Part III 10 CFR 835, Occupational Radiation Protection; Final. · established in DOE Order 5480.11, ‘‘Radiation Protection for Occupational Workers.’’ In addition, DOE codified

fede

ral r

egiste

r

59661

WednesdayNovember 4, 1998

Part III

Department ofEnergy10 CFR Part 835Occupational Radiation Protection; FinalRule

59662 Federal Register / Vol. 63, No. 213 / Wednesday, November 4, 1998 / Rules and Regulations

DEPARTMENT OF ENERGY

10 CFR Part 835

[Docket No.: EH–RM–96–835]

RIN 1901–AA59

Occupational Radiation Protection

AGENCY: Department of Energy.ACTION: Final rule.

SUMMARY: The Department of Energy(DOE) is amending its primarystandards for occupational radiationprotection. This final rule is theculmination of a systematic analysis toidentify the elements of acomprehensive radiation protectionprogram and determine those elementsof such a program that should becodified as DOE continues its transitionfrom a system of contractually-basednuclear safety standards to regulatory-based requirements. The final rulecodifies requirements previouslyestablished in DOE’s contractually-based standards, clarifies certain issuesidentified during implementation ofprograms to ensure compliance with theoriginal rule, and corrects minor errors.EFFECTIVE DATE: The amendments to thisregulation become effective onDecember 4, 1998.FOR FURTHER INFORMATION CONTACT: Dr.Joel Rabovsky, U.S. Department ofEnergy, Office of Worker ProtectionPrograms and Hazards Management,EH–52, 19901 Germantown Road,Germantown, MD 20874, (301) 903–2135.SUPPLEMENTARY INFORMATION:I. BackgroundII. Discussion of Significant ChangesIII. Review Under the National

Environmental Policy ActIV. Review Under the Regulatory Flexibility

ActV. Review Under Executive Order 12866VI. Review Under Executive Order 12612VII. Review Under Executive Order 12988VIII. Review Under Paperwork Reduction ActIX. Review Under the Unfunded Mandates

Reform ActX. Review Under Small Business Regulatory

Enforcement Fairness Act of 1996

I. Background

On December 14, 1993, DOEpublished a final rule, 10 CFR part 835,‘‘Occupational Radiation Protection’’(58 FR 65458), which establishedregulatory requirements consistent withthe ‘‘Radiation Protection Guidance toFederal Agencies for OccupationalExposure’’ (52 FR 2822) (Guidance toFederal Agencies), as well as guidanceissued by authoritative organizations,including the National Council onRadiation Protection and Measurements

(NCRP) and the InternationalCommission on Radiological Protection(ICRP). Many of the codifiedrequirements were previouslyestablished in DOE Order 5480.11,‘‘Radiation Protection for OccupationalWorkers.’’ In addition, DOE codified in10 CFR part 835 the ‘‘as low as isreasonably achievable’’ (ALARA)process as the primary means ofmaintaining occupational radiationdoses below regulatory limits.

As a result of an initiative to eliminateredundant and unnecessarily stringentrequirements, DOE conducted asystematic analysis to identify theelements of a comprehensive radiationprotection program and determine thoseelements of such a program that shouldbe codified as DOE continues itstransition from a system ofcontractually-based nuclear safetystandards to regulatory-basedrequirements. The systematic analysisincluded an evaluation of DOE’sobjectives for occupational radiationprotection programs, includingstructured analyses of existing standardsfor similar programs, operationaloccurrences within the DOE complex,and provisions in the original rule. Theanalysis also included reviews of therequirements in DOE Notice 441.1,‘‘Radiological Protection for DOEActivities,’’ (extended by DOE N 441.2and 441.3) and the provisions of the‘‘DOE Radiological Control Manual’’(Manual). DOE proposed to codifyrequirements in use within the DOEcomplex to ensure that worker healthand safety programs would continue tobe maintained at a level commensuratewith workplace hazards. DOE alsoconsidered approaches used by nationaland international radiation protectionorganizations and experiencethroughout the DOE complex inachieving compliance with 10 CFR part835. The systematic analysis isdocumented in a report entitled,‘‘Development of the 1996 ProposedAmendment to 10 CFR part 835,Occupational Radiation Protection,’’(regulatory development document,November 1996) which may be viewedin the DOE Freedom of InformationReading Room at Room 1E–190, 1000Independence Avenue, SW,Washington, DC, 20585, (202) 586–6020.

On December 23, 1996, DOEpublished a Notice of ProposedRulemaking that would amend 10 CFRpart 835 by:

1. Modifying the scope to explicitlyexclude radioactive materialtransportation and certain activitiesconducted on foreign soil;

2. Adding requirements for areaposting and sealed radioactive sourcecontrol;

3. Adding a removable surfacecontamination value for tritium, to beused to identify the need for areaposting and imposition of certainradioactive material controls;

4. Expanding and clarifyingprovisions of the rule to addressemergent radiation protection issues;

5. Deleting certain provisions, asappropriate, to eliminate redundant andexcessively stringent regulatoryrequirements; and

6. Clarifying and correcting minorerrors.

As discussed in this Notice of FinalRulemaking, the final rule wasdeveloped in consideration of theextensive input received during twopublic hearings and through written andelectronic public comments.

The schedule for achievingcompliance with the amendments to 10CFR part 835 is as follows. The finalrule will become effective 30 daysfollowing publication in the FederalRegister. As provided at § 835.101(g)(3),updated radiation protection programs(RPPs) must be submitted to DOE within180 days following the effective date ofthe final rule. Changes that do notdecrease the effectiveness of the RPPmay be implemented prior to DOEapproval. Changes that decrease theeffectiveness of the RPP require DOEapproval prior to implementation. Asprovided at § 835.101(i), an update ofthe RPP shall be considered approved180 days after its initial submissionunless rejected by DOE at an earlierdate. The final rule, at § 835.101(f),requires full compliance with theregulatory changes within 180 days ofRPP approval except for radiobioassayprogram accreditation required under§ 835.402(d). Because of the breadth ofthe joint DOE/DOE-contractor effortneeded to accomplish radiobioassayprogram accreditation, at § 835.101(f)DOE has established January 1, 2002 asthe compliance date for theradiobioassay program accreditationrequirements.

II. Discussion of Significant ChangesThe discussion of the significant

changes to 10 CFR part 835 and theresponse to public comments isorganized according to subpart. Whenthere was more than one significantchange in a subpart the significantchanges are generally listed in order ofsection. The topic addressed by eachsignificant change is listed. In manycases, inclusion of a change to theprovisions in one subpart or sectionrequired changes to other subparts or

59663Federal Register / Vol. 63, No. 213 / Wednesday, November 4, 1998 / Rules and Regulations

sections of the regulation either forinternal consistency or to resolve apublic comment. For example a numberof changes to the provisions of the rulerequired concomitant changes to thedefinitions or recordkeepingrequirements. Accordingly, thediscussion of a change may referenceother subparts in addition to the one inwhich the primary change was made.This organization of the discussion ofthe significant changes to 10 CFR part835 and the response to publiccomments was chosen to more clearlyexplain the changes and how DOEresponded to the public comments.

A. General Provisions, Subpart A

1. Nuclear Explosive and WeaponSurety Program

Proposed AmendmentDOE proposed to revise the Nuclear

Explosive and Weapon Surety Programexclusion at § 835.1(b)(3) to clearlyindicate that the exclusion applies onlyto the extent that compliance with 10CFR part 835 would compromise theeffectiveness of activities essential toprevention of an accidental orunauthorized detonation. This actionwas initiated to ensure that radiationprotection programs are implementedthat do not compromise the overridinggoal of preventing such incidents.

Summary of Public Comments andDisposition

DOE received comments indicatingthat this exclusion should also beextended to address the provisions ofCG-TSS-S2, ‘‘Transportation SafeguardsSystem Classification and UnclassifiedControlled Information Guide(Supplement),’’ which states that ‘‘Thefact that a specific SST (Safe SecureTrailer)/SSR (Safe Secure Railcar) isloaded or empty is CNSI (controllednuclear safeguards information).’’ Thecommenters believe that certain postingand labeling provisions of 10 CFR part835 would provide indication of theloaded or empty status of affectedvehicles, contrary to the referencedguidance. DOE believes that the existingexclusion already provides theflexibility needed for implementation ofprograms consistent with CG-TSS-S2.Indeed, the situation presented by thecommenters is exactly the type ofcondition for which the exclusion isintended.

Final RuleAfter further consideration, DOE has

determined that the proposedclarification is not needed. Ruling 1995–1 makes it clear that the existinglanguage recognizes ‘‘the paramount

importance of preventing accidental orunauthorized nuclear detonations andensuring that the requirements in (part835) do not come into conflict with anyactivities necessary to prevent suchdetonation. However, [the language is]not intended to relieve the personresponsible for a DOE nuclear facility ora DOE activity from complying with therequirements in (part 835) to the extentthey do not interfere with the conductof activities undertaken to prevent anaccidental or unauthorized detonation.’’(61 FR 4212, February 5, 1996.)

2. Radioactive Material Transportation

Proposed Amendment

DOE standards for packaging andtransporting radioactive material areaddressed in DOE Orders. DOE Orders460.1A, ‘‘Packaging and TransportationSafety,’’ and 460.2, ‘‘DepartmentalMaterials Transportation and PackagingManagement,’’ provide DOErequirements for packaging andtransportation of radioactive material.Requirements for radioactive materialtransported under DOE’s nationalsecurity mission are provided in DOEOrder 5610.12, ‘‘Packaging and Off-siteTransportation of Nuclear Componentsand Special Assemblies Associated withthe Nuclear Explosive and WeaponSafety Program,’’ and DOE Order5610.14, ‘‘Transportation SafeguardsSystem Program Operations.’’ Therequirements of these Orders areconsistent with Department ofTransportation (DOT) regulatoryrequirements and provide theframework for ensuring transportationsafety. Certain provisions of 10 CFR part835 complement these transportationsafety directives by ensuring thatindividuals are afforded an adequatelevel of radiation protection whilepreparing radioactive materials fortransportation and taking possession ofradioactive material from transportation.

Although the absence of provisionspertaining to radioactive materialtransportation was addressed in thepreamble for the original Rulemaking(58 FR 65465), DOE did not explicitlyexclude radioactive materialtransportation from the scope of 10 CFRpart 835. Consistent with its originalintent as expressed in the preamble ofthe final rule, DOE proposed anexclusion at § 835.1(b)(4) for radioactivematerial transportation conducted inaccordance with applicable DOE Orders.DOE also proposed a definition of‘‘radioactive material transportation’’ at§ 835.2(a) to clarify the distinctionbetween the process of transportingradioactive materials, which would beexcluded from 10 CFR part 835, and

those activities leading to or resultingfrom radioactive material transportation,which would be subject to 10 CFR part835. The proposed definition included aspecified threshold (specific activity)consistent with DOT requirements at 49CFR 171–179.


Public comments supported DOE’sintent to exclude radioactive materialtransportation, but indicated that theproposed approach did not clearlyestablish the interface between 10 CFRpart 835 and applicable transportationrequirements. Other commentsindicated that the term ‘‘specificactivity’’ in the proposed § 835.2(a)definition of the term ‘‘radioactivematerial transportation’’ could bemisconstrued, potentially resulting innon-compliant conditions.

Final RuleThe final rule clearly establishes the

interface between the occupationalradiation protection and transportationrequirements. This approach makes itclear that 10 CFR part 835 does notapply to the radioactive materialtransportation, which is defined to bemovement of radioactive material that issubject to DOE Orders or DOTregulations. The definition ofradioactive material transportation isindependent of the geographicallocation of the material beingtransported (i.e., inside or outside of thearea controlled by DOE) and alsoindependent of the radiologicalcharacteristics (e.g., specific activity) ofthe material in question. As a result ofthis revised approach, DOE has notincluded the term ‘‘specific activity’’ inthe § 835.2(a) definition of the term‘‘radioactive material transportation.’’

3. DOE Activities Conducted on ForeignSoil

Proposed AmendmentDOE proposed to add an exclusion at

§ 835.1(b)(5) for DOE activitiesconducted on foreign soil and underrequirements agreed to between theforeign government and the UnitedStates. DOE proposed this exclusion inrecognition of the primacy of foreigngovernments’ occupational radiationprotection requirements.


Several commenters indicated that thedevelopment and approval ofagreements with foreign governmentsmay require action by the StateDepartment and that DOE contractorscould not take independent actions to


ensure that appropriate agreements havebeen reached. However, DOE activities,including those performed on foreignsoil, are conducted under thecognizance of the responsible DOEProgram Office and these offices areresponsible for ensuring that suchagreements are in effect beforeauthorizing the conduct of the activities.The only action required of the DOEcontractor will be to ensure that theDOE Program Office has established, orverified the establishment of, theappropriate agreements. Also, theactivity is not excluded unless there areoccupational radiation protectionrequirements agreed upon.

Final Rule

The final rule includes the exclusionfor DOE activities conducted on foreignsoil at § 835.1(b)(5).

4. Applicability of Occupational DoseReceived From Excluded Activities

Proposed Amendment

At §§ 835.1(c), 835.202(a), and835.202(b), DOE proposed changes toclarify the requirements for accountingfor occupational doses received fromnon-DOE activities. The proposedamendment indicated that, even thoughcertain activities are excluded from thescope of the rule at § 835.1(b), anindividual’s occupational dose resultingfrom excluded activities would beapplied toward determination ofcompliance with the occupational doselimits established in subpart C of 10CFR part 835. This is necessary toensure that an individual’s annualaggregate occupational dose ismaintained below the limits specified inthe Federal Guidance. This wouldinclude occupational doses receivedfrom activities licensed by the NuclearRegulatory Commission (NRC) and itsagreement states, activities conductedunder the authority of the Director,Naval Nuclear Propulsion Program,activities conducted under the NuclearExplosive and Weapon Surety Program,radioactive material transportationactivities, and activities conductedunder the auspices of foreigngovernments. However, radiation dosesreceived from background radiation, asa patient for the purposes of medicaldiagnosis or therapy, and fromparticipation as a subject in medicalresearch programs are not consideredoccupational doses and would not beconsidered in determining compliancewith the occupational dose limits.Furthermore, occupational dosereceived as a result of authorizedemergency exposures and plannedspecial exposures, although

occupational in nature, would not beconsidered in determining compliancewith the dose limits established at§ 835.202(a).


Commenters generally supported thisclarification of DOE policy.

Final Rule

The final rule adopts the proposedclarification that all occupational doses,other than doses resulting fromauthorized emergency exposures andplanned special exposures, shall beconsidered in determining compliancewith the limits set forth in §§ 835.202,and 835.207. Section § 835.206, Limitsfor the embryo/fetus, was included inthis provision for consistency andcompleteness. Because § 835.1302establishes the appropriate criteria forauthorizing exposures under emergencyconditions, DOE has instituted aneditorial change to reference thissection. Procedures for handling dosesresulting from authorized emergencyexposures and planned specialexposures are discussed in Section II.Cof this Notice of Final Rulemaking,‘‘Limitation of Individual Doses.’’

5. Definitions

DOE proposed to add, revise, orremove the definitions of a number ofterms that appear at § 835.2(a) and (b) asfollows:

a. Adding definitions of the terms‘‘accountable sealed radioactivesource,’’ ‘‘derived air concentration-hour,’’ ‘‘occupational dose,’’‘‘radioactive material area,’’ ‘‘radioactivematerial transportation,’’ ‘‘radiologicalcontrol technician,’’ ‘‘real time airmonitoring,’’ ‘‘respiratory protectivedevice,’’ ‘‘sealed radioactive source,’’‘‘source leak test,’’ and ‘‘week.’’

b. Revising the definitions of theterms ‘‘airborne radioactive material orairborne radioactivity,’’ ‘‘airborneradioactivity area,’’ ‘‘contaminationarea,’’ ‘‘controlled area,’’ ‘‘DOEactivity,’’ ‘‘high contamination area,’’‘‘member of the public,’’ ‘‘monitoring,’’‘‘radiological area,’’ ‘‘year,’’ ‘‘committeddose equivalent,’’ ‘‘cumulative totaleffective dose equivalent,’’ ‘‘effectivedose equivalent,’’ ‘‘external dose orexposure,’’ ‘‘internal dose or exposure,’’‘‘quality factor,’’ ‘‘total effective doseequivalent,’’ and ‘‘weighting factor.’’

c. Removing the definitions of theterms ‘‘ambient air,’’ ‘‘continuous airmonitor,’’ ‘‘collective dose,’’ and‘‘occupational exposure.’’

The effects of these proposed changes,significant public comments on theseproposed changes, and any resulting

changes are discussed in this Notice ofFinal Rulemaking as these terms appearin the final rule.

6. Intervals Between Required Activities

Proposed Rule

DOE proposed to revise the requiredintervals for internal audits, instrumentand equipment calibration andmaintenance, and radiation safetyretraining from the specified number ofyears to the equivalent number ofmonths. This change was proposed toeliminate any confusion resulting fromthe § 835.2(a) definition of the term‘‘year,’’ which specifically defined theyear in terms necessary to ensurecompliance with the subpart C doselimits.


DOE received a number of commentsindicating that the required intervalsappeared to be somewhat arbitrary andshould therefore include some degree offlexibility to accommodate operationaland scheduling needs. DOE agrees withthese observations.

Final Rule

DOE has included a provision at§ 835.3(e) that will allow a 30 dayautomatic extension in the requiredtime interval to accommodateoperational and scheduling constraints.The extension is considered to beautomatic in that there is norequirement to obtain DOE or otherapproval for the extension. Thisprovision addresses the requirements of§§ 835.102, 835.901, and 835.1202 forinternal audits, radiation safety training,and sealed radioactive sourceinventories and leak tests, respectively.Because of the varying lengths of thecalendar months, DOE has not provideda definition of the term ‘‘month.’’ DOEexpects that those entities responsiblefor ensuring compliance with 10 CFRpart 835 will undertake those measuresnecessary to perform the requiredactivities within the prescribed timeframe (i.e., if a sealed radioactive sourceis leak tested on January 15, DOE wouldexpect the subsequent leak test to beperformed on or before July 15 of thesame year). When operational orscheduling considerations precludeadherence to that schedule, then onemay consider utilization of the 30 dayextension (i.e., the leak test could beperformed no later than August 14 ofthe same year).


7. Radiological Units

Proposed Amendment

DOE proposed to delete the § 835.4prohibition on use of the international(SI) radiological units. The internationalsystem of radiological units iscommonly used for calculational andreference purposes. As proposed,§ 835.4 would continue to require theuse of the special radiological units inrequired records. Consistent with itshistorical endorsement of the specialunits and in recognition of thecapabilities of many commercially-available instruments in use throughoutthe DOE complex, DOE also proposed tospecifically allow for use of subunitsand multiples of the unit ‘‘roentgen.’’


Although some comments indicatedthat DOE should proceed toward use ofthe SI units for required records, DOEbelieves that considerations ofconsistency with records required bythe NRC and its agreement statesoverride the impetus toward use of SIunits.

Final Rule

As proposed, § 835.4 of the final ruleallows the use of the internationalsystem of units for calculations orreference purposes. Records required by10 CFR part 835 will continue to bemaintained using the specialradiological units of curie, rad,roentgen, and rem.

B. Management and AdministrativeRequirements, Subpart B

1. Documented Radiation ProtectionPrograms

Proposed Rule

Paragraph 835.101(g) of the originalrule requires that those entities subjectto the requirements of 10 CFR part 835submit an update of the documentedradiation protection program (RPP)within 180 days of the effective date ofany regulatory modifications. DOEproposed to establish provisions at§ 835.101(f) requiring compliance withamendments to 10 CFR part 835 no laterthan 180 days following approval of theupdated RPP, except for the provisionsof § 835.402(d) for radiobioassayprogram accreditation. Because of theextent of the joint DOE/DOE contractoreffort necessary to complete theradiobioassay program accreditations,DOE proposed a compliance date ofJanuary 1, 2000 for this provision. DOEalso proposed to delete outdatedprovisions codified at § 835.101 (f) and(g).


Several commenters indicated thatDOE’s proposed compliance date ofJanuary 1, 2000 for radiobioassayprogram accreditation may beinappropriate due to the lack ofexperience in implementing theaccreditation program. Other commentsindicated that DOE delays inimplementing the program might resultin a state of non-compliance for DOE-contractors. DOE agrees that more timemay be necessary to complete therequired program accreditations.

Final Rule

DOE has codified the proposed 180day period for achieving compliancewith the amendments to 10 CFR part835, except for the radiobioassayprogram accreditation requirements of§ 835.402(d). DOE has extended the datefor compliance with the radiobioassayprogram accreditation requirementsuntil January 1, 2002 to accommodatethe planned schedule to completeprogram accreditations throughout theDOE complex. DOE expects thisextension to provide ample time forcompletion of the programaccreditations. Should significant delaysoccur in performing the programaccreditations, DOE could exerciseappropriate enforcement discretion.These changes will not affect thecompliance status of personneldosimetry programs currentlyaccredited, or excepted fromaccreditation, under the existingDepartment of Energy LaboratoryAccreditation Program (DOELAP)standards.

