofAtkinson.’’ Fraunhofer Institutunpublished report ITA 42.

42a. Porcella, D. B., P. Chu, and M. A.Allan. 1996. Inventory of NorthAmerican Hg Emissions to theAtmosphere: Relationship to the GlobalMercury Cycle. Pp. 179–190 in Baeyens,W., R. Ebinghaus, and O. Vasiliev, eds.,Global and Regional Mercury Cycles:Sources, Fluxes and Mass Balances.

43. Rand, G.M. 1995. Fundamentals ofAquatic Toxicology, 2nd. ed. TaylorFrancis, Washington, DC 1125 pp.

43a. Robertson, B. K. and Alexander,M. 1998. ‘‘Sequestration of DDT andDieldrin in Soil: Disappearance of AcuteToxicity but not Compounds.’’ Environ.Toxicol. Chem. 17: 1034–1038.

44. Rodan, B. and N. Eckley. 1997.Science-policy Assessment of POPsScreening Criteria: Report to the USEPAInternational Toxics CoordinatingCommittee. Draft, 21 August 1997.

45. Rodan, B., D.W. Pennington, N.Eckley and R.S. Boethling. 1999.Screening for Persistent OrganicPollutants: Techniques to Provide aScientific Basis for POPs Criteria inInternational Negotiations. Environ. Sci.Technol., in press.

46. Springborn Laboratories, Inc.1989. Determination of theBiodegradability ofTetrabromobisphenol A in a Soil underAerobic Conditions. SLI Report: 88–11–2848. Submitted on behalf of theBrominated Flame Retardants IndustryPanel. EPA Docket #40–8998097.

47. Springborn Laboratories, Inc.1989. Determination of theBiodegradability ofTetrabromobisphenol A in a Soil underAnaerobic Conditions. SLI Report: 88–11–2849. Submitted on behalf of theBrominated Flame Retardants IndustryPanel. EPA Docket #40–8998097.

48. Springborn Laboratories, Inc.1989. Tetrabromobisphenol ADetermination of the Biodegradability ina Sediment/Soil Microbial System. SLIReport: 89–8–3070. Submitted on Behalfof the Brominated Flame RetardantsIndustry Panel. EPA Docket #40–89000034.

49. Stumm, W. and J.J. Morgan. 1996.Aquatic Chemistry, 3rd ed. New York:Wiley.

50. Syracuse Research Corporation.March 1999. The Environmental Fate ofLead and Lead Compounds. Prepared

for David G. Lynch, U.S. EnvironmentalProtection Agency, under ContractNumber SRC 68–D5–0012.

51. Syracuse Research Corporation,1998. ‘‘EQC Model Output for ToxicsRelease Inventory PBT Rule Chemicals’’(PBT Docket #B1–042)

51a. Tang, J., Carroquino, M.J.,Robertson, B.K., and Alexander, M.1998. ‘‘Combined Effect of Sequestrationand Bioremediation in Reducing theBioavailability of Polycyclic AromaticHydrocarbons.’’ Soil. Environ. Sci.Technol. 32: 3586–3590.

52. Tyler, J.E. 1976. Transmission ofSunlight in Natural Water BodiesSymposium on Nonbiological Transportand Transformation of Pollutants onLand and Water: Processes and CriticalData Required for PredictiveDescription, National Bureau ofStandards.

53. Toet, C. and S. Arai. IndirectExposure of Human Beings to OrganicCompounds. Discussion Document 4,Working Group III: Models for IndirectExposure by Food and Drinking Water.Distributed at the OECD Workshop onthe Application of Simple Models forEnvironmental Exposure Assessment,Berlin, Germany, 11–13 December 1991.

54. United Nations EconomicCommission for Europe (UNECE) Long-Range Transboundary Air Pollution(LRTAP). March 31, 1998. DraftComposite Negotiating Text for aProtocol on Persistent OrganicPollutants. UNECE, EB.AIR/1998/2.

55. United Nations EconomicCommission for Europe (UNECE) LongRange-Transboundary Air Pollution(LRTAP). 1998. Protocol to the 1979Convention on Long-RangeTransboundary Air Pollution (LRTAP)on Heavy Metals (Draft), to BeSubmitted to the Ministerial Conference‘‘Environment for Europe’’ (Arhus,Denmark, June 23-25, 1998). Website:http://www.unece.org/env/protocol/98hm.htm.

56. United Nations EnvironmentProgramme (UNEP) Criteria ExpertGroup (CEG) for Persistent OrganicPollutants (POPs). September 17, 1998.The Development of Science-basedCriteria and a Procedure for IdentifyingAdditional Persistent Organic Pollutantsas Candidates for Future InternationalAction. UNEP/POPS/INC/CEG/1/2.

57. United Nations EnvironmentProgramme (UNEP) Governing CouncilDecisions 20/24. 1999. Declaration inSupport of International Effort to ProtectHuman Health and the EnvironmentThrough Measures to Reduce and/orEliminate Emission and Discharges ofPOPs.

58. USEPA. AQUIRE, the AquaticToxicity Information Retrieval Database.

September 22, 1995. http://www.epa.gov/medatwrk/databases/aquire.html.

