# Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards: Pharmaceutical Manufacturing Category > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A95-5663 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** May 2, 1995 - **Citation:** 60 FR 21592 ## Text SUMMARY: This proposed rule would limit the discharge of pollutants into waters of the United States and the introduction of pollutants into publicly owned treatment works by existing and new facilities that manufacture pharmaceuticals. The proposed rule establishes limitations on pollutants, but does not specify the technology to be employed to achieve compliance. The Agency intends that this proposed rule will have a common technology basis with a rule yet to be proposed to control air emissions to allow coordinated and cost effective compliance planning by the industry. This proposed rule would annually reduce priority pollutant discharges from this industry by an estimated 15.7 million pounds and total pollutant discharges by 139 million pounds at an estimated annual cost of $80 million (1994 $). The benefits include reductions in both carcinogenic and non-carcinogenic risk, ecological and recreational benefits due to improved water quality, and benefits to publicly owned treatment works such as improved worker health and safety. As a result of consultation with stakeholders, the preamble solicits comments and data not only on issues raised by EPA, but also on those issues raised by State and local governments who will be implementing these regulations and by industry representatives who will be affected by them. DATES: Comments on the proposed rule must be received by July 31, 1995 at the address noted below. EPA will conduct a public hearing on the effluent pretreatment standards included in the proposed rule. EPA will publish in the Federal Register an announcement of the public hearing. ADDRESSES: Send written comments on this proposal in triplicate and in electronic form if possible to Mr. David Hoadley, Engineering and Analysis Division (4303), U.S. EPA, 401 M Street SW., Washington, DC 20460. The public record supporting the proposed effluent limitations guidelines and standards is in the Water Docket located in the basement of the EPA Headquarters building, Room L102, 401 M Street SW., Washington, DC 20460, telephone number (202) 260-3027. EPA regulations at 40 CFR part 2 provide that a reasonable fee may be charged for copying. FOR FURTHER INFORMATION CONTACT: Background documents supporting the proposed regulations are described in the ``Background Documents'' section below. Contact the Office of Water Resource Center, RC-4100, at the U.S. EPA, Washington, DC address shown above, telephone (202) 260- 7786, for the voice mail publication request line. For additional information on the engineering aspects of the regulation, contact Dr. Frank H. Hund, Engineering and Analysis Division (4303), U.S. EPA, 401 M Street SW., Washington, DC 20460, at (202) 260-7182. For additional information on the economic and statistical aspects of the regulation, contact Mr. Neil Patel at the address above at (202) 260-5405. For additional engineering information on the preliminary air emissions control aspects of this rule, contact Mr. Randy McDonald, Office of Air Quality Planning and Standards (MD-13), Research Triangle Park, NC 27711, at (919) 541-5402. SUPPLEMENTARY INFORMATION: Overview The preamble describes the definitions, acronyms, and abbreviations used in this notice; the background documents that support these proposed regulations; the legal authority of this rule; a summary of the proposal; background information; and the technical and economic methodologies used by the Agency to develop these proposed regulations. This preamble also solicits comment and data on all aspects of this rulemaking, including on specific areas of interest. Confidential Business Information EPA notes that many documents in the record supporting this proposed rule have been claimed as confidential business information and, therefore, are not included in the record that is available to the public in the Water Docket. To support the rulemaking, EPA is presenting certain information in aggregated form or is masking plant identities to preserve confidentiality claims. Further, the Agency has withheld from disclosure some data not claimed as confidential business information because release of this information could indirectly reveal information claimed to be confidential. Plant-specific data that have been claimed as confidential business information are available to the company that submitted the information. To ensure that all CBI is protected in accordance with EPA regulations, any requests for company-specific data should be submitted on that company's letterhead and signed by a responsible official authorized to receive such data. The request must list the specific data requested and include the following statement, ``I certify that EPA is authorized to transfer confidential business information submitted by my company, and that I am authorized to receive it.'' Organization of this document: I. Definitions, Acronyms, and Abbreviations II. Background Documents III. Legal Authority IV. Summary and Scope of the Proposed Rule A. Effluent Limitations Guidelines and Standards 1. Subcategorization 2. Best Practicable Control Technology Currently Available (BPT) 3. Best Conventional Pollutant Control Technology (BCT) 4. Best Available Technology Economically Achievable (BAT) 5. New Source Performance Standards (NSPS) 6. Pretreatment Standards for Existing Sources (PSES) 7. Pretreatment Standards for New Sources (PSNS) 8. Best Management Practices (BMPs) B. Scope of the Proposed Rule V. Background A. Clean Water Act 1. Statutory Requirements of Regulations 2. Prior Regulations 3. Litigation History 4. Section 304(m) Requirements B. Clean Air Act C. Resource Conservation and Recovery Act (RCRA) D. Pollution Prevention Act of 1990 E. Common Sense Initiative VI. Regulatory Development Under the Clean Water Act A. Background B. Goals C. Technical Approach 1. Information Collection 2. Summary of Public Participation 3. Development of Effluent Limitations Control Technology Options 4. Analyses of Regulatory Alternatives VII. Description of the Industry A. Pharmaceutical Manufacturing Facilities B. Manufacturing Processes 1. Fermentation 2. Biological and Natural Extraction 3. Chemical Synthesis [[Page 21593]] 4. Mixing/Compounding/Formulating VIII. Summary of Data Gathering Efforts A. Technical and Economic Data 1. 1989 Screener Survey of the Pharmaceutical Industry 2. 