Pharma App 1997

8/3/2019 Pharma App 1997

1/53

Pharmaceutical Industry Federal Statutes and Regulations

VI. SUMMARY OF APPLICABLE FEDERAL STATUTES AND REGULATIONS

This section discusses the Federal regulations that may apply to this sector.

The purpose of this section is to highlight and briefly describe the applicableFederal requirements, and to provide citations for more detailed information.

The three following sections are included:

Section VI.A contains a general overview of major statutesSection VI.B contains a list of regulations specific to this industrySection VI.C contains a list of pending and proposed regulationsSection VI.D contains a general overview of other federal statutes applicable to the industrySection VI.E. contains a general overview of state regulations affecting theindustry.The descriptions within Section VI are intended solely for generalinformation. Depending upon the nature or scope of the activities at a

particular facility, these summaries may or may not necessarily describe allapplicable environmental requirements. Moreover, they do not constituteformal interpretations or clarifications of the statutes and regulations. For

further information readers should consult the Code of Federal Regulationsand state or local regulatory agencies. EPA Hotline contacts are alsoprovided for each major statute.

VI.A. General Description of Major Statutes

Resource Conservation And Recovery Act (RCRA)

RCRA of 1976, which amended the Solid Waste Disposal Act, addresses

solid (Subtitle D) and hazardous (Subtitle C) waste management activities.The Hazardous and Solid Waste Amendments (HSWA) of 1984 strengthenedRCRAs waste management provisions and added Subtitle I, which governs

underground storage tanks (USTs).

Regulations promulgated pursuant to Subtitle C of RCRA (40 CFR Parts

260-299) establish a cradle-to-grave system governing hazardous wastefrom the point of generation to disposal. RCRA hazardous wastes include the

specific materials listed in the regulations (commercial chemical products,designated with the code "P" or "U"; hazardous wastes from specificindustries/sources, designated with the code "K"; or hazardous wastes from

non-specific sources, designated with the code "F") or materials whichexhibit a hazardous waste characteristic (ignitability, corrosivity, reactivity,or toxicity and designated with the code "D").

Regulated entities that generate hazardous waste are subject to wasteaccumulation, manifesting, and record keeping standards. Facilities must

Sector Notebook Project 97 September 1997

8/3/2019 Pharma App 1997

2/53


obtain a permit either from EPA or from a State agency which EPA hasauthorized to implement the permitting program if they store hazardouswastes for more than 90 days before treatment or disposal. Facilities may

treat hazardous waste stored in less-than-ninety-day tanks or containerswithout a permit. Subtitle C permits contain general facility standards such

as contingency plans, emergency procedures, record keeping and reportingrequirements, financial assurance mechanisms, and unit-specific standards.RCRA also contains provisions (40 CFR Part 264 Subpart S and 264.10) forconducting corrective actions which govern the cleanup of releases of

hazardous waste or constituents from solid waste management units atRCRA-regulated facilities.

Although RCRA is a Federal statute, many States implement the RCRAprogram. Currently, EPA has delegated its authority to implement variousprovisions of RCRA to 47 of the 50 States and to two U.S. territories.

Delegation has not been given to Alaska, Hawaii, or Iowa.

Most RCRA requirements are not industry specific but apply to any companythat generates, transports, treats, stores, or disposes of hazardous waste. Hereare some important RCRA regulatory requirements:

Identification of Solid and Hazardous Wastes (40 CFR Part 261)lays out the procedure every generator should follow to determinewhether the material in question created is considered a hazardous

waste, solid waste, or is exempted from regulation.

Standards for Generators of Hazardous Waste (40 CFR Part 262)establishes the responsibilities of hazardous waste generatorsincluding obtaining an EPA ID number, preparing a manifest,ensuring proper packaging and labeling, meeting standards for waste

accumulation units, and record keeping and reporting requirements.Generators can accumulate hazardous waste for up to 90 days (or 180days depending on the amount of waste generated) without obtaining

a permit.

Land Disposal Restrictions (LDRs) (40 CFR Part 268) areregulations prohibiting the disposal of hazardous waste on land

without prior treatment. Under the LDRs program, materials mustmeet LDR treatment standards prior to placement in a RCRA land

disposal unit (landfill, land treatment unit, waste pile, or surfaceimpoundment). Generators of waste subject to the LDRs mustprovide notification of such to the designated TSD facility to ensure

proper treatment prior to disposal.

Used Oil Management Standards (40 CFR Part 279) impose


8/3/2019 Pharma App 1997

3/53


management requirements affecting the storage, transportation,burning, processing, and re-refining of the used oil. For parties thatmerely generate used oil, regulations establish storage standards. For

a party considered a used oil processor, re-refiner, burner, or marketer(one who generates and sells off-specification used oil), additional

tracking and paperwork requirements must be satisfied.

RCRA contains unit-specific standards for all units used to store,

treat, or dispose of hazardous waste, including Tanks and

Containers. Tanks and containers used to store hazardous waste

with a high volatile organic concentration must meet emissionstandards under RCRA. Regulations (40 CFR Part 264-265, SubpartCC) require generators to test the waste to determine the

concentration of the waste, to satisfy tank and container emissionsstandards, and to inspect and monitor regulated units. Theseregulations apply to all facilities that store such waste, including large

quantity generators accumulating waste prior to shipment off-site.

Underground Storage Tanks (USTs) containing petroleum and

hazardous substances are regulated under Subtitle I of RCRA.Subtitle I regulations (40 CFR Part 280) contain tank design andrelease detection requirements, as well as financial responsibility and

corrective action standards for USTs. The UST program alsoincludes upgrade requirements for existing tanks that must be met byDecember 22, 1998.

Boilers and Industrial Furnaces (BIFs) that use or burn fuelcontaining hazardous waste must comply with strict design andoperating standards. BIF regulations (40 CFR Part 266, Subpart H)

address unit design, provide performance standards, require emissionsmonitoring, and restrict the type of waste that may be burned.

EPA's RCRA/Superfund/UST Hotline, at (800) 424-9346, responds to

questions and distributes guidance regarding all RCRA regulations. TheRCRA Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., ET, excluding

Federal holidays.

Comprehensive Environmental Response, Compensation, And Liability Act (CERCLA)

CERCLA, a 1980 law commonly known as Superfund, authorizes EPA to

respond to releases, or threatened releases, of hazardous substances that mayendanger public health, welfare, or the environment. CERCLA also enablesEPA to force parties responsible for environmental contamination to clean it

up or to reimburse the Superfund for response costs incurred by EPA. TheSuperfund Amendments and Reauthorization Act (SARA) of 1986 revised


8/3/2019 Pharma App 1997

4/53


various sections of CERCLA, extended the taxing authority for Superfund,and created a free-standing law, SARA Title III, also known as theEmergency Planning and Community Right-to-Know Act (EPCRA).

The CERCLA hazardous substance release reporting regulations (40 CFR

Part 302) direct the person in charge of a facility to report to the NationalResponse Center (NRC) any environmental release of a hazardous substance

which equals or exceeds a reportable quantity. Reportable quantities aredefined and listed in 40 CFR 302.4. A release report may trigger a response

by EPA, or by one or more Federal or State emergency response authorities.

EPA implements hazardous substance responses according to proceduresoutlined in the National Oil and Hazardous Substances Pollution Contingency

Plan (NCP) (40 CFR Part 300). The NCP includes provisions for permanentcleanups, known as remedial actions, and other cleanups referred to as"removals." EPA generally takes remedial actions only at sites on the

National Priorities List (NPL), which currently includes approximately 1300sites. Both EPA and states can act at other sites; however, EPA providesresponsible parties the opportunity to conduct removal and remedial actions

and encourages community involvement throughout the Superfund responseprocess.

EPA's RCRA/Superfund and EPCRA Hotline, at (800) 424-9346, answers

questions and references guidance pertaining to the Superfund program. TheCERCLA Hotline operates weekdays from 9:00 a.m. to 6:00 p.m., ET,

excluding Federal holidays.

Emergency Planning And Community Right-To-Know Act (EPCRA)

The Superfund Amendments and Reauthorization Act (SARA) of 1986

created EPCRA, also known as SARA Title III, a statute designed to improvecommunity access to information about chemical hazards and to facilitate thedevelopment of chemical emergency response plans by State and local

governments. EPCRA required the establishment of State emergencyresponse commissions (SERCs), responsible for coordinating certainemergency response activities and for appointing local emergency planning

committees (LEPCs).

EPCRA and the EPCRA regulations (40 CFR Parts 350-372) establish four

types of reporting obligations for facilities which store or manage specifiedchemicals:

EPCRA 302 requires facilities to notify the SERC and LEPC of thepresence of any "extremely hazardous substance" (the list of suchsubstances is in 40 CFR Part 355, Appendices A and B) if it has such


8/3/2019 Pharma App 1997

5/53


substance in excess of the substance's threshold planning quantity,and directs the facility to appoint an emergency response coordinator.