59. USEPA. Integrated RiskInformation System (IRIS). ‘‘Arsenic,Inorganic,’’ at http://www.epa.gov/iris/subst/0278.htm. Downloaded July 1999.

60. USEPA. Integrated RiskInformation System (IRIS). ‘‘Chromium(VI),’’ Internet site: http://www.epa.gov/iris/subst/0144.htm. Downloaded July1999.

61. USEPA. Integrated RiskInformation System (IRIS). ‘‘Seleniumand Compounds.’’ Internet site: http://www.epa.gov/iris/subst/0472.htm. July19, 1999.

62. USEPA. 1995. Great Lakes WaterQuality Initiative Technical SupportDocument for the Procedure toDetermine Bioaccumulation Factors.EPA–820–B–95–005. USEPA, Office ofWater: Washington, DC.

63. USEPA. 1997. ReregistrationEligibility Decision (RED)Pendimethalin. Office of Prevention,Pesticides and Toxic Substances. EPA738–R–97–007.

64. USEPA, ATSDR. The Effects ofGreat Lakes Contaminants on HumanHealth: Report to Congress (1986)Internet at: www.epa.gov/glnpo/health/atsdr.htm.

65. USEPA, OAQPS/ORD. 1997.Mercury Study Report to Congress.

66. USEPA, OIA. TechnicalInformation Package for Lead. Internetsite: http://www.epa.gov/oiamount/tips/lead2.htm. Downloaded March 1999.

66a. USEPA, OPPT. 1999.Bioavailability of Metals. Memorandumfrom David Lynch, ExposureAssessment Branch to Maria Doa, ToxicRelease Inventory Branch, October 1999.

67. USEPA, OPPT. 1999. EconomicAnalysis of the Final Rule to ModifyReporting of Persistent BioaccumulativeToxic Chemicals under EPCRA Section313.

67a. USEPA, OPPT. 1999. EconomicAnalysis: Supplemental Information onthe Distribution of Additional Reportingfrom SIC Codes at Various LowerReporting Thresholds.

68. USEPA, OPPT. Persistent,Bioaccumulative Substances on theToxics Release Inventory (TRI): Reporton Persistence Screening Criteria.Boethling, R.S., U.S. EnvironmentalProtection Agency. September 4, 1997.

69. USEPA, OPPT. 1999. Response toComments Received on the January 5,1999 Proposed Rule (64 FR 688) toLower the EPCRA Section 313 ReportingThresholds for Persistent,Bioaccumulative Toxic (PBT) Chemicalsand to Add Certain PBT Chemicals tothe EPCRA Section 313 List of ToxicChemicals and Response to Comments



Received on the May 7, 1997 ProposedRule (62 FR 24887) to Add a Categoryof Dioxin and Dioxin-like Compoundsto the EPCRA Section 313 List of ToxicChemicals. Office of PollutionPrevention and Toxics, U.S.Environmental Protection Agency,Washington, DC.

70. USEPA, OPPT. 1999. SupportDocument for the Addition of CertainChemicals to Section 313 of theEmergency Planning and CommunityRight-to-Know Act. U.S. EnvironmentalProtection Agency, Washington DC.

71. USEPA, OPPT. September 1998.Technical Support Document forDetermination of Bioaccumulation(BAF) and Bioconcentration (BCF)Values for Persistent BioaccumulativeToxic (PBT) Chemicals and forIdentification of PBT Chemicals. JerrySmrchek, Ph.D., Biologist, ExistingChemicals Assessment Branch, RiskAssessment Division.

71a. USEPA, OPPT. 1999. UnfundedMandates Reform Act Statement. FinalRule.

72. USEPA, ORD. 1986. Air QualityCriteria for Lead. Research TrianglePark, NC. EPA, Office of Research andDevelopment, Office of Health andEnvironmental Assessment. EPA600/8–83–028bF.

73. USEPA, ORD. 1998. The Inventoryof Sources of Dioxin in the UnitedStates. Review Draft. EPA 600–P–98–002Aa.

74. USEPA, OSWER. June 1997.Waste Minimization Prioritization ToolBeta Test Version 1.0 User’s Guide andSystem Documentation (Draft).Appendix D Draft Prioritized ChemicalList. U.S. Environmental ProtectionAgency, Washington DC, EPA530–R–97–019.

75. USEPA, OW. Mercury Update:Impact on Fish Advisories. EPA–823–F–99–016.

76. USEPA, OW. PolychlorinatedBiphenyls (PCBs) Update: Impact onFish Advisories. EPA–823–F–99–019.

77. USEPA, OW. Toxaphene Update:Impact on Fish Advisories. EPA–823–F–99–018.

78. Van den Berg M, Birnbaum L,Bosveld A T.C., Brunstrom B, Cook P,Feeley M, Giesy J, Hanberg A, HasegawaR , Kennedy S, Kubiak T , Larsen J.C.,.Rolaf van Leeuwen, A.K. Djien Liem,Nolt C, Peterson R, Poellinger L, Safe S,Schrenk D, Til D. Toxic EquivalencyFactors (TEFs) for PCBs, PCDDs, PCDFsfor Humans and Wildlife.Environmental Health Perspectives vol106 December 1998.