1990 Pharmaceutical Manufacturing Industry Survey 3. Sampling and Analytical Program B. Air Emission Data IX. Development of Effluent Limitations Guidelines and Standards A. Industry Subcategorization 1. Introduction 2. Current Subcategorization 3. Rationale for Maintaining the Current Subcategorization 4. Subcategory Regulation Not Revised B. Water Use, Wastewater Discharge and Characterization 1. Water Use and Wastewater Generation 2. Wastewater Discharge 3. Wastewater Characterization C. Selection of Pollutant Parameters 1. Pollutants Regulated 2. Pollutants Not Regulated D. Available Technologies 1. Pollution Prevention Technologies Considered 2. In-plant Technologies Considered 3. End-of-Pipe Technologies Considered E. Rationale for Selection of Technology Bases for Proposed Regulations 1. BPT 2. BCT 3. BAT 4. NSPS 5. PSES 6. PSNS 7. BMPs F. Determination of Long-Term Averages, Variability Factors, and Limitations G. Costs 1. BPT 2. BAT 3. PSES H. Pollutant Reductions 1. Conventional Pollutants 2. Priority Pollutants 3. Nonconventional Pollutants I. Regulatory Implementation 1. Applicability 2. Upset and Bypass Provisions 3. Variances and Modifications 4. Relationship of Effluent Limitations to NPDES Permits and Monitoring Requirements 5. Best Management Practices 6. Analytical Methods X. Regulation of the Pharmaceutical Manufacturing Industry Under the Clean Air Act Amendments of 1990 A. Preliminary Development of Air Emissions Standards B. Potential Interaction of Proposed Effluent Limitations Guidelines and Future Air Emissions Standards XI. Impacts of Regulatory Options Considered in this Rulemaking A. Regulatory Options B. Economic Impact Considerations 1. Introduction 2. Projected Facility Economic Impacts 3. Projected Owner Company-Level Economic Impacts 4. Projected Employment Losses and Gains and Community-Level Economic Impacts 5. Projected Foreign Trade Impacts 6. Regulatory Flexibility Analysis 7. Projected Distributional Impacts 8. Projected Impacts on New Sources 9. Regulatory Impact Assessment XII. Relationship of Proposed Effluent Guidelines to EPA's Hazardous Waste Initiatives A. Relationship to Rulemaking Activities Under RCRA 1. Introduction and Overview of Land Ban Regulations 2. The Land Disposal Restrictions Program 3. Phase 3 and the Pharmaceutical Effluent Guidelines B. Coordination With Waste Minimization and Combustion Strategy 1. Waste Minimization 2. Combustion XIII. Administrative Requirements A. Changes in Format and Name B. Docket and Public Record C. Clean Water Act Procedural Requirements D. Executive Order 12866 E. Regulatory Flexibility Act F. Reduction of Unfunded Mandates and Consultation with State Local, and Tribal Governments G. Paperwork Reduction Act XIV. Solicitation of Data and Comments A. Introduction and General Solicitation B. Specific Data and Comment Solicitations I. Definitions, Acronyms, and Abbreviations 1989 Pharmaceutical Screener Questionnaire--A short questionnaire distributed by EPA to all known pharmaceutical facilities in June 1989 in order to identify plants which manufacture pharmaceutical products. 1990 Detailed Questionnaire--The 1990 Pharmaceutical Manufacturing Survey. A questionnaire sent by EPA to certain facilities in the pharmaceutical manufacturing industry in September 1991 to gather technical and financial information. The questionnaire was sent to those facilities likely to be affected by promulgation of revised effluent limitations guidelines, pretreatment standards, and new source performance standards for this industry. Administrator--The Administrator of the U.S. Environmental Protection Agency. Agency--The U.S. Environmental Protection Agency. Annual average--The mean concentration, mass loading or production- normalized mass loading of a pollutant over a period of 365 consecutive days (or such other period of time determined by the permitting authority to be sufficiently long to encompass expected variability of the concentration, mass loading or production-normalized mass loading at the relevant point of measurement). Average monthly discharge limitation--The highest allowable average of ``daily discharges'' over a calendar month, calculated as the sum of all ``daily discharges'' measured during a calendar month divided by the number of ``daily discharges'' measured during that month. BAT--The best available technology economically achievable, as described in Section 304(b)(2) of the Clean Water Act. Bench-scale operation--Laboratory testing of materials, methods, or processes on a small scale, such as on a laboratory worktable. BCT--The best conventional pollutant control technology, as described in section 304(b)(4) of the Clean Water Act. BID--Background Information Document, which presents the technical basis for air pollution controls under the Clean Air Act. Biological and Natural Extraction--The chemical and physical extraction of pharmaceutically active ingredients from natural sources such as plant roots and leaves, animal glands, and parasitic fungi. The process operations involving biological and natural extraction define subcategory B (40 CFR 439, subpart B). BMP or BMPs--Best management practices, as described in section 304(e) of the Clean Water Act. BOD5--Five-Day Biochemical Oxygen Demand. A measure of biochemical decomposition of organic matter in a water sample. It is determined by measuring the dissolved oxygen consumed by microorganisms to oxidize the organic contaminants in a water sample under standard laboratory conditions of five days and 20 deg.C. BOD5 is not related to the oxygen requirements in chemical combustion. Boiler--Any enclosed combustion device that extracts useful energy in the form of steam and is not an incinerator. BPT--The best practicable control technology currently available, as described in section 304(b)(1) of the Clean Water Act. CAA--Clean Air Act. The Air Pollution Prevention and Control Act (42 U.S.C. 7401 et seq.), as amended, inter alia, by the Clean Air Act Amendments of 1990 (Pub. L. 101-549, 104 Stat. 2399). Chemical Synthesis--The process(es) of using a chemical reaction or a series of chemical reactions to manufacture pharmaceutically active ingredients. The chemical synthesis process operations define subcategory C (40 CFR 439, subpart C). Clarifier--A treatment unit designed to remove suspended materials from wastewater, typically by sedimentation. Closed vent system--A system that is not open to the atmosphere and is composed of piping, ductwork, [[Page 21594]] connections, and, if necessary, flow-inducing devices that transport gas or vapor from an emission point to a control device or back into the process. CN--Abbreviation for total cyanide. COD--Chemical oxygen demand (COD)--A nonconventional bulk parameter that measures the total oxygen-consuming capacity of wastewater. This parameter is a measure of materials in water or wastewater that are biodegradable and materials that are resistant (refractory) to biodegradation. Refractory compounds slowly exert demand on downstream receiving water resources. Certain of the compounds measured by this parameter have been found to have carcinogenic, mutagenic, and similar adverse effects, either singly or in