DOE has deleted the outdatedprovisions of § 835.101 (f) and (g) asproposed.

2. Education and Training of CognizantIndividuals

Proposed Amendment

To address a number of shortcomingsin its provisions for training radiologicalcontrol technicians identified during itssystematic analysis, DOE proposed tocodify a definition of ‘‘radiologicalcontrol technician’’ at § 835.2(a). DOEalso solicited comments on fouralternative approaches that werediscussed in the preamble of the Noticeof Proposed Rulemaking.


Public comments indicated thatDOE’s proposed definition of the term‘‘radiological control technician’’ didnot adequately describe the roles andresponsibilities of individuals filling

this position. DOE received commentsendorsing each of the proposedalternative approaches, with themajority of the comments endorsingAlternative Approach 4 as discussed inthe preamble of DOE’s Notice ofProposed Rulemaking.

Final Rule

To satisfy its programmatic objectivesfor occupational radiation protectionprograms, DOE has codified anapproach consistent with that discussedas Alternative Approach 4 in its Noticeof Proposed Rulemaking. Under thisapproach, DOE has eliminated thespecific requirements for radiologicalcontrol technician training from subpartJ of 10 CFR part 835 and added at§ 835.103 a requirement for allindividuals responsible for ensuringcompliance with the rule to have theappropriate education, training, andskills. This approach provides theflexibility necessary to address the widerange of individuals involved indeveloping and implementing measuresnecessary for ensuring compliance with10 CFR part 835, including cognizantmanagers, supervisors, auditors,engineers, clerks, and technicians.

3. Written Procedures

Proposed Rule

In its Notice of Proposed Rulemaking,DOE noted that the existing rule did notestablish requirements for writtenprocedures that consistently addressedthe hazards associated with thespecified activity. DOE believes that,due to the wide variation of radiologicalactivities and their associated hazardsconducted at DOE facilities, requiringwritten procedures for specific types ofactivities may divert resources fromactive management of higher-hazardactivities to administrative control oflower-hazard activities. DOE discussedtwo alternative approaches in its Noticeof Proposed Rulemaking. AlternativeApproach 1 would eliminate most or allof the requirements for writtenprocedures and leave the determinationof the need for written procedures to thecognizant DOE Program Office.Alternative Approach 2 would eliminatemost or all of the existing requirementsfor written procedures in favor of ageneral requirement that writtenprocedures be developed andimplemented commensurate with theradiological hazards created by theactivity and consistent with theeducation, training, and skills of theaffected individuals.



Public comments overwhelminglyfavored Alternative Approach 2.Commenters indicated that thisapproach would provide for anappropriate level of radiological safetywhile providing the flexibility needed toaddress the wide range of DOEactivities. DOE agrees with the publiccomments.

Final RuleDOE has established a requirement at

§ 835.104 consistent with that describedas Alternative Approach 2 in its Noticeof Proposed Rulemaking. As a result ofthis change, DOE has deleted specificrequirements for written proceduresfrom §§ 835.501(d), 835.1001(a),835.1001(b), 835.1003(a), 835.1101(c),and 835.1102(c)(3) (formerly835.404(d)). In addition, proposedrequirements for written procedures at§§ 835.405(f) and 835.1201(a) wereomitted from the final rule.

DOE’s adoption of this approach isnot intended to imply a globalrequirement that written procedures bedeveloped and implemented to addressall of the requirements of 10 CFR part835. In evaluating the need for writtenprocedures addressing any particularprovision of 10 CFR part 835,consideration must be given to thenature and extent of the radiologicalhazards, the complexity of the measuresnecessary to achieve compliance, andthe education, training and skills of theindividuals who must implement thosemeasures. Under such a regimen, a lowhazard activity employing a stable staffof highly educated and skilled workershaving an advanced knowledge ofradiation protection principles andpractices could have fewer and lessdetailed procedures than a higherhazard activity employing a transientforce of workers with less knowledge ofradiation protection principles andpractices. The adequacy of the writtenprocedures is ultimately determined bythe appropriate implementation of thenecessary compliance measures by theaffected individuals.

Because the scope of subpart B of 10CFR part 835 has been expanded, DOEhas changed the title of this subpart to‘‘Management and AdministrativeRequirements.’’

C. Limitation of Individual Doses,Subpart C

1. Summing of Internal and ExternalDoses

Proposed AmendmentDOE proposed to revise § 835.203(a)

to provide flexibility in requirements forsumming of individual internal and

external dose equivalents to determinethe total effective dose equivalent. Asproposed, § 835.203(a) would requiresumming only when the individual wasmonitored in accordance with § 835.402(that is, when the individual’s dose waslikely to exceed the mandatoryindividual monitoring thresholds) orwhen the individual’s dose exceededthe mandatory monitoring thresholds,regardless of a priori expectations.

DOE also proposed to delete§ 835.203(c) because this provision isredundant with provisions included inthe § 835.2(b) definition of the term‘‘weighting factor.’’


DOE received comments indicatingthat all monitored individual internaland external doses should be summedto determine the total effective doseequivalent. Commenters noted thatthese data were available and could beimportant in future dose reconstructionor litigation efforts. DOE agrees withthese comments. Although DOE isconcerned about the administrativeburden associated with the need to sumtrivial internal and external doses, DOEhas provided ample flexibility forameliorating such burdens throughcodification of the individualmonitoring thresholds provided at§ 835.402.

Final RuleDOE has omitted the proposed change

from § 835.203(a), but deleted thesecond sentence of § 835.203(a) becausethis sentence is redundant withprovisions included in the definition ofthe term ‘‘effective dose equivalent’’ at§ 835.2(b). DOE has deleted § 835.203(c),as proposed.

2. Planned Special Exposures

Proposed AmendmentDOE proposed changes to the 10 CFR

part 835 requirements for conductingplanned special exposures in excess ofthe dose limits established at § 835.202.The proposed changes included:

a. Changing the § 835.204(a)(1)reference from § 835.202(a)(1) to§ 835.202(a) to indicate that all of the§ 835.202 dose limits apply.

b. Revising § 835.204(c) to indicatethat doses resulting from plannedspecial exposures may exceed thenumerical values established at§ 835.202(a) without actually exceedingthe occupational dose limits.

c. Clarifying documentationrequirements for planned specialexposures at § 835.204(d).

DOE also solicited comments on thepossibility of deleting the provisions forplanned special exposures because

these provisions have not been used todate.


Commenters generally supported theproposed changes to the provisions forplanned special exposures. Manycommenters indicated that theprovisions for planned specialexposures should be retained to providethe maximum practical degree offlexibility.

Final Rule

Consistent with the commentsreceived, DOE has retained theprovisions for planned specialexposures, with the proposed revisions,in the final rule.

3. Radiation Dose Limits

Proposed Amendment

DOE proposed editorial changes to§ 835.207 and the heading of thatsection to clarify that the dose limits forminors apply to doses resulting fromoccupational exposure only. DOE alsoproposed to add deterministic doselimits for minors consistent with theFederal Guidance. Non-occupationalexposure of minors is subject to the doselimits established at § 835.208 formembers of the public entering acontrolled area. DOE also proposedchanges to § 835.208 to clarify that themember of the public dose limit appliesto members of the public in thecontrolled area only. DOE proposed torevise the definition of ‘‘member of thepublic’’ at § 835.2(a) to clearlydistinguish members of the public fromtemporary or transient workers orvisiting scientists who could receiveoccupational doses.

DOE proposed to revise the definitionof ‘‘cumulative total effective doseequivalent’’ (CTEDE) at § 835.2(b) toinclude all total effective doseequivalent (TEDE) values, whereavailable, from January 1, 1989, whetheror not the dose was received at that DOEsite or facility.


Several commenters questionedDOE’s proposed approach to controllingdoses to minors, pointing out that aminor could possibly receive 0.1 rem ina year occupational dose and 0.1 rem ina year as a member of the public.Although this scenario is possible, theresulting maximum dose is well belowthe most recent recommendations ofscientific bodies for exposures that donot occur repeatedly.


DOE did not receive any substantivecomments on the proposed change tothe definition of the term ‘‘cumulativetotal effective dose equivalent.’’

Final RuleDOE has adopted the changes,

essentially as proposed. DOE has alsomade editorial changes to §§ 835.207and 835.208 for clarity. These changesinclude omitting, in § 835.207, theproposed occupational dose limit forminors of 10% of the § 835.202(a)(2)limit. This limit is redundant becausethe 0.1 rem total effective doseequivalent limit for minors is alwaysmore restrictive.

4. Exposures to Airborne Radionuclides

Proposed AmendmentDOE proposed to delete § 835.209(b)

because of redundancy with other rulerequirements for inhalation exposuresand external exposures from airborneradionuclides.


DOE did not receive any substantivecomments on the proposed deletion.

Final RuleDOE has deleted § 835.209(b) and

redesignated § 835.209(c) as§ 835.209(b). In addition, DOE hasinitiated an editorial change by deletingthe word ‘‘representative’’ from§ 835.209(c)(3) (redesignated as§ 835.209(b)(3)). This word wasredundant with the remainingrequirement that the internal doseestimate based upon air concentrationvalues must be as or more accurate thanthat based upon bioassay results.

D. Monitoring of Individuals and Areas,Subpart E

1. General Requirements for Area andIndividual Monitoring

Proposed AmendmentIn reviewing the requirements of 10

CFR part 835, DOE noted that the terms‘‘monitoring’’ and ‘‘survey’’ were notused consistent with the definitionsprovided at § 835.2(a). DOE proposedchanges to the definition of the term‘‘monitoring’’ at § 835.2(a) to clearlyestablish that ‘‘monitoring’’ involvesmeasurement of radiological conditionsand the subsequent use of the results ofthese measurements to evaluatepotential and actual exposures toionizing radiation. As proposed, theterm ‘‘survey,’’ would be more directlyrelated to the assessment of workplaceor material radiological conditionsthrough direct measurement,assessment, or calculation for the

purposes of hazards assessment. DOEproposed changes throughout the rule toensure consistent application of theseterms.

DOE proposed to clarify therequirements of §§ 835.401(c) and835.703(d) by making the calibrationrequirements apply to both‘‘instruments’’ and ‘‘equipment.’’ Thisclarification is consistent with currentfield practice with regard to equipment,such as an air sampler, that, althoughincorporated into or associated withinstrumentation systems, does not haveany instrumentation.


DOE received a number of commentssupporting its attempt to clarify the‘‘monitoring’’ and ‘‘surveying’’terminology. However, commentsindicated that the usage of these termsremained inconsistent.

With regard to the proposed§ 835.401(c) requirements for calibrationand maintenance of instruments andequipment, DOE received a number ofcomments indicating that the requiredone year calibration frequency wasoverly stringent given the reliability ofmany modern instruments, particularlycertain fixed monitors. Othercommenters indicated that the term‘‘equipment’’ could conceivably beextended to include vehicles,calculators, and other equipmentroutinely used in the course of areamonitoring.

Commenters indicated that the use ofthe undefined term ‘‘workplace’’ in thissubpart could result in confusionregarding the scope of the requirements.Commenters also indicated that the useof the term ‘‘area monitoring’’ at§ 835.401(b) seemed to imply thatstationary area monitors were requiredunder certain conditions.

Final RuleDOE has determined that, for

regulatory purposes as established in 10CFR part 835, there is no substantivedifference between the uses of the terms‘‘monitoring’’ and ‘‘survey.’’ Therefore,in the final rule DOE has revised thedefinition of the term ‘‘monitoring’’ anddeleted the term ‘‘survey,’’ replacingthis term with ‘‘monitoring’’ (asmodified) throughout the rule. DOE hasalso deleted the undefined terms‘‘sampling’’ and ‘‘measurements’’ infavor of the defined term ‘‘monitoring.’’

DOE has deleted the term‘‘workplace’’ from subpart E of 10 CFRpart 835, instead adopting aperformance-oriented approach of‘‘monitoring of individuals and areas.’’In a related editorial change, DOE has

deleted the term ‘‘area monitoring’’ fromproposed § 835.401(b) and redesignatedthe remaining text as § 835.401(a)(6) toeliminate any connotation regardingrequirements for stationary radiationmonitors. DOE has also substituted thedefined term ‘‘individual’’ for theundefined term ‘‘personnel’’ in thisprovision.

In response to comments on DOE’srequirements for calibration andmaintenance of instruments andequipment, DOE has revised theserequirements (at redesignated§ 835.401(b)(1)) such that calibrationand maintenance will be required‘‘periodically’’ on an ‘‘establishedfrequency.’’ This change is consistentwith NRC requirements at 10 CFR20.1501 and provides flexibility foracceptance of recommendationsprovided in various consensusstandards accepted by the instrumentcalibration community and used withinthe DOE complex. DOE will provideguidance regarding measures forestablishing appropriate maintenanceand calibration frequencies and properapplication of these requirements to‘‘equipment’’ used for monitoring.

As used in 10 CFR part 835,instruments and equipment used formonitoring includes devices used forboth area monitoring (e.g., portable andinstalled radiation, contamination, andairborne radioactivity sampling andmonitoring devices) and individualmonitoring devices (e.g.,thermoluminescent dosimeters, pocketion chambers, track etch dosimeters,and electronic dosimeters). Note that thecalibration of personnel dosimeters thatare required under § 835.402 isaddressed by the DOELAP for personneldosimetry.

2. Individual Monitoring and DoseDetermination

Proposed Amendment

DOE proposed several changes to theexisting requirements for monitoringindividual radiation doses. Theproposed changes included:

a. Clarifying the requirements forexternal and internal dose monitoringprograms at § 835.402(b) and (d) byproviding that such programs must becapable of demonstrating compliancewith all of the individual doseequivalent limits in subpart C. Thisapproach is consistent with DOE’spreviously established requirements forrecords required under § 835.701(a).

b. Revising the monitoringrequirements for minors at§ 835.402(a)(3) and (c)(3) to expresslystate that these requirements apply tooccupationally exposed minors only.


Minors who are not occupationallyexposed are subject to the member ofthe public monitoring requirementsfound at § 835.402(a)(4) and (c)(4).

c. Deleting from § 835.402(c)(1) themonitoring threshold based on organand tissue committed dose equivalent.The monitoring threshold based uponcommitted effective dose equivalentobviates the need for this thresholdbecause, through application of theweighting factors defined at § 835.2(b),the committed effective dose equivalentalways provides a more restrictive basisfor individual monitoring.

d. Changing § 835.402(a)(1)(i) torequire individual monitoring on thebasis of deep dose equivalent ratherthan effective dose equivalent becausedeep dose equivalent is the parameteractually monitored by existingdosimetry programs.

e. Removing provisions at§ 835.402(a)(1)(iv) for measuring deepdose equivalent from external sources toany organ or tissue other than the lensof the eye because any doses meetingthis condition are adequately addressedby § 835.402(a)(1)(i).

f. Clarifying § 835.402(a)(4) and (c)(4)to indicate that these provisions applyto members of the public inside thecontrolled area only.


Commenters indicated that theproposed § 835.402(a)(1)(i) requirementfor monitoring of deep dose equivalent,as worded, would challenge thecapabilities of modern dosimetrysystems. While the technical basis forthe comments was not clear, reflectionon these comments revealed that thewording in the proposed rule couldsuggest the basis for initiatingmonitoring was the highest dosereceived by any portion of the wholebody. Furthermore, although deep doseequivalent is the quantity mostcommonly measured, effective doseequivalent is the appropriate criterionupon which the mandatory individualmonitoring threshold should be basedbecause the corresponding occupationaldose limits are stated in terms ofeffective dose equivalent.

Final Rule

DOE agrees with the public commentsregarding the proposed change to§ 835.402(a)(1)(i). The language in theoriginal version of 10 CFR part 835 hasbeen retained. DOE has included theother proposed changes in the final rule.

3. Program Accreditation

Proposed Amendment

DOE proposed a number ofenhancements and additions to theexisting requirements for the DOELAP.These proposed changes included:

a. Amending § 835.402(b) to indicatethat, except as discussed below,personnel dosimetry programs must beeither accredited under the DOELAP orexcepted from accreditation under thatprogram.

b. Amending § 835.402(d) to requireradiobioassay program accreditation orexception through the recentlydeveloped DOELAP for Radiobioassay.This proposed change was intended toensure the integrity of radiobioassayprograms and prevent recurrence ofrecent adverse events.

c. Revising § 835.402(b) and (d) tolimit the scope of the DOELAPrequirements to personnel dosimetryand radiobioassay programsimplemented to ensure compliance with§ 835.402 (i.e., monitoring whenindividual doses are likely to exceed thestated thresholds). In a related change,because § 835.401(b) addressescalibration of instruments andequipment used for monitoring andDOELAP for Personnel Dosimetryprovides appropriate dosimetry systemperformance criteria, DOE proposed todelete the dosimeter calibrationrequirement from § 835.402(b).

d. Adding § 835.402(e) to require thatexternal dosimetry and bioassayprograms conform to the most recentrevisions of the DOELAP technicalstandards or be subject to review andapproval of the Secretarial Officerresponsible for environment, safety, andhealth matters (currently the AssistantSecretary for Environment, Safety andHealth). For those programs that are notaccredited or excepted from theaccreditation program, this provisionwould also allow this same officer toprovide approval if the programsdemonstrate performance equivalent tothose accredited under the DOELAP.This provision would ensure that, to theextent practical, DOE radiationprotection programs will reflect thelatest advances in the sciences ofexternal and internal dosimetry. Toprevent the automatic loss ofaccreditation status as a result ofchanges to the DOELAP technicalstandards, the DOELAP technicalstandards provide that changes in thestandards become effective only duringthe ensuing accreditation cycle.


Several commenters suggested that allindividual dose measurements beperformed under an accrediteddosimetry program in order to maintaincredibility of all monitoring data.However, DOE does not believe that isappropriate to impose regulatoryaccreditation requirements onmonitoring programs that are notrequired by regulation. Existingregulatory provisions at § 835.402(a) and(c) require individual monitoring for allindividuals likely to receive a doseequivalent exceeding the specifiedthresholds. As part of a comprehensiveradiation protection program, measuresused to identify these individualsshould include comprehensive,documented area monitoring and couldinclude, if management so chooses,individual monitoring. Section 835.401establishes minimum requirements forperforming such monitoring, includingrequirements for calibration andmaintenance of instruments andequipment used to perform themonitoring. As required by§§ 835.701(a) and 835.703, themonitoring results must be documented.

Several commenters recommendedthat DOE revise the rule to permit DOEfacilities to procure the services ofdosimetry processors who areaccredited by the National VoluntaryLaboratory Accreditation Program(NVLAP) administered through theNational Institute of Standards andTechnology, as an alternative toaccreditation under the DOELAP forpersonnel dosimetry. These commentsnoted the NRC’s regulations requirelicensees to use dosimetry processorswith NVLAP accreditation. They arguedthat permitting NVLAP accreditation inlieu of DOELAP accreditation, wouldmaximize private sector competition forDOE contracts. DOE has not acceptedthe commenters’ recommendationsbecause NVLAP accreditation does notmeet DOE’s requirement for an externaldose monitoring program. DOELAPaccreditation covers both the facility’sand the processor’s quality assuranceprogram, whereas NVLAP only dealswith the dosimetry processor. Thecommenter’s reference to the NRC’s useof NVLAP accreditation for dosimetryprocessors ignores the fact that NRC hasthe resources to perform frequent on-siteinspections of a facility’s dosimetryprogram. In the absence of suchresources at DOE facilities, DOE reliesupon the DOELAP accreditation toensure that a facility’s personneldosimetry program provides accurateresults.


DOE received comments on itsproposal to require DOELAPaccreditation, exception fromaccreditation under DOELAP, orDOELAP equivalency, for radiobioassayprograms that would satisfy the internaldose monitoring program requirementin the rule. The commenters argued thatit would be premature to impose thisrequirement because DOE has notcompleted the process for developingaccreditation standards forradiobioassay programs. As discussed inconnection with § 835.101, concerningthe effective date of the rule, DOE hasresponded to these concerns byextending the deadline for complyingwith this provision to January 1, 2002.In any event, § 835.402(d) provides forSecretarial Officer approval ofradiobioassay programs that are notaccredited under DOELAP.