EPCRA 304 requires the facility to notify the SERC and the LEPC

in the event of a release equaling or exceeding the reportable quantity

of a CERCLA hazardous substance or an EPCRA extremelyhazardous substance.

EPCRA 311 and 312 require a facility at which a hazardouschemical, as defined by the Occupational Safety and Health Act, is

present in an amount exceeding a specified threshold to submit to theSERC, LEPC and local fire department material safety data sheets(MSDSs) or lists of MSDS's and hazardous chemical inventory forms

(also known as Tier I and II forms). This information helps the localgovernment respond in the event of a spill or release of the chemical.

EPCRA 313 requires manufacturing facilities included in SIC codes

20 through 39, which have ten or more employees, and whichmanufacture, process, or use specified chemicals in amounts greater

than threshold quantities, to submit an annual toxic chemical releasereport. This report, commonly known as the Form R, covers releasesand transfers of toxic chemicals to various facilities and

environmental media, and allows EPA to compile the national ToxicRelease Inventory (TRI) database.

All information submitted pursuant to EPCRA regulations is publicly

accessible, unless protected by a trade secret claim.

EPA's RCRA, Superfund and EPCRA Hotline, at (800) 424-9346, answers

questions and distributes guidance regarding the emergency planning andcommunity right-to-know regulations. The EPCRA Hotline operatesweekdays from 9:00 a.m. to 6:00 p.m., ET, excluding Federal holidays.

Clean Water Act (CWA)

The primary objective of the Federal Water Pollution Control Act, commonlyreferred to as the CWA, is to restore and maintain the chemical, physical, and

biological integrity of the nation's surface waters. Pollutants regulated underthe CWA include "priority" pollutants and various toxic pollutants;

"conventional" pollutants, such as biochemical oxygen demand (BOD), totalsuspended solids (TSS), fecal coliform, oil and grease, and pH; and "non-conventional" pollutants which are pollutants not identified as either

conventional or priority.

The CWA regulates both direct and indirect discharges. The National


8/3/2019 Pharma App 1997

6/53


Pollutant Discharge Elimination System (NPDES) program (CWA 402)

controls direct discharges into navigable waters. Direct discharges or "pointsource" discharges are from sources such as pipes and sewers. NPDESpermits, issued by either EPA or an authorized State (EPA has authorized 42

States to administer the NPDES program), contain industry-specific,

technology-based and/or water quality-based limits, and establish pollutantmonitoring requirements. A facility that intends to discharge into the nation's

waters must obtain a permit prior to initiating its discharge. A permitapplicant must provide quantitative analytical data identifying the types of

pollutants present in the facility's effluent. The permit will then set forth theconditions and effluent limitations under which a facility may make adischarge.

A NPDES permit may also include discharge limits based on Federal or Statewater quality criteria or standards that were designed to protect designated

uses of surface waters, such as supporting aquatic life or recreation. Thesestandards, unlike the technological standards, generally do not take intoaccount technological feasibility or costs. Water quality criteria and

standards vary from state to state, and site to site, depending on the useclassification of the receiving body of water. Most states follow EPAguidelines, which propose aquatic life and human health criteria for many of

the 126 priority pollutants.

Storm Water Discharges

In 1987 the CWA was amended to require EPA to establish a program to

address storm water discharges. In response, EPA promulgated the NPDESstorm water permit application regulations. These regulations require thatfacilities with the following storm water discharges apply for an NPDESpermit: (1) a discharge associated with industrial activity; (2) a discharge

from a large or medium municipal storm sewer system; or (3) a dischargewhich EPA or the State determines to contribute to a violation of a water

quality standard or is a significant contributor of pollutants to waters of theUnited States.

The term "storm water discharge associated with industrial activity" meansa storm water discharge from one of 11 categories of industrial activity

defined at 40 CFR 122.26. Six of the categories are defined by SIC codeswhile the other five are identified through narrative descriptions of theregulated industrial activity. If the primary SIC code of the facility is one ofthose identified in the regulations, the facility is subject to the storm water

permit application requirements. If any activity at a facility is covered by oneof the five narrative categories, storm water discharges from those areaswhere the activities occur are subject to storm water discharge permit

application requirements.


8/3/2019 Pharma App 1997

7/53


Those facilities/activities that are subject to storm water discharge permitapplication requirements are identified below. To determine whether a

particular facility falls within one of these categories, the regulation shouldbe consulted.

Category i: Facilities subject to storm water effluent guidelines, new

source performance standards, or toxic pollutant effluent standards.

Category ii: Facilities classified as SIC 24-lumber and wood

products (except wood kitchen cabinets); SIC 26-paper and alliedproducts (except paperboard containers and products); SIC 28-chemicals and allied products (except drugs and paints); SIC 291-

petroleum refining; and SIC 311-leather tanning and finishing, 32(except 323)-stone, clay, glass, and concrete, 33-primary metals,3441-fabricated structural metal, and 373-ship and boat building and

repairing.

Category iii: Facilities classified as SIC 10-metal mining; SIC 12-

coal mining; SIC 13-oil and gas extraction; and SIC 14-nonmetallicmineral mining.

Category iv: Hazardous waste treatment, storage, or disposal

facilities.

Category v: Landfills, land application sites, and open dumps that

receive or have received industrial wastes.

Category vi: Facilities classified as SIC 5015-used motor vehicleparts; and SIC 5093-automotive scrap and waste material recycling

facilities.

Category vii: Steam electric power generating facilities.

Category viii: Facilities classified as SIC 40-railroad transportation;SIC 41-local passenger transportation; SIC 42-trucking andwarehousing (except public warehousing and storage); SIC 43-U.S.

Postal Service; SIC 44-water transportation; SIC 45-transportation byair; and SIC 5171-petroleum bulk storage stations and terminals.

Category ix: Sewage treatment works.

Category x: Construction activities except operations that result inthe disturbance of less than five acres of total land area.


8/3/2019 Pharma App 1997

8/53


Category xi: Facilities classified as SIC 20-food and kindredproducts; SIC 21-tobacco products; SIC 22-textile mill products; SIC23-apparel related products; SIC 2434-wood kitchen cabinets

manufacturing; SIC 25-furniture and fixtures; SIC 265-paperboard

containers and boxes; SIC 267-converted paper and paperboardproducts; SIC 27-printing, publishing, and allied industries; SIC 283-

drugs; SIC 285-paints, varnishes, lacquer, enamels, and alliedproducts; SIC 30-rubber and plastics; SIC 31-leather and leather

products (except leather and tanning and finishing); SIC 323-glassproducts; SIC 34-fabricated metal products (except fabricatedstructural metal); SIC 35-industrial and commercial machinery and

computer equipment; SIC 36-electronic and other electricalequipment and components; SIC 37-transportation equipment (exceptship and boat building and repairing); SIC 38-measuring, analyzing,

and controlling instruments; SIC 39-miscellaneous manufacturingindustries; and SIC 4221-4225-public warehousing and storage.

Pretreatment Program

Another type of discharge that is regulated by the CWA is one that goes to a

publicly-owned treatment works (POTWs). The national pretreatment

program (CWA 307(b)) controls the indirect discharge of pollutants toPOTWs by "industrial users." Facilities regulated under 307(b) must meetcertain pretreatment standards. The goal of the pretreatment program is to

protect municipal wastewater treatment plants from damage that may occur

when hazardous, toxic, or other wastes are discharged into a sewer systemand to protect the quality of sludge generated by these plants. Discharges to

a POTW are regulated primarily by the POTW itself, rather than the State orEPA.

EPA has developed technology-based standards for industrial users ofPOTWs. Different standards apply to existing and new sources within eachcategory. "Categorical" pretreatment standards applicable to an industry on

a nationwide basis are developed by EPA. In addition, another kind ofpretreatment standard, "local limits," are developed by the POTW in order toassist the POTW in achieving the effluent limitations in its NPDES permit.

Regardless of whether a State is authorized to implement either the NPDES

or the pretreatment program, if it develops its own program, it may enforcerequirements more stringent than Federal standards.

Spill Prevention, Control and Countermeasure Plans

The 1990 Oil Pollution Act requires that facilities that could reasonably be


8/3/2019 Pharma App 1997

9/53


expected to discharge oil in harmful quantities prepare and implement morerigorous Spill Prevention Control and Countermeasure (SPCC) Plan requiredunder the CWA (40 CFR 112.7). There are also criminal and civil penalties

for deliberate or negligent spills of oil. Regulations covering response to oildischarges and contingency plans (40 CFR Part 300), and Facility Response

Plans to oil discharges (40 CFR 112.20) and for PCB transformers andPCB-containing items were revised and finalized in 1995.