combination. It is expressed as the amount of oxygen consumed by a chemical oxidant in a specific test. Combustion device--An individual unit of equipment, including but not limited to, an incinerator or boiler, used for the thermal oxidation of organic hazardous air pollutant vapors. Condensate--Any material that has condensed from a gaseous phase into a liquid phase. Continuous discharge--Discharge that occurs without interruption throughout the operating hours of the facility. Control Techniques Guidance (CTG)--A document prepared to provide State and local air pollution authorities with an information base for proceeding with analysis of Reasonably Available Control Technology (RACT) to meet Clean Air Act statutory requirements. Controlled-release discharge--A discharge that occurs at a rate that is intentionally varied to accommodate fluctuations in receiving stream assimilative capacity or for other reasons. Conventional pollutants--The pollutants identified in section 304(a)(4) of the Clean Water Act and the regulations thereunder (i.e., biochemical oxygen demand (BOD5), total suspended solids (TSS), oil and grease, fecal coliform and pH). CWA--Clean Water Act. The Federal Water Pollution Control Act Amendments of 1972 (33 U.S.C. 1251 et seq.), as amended, inter alia, by the Clean Water Act of 1977 (Pub. L. 95-217) and the Water Quality Act of 1987 (Pub. L. 100-4). Daily discharge--The discharge of a pollutant measured during any calendar day or any 24-hour period that reasonably represents a calendar day for purposes of sampling. For pollutants with limitations expressed in units of mass, the daily discharge is calculated as the total mass of the pollutant discharged over the day. For pollutants with limitations expressed in other units of measurement, the daily discharge is calculated as the average measurement of the pollutant over the day. Direct discharger--A facility that discharges or may discharge treated or untreated process wastewaters, non-contact cooling waters, or non-process wastewaters (including stormwater runoff) into waters of the United States. Effluent--Wastewater discharges. Effluent limitation--Any restriction, including schedules of compliance, established by a State or the Administrator on quantities, rates, and concentrations of chemical, physical, biological, and other constituents which are discharged from point sources into waters of the United States, the waters of the contiguous zone, or the ocean. Emission--Passage of air pollutants into the atmosphere via a gas stream or other means. Emission point--Any location within a source from which air pollutants are emitted, including an individual process vent, an opening within a wastewater collection and treatment system, or an open piece of process equipment. EOP effluent--Final plant effluent discharged to waters of the United States or to a POTW. EOP treatment--End-of-pipe treatment facilities or systems used to treat process wastewaters, non-process wastewaters (including stormwater runoff) after the wastewaters have left the process area of the facility and prior to discharge. End-of-pipe treatment generally does not include facilities or systems where products or by-products are separated from process wastewaters and returned to the process or directed to air emission control devices. EPA--The U.S. Environmental Protection Agency. General Provisions--General Provisions for national emission standards for hazardous air pollutants and other regulatory requirements pursuant to section 112 of the Clean Air Act, as amended November 15, 1990. The General Provisions, located in subpart A of part 63 of title 40 of the Code of Federal Regulations, codify procedures and criteria to implement emission standards for stationary sources that emit (or have the potential to emit) one or more of the 189 chemicals listed as hazardous air pollutants in section 112(b) of the Clean Air Act as amended in 1990. EPA published the NESHAP General Provisions in the Federal Register on March 16, 1993 (59 FR 12408). The term General Provisions also refers to the General Provisions for the effluent limitations guidelines and standards proposed today, to be located at 40 CFR part 439. Fermentation--A chemical change induced by a living organism or enzyme, specifically bacteria or the microorganisms occurring in unicellular plants such as yeast, molds, or fungi. Process operations that utilize fermentation to manufacture pharmaceutically active ingredients define subcategory A (40 CFR 439, subpart A). HAP--Hazardous Air Pollutant. Any of the 189 chemicals listed under section 112(b) of the Clean Air Act. HON--Hazardous Organic NESHAP. As used in this notice, it refers to the standard published by EPA for the Synthetic Organic Chemical Manufacturing Industry (SOCMI) on April 22, 1994 (59 FR 19402). Incinerator--An enclosed combustion device that is used for destroying organic compounds. Auxiliary fuel may be used to heat waste gas to combustion temperatures. Any energy recovery section present is not physically formed into one manufactured or assembled unit with the combustion section; rather, the energy recovery section is a separate section following the combustion section and the two are joined by ducts or connections carrying flue gas. Indirect discharger--A facility that discharges or may discharge wastewaters into a publicly owned treatment works. Individual drain system--The system used to convey process wastewater streams away from the pharmaceutical manufacturing process equipment or tank, or process wastewater collection and treatment system unit. The term includes all process drains and junction boxes, together with their associated sewer lines and other junction boxes, manholes, sumps and lift stations. The individual drain system is designed to segregate the vapors within the system from other drain systems. A separate storm sewer system, which is a drain and collection system designed and operated for the purpose of collecting storm runoff at a facility, and which is segregated from all other individual drain systems, is excluded from this definition. In-plant Control Technologies--These include controls or measures applied within the manufacturing process to reduce or eliminate pollutant and hydraulic loadings; these also include technologies, such as steam stripping and cyanide destruction, applied directly to wastewater generated by manufacturing processes. [[Page 21595]] IU--Industrial User. Synonym for ``Indirect Discharger.'' Junction box--A manhole access point to a wastewater sewer system or a lift station. LTA--Long-term average. For purposes of proposed effluent limitations guidelines and standards, average pollutant levels achieved over a period of time by a plant, subcategory, or technology option. LTAs were used in developing the limitations and standards in today's proposed regulation. MACT--Maximum Achievable Control