79. Viluksela, M., Stahl, B.U.,Birnbaum, L.S., Rozman, K.K. October1997. Subchronic/chronic toxicity of1,2,3,4,6,7,8-heptachlorodibenzo-p-

dioxin (HpCDD) in rats. Part II.Biochemical effects. Toxicol. Appl.Pharmacol. 146(2):217–26.

80. Viluksela, M., Stahl, B.U.,Birnbaum, L.S., Schramm, K.W.,Kettrup, A., Rozman, K.K. October 1997.Subchronic/chronic toxicity of1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin (HpCDD) in rats. Part I. Design,general observations, hematology, andliver concentrations. Toxicol. Appl.Pharmacol. 146(2):207-16.

81. Wania, F. and D. Mackay. 1996.Tracking the Distribution of PersistentOrganic Pollutants. Environ. Sci.Technol. 30: 390A–396A.

82. Webster E, Mackay D, Wania F.1998. Evaluating EnvironmentalPersistence. Environ. Toxicol. Chem.17:2148–2158.

83. World Health Organization, 1995.Environmental Health Criteria(EHC)172, Tetrabromobisphenol A andDerivatives.

84. Zimdahl, R.L. and R.K. Skogerboe.1977. Behavior of Lead in Soil. Environ.Sci. Technol. 11:1202–1207.

IX. Which Regulatory AssessmentRequirements Apply to This Action?

A. What is the Determination underExecutive Order 12866

Under Executive Order 12866,entitled Regulatory Planning andReview (58 FR 51735, October 4, 1993),this is an economically ‘‘significantregulatory action’’ because it is likely tohave an annual effect of $100 million ormore. This action was submitted to theOffice of Management and Budget(OMB) for review, and any substantivecomments or changes made during thatreview have been documented in thepublic version of the official record.

EPA has prepared an economicanalysis of the impact of this action,which is contained in a documententitled Economic Analysis of the FinalRule to Modify Reporting of PersistentBioaccumulative Toxic Chemicals underEPCRA Section 313 (Ref. 67). Thisdocument is available as a part of thepublic version of the official record forthis action (instructions for accessingthis document are contained in UnitI.B.) and is discussed in Unit VII.

B. What is the Determination under theRegulatory Flexibility Act?

Pursuant to section 605(b) of theRegulatory Flexibility Act (RFA) (5U.S.C. 601 et seq.), the EPAAdministrator hereby certifies that thisfinal rule will not have a significanteconomic impact on a substantialnumber of small entities. The factualbasis for this determination is presentedin the small entity impact analysis

prepared as part of the EconomicAnalysis for this final rule (Ref. 67),which is also discussed in detail in UnitVII. and contained in the public versionof the official record for this rule. Thefollowing is a brief summary of theAgency’s factual basis for thiscertification.

For the purpose of analyzing potentialimpacts on small entities, EPA used theRFA definition of small entities insection 601(6) of the RFA. Under thissection, small entities include smallgovernments, small non-profitorganizations, and small businesses. Nosmall organizations are expected to beaffected by this final rule. EPA definedsmall governments using the RFAdefinition of jurisdictions with apopulation of less than 50,000, anddefined a small business using the smallbusiness size standards established bythe Small Business Administration(SBA), which are generally based on thenumber of employees or annual sales/revenue a business in a particularindustrial sector has.

Based on EPA’s economic analysis,approximately 11,300 facilities areexpected to submit approximately20,000 additional Form R reportsannually. Of these facilities,approximately 3,100 are expected to fileTRI reports for the first time as a resultof today’s action. EPA estimates that thecost for collecting this informationaverages $5,079 per Form R in the firstreporting year, and $3,557 insubsequent years. EPA estimates thatthere are 15 small governments that maybe affected by the rule (i.e., EPAanalysis estimates that these entitiesmay have to file one or more reportsunder the final rule). EPA estimates thatnone of these small governments willbear annual costs greater than 1% ofannual government revenues. EPAestimates that 5 small businesses of theapproximately 4,400 small businessespotentially affected by the rule willexperience annual compliance costsbetween 1% and 3% of annual salesafter the first year of reporting. Giventhe relatively small estimated impactson small entities, EPA believes that therule will not have a significanteconomic impact on a substantialnumber of small entities. Thisdetermination is for the entirepopulation of small entities potentiallyaffected by this rule, since the test forcertification is whether the rule as awhole has a significant economicimpact on a substantial number of smallentities.

Notwithstanding the Agency’scertification of this rule under section605(b) of the RFA, EPA remainscommitted to minimizing real impacts



on small entities where this does notunacceptably compromise theinformational benefits of the rule.Although not required, EPA intends toprepare guidance for reporting ondioxin that will assist facilities indetermining their compliance needs andin properly completing the form, whichwill help ensure that small entitiesreceive assistance to ease their burdenof compliance. EPA has prepared suchdocuments for current reporters and hasreceived positive feedback on theirutility from the targeted facilities. Inaddition, the Agency is alwaysinterested in any comments regardingthe economic impacts that thisregulatory action would impose onsmall entities, particularly suggestionsfor minimizing that impact. Suchcomments may be submitted to theAgency at any time, to the address listedin Unit I.B.