Several commenters objected toproposed § 835.402(e), which wouldhave required Secretarial Officerapproval of personnel dosimetry andradiobioassay programs that do notcomply with the latest edition of DOE’stechnical standards governing programaccreditation. They argued thatincorporation by reference of thetechnical standards was inappropriatebecause the requirements in thetechnical standards had not beenproposed for public comment in arulemaking. In light of these comments,DOE has deleted the reference to DOE’stechnical standards for accreditation inthe regulatory text of the final rule. DOEdoes not intend to codify theaccreditation standards through thisrulemaking. DOE technical standardsare guidance documents to assistcontractors in implementing regulatoryrequirements. As a matter of policy(DOE P 450.2A, May 15, 1996), DOEroutinely seeks public comments onguidance documents issued toimplement environment, safety andhealth requirements at DOE sites. OnApril 24, 1997, DOE published a noticeof availability of draft guides andtechnical standards for the OccupationalRadiation Protection Program (62 FR19940). At that time, DOE invited publiccomment on draft technical standard,‘‘Department of Energy LaboratoryAccreditation Program Administration,’’which includes requirements forpersonnel dosimetry and radiobioassayprogram accreditation. The revisedregulatory provisions will accomplishDOE’s purpose of providing thatprograms which DOE accredits, orexcepts from accreditation, underDOELAP will satisfy the requirementsin this rule for programs that areimplemented to demonstrate

compliance with § 835.402(a) and (c).Accreditation under DOELAP willobviate the need for contractors tosecure approval of the AssistantSecretary for Environment, Safety andHealth.

Final Rule

In the final rule DOE has revised§ 835.402(b) and (d) to provide thatcontractors may demonstrate theadequacy of external and internal dosemonitoring programs, respectively, bysubmitting their programs to theSecretarial Officer responsible forenvironment, safety and health forapproval in lieu of accreditation orexception from accreditation under theDOELAP. Alternative programs will beapproved if their performance isdemonstrated to be substantiallyequivalent to that of accreditedprograms. This change makesunnecessary, and DOE has deleted,proposed § 835.402(e), which wouldhave required Secretarial Officerapproval of programs not complyingwith the latest edition of the technicalstandards for DOELAP accreditation.

DOE has adopted the other changes asproposed, with minor editorialcorrections.

4. Air Monitoring

Proposed Amendment

DOE proposed to revise the§ 835.403(a)(1) air sampling requirementto be based on potential individualexposures in derived air concentration(DAC)-hours in a year rather than apercentage of the annual limit on intake(ALI) because the values provided inappendices A and C of 10 CFR part 835are listed as DACs. DOE proposed toadd § 835.403(a)(2) to require that airsampling be performed whenrespiratory protective devices areprescribed to protect individuals fromexposure to airborne radionuclides.DOE also proposed an editorial changeto delete § 835.403(b), eliminatingredundancy with § 835.401(b).

To enhance air monitoring programs,DOE proposed to provide more practicaland technically accurate criteria at§ 835.403 for the use of real-time airmonitors based on potential releasesthat would exceed a defined thresholdexposure levels of 40 DAC-hours in aweek. In a related change, DOEproposed to replace the term‘‘continuous air monitor’’ with the term‘‘real-time air monitor’’ with supportingchanges to the definitions provided at§ 835.2(a). DOE also proposed to add adefinition of the term ‘‘week’’ at§ 835.2(a).


DOE received a number of commentsindicating that the proposed revision ofthe requirements for real-time airmonitoring was unclear and did notacknowledge the actual capabilities ofavailable monitors. Other commentersindicated that the proposed definition ofthe term ‘‘week,’’ based upon a periodbeginning on Monday, might causeunnecessary changes in existingschedules for real-time air monitor filterchanges. Several commenters indicatedthat the proposed provisions for airsampling when respiratory protectivedevices are prescribed could beconstrued to mean that an air samplemust be taken each time an individualenters an area wearing a respiratoryprotective device.

DOE received comments indicatingthat the existing criterion based uponthe percentage of an ALI was moreappropriate for prospectiveestablishment of air monitoringprograms. DAC-hours are related to thefraction of an ALI in a consistent andfixed manner; therefore, potentialexposures in units of DAC-hours are anappropriate basis for prospectivelydetermining the need for air sampling.

Final Rule

As suggested through publiccomments, DOE clarified the mandatoryairborne radioactivity monitoringcriteria in the final rule. Section835.403(a) of the final rule requires theimplementation of air samplingprograms in areas in which anindividual is expected to be exposed inexcess of 40 DAC-hours in a year. Thefinal rule clarifies that airborneradioactivity monitoring during use ofrespiratory protective equipment isrequired ‘‘as necessary’’ to characterizethe hazard. This provision is consistentwith requirements imposed by both theNRC and the Occupational Safety andHealth Administration (OSHA) (see 10CFR 20.1703(a)(3), ‘‘Use of individualrespiratory protection equipment,’’ and29 CFR part 1910, ‘‘Occupational Safetyand Health Standards,’’§ 1910.134(d)(1)(iii), respectively).

The § 835.403(b) criterion for real-time air monitoring is based upon theneed to alert potentially exposedindividuals of the need for action toreduce or terminate exposures toairborne radioactive material. Thisapproach provides more flexibility forimplementation on a site-and facility-specific basis, taking into accountrealistic event scenarios, source terms,and instrument capabilities. Thisrequirement acknowledges the wide


variety of configurations and hazardsassociated with DOE activities and thelimitations of currently available real-time air monitoring equipment. DOE’simplementing guidance provides anacceptable approach for achievingcompliance with this provision. Therestructuring of the requirements forreal-time air monitoring renderedproposed § 835.403(c) redundant; DOEhas therefore deleted this provision.

In support of the revised provisions,§ 835.2(a) provides definitions for theterms ‘‘derived air concentration-hour(DAC-hour),’’ ‘‘real-time airmonitoring,’’ ‘‘respiratory protectivedevice,’’ and ‘‘week’’ which are used at§ 835.403. In consideration of publiccomments, DOE has revised theproposed definition of the term ‘‘week’’to omit a mandatory starting day. Inaddition, DOE has deleted thedefinitions of ‘‘ambient air’’ and‘‘continuous air monitor’’ because theseterms are no longer used in 10 CFR part835.

5. Contamination MonitoringIn consideration of public comments

received, DOE has revised the § 835.404requirements for contaminationmonitoring and control and movedthese requirements to § 835.1102. Theproposed changes, public comments,and final rule provisions are discussedin full in Section II.J of this Notice ofFinal Rulemaking.

6. Receipt of Packages of RadioactiveMaterial

Proposed AmendmentDOE proposed to add requirements at

§ 835.405 for surveys of packages ofradioactive material received fromradioactive material transportation toensure adequate protection is providedto individuals, including warehouse andoffice workers, who may be exposed tothese materials. The proposedprovisions included requirements fortaking possession of radioactive materialpackages from transport and performingsurveys of these packages. At835.405(d), DOE proposed to establishrequirements for completion of thenecessary surveys within three hours ofreceipt of the package (if receivedduring working hours) or within threehours of the beginning of the followingworking day (if received after workinghours). The proposed requirements aresimilar to NRC requirements at 10 CFR20.1906.


Several commenters suggested thatthe time provision included in theproposed amendment was unnecessarily

stringent. During evaluation andresolution of these comments, DOEdetermined that the nature of many ofits sites and facilities and the stringencyof the requirements for radioactivematerial transportation indicate that thisobservation is accurate.

Final Rule

In deference to the commentsreceived and in recognition of thevariety of sites and facilities subject to10 CFR part 835, DOE has extended thetime required for monitoring packagesreceived from radioactive materialtransportation to 8 hours after thebeginning of the working day followingthe receipt of the package. In practice,the actual interval may also beconstrained by the requirements forindividual monitoring and radiationsafety training at §§ 835.402 and835.901 respectively, and by theALARA requirements at § 835.101.

As used in § 835.405, a ‘‘working day’’is considered to be the interval of timewithin each 24 hour period duringwhich the building or area in which thereceived package is stored is routinelyoccupied or available for operationsother than emergency activities. Forexample, if the received package isstored in a warehouse awaiting therequired monitoring and that warehouseis occupied or accessible to shippingand receiving personnel, then theworking day is that period of timewithin each 24 hour period duringwhich the shipping and receivingpersonnel are scheduled to be workingor to have ready access to thewarehouse. The working day does notinclude periods during which shippingand receiving personnel would have toreturn to work on a non-scheduled basisto address emergent issues requiringtheir attendance.

E. Entry Control Program, Subpart F

Proposed Amendment

DOE proposed more detailedprovisions for written workauthorizations at § 835.501(e) to addressoperational occurrences throughout theDOE complex. DOE also proposed torevise § 835.502 to add measures forcontrol of access to high radiation areas.The proposed control measures wereconsistent with those previouslyestablished in the Manual and includedrequirements for use of a supplementaldosimetry device and appropriate areasurveys.


Commenters expressed concern thatthe proposed § 835.501(e) entry control

requirements were inappropriate forrelatively minor hazards present inareas such as radiation areas. Withregard to the proposed high radiationarea access control requirements,commenters also indicated that devicescapable of rendering an immediateindication of an individual’s integrateddose resulting from neutron radiationare not commercially available. Severalcommenters also indicated that theproposed § 835.502(c) requirements forcontrol of access to very high radiationareas could be taken to mean that therequired controls must be impenetrable.DOE agrees that these issues requireclarification.

Final RuleRegarding low-hazard radiological

areas, the final rule provides significantflexibility for implementation of accesscontrols on a facility-and hazard-specific basis. The writtenauthorizations required by 835.501(d)must specify radiation protectionmeasures consistent with existing andpotential hazards. DOE does not intendfor this provision to establish a globalrequirement for the development andimplementation of radiological workpermits to address all entries intoradiological areas. The writtenauthorization may take the form ofgenerally applicable procedures, asappropriate. Guidance on the use ofwritten authorizations will be publishedin DOE’s Radiological Control Standard.As a result of the deletion of specificrequirements for written procedures(discussed in Section II.B.3 of thisNotice of Final Rulemaking), DOE hasredesignated proposed § 835.501(e) as§ 835.501(d) in the final rule.

To address the unavailability ofdevices capable of providing animmediate indication of an individual’sdose resulting from exposure to neutronradiation in a high radiation area,§ 835.502(a)(2) allows for supplementaldosimeters or other means ofimmediately estimating or measuringthe individuals’ integrated doses duringthe area entry. The other means mayinclude knowledge of the area exposurerates combined with tracking ofindividual access times. Consistent withthe existing definition of the terms‘‘high radiation area’’ and ‘‘very highradiation area,’’ DOE has revised theproposed requirements to indicate thatthe required devices and measures mustbe capable of estimating the affectedindividual’s deep dose equivalent,rather than the dose equivalent. DOEalso provided an editorial correction at§ 835.502(b)(2), substituting the definedterm ‘‘individuals’’ for the undefinedterm ‘‘personnel.’’


In response to public comments, DOEhas clarified § 835.502(c) to indicate thatthe additional controls required for veryhigh radiation areas need to besufficient to prevent ‘‘unauthorized orinadvertent’’ entries rather than toprohibit entry into the area.

F. Posting and Labeling, Subpart G

1. Controlled Area and RadiologicalArea Posting Requirements

Proposed AmendmentDOE proposed several changes to

clarify and simplify requirements forarea hazard posting and to provideadditional flexibility in implementingthese requirements. In acknowledgmentof the differing hazards and controlsassociated with removable and fixedradioactive contamination, DOEproposed to revise the § 835.2(a)definitions of ‘‘contamination area’’ and‘‘high contamination area’’ to be basedupon removable surface contaminationlevels only and to clearly establish theseareas based on accessibility rather thanthe general reference to ‘‘working areas’’which appeared at § 835.601(a). DOEproposed a similar change to the§ 835.2(a) definition of the term‘‘airborne radioactivity area.’’ DOE alsoproposed to move the controlled areamaximum dose expectation from the§ 835.2(a) ‘‘controlled area’’ definition tothe § 835.602(a) controlled area postingprovision.

Because radiological area terms aredefined at § 835.2(a), DOE proposed toremove redundant definitions imbeddedin the posting provisions at § 835.603.DOE also proposed to delete therequirement for DOE approval ofwarning signs from § 835.601(b) becauseacceptable signs are described in DOE’simplementing guidance and DOE didnot intend to establish a formal processfor approval of radiological postings andlabels. In addition, DOE proposed toexpand its provision at § 835.601(e)(redesignated as § 835.601(d) in theproposed amendment) allowingmodification of postings and labels toaccommodate special considerations ofDOE activities involving privateresidences to also include privatebusinesses.

Consistent with NRC requirementspublished at 10 CFR 20.1902, DOEproposed to amend § 835.603(b), (d),and (f) to allow use of the words‘‘Caution’’ or ‘‘Danger’’ on postings forhigh radiation, high contamination, andairborne radioactivity areas,respectively. This proposed changewould accommodate the wide range ofradiological conditions that may bepresent in these areas to provide somedegree of flexibility in their posting.

Proposed § 835.604(a) would create anexception from posting requirements forperiods of less than 8 continuous hoursas long as the radiological area is placedunder continuous observation andcontrol of a person able to implementthe required access and exposurecontrol measures. This exception wouldcover temporary conditions or activitiessuch as maintenance, repair or cleanupactivities so long as the absence ofposting is kept to within the prescribedtime and the prescribed controlmeasures are implemented.

DOE also proposed to add§ 835.604(b) and (c) delineating specificexceptions from the radiological areaposting requirements of § 835.603,recognizing that compensatory measuresmay be implemented that would obviatethe need for area posting. The proposedexceptions are similar to thoseestablished by the NRC at 10 CFR20.1903.


DOE received several commentsindicating that the proposed definitionof the term ‘‘airborne radioactivity area’’should include an exposure-basedcriterion (i.e., based upon potentialindividual exposures in term of dose,percentage of an ALI, or DAC-hours)instead of, or in addition to, the existingcriterion based upon the absoluteairborne radioactivity concentration.DOE agrees that this issue requiresclarification.

Some commenters expressed supportfor the current 10 CFR part 835 postingprovisions based upon the identificationof ‘‘working areas.’’ However, the term‘‘working areas’’ is not defined and DOEdoes not believe that posting of only‘‘working areas’’ provides adequateprotection of individuals approaching orentering radiological areas in whichthere is no work in progress. Thecommenters did not provide anyevidence that such a practice wouldprovide for adequate protection.

DOE received a number of commentson the proposed allowance for the useof ‘‘Caution’’ or ‘‘Danger’’ on certainradiological hazard warning signs.Commenters indicated that the terms‘‘Caution’’ and ‘‘Danger’’ are notinterchangeable and that the term‘‘Danger’’ generally carries aconnotation of greater hazard than‘‘Caution.’’ While DOE agrees with theseobservations, DOE believes that, in thecontinuum of possible radiologicalconditions associated with DOEactivities, the threshold at which‘‘Danger’’ becomes more appropriatethan ‘‘Caution’’ most likely liessomewhere within those conditions

described in the § 835.2(a) definitions of‘‘airborne radioactivity area,’’ ‘‘highradiation area,’’ and ‘‘highcontamination area.’’ Furthermore,individual protective actions requiredfor entry into these areas are dependentupon the radiological area title, not the‘‘Caution’’ or ‘‘Danger’’ heading. DOEbelieves that the demarcation betweenthose conditions requiring ‘‘Caution’’and ‘‘Danger’’ headings is best left to thediscretion of those responsible forindividual DOE activities to ensure thatactivity-specific conditions areaddressed. Therefore, DOE believes thatit is appropriate to allow flexibility inthe use of the ‘‘Caution’’ and ‘‘Danger’’headings for posting of high radiation,high contamination, and airborneradioactivity areas.

Some commenters indicated thatprovisions for alternative measures forDOE activities conducted at privateresidences and businesses should beextended to DOE activities conductedon state- and Federally-owned lands.However, DOE does not believe thatconsiderations of individual propertyrights and property value impactsextend to DOE activities conducted onstate and Federal lands. Furthermore,the great majority of DOE activities areconducted at state-and Federally-ownedsites. Such an exception would negatethe specific posting requirements foressentially all DOE activities.

Commenters generally supportedDOE’s proposed exceptions to theradiological posting requirements.However, comments indicated that theproposed § 835.604(c) exception forpackages received from radioactivematerial transportation should not applyto damaged packages. DOE agrees thatthis issue requires specific attention.

Final RuleDOE has revised the § 835.2(a)

definition of the term ‘‘airborneradioactivity area’’ such that postingand control of these areas will berequired when the airborne radioactivityconcentration exceeds the DAC valuesprovided in appendix A or C of 10 CFRpart 835 or when an individual presentin the area without a respiratoryprotective device could be exposed toairborne radioactive material in excessof 12 DAC-hours in a week. Thisdefinition is similar to that provided bythe NRC at 10 CFR 20.1003.

DOE has codified the changes to theradiological hazard postingrequirements as proposed. In the finalrule, DOE has deleted § 835.601(a) toeliminate redundancy. As a result,§ 835.601(b)—(d) have beenredesignated as § 835.601(a)—(c),respectively. The § 835.604 radiological


area posting exceptions do not apply tothe radiological area entry controlrequirements established at §§ 835.501and 835.502 or to the radiation safetytraining requirements at § 835.901. Inresponse to public comments, DOE hasrestricted the scope of the postingexception for packages received fromradioactive material transportation tothose packages received in a non-degraded condition.

2. Radioactive Material Area Posting

Proposed Amendment

To ensure that individuals enteringcontrolled areas but not enteringradiological areas are adequatelyprotected, DOE proposed requirementsfor posting of radioactive material areassimilar to the existing requirements ofDOE N 441.1 (extended by DOE N 441.2and DOE N 441.3). The proposedposting requirements were based onquantities of radioactive materials thatexceeded 10 times the threshold valuesproposed in appendix E of 10 CFR part835 and were similar to NRCrequirements at 10 CFR 20.1902. DOEproposed to define ‘‘radioactive materialarea’’ and include this term in thedefinition of ‘‘radiological area’’ at§ 835.2(a) and establish requirements forposting radioactive material areas at§ 835.603(g). DOE also proposedexceptions to the radioactive materialarea posting requirements at§ 835.604(b).


DOE received numerous comments onthese proposed requirements. The majorissues included: (1) The thresholdvalues (based on ten times the activitylevels provided in proposed appendix Eof 10 CFR part 835) which wouldrequire posting of radioactive materialareas were overly restrictive; (2) thehazards present in a radioactive materialarea, as defined, did not warrant theimposition of specific entry controls andradiation safety training programsrequired for radiological areas; (3)posting of radioactive material areasshould not be required when theradioactive material consists solely ofactivated structures or installedcomponents; and (4) there is noapparent difference between the hazardsin a controlled area and a radioactivematerial area, as defined at § 835.2(a).

DOE agrees that: (1) The proposedappendix E values, as a basis fordefining a radioactive materials area,were somewhat restrictive; (2) posting ofradioactive material areas should not berequired when the material solelyconsists of structures or installed

components which have been activated;and (3) the hazards present in aradioactive material area, as defined, arenot always significantly different thanthe hazards in a controlled area andwould not always warrant imposition ofthe entry controls required for thedefined radiological areas.

Final RuleDOE recognizes the fact that the

radiological conditions expected inradioactive material areas, as proposed,are less hazardous than those present inradiological areas as defined in theoriginal rule. Accordingly, a lessrestrictive approach to radiologicalprotection is warranted. In the finalrule, DOE has omitted the term‘‘radioactive material area’’ from the§ 835.2(a) definition of ‘‘radiologicalarea.’’ Therefore, radioactive materialareas will not be subject to the specificentry control provisions of § 835.501. Asa result of the codification of hazard-based radiation safety trainingrequirements at § 835.901 (discussed inSection II.H. of this Notice of FinalRulemaking), applicability of theradiation safety training requirementsfor entry into radioactive material areaswill be subject to an evaluation of theactivities to be performed in the areaand the degree of actual or potentialexposure to radiological hazards.

Section 835.603(g) of the final rulerequires posting of radioactive materialareas at the entry points to accessibleareas where there exist items orcontainers of radioactive material inexcess of the revised appendix E valuesas published, rather than ten times theappendix E values, as proposed. Thebasis for the revised appendix E valuesis discussed in detail in Section II.K ofthis Notice of Final Rulemaking.Because of the minimal hazards presentin radioactive material areas, DOE hasomitted the allowance for the use of the‘‘Danger’’ heading from the § 835.603(g)requirement for posting of radioactivematerial areas.

DOE has included proposedexceptions to the radioactive materialarea posting requirement at § 835.604. Inresponse to the comments received,DOE has included another postingexception for areas in which theradioactive material consists solely ofstructures or installed componentswhich have been activated, such asactivation by exposure to neutronradiation or radiation incident tooperation of a particle accelerator. DOEexpects that this exception will mostcommonly be applied to building andshielding structures associated withnuclear reactors and particleaccelerators. Note that these structures

and components are not excepted fromthe radiological area postingrequirements.