Technology. Technology basis for the national emission standards for hazardous air pollutants. Major source--As defined in section 112(a) of the Clean Air Act, major source is any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit, considering controls, in the aggregate 10 tons per year or more of any hazardous air pollutant or 25 tons per year or more of any combination of hazardous air pollutants. Maximum daily discharge limitation--The highest allowable daily discharge of a pollutant measured during a calendar day or any 24 hour period that reasonably represents a calendar day for purposes of sampling. Mg--Megagram. One million (10\6\) grams, or one metric ton. Metric ton--One thousand (10\3\) kilograms (abbreviated as kkg), or one megagram. A metric ton is equal to 2,204.5 pounds. Minimum level--The level at which an analytical system gives recognizable signals and an acceptable calibration point. Mixing/Compounding/Formulating--Processes through which pharmaceutically active ingredients are put in dosage forms. Processes involving mixing/compounding/formulating define subcategory D (40 CFR 439, subpart D). Modification--As defined in section 112(a) of the Clean Air Act, modification is any physical change in, or change in the method of operation of, a major source which increases the actual emissions of any hazardous air pollutant emitted by such source by more than a de minimis amount or which results in the emission of any hazardous air pollutant not previously emitted by more than a de minimis amount. NESHAP--National Emission Standard for Hazardous Air Pollutants. Emission standard promulgated that has been or will be promulgated under section 112(d) of the Clean Air Act for hazardous air pollutants listed in section 112(b) of the Clean Air Act. New Source--As defined in 40 CFR 122.2, 122.29, and 403.3(k), a new source is any building, structure, facility, or installation from which there is or may be a discharge of pollutants, the construction of which commenced (1) For purposes of compliance with New Source Performance Standards, after the promulgation of such standards being proposed today under CWA section 306; or (2) for the purposes of compliance with Pretreatment Standards for New Sources, after the publication of proposed standards under CWA section 307(c), if such standards are thereafter promulgated in accordance with that section. Nonconventional pollutants--Pollutants that are neither conventional pollutants nor toxic pollutants. Non-detect value--A concentration-based measurement reported below the minimum level that can reliably be measured by the analytical method for the pollutant. Non-water quality environmental impact--An environmental impact of a control or treatment technology, other than to surface waters. NPDES--The National Pollutant Discharge Elimination System authorized under section 402 of the CWA. The Clean Water Act requires NPDES permits for discharge of pollutants from any point source into waters of the United States. NRDC--Natural Resources Defense Council. NSPS--New Source Performance Standards. As used in this notice, this term refers to standards for new sources under section 306 of the CWA. OMB--Office of Management and Budget. Outfall--The mouth of conduit drains and other conduits from which a plant discharges effluent into receiving waters. Pharmaceutically active ingredient--Any substance considered to be an active ingredient by Food and Drug Administration regulations (21 CFR 210.3(6)(7)). Pilot-scale operation--The trial operation of processing equipment, which is the intermediate stage between laboratory experimentation and full-scale operation in the development of a new process or product. Point of Generation--The location where the process wastewater stream exits the pharmaceutical process equipment. Point source category--A category of sources of water pollutants that are included within the definition of ``point source'' in section 502(14) of the Clean Water Act. Pollutant (to water)--Dredged spoil, solid waste, incinerator residue, filter backwash, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, certain radioactive materials, heat, wrecked or discarded equipment, rock, sand, cellar dirt, and industrial, municipal, and agricultural waste discharged into water. See CWA section 502(6); 40 CFR 122.2. POTW or POTWs--Publicly owned treatment works, as defined at 40 CFR 403.3(o). Pretreatment standard--A regulation specifying industrial wastewater effluent quality required for discharge to a POTW. Primary fuel--The fuel that provides the principal heat input to a combustion device. To be considered primary, the fuel must be able to sustain operation of the combustion device without the addition of other fuels. Priority pollutants--The toxic pollutants listed in 40 CFR part 403, Appendix A (printed immediately following 40 CFR 423.17). Process changes--Alterations in process operating conditions, equipment, or chemical use that reduce the formation of chemical compounds that are pollutants and/or pollutant precursors. Process emission point--A gas stream that contains hazardous air pollutants discharged during operation of process equipment. Process emission points include gas streams that are discharged directly to the atmosphere, discharged to the atmosphere via vents or open process equipment, or discharged after diversion through a product recovery device. Process unit--A piece of equipment, such as a chemical reactor or fermentation tank, associated with pharmaceutical manufacturing operations. Process wastewater--Any water that, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, byproduct, or waste product. Process wastewater includes surface runoff from the immediate process area that has the potential to become contaminated. (1) For purposes of this part, the following materials are excluded from the definition of process wastewater: 1. Trimethyl silanol; 2. Any active anti-microbial materials; 3. Wastewater from imperfect fermentation batches; and 4. Process area spills. [[Page 21596]] (2) For purposes of this part, the following waters and wastewaters are excluded from the definition of process wastewater: noncontact cooling water, utility wastewaters, general site surface runoff, groundwater (e.g., contaminated groundwaters from on-site or off-site groundwater remediation projects), and other water generated on site that are not process wastewaters. The discharge of such waters and wastewaters must be regulated separately. Process wastewater collection system--A piece of equipment, structure, or transport mechanism used in conveying or storing a process wastewater stream. Examples of process wastewater collection system equipment include individual drain systems, wastewater tanks, surface impoundments, and containers. Process wastewater stream--When used in connection with CAA obligations, any HAP-containing liquid that results from either direct or indirect contact of water with organic compounds. Process water--Water used to dilute, wash, or carry raw materials or any other materials used in pharmaceutical manufacturing processes. PSES--Pretreatment standards for existing sources of indirect discharges, under section 307(b) of the CWA. PSNS--Pretreatment standards for new sources of indirect discharges, under sections 307(c) of the CWA. RCRA--Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. 