EPAs Office of Water, at (202) 260-5700, will direct callers with questionsabout the CWA to the appropriate EPA office. EPA also maintains a

bibliographic database of Office of Water publications which can beaccessed through the Ground Water and Drinking Water resource center, at(202) 260-7786.

Safe Drinking Water Act (SDWA)

The SDWA mandates that EPA establish regulations to protect human health

from contaminants in drinking water. The law authorizes EPA to developnational drinking water standards and to create a joint Federal-State systemto ensure compliance with these standards. The SDWA also directs EPA to

protect underground sources of drinking water through the control ofunderground injection of liquid wastes.

EPA has developed primary and secondary drinking water standards underits SDWA authority. EPA and authorized states enforce the primary drinkingwater standards, which are, contaminant-specific concentration limits that

apply to certain public drinking water supplies. Primary drinking waterstandards consist of maximum contaminant level goals (MCLGs), which arenon-enforceable health-based goals, and maximum contaminant levels

(MCLs), which are enforceable limits set as close to MCLGs as possible,considering cost and feasibility of attainment.

The SDWA Underground Injection Control (UIC) program (40 CFR Parts144-148) is a permit program which protects underground sources ofdrinking water by regulating five classes of injection wells. UIC permits

include design, operating, inspection, and monitoring requirements. Wellsused to inject hazardous wastes must also comply with RCRA corrective

action standards in order to have RCRA permit by rule status, and must meetapplicable RCRA land disposal restrictions standards. The UIC permitprogram is primarily state-enforced, since EPA has authorized all but a fewstates to administer the program.

The SDWA also provides for a Federally-implemented Sole Source Aquiferprogram, which prohibits Federal funds from being expended on projects that

may contaminate the sole or principal source of drinking water for a given


8/3/2019 Pharma App 1997

10/53


area, and for a State-implemented Wellhead Protection program, designed toprotect drinking water wells and drinking water recharge areas.

EPAs Safe Drinking Water Hotline, at (800) 426-4791, answers questions

and distributes guidance pertaining to SDWA standards. The Hotline

operates from 9:00 a.m. through 5:30 p.m., ET, excluding Federal holidays.

Toxic Substances Control Act (TSCA)

TSCA granted EPA authority to create a regulatory framework to collect dataon chemicals in order to evaluate, assess, mitigate, and control risks whichmay be posed by their manufacture, processing, and use. TSCA provides a

variety of control methods to prevent chemicals from posing unreasonablerisk.

TSCA standards may apply at any point during a chemicals life cycle.Under TSCA 5, EPA has established an inventory of chemical substances.

If a chemical is not already on the inventory, and has not been excluded byTSCA, a premanufacture notice (PMN) must be submitted to EPA prior tomanufacture or import. The PMN must identify the chemical and provide

available information on health and environmental effects. If available dataare not sufficient to evaluate the chemicals effects, EPA can imposerestrictions pending the development of information on its health and

environmental effects. EPA can also restrict significant new uses ofchemicals based upon factors such as the projected volume and use of thechemical.

Under TSCA 6, EPA can ban the manufacture or distribution in commerce,limit the use, require labeling, or place other restrictions on chemicals that

pose unreasonable risks. Among the chemicals EPA regulates under 6authority are asbestos, chlorofluorocarbons (CFCs), and polychlorinatedbiphenyls (PCBs).

EPAs TSCA Assistance Information Service, at (202) 554-1404, answersquestions and distributes guidance pertaining to Toxic Substances ControlAct standards. The Service operates from 8:30 a.m. through 4:30 p.m., ET,

excluding Federal holidays.

Clean Air Act (CAA)

The CAA and its amendments, including the Clean Air Act Amendments(CAAA) of 1990, are designed to protect and enhance the nation's airresources so as to promote the public health and welfare and the productive

capacity of the population. The CAA consists of six sections, known asTitles, which direct EPA to establish national standards for ambient airquality and for EPA and the States to implement, maintain, and enforce these


8/3/2019 Pharma App 1997

11/53


standards through a variety of mechanisms. Under the CAAA, manyfacilities will be required to obtain permits for the first time. State and localgovernments oversee, manage, and enforce many of the requirements of the

CAAA. CAA regulations appear at 40 CFR Parts 50-99.Pursuant to Title I of the CAA, EPA has established national ambient air

quality standards (NAAQSs) to limit levels of "criteria pollutants," includingcarbon monoxide, lead, nitrogen dioxide, particulate matter, volatile organiccompounds (VOCs), ozone, and sulfur dioxide. Geographic areas that meetNAAQSs for a given pollutant are classified as attainment areas; those that

do not meet NAAQSs are classified as non-attainment areas. Under 110 ofthe CAA, each State must develop a State Implementation Plan (SIP) toidentify sources of air pollution and to determine what reductions are

required to meet Federal air quality standards. Revised NAAQSs forparticulates and ozone were proposed in 1996 and may go into effect as earlyas late 1997.

Title I also authorizes EPA to establish New Source Performance Standards

(NSPSs), which are nationally uniform emission standards for new stationarysources falling within particular industrial categories. NSPSs are based onthe pollution control technology available to that category of industrial

source.

Under Title I, EPA establishes and enforces National Emission Standards for

Hazardous Air Pollutants (NESHAPs), nationally uniform standards orientedtowards controlling particular hazardous air pollutants (HAPs). Title I,section 112(c) of the CAA further directed EPA to develop a list of sources

that emit any of 189 HAPs, and to develop regulations for these categoriesof sources. To date, EPA has listed 174 categories and developed a schedulefor the establishment of emission standards. The emission standards will be

developed for both new and existing sources based on "maximum achievablecontrol technology (MACT)." The MACT is defined as the controltechnology achieving the maximum degree of reduction in the emission of

the HAPs, taking into account cost and other factors.

Title II of the CAA pertains to mobile sources, such as cars, trucks, buses,

and planes. Reformulated gasoline, automobile pollution control devices,and vapor recovery nozzles on gas pumps are a few of the mechanisms EPA

uses to regulate mobile air emission sources.

Title IV of the CAA establishes a sulfur dioxide emissions program designed

to reduce the formation of acid rain. Reduction of sulfur dioxide releaseswill be obtained by granting to certain sources limited emissions allowances,which, beginning in 1995, will be set below previous levels of sulfur dioxide

releases.

Title V of the CAA of 1990 created a permit program for all "major sources"


8/3/2019 Pharma App 1997

12/53


(and certain other sources) regulated under the CAA. One purpose of theoperating permit is to include in a single document all air emissionsrequirements that apply to a given facility. States are developing the permit

programs in accordance with guidance and regulations from EPA. Once aState program is approved by EPA, permits will be issued and monitored by

that State.

Title VI of the CAA is intended to protect stratospheric ozone by phasing outthe manufacture of ozone-depleting chemicals and restrict their use and

distribution. Production of Class I substances, including 15 kinds ofchlorofluorocarbons (CFCs) and chloroform, were phased out (except foressential uses) in 1996.

EPA's Clean Air Technology Center, at (919) 541-0800, provides generalassistance and information on CAA standards. The Stratospheric OzoneInformation Hotline, at (800) 296-1996, provides general information about

regulations promulgated under Title VI of the CAA, and EPA's EPCRA Hotline, at (800) 535-0202, answers questions about accidental release

prevention under CAA 112(r). In addition, the Clean Air TechnologyCenters website includes recent CAA rules, EPA guidance documents, andupdates of EPA activities (www.epa.gov/ttn then select Directory and then

CATC).


8/3/2019 Pharma App 1997

13/53


VI.B. Industry Specific Requirements

The pharmaceutical industry is affected by several major federal

environmental statutes. In addition, the industry is subject to numerous lawsand regulations from state and local governments designed to protect and

improve the nations health, safety, and environment. A summary of themajor federal regulations affecting the pharmaceutical industry follows.

Clean Air Act (CAA)

The original CAA authorized EPA to set limits on pharmaceutical plantemissions. Some of these new source performance standards (NSPS) apply

to pharmaceutical manufacturers including those for flares (40 CFR Part 60Subpart A), and storage of volatile organic liquids (40 CFR Part 60 SubpartKb). The Clean Air Act Amendments of 1990 set control standards by

industrial sources for 41 pollutants to be met by 1995 and for 148 otherpollutants to be reached by 2003. Under the air toxics provisions of the

CAAA, more sources are covered including small businesses. The HazardousOrganic National Emissions Standard for Hazardous Air Pollutants, alsoknown as HON, covers hundreds of chemicals and thousands of process

units. The pharmaceutical industry is affected by standards for equipmentleaks (40 CFR Part 63 Subpart H), equipment leaks from pharmaceuticalprocesses using carbon tetrachloride or methylene chloride (40 CFR Part 63

Subpart I), and standards for emissions from halogenated solvent cleaning(40 CFR Part 63 Subpart T). The HON also includes innovative provisionssuch as emissions trading, that offer industry flexibility in complying with the

rule's emissions goals.