Because the term ‘‘radioactivematerial area’’ has been deleted from the§ 835.2(a) definition of the term‘‘radiological area,’’ DOE has revised theheading of § 835.603 and the provisionsof § 835.602(a) to reflect the inclusion ofthe radioactive material area postingrequirements in subpart G of 10 CFRpart 835.

3. Radioactive Material Labeling

Proposed AmendmentTo augment and clarify existing

requirements, DOE proposed to addrequirements for labeling items andcontainers of radioactive materials at§ 835.605, with appropriate exceptionsbeing proposed at § 835.606. Theseproposed provisions are similar to thosein the Manual and consistent withrequirements imposed by the NRC at 10CFR 20.1904 and 20.1905.


DOE received comments indicatingthat, because the proposed labelingprovisions were based upon theproposed appendix E total activityvalues, they were not adequate to ensureproper labeling of items havingremovable contamination exceeding the10 CFR part 835 appendix D surfaceradioactivity values. However, eventhough labeling of contaminated itemsis not explicitly required by the rule,adequate controls are established under§§ 835.1101 and 835.1102 which willrequire that either labeling or equivalentmeasures be implemented to informindividuals of the contaminationhazard.

DOE also received comments on theproposed exceptions from the labelingrequirements. Commenters indicatedthat exceptions should also be providedfor nuclear weapons and theircomponents, for inaccessible radioactivematerial, and for activated buildingcomponents. DOE agrees with thesecomments.

Final RuleDOE has codified the proposed

requirements for labeling with minoreditorial changes. Section 835.605requires labeling of radioactive itemsand containers of radioactive materials.Section 835.606 provides an exceptionfrom the labeling requirements for itemsand containers having a total activity ofless than 1⁄10 of the appendix E valuesrather than at the proposed appendix Evalues because DOE has reevaluated theappendix E values to address concernsregarding the stringency of the proposed


requirements for accountable sealedradioactive sources (see discussion inSection II.K. of this Notice of FinalRulemaking). Because §§ 835.1101 and835.1102 establish appropriaterequirements for control ofcontaminated material and equipment,DOE has not included specificrequirements for labeling ofcontaminated items in this subpart.

In response to the comments received,DOE has revised the radioactivematerial labeling exceptions proposed at§ 835.606 to include nuclear weaponsand their components and inaccessibleradioactive material. In addition, theexception from the § 835.601 design andcolor specifications for labels applied tosealed radioactive sources, proposed at§ 835.1201(b), has been codified at§ 835.606(b).

G. Records and Reports, Subparts H andI

Proposed Amendment

DOE proposed a number of changes toits requirements for recordsdemonstrating compliance with 10 CFRpart 835. The proposed changesincluded:

1. Revising §§ 835.203(a) and835.702(b) to provide that, whenmonitoring is performed, but notrequired by § 835.402, internal andexternal doses must be summed andrecords must be maintained only if thedoses determined by the non-mandatorymonitoring exceed the thresholds of§ 835.402. This proposed change wasintended to reduce the burden ofrecordkeeping consistent with therecommendations in the Guidance toFederal Agencies.

2. Deleting the words ‘‘caused bycontamination on the skin’’ from§ 835.702(b) to ensure consistency withthe referenced requirements at§ 835.205.

3. Revising § 835.702(c)(1) to providethat records must be sufficient todemonstrate compliance with all of thesubpart C dose limits. This provision isconsistent with § 835.701(a).

4. Deleting the requirement at§ 835.702(c)(4)(iii) to record theestimated intake associated withinternal dose assessments. This changewas necessary because determination ofthe individual dose equivalent resultingfrom intakes of certain radionuclides,such as tritium, does not requiredetermination of the estimated intake.

5. Revising § 835.702(d) and (e) suchthat acceptance of written estimates ofan individual’s prior occupational doseis based upon an inability to obtainformal records, rather than the absenceof those records. DOE also proposed to

revise § 835.702(d) consistent with thepreviously discussed clarification of thecomponents of occupational dose and toreference DOE Orders for authorizingemergency exposures. DOE furtherproposed to revise § 835.702(e) toindicate that efforts to obtain records ofprior years doses were necessary onlyfor those individuals monitored inaccordance with § 835.402.

6. Technical and editorial changes toclarify the recordkeeping provisions andto ensure consistency with otherchanges included in subparts J and M.DOE also proposed to revise§ 835.704(d) to require documentationof revocations of declarations ofpregnancy.

7. Because some individuals may nothave social security numbers, DOEproposed to revise § 835.801(a) to allowfor use of another unique identificationnumber in reports associated with suchindividuals.


DOE received a number of commentsindicating that the results of allindividual monitoring that is performedshould be recorded. DOE agrees that thisapproach has merit. Furthermore, DOEhas provided adequate flexibility underthe individual monitoring requirementsof § 835.402 to eliminate any onerousadministrative burdens resulting fromrecords of trivial doses.

DOE received comments indicatingthat the term ‘‘accident’’ was not clearlydefined, resulting in uncertainty aboutthe proper application of the individualmonitoring records requirement of§ 835.702(a).

DOE received comments suggestingthat the proposed change to § 835.702(e)was not needed because, in the absenceof a cumulative dose limit, writtenestimates would not serve anysubstantive purpose. DOE agrees withthis observation.

Final Rule

DOE has revised § 835.702(a) to deletereference to accidents and to specifythat records be maintained to documentunplanned doses exceeding themonitoring thresholds of § 835.402.

In consideration of the commentsreceived, DOE has not included theproposed changes to § 835.702(b) in thefinal rule.

Consistent with the changes to§ 835.1302 discussed in Section II.L ofthis Notice of Final Rulemaking, DOEhas revised § 835.702(d) to reference theemergency exposure authorizationmeasures included in that section.

DOE has also not included in the finalrule the proposed change to § 835.702(e)

allowing written estimates of prior yearsdoses. DOE has included the remainingchanges with minor editorial correctionsto enhance clarity.

DOE’s review of 10 CFR part 835revealed the fact that § 835.702(c)(2)inappropriately invoked therequirements of certain DOE Orders.The applicability of these Orders isestablished through DOE contractualprocesses. DOE has revised the text todelete this invocation of DOE Orders.

Consistent with changes discussedelsewhere in this Notice of FinalRulemaking, DOE has revised theheading of § 835.703 and language at§ 835.703(a) and (e) to eliminate the useof the term ‘‘workplace’’ and toreference those subparts of the rule(subparts E and L) that establishmonitoring requirements.

Because individuals generally do notrecord the results of contaminationmonitoring upon exiting contaminationand high contamination areas and thereis little perceived value in maintainingsuch records, DOE has clarified§ 835.703(a) to permit such a practice. Inconsideration of comments on thespecificity of the proposed § 835.703(c)recordkeeping provisions, DOE has notincluded the second portion ofproposed § 835.703(c) regardinginformational content of these recordsin the final rule. DOE has revised therecordkeeping requirements of§ 835.703(d) consistent with the changesmade to § 835.401.

In recognition of the need to recordthe estimated date of conception for adeclared pregnant worker (in order todetermine compliance with theapplicable dose limit for the embryo/fetus), DOE has clearly stated this as arequirement at § 835.704(d). Also,consistent with the changes made at§ 835.401, DOE has deleted the term‘‘workplace’’ from § 835.704(e).

H. Radiation Safety Training, Subpart J

1. Training Course Content andAdministration

Proposed AmendmentWhen 10 CFR part 835 was originally

developed, the detailed radiation safetytraining requirements provided in theManual obviated the need to specifyminimum training course content in therule. Because the Manual is no longermandatory, DOE proposed to specifyminimum training course content at§ 835.901(b). Also at § 835.901(b), DOEproposed requirements that wouldallow more liberal acceptance of anindividual’s previous radiation safetytraining.

DOE proposed to further consolidateand simplify its requirements for


radiation safety training. Under theproposed amendment, the level oftraining required would be based uponthe areas entered by the individualunescorted, the activities performed,and the likely doses, rather than theindividual’s classification as a memberof the public, general employee, orradiological worker. Implementation ofthis hierarchical approach to trainingwould result in the appropriate level ofradiation safety training for generalemployees, with a higher level oftraining required for radiologicalworkers. This approach is consistentwith field experience and feedback fromDOE operating contractors and is similarto the approach previously taken byDOE in DOE Order 5480.11 andcurrently taken by the NRC in 10 CFRpart 19, ‘‘Notices, Instructions andReports to Workers: Inspection andInvestigations.’’ DOE proposed toeliminate the examination requirementfor individuals who are not permittedunescorted access to radiological areasand who do not perform unescortedassignments as a radiological worker.DOE also proposed to provide specificrequirements at § 835.901(f) forindividuals who may act as escorts ofindividuals who have not completedrequired training.


Public comments generally endorsedDOE’s proposed hierarchical approachto radiation safety training. However,some commenters were concerned thatthe proposed approach, which wouldrequire an individual to completeradiation safety training prior to beingoccupationally exposed to radiation,would needlessly penalize thosefacilities that conduct training insidethe controlled area or in other areas inwhich trivial occupational exposuresmay occur. However, as proposed,§ 835.901(c) (§ 835.901(b) in theproposed rule) requires training to theextent appropriate to the individual’sdegree of exposure to potentialradiological hazards. Under thecircumstances described, the ‘‘extentappropriate’’ may be minimal (perhapsa briefing on appropriate alarmresponses).

Comments indicated that theproposed § 835.901(b)(3) requirement toprovide training on ‘‘measuresimplemented at the facility to minimizeexposures’’ was inappropriate, as thereis no requirement to ‘‘minimizeexposures.’’ Other comments indicatedthat it was unnecessary for the requiredtraining to be appropriate to‘‘anticipated and actual’’ workassignments; training appropriate to the

individual’s work assignments shouldbe sufficient. DOE agrees with theseobservations.

DOE received comments indicatingthat the existing § 835.2(a) definition ofthe term ‘‘radiological worker’’ wasoverly restrictive and unclear due to itsinclusion of individuals who operateradiation producing devices.Commenters indicated that thisinclusion could require extensivetraining and testing of individuals whooperate devices emitting nominalamounts of radiation or those whooperate devices such as televisions andcomputer monitors. However, consumerdevices that emit nominal amounts ofradiation are clearly excluded from thescope of 10 CFR part 835 under theprovisions of 835.1(b)(6) and the related§ 835.2(a) definition of ‘‘background.’’Although the proposed provisions of§ 835.901(d) (see § 835.901(b) in thefinal rule) would require training andtesting of individuals who operate otherradiation producing devices, theprovisions of § 835.901(c) (see§ 835.901(b) in the proposed rule)would only require that such training beappropriate to the extent of theindividual’s potential exposure toradiological hazards.

Although many commenters favoredDOE’s proposed relaxation of theexamination requirements, othercommenters indicated that anexamination should be required for allforms of training to ensure that thestudent has an understanding of thematerial presented. DOE agrees thatexaminations are useful tools forassessing the retention of information bythe student. However, as stated in DOE’sNotice of Proposed Rulemaking, theradiological hazards present in thoseportions of controlled areas which areoutside of radiological areas are sominimal that the information neededprior to entry does not warrant aregulatory requirement for anexamination. However, the absence ofthis regulatory requirement does notpreclude DOE’s operating entities fromadministering an examination.

Several commenters indicated thatDOE’s proposed requirements for use ofescorts in lieu of training were unclearbecause of the use of the phrase ‘‘wherean escort is required.’’ Thesecommenters correctly pointed out thatthe proposed § 835.901(c) and (d) wouldpermit, but would not explicitly require,the use of escorts.

Other commenters were concernedthat the retraining requirements ofproposed § 835.901(g) might requireindividuals to complete the fullintroductory radiation safety training

course every 24 months. DOE agreesthat this issue requires clarification.

Final Rule

As proposed, DOE has reformattedsubpart J into one section in the finalrule, codifying an approach similar tothat previously published in the Manualand eliminating redundancy. DOE hasomitted proposed § 835.901(a) from thefinal rule because that paragraph wouldnot establish any substantiverequirements. DOE has also eliminatedthe examination requirement forindividuals who are not permittedunescorted access to radiological areasand who do not perform unescortedassignments as a radiological worker, asproposed. Although not a regulatoryrequirement, DOE contractors may stillchoose to administer examinations or toundertake other means of assessingindividual understanding, such asinteractive classroom discussions.

DOE has included at § 835.901(c)(§ 835.901(b) in the proposedamendment) a requirement for trainingto be provided to the extent appropriateto the individual’s work assignment.DOE has also included at § 835.901(c)(3)(proposed § 835.901(b)(3)) a requirementthat the training address measures usedto ‘‘manage doses and maintain dosesALARA,’’ rather than ‘‘minimize’’ doses.This modification makes clear thedistinction between maintaining doseswell below the dose limits using theALARA process and maintaining doseswell below the dose limits byminimizing doses regardless of otherconsiderations.

DOE has established requirementsapplicable to instances in which escortsare used, rather than required, in lieu oftraining at revised § 835.901(d)(§ 835.901(f) in the proposedamendment).

With regard to the requirements forbiennial retraining, DOE has eliminatedthe use of the undefined term‘‘retraining.’’ Section 835.901(e) of thefinal rule requires affected individualsto complete the required training at leastevery 24 months. Like the initialtraining, this follow-on training is forindividuals subject to the requirementsof § 835.901(a) and (b), and is subject tothe provisions of § 835.901(c). Thus, thecontent and scheduling (prior to the endof the two year time interval) of suchtraining needs to incorporateconsiderations of the individual’s priortraining, work assignments, and degreeof exposure to radiological hazards, aswell as significant changes to radiationprotection policies and procedures thataffect the individual.


2. Radiological Control TechnicianTraining [§ 835.903]

DOE also proposed changes to the 10CFR part 835 requirements for trainingof radiological control technicians.These changes are discussed in detail inSection II.B.3. of this Notice of FinalRulemaking.

I. Design and Control, Subpart K

Proposed Amendment

Experience in implementing programsto ensure compliance with 10 CFR part835 revealed that the design objectivescurrently included at § 835.1002(b) and(c) may not be practical in developingcertain modifications to existingfacilities. Therefore, DOE proposed todelete § 835.1002(b) and (c). DOE alsoproposed to move the remainingrequirements in paragraphs (a) and (d)of § 835.1002 to § 835.1001.

The design criteria established at§ 835.1003(a) did not include all of theoccupational dose limits of § 835.202,e.g. the lens of the eye dose limitestablished at § 835.202(a)(3). Thisomission implied that the design of newfacilities or modification of existingfacilities could include design featuresthat would result in doses exceeding thelens of the eye dose equivalent limit of15 rem established at § 835.202. DOEproposed to correct this omission byincluding all applicable occupationaldose limits established at § 835.202 inthis section.


Comments indicated that the phrase‘‘as low as is reasonably achievable’’ at§ 835.1001(a) could be construed tohave a meaning that differed from‘‘ALARA’’ as defined at § 835.2(a).

Many commenters stated that DOEshould retain the numerical designobjectives provided at § 835.1002.Although achievement of the numericaldesign objectives may not be practical insome cases (particularly for minormodifications of existing facilities), thedesign objectives are importantcomponents of the ALARA process.Public comments suggested thatelimination of the numerical designobjectives could result in confusion overwhen to apply quantitative designobjectives and the appropriatemagnitude of those objectives.Comments also indicated that§ 835.1003(b) did not establish anysubstantive requirements beyond thoseestablished in subpart E of 10 CFR part835.

DOE agrees with these observations.

Final RuleAt § 835.1001(a), DOE has substituted

‘‘ALARA’’ for ‘‘as low as is reasonablyachievable.’’

Because procedural requirements area type of administrative control, DOEhas deleted the term ‘‘proceduralrequirements’’ from § 835.1001 anddeleted the term ‘‘procedures’’ from§ 835.1003 to eliminate redundancy. Forconsistency, DOE has revised theheading of § 835.1003 to read‘‘Workplace Controls.’’

Because the use of quantitative designobjectives plays a significant role in theALARA process as it applies to facilitydesign, DOE has chosen to defer thiscritical change until more experience isgained through implementation of theseregulatory provisions. DOE has acceptedthe public comments and has retainedthe numerical design objectives of§ 835.1002; however, DOE has retainedthe proposed editorial change at§ 835.1002 (proposed § 835.1001(c))substituting the term ‘‘existingfacilities’’ for the term ‘‘old facilities.’’DOE will address its concerns with theapplication of these requirementsthrough enhanced guidance forachieving compliance. DOE hasincluded in the final rule the proposedchange related to the lens of the eyedose limit. In consideration of publiccomments, DOE has also deleted§ 835.1003(b) from the final rule.

J. Radioactive Contamination Control,Subpart L

Proposed AmendmentConsistent with the changes to the

§ 835.2(a) definitions of the terms‘‘contamination area’’ and ‘‘highcontamination area,’’ DOE proposedchanges to the § 835.404 requirementsfor areas having only fixedcontamination exceeding the appendixD total surface radioactivity values.

DOE proposed several changes toappendix D of 10 CFR part 835, whichprovides mandatory surfaceradioactivity values for contaminationcontrol. DOE proposed to add the word‘‘alpha’’ after the values for uraniumisotopes in appendix D to clarify theapplicability of these values. DOE alsoproposed to add to appendix D of 10CFR part 835 a contamination controlvalue of 10,000 disintegrations perminute per 100 square centimeters forsurfaces contaminated with tritium andFootnote 6 to explain the use of thisvalue. The surface contamination valuewould be used to determine theapplicability of the § 835.603contamination hazard postingprovisions and the §§ 835.404 and835.1101 contamination control

provisions. DOE has prepared anEnvironmental Assessment, available atDOE’s Freedom of Information ReadingRoom at the address provided above,that addresses this change in detail.

DOE also proposed to move theexisting requirements of § 835.1101(d)to § 835.703(c) to consolidaterecordkeeping requirements and to adda new requirement for removal ofradioactive material labels from releasedmaterials and equipment at§ 835.1101(d).


Public comments were generallysupportive of DOE’s proposed changesto the requirements for control ofradioactive contamination. Publiccomments also indicated that therecordkeeping requirements of proposed§ 835.703(c) were overly prescriptive incomparison to related requirements ofthe rule. Public comments alsoindicated that a literal reading of§ 835.404(f) would indicate that theperformance of individualcontamination monitoring by someoneother than the individual exiting acontamination or high contaminationarea (i.e., individual frisking byradiological control technicians) wouldbe contrary to 10 CFR part 835. DOEagrees with these observations.

Comments indicated that the relatedrequirements of §§ 835.404 and835.1101 were confusing and possiblycontradicting. The existing provisions of§ 835.404 establish requirements forcontrol of areas contaminated byradioactive material; the provisions of§ 835.1101 establish similarrequirements for materials andequipment contaminated by radioactivematerials. Upon reexamination of theserequirements in light of the commentsreceived, DOE believes that there isopportunity for simplification andclarification of the rule.

Final RuleDOE has combined and simplified the

requirements of §§ 835.404 and835.1101 in the final rule as follows:

a. Although the provisions of§ 835.404 were specifically related tocontrolling the spread of contamination,they were located in subpart E, whichwas entitled ‘‘Monitoring in theWorkplace.’’ Therefore, DOE has movedthese requirements, with revisionsdiscussed below, to subpart L.

b. Although the title of subpart Lindicates that the subject matter isrelated to ‘‘Releases of Materials andEquipment from Radiological Areas,’’the requirements are more specificallyrelated to retention and control of


contaminated materials in radiologicalareas. Therefore, DOE has retitledsubpart L, ‘‘Radioactive ContaminationControl.’’

c. DOE has clarified and simplifiedthe structure of § 835.1101(a).

d. DOE has retained paragraphs835.1101(b) and (c) with minor editorialclarifications. Consistent with thediscussion in Section II.B.3 of thisNotice of Final Rulemaking regardingwritten procedures, DOE has omittedthe requirement for written procedures(formerly § 835.1101(c)(3)).

e. Because the existing requirementsof § 835.404(a) established nosubstantive requirements, DOE hasomitted this paragraph from the finalrule.

f. DOE has redesignated paragraph835.404(b) as § 835.1102(a) in the finalrule.

g. DOE has edited paragraph835.404(c) and redesignated it as§ 835.1102(b) in the final rule. DOE hasomitted the provision related to postingof contamination hazards (formerly§ 835.404(c)(1)) because this provision isredundant with § 835.603(e) and (f).

h. DOE has edited paragraph835.404(d) and redesignated it as§ 835.1102(c) in the final rule.Consistent with the discussion inSection II.B.3 of this Notice of FinalRulemaking regarding writtenprocedures, DOE has omitted therequirement for written procedures(formerly § 835.404(d)(5)).

i. Because of the changes to the§ 835.2(a) definitions of ‘‘contaminationarea’’ and ‘‘high contamination area’’discussed above, the areas discussed at§ 835.404(d) (i.e., those having fixedcontamination at levels exceeding theappendix D total contamination values,but removable contamination levelsbelow the appendix D removablecontamination values) would no longerbe considered radiological areas. Thisrenders the provisions of § 835.404(e)redundant; therefore, DOE has omittedthese requirements from the final rule.

j. DOE has clarified § 835.404(f) andredesignated it as § 835.1102(d).

k. DOE has revised the language at§ 835.404(g) for clarity and redesignatedit as § 835.1102(e).