6901, et seq.). Research--Bench-scale activities or operations used in research and/or product development of a pharmaceutical product. The Research operations define subcategory E (40 CFR 439, Subpart E). SIC--Standard Industrial Classification. A numerical categorization system used by the U.S. Department of Commerce to denote segments of industry. An SIC code refers to the principal product, or group of products, produced or distributed, or to services rendered by an operating establishment. SIC codes are used to group establishments by the primary activity in which they are engaged. Source Category--A category of major or area sources of hazardous air pollutants. Source Reduction--The reduction or elimination of waste generation at the source, usually within a process. A source reduction practice is any practice that (1) Reduces the amount of any hazardous substance, pollutant, or contaminant entering any waste stream or otherwise released into the environment (including fugitive emissions) prior to recycling, treatment, or disposal; and (2) reduces the hazards to public health and the environment associated with the release of such substances, pollutants, or contaminants. Stationary source--Any building, structure, facility, or installation that emits or may emit any air pollutant. See CAA section 111(a)(3). Support Document(s)--see section II for titles. TDD--Technical Development Document TEQ--Toxic Equivalent. TSCA--Toxic Substances Control Act (15 U.S.C. 2601, et seq.). TSS--Total Suspended Solids. Toxic pollutants--the pollutants designated by EPA as toxic in 40 CFR 401.15. Variability factor--The daily variability factor is the ratio of the estimated 99th percentile of the distribution of daily values divided by the expected value, or mean, of the distribution of the daily data. The monthly variability factor is the estimated 95th percentile of the monthly averages of the data divided by the expected value of the monthly averages. VOC--Volatile Organic Compound--means any organic compound, excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate, which participates in atmospheric photochemical reactions other than those that the Administrator designates as having negligible photochemical reactivity. The Administrator has designated the following organic compounds as negligibly reactive: methane; ethane; methylene chloride; methyl chloroform; CFC-113; CFC-11; CFC-12; CFC-22; CFC-23; CFC-114; CFC-115; HCFC-123; HFC-134a; HCFC-141b; HCFC-142b; HCFC-124; HFC-125; HFC-134; HFC-143a; HFC-152a; and perfluorocarbon compounds which fall into these classes: (i) Cyclic, branched, or linear, completely fluorinated alkanes; (ii) cyclic, branched, or linear, completely fluorinated ethers with no unsaturations; cyclic, branched, or linear, completely fluorinated tertiary amines with no unsaturations; and (iv) sulfur containing perfluorocarbons with no unsaturations and with sulfur bonds only to carbon and fluorine. 40 CFR 51.100(s)(1). Waters of the United States--the same meaning set forth in 40 CFR 122.2. Zero discharge (ZD)--No discharge of wastewater to waters of the United States or to a POTW. II. Background Documents The rule proposed today is supported by several major documents: (1) EPA's technical conclusions concerning the wastewater regulations are detailed in the ``Development Document for Proposed Effluent Limitations Guidelines and Standards for the Pharmaceutical Manufacturing Point Source Category,'' hereafter referred to as the Technical Development Document (TDD) (EPA 821-R-95-019), (2) the Agency's economic analysis is found in the ``Economic Impact and Regulatory Flexibility Analysis of Proposed Effluent Guidelines for the Pharmaceutical Manufacturing Industry,'' hereafter called the Economic Impact Analysis (EPA 821-R-95-018), (3) the regulatory impact analysis (including the Agency's assessment of environmental benefits) is detailed in the ``Regulatory Impact Assessment of Proposed Effluent Guidelines for the Pharmaceutical Manufacturing Industry,'' hereafter called the Regulatory Impact Assessment (EPA 821-R-95-017), (4) an analysis of the incremental costs and pollutant removals for the proposed effluent limitations guidelines and standards is presented in ``Cost-effectiveness Analysis of Proposed Effluent Limitations Guidelines for the Pharmaceutical Manufacturing Industry,'' (EPA 821-R- 95-015), (5) analytical methods used in the development of the proposed effluent limitations guidelines and standards are found in ``Analytical Methods for the Determination of Pollutants in Pharmaceutical Manufacturing Industry Wastewater,'' a compendium of analytical methods (EPA 821-R-95-014), and (6) the statistical (EPA 821-R-95-016) support for today's proposed effluent limitations guidelines and standards is found in ``Statistical Support Document for the Proposed Effluent Limitations Guidelines for the Pharmaceutical Manufacturing Industry.'' III. Legal Authority This regulation is being proposed under the authority of sections 301, 304, 306, 307, 308, and 501 of the Clean Water Act, 33 U.S.C. 1311, 1314, 1316, 1317, 1318, and 1361. IV. Summary and Scope of the Proposed Rule In today's notice, EPA proposes effluent limitations guidelines and standards for process wastewater generated by the pharmaceutical manufacturing industry. Section IX of this notice discusses the rationale for [[Page 21597]] the proposed guidelines and standards. This summary section highlights the technology bases and other key aspects of the proposed rule. The technology descriptions in this section are presented in abbreviated form; more detailed descriptions are included in the TDD. Today's notice presents the Agency's proposed regulatory approach and several others that EPA considered. The Agency's proposal is based on comments received from interested parties during the development of this proposed rule, and on detailed evaluation of the available data. As indicated below in the discussion of the specifics of the proposal, the Agency welcomes comment on all options, issues, rationale, and proposed decisions and encourages commenters to submit additional data during the comment period (see section XIV of this preamble). In particular, the Agency welcomes comments on the treatment technologies that EPA has selected as the basis for the limitations and standards being proposed today. For example, EPA bases its proposed standards for new