Information relating to thisdetermination has been provided to theChief Counsel for Advocacy of the SmallBusiness Administration, and isincluded in the public version of theofficial record for this rulemaking.

C. What is the Determination under thePaperwork Reduction Act?

The information collectionrequirements contained in this final rulehave been submitted to OMB under thePaperwork Reduction Act (PRA), 44U.S.C. 3501 et seq., and in accordancewith the procedures at 5 CFR 1320.11.OMB has approved the existingreporting and recordkeepingrequirements EPA Toxic ChemicalRelease Inventory Form R (EPA FormNo. 9350-1), supplier notification, andpetitions under OMB Control No. 2070–0093 (EPA ICR No. 1363). AnInformation Collection Request (ICR)document has been prepared by EPA(EPA ICR No. 1363.10) to amend theexisting ICR to include the burdenassociated with the lower reportingthresholds, and a copy may be obtainedfrom Sandy Farmer, Office ofInformation Collections (OIC); U.S.Environmental Protection Agency(2137), 401 M St., SW., Washington, DC20460, by calling (202) 260–2740, orelectronically by sending an e-mailmessage to ‘‘[email protected].’’ Anelectronic copy has also been postedwith this Federal Register document onEPA’s Homepage with other informationrelated to this action as described inUnit I.B., and may also be downloadedfrom the Internet at http://www.epa.gov.icr/.

An Agency may not conduct orsponsor, and a person is not required torespond to a collection of informationsubject to OMB approval under the PRA

unless it displays a currently valid OMBcontrol number. The OMB controlnumbers for EPA’s regulations, afterinitial publication in the FederalRegister, are maintained in a list at 40CFR part 9. The informationrequirements contained in this final ruleare not effective until OMB approvesthem.

EPCRA section 313 requires owners oroperators of certain facilitiesmanufacturing, processing, or otherwiseusing any of over 600 listed toxicchemicals and chemical categories inexcess of the applicable thresholdquantities, and meeting certainrequirements (i.e., at least 10 Full TimeEmployees or the equivalent), to reportenvironmental on-site releases andtransfers off-site for release andtreatment. Under section 6607 of thePPA, facilities must also provideinformation on the quantities of thetoxic chemicals in certain wastestreams, and the efforts made to managethose waste quantities. The regulationscodifying the EPCRA section 313reporting requirements appear at 40 CFRpart 372. Respondents may designatethe specific chemical identity of asubstance as a trade secret, pursuant toEPCRA section 322 (42 U.S.C. 11042).Regulations codifying the trade secretprovisions can be found at 40 CFR part350. Under the final rule, all facilitiesreporting under EPCRA section 313 onPBT chemicals would have to use theForm R (EPA Form No. 9350-1), whichis currently approved by OMB.

For Form R, EPA estimates theindustry reporting burden for collectingthis information (includingrecordkeeping) to average 74 hours perreport in the first year, at an estimatedcost of $5,079 per Form R. Insubsequent years, the burden isestimated to average 52.1 hours perreport, at an estimated cost of $3,557 perForm R. These estimates include thetime needed to review instructions;search existing data sources; gather andmaintain the data needed; complete andreview the collection of information;and transmit or otherwise disclose theinformation. The actual burden on anyspecific facility may be different fromthis estimate depending on thecomplexity of the facility’s operationsand the profile of the releases at thefacility.

This final rule is estimated to resultin reports from 11,300 respondents. Ofthese, 3,100 facilities are estimated to bereporting under EPCRA section 313 forthe first time as a result of the rule,while 8,200 are currently reportingfacilities that will be submittingadditional reports. These facilities willsubmit an estimated additional 20,000

Form Rs. This rule therefore results inan estimated total burden of 2.1 millionhours in the first year, and 1.2 millionhours in subsequent years, at a totalestimated industry cost of $145 millionin the first year and $80 million insubsequent years. The existing ICR willbe amended to include an additionalannual burden of 1.5 million hours(annual average burden for the first 3years of ICR approval).

Under the PRA, ‘‘burden’’ means thetotal time, effort, or financial resourcesexpended by persons to generate,maintain, retain, or disclose or provideinformation to or for a Federal agency.This includes, where applicable, thetime needed to review instructions;develop, acquire, install, and utilizetechnology and systems for the purposesof collecting, validating, and verifyinginformation, processing andmaintaining information, and disclosingand providing information; adjust theexisting ways to comply with anypreviously applicable instructions andrequirements; train personnel to be ableto respond to a collection ofinformation; search data sources;complete and review the collection ofinformation; and transmit or otherwisedisclose the information. EPA’s burdenestimates for the rule take into accountall of the above elements, consideringthat under section 313, no additionalmeasurement or monitoring may beimposed for purposes of reporting.