Specific industries are regulated under other National Emission Standards for

Hazardous Air Pollutants (NESHAP). These standards are being developedfor the pharmaceutical industry (see Section VI. C). Title V of the CAAintroduces a new permit system that will require all major sources to obtain

operating permits to cover all applicable control requirements. States wererequired to develop and implement the program in 1993 and the first permitswere issued in 1994. In December 1994, Schering-Plough Pharmaceuticals

facility in Kenilworth, New Jersey, was the first in the nation to receive afacility-wide permit under this Title V program.


The Clean Water Act, first passed in 1972 and amended in 1977 and 1987,gives EPA the authority to regulate effluents from sewage treatment works,chemical plants, and other industrial sources into waters. The act sets best

available technology standards for treatment of wastes for both direct andindirect (to a Publicly Owned Treatment Works (POTW)) discharges. In1983, EPA proposed effluent guidelines for the pharmaceutical


8/3/2019 Pharma App 1997

14/53


manufacturing point source category. These guidelines are currentlyundergoing revisions (see Section VI. C). The implementation of theguidelines is left to the states who issue National Pollutant Discharge

Elimination System (NPDES) permits for each facility.

The pharmaceutical manufacturing effluent guidelines for point sourcecategory (40 CFR Part 439) is divided into process specific effluentguidelines as follows:

Fermentation - 40 CFR Part 439 Subpart A,Natural product extraction - 40 CFR Part 439 Subpart B,Chemical synthesis - 40 CFR Part 439 Subpart C, Mixing, compounding, formulation - 40 CFR Part 439 Subpart D, and Research - 40 CFR Part 439 Subpart E.Each Subpart consists of effluent limitations representing the amount ofeffluent reduction possible by using either best practicable control

technologies (BPT), best conventional pollution technologies (BCT), or bestavailable technologies (BAT). BPTs are used for discharges from existingpoint sources to control conventional and non-conventional pollutants as well

as some priority pollutants. BCTs are used for discharges from point sourcesto control conventional pollutants. Finally, BATs are used to control prioritypollutants and non-conventional pollutants when directly discharged into the

nations waters. Standards are provided for cyanide, biologic oxygen demand(BOD), chemical oxygen demand (COD), total suspended solids (TSS) andpH. Guidelines for BCT and BAT for the research category, new source

performance standards (NSPS), and pre-treatment standards for new andexisting sources, are being revised and are in the final rule stage (see SectionVI. C).

The Storm Water Rule (40 CFR 122.26) requires pharmaceutical facilitiesdischarging storm water associated with industrial activities (40 CFR

122.26 (b)(14)(xi)) to apply for storm water permits.

Safe Drinking Water Act Underground Injection Control Program

The federal Underground Injection Control (UIC) program was established

under the provisions of the SDWA of 1974. This federal program prescribesminimum requirements for effective state UIC programs. Since ground wateris a major source of drinking water in the United States, the UIC program

requirements were designed to prevent contamination of UndergroundSources of Drinking Water (USDW) resulting from the operation of injectionwells. A USDW is defined as an aquifer or its portion which supplies any

public water system or contains a sufficient quantity of ground water tosupply a public water system, or contains less than 10,000 milligrams perliter total dissolved solids and is not an exempted aquifer.


8/3/2019 Pharma App 1997

15/53


Since the passage of the Safe Drinking Water Act, state and federalregulatory agencies have modified existing programs or developed newstrategies to protect ground water by establishing regulations to control the

permitting, construction, operation, monitoring, and closure of injectionwells. In Michigan, where all five of the pharmaceutical industrys injection

wells are located, the state has not sought authority to implement the federalUIC program but does regulate use of injection wells through state law. TheEPA is the responsible regulatory agency for implementing the UIC programin the state.

The five wells used by the pharmaceutical companies in Michigan are termedhazardous Class I injection wells since they inject hazardous waste into

formations below the USDW. The process of selecting a site for a Class Idisposal well involves evaluating many conditions with the most importantbeing the determination that the underground formations possess the natural

ability to contain and isolate the injected waste. A detailed study isconducted to determine the suitability of the underground formation for

disposal. The receiving formation must be far below any usable groundwaters and be separated from them by confining layers of rock, whichprevent fluid migration into the ground water. The injection zone in the

receiving formation must be of sufficient size and have sufficient pore spaceto accept and maintain the injected wastes.

Class I injection wells are regulated in 40 CFR Part 146, Subpart G. SubpartG requires facilities with injection wells to submit operating reports and tosubmit plans for testing and monitoring the wastes, hydrogeologic conditions,

condition of the well materials, mechanical integrity of the well, and ambientconditions in adjacent aquifers. Subpart G also sets criteria for siting ClassI hazardous waste injection wells, construction requirements, corrective

action procedures, operating requirements, and closure plans.

Resource Conservation and Recovery Act (RCRA)

The Resource Conservation and Recovery Act (RCRA) was enacted in 1976to address problems related to hazardous and solid waste management.

RCRA gives EPA the authority to establish a list of solid and hazardouswastes and to establish standards and regulations for the treatment, storage,

and disposal of these wastes. Regulations in Subtitle C of RCRA address theidentification, generation, transportation, treatment, storage, and disposal ofhazardous wastes. These regulations are found in 40 CFR Part 124 and CFR

Parts 260-279. Under RCRA, persons who generate waste must determinewhether the waste is defined as solid waste or hazardous waste. Solid wastesare considered hazardous wastes if they are listed by EPA as hazardous or if

they exhibit characteristics of a hazardous waste: toxicity, ignitability,corrosivity, or reactivity.


8/3/2019 Pharma App 1997

16/53


Products, intermediates, and off-specification products potentially generatedat pharmaceutical facilities that are considered hazardous wastes are listed in40 CFR Part 261.33(f). Some of the handling and treatment requirements

for RCRA hazardous waste generators are covered under 40 CFR Part 262and include the following: determining what constitutes a RCRA hazardous

waste (Subpart A); manifesting (Subpart B); packaging, labeling, andaccumulation time limits (Subpart C); and record keeping and reporting(Subpart D).

Many pharmaceutical facilities store some hazardous wastes at the facility formore than 90 days, and are therefore, a storage facility under RCRA. Storagefacilities are required to have a RCRA treatment, storage, and disposal

facility (TSDF) permit (40 CFR Part 262.34). Some pharmaceutical facilitiesare considered TSDF facilities and are subject to the following regulationscovered under 40 CFR Part 264: contingency plans and emergency

procedures (40 CFR Part 264 Subpart D); manifesting, record keeping, andreporting (40 CFR Part 264 Subpart E); use and management of containers

(40 CFR Part 264 Subpart I); tank systems (40 CFR Part 264 Subpart J);surface impoundments (40 CFR Part 264 Subpart K); land treatment (40 CFRPart 264 Subpart M); corrective action of hazardous waste releases (40 CFR

Part 264 Subpart S); air emissions standards for process vents of processesthat process or generate hazardous wastes (40 CFR Part 264 Subpart AA);emissions standards for leaks in hazardous waste handling equipment (40

CFR Part 264 Subpart BB); and emissions standards for containers, tanks,and surface impoundments that contain hazardous wastes (40 CFR Part 264Subpart CC).

A number of RCRA wastes have been prohibited from land disposal unlesstreated to meet specific standards under the RCRA Land Disposal Restriction

(LDR) program. The wastes covered by the RCRA LDRs are listed in 40CFR Part 268 Subpart C and include a number of wastes commonlygenerated at pharmaceutical facilities. Standards for the treatment and

storage of restricted wastes are described in Subparts D and E, respectively.

Many pharmaceutical manufacturing facilities are also subject to the

underground storage tank (UST) program (40 CFR Part 280). The USTregulations apply to facilities that store either petroleum products or

hazardous substances (except hazardous waste) identified under theComprehensive Environmental Response, Compensation, and Liability Act.UST regulations address design standards, leak detection, operating practices,

response to releases, financial responsibility for releases, and closurestandards.


8/3/2019 Pharma App 1997

17/53


Comprehensive Environmental Response Compensation and Liability Act (CERCLA)

The Comprehensive Environmental Response Compensation and Liability

Act of 1980 (CERCLA) and the Superfund Amendments and ReauthorizationAct of 1986 (SARA) provide the basic legal framework for the federal

Superfund program to clean up abandoned hazardous waste sites (40 CFRPart 305). The 1986 SARA legislation extended these taxes for five yearsand adopted a new broad-based corporate environmental tax, applicable tothe allied chemicals (SIC 28) industry, which includes the pharmaceuticals

industry. In 1990, Congress passed a simple reauthorization that did notsubstantially change the law but extended the program authority until 1994and the taxing authority until the end of 1995. A comprehensive

reauthorization was considered in 1994, but not passed. Since the expirationof the taxing authority on December 31, 1995, taxes for Superfund have beentemporarily suspended. The taxes can only be reinstated by reauthorization

of Superfund or an omnibus reconciliation act which could specificallyreauthorize taxing authority. The allied chemical industry pays about $300

million a year in Superfund chemical feedstock taxes. Superfunds liabilitystandard is such that Potentially Responsible Parties (PRPs) may pay theentire cost of clean-up at sites, even though they may be responsible for only

a fraction of the waste.