DOE has reconsidered its proposal toadd § 835.1101(d) establishingrequirements for removal of radioactivematerial labels from released materialsand equipment. Although DOEconsiders materials and equipmentmeeting the requirements of§ 835.1101(a) to be appropriate forrelease from radiological areas, suchmaterials and equipment are notnecessarily ‘‘non-radioactive’’ andconditions may arise under which

retention of the radioactive materiallabels is appropriate. DOE has thereforeomitted this provision from the finalrule.

As before, the requirements of§ 835.1101 address release of materialsand equipment from radiological areasto controlled areas. DOE requirementsfor release of materials and equipmentfrom its control are addressed in DOEenvironmental protection standards.

K. Control of Sealed RadioactiveSources, Subpart M

Proposed Amendment

DOE proposed to add subpart M to 10CFR part 835 to establish requirementsfor control of sealed radioactive sources.These requirements would supersedesimilar requirements established in DOENotice 5400.9, ‘‘Sealed RadioactiveSource Accountability’’ (extendedthrough DOE Notice 5400.13 andsuperseded by DOE N 441.1 throughDOE N 441.3). DOE proposed to add theterms ‘‘accountable sealed radioactivesource,’’ ‘‘sealed radioactive source,’’and ‘‘source leak test’’ at § 835.2(a) andto add recordkeeping requirements at§ 835.704(f). DOE also proposed to addappendix E to 10 CFR part 835 toestablish threshold values for sealedradioactive source accountability,radioactive material labeling, andradioactive material area posting.


Although many commenterssupported DOE’s efforts to codifyrequirements for sealed radioactivesource control, several commentersindicated that the accountabilitythreshold values proposed for inclusionin appendix E of 10 CFR part 835 wereoverly restrictive. Commenters alsoindicated that the definition of ‘‘sealedradioactive source’’ was too broad toallow for exclusion of certain items,such as reactor fuel elements, that arenot commonly produced or used assealed radioactive sources. In addition,several commenters indicated thatDOE’s proposed minimum activityrequiring performance of periodic leaktests (0.005 microcuries) was overlyrestrictive.

Commenters indicated thatinaccessible sources should be exceptedfrom the requirements for leak testingand inventory. Such a measure wouldobviate the need to disassemble facilitycomponents and instruments for thepurpose of performing the inventoriesand leak tests. Commenters alsoindicated that common contaminationcontrol measures are capable ofminimizing, but perhaps not preventing,

the spread of contamination as would berequired by proposed § 835.1202(e).


Final RuleIn response to public comments, DOE

has revised the § 835.2(a) definition ofthe term ‘‘sealed radioactive source’’ toexclude reactor fuel elements, nuclearexplosive devices, and radioisotopethermoelectric generators. DOE hasincluded the definitions of ‘‘accountablesealed radioactive source’’ and ‘‘sourceleak test’’ at § 835.2(a) as proposed. DOEhas revised § 835.1202(d) to provide anexception from leak testing andinventory for sealed radioactive sourcesthat are inaccessible. DOE has alsorevised § 835.1202(e) to indicate that therequired contamination controlmeasures must ‘‘minimize’’ the spreadof contamination.

DOE has revised the proposedappendix E values. DOE determined theappendix E values in the final rule asfollows: For each radionuclide, DOEconsidered two scenarios: (1) theactivity quantity resulting in a deepdose equivalent from external radiationof 0.1 rem (0.001 sievert) assuming anindividual was irradiated for a period of12 hours per day at a distance of 1 meterfrom the source for 365 days; and (2) theactivity quantity resulting in acommitted effective dose equivalent of0.1 rem (0.001 sievert) assuming aninstantaneous intake of 0.001% of thematerial by an individual. DOEcompared the activity quantities for thedeep dose equivalent and the committedeffective dose equivalent and selectedthe more restrictive value as the basisfor the accountability threshold value.DOE selected the value of 0.1 rem as thebasis for the revised appendix E valuesfor consistency with DOE’s mandatorythreshold for monitoring of generalemployee dose (see § 835.402) and doselimit for members of the public incontrolled areas (see § 835.208). DOEalso assumed more realistic values forthe exposure time and intake factor andeliminated the arbitrary 300 microcurieactivity cap. The basis for the appendixE values is discussed in more detail ina technical basis document available inDOE’s Freedom of Information ReadingRoom at the address provided above.

Because all of the revised appendix Evalues are greater than 0.005microcuries, DOE has deleted thisthreshold from the requirements forsealed radioactive source leak tests(proposed § 835.1202(b)). DOE has alsoomitted the proposed requirement forwritten procedures from the final rule.For details on this omission, see SectionII.B.3 of this Notice of FinalRulemaking. Finally, because DOE’s


reevaluation of the appendix E valuesresulted in significant increases in all ofthe accountability threshold values,DOE has codified a general requirementat § 835.1201 for all radioactive sources(both accountable and non-accountable)to be used, handled, and stored in amanner commensurate with theradiological hazards created by theoperation involving the sources. DOEwill provide implementing guidance todiscuss acceptable methods forachieving compliance with thisprovision.

The basis for the control of sealedradioactive sources is a hierarchy ofincreasing radiological controls basedupon the maximum credible doseconsequence resulting from the loss ofa source. The maximum credible doseconsequence should not be consideredto be a release criterion. Under therequirements of 10 CFR part 835, somedegree of radiological control is requiredfor all sealed radioactive sources,regardless of their activity. Thishierarchy of controls reduces thelikelihood of losing a sealed radioactivesource. Thus the approach to sealedradioactive source control is analogousto that taken in nuclear safety. As thepotential consequences of a credibleincident increase, additional controlsare imposed to reduce the probabilitythat the incident will occur and mitigatethe consequences of that incident.

For the lowest activity sealedradioactive sources, a minimal level ofradiological control is required basedupon the hazards associated with theoperations involving the sources. Morespecific actions are not considerednecessary and are therefore notspecified.

For sealed radioactive sources whoseloss could result in a maximum credibledose consequence of 0.1 rem or more ina year, additional controls are imposed.The requirement for semi-annualinventories reduces the possibility oflosing the source and, by triggeringinvestigative action, mitigates theconsequences of a lost source. Therequirement for semi-annual leak testingprovides a means of monitoring theintegrity of the source and likewisetriggers action to mitigate theconsequences of a leaking source.

L. Accident and Emergency Exposures,Subpart N

Proposed Amendment

DOE proposed to correct§ 835.1301(a), (b), and (d) by deletingreferences to § 835.205, which providesno dose limits. Consistent with changesto § 835.204, DOE proposed to revise§ 835.1301(a) to indicate that doses

resulting from accident and emergencyexposures may exceed the numericalvalues established at § 835.202(a)without violating the occupational doselimits. Both accident and emergencydoses are considered occupational dosesand are included in a generalemployee’s occupational dose record,but emergency doses are explicitlyexcluded from consideration indetermining compliance with theoccupational dose limits at § 835.202(a).

DOE proposed to delete § 835.1302(d)because these provisions are adequatelyaddressed in related DOE Orders andemergency management guides.

DOE clarified § 835.1304 bysubstituting the defined term‘‘individual’’ for the term ‘‘personnel’’which eliminates any confusionregarding the coverage of the personalnuclear accident dosimetry provisions.DOE also proposed to remove thereference to ‘‘all personnel’’ to provideflexibility in implementing the personalnuclear accident dosimetry provisions.


Regarding accident and emergencyexposures, public comments indicatedthat DOE had failed to clearly define theterms ‘‘accident’’ and ‘‘emergency,’’resulting in uncertainty about theproper application of these provisions.

Comments regarding the proposedapproach basing personal nuclearaccident dosimetry requirements on theneed for nuclear criticality alarmsindicated that this approach would beimpractical due to the vagueness of thereferenced requirements for thesealarms.


Final RuleDOE has included the proposed

changes into the final rule.Consistent with the clarification of the

requirements for accounting foroccupational doses, including dosesresulting from authorized plannedspecial exposures and emergencyexposures, DOE has deleted the term‘‘accident’’ from § 835.1301(a). Thisdeletion results from DOE’s recognitionthat, except for doses resulting fromplanned special exposures andauthorized emergency exposures, alldoses in excess of the regulatory limitsmay be considered to be ‘‘accidents.’’Under such circumstances, DOEbelieves that provisions allowingaffected individuals to return to workwithout further detailed review subvertsthe intent of the § 835.202 occupationaldose limits. DOE believes that it is mostappropriate for this section to addressdoses resulting from authorized

emergency exposures. Despite thischange, DOE recognizes the fact thatissues of individual work rights andDOE liability may arise as a result of‘‘accidental’’ exposures exceeding theregulatory dose limits. Mechanisms foraddressing doses resulting fromaccidents, and authorizations to returnaffected individuals to work, existwithin the exemption processestablished in 10 CFR part 820.

In response to public comments, DOErevised the text in § 835.1301(c) and (d)to eliminate the terms ‘‘emergency’’ and‘‘accident’’ and specify that thenotification and resumption provisionsapply when doses were received inexcess of the limits of § 835.202, exceptthose doses received in accordance with§ 835.204.

As discussed above with regard to§ 835.702(c)(2), DOE found that§ 835.1301(e) inappropriately invokedthe requirements of DOE Orders. Theapplicability of these Orders isestablished through DOE contractualprocesses. Therefore, DOE has deletedthis provision.

To resolve issues related torequirements for personal nuclearaccident dosimetry, DOE has revised therequirement to simply indicate that thenuclear accident dosimetry system mustinclude personal nuclear accidentdosimeters. This approach will allow forflexible implementation on a site-andfacility-specific basis.

M. Use of Appendices

Proposed Amendment

DOE proposed to clarify theapplication of the data presented in theappendices of 10 CFR part 835 byadding introductory text to eachappendix referencing those sections ofthe rule requiring use of the appendix.DOE also proposed to delete theabsorption factor (f1) values and therelated footnote (footnote 5) fromappendix A of 10 CFR part 835 becauseabsorption factors and alternativeabsorption factors are neither used norreferenced in the rule. DOE determinedthat 10 CFR part 835 established nosubstantive requirements for use of thedata presented in appendix B, andtherefore proposed to delete appendixB.

DOE’s review of exemption requestsconcerning occupational exposure to220Rn and 222Rn and their daughterproducts revealed that DAC values forthese radioisotopes are inappropriatelyreferenced in both appendices A and C.Exposure to these radionuclides resultsin a lung dose and therefore, the airimmersion DACs in appendix C areinappropriate. Accordingly, DOE


proposed to delete the air immersionDAC values for 220Rn and 222Rn fromappendix C.

Experience in implementing programsthat ensure compliance with 10 CFRpart 835 has proven that the exposureconditions used to determine theappendix C DAC values (immersion ina semi-infinite cloud) often differ fromthose at DOE facilities (i.e., exposure inrelatively small enclosures). Use of theappendix C DAC values under theseconditions can result in theoverestimation of individual doses.Therefore, DOE proposed to reviseappendix C, note b., to allowmodification of the DAC values tocompensate for immersion in a cloud offinite dimensions and to provideinstructions for determining the DAC ofa mixture of radionuclides.


Although several commenterssuggested that the data in appendix Bwere useful and should be retained, thecorrelation of chemical form to lungretention class is available directly fromTable 3 of Federal Guidance ReportNumber 11, ‘‘Limiting Values ofRadionuclide Intake and AirConcentration and Dose ConversionFactors for Inhalation, Submersion, andIngestion.’’

Commenters favored DOE’s proposalto allow for modification of theappendix C values. However, contraryto the information provided in appendixC, note b., these values were calculatedbased upon an exposure of 2000 hoursper year, and not based upon acontinuous exposure.

Final RuleDOE has included the proposed

changes in the final rule with minoreditorial corrections. For consistencywith the existing provisions associatedwith appendix C of 10 CFR part 835,DOE has included a note with appendixA of 10 CFR part 835 that will allow useof the sum of the fractions rule whenthere exists a mixture of radionuclidesin the area of interest. DOE has alsorevised appendix C, note b., to reflectthe 2000 hour per year exposure basisof the values.

Consistent with terminology usedthroughout the rule and in DOE’sguidance documents, DOE has alsoretitled the table in appendix D of 10CFR part 835 ‘‘Surface ContaminationValues.’’

N. Corrections and Clarifications

Proposed AmendmentDOE proposed numerous editorial

corrections and technical clarifications

that do not change the requirements ofthe rule or the measures necessary toensure regulatory compliance. Theproposed changes included:

1. Correction of the definitions of‘‘airborne radioactive material’’, and‘‘year’’ (§ 835.2(a)) and ‘‘external dose orexposure,’’ and ‘‘quality factor’’(§ 835.2(b));

2. Clarification of the application ofthe mean quality factors for neutronsprovided at § 835.2(b);

3. Deletion of § 835.2(d) because theconvention stated in that paragraph forthe use of singular, plural, masculine,and feminine terms is not used in part835;

4. Revision of the requirements of§ 835.102 for clarity;

5. Change of the heading of § 835.202to ‘‘Occupational dose limits for generalemployees’’ to accurately reflect thecontent of that section;

6. Deletion from § 835.203(a) and the§ 835.2(b) definition of ‘‘total effectivedose equivalent’’ the provision relatedto substitution of deep dose equivalentfor effective dose equivalent fromexternal exposure. This provision isredundant with the revised definition of‘‘effective dose equivalent’’ proposed at§ 835.2(b).


DOE received no substantivecomments on these changes.

Final Rule

DOE has included the proposedchanges in the final rule.

III. Review Under the NationalEnvironmental Policy Act

DOE has reviewed the promulgationof this amendment to 10 CFR part 835under the National EnvironmentalPolicy Act (NEPA) of 1969 (42 U.S.C.4321 et seq.) and the Council onEnvironmental Quality regulations forimplementing NEPA (40 CFR parts1500–1508). DOE has completed anEnvironmental Assessment and on thebasis of that information has issued aFinding of No Significant Impact(FONSI) for this amendment. TheFONSI and the EnvironmentalAssessment update the FONSI andEnvironmental Assessment issued whenthe proposed amendment was publishedfor public comment and reflect changesin the final rule made in response topublic comments. The EnvironmentalAssessment and FONSI are available forinspection at the DOE Freedom ofInformation Reading Room, 1E–190,1000 Independence Ave. SW,Washington, DC 20585, between the

hours of 9 a.m. and 4 p.m., Mondaythrough Friday, except Federal holidays.

IV. Review Under RegulatoryFlexibility Act

The Regulatory Flexibility Act, 5U.S.C. 601–612, requires that an agencyprepare an initial regulatory flexibilityanalysis and publish it at the time ofpublication of general notice ofrulemaking for the rule. Thisrequirement does not apply if theagency certifies that the rule will not, ifpromulgated, have a significanteconomic impact on a substantialnumber of small entities. 5 U.S.C.605(b).

Today’s action amends DOE’sregulations governing programsestablished at DOE facilities to protectindividuals from ionizing radiationresulting from DOE activities. Thecontractors who manage and operateDOE facilities are responsible forimplementing the occupationalradiation protection program. DOE hasconsidered whether management andoperating (M&O) contractors are ‘‘smallbusinesses,’’ as that term is defined bythe Regulatory Flexibility Act (5 U.S.C.601(3)). The Regulatory Flexibility Act’sdefinition incorporates the definition of‘‘small business concern’’ in the SmallBusiness Act, which the Small BusinessAdministration (SBA) has developedthrough size standards in 13 CFR part121. Small businesses are businessconcerns which, together with theiraffiliates, have no more than 500 to 1500employees, varying by SIC category, andannual receipts of between $0.5 millionto $25 million, again varying by SICcategory—Title 13 CFR part 121. DOE’sM&O contractors exceed the SBA’s sizestandards for small businesses. Inaddition, it is noted that M&Ocontractors are reimbursed through theircontracts with DOE for the costs ofcomplying with DOE occupationalradiation protection requirements. Theywill not, therefore, be adverselyimpacted by the requirements in therule. For these reasons, DOE certifiesthat the final rule will not have asignificant economic impact on asubstantial number of small entities.

V. Review Under Executive Order12866

Today’s regulatory action has beendetermined not to be a ‘‘significantregulatory action’’ under ExecutiveOrder 12866, ‘‘Regulatory Planning andReview,’’ (58 FR 51735, October 4,1993). Accordingly, today’s action wasnot subject to review under theExecutive Order by the Office ofInformation and Regulatory Affairs


within the Office of Management andBudget.

VI. Review Under Executive Order12612

Executive Order 12612, 52 FR 41685(October 30, 1987) requires thatregulations, rules, legislation, and anyother policy actions be reviewed for anysubstantial direct effects on States, onthe relationship between the NationalGovernment and the States, or in thedistribution of power andresponsibilities among various levels ofgovernment. If there are sufficientsubstantial direct effects, then theExecutive Order requires preparation ofa federalism assessment to be used in alldecisions involved in promulgating andimplementing a policy action.

This final rule would not have asubstantial direct effect on theinstitutional interests or traditionalfunctions of States.

VII. Review Under Executive Order12988

With respect to the review of existingregulations and the promulgation ofnew regulations, section 3(a) ofExecutive Order 12988, ‘‘Civil JusticeReform,’’ 61 FR 4729 (February 7, 1996),imposes on Executive agencies thegeneral duty to adhere to the followingrequirements:

(1) Eliminate drafting errors andambiguity; (2) write regulations tominimize litigation; and (3) provide aclear legal standard for affected conductrather than a general standard andpromote simplification and burdenreduction. With regard to the reviewrequired by section 3(a), section 3(b) ofExecutive Order 12988 specificallyrequires that Executive agencies makeevery reasonable effort to ensure that theregulation: (1) clearly specifies thepreemptive effect, if any; (2) clearlyspecifies any effect on existing Federallaw or regulation; (3) provides a clearlegal standard for affected conductwhile promoting simplification andburden reduction; (4) specifies theretroactive effect, if any; (5) adequatelydefines key terms; and (6) addressesother important issues affecting clarityand general draftsmanship under anyguidelines issued by the AttorneyGeneral. Section 3(c) of Executive Order12988 requires Executive agencies toreview regulations in light of applicablestandards in section 3(a) and section3(b) to determine whether they are metor it is unreasonable to meet one ormore of them. DOE has completed therequired review and determined that theamendments to 10 CFR part 835 meetthe relevant standards of ExecutiveOrder 12988.

VIII. Review Under PaperworkReduction Act

DOE submitted the proposedcollections of information in this rule tothe Office of Management and Budgetfor review under section 3507(d) of thePaperwork Reduction Act of 1995 (42U.S.C. 3507(d)), and, by separate noticeon May 26, 1998, invited publiccomment on DOE’s statement of needand estimates of the burden of thecollection of information in 10 CFR part835 (63 FR 28495). The information thatDOE management and operatingcontractors are required to produce,maintain and report is necessary topermit the Department and itscontractors to manage and overseehealth and safety programs that controlworker exposure to radiation. DOEestimates that the total annual burden ofthe collection of informationrequirements to be 50,000 hours for theapproximately 50 contractors subject tothe rule.

The Office of Management and Budgethas approved the collections ofinformation in 10 CFR part 835 andassigned to the part OMB Number 1910–5105. An agency may not conduct orsponsor, and a person is not required torespond to a collection of informationunless it displays a currently valid OMBcontrol number (5 CFR 1320.5(b)).

IX. Review Under the UnfundedMandates Reform Act

Title II of the Unfunded MandatesReform Act of 1995 (the Act), Pub.L.104–4 on March 22, 1995, codified at 2U.S.C. 1501–1571, requires each Federalagency, to the extent permitted by law,to prepare a written assessment of theeffects of any Federal mandate in aproposed or final agency rule that mayresult in the expenditure by State, local,and tribal governments, in the aggregateor by the private sector, of $100 millionor more (adjusted annually for inflation)in any one year. Section 204(a) of theAct, codified at 2 U.S.C. 1534(a),requires the Federal agency to developan effective process to permit timelyinput by elected officers (or theirdesignees) of State, local, and tribalgovernments on proposals containing‘‘significant Federal intergovernmentalmandates.’’ Section 203(a) of the Act,codified at 2 U.S.C. 1533(a), providesthat before establishing any regulatoryrequirements that might significantly oruniquely affect small governments, theagency shall have developed a plan that,among other things, provides for noticeto potentially affected smallgovernments, if any, and enablesofficials of affected small governmentsto provide meaningful and timely input

in the development of regulatoryproposals containing significantintergovernmental Federal mandates.