sources primarily on steam stripping with distillation technology. For most existing sources, EPA bases the proposed limitations and standards primarily on steam stripping technology, which is less costly and less energy intensive than distillation technology. EPA expects a variety of human health, environmental, and economic benefits to result from these reductions in effluent loadings and, in some cases, air emissions. In particular, the benefits include: human health and agricultural benefits due to reductions in emissions of ozone precursors (i.e., reductions in VOC emissions); human health benefits due to reductions in excess cancer risk; human health benefits due to reductions in non-carcinogenic risk; ecological and recreational benefits due to improved water quality; and benefits to publicly owned treatment works (POTWs) from reductions in interference, passthrough, and sludge contamination problems and improvements in worker health and safety. EPA monetized the estimated benefits for reductions in air emissions of ozone precursors and cancer risk reductions, but is unable to quantify the dollar magnitude of benefits from the other benefit categories. Therefore, the reported benefit estimate understates the total benefits of the proposed rule. EPA estimates that the annual benefits resulting from the proposed rule will range from $231,000 to $7.6 million ($1994). EPA has internally coordinated among relevant program offices in developing this rule. Section X of this preamble describes close coordination between the Office of Water and the Office of Air and Radiation on this proposed water rule and an air rule that will be proposed at a later date for the pharmaceutical manufacturing industry. As explained in detail in Section X, the Agency intends that direct and indirect dischargers will be able to employ a single steam stripper design to achieve the requirements of both final rules. It is also the Agency's intent, upon promulgation, that both rules will apply to essentially the same high concentration, low volume process wastewater streams in which the bulk of the volatile organic pollutants are contained (see Section X for details). The practical effect of this approach will be that only a relatively small portion (i.e., substantially less than half) of all process wastewaters will require control of volatile organic pollutants (e.g., by steam stripping) to achieve compliance with both rules. In the air rule, EPA also will develop air emission standards for other emission points (e.g., process vents, process area fugitive emissions, etc.). Also, Section XII of this preamble describes coordination between the Office of Water and the Office of Solid Waste and Emergency Response regarding the hazardous waste implications of this proposed water rule, including recovering ignitable nonhalogenated organics and reusing them as ``clean fuels.'' The Agency has worked with the Food and Drug Administration (FDA) to explore pollution prevention opportunities to the maximum extent feasible. EPA shared with FDA information and data gathered from the industry in responses to EPA's detailed Section 308 questionnaire. This was done to assist FDA in evaluating the environmental impacts of revised drug manufacturing processes (as described in ``supplement'' applications) and of new drug manufacturing processes. These reviews will ensure that opportunities for solvent use minimization/elimination and water-based manufacturing processes (e.g., water-based tablet coating) are considered and adopted within the constraints of maintaining the efficacy of both existing and new pharmaceutical products. EPA has involved stakeholders and interested parties, including state and local governments, in the process of developing this rule. Since the inception of the project in 1986, there have been periodic meetings with the industry and its trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), to discuss progress on the rulemaking. The Agency also has met with the Natural Resources Defense Council (NRDC) to discuss progress on this rulemaking. Because most of the facilities affected by this proposal are indirect dischargers, the Agency conducted an outreach survey in 1990 to a limited number of POTWs substantially affected by one or more pharmaceutical manufacturing facilities to solicit their input on the need for this proposed rule and pertinent technical issues. The Agency also held a public meeting on May 23, 1994. EPA representatives of the Office of Water and the Office of Air and Radiation outlined the underlying technical basis and options being considered for this proposal, the efforts to coordinate the future air rule and this proposed water rule, and took comments and questions from the audience. The Agency also consulted recently with representatives of selected POTWs regarding underlying technical aspects of this proposal. The Agency plans to have additional discussions with stakeholders and interested parties during the comment period to minimize the potential for unfunded mandates and to help ensure that the Agency has the views of such parties and the best possible data upon which to base a decision for the final rule. EPA's final rule may be based upon any technologies, rationale or approaches that are a logical outgrowth of this proposal, including any options discussed in this or subsequent Federal Register documents. A. Effluent Limitations Guidelines and Standards 1. Subcategorization EPA is proposing to maintain the subcategorization scheme under the existing effluent limitations guidelines and standards for this industry (in part 439). The rationale for maintaining the existing subcategorization scheme is detailed in section IX.A. 2. Best Practicable Control Technology Currently Available (BPT) EPA is proposing to revise the BPT effluent limitations guidelines for biochemical oxygen demand (BOD5), COD, and total suspended solids (TSS) for four subcategories of the pharmaceutical manufacturing industry. These proposed revisions are based on the application of advanced biological treatment. EPA also is proposing to revise the BPT effluent limitations guidelines for CN (Total Cyanide) for facilities with subcategory A and/or C operations, based on in-plant cyanide destruction technology. As discussed in [[Page 21598]] Section IX.E., below, EPA also is proposing to repeal the existing BPT cyanide limitations for facilities with subcategory B and/or D operations. The proposed BPT effluent limitations are defined by the performance of the average of the best plants in the subcategory. The development of proposed BPT effluent limitations is discussed in section IX.E.1 of this notice and in Section 8 of the TDD. 3. Best Conventional Pollutant Control Technology (BCT) EPA is proposing to revise the BCT effluent limitations guidelines for BOD5 and TSS for four subcategories of the pharmaceutical manufacturing industry. In all cases, the proposed BCT effluent limitations are equal to the proposed BPT effluent limitations. The development of proposed BCT effluent limitations is further explained in section IX.E.2. 