D. What are the Determinations underthe Unfunded Mandates Reform Actand Executive Orders 12875 and 13084?

Pursuant to Title II of the UnfundedMandates Reform Act of 1995 (UMRA)(Public Law 104–4), EPA hasdetermined that this action contains aFederal mandate that may result inexpenditures of $100 million or morefor the private sector in any 1 year, butthat it will not result in suchexpenditures for State, local, and tribalgovernments, in the aggregate.Accordingly, EPA has prepared awritten statement for this rule pursuantto section 202 of UMRA, and thatstatement is available in the publicversion of the official record for thisrulemaking (Ref. 71a). The costsassociated with this action are estimatedin the economic analysis prepared forthis rule (Ref. 67), which is alsoincluded in the public version of theofficial record and summarized in UnitVII. The following is a brief summary ofthe UMRA statement for the rule.

This rule is being promulgatedpursuant to sections 313(d)(1) and (2),313(f)(2), 313(g), 313(h), and 328 ofEPCRA, 42 U.S.C. 11023(d)(1)–(2),11023(f)(2), 11023(g), 11023(h) and



11048; PPA section 6607, 42 U.S.C.13106. The economic analysis containsan analysis of the benefits and costs ofthis rule, which estimates that the totalindustry costs of the rule will be $145million in the first year and $80 millionper year thereafter, and concludes thatthe benefits will be significant butcannot be assigned a dollar value due tothe lack of adequate methodologies.EPA believes that the benefits providedby the information to be reported underthis rule will significantly outweigh thecosts imposed by today’s action. Thebenefits of the information will in turnhave positive effects on health, safety,and the natural environment throughthe behavioral changes that may resultfrom that information.

EPA has not identified any Federalfinancial resources that are available tocover the costs of this rule. As set forthin the economic analysis, EPA hasestimated the future industrycompliance costs (after the first year) ofthis rule to be $80 million annually. Ofthose entities affected by today’s action,EPA has not identified anydisproportionate budgetary impact onany particular region, government, orcommunity, or on any segment of theprivate sector. Based on the economicanalysis, EPA has concluded that it ishighly unlikely that this rule will havean appreciable effect on the nationaleconomy.

EPA has determined that it is notrequired to develop a small governmentagency plan as specified by section 203of UMRA or to conduct priorconsultation with State, local, or tribalgovernments under section 204 ofUMRA, because the rule will notsignificantly or uniquely affect smallgovernments and does not contain asignificant Federal intergovernmentalmandate.

Finally, EPA believes this rulecomplies with section 205(a) of UMRA.The objective of this rule is to expandthe public benefits of the TRI programby exercising EPA’s discretionaryauthority to add chemicals to theprogram and to lower reportingthresholds, thereby increasing theamount of information available to thepublic regarding the use, management,and disposition of PBT chemicals andenabling a more comprehensive view ofPBT chemical exposures. In makingadditional information availablethrough TRI, the Agency increases theutility of TRI data as an effective tool forempowering local communities, thepublic sector, industry, other agencies,and State and local governments tobetter evaluate risks to public healthand the environment.

As described in Unit IV.D., EPAconsidered burden in the thresholdselection. Existing burden-reducingmeasures (e.g., the laboratory exemptionand the otherwise use exemptions,which include the routine janitorial orfacility grounds maintenanceexemption, motor vehicle maintenanceexemption, structural componentexemption, intake air and waterexemption and the personal useexemption) will continue to apply to thefacilities that file new reports as a resultof this rule. EPA also will be assistingsmall entities subject to the rule, bysuch means as providing meetings,training, and compliance guides in thefuture, which also will ease the burdensof compliance. Many steps have beenand will be taken to further reduce theburden associated with this rule, and toEPA’s knowledge there is no availablealternative to the rule that would obtainthe equivalent information in a lessburdensome manner. For all of thesereasons, EPA believes the rule complieswith UMRA section 205(a).

In addition, today’s rule does notcreate an unfunded Federal mandate onState, local or tribal governments, nordoes it significantly or uniquely affectthe communities of Indian tribalgovernments. Accordingly, therequirements of section 1(a) ofExecutive Order 12875, entitledEnhancing the IntergovernmentalPartnership (58 FR 58093, October 28,1993), and section 3(b) of ExecutiveOrder 13084, entitled Consultation andCoordination with Indian TribalGovernments (63 FR 27655, May 19,1998), do not apply to this proposedrule.

E. What are the Determinations underExecutive Orders 12898 and 13045?

Pursuant to Executive Order 12898,entitled Federal Actions to AddressEnvironmental Justice in MinorityPopulations and Low-IncomePopulations (59 FR 7629, February 16,1994), the Agency must considerenvironmental justice related issueswith regard to the potential impacts ofthis action on environmental and healthconditions in low-income populationsand minority populations. Pursuant toExecutive Order 13045, entitledProtection of Children fromEnvironmental Health Risks and SafetyRisks (62 FR 19885, April 23, 1997), ifan action is economically significantunder Executive Order 12866, theAgency must, to the extent permitted bylaw and consistent with the Agency’smission, identify and assess theenvironmental health risks and safetyrisks that may disproportionately affectchildren.

By lowering the section 313 reportingthresholds for PBT chemicals, EPA willprovide communities across the UnitedStates (including low-incomepopulations and minority populations)with access to data that may assist themin lowering exposures and consequentlyreducing chemical risks for themselvesand their children. This information canalso be used by government agenciesand others to identify potentialproblems, set priorities, and takeappropriate steps to reduce anypotential risks to human health and theenvironment. Therefore, theinformational benefits of the rule willhave a positive impact on the humanhealth and environmental impacts ofminority populations, low-incomepopulations, and children.