The final rule published today doesnot contain any Federal mandate thatwould result in any expenditure byState, local or tribal government. Theprovisions of 10 CFR part 835 applyonly to activities conducted by or forDOE. Therefore, the requirements ofTitle II of the Unfunded MandatesReform Act of 1995 do not apply.

X. Review Under Small BusinessRegulatory Enforcement Fairness Act of1996

As required by 5 U.S.C. 801, DOE willreport to Congress promulgation of thisrule prior to its effective date. Thereport will state that it has beendetermined that the rule is not a ‘‘majorrule’’ as defined by 5 U.S.C. 804(2).

List of Subjects in 10 CFR Part 835

Emergency radiation exposures,Nuclear material, Occupational safetyand health, Radiation exposures,Radiation protection, Radioactivematerial, Reporting and recordkeepingrequirements, Safety duringemergencies, Training.

Issued in Washington, DC, on October 29,1998.Peter N. Brush,Acting Assistant Secretary, Environment,Safety and Health.

For the reasons set forth in thepreamble, Title 10, Code of FederalRegulations, part 835 is amended as setforth below:

PART 835—OCCUPATIONALRADIATION PROTECTION

1. The authority citation for part 835continues to read as follows:

Authority: 42 U.S.C. 2201; 7191.

Subpart A—General Provisions

2. Section 835.1 is amended byrevising the introductory text ofparagraph (b) and paragraph (b)(3),redesignating paragraph (b)(4) as (b)(6),and by adding paragraphs (b)(4), (b)(5),and (c) as follows:

§ 835.1 Scope.

* * * * *(b) Exclusion. Except as discussed in

paragraph (c) of this section, therequirements in this part do not applyto:* * * * *

(3) Activities conducted under theNuclear Explosives and Weapons SuretyProgram relating to the prevention ofaccidental or unauthorized nucleardetonations;


(4) Radioactive materialtransportation as defined in this part;

(5) DOE activities conducted outsidethe United States on territory under thejurisdiction of a foreign government tothe extent governed by occupationalradiation protection requirementsagreed to between the United States andthe cognizant government; or

(6) Background radiation, radiationdoses received as a patient for thepurposes of medical diagnosis ortherapy, or radiation doses receivedfrom participation as a subject inmedical research programs.

(c) Occupational doses received as aresult of excluded activities andradioactive material transportation, aslisted in paragraphs (b)(1) through (b)(5)of this section, shall be consideredwhen determining compliance with theoccupational dose limits at §§ 835.202and 835.207, and with the limits for theembryo/fetus at § 835.206. Occupationaldoses resulting from authorizedemergency exposures and plannedspecial exposures shall not beconsidered when determiningcompliance with the dose limits at§§ 835.202 and 835.207.

3. At § 835.2, paragraph (a) isamended by removing definitions of theterms ‘‘ambient air’’, ‘‘continuous airmonitor’’, ‘‘DOE activities’’,‘‘occupational exposure’’,‘‘representative’’, and ‘‘survey’’; byadding in alphabetical order, definitionsfor the terms ‘‘accountable sealedradioactive source’’, ‘‘derived airconcentration-hour’’, ‘‘DOE activity’’,‘‘occupational dose’’, ‘‘radioactivematerial area’’, ‘‘radioactive materialtransportation’’, ‘‘real-time airmonitoring’’, ‘‘respiratory protectivedevice’’, ‘‘sealed radioactive source’’,‘‘source leak test’’, and ‘‘week’’; andrevising the definitions of the terms‘‘airborne radioactive material orairborne radioactivity’’, ‘‘airborneradioactivity area’’, ‘‘contaminationarea’’, ‘‘controlled area’’, ‘‘declaredpregnant worker’’, ‘‘general employee’’,‘‘high contamination area’’, ‘‘member ofthe public’’, ‘‘monitoring’’, ‘‘radiologicalarea’’, and ‘‘year’’ to read as follows. At§ 835.2, paragraph (b), the definition of‘‘collective dose’’ is removed, thedefinition of ‘‘dose’’ is added, and thedefinitions of the terms ‘‘cumulativetotal effective dose equivalent’’,‘‘effective dose equivalent’’, ‘‘externaldose or exposure’’, ‘‘quality factor’’,‘‘total effective dose equivalent’’, and‘‘weighting factor’’ are revised asfollows. Paragraph (d) of § 835.2 isremoved.

§ 835.2 Definitions.(a) As used in this part:

Accountable sealed radioactivesource means a sealed radioactivesource having a half-life equal to orgreater than 30 days and an isotopicactivity equal to or greater than thecorresponding value provided inappendix E of this part.

Airborne radioactive material orairborne radioactivity means radioactivematerial dispersed in the air in the formof dusts, fumes, particulates, mists,vapors, or gases.

Airborne radioactivity area means anyarea, accessible to individuals, where:

(1) The concentration of airborneradioactivity, above natural background,exceeds or is likely to exceed thederived air concentration (DAC) valueslisted in appendix A or appendix C ofthis part; or

(2) An individual present in the areawithout respiratory protection couldreceive an intake exceeding 12 DAC-hours in a week.* * * * *

Contamination area means any area,accessible to individuals, whereremovable surface contamination levelsexceed or are likely to exceed theremovable surface contamination valuesspecified in appendix D of this part, butdo not exceed 100 times those values.* * * * *

Controlled area means any area towhich access is managed by or for DOEto protect individuals from exposure toradiation and/or radioactive material.

Declared pregnant worker means awoman who has voluntarily declared toher employer, in writing, her pregnancyfor the purpose of being subject to theoccupational dose limits to the embryo/fetus as provided at § 835.206. Thisdeclaration may be revoked, in writing,at any time by the declared pregnantworker.* * * * *

Derived air concentration-hour (DAC-hour) means the product of theconcentration of radioactive material inair (expressed as a fraction or multipleof the DAC for each radionuclide) andthe time of exposure to thatradionuclide, in hours.

DOE activity means an activity takenfor or by DOE in a DOE operation orfacility that has the potential to result inthe occupational exposure of anindividual to radiation or radioactivematerial. The activity may be, but is notlimited to, design, construction,operation, or decommissioning. To theextent appropriate, the activity mayinvolve a single DOE facility oroperation or a combination of facilitiesand operations, possibly including anentire site or multiple DOE sites.* * * * *

General employee means anindividual who is either a DOE or DOEcontractor employee; an employee of asubcontractor to a DOE contractor; or anindividual who performs work for or inconjunction with DOE or utilizes DOEfacilities.

High contamination area means anyarea, accessible to individuals, whereremovable surface contamination levelsexceed or are likely to exceed 100 timesthe removable surface contaminationvalues specified in appendix D of thispart.* * * * *

Member of the public means anindividual who is not a generalemployee. An individual is not a‘‘member of the public’’ during anyperiod in which the individual receivesan occupational dose.* * * * *

Monitoring means the measurement ofradiation levels, airborne radioactivityconcentrations, radioactivecontamination levels, quantities ofradioactive material, or individual dosesand the use of the results of thesemeasurements to evaluate radiologicalhazards or potential and actual dosesresulting from exposures to ionizingradiation.* * * * *

Occupational dose means anindividual’s ionizing radiation dose(external and internal) as a result of thatindividual’s work assignment.Occupational dose does not includedoses received as a medical patient ordoses resulting from backgroundradiation or participation as a subject inmedical research programs.* * * * *

Radioactive material area means anyarea within a controlled area, accessibleto individuals, in which items orcontainers of radioactive material existand the total activity of radioactivematerial exceeds the applicable valuesprovided in appendix E of this part.

Radioactive material transportationmeans the movement of radioactivematerial by aircraft, rail, vessel, orhighway vehicle when such movementis subject to Department ofTransportation regulations or DOEOrders that govern such movements.Radioactive material transportation doesnot include preparation of material orpackagings for transportation,monitoring required by this part, storageof material awaiting transportation, orapplication of markings and labelsrequired for transportation.

Radiological area means any areawithin a controlled area defined in thissection as a ‘‘radiation area,’’ ‘‘highradiation area,’’ ‘‘very high radiation


area,’’ ‘‘contamination area,’’ ‘‘highcontamination area,’’ or ‘‘airborneradioactivity area.’’* * * * *

Real-time air monitoring meansmeasurement of the concentrations orquantities of airborne radioactivematerials on a continuous basis.* * * * *

Respiratory protective device meansan apparatus, such as a respirator, wornby an individual for the purpose ofreducing the individual’s intake ofairborne radioactive materials.

Sealed radioactive source means aradioactive source manufactured,obtained, or retained for the purpose ofutilizing the emitted radiation. Thesealed radioactive source consists of aknown or estimated quantity ofradioactive material contained within asealed capsule, sealed between layer(s)of non-radioactive material, or firmlyfixed to a non-radioactive surface byelectroplating or other means intendedto prevent leakage or escape of theradioactive material. Sealed radioactivesources do not include reactor fuelelements, nuclear explosive devices,and radioisotope thermoelectricgenerators.

Source leak test means a test todetermine if a sealed radioactive sourceis leaking radioactive material.* * * * *

Week means a period of sevenconsecutive days.

Year means the period of timebeginning on or near January 1 andending on or near December 31 of thatsame year used to determinecompliance with the provisions of thispart. The starting and ending date of theyear used to determine compliance maybe changed provided that the change ismade at the beginning of the year andthat no day is omitted or duplicated inconsecutive years.

(b) * * *Cumulative total effective dose

equivalent means the sum of all totaleffective dose equivalent valuesrecorded for an individual, whereavailable, for each year occupationaldose was received, beginning January 1,1989.* * * * *

Dose is a general term for absorbeddose, dose equivalent, effective doseequivalent, committed dose equivalent,committed effective dose equivalent, ortotal effective dose equivalent asdefined in this part.* * * * *

Effective dose equivalent (HΕ) meansthe summation of the products of thedose equivalent received by specifiedtissues of the body (HΤ) and the

appropriate weighting factor (wΤ)—thatis, HΕ = ΣwΤHΤ. It includes the dosefrom radiation sources internal and/orexternal to the body. For purposes ofcompliance with this part, deep doseequivalent to the whole body may beused as effective dose equivalent forexternal exposures. The effective doseequivalent is expressed in units of rem(or sievert).

External dose or exposure means thatportion of the dose equivalent receivedfrom radiation sources outside the body(i.e., ‘‘external sources’’).* * * * *

Quality factor (Q) means themodifying factor used to calculate thedose equivalent from the absorbed dose;the absorbed dose (expressed in rad orgray) is multiplied by the appropriatequality factor.

(i) The quality factors to be used fordetermining dose equivalent in rem areas follow:

QUALITY FACTORS

Radiation type Qualityfactor

X-rays, gamma rays, positrons,electrons (including tritiumbeta particles) .......................... 1

Neutrons, ≤10 keV ...................... 3Neutrons, >10 keV ...................... 10Protons and singly-charged par-

ticles of unknown energy withrest mass greater than oneatomic mass unit ..................... 10

Alpha particles and multiple-charged particles (and par-ticles of unknown charge) ofunknown energy ...................... 20

When spectral data are insufficient toidentify the energy of the neutrons, aquality factor of 10 shall be used.

(ii) When spectral data are sufficientto identify the energy of the neutrons,the following mean quality factor valuesmay be used:

QUALITY FACTORS FOR NEUTRONS

[Mean quality factors, Q̄ (maximum value in a30-cm dosimetry phantom), and values ofneutron flux density that deliver in 40 hours,a maximum dose equivalent of 0.1 rem(0.001 sievert). Where neutron energy fallsbetween listed values, the more restrictivemean quality factor shall be used.]

Neutron energy(MeV)

Meanquality fac-

tor

Neutronflux

density(cm¥2s¥1)

2.5×10¥8 thermal .. 2 6801×10¥7 ................... 2 6801×10¥6 ................... 2 5601×10¥5 ................... 2 5601×10¥4 ................... 2 5801×10¥3 ................... 2 6801×10¥2 ................... 2.5 700

QUALITY FACTORS FOR NEUTRONS—Continued

[Mean quality factors, Q̄ (maximum value in a30-cm dosimetry phantom), and values ofneutron flux density that deliver in 40 hours,a maximum dose equivalent of 0.1 rem(0.001 sievert). Where neutron energy fallsbetween listed values, the more restrictivemean quality factor shall be used.]

Neutron energy(MeV)

Meanquality fac-

tor

Neutronflux

density(cm¥2s¥1)

1×10¥1 ................... 7.5 1155×10¥1 ................... 11 271 ............................. 11 192.5 .......................... 9 205 ............................. 8 167 ............................. 7 1710 ........................... 6.5 1714 ........................... 7.5 1220 ........................... 8 1140 ........................... 7 1060 ........................... 5.5 111×10 2 ..................... 4 142×10 2 ..................... 3.5 133×10 2 ..................... 3.5 114×10 2 ..................... 3.5 10

* * * * *Total effective dose equivalent (TEDE)

means the sum of the effective doseequivalent (for external exposures) andthe committed effective dose equivalent(for internal exposures).

Weighting factor (wT) means thefraction of the overall health risk,resulting from uniform, whole bodyirradiation, attributable to specific tissue(T). The dose equivalent to tissue (HT)is multiplied by the appropriateweighting factor to obtain the effectivedose equivalent contribution from thattissue. The weighting factors are asfollows:

WEIGHTING FACTORS FOR VARIOUSORGANS AND TISSUES

Organs or tissues, T Weightingfactor, wT

Gonads ..................................... 0.25Breasts ...................................... 0.15Red bone marrow ..................... 0.12Lungs ........................................ 0.12Thyroid ...................................... 0.03Bone surfaces ........................... 0.03Remainder 1 .............................. 0.30Whole body 2 ............................. 1.00

1 ‘‘Remainder’’ means the five other organsor tissues, excluding the skin and lens of theeye, with the highest dose (e.g., liver, kidney,spleen, thymus, adrenal, pancreas, stomach,small intestine, and upper large intestine). Theweighting factor for each remaining organ ortissue is 0.06.

2 For the case of uniform external irradiationof the whole body, a weighting factor (wT)equal to 1 may be used in determination ofthe effective dose equivalent.

(c) * * *


4. Section 835.3 is amended byadding paragraph (e) as follows:

§ 835.3 General Rule

* * * * *(e) For those activities that are

required by §§ 835.102, 835.901(e),835.1202 (a), and 835.1202(b), the timeinterval to conduct these activities maybe extended by a period not to exceed30 days to accommodate schedulingneeds.

§ 835.4 [Amended]5. Section 835.4 is amended by

adding ‘‘roentgen,’’ after ‘‘rad,’’ in thefirst sentence and removing the lastsentence.

Subpart B—Management andAdministrative Requirements

6. The heading of subpart B is revisedto read as set forth above.

6a. Section 835.101 is amended byrevising paragraph (f) to read as follows,removing paragraph (g), andredesignating paragraphs (h), (i), and (j)as (g), (h), and (i) respectively; inparagraph (d), the reference to‘‘§ 835.101(i)’’ is changed to‘‘§ 835.101(h)’’.

§ 835.101 Radiation protection programs.

* * * * *(f) The RPP shall include plans,

schedules, and other measures forachieving compliance with regulationsof this part. Unless otherwise specifiedin this part, compliance withamendments to this part shall beachieved no later than 180 daysfollowing approval of the revised RPPby DOE. Compliance with therequirements of § 835.402(d) forradiobioassay program accreditationshall be achieved no later than January1, 2002.* * * * *

7. Section 835.102 is revised to readas follows:

§ 835.102 Internal audits.Internal audits of the radiation

protection program, includingexamination of program content andimplementation, shall be conductedthrough a process that ensures that allfunctional elements are reviewed noless frequently than every 36 months.

8. Section 835.103 is added asfollows:

§ 835.103 Education, training and skills.Individuals responsible for

developing and implementing measuresnecessary for ensuring compliance withthe requirements of this part shall havethe appropriate education, training, andskills to discharge these responsibilities.

9. Section 835.104 is added asfollows:

§ 835.104 Written procedures.Written procedures shall be

developed and implemented asnecessary to ensure compliance withthis part, commensurate with theradiological hazards created by theactivity and consistent with theeducation, training, and skills of theindividuals exposed to those hazards.

10. Section 835.202 is amended byrevising the section heading, revisingthe introductory text of paragraph (a),and revising paragraphs (b) and (c) toread as follows:

§ 835.202 Occupational dose limits forgeneral employees.

(a) Except for planned specialexposures conducted consistent with§ 835.204 and emergency exposuresauthorized in accordance with§ 835.1302, the occupational dosereceived by general employees shall becontrolled such that the following limitsare not exceeded in a year:* * * * *

(b) All occupational doses receivedduring the current year, except dosesresulting from planned specialexposures conducted in compliancewith § 835.204 and emergencyexposures authorized in accordancewith § 835.1302, shall be included whendemonstrating compliance with§§ 835.202(a) and 835.207.

(c) Doses from background,therapeutic and diagnostic medicalradiation, and participation as a subjectin medical research programs shall notbe included in dose records or in theassessment of compliance with theoccupational dose limits.

11. Section 835.203 is amended byrevising the section heading andparagraph (a) to read as follows and byremoving paragraph (c):

§ 835.203 Combining internal and externaldose equivalents.

(a) The total effective dose equivalentduring a year shall be determined bysumming the effective dose equivalentfrom external exposures and thecommitted effective dose equivalentfrom intakes during the year.* * * * *

12. Section 835.204 is amended byrevising paragraphs (a)(1), (a)(3), (c)(1),(c)(2) and (d) to read as follows:

§ 835.204 Planned special exposures.(a) * * *(1) The planned special exposure is

considered only in an exceptionalsituation when alternatives that mightprevent a radiological worker from

exceeding the limits in § 835.202(a) areunavailable or impractical;* * * * *

(3) Joint written approval is receivedfrom the appropriate DOE Headquartersprogram office and the SecretarialOfficer responsible for environment,safety and health matters.* * * * *

(c) * * *(1) In a year, the numerical values of

the dose limits established at§ 835.202(a); and

(2) Over the individual’s lifetime, fivetimes the numerical values of the doselimits established at § 835.202(a).

(d) Prior to a planned specialexposure, written consent shall beobtained from each individual involved.Each such written consent shall include:

(1) The purpose of the plannedoperations and procedures to be used;

(2) The estimated doses andassociated potential risks and specificradiological conditions and otherhazards which might be involved inperforming the task; and

(3) Instructions on the measures to betaken to keep the dose ALARAconsidering other risks that may bepresent.* * * * *


§ 835.207 Occupational dose limits forminors.

The dose equivalent limits for minorsoccupationally exposed to radiationand/or radioactive materials at a DOEactivity are 0.1 rem (0.001 sievert) totaleffective dose equivalent in a year and10% of the occupational dose limitsspecified at § 835.202(a)(3) and (a)(4).


§ 835.208 Limits for members of the publicentering a controlled area.

The total effective dose equivalentlimit for members of the public exposedto radiation and/or radioactive materialduring access to a controlled area is 0.1rem (0.001 sievert) in a year.

§ 835.209 [Amended]15. Section 835.209 is amended by

changing the first ‘‘to’’ to ‘‘of’’ inparagraph (a), removing paragraph (b),redesignating paragraph (c) as (b), andremoving the word ‘‘representative’’from (b)(3).

Subpart E—Monitoring of Individualsand Areas

16. The heading of Subpart E isrevised to read as set forth above.

16a. Section 835.401 is amended byremoving paragraph (b), redesignating


paragraph (c) as (b), revising paragraphs(a), introductory text, (a)(2), (a)(4), (a)(5),(a)(6), and revising in newlyredesignated paragraph (b), theintroductory text, and (b)(1) to read asfollows:

§ 835.401 General requirements.(a) Monitoring of individuals and

areas shall be performed to:(1) * * *(2) Document radiological conditions;(3) * * *(4) Detect the gradual buildup of

radioactive material;(5) Verify the effectiveness of

engineering and process controls incontaining radioactive material andreducing radiation exposure; and

(6) Identify and control potentialsources of individual exposure toradiation and/or radioactive material.