Title III of the 1986 SARA amendments (also known as Emergency

Response and Community Right-to-Know Act, EPCRA) requires allmanufacturing facilities, including pharmaceutical facilities, to report annualinformation to the public about stored toxic substances as well as release of

these substances into the environment (42 U.S.C. 9601). This is known asthe Toxic Release Inventory (TRI). EPCRA also establishes requirements forfederal, state, and local governments regarding emergency planning. In 1994,

over 300 more chemicals were added to the list of chemicals for whichreporting is required.

Toxic Substances Control Act (TSCA)

The pharmaceutical industry is specifically excluded from some of the

requirements of TSCA. Any drugs manufactured, processed, and distributedin commerce are excluded by definition from the Inventory Reporting

Regulations (40 CFR Part 710.4(c)) and the Pre-Manufacturing Noticerequirements (40 CFR 720.30(a)) of TSCA.


8/3/2019 Pharma App 1997

18/53


VI.C. Pending and Proposed Regulatory Requirements

Clean Air Act (CAA)

Under the Clean Air Act, National Emissions Standards for Hazardous Air

Pollutants (NESHAPS) are being developed for the pharmaceuticalmanufacturing industry.


As part of the Clean Water Act revision process, the effluent guidelines forthe pharmaceutical industry (40 CFR 439) are currently being revised and

reviewed. A major part of the review considers the inclusion of limitationsfor toxic and non-conventional volatile organic pollutants. Additionally, the1983 New Source Performance Standards (NSPS) for conventional pollutants

will also be reevaluated.


8/3/2019 Pharma App 1997

19/53


VI.D. Other Federal Regulations Affecting the Pharmaceutical Industry

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is part of the Department of

Health and Human Services. FDA has the statutory authority to regulate awide range of products such as prescription and over-the-counter drugs,foods, biologics (e.g., blood plasma, vaccines), medical devices (e.g.,needles, heart valves), veterinary drugs, cosmetics and consumer goods that

emit radiation. This authority has been granted to FDA by Congress undervarious laws including the Federal Food, Drug and Cosmetic Act and thePublic Health Service Act.

There are five Centers within FDA that deal with FDA-regulated articles:Center for Drug Evaluation and Research (CDER), Center for Biologics

Evaluation and Research (CBER), Center for Veterinary Medicine (CVM),Center for Devices and Radiological Health (CDRH), and Center for Food

Safety and Applied Nutrition (CFSAN). The Centers review scientificinformation provided by persons wishing to place FDA-regulated articles intointerstate commerce in order to determine whether regulatory requirements

are met. FDA has offices throughout the U.S. where testing of FDA-regulated articles is performed and where investigators are based.Investigators go to U.S. and foreign manufacturing facilities and other types

of facilities involved in FDA-regulated activities to verify that they are incompliance with FDA regulations.

FDAs general approach to regulating various articles is similar, however,due to the diverse nature of these products, there are regulatory requirementstailored to each type of FDA-regulated article. Below is a summary of

information relating to the type of products regulated by CDER. Additionalinformation on other FDA-regulated articles may be located in 21 CFR or bycontacting FDA directly.

The manufacturing facilities that produce drugs for human use are regulatedby CDER. The methods, facilities, and controls used for the manufacture,

processing, and packing of a drug are reviewed by FDA to determine whetherthey are adequate to ensure and preserve the drugs identity, strength, quality

and purity. These characteristics are critical to ensure the safety and efficacyof a drug for human use. CDER conducts a scientific review ofmanufacturing methods and process controls for the drug substance and drug

product. Field investigators conduct on-site reviews to verify the accuracyof the information submitted to CDER and to determine facility compliancewith FDAs Good Manufacturing Practices (GMPs).

FDAs review of a pharmaceutical facility does not include auditingcompliance with regulations pertaining to the protection of the environment.


8/3/2019 Pharma App 1997

20/53


However, in accordance with the National Environmental Policy Act of 1969(NEPA), which requires all Federal agencies to assess the environmentalimpacts of their actions, CDER has integrated the consideration of the

environmental impacts of approving drug product applications into itsregulatory process (21 CFR Part 25). When an environmental review under

NEPA is required, the review focuses on the environmental impacts ofconsumer use and disposal of the drug and is based on information submittedby the manufacturers, or on a manufacturers certification that an applicationfalls within an established category of applications excluded from the

requirement to submit information.

After the original approval from CDER, an applicant may wish or need to

make changes in the method of manufacture, testing, etc. described in theirapplication. An applicant is required to notify FDA about each change ineach condition established in an approved application (e.g., ingredients,

solvents, processes) beyond the variations already provided for in theapplication (21 CFR 314.70(a)). Depending on the type of change, the

applicant notifies FDA about it in (1) a supplement requiring FDA approvalbefore the change is made (314.70(b)), (2) a supplement for changes thatmay be made before FDA approval (314.70(c)), or (3) an annual report

(314.70(d)). Changes requiring FDA approval before they are made mayinclude changes in the synthesis of the drug product or changes in solvents;the addition or deletion of an ingredient; and changes in the method of

manufacture or in-process control of the drug product manufacturing process.The regulations specify the method of reporting certain changes. CDER alsoprovides additional guidance on the method of reporting changes and

documentation needed to support changes in guidance for industry (e.g.,Guidance for Industry, Immediate Release Solid Oral Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls,InVitro Dissolution Testing and In Vivo Bioequivalence Documentation,November 1995).

The changes in a manufacturing process that a manufacturer may wish toundertake to prevent or reduce pollution would most likely be reported in asupplement requiring FDA approval before the change could be made (e.g.,

314.70(b)(1)(iv) and 314.70(b)(2)(v)). Changes such as these often requirethe manufacturer, before submitting the supplemental application to the FDA,

to generate data that demonstrate the proposed change does not adverselyaffect the identity, strength, quality or purity of the drug. An applicant mayask FDA to expedite its review if a delay in making the change would impose

an extraordinary hardship on the applicant (314.70(b)). For changes relatingto pollution prevention, expedited review is typically reserved for thosechanges mandated by the Federal, State or local environmental protection

agencies, which must be accomplished within a specified time frame. Thegranting of an expedited review does not change the type of documentationthat needs to be submitted to CDER to support the change.


8/3/2019 Pharma App 1997

21/53


Summary of FDA Regulations Applicable to the Pharmaceutical Industry

Statutory Authority

The Federal Food Drug and Cosmetic Act, principally Sections 201, 301,501, 502, 503, 505, 506, 507, 512, 701, 704.

CDER Regulations

21 CFR Parts 300-499

Manufacturing Information Submittal

Manufacturing Information Submitted to CDER in Investigational New Drug

Applications (INDs), New Drug Applications (NDAs), AntibioticApplications, Abbreviated New Drug Applications (ANDAs), and

Abbreviated Antibiotic Drug Applications (AADAs)

INDs: 312.23(a)(7)(i)

Other applications: 314.50(d)(1)(i) and 314.50(d)(1)(ii)(a)

Reporting Changes in Manufacturing Methods and Controls to CDER

IND Information amendments: 312.31Supplements and other changes to an approved application: 314.70

Good Manufacturing Practices (GMPs)

Current Good Manufacturing Practice in Manufacturing, Processing,Packing, or Holding of Drugs; General, Part 210

Current Good Manufacturing Practice for Finished Pharmaceuticals: Part 211


8/3/2019 Pharma App 1997

22/53


VI.E. Other Statutes and Regulations Affecting the Pharmaceutical Industry

State Statutes and Regulations

Most states have long-established broad-based environmental regulatory

programs. Many of these regulatory schemes were enacted to implementfederal programs and have been granted local primacy by the USEPA.Generally, the state programs are allowed to be more restrictive than federalrequirements and, in some cases, they are.

Some states with high concentrations of pharmaceutical manufacturingfacilities, have their own regulations pertaining specifically to the industry.

For example, both New York and New Jersey have Reasonably AchievableControl Technology (RACT) requirements for process specific volatileorganic compound (VOC) emissions. Other states may have similar

requirements under their own State Implementation Plans (SIPs).