F. What are the Determinations underExecutive Orders 13132 and 12612?

On August 4, 1999, President Clintonissued a new executive order onfederalism, Executive Order 13132,entitled Federalism (64 FR 43255,August 10, 1999), which will take effecton November 2, 1999. In the interim, thecurrent Executive Order 12612, entitledFederalism (52 FR 41685, October 30,1987) still applies. This action isexpected to have a limited impact onmunicipal governments which operateelectric utilities. EPA estimates that 39municipalities operate 49 publiclyowned electric utility facilities. Of thesefacilities, 44 are expected to fileadditional reports as a result of thisaction. Therefore EPA concludes thatthis rule will not have a substantialdirect effect on States, on therelationship between the nationalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government, as specified inExecutive Order 12612.

G. What are the Determinations underthe National Technology Transfer andAdvancement Act?

Section 12(d) of the NationalTechnology Transfer and AdvancementAct of 1995 (NTTAA) (15 U.S.C. 272note) directs EPA to use voluntaryconsensus standards in its regulatoryactivities unless doing so would beinconsistent with applicable law orimpractical. Voluntary consensusstandards are technical standards (e.g.,materials specifications, test methods,sampling procedures, etc.) that aredeveloped or adopted by voluntaryconsensus standards bodies. TheNTTAA directs EPA to provideCongress, through OMB, explanationswhen the Agency decides not to use



available and applicable voluntaryconsensus standards.

This action does not involve technicalstandards, nor did EPA consider the useof any voluntary consensus standards.In general, EPCRA does not prescribetechnical standards to be used forthreshold determinations or completionof EPCRA section 313 reports. EPCRAsection 313(g)(2) states that ‘‘In order toprovide the information required underthis section, the owner or operator of afacility may use readily available data(including monitoring data) collectedpursuant to other provisions of law, or,where such data are not readilyavailable, reasonable estimates of theamounts involved. Nothing in thissection requires the monitoring ormeasurement of the quantities,concentration, or frequency of any toxicchemical released into the environmentbeyond that monitoring andmeasurement required under otherprovisions of law or regulation.’’

H. What are the Determinations underthe Congressional Review Act?

The Congressional Review Act, 5U.S.C. 801 et seq., as added by the SmallBusiness Regulatory EnforcementFairness Act of 1996, generally providesthat before a rule may take effect, theagency promulgating the rule mustsubmit a rule report, which includes acopy of the rule, to each House of theCongress and to the Comptroller General

of the United States. EPA will submit areport containing this rule and otherrequired information to the U.S. Senate,the U.S. House of Representatives, andthe Comptroller General of the UnitedStates prior to publication of the rule inthe Federal Register. A major rulecannot take effect until 60 days after itis published in the Federal Register.This action is a ‘‘major rule’’ as definedby 5 U.S.C. 804(2). This rule will beeffective December 31, 1999.

List of Subjects in 40 CFR Part 372

Environmental protection,Community right-to-know, Hazardoussubstances, Intergovernmental relations,Reporting and recordkeepingrequirements, Superfund.

Dated: October 25, 1999.Carol M. Browner,Administrator.

Therefore, 40 CFR part 372 isamended as follows:

PART 372—[AMENDED]

1. The authority citation for part 372continues to read as follows:

Authority: 42 U.S.C. 11023 and 11048.

§ 372.22 [Amended]

2. In § 372.22(c), remove the phrase‘‘§ 372.25 or § 372.27.’’ and add in itsplace ‘‘§ 372.25, § 372.27, or § 372.28.’’.

§ 372.25 [Amended]

3. Section 372.25 is amended asfollows:

i. In the introductory text of § 372.25,remove the first clause ‘‘Except asprovided in § 372.27,’’ and add in itsplace ‘‘Except as provided in §§ 372.27and 372.28,’’.

ii. In paragraphs (f), (g), and (h),remove the reference ‘‘§ 372.25’’ andadd in its place ‘‘§ 372.25, § 372.27, or§ 372.28’’.

4. In § 372.27, add a new paragraph(e) to read as follows:

§ 372.27 Alternate threshold andcertification.

* * * * *(e) The provisions of this section do

not apply to any chemicals listed in§ 372.28.

5. Add a new § 372.28 to subpart B toread as follows:

§ 372.28 Lower thresholds for chemicalsof special concern.

(a) Notwithstanding § 372.25 or§ 372.27, for the toxic chemicals setforth in this section, the thresholdamounts for manufacturing (includingimporting), processing, and otherwiseusing such toxic chemicals are as setforth in this section.

(1) Chemical listing in alphabeticorder.