(b) Instruments and equipment usedfor monitoring shall be:

(1) Periodically maintained andcalibrated on an established frequency;* * * * *


§ 835.402 Individual monitoring.(a) For the purpose of monitoring

individual exposures to externalradiation, personnel dosimeters shall beprovided to and used by:

(1) Radiological workers who, undertypical conditions, are likely to receiveone or more of the following:

(i) An effective dose equivalent to thewhole body of 0.1 rem (0.001 sievert) ormore in a year;

(ii) A shallow dose equivalent to theskin or to any extremity of 5 rems (0.05sievert) or more in a year;

(iii) A lens of the eye dose equivalentof 1.5 rems (0.015 sievert) or more in ayear;

(2) Declared pregnant workers whoare likely to receive from externalsources a dose equivalent to theembryo/fetus in excess of 10 percent ofthe limit at § 835.206(a);

(3) Occupationally exposed minorslikely to receive a dose in excess of 50percent of the applicable limits at§ 835.207 in a year from externalsources;

(4) Members of the public entering acontrolled area likely to receive a dosein excess of 50 percent of the limit at§ 835.208 in a year from externalsources; and

(5) Individuals entering a high or veryhigh radiation area.

(b) External dose monitoring programsimplemented to demonstratecompliance with § 835.402(a) shall beadequate to demonstrate compliancewith the dose limits established insubpart C of this part and shall be:

(1) Accredited, or excepted fromaccreditation, in accordance with theDOE Laboratory Accreditation Programfor Personnel Dosimetry; or

(2) Determined by the SecretarialOfficer responsible for environment,safety and health matters to haveperformance substantially equivalent tothat of programs accredited under theDOE Laboratory Accreditation Programfor Personnel Dosimetry.

(c) For the purpose of monitoringindividual exposures to internalradiation, internal dosimetry programs(including routine bioassay programs)shall be conducted for:

(1) Radiological workers who, undertypical conditions, are likely to receivea committed effective dose equivalent of0.1 rem (0.001 sievert) or more from alloccupational radionuclide intakes in ayear;

(2) Declared pregnant workers likelyto receive an intake or intakes resultingin a dose equivalent to the embryo/fetusin excess of 10 percent of the limitstated at § 835.206(a);

(3) Occupationally exposed minorswho are likely to receive a dose inexcess of 50 percent of the applicablelimit stated at § 835.207 from allradionuclide intakes in a year; or

(4) Members of the public entering acontrolled area likely to receive a dosein excess of 50 percent of the limitstated at § 835.208 from all radionuclideintakes in a year.

(d) Internal dose monitoring programsimplemented to demonstratecompliance with § 835.402(c) shall beadequate to demonstrate compliancewith the dose limits established insubpart C of this part and shall be:

(1) Accredited, or excepted fromaccreditation, in accordance with theDOE Laboratory Accreditation Programfor Radiobioassay; or,

(2) Determined by the SecretarialOfficer responsible for environment,safety and health matters to haveperformance substantially equivalent tothat of programs accredited under theDOE Laboratory Accreditation Programfor Radiobioassy.


§ 835.403 Air monitoring.(a) Monitoring of airborne

radioactivity shall be performed:(1) Where an individual is likely to

receive an exposure of 40 or more DAC-hours in a year; or

(2) As necessary to characterize theairborne radioactivity hazard whererespiratory protective devices forprotection against airborneradionuclides have been prescribed.

(b) Real-time air monitoring shall beperformed as necessary to detect and

provide warning of airborneradioactivity concentrations thatwarrant immediate action to terminateinhalation of airborne radioactivematerial.

§ 835.404 [Reserved]19. Section 835.404 is removed and

reserved.20. Section 835.405 is added to

subpart E to read as follows:

§ 835.405 Receipt of packages containingradioactive material.

(a) If packages containing quantities ofradioactive material in excess of a TypeA quantity (as defined at 10 CFR 71.4)are expected to be received fromradioactive material transportation,arrangements shall be made to either:

(1) Take possession of the packagewhen the carrier offers it for delivery; or

(2) Receive notification as soon aspracticable after arrival of the package atthe carrier’s terminal and to takepossession of the package expeditiouslyafter receiving such notification.

(b) Upon receipt from radioactivematerial transportation, externalsurfaces of packages known to containradioactive material shall be monitoredif the package:

(1) Is labeled with a RadioactiveWhite I, Yellow II, or Yellow III label (asspecified at 49 CFR 172.403 and172.436–440); or

(2) Has been transported as lowspecific activity material (as defined at10 CFR 71.4) on an exclusive usevehicle (as defined at 10 CFR 71.4); or

(3) Has evidence of degradation, suchas packages that are crushed, wet, ordamaged.

(c) The monitoring required byparagraph (b) of this section shallinclude:

(1) Measurements of removablecontamination levels, unless thepackage contains only special form (asdefined at 10 CFR 71.4) or gaseousradioactive material; and

(2) Measurements of the radiationlevels, unless the package contains lessthan a Type A quantity (as defined at 10CFR 71.4) of radioactive material.

(d) The monitoring required byparagraph (b) of this section shall becompleted as soon as practicablefollowing receipt of the package, but notlater than 8 hours after the beginning ofthe working day following receipt of thepackage.

Subpart F—Entry Control Program

21. Section 835.501 is amended byrevising paragraph (d) as follows:

§ 835.501 Radiological areas.

* * * * *


(d) Written authorizations shall berequired to control entry into andperform work within radiological areas.These authorizations shall specifyradiation protection measurescommensurate with the existing andpotential hazards.

22. At § 835.502, paragraphs (a), (b),and (c) are redesignated as paragraphs(b), (c), and (d) respectively; theparagraph heading of redesignatedparagraph (b) is revised; a newparagraph (a) is added and redesignatedparagraphs (b)(2) and (c) are revised asfollows:

§ 835.502 High and very high radiationareas.

(a) The following measures shall beimplemented for each entry into a highradiation area:

(1) The area shall be monitored asnecessary during access to determinethe exposure rates to which theindividuals are exposed; and

(2) Each individual shall bemonitored by a supplemental dosimetrydevice or other means capable ofproviding an immediate estimate of theindividual’s integrated deep doseequivalent during the entry.

(b) Physical controls. * * *(1) * * *(2) A device that functions

automatically to prevent use oroperation of the radiation source or fieldwhile individuals are in the area;* * * * *

(c) Very high radiation areas. Inaddition to the above requirements,additional measures shall beimplemented to ensure individuals arenot able to gain unauthorized orinadvertent access to very high radiationareas.

Subpart G—Posting and Labeling


§ 835.601 General requirements.

(a) Except as otherwise provided inthis subpart, postings and labelsrequired by this subpart shall includethe standard radiation warning trefoil inblack or magenta imposed upon ayellow background.

(b) Signs required by this subpartshall be clearly and conspicuouslyposted and may include radiologicalprotection instructions.

(c) The posting and labelingrequirements in this subpart may bemodified to reflect the specialconsiderations of DOE activitiesconducted at private residences orbusinesses. Such modifications shallprovide the same level of protection to

individuals as the existing provisions inthis subpart.

24. Section 835.602 is amended byrevising paragraph (a) to read as follows:

§ 835.602 Controlled areas.(a) Each access point to a controlled

area (as defined at § 835.2) shall beposted whenever radiological areas orradioactive material areas exist in thearea. Individuals who enter onlycontrolled areas without enteringradiological areas or radioactivematerial areas are not expected toreceive a total effective dose equivalentof more than 0.1 rem (0.001 sievert) ina year.* * * * *


§ 835.603 Radiological areas andradioactive material areas.

Each access point to radiological areasand radioactive material areas (asdefined at § 835.2) shall be posted withconspicuous signs bearing the wordingprovided in this section.

(a) Radiation area. The words‘‘Caution, Radiation Area’’ shall beposted at each radiation area.

(b) High radiation area. The words‘‘Caution, High Radiation Area’’ or‘‘Danger, High Radiation Area’’ shall beposted at each high radiation area.

(c) Very high radiation area. Thewords ‘‘Grave Danger, Very HighRadiation Area’’ shall be posted at eachvery high radiation area.

(d) Airborne radioactivity area. Thewords ‘‘Caution, Airborne RadioactivityArea’’ or ‘‘Danger, AirborneRadioactivity Area’’ shall be posted ateach airborne radioactivity area.

(e) Contamination area. The words‘‘Caution, Contamination Area’’ shall beposted at each contamination area.

(f) High contamination area. Thewords ‘‘Caution, High ContaminationArea’’ or ‘‘Danger, High ContaminationArea’’ shall be posted at each highcontamination area.

(g) Radioactive material area. Thewords ‘‘Caution, RadioactiveMaterial(s)’’ shall be posted at eachradioactive material area.

26. Section 835.604 is added tosubpart G to read as follows:

§ 835.604 Exceptions to postingrequirements.

(a) Areas may be excepted from theposting requirements of § 835.603 forperiods of less than 8 continuous hourswhen placed under continuousobservation and control of an individualknowledgeable of, and empowered toimplement, required access andexposure control measures.

(b) Areas may be excepted from theradioactive material area postingrequirements of § 835.603(g) when:

(1) Posted in accordance with§§ 835.603(a) through (f); or

(2) Each item or container ofradioactive material is labeled inaccordance with this subpart such thatindividuals entering the area are madeaware of the hazard; or

(3) The radioactive material ofconcern consists solely of structures orinstalled components which have beenactivated (i.e., such as by being exposedto neutron radiation or particlesproduced by an accelerator).

(c) Areas containing only packagesreceived from radioactive materialtransportation labeled and in non-degraded condition need not be postedin accordance with § 835.603 until thepackages are monitored in accordancewith § 835.405.


§ 835.605 Labeling items and containers.Except as provided at § 835.606, each

item or container of radioactive materialshall bear a durable, clearly visible labelbearing the standard radiation warningtrefoil and the words ‘‘Caution,Radioactive Material’’ or ‘‘Danger,Radioactive Material.’’ The label shallalso provide sufficient information topermit individuals handling, using, orworking in the vicinity of the items orcontainers to take precautions to avoidor control exposures.


§ 835.606 Exceptions to labelingrequirements.

(a) Items and containers may beexcepted from the radioactive materiallabeling requirements of § 835.605when:

(1) Used, handled, or stored in areasposted and controlled in accordancewith this subpart and sufficientinformation is provided to permitindividuals to take precautions to avoidor control exposures; or

(2) The quantity of radioactivematerial is less than one tenth of thevalues specified in appendix E of thispart; or

(3) Packaged, labeled, and marked inaccordance with the regulations of theDepartment of Transportation or DOEOrders governing radioactive materialtransportation; or

(4) Inaccessible, or accessible only toindividuals authorized to handle or usethem, or to work in the vicinity; or

(5) Installed in manufacturing,process, or other equipment, such asreactor components, piping, and tanks;or


(6) The radioactive material consistssolely of nuclear weapons or theircomponents.

(b) Radioactive material labels appliedto sealed radioactive sources may beexcepted from the color specifications of§ 835.601(a).

Subpart H—Records

29. In § 835.702, paragraphs (a), (b),(c), (d), and (e) are revised to read asfollows:

§ 835.702 Individual monitoring records.

(a) Records shall be maintained todocument doses received by allindividuals for whom monitoring wasrequired pursuant to § 835.402 and todocument doses received duringplanned special exposures, unplanneddoses exceeding the monitoringthresholds of § 835.402, and authorizedemergency exposures.

(b) The results of individual externaland internal dose monitoring that isperformed, but not required by§ 835.402, shall be recorded. Recordingof non-uniform shallow dose equivalentto the skin is not required if the dose isless than 2 percent of the limit specifiedfor the skin at § 835.202(a)(4).

(c) The records required by thissection shall:

(1) Be sufficient to evaluatecompliance with subpart C of this part;

(2) Be sufficient to provide doseinformation necessary to completereports required by subpart I of this part;

(3) Include the following quantitiesfor external dose received during theyear:

(i) The effective dose equivalent fromexternal sources of radiation (deep doseequivalent may be used as effective doseequivalent for external exposure);

(ii) The lens of the eye doseequivalent;

(iii) The shallow dose equivalent tothe skin; and

(iv) The shallow dose equivalent tothe extremities.

(4) Include the following informationfor internal dose resulting from intakesreceived during the year:

(i) Committed effective doseequivalent;

(ii) Committed dose equivalent to anyorgan or tissue of concern; and

(iii) Identity of radionuclides.(5) Include the following quantities

for the summation of the external andinternal dose:

(i) Total effective dose equivalent in ayear;

(ii) For any organ or tissue assignedan internal dose during the year, thesum of the deep dose equivalent fromexternal exposures and the committed

dose equivalent to that organ or tissue;and

(iii) Cumulative total effective doseequivalent.

(6) Include the dose equivalent to theembryo/fetus of a declared pregnantworker.

(d) Documentation of all occupationaldoses received during the current year,except for doses resulting from plannedspecial exposures conducted incompliance with § 835.204 andemergency exposures authorized inaccordance with § 835.1302(d), shall beobtained to demonstrate compliancewith § 835.202(a). If complete recordsdocumenting previous occupationaldose during the year cannot be obtained,a written estimate signed by theindividual may be accepted todemonstrate compliance.

(e) For radiological workers whoseoccupational dose is monitored inaccordance with § 835.402, reasonableefforts shall be made to obtain completerecords of prior years occupationalinternal and external doses.* * * * *

30. In § 835.703, paragraphs (a), (b),(c), and (d) are revised to read asfollows:

§ 835.703 Other monitoring records.

* * * * *(a) Results of monitoring for radiation

and radioactive material as required bysubparts E and L of this part, except formonitoring required by § 835.1102(d);

(b) Results of monitoring used todetermine individual occupational dosefrom external and internal sources;

(c) Results of monitoring for therelease and control of material andequipment as required by § 835.1101;and

(d) Results of maintenance andcalibration performed on instrumentsand equipment as required by§ 835.401(b).

31. Section 835.704, paragraph (a) isamended by removing the reference to’’, 835.902, and 835.903’’; paragraphs (d)and (e) are revised and a new paragraph(f) is added as follows:

§ 835.704 Administrative records.

* * * * *(d) Written declarations of pregnancy,

including the estimated date ofconception, and revocations ofdeclarations of pregnancy shall bemaintained.

(e) Changes in equipment, techniques,and procedures used for monitoringshall be documented.

(f) Records shall be maintained asnecessary to demonstrate compliancewith the requirements of §§ 835.1201and 835.1202 for sealed radioactive

source control, inventory, and sourceleak tests.

Subpart I—Reports to Individuals

32. Section 835.801, paragraph (a) isrevised to read as follows:

§ 835.801 Reports to individuals.(a) Radiation exposure data for

individuals monitored in accordancewith § 835.402 shall be reported asspecified in this section. Theinformation shall include the datarequired under § 835.702(c). Eachnotification and report shall be inwriting and include: the DOE site orfacility name, the name of theindividual, and the individual’s socialsecurity number, employee number, orother unique identification number.* * * * *

Subpart J—Radiation Safety Training

33. In subpart J, § 835.901 is revisedto read as follows:

§ 835.901 Radiation safety training.(a) Each individual shall complete

radiation safety training on the topicsestablished at § 835.901(c)commensurate with the hazards in thearea and the required controls:

(1) Before being permitted unescortedaccess to controlled areas; and

(2) Before receiving occupational doseduring access to controlled areas at aDOE site or facility.

(b) Each individual shall demonstrateknowledge of the radiation safetytraining topics established at§ 835.901(c), commensurate with thehazards in the area and requiredcontrols, by successful completion of anexamination and performancedemonstrations:

(1) Before being permitted unescortedaccess to radiological areas; and

(2) Before performing unescortedassignments as a radiological worker.

(c) Radiation safety training shallinclude the following topics, to theextent appropriate to each individual’sprior training, work assignments, anddegree of exposure to potentialradiological hazards:

(1) Risks of exposure to radiation andradioactive materials, including prenatalradiation exposure;

(2) Basic radiological fundamentalsand radiation protection concepts;

(3) Physical design features,administrative controls, limits, policies,procedures, alarms, and other measuresimplemented at the facility to managedoses and maintain doses ALARA,including both routine and emergencyactions;

(4) Individual rights andresponsibilities as related to


implementation of the facility radiationprotection program;

(5) Individual responsibilities forimplementing ALARA measuresrequired by § 835.101; and

(6) Individual exposure reports thatmay be requested in accordance with§ 835.801.

(d) When an escort is used in lieu oftraining in accordance with paragraph(a) or (b) of this section, the escort shall:

(1) Have completed radiation safetytraining, examinations, and performancedemonstrations required for entry to thearea and performance of the work; and

(2) Ensure that all escortedindividuals comply with thedocumented radiation protectionprogram.

(e) Radiation safety training shall beprovided to individuals when there is asignificant change to radiationprotection policies and procedures thatmay affect the individual and atintervals not to exceed 24 months. Suchtraining provided for individuals subjectto the requirements of § 835.901(b)(1)and (b)(2) shall include successfulcompletion of an examination.

§§ 835.902 and 835.903 [Removed andReserved]

34. Sections 835.902 and 835.903 ofsubpart J are removed and reserved.

Subpart K—Design and Control

35. In Subpart K, section 835.1002 isamended by changing the word ‘‘old’’ to‘‘existing’’, and section 835.1001 isrevised to read as follows:

§ 835.1001 Design and control.(a) Measures shall be taken to

maintain radiation exposure incontrolled areas ALARA throughphysical design features andadministrative control. The primarymethods used shall be physical designfeatures (e.g., confinement, ventilation,remote handling, and shielding).Administrative controls shall beemployed only as supplementalmethods to control radiation exposure.

(b) For specific activities where use ofphysical design features is demonstratedto be impractical, administrativecontrols shall be used to maintainradiation exposures ALARA.


§ 835.1003 Workplace controls.During routine operations, the

combination of physical design featuresand administrative controls shallprovide that:

(a) The anticipated occupational doseto general employees shall not exceedthe limits established at § 835.202; and

(b) The ALARA process is utilized forpersonnel exposures to ionizingradiation.

Subpart L—Radioactive ContaminationControl

37. The heading of subpart L isrevised to read as set forth above.

37a. Section 835.1101 is revised and§ 835.1102 is added to read as follows:

§ 835.1101 Control of material andequipment.

(a) Except as provided in paragraphs(b) and (c) of this section, material andequipment in contamination areas, highcontamination areas, and airborneradioactivity areas shall not be releasedto a controlled area if:

(1) Removable surface contaminationlevels on accessible surfaces exceed theremovable surface contamination valuesspecified in appendix D of this part; or

(2) Prior use suggests that theremovable surface contamination levelson inaccessible surfaces are likely toexceed the removable surfacecontamination values specified inappendix D of this part.

(b) Material and equipment exceedingthe removable surface contaminationvalues specified in appendix D of thispart may be conditionally released formovement on-site from one radiologicalarea for immediate placement in anotherradiological area only if appropriatemonitoring is performed andappropriate controls for the movementare established and exercised.

(c) Material and equipment with fixedcontamination levels that exceed thetotal contamination values specified inappendix D of this part may be releasedfor use in controlled areas outside ofradiological areas only under thefollowing conditions:

(1) Removable surface contaminationlevels are below the removable surfacecontamination values specified inappendix D of this part; and

(2) The material or equipment isroutinely monitored and clearly markedor labeled to alert personnel of thecontaminated status.

§ 835.1102 Control of areas.

(a) Appropriate controls shall bemaintained and verified which preventthe inadvertent transfer of removablecontamination to locations outside ofradiological areas under normaloperating conditions.

(b) Any area in which contaminationlevels exceed the values specified inappendix D of this part shall becontrolled in a manner commensuratewith the physical and chemicalcharacteristics of the contaminant, the

radionuclides present, and the fixed andremovable surface contamination levels.

(c) Areas accessible to individualswhere the measured total surfacecontamination levels exceed, but theremovable surface contamination levelsare less than, corresponding surfacecontamination values specified inappendix D of this part, shall becontrolled as follows when locatedoutside of radiological areas:

(1) The area shall be routinelymonitored to ensure the removablesurface contamination level remainsbelow the removable surfacecontamination values specified inappendix D of this part; and

(2) The area shall be conspicuouslymarked to warn individuals of thecontaminated status.

(d) Individuals exiting contamination,high contamination, or airborneradioactivity areas shall be monitored,as appropriate, for the presence ofsurface contamination.

(e) Protective clothing shall berequired for entry to areas in whichremovable contamination exists at levelsexceeding the removable surfacecontamination values specified inappendix D of this part.

38. Subpart M is added, consisting of§§ 835.1201 and 835.1202, to read asfollows:

Subpart M—Sealed Radioactive SourceControl

§ 835.1201 Sealed radioactive sourcecontrol.

Sealed radioactive sources shall beused, handled, and stored in a mannercommensurate with the hazardsassociated with operations involving thesources.

§ 835.1202 Accountable sealed radioactivesources.

(a) Each accountable sealedradioactive source shall be inventoriedat intervals not to exceed six months.This inventory shall:

(1) Establish the physical location ofeach accountable sealed radioactivesource;

(2) Verify the presence and adequacyof associated postings and labels; and

(3) Establish the adequacy of storagelocations, containers, and devices.