International Standards

The U.S. Pharmaceutical industry is largely an international industry in which

many companies have manufacturing facilities and sales and distributionoperations in countries other than the U.S. In addition to U.S. federal statutesand regulations there are international laws, regulations, treaties, conventions

and initiatives which are drivers of the environmental programs ofpharmaceutical companies. The Basel Convention, ISO 14000 standards, theenvironmental requirements of NAFTA, and the evolving European Union

Directives and Regulations are a few examples of important internationalenvironmental standards and programs which affect this industry.

Drug Enforcement Administration Regulations

Pharmaceutical manufacturing operations may also be regulated under the

Controlled Substances Act. This Act regulates the manufacture, distribution,and dispensing of controlled substances and is enforced by the DrugEnforcement Administration (DEA). Examples of pharmaceutical products

regulated under this Act include Demerol, Percodan, Ritalin, Valium, andDarvon. A list of controlled substances can be found in 1308 of 21 CFR.


8/3/2019 Pharma App 1997

23/53


The statute provides closed system for virtually every person wholegitimately handles controlled substances, other than the ultimate user. Asa means of controlling the distribution of regulated products, DEA sets

quotas limiting the quantities which may be manufactured or produced to thatamount which is necessary to meet the legitimate needs of the United States.

The regulations set specific requirements for how such compounds arehandled and stored at a manufacturing facility. In addition, when disposedof, these substances must be destroyed in the presence of DEA personnel inaccordance with the regulations found in 21 CFR, Section 1307.21.


8/3/2019 Pharma App 1997

24/53

Page 116 intentionally left blank.

8/3/2019 Pharma App 1997

25/53

Pharmaceutical Industry Compliance and Enforcement History

VII. COMPLIANCE AND ENFORCEMENT HISTORY

Background

Until recently, EPA has focused much of its attention on measuring

compliance with specific environmental statutes. This approach allows theAgency to track compliance with the Clean Air Act, the ResourceConservation and Recovery Act, the Clean Water Act, and otherenvironmental statutes. Within the last several years, the Agency has begun

to supplement single-media compliance indicators with facility-specific,multimedia indicators of compliance. In doing so, EPA is in a better positionto track compliance with all statutes at the facility level, and within specific

industrial sectors.

A major step in building the capacity to compile multimedia data for

industrial sectors was the creation of EPA's Integrated Data for EnforcementAnalysis (IDEA) system. IDEA has the capacity to read into the Agency's

single-media databases, extract compliance records, and match the recordsto individual facilities. The IDEA system can match Air, Water, Waste,Toxics/Pesticides/EPCRA, TRI, and Enforcement Docket records for a given

facility, and generate a list of historical permit, inspection, and enforcementactivity. IDEA also has the capability to analyze data by geographic area andcorporate holder. As the capacity to generate multimedia compliance data

improves, EPA will make available more in-depth compliance andenforcement information. Additionally, sector-specific measures of successfor compliance assistance efforts are under development.

Compliance and Enforcement Profile Description

Using inspection, violation, and enforcement data from the IDEA system,this section provides information regarding the historical compliance andenforcement activity of this sector. In order to mirror the facility universe

reported in the Toxic Chemical Profile, the data reported within this sectionconsists of records only from the TRI reporting universe. With this decision,the selection criteria are consistent across sectors with certain exceptions.

For the sectors that do not normally report to the TRI program, data havebeen provided from EPA's Facility Indexing System (FINDS) which tracks

facilities in all media databases. Please note, in this section, EPA does notattempt to define the actual number of facilities that fall within each sector.Instead, the section portrays the records of a subset of facilities within the

sector that are well defined within EPA databases.

As a check on the relative size of the full sector universe, most notebooks

contain an estimated number of facilities within the sector according to theBureau of Census (See Section II). With sectors dominated by smallbusinesses, such as metal finishers and printers, the reporting universe within


8/3/2019 Pharma App 1997

26/53


the EPA databases may be small in comparison to Census data. However,the group selected for inclusion in this data analysis section should beconsistent with this sector's general makeup.

Following this introduction is a list defining each data column presented

within this section. These values represent a retrospective summary ofinspections and enforcement actions, and solely reflect EPA, State, and localcompliance assurance activities that have been entered into EPA databases.To identify any changes in trends, the EPA ran two data queries, one for the

five calendar years (April 1, 1992 to March 31, 1997) and the other for themost recent twelve-month period (April 1, 1996 to March 31, 1997). Thefive-year analysis gives an average level of activity for that period for

comparison to the more recent activity.

Because most inspections focus on single-media requirements, the data

queries presented in this section are taken from single media databases.These databases do not provide data on whether inspections are state/local or

EPA-led. However, the table breaking down the universe of violations doesgive the reader a crude measurement of the EPA's and states' efforts withineach media program. The presented data illustrate the variations across EPA

aRegions for certain sectors. This variation may be attributable to state/localdata entry variations, specific geographic concentrations, proximity topopulation centers, sensitive ecosystems, highly toxic chemicals used in

production, or historical noncompliance. Hence, the exhibited data do notrank regional performance or necessarily reflect which regions may have themost compliance problems.

Compliance and Enforcement Data Definitions

General Definitions

Facility Indexing System (FINDS) -- this system assigns a common facility

number to EPA single-media permit records. The FINDS identificationnumber allows EPA to compile and review all permit, compliance,enforcement and pollutant release data for any given regulated facility.

Integrated Data for Enforcement Analysis (IDEA) -- is a data integration

system that can retrieve information from the major EPA program officedatabases. IDEA uses the FINDS identification number to link separate data

records from EPAs databases. This allows retrieval of records from across

aEPA Regions include the following states: I (CT, MA, ME, RI, NH, VT); II (NJ, NY, PR, VI); III (DC, DE, MD,

PA, VA, WV); IV (AL, FL, GA, KY, MS, NC, SC, TN); V (IL, IN, MI, MN, OH, WI); VI (AR, LA, NM, OK, TX);VII (IA, KS, MO, NE); VIII (CO, MT, ND, SD, UT, WY); IX (AZ, CA, HI, NV, Pacific Trust Territories); X (AK,ID, OR, WA).


8/3/2019 Pharma App 1997

27/53


media or statutes for any given facility, thus creating a master list ofrecords for that facility. Some of the data systems accessible through IDEAare: AIRS (Air Facility Indexing and Retrieval System, Office of Air and

Radiation), PCS (Permit Compliance System, Office of Water), RCRIS(Resource Conservation and Recovery Information System, Office of Solid

Waste), NCDB (National Compliance Data Base, Office of Prevention,Pesticides, and Toxic Substances), CERCLIS (ComprehensiveEnvironmental and Liability Information System, Superfund), and TRIS(Toxic Release Inventory System). IDEA also contains information from

outside sources such as Dun and Bradstreet and the Occupational Safety andHealth Administration (OSHA). Most data queries displayed in notebooksections IV and VII were conducted using IDEA.

Data Table Column Heading Definitions

Facilities in Search -- are based on the universe of TRI reporters within thelisted SIC code range. For industries not covered under TRI reportingrequirements (metal mining, nonmetallic mineral mining, electric power

generation, ground transportation, water transportation, and dry cleaning), orindustries in which only a very small fraction of facilities report to TRI (e.g.,printing), the notebook uses the FINDS universe for executing data queries.

The SIC code range selected for each search is defined by each notebook'sselected SIC code coverage described in Section II.

Facilities Inspected --- indicates the level of EPA and state agencyinspections for the facilities in this data search. These values show what

percentage of the facility universe is inspected in a one-year or five-yearperiod.

Number of Inspections -- measures the total number of inspectionsconducted in this sector. An inspection event is counted each time it is

entered into a single media database.

Average Time Between Inspections -- provides an average length of time,

expressed in months, between compliance inspections at a facility within thedefined universe.

Facilities with One or More Enforcement Actions -- expresses the numberof facilities that were the subject of at least one enforcement action within thedefined time period. This category is broken down further into federal andstate actions. Data are obtained for administrative, civil/judicial, and

criminal enforcement actions. Administrative actions include Notices ofViolation (NOVs). A facility with multiple enforcement actions is onlycounted once in this column, e.g., a facility with 3 enforcement actions

counts as 1 facility.


8/3/2019 Pharma App 1997

28/53


Total Enforcement Actions -- describes the total number of enforcement

actions identified for an industrial sector across all environmental statutes.A facility with multiple enforcement actions is counted multiple times, e.g.,a facility with 3 enforcement actions counts as 3.

State Lead Actions -- shows what percentage of the total enforcementactions are taken by state and local environmental agencies. Varying levels

of use by states of EPA data systems may limit the volume of actionsrecorded as state enforcement activity. Some states extensively reportenforcement activities into EPA data systems, while other states may use

their own data systems.

Federal Lead Actions -- shows what percentage of the total enforcementactions are taken by the United States Environmental Protection Agency.

This value includes referrals from state agencies. Many of these actionsresult from coordinated or joint state/federal efforts.