Chemical name CAS No. Reporting threshold

Aldrin ....................................................................................... 00309–00–2 100Benzo(g,h,i)perylene ............................................................... 00191–24–2 10Chlordane ................................................................................ 00057–74–9 10Heptachlor ............................................................................... 00076–44–8 10Hexachlorobenzene ................................................................ 00118–74–1 10Isodrin ...................................................................................... 00465–73–6 10Mercury ................................................................................... 07439–97–6 10Methoxychlor ........................................................................... 00072–43–5 100Octachlorostyrene ................................................................... 29082–74–4 10Pendimethalin .......................................................................... 40487–42–1 100Pentachlorobenzene ............................................................... 00608–93–5 10Polychlorinated biphenyl (PCBs) ............................................ 01336–36–3 10Tetrabromobisphenol A ........................................................... 00079–94–7 100Toxaphene .............................................................................. 08001–35–2 10Trifluralin .................................................................................. 01582–09–8 100

(2) Chemical categories in alphabeticorder.

Category name Reporting threshold

Dioxin and dioxin-like compounds (Manufacturing; and the processing or otherwise use of dioxin and dioxin-like compounds if the dioxin and dioxin-like compounds are present as contaminants in a chemical and ifthey were created during the manufacturing of that chemical) (This category includes only those chemi-cals listed below).

0.1 grams

67562–39–4 1,2,3,4,6,7,8-Heptachlorodibenzofuran



Category name Reporting threshold

55673–89–7 1,2,3,4,7,8,9-Heptachlorodibenzofuran70648–26–9 1,2,3,4,7,8-Hexachlorodibenzofuran57117–44–9 1,2,3,6,7,8-Hexachlorodibenzofuran72918–21–9 1,2,3,7,8,9-Hexachlorodibenzofuran60851–34–5 2,3,4,6,7,8-Hexachlorodibenzofuran39227–28–6 1,2,3,4,7,8-Hexachlorodibenzo-p-dioxin57653–85–7 1,2,3,6,7,8-Hexachlorodibenzo-p-dioxin19408–74–3 1,2,3,7,8,9-Hexachlorodibenzo-p-dioxin35822–46–9 1,2,3,4,6,7,8-Heptachlorodibenzo-p-dioxin39001–02–0 1,2,3,4,6,7,8,9-Octachlorodibenzofuran03268–87–9 1,2,3,4,6,7,8,9-Octachlorodibenzo-p-dioxin57117–41–6 1,2,3,7,8-Pentachlorodibenzofuran57117–31–4 2,3,4,7,8-Pentachlorodibenzofuran40321–76–4 1,2,3,7,8-Pentachlorodibenzo-p-dioxin51207–31–9 2,3,7,8-Tetrachlorodibenzofuran01746–01–6 2,3,7,8 Tetrachlorodibenzo-p-dioxin

Mercury compounds 10

Polycyclic aromatic compounds (PACs) (This category includes only those chemicals listed below). 100

00056–55–3 Benz(a)anthracene00205–99–2 Benzo(b)fluoranthene00205–82–3 Benzo(j)fluoranthene00207–08–9 Benzo(k)fluoranthene00206–44–0 Benzo(j,k)fluorene00189–55–9 Benzo(r,s,t)pentaphene00218–01–9 Benzo(a)phenanthrene00050–32–8 Benzo(a)pyrene00226–36–8 Dibenz(a,h)acridine00224–42–0 Dibenz(a,j)acridine00053–70–3 Dibenzo(a,h)anthracene00194–59–2 7H-Dibenzo(c,g)carbazole05385–75–1 Dibenzo(a,e)fluoranthene00192–65–4 Dibenzo(a,e)pyrene00189–64–0 Dibenzo(a,h)pyrene00191–30–0 Dibenzo(a,l)pyrene00057–97–6 7,12-Dimethylbenz(a)anthracene00193–39–5 Indeno[1,2,3-cd]pyrene00056–49–5 3-Methylcholanthrene03697–24–3 5-Methylchrysene05522–43–0 1-Nitropyrene

(b) The threshold determinationprovisions under § 372.25(c) through (h)and the exemptions under § 372.38(b)through (h) are applicable to the toxicchemicals listed in paragraph (a) of thissection.

§ 372.30 [Amended]


i. In paragraph (a), remove the phrase‘‘in § 372.25 at’’ and add in its place ‘‘in§ 372.25, § 372.27, or § 372.28 at’’.

ii. In paragraphs (b)(1), theintroductory text of (b)(3), (b)(3)(i), and(b)(3)(iv), remove the reference‘‘§ 372.25’’ and add in its place‘‘§ 372.25, § 372.27, or § 372.28’’.

§ 372.38 [Amended]


i. In paragraph (a), add the followingsentence at the end of the paragraph toread as follows: ‘‘This exemption doesnot apply to toxic chemicals listed in§ 372.28, except for purposes of§ 372.45(d)(1).’’.

ii. In paragraphs (b), (c) introductorytext, (d) introductory text, and (f),remove the reference ‘‘§ 372.25’’ andadd in its place ‘‘§ 372.25, § 372.27, or§ 372.28’’.

iii. In paragraphs (g) and (h), removethe phrase ‘‘§ 372.25 or § 372.27’’ andadd in its place ‘‘§ 372.25, § 372.27, or§ 372.28’’.


i. In the table in paragraph (a), revisethe entry for ‘‘Vanadium’’ andalphabetically add four chemicals.

ii. In the table in paragraph (b), revisethe CAS no. entry ‘‘7440–62–2’’ and addfour chemicals in numerical CAS no.sequence.

iii. In the table in paragraph (c),alphabetically add two categories,‘‘dioxin and dioxin-like compounds’’and ‘‘vanadium’’, and alphabeticallyadd two chemicals, ‘‘benzo(j,k)fluorene’’and ‘‘3-methylcholanthrene’’, under thepolycyclic aromatic compounds (PACs)category.