(b) Except for sealed radioactivesources consisting solely of gaseousradioactive material or tritium, eachaccountable sealed radioactive sourceshall be subject to a source leak testupon receipt, when damage issuspected, and at intervals not to exceedsix months. Source leak tests shall becapable of detecting radioactive materialleakage equal to or exceeding 0.005microcurie.


(c) Notwithstanding the requirementsof paragraph (b) of this section, anaccountable sealed radioactive source isnot subject to periodic source leaktesting if that source has been removedfrom service. Such sources shall bestored in a controlled location, subjectto periodic inventory as required byparagraph (a) of this section, and subjectto source leak testing prior to beingreturned to service.

(d) Notwithstanding the requirementsof paragraphs (a) and (b) of this section,an accountable sealed radioactivesource is not subject to periodicinventory and source leak testing if thatsource is located in an area that isunsafe for human entry or otherwiseinaccessible.

(e) An accountable sealed radioactivesource found to be leaking radioactivematerial shall be controlled in a mannerthat minimizes the spread of radioactivecontamination.

Subpart N—Emergency ExposureSituations

39. In § 835.1301, paragraphs (a),introductory text, (b), (c), and (d) arerevised to read as follows:

§ 835.1301 General provisions.

(a) A general employee whoseoccupational dose has exceeded thenumerical value of any of the limitsspecified in § 835.202 as a result of anauthorized emergency exposure may bepermitted to return to work inradiological areas during the currentyear providing that all of the followingconditions are met:* * * * *

(b) All doses exceeding the limitsspecified in § 835.202 shall be recordedin the affected individual’s occupationaldose record.

(c) When the conditions under whicha dose was received in excess of thelimits specified in § 835.202, exceptthose received in accordance with§ 835.204, have been eliminated,operating management shall notify theHead of the responsible DOE fieldorganization.

(d) Operations after a dose wasreceived in excess of the limits specifiedin § 835.202, except those received inaccordance with § 835.204, may beresumed only with the approval of DOE.

40. Section 835.1302 is revised inparagraphs (b), (c), and (d) as follows:

§ 835.1302 Emergency exposuresituations.

* * * * *(b) Operating management shall

weigh actual and potential risks againstthe benefits to be gained.

(c) No individual shall be required toperform a rescue action that mightinvolve substantial personal risk.

(d) Each individual authorized toperform emergency actions likely toresult in occupational doses exceedingthe values of the limits provided at§ 835.202(a) shall be trained inaccordance with § 835.901(b) andbriefed beforehand on the known oranticipated hazards to which theindividual will be subjected.* * * * *

41. At § 835.1304, paragraphs (a) and(b)(1), the word ‘‘personnel’’ is revisedto read ‘‘individuals’’ and paragraph(b)(4) is revised as follows:

§ 835.1304 Nuclear accident dosimetry.

* * * * *(b) * * *(4) Personal nuclear accident

dosimeters.42. Appendix A of Part 835 is

amended by removing footnote 5 fromthe Footnotes for Appendix A and,adding the following two paragraphs atthe beginning of the introductory text:

Appendix A to Part 835—Derived AirConcentrations (DAC) for ControllingRadiation Exposure to Workers at DOEFacilities

The data presented in appendix A are tobe used for controlling individual internaldoses in accordance with § 835.209,identifying the need for air monitoring inaccordance with § 835.403, and identifyingthe need for posting of airborne radioactivityareas in accordance with § 835.603(d).

The DAC values are given for individualradionuclides. For known mixtures ofradionuclides, determine the sum of the ratioof the observed concentration of a particularradionuclide and its corresponding DAC forall radionuclides in the mixture. If this sumexceeds unity (1), then the DAC has beenexceeded. For unknown radionuclides, themost restrictive DAC (lowest value) for thoseisotopes not known to be absent shall beused.

* * * * *

Appendix B—[Removed and Reserved]

43. Appendix B to Part 835 is removed andreserved.

44. Appendix C to Part 835 is amended byremoving the entries for the radionuclidesRn-220 and Rn-222 and their correspondinghalf-lives and air immersion DACs from thetable and revising the introductory textpreceding the table as follows:

Appendix C to Part 835—Derived AirConcentration (DAC) for Workers FromExternal Exposure During Immersion ina Contaminated Atmospheric Cloud

* * * * *a. The data presented in appendix C are to

be used for controlling occupationalexposures in accordance with § 835.209,

identifying the need for air monitoring inaccordance with § 835.403, and identifyingthe need for posting of airborne radioactivityareas in accordance with § 835.603(d).

b. The air immersion DAC values shown inthis appendix are based on a stochastic doselimit of 5 rems (0.05 Sv) per year or anonstochastic (organ) dose limit of 50 rems(0.5 Sv) per year. Four columns ofinformation are presented: (1) Radionuclide;(2) half-life in units of seconds (s), minutes(min), hours (h), days (d), or years (yr); (3)air immersion DAC in units of µCi/ml; and(4) air immersion DAC in units of Bq/m3. Thedata are listed by radionuclide in order ofincreasing atomic mass. The air immersionDACs were calculated for a continuous,nonshielded exposure via immersion in asemi-infinite atmospheric cloud. The DACslisted in this appendix may be modified toallow for submersion in a cloud of finitedimensions.

c. The DAC value for air immersion listedfor a given radionuclide is determined eitherby a yearly limit on effective dose equivalent,which provides a limit on stochasticradiation effects, or by a limit on yearly doseequivalent to any organ, which provides alimit on nonstochastic radiation effects. Formost of the radionuclides listed, the DACvalue is determined by the yearly limit oneffective dose equivalent. Thus, the few caseswhere the DAC value is determined by theyearly limit on shallow dose equivalent tothe skin are indicated in the table by anappropriate footnote. Again, the DACs listedin this appendix account only for immersionin a semi-infinite cloud and do not accountfor inhalation or ingestion exposures.

d. Three classes of radionuclides areincluded in the air immersion DACs asdescribed below.

(1) Class 1. The first class of radionuclidesincludes selected noble gases and short-livedactivation products that occur in gaseousform. For these radionuclides, inhalationdoses are negligible compared to the externaldose from immersion in an atmosphericcloud.

(2) Class 2. The second class ofradionuclides includes those for which aDAC value for inhalation has beencalculated, but for which the DAC value forexternal exposure to a contaminatedatmospheric cloud is more restrictive (i.e.,results in a lower DAC value). Theseradionuclides generally have half-lives of afew hours or less, or are eliminated from thebody following inhalation sufficientlyrapidly to limit the inhalation dose.

(3) Class 3. The third class of radionuclidesincludes selected isotopes with relativelyshort half-lives. These radionuclidestypically have half-lives that are less than 10minutes, they do not occur as a decayproduct of a longer lived radionuclide, orthey lack sufficient decay data to permitinternal dose calculations. Theseradionuclides are also typified by aradioactive emission of highly intense, high-energy photons and rapid removal from thebody following inhalation.

e. The DAC values are given for individualradionuclides. For known mixtures ofradionuclides, determine the sum of the ratioof the observed concentration of a particular


radionuclide and its corresponding DAC forall radionuclides in the mixture. If this sumexceeds unity (1), then the DAC has beenexceeded. For unknown radionuclides, themost restrictive DAC (lowest value) for thoseisotopes not known to be absent shall beused.

* * * * *

45. Appendix D to part 835 is revisedas follows:

Appendix D to Part 835—SurfaceContamination Values

The data presented in appendix D are to beused in identifying the need for posting of

contamination and high contamination areasin accordance with § 835.603(e) and (f) andidentifying the need for surfacecontamination monitoring and control inaccordance with §§ 835.1101 and 835.1102.

SURFACE CONTAMINATION VALUES 1 IN DPM/100 CM 2

Radionuclide Removable 2 4 Total (Fixed +Removable) 2, 3

U-nat, U-235, U-238, and associated decay products .................................................................................... 7 1,000 7 5,000Transuranics, Ra-226, Ra-228, Th-230, Th-228, Pa-231, Ac-227, I-125, I-129 ............................................. 20 500Th-nat, Th-232, Sr-90, Ra-223, Ra-224, U-232, I-126, I-131, I-133 ............................................................... 200 1,000Beta-gamma emitters (nuclides with decay modes other than alpha emission or spontaneous fission) ex-

cept Sr-90 and others noted above 5 ........................................................................................................... 1,000 5,000Tritium and tritiated compounds 6 .................................................................................................................... 10,000 N/A

1 The values in this appendix, with the exception noted in footnote 5, apply to radioactive contamination deposited on, but not incorporated intothe interior or matrix of, the contaminated item. Where surface contamination by both alpha-and beta-gamma-emitting nuclides exists, the limitsestablished for alpha-and beta-gamma-emitting nuclides apply independently.

2 As used in this table, dpm (disintegrations per minute) means the rate of emission by radioactive material as determined by correcting thecounts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation.

3 The levels may be averaged over one square meter provided the maximum surface activity in any area of 100 cm 2 is less than three timesthe value specified. For purposes of averaging, any square meter of surface shall be considered to be above the surface contamination value if:(1) From measurements of a representative number of sections it is determined that the average contamination level exceeds the applicablevalue; or (2) it is determined that the sum of the activity of all isolated spots or particles in any 100 cm 2 area exceeds three times the applicablevalue.

4 The amount of removable radioactive material per 100 cm 2 of surface area should be determined by swiping the area with dry filter or softabsorbent paper, applying moderate pressure, and then assessing the amount of radioactive material on the swipe with an appropriate instru-ment of known efficiency. (Note—The use of dry material may not be appropriate for tritium.) When removable contamination on objects of sur-face area less than 100 cm 2 is determined, the activity per unit area shall be based on the actual area and the entire surface shall be wiped. It isnot necessary to use swiping techniques to measure removable contamination levels if direct scan surveys indicate that the total residual surfacecontamination levels are within the limits for removable contamination.

5 This category of radionuclides includes mixed fission products, including the Sr-90 which is present in them. It does not apply to Sr-90 whichhas been separated from the other fission products or mixtures where the Sr-90 has been enriched.

6 Tritium contamination may diffuse into the volume or matrix of materials. Evaluation of surface contamination shall consider the extent towhich such contamination may migrate to the surface in order to ensure the surface contamination value provided in this appendix is not exceed-ed. Once this contamination migrates to the surface, it may be removable, not fixed; therefore, a ‘‘Total’’ value does not apply.

7 (alpha)

46. Appendix E to Part 835 is added as follows:

Appendix E to Part 835—Values for Establishing Sealed Radioactive Source Accountability and Radioactive MaterialPosting and Labeling Requirements

The data presented in this appendix E are to be used for identifying accountable sealed radioactive sources as defined at § 835.2(a),establishing the need for radioactive material area posting in accordance with § 835.603(g), and establishing the need for radioactivematerial labeling in accordance with § 835.605.

Note: The data are listed in alphabetical order by nuclide.

Nuclide Activity(µCi) Nuclide Activity

(µCi) Nuclide Activity(µCi)

Ac-227 ......................................... 1.5E+00 H-3 .............................................. 1.6E+08 Re-184m ..................................... 1.5E+02Ag-105 ......................................... 2.1E+06 Hf-172 ......................................... 3.1E+04 Re-186m ..................................... 2.8E+05Ag-108m ...................................... 1.8E+01 Hf-175 ......................................... 1.8E+06 Rh-101 ........................................ 2.5E+05Ag-110m ...................................... 2.2E+01 Hf-178m ...................................... 4.1E+03 Rh-102 ........................................ 8.3E+04Al-26 ............................................ 1.6E+01 Hf-181 ......................................... 3.5E+02 Rh-102m ..................................... 2.1E+05Am-241 ........................................ 2.3E+01 Hf-182 ......................................... 3.0E+03 Ru-103 ........................................ 4.4E+02Am-242m ..................................... 2.4E+01 Hg-194 ........................................ 3.5E+04 Ru-106 ........................................ 2.1E+04Am-243 ........................................ 2.3E+01 Hg-203 ........................................ 4.9E+02 S-35 ............................................ 4.0E+06As-73 ........................................... 5.4E+02 Ho-166m ..................................... 2.2E+01 Sb-124 ........................................ 9.1E+01Au-195 ......................................... 4.8E+02 I-125 ........................................... 3.5E+02 Sb-125 ........................................ 6.8E+01Ba-133 ......................................... 5.2E+01 I-129 ........................................... 1.8E+02 Sc-46 .......................................... 6.2E+01Be-10 ........................................... 2.8E+04 In-114m ...................................... 7.8E+02 Se-75 .......................................... 6.4E+01Be-7 ............................................. 3.2E+03 Ir-192 .......................................... 1.4E+02 Se-79 .......................................... 1.0E+06Bi-207 .......................................... 1.7E+01 Ir-192m ....................................... 2.6E+04 Si-32 ........................................... 9.9E+03Bi-208 .......................................... 1.5E+01 Ir-194m ....................................... 2.7E+01 Sm-145 ....................................... 9.1E+05Bi-210m ....................................... 1.3E+03 K-40 ............................................ 2.8E+02 Sm-146 ....................................... 1.2E+02Bk-247 ......................................... 1.7E+01 La-137 ........................................ 1.1E+05 Sm-151 ....................................... 2.5E+05Bk-249 ......................................... 7.2E+03 Lu-173 ........................................ 4.4E+05 Sn-113 ........................................ 3.1E+02C-14 ............................................. 4.8E+06 Lu-174 ........................................ 2.5E+05 Sn-119m ..................................... 3.3E+02Ca-41 ........................................... 7.4E+06 Lu-174m ..................................... 3.9E+05 Sn-121m ..................................... 8.7E+05Ca-45 ........................................... 1.5E+06 Lu-177m ..................................... 5.8E+01 Sn-123 ........................................ 1.3E+04Cd-109 ......................................... 1.6E+02 Md-258 ....................................... 6.0E+02 Sn-126 ........................................ 1.8E+02Cd-113m ...................................... 6.5E+03 Mn-53 ......................................... 2.0E+07 Sr-85 ........................................... 1.2E+02


Nuclide Activity(µCi) Nuclide Activity

(µCi) Nuclide Activity(µCi)

Cd-115m ...................................... 1.0E+04 Mn-54 ......................................... 6.5E+01 Sr-89 ........................................... 2.4E+05Ce-139 ......................................... 2.4E+02 Mo-93 ......................................... 7.7E+01 Sr-90 ........................................... 7.7E+03Ce-141 ......................................... 2.4E+03 Na-22 .......................................... 1.9E+01 Ta-179 ........................................ 1.5E+06Ce-144 ......................................... 1.5E+03 Nb-91 .......................................... 7.0E+01 Ta-182 ........................................ 7.3E+01Cf-248 .......................................... 2.0E+02 Nb-91m ....................................... 3.6E+02 Tb-157 ........................................ 2.5E+03Cf-249 .......................................... 1.7E+01 Nb-92 .......................................... 1.8E+01 Tb-158 ........................................ 3.9E+04Cf-250 .......................................... 3.8E+01 Nb-93m ....................................... 4.4E+02 Tb-160 ........................................ 1.2E+02Cf-251 .......................................... 1.7E+01 Nb-94 .......................................... 2.3E+01 Tc-95m ....................................... 1.3E+02Cf-252 .......................................... 6.4E+01 Nb-95 .......................................... 3.4E+02 Tc-97 .......................................... 8.1E+01Cf-254 .......................................... 3.4E+01 Ni-59 ........................................... 7.5E+06 Tc-97m ....................................... 3.6E+02Cl-36 ............................................ 4.6E+05 Ni-63 ........................................... 3.2E+06 Tc-98 .......................................... 2.5E+01Cm-241 ........................................ 6.8E+04 Np-235 ........................................ 1.2E+02 Tc-99 .......................................... 6.8E+06Cm-242 ........................................ 5.8E+02 Np-236 ........................................ 2.2E+01 Te-121m ..................................... 1.9E+02Cm-243 ........................................ 3.3E+01 Np-237 ........................................ 1.9E+01 Te-123m ..................................... 2.8E+02Cm-244 ........................................ 4.0E+01 Os-185 ........................................ 1.4E+02 Te-125m ..................................... 4.4E+02Cm-245 ........................................ 2.2E+01 Os-194 ........................................ 1.5E+04 Te-127m ..................................... 8.0E+02Cm-246 ........................................ 2.2E+01 Pa-231 ........................................ 7.8E+00 Te-129m ..................................... 2.3E+03Cm-247 ........................................ 2.4E+01 Pb-202 ........................................ 1.0E+05 Th-228 ........................................ 2.9E+01Cm-248 ........................................ 6.0E+00 Pb-205 ........................................ 9.1E+01 Th-229 ........................................ 4.7E+00Cm-250 ........................................ 1.1E+00 Pb-210 ........................................ 9.2E+01 Th-230 ........................................ 3.1E+01Co-56 ........................................... 4.0E+01 Pd-107 ........................................ 7.8E+05 Th-232 ........................................ 6.1E+00Co-57 ........................................... 2.3E+02 Pm-143 ....................................... 1.3E+02 Ti-44 ........................................... 1.6E+02Co-58 ........................................... 1.4E+02 Pm-144 ....................................... 2.9E+01 Tl-204 ......................................... 2.2E+04Co-60 ........................................... 1.8E+01 Pm-145 ....................................... 2.6E+02 Tm-170 ....................................... 8.4E+03Cs-134 ......................................... 2.7E+01 Pm-146 ....................................... 4.5E+01 Tm-171 ....................................... 2.8E+04Cs-135 ......................................... 2.2E+06 Pm-147 ....................................... 2.5E+05 U-232 .......................................... 1.5E+01Cs-137 ......................................... 6.0E+01 Pm-148m .................................... 1.1E+02 U-233 .......................................... 7.4E+01Dy-159 ......................................... 4.1E+06 Po-209 ........................................ 6.3E+03 U-234 .......................................... 7.5E+01Es-254 ......................................... 6.3E+01 Po-210 ........................................ 1.1E+03 U-235 .......................................... 6.7E+01Es-255 ......................................... 4.6E+04 Pt-193 ......................................... 4.4E+07 U-236 .......................................... 8.0E+01Eu-148 ......................................... 7.0E+05 Pu-236 ........................................ 6.9E+01 U-238 .......................................... 8.4E+01Eu-149 ......................................... 5.3E+06 Pu-237 ........................................ 3.3E+02 V-49 ............................................ 2.9E+07Eu-152 ......................................... 3.1E+01 Pu-238 ........................................ 2.5E+01 W-181 ......................................... 1.1E+03Eu-154 ......................................... 3.1E+01 Pu-239 ........................................ 2.3E+01 W-185 ......................................... 3.9E+06Eu-155 ......................................... 3.7E+02 Pu-240 ........................................ 2.3E+01 W-188 ......................................... 6.4E+04Fe-55 ........................................... 3.7E+06 Pu-241 ........................................ 1.2E+03 Y-88 ............................................ 3.4E+01Fe-59 ........................................... 2.0E+02 Pu-242 ........................................ 2.4E+01 Y-91 ............................................ 5.0E+04Fe-60 ........................................... 1.3E+04 Pu-244 ........................................ 2.5E+01 Yb-169 ........................................ 5.5E+02Fm-257 ........................................ 4.3E+02 Ra-226 ........................................ 1.2E+03 Zn-65 .......................................... 1.1E+02Gd-146 ......................................... 2.6E+05 Ra-228 ........................................ 2.1E+03 Zr-88 ........................................... 1.2E+02Gd-148 ......................................... 3.0E+01 Rb-83 .......................................... 9.2E+01 Zr-93 ........................................... 3.1E+04Gd-151 ......................................... 1.1E+06 Rb-84 .......................................... 2.0E+02 Zr-95 ........................................... 2.0E+02Gd-153 ......................................... 2.1E+02 Re-183 ........................................ 5.4E+02Ge-68 ........................................... 5.7E+02 Re-184 ........................................ 2.6E+02

Any alpha emitting radionuclide not listedabove and mixtures of alpha emitters ofunknown composition have a value of 10microcuries.

Any radionuclide other than alphaemitting radionuclides not listed above andmixtures of beta emitters of unknowncomposition have a value of 100 microcuries.

Note: Where there is involved acombination of radionuclides in knownamounts, derive the value for thecombination as follows: determine, for eachradionuclide in the combination, the ratiobetween the quantity present in thecombination and the value otherwiseestablished for the specific radionuclide

when not in combination. If the sum of suchratios for all radionuclides in thecombination exceeds unity (1), then theaccountability criterion has been exceeded.

[FR Doc. 98–27366 Filed 11–3–98; 8:45 am]

BILLING CODE 6450–01–P

Documents

Part III 10 CFR 835, Occupational Radiation Protection; Final. · established in DOE Order 5480.11, ‘‘Radiation Protection for Occupational Workers.’’ In addition, DOE codified