4. Best Available Technology Economically Achievable (BAT) The Agency is proposing to revise the BAT effluent limitations guidelines for four subcategories of the pharmaceutical manufacturing industry to control priority and nonconventional pollutants. Table IV.A-1 is a summary of the technology basis for the proposed BAT effluent limitations for each subcategory. Table IV.A-1.--Proposed Technology Basis for BAT Effluent Limitations ---------------------------------------------------------------------------------------------------------------- Proposed subpart Name of subcategory Proposed technology basis ---------------------------------------------------------------------------------------------------------------- A................... Fermentation........................... In-plant steam stripping and cyanide destruction followed by advanced biological treatment. B................... Natural Extraction..................... Advanced biological treatment. C................... Chemical Synthesis..................... In-plant steam stripping and cyanide destruction followed by advanced biological treatment. D................... Mixing/Compounding/Formulating......... Advanced biological treatment.\1\ ---------------------------------------------------------------------------------------------------------------- \1\Same technology basis as for proposed BPT limitations. The pollutants that EPA proposes to regulate and the points of monitoring to establish compliance with the limitations vary for each subcategory and are described in sections IX.C and IX.E.3. 5. New Source Performance Standards (NSPS) a. Priority and Nonconventional Pollutants. EPA is proposing revised NSPS for four subcategories of the pharmaceutical manufacturing industry. For facilities with subcategory A and/or C and B and/or D operations, EPA is proposing NSPS to be more stringent than the proposed BAT effluent limitations and is basing those standards primarily on steam stripping with distillation technology. The development of proposed NSPS for priority and nonconventional pollutants is discussed in section IX.E.4. b. Conventional Pollutants. EPA is proposing to revise NSPS pertaining to discharges of BOD5, COD and TSS for four subcategories of the pharmaceutical manufacturing industry at a level equal to the discharge characteristics of the best performing plant. A summary of the pollutants and subcategories proposed to be regulated is presented in section IX.C. The development of proposed NSPS for conventional pollutants and COD is discussed in section IX.E.4. 6. Pretreatment Standards for Existing Sources (PSES) EPA is proposing to revise PSES for four subcategories of the pharmaceutical manufacturing industry for the priority and nonconventional pollutants to be controlled by technologies summarized in Table IV.A-2. EPA also co-proposes two different pass-through determinations for 33 less strippable volatile organic pollutants. PSES are further discussed in section IX.E.5. Table IV.A-2.--Proposed Technology Basis for PSES Effluent Limitations ---------------------------------------------------------------------------------------------------------------- Proposed subpart Name of subcategory Proposed technology basis ---------------------------------------------------------------------------------------------------------------- A................... Fermentation........................... In-plant cyanide destruction; in-plant steam stripping. B.................. Natural Extraction..................... In-plant steam stripping. C................... Chemical Synthesis..................... In-plant cyanide destruction; in-plant steam stripping. D.................. Mixing/Compounding/Formulating......... In-plant steam stripping. ---------------------------------------------------------------------------------------------------------------- 7. Pretreatment Standards for New Sources (PSNS) EPA is proposing to revise PSNS for four subcategories of the pharmaceutical manufacturing industry for the same priority and nonconventional pollutants controlled by the proposed PSES, but based on steam stripping with distillation technology. As under PSES, EPA co- proposes two different pass-through determinations for 33 less strippable volatile organic pollutants. PSNS are further discussed in section IX.E.6. 8. Best Management Practices (BMPs) The Agency is not proposing today BMPs for the pharmaceutical manufacturing point source category. However, the Agency is soliciting comment on whether BMPs are applicable to pharmaceutical manufacturing facilities and, if so, what they should be. See Section XIV of this preamble, solicitation number 31. B. Scope of the Proposed Rule The rule proposed today covers four subcategories of the pharmaceutical manufacturing point source category. As discussed in Section IX.A.4, below, EPA does not propose to revise the effluent limitations guidelines applicable to Subcategory E (Pharmaceutical Research) facilities and subcategory E operations at facilities with subcategory A through D operations. These activities will be covered by the existing BPT effluent limitations regulations for this [[Page 21599]] subcategory and subject to BAT and BCT limitations, where appropriate, set on a case-by-case basis using best professional judgment (BPJ). Pharmaceutical manufacturers use many different raw materials and manufacturing processes to create a wide range of products. These products include medicinal and feed grades of all organic chemicals having therapeutic value, whether obtained by chemical synthesis, fermentation, extraction from naturally occurring plant or animal substances, or by refining a technical grade product. The pharmaceutical products, processes and activities covered by this proposal include: a. Biological products covered by the U.S. Department of Commerce, Bureau of the Census Standard Industrial Classification (SIC) Code No. 2836, with the exception of diagnostic substances. (Products covered by SIC Code No. 2836 were formerly covered under the 1977 SIC Code No. 2831.) b. Medicinal chemicals and botanical products covered by SIC Code No. 2833; c. Pharmaceutical products covered by SIC Code No. 2834; d. All fermentation, biological and natural extraction, chemical synthesis and formulation products considered to be pharmaceutically active ingredients by the Food and Drug Administration that are not covered by SIC Code Nos. 2833, 2834, and 2836; e. Multiple end-use products derived from pharmaceutical manufacturing operations (e.g., components of formulations, intermediates, or final products, provided that the primary use of the product is intended for pharmaceutical purposes); f. Products