Enforcement to Inspection Rate -- is a ratio of enforcement actions toinspections, and is presented for comparative purposes only. This ratio is arough indicator of the relationship between inspections and enforcement. It

relates the number of enforcement actions and the number of inspections thatoccurred within the one-year or five-year period. This ratio includes theinspections and enforcement actions reported under the Clean Water Act

(CWA), the Clean Air Act (CAA) and the Resource Conservation andRecovery Act (RCRA). Inspections and actions from the TSCA/FIFRA/EPCRA database are not factored into this ratio because most of the actions

taken under these programs are not the result of facility inspections. Also,this ratio does not account for enforcement actions arising from non-inspection compliance monitoring activities (e.g., self-reported water

discharges) that can result in enforcement action within the CAA, CWA, andRCRA.

Facilities with One or More Violations Identified -- indicates thepercentage of inspected facilities having a violation identified in one of thefollowing data categories: In Violation or Significant Violation Status

(CAA); Reportable Noncompliance, Current Year Noncompliance,Significant Noncompliance (CWA); Noncompliance and Significant

Noncompliance (FIFRA, TSCA, and EPCRA); Unresolved Violation andUnresolved High Priority Violation (RCRA). The values presented for thiscolumn reflect the extent of noncompliance within the measured time frame,but do not distinguish between the severity of the noncompliance. Violation

status may be a precursor to an enforcement action, but does not necessarilyindicate that an enforcement action will occur.


8/3/2019 Pharma App 1997

29/53


Media Breakdown of Enforcement Actions and Inspections -- four

columns identify the proportion of total inspections and enforcement actionswithin EPA Air, Water, Waste, and FIFRA/TSCA/EPCRA databases. Eachcolumn is a percentage of either the Total Inspections, or the Total

Actions column.

VII.A. Pharmaceutical Industry Compliance History

Table 20 provides an overview of the reported compliance and enforcement

data for the pharmaceutical industry over the past five years (April 1992 toApril 1997). These data are also broken out by EPA Region therebypermitting geographical comparisons. A few points evident from the data are

listed below.

Region II has more than twice the number of pharmaceutical facilitiesthan any other Region and more than half of all inspections nationallywere carried out in this Region. The high rate of inspections inrelation to the number of facilities is reflected in the Regions

relatively low average time between inspections (6 months)

Regions VI had only five pharmaceutical facilities (identified by theIDEA system) and a relatively high average time betweeninspections. However, in the past five years four enforcement actionswere brought against facilities in the Region, giving it one of the

highest enforcement to inspection rates.

Region X had only one pharmaceutical facility identified by theIDEA system. In the past five years this facility was inspected twiceand had two enforcement action brought against it.


8/3/2019 Pharma App 1997

30/53

SectorNoteboo

kProject Table 20: Five-Year Enforcement and Compliance Summary for the Pharmaceuti

A B C D E F G H

Region Facilities

in Search

Facilities

Inspecte

d

Number of

Inspections

Average

Months

Between

Inspections

Facilities with

1 or More

Enforcement

Actions

Total

Enforcement

Actions

Percent

State

Lead

Actions

Pe

Fe

L

A

I 8 5 11 44 0 0 0%

II 60 53 624 6 21 95 84%

III 18 16 111 10 3 3 100% IV 24 17 227 6 4 12 83%

V 22 16 143 9 4 5 60%

VI 5 5 17 18 1 4 0%

VII 12 8 37 19 1 1 100%

VIII 6 5 22 16 0 0 0%

IX 8 3 7 69 0 0 0%

X 1 1 2 30 1 2 50%

TOTAL

164 129 1,201 8 35 122 80%

126

September1997

8/3/2019 Pharma App 1997

31/53


VII.B. Comparison of Enforcement Activity Between Selected Industries

Tables 21 and 22 allow the compliance history of the pharmaceutical industry

to be compared with the other industries covered by the industry sectornotebooks. Comparisons between Tables 21 and 22 permit the identification

of trends in compliance and enforcement records of the industry bycomparing data covering the last five years to that of the past year. Somepoints evident from the data are listed below.

The pharmaceutical industry had one of the highest inspection ratesas indicated by its relatively low average time between inspections (8months) compared to other industries.

Compared to other sectors, the pharmaceutical industry had arelatively high enforcement to inspection rate (0.07) and a relatively

high percent of facilities inspected with violations (105 percent).

Tables 23 and 24 provide a more in-depth comparison between thepharmaceutical industry and other sectors by breaking out the compliance andenforcement data by environmental statute. As in Tables 21 and 22, the data

cover the last five years (Table 23) and the previous year (Table 24) tofacilitate the identification of recent trends. A few points evident from thedata are listed below.

Over the past five years, about 80 percent of the industrysinspections were for CAA and RCRA. Over the past year CAA and

RCRA inspections accounted for almost 90 percent of inspections.This trend is primarily due to an increase in CAA inspections and adecrease in CWA and FIFRA/TSCA/EPCRA/Other inspections.

The percentage of CAA enforcement actions increased from 49percent over the past five years to 71 percent in the past year. At the

same time the percentage of CWA enforcement actions decreasedfrom 25 percent to 14 percent.