The revisions and additions read asfollows:

§ 372.65 Chemicals and chemicalcategories to which the part applies.

* * * * *(a) * * *



Chemical name CAS No. Effective date

* * * * * * *Benzo(g,h,i)perylene 00191–24–2 1/00

* * * * * * *Octachlorostyrene 29082–74–4 1/00

* * * * * * *Pentachlorobenzene 00608–93–5 1/00

* * * * * * *Tetrabromobisphenol A 00079–94–7 1/00

* * * * * * *Vanadium (except when contained in an alloy) 7440–62–2 1/00

* * * * * * *

(b) * * *

CAS No. Chemical name Effective date

* * * * * * *7440–62–2 Vanadium (except when contained in an alloy) 1/00

* * * * * * *00079–94–7 Tetrabromobisphenol A 1/0000191–24–2 Benzo(g,h,i)perylene 1/0000608–93–5 Pentachlorobenzene 1/00

* * * * * * *29082–74–4 Octachlorostyrene 1/00

* * * * * * *

(c) * * *

Category name Effective date

* * * * * * *Dioxin and dioxin-like compounds (Manufacturing; and the processing or otherwise use of dioxin and

dioxin-like compounds if the dioxin and dioxin-like compounds are present as contaminants in a chemicaland if they were created during the manufacturing of that chemical)

(This category includes only those chemicals listed below) 1/0067562–39–4 1,2,3,4,6,7,8-Heptachlorodibenzofuran55673–89–7 1,2,3,4,7,8,9-Heptachlorodibenzofuran70648–26–9 1,2,3,4,7,8-Hexachlorodibenzofuran57117–44–9 1,2,3,6,7,8-Hexachlorodibenzofuran72918–21–9 1,2,3,7,8,9-Hexachlorodibenzofuran60851–34–5 2,3,4,6,7,8-Hexachlorodibenzofuran39227–28–6 1,2,3,4,7,8-Hexachlorodibenzo-p-dioxin57653–85–7 1,2,3,6,7,8-Hexachlorodibenzo-p-dioxin19408–74–3 1,2,3,7,8,9-Hexachlorodibenzo-p-dioxin35822–46–9 1,2,3,4,6,7,8-Heptachlorodibenzo-p-dioxin39001–02–0 1,2,3,4,6,7,8,9-Octachlorodibenzofuran03268–87–9 1,2,3,4,6,7,8,9-Octachlorodibenzo-p-dioxin57117–41–6 1,2,3,7,8-Pentachlorodibenzofuran57117–31–4 2,3,4,7,8-Pentachlorodibenzofuran40321–76–4 1,2,3,7,8-Pentachlorodibenzo-p-dioxin51207–31–9 2,3,7,8-Tetrachlorodibenzofuran01746–01–6 2,3,7,8-Tetrachlorodibenzo-p-dioxin



Category name Effective date

* * * * * * *Polycyclic aromatic compounds (PACs): This category includes only those chemicals listed below).

* * * * * * *00206–44–0 Benzo(j,k)fluorene 1/00

* * * * * * *00056–49–5 3-Methylcholanthrene 1/00

* * * * * * *Vanadium compounds 1/00

9. In § 372.85, revise the introductorytext of paragraph (b)(15)(i), add a newparagraph (b)(15)(ii), and reviseparagraphs (b)(16)(i)(B) and (b)(16)(ii)(B)to read as follows:

§ 372.85 Toxic chemical release reportingform and instructions.

* * * * *(b) * * *(15) * * *(i) An estimate of total releases in

pounds (except for dioxin and dioxin-like compounds, which shall bereported in grams) per year (releases ofless than 1,000 pounds per year may beindicated in ranges, except forchemicals set forth in § 372.28) from thefacility plus an indication of the basis ofestimate for the following:

* * * * *(ii) Report a distribution of the

chemicals included in the dioxin anddioxin-like compounds category. Suchdistribution shall either represent thedistribution of the total quantity ofdioxin and dioxin-like compoundsreleased to all media from the facility;or its one best media-specificdistribution.

(16) * * *(i) * * *(B) An estimate of the amount of the

chemical transferred in pounds (exceptfor dioxin and dioxin-like compounds,which shall be reported in grams) peryear (transfers of less than 1,000 poundsper year may be indicated as a range,except for chemicals set forth in

§ 372.28) and an indication of the basisof the estimate.

* * * * *(ii) * * *(B) An estimate of the amount of the

chemical in waste transferred in pounds(except for dioxin and dioxin-likecompounds, which shall be reported ingrams) per year (transfers of less than1,000 pounds may be indicated inranges, except for chemicals set forth in§ 372.28) to each off-site location, andan indication of the basis for theestimate and an indication of the typeof treatment or disposal used.

* * * * *

[FR Doc. 99–28169 Filed 10–28–99; 8:45 am]BILLING CODE 6560–50–F