8/3/2019 Pharma App 1997

32/53


Table21:Five-YearEnforcementandComplianceSummaryforSe

lectedIndustries

J

Enforcement

to

Inspection

Rate

0.0

7

0.0

4

0.0

5

0.0

5

0.0

6

0.1

0

0.0

4

0.1

0

0.0

6

0.0

8

0.0

9

0.10

0.1

1

0.0

8

0.2

5

0.0

6

0.0

8

0.0

7

0.0

8

0.1

1

0.0

8

0.0

6

0.0

7

0.1

3

0.0

6

0.0

9

0.1

0

0.0

6

I

Percent

Federal

Lead

Actions

47%

11%

21%

23%

10%

30%

19%

20%

12%

26%

24%

20%

35%

26%

32%

18%

25%

29%

29%

22%

25%

20%

18%

16%

16%

39%

12%

24%

HPercent

StateLead

Actions

53%

89%

79%

77%

90%

70%

81%

80%

88%

74%

76%

80%

65%

74%

68%

82%

75%

71%

71%

78%

75%

80%

82%

84%

84%

61%

88%

76%

GTotal

Enforcement

Actions

111

132

309

622

83

265

91

478

428

235

219

122

468

102

763

276

277

305

191

174

600

251

413

32

774

70

97

789

F

Facilitieswith1

orMore

Enforcement

Actions

63

88

149

385

53

134

65

150

238

89

93

35

153

47

124

178

97

121

113

68

365

150

253

20

375

36

48

403

EAverage

Months

Between

Inspections 4

652

46

25

15

15

13 6

46 9 8 8 6 1

2 325

11 5

16 7

22

17

13 9

36

38

27

14

D

Numbero

f

Inspection

s

1,600

3,748

6,071

12,826

1,465

2,767

2,379

4,630

7,691

3,087

2,430

1,201

4,294

1,293

3,081

4,383

3,474

4,476

2,535

1,640

7,914

4,500

5,912

243

12,904

816

973

14,210

C

Facilities

Inspected

378

741

1,9

02

2,8

03

267

473

386

430

2,0

92

286

263

129

355

164

148

981

388

275

424

161

1,8

58

863

927

37

3,2

63

192

231

2,1

66

B

Facilities

in

Search

1,2

32

3,2

56

4,6

76

5,2

56

355

712

499

484

5,8

62

441

329

164

425

263

156

1,8

18

615

349

669

203

2,9

06

1,2

50

1,2

60

44

7,7

86

514

444

3,2

70

A

IndustrySector

MetalMining

CoalMining

OilandGasExtraction

Non-MetallicMineralMining

Textiles

LumberandWood

Furniture

PulpandPaper

Printing

InorganicChemicals

ResinsandManmadeFibers

Pharmaceuticals

OrganicChemicals

AgriculturalChemicals

PetroleumRefining

RubberandPlastic

Stone,Clay,Glassand

Concrete

IronandSteel

MetalCastings

NonferrousMetals

FabricatedMetalProducts

Electronics

AutomobileAssembly

ShipbuildingandRepair

GroundTransportation

WaterTransportation

AirTransportation

FossilFuelElectricPower


8/3/2019 Pharma App 1997

33/53

SectorNotebookProject

129

September1997

Table 22: One-Year Enforcement and Compliance Summary for Selected Industries

A B C D E F

Industry Sector

Facilities

in Search

Facilities

Inspected

Number of

Inspections

Facilities with 1 or More

Violations

Facilities with 1 or more

Enforcement Actions

Number Percent* Number Percent*Metal Mining 1,232 142 211 102 72% 9 6%

Coal Mining 3,256 362 765 90 25% 20 6%

Oil and Gas Extraction 4,676 874 1,173 127 15% 26 3%

Non-Metallic Mineral Mining 5,256 1,481 2,451 384 26% 73 5%

Textiles 355 172 295 96 56% 10 6%

Lumber and Wood 712 279 507 192 69% 44 16%

Furniture 499 254 459 136 54% 9 4%

Pulp and Paper 484 317 788 248 78% 43 14%

Printing 5,862 892 1,363 577 65% 28 3%

Inorganic Chemicals 441 200 548 155 78% 19 10%

Resins and Manmade Fibers 329 173 419 152 88% 26 15%

Pharmaceuticals 164 80 209 84 105% 8 10%

Organic Chemicals 425 259 837 243 94% 42 16%

Agricultural Chemicals 263 105 206 102 97% 5 5%

Petroleum Refining 156 132 565 129 98% 58 44%

Rubber and Plastic 1,818 466 791 389 83% 33 7%

Stone, Clay, Glass and Concrete 615 255 678 151 59% 19 7%

Iron and Steel 349 197 866 174 88% 22 11%

Metal Castings 669 234 433 240 103% 24 10%

Nonferrous Metals 203 108 310 98 91% 17 16%

Fabricated Metal 2,906 849 1,377 796 94% 63 7%

Electronics 1,250 420 780 402 96% 27 6%

Automobile Assembly 1,260 507 1,058 431 85% 35 7%

Shipbuilding and Repair 44 22 51 19 86% 3 14%

Ground Transportation 7,786 1,585 2,499 681 43% 85 5% Water Transportation 514 84 141 53 63% 10 12%

Air Transportation 444 96 151 69 72% 8 8%

Fossil Fuel Electric Power 3,270 1,318 2,430 804 61% 100 8%

Dry Cleaning 6,063 1,234 1,436 314 25% 12 1%

*Percentages in Columns E and F are based on the number of facilities inspected (Column C). Percentages can exceed 100% beoccur without a facility inspection.

8/3/2019 Pharma App 1997

34/53


Sector Notebook Project September 1997130

Table23:Five-YearInspectionand

EnforcementSummarybyStatuteforSelectedIndustries

IndustrySector

Facilities

Inspected

Total

Inspections

Total

Enforcement

Actions

CleanAirAct

CleanWaterAct

RCRA

FIFRA/TS

CA/

EPCRA/Other

%o

fTotal

Inspections

%o

f

Total

Actions

%o

fTotal

Inspections

%of

Total

Actio

ns

%o

fTotal

Inspections

%o

f

Total

Actions

%o

fTotal

Inspections

%o

f

Total

A

ctions

MetalMining

378

1,6

00

111

39%

19%

52%

5

2%

8%

12%

1%

17%

CoalMining

741

3,7

48

132

57%

64%

38%

2

8%

4%

8%

1%

1%

OilandGasExtraction

1,9

02

6,0

71

309

75%

65%

16%

1

4%

8%

18%

0%

3%


2,8

03

12,8

26

622

83%

81%

14%

1

3%

3%

4%

0%

3%

Textiles

267

1,4

65

83

58%

54%

22%

2

5%

18%

14%

2%

6%

LumberandWood

473

2,7

67

265

49%

47%

6%

6%

44%

31%

1%

16%

Furniture

386

2,3

79

91

62%

42%

3%

0%

34%

43%

1%

14%

PulpandPaper

430

4,6

30

478

51%

59%

32%

2

8%

15%

10%

2%

4%

Printing

2,0

92

7,6

91

428

60%

64%

5%

3%

35%

29%

1%

4%

InorganicChemicals

286

3,0

87

235

38%

44%

27%

2

1%

34%

30%

1%

5%


263

2,4

30

219

35%

43%

23%

2

8%

38%

23%

4%

6%

Pharmaceuticals

129

1,201

122

35%

49%

15%

2

5%

45%

20%

5%

5%

OrganicChemicals

355

4,2

94

468

37%

42%

16%

2

5%

44%

28%

4%

6%


164

1,2

93

102

43%

39%

24%

2

0%

28%

30%

5%

11%

PetroleumRefining

148

3,0

81

763

42%

59%

20%

1

3%

36%

21%

2%

7%

RubberandPlastic

981

4,3

83

276

51%

44%

12%

1

1%

35%

34%

2%

11%

Stone,Clay,Glassand

Concrete

388

3,4

74

277

56%

57%

13%

9%

31%

30%

1%

4%

IronandSteel

275

4,4

76

305

45%

35%

26%

2

6%

28%

31%

1%

8%

MetalCastings

424

2,5

35

191

55%

44%

11%

1

0%

32%

31%

2%

14%

NonferrousMetals

161

1,6

40

174

48%

43%

18%

1

7%

33%

31%

1%

10%

FabricatedMetal

1,8

58

7,9

14

600

40%

33%

12%

1

1%

45%

43%

2%

13%

Electronics

863

4,5

00

251

38%

32%

13%

1

1%

47%

50%

2%

7%

AutomobileAssembly

927

5,9

12

413

47%

39%

8%

9%

43%

43%

2%

9%


37

243

32

39%

25%

14%

2

5%

42%

47%

5%

3%


3,2

63

12,9

04

774

59%

41%

12%

1

1%

29%

45%

1%

3%

WaterTransportation

192

816

70

39%

29%

23%

3

4%

37%

33%

1%

4%

AirTransportation

231

973

97

25%

32%

27%

2

0%

48%

48%

0%

0%


2,1

66

14,2

10

789

57%

59%

32%

2

6%

11%

10%

1%

5%

DryCleaning

2,3

60

3,8

13

66

56%

23%

3%

6%

41%

71%

0%

0%

8/3/2019 Pharma App 1997

35/53


Table24:One-YearInspection

andEnforcementSummarybyStatuteforSelectedIndustries

FI

FRA/TSCA/

EP

CRA/Other %

of

Total

Actions

30%

0%

0%

0%

0%

40%

9%

1%

0%

6%

5%

0%

0%

9%

10%0

%0%

0%

0%

7%

0%

5%

0%

0%

1%

9%

0%

0%

0%

%ofT

otal

Inspections

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

0%

RCRA

%o

f

Total

Actions

30%

5%

24%

2%

8%

25%

45%

7%

23%

25%

5%

14%

34%

36%

15%

23%

30%

24%

35%

30%

57%

53%

47%

50%

44%

45%

25%

5%

38%

%o

fTotal

Inspections

8%

4%

9%

3%

17%

44%

32%

14%

33%

39%

38%

45%

47%

30%

34%

35%

28%

26%

30%

41%

43%

43%

41%

35%

26%

38%

57%

9%

30%

CleanWaterAct

%o

f

Total

Actions

40%

14%

9%

9%

17%

5%

0%

19%

0%

9%

38%

14%

13%

0%

8%

13%

7%

29%

8%

20%

2%

5%

6%

50%

10%

36%

42%

21%

6%

%o

fTotal

Inspections

40%

40%

10%

10%

17%

6%

2%

32%

4%

26%

24%

11%

13%

22%

17%

10%

10%

23%

10%

15%

11%

14%

7%

11%

11%

24%

15%

32%

1%

CleanAirAct %

of

Total

Actions

0%

82%

68%

89%

75%

30%

45%

73%

77%

59%

51%

71%

54%

55%

67%

64%

63%

47%

58%

43%

41%

37%

47%

0%

46%

9%

33%

73%

56%

%o

fTotal

Inspections

52%

56%

82%

87%

66%

51%

66%

54%

63%

35%

38%

43%

40%

48%

49%

55%

62%

52%

60%

44%

46%

44%

53%

54%

64%

38%

28%

59%

69%

Total

Enforceme

nt

Actions 10 22 34 91 12 52 11 74 53 31 36 14 56 11 132 41 27 34 26 28 83 43 47 4 103 11 12 135 16

Total

Inspections

211

765

1,1

73

2,4

51

295

507

459

788

1,3

63

548

419

209

837

206

565

791

678

866

433

310

1,3

77

780

1,0

58

51

2,4

99

141

151

2,4

30

1,4

36

Facilities

Inspected

142

362

874

1,4

81

172

279

254

317

892

200

173

80

259

105

132

466

255

197

234

108

849

420

507

22

1,5

85

84

96

1,3

18

1,2

34

IndustrySector

MetalMining

CoalMining

OilandGasExtraction


Textiles

LumberandWood

Furniture

PulpandPaper

Printing

InorganicChemicals


Pharmaceuticals

OrganicChemicals


PetroleumRefining

RubberandPlastic

Stone,Clay,

GlassandConcrete

IronandSteel

MetalCastings

NonferrousMetals

FabricatedMetal

Electronics

AutomobileAssembly



WaterTransportation

AirTransportation


DryCleaning


8/3/2019 Pharma App 1997

36/53


VII.C. Review of Major Legal Actions

This section provides summary information about major cases that

Documents

Pharma App 1997