not covered by SIC Code Nos. 2833, 2834, and 2836 if they are manufactured by a pharmaceutical manufacturer by processes that generate wastewaters that in turn closely correspond to those of pharmaceutical products; g. Cosmetic preparations covered by SIC Code No. 2844 that function as a skin treatment. (This group of preparations does not include products such as lipsticks or perfumes that serve to enhance appearance or to provide a pleasing odor, but do not provide skin care. In general, this also excludes deodorants, manicure preparations, and shaving preparations that do not function primarily as a skin treatment.); and h. Pharmaceutical research that includes biological, microbiological, and chemical research, product development, clinical and pilot-scale activities. (This does not include farms that breed, raise, and/or hold animals for research at another site. This also does not include ordinary feedlot or farm operations utilizing feed that contains pharmaceutically active ingredients.) Pilot-scale and product development operations conducted at research facilities would be subject to the specific manufacturing subcategory limitations and standards corresponding to the subcategory wastewater that the research facility's wastewater resembles. For example, a pilot chemical synthesis operation that generates wastewater that is similar to wastewater generated by chemical synthesis manufacturing would be subject to the subcategory C limitations and standards. A number of products and/or activities such as surgical and medical manufacturing and medical laboratory activity are not part of the pharmaceutical manufacturing category. A descriptive listing of the products and activities that are specifically excluded from the pharmaceuticals manufacturing category may be found in section 2 of the TDD. V. Background A. Clean Water Act 1. Statutory Requirements of Regulations The objective of the Clean Water Act (CWA) is to ``restore and maintain the chemical, physical, and biological integrity of the Nation's waters''. Section 101(a) of the CWA. To assist in achieving this objective, EPA issues effluent limitations guidelines, pretreatment standards, and new source performance standards for industrial dischargers. These guidelines and standards are summarized below: a. Best Practicable Control Technology Currently Available (BPT)-- section 304(b)(1) of the CWA. BPT effluent limitations guidelines apply to all discharges from existing direct dischargers. BPT guidelines are based on the average of the best performance achieved by plants in a category or subcategory utilizing currently available technology. In establishing BPT, EPA considers the cost of achieving effluent reductions in relation to the effluent reduction benefits, the age of equipment and facilities, the processes employed, process changes required, engineering aspects of the control technologies, non-water quality environmental impacts (including energy requirements), and other factors as the EPA Administrator deems appropriate. Section 304(b)(1)(B) of the CWA. Where existing performance is uniformly inadequate within a category or subcategory, BPT may be transferred from a different subcategory or category. b. Best Conventional Pollutant Control Technology (BCT)--section 304(b)(4) of the CWA. The 1977 amendments to the CWA established BCT as an additional level of control for discharges of conventional pollutants from existing industrial point sources. Section 304(a)(4) designates the following as conventional pollutants: biochemical oxygen demanding pollutants (measured as BOD5), total suspended solids (TSS), fecal coliform, pH, and any additional pollutants defined by the Administrator as conventional. The Administrator designated oil and grease as an additional conventional pollutant on July 30, 1979 (44 FR 44501). See 40 CFR 401.16. In addition to other factors specified in section 304(b)(4)(B), the CWA requires that BCT limitations be established in light of a two part ``cost-reasonableness'' test. EPA issued a methodology for the development of BCT limitations on July 9, 1986 (51 FR 24974). c. Best Available Technology Economically Achievable (BAT)--section 304(b)(2) of the CWA. In general, BAT effluent limitations guidelines represent the best economically achievable performance of plants in the industrial subcategory or category, based on available technology. The CWA establishes BAT as a principal means of controlling the direct discharge of toxic and nonconventional pollutants to waters of the United States. The factors considered in assessing BAT include the age of equipment and facilities involved, the process employed, potential process changes, and non-water quality environmental impacts, including energy requirements. The Agency retains considerable discretion in assigning the weight to be accorded these factors. As with BPT, where existing performance is uniformly inadequate within a category or subcategory, BAT may be transferred from a different category or subcategory. BAT may be based upon process changes or internal controls, even when these technologies are not common industry practice. d. New Source Performance Standards (NSPS)--section 306 of the CWA. NSPS are based on the best available demonstrated treatment technology. New plants have the opportunity to install the best and most efficient production processes and wastewater treatment technologies. As a result, NSPS should represent the most stringent controls attainable through the application of the best available control technology for all pollutants (i.e., conventional, nonconventional, and toxic pollutants). In establishing NSPS, [[Page 21600]] EPA is directed to take into consideration the cost of achieving the effluent reduction and any non-water quality environmental impacts and energy requirements. e. Pretreatment Standards for Existing Sources (PSES)--section 307(b) of the CWA. PSES are designed to prevent the discharge of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of publicly owned treatment works (POTWs). The CWA authorizes EPA to establish pretreatment standards for pollutants that pass through POTWs or interfere with treatment processes or sludge disposal methods at POTWs. Pretreatment standards are technology-based and are analogous to BAT effluent limitations guidelines. See Section IX.E.5.(ii) for discussion of EPA's pass- through methodology. The General Pretreatment Regulations, which set forth the framework for the implementation of categorical pretreatment standards, are found at 40 CFR part 403. Those regulations contain a definition of pass- through that addresses localized rather than national instances of pass-through and establish pretreatment standards that apply to all nondomestic dischargers. For national instances of pass-through, EPA performs an analysis based on the procedures set forth at 52 FR 1586 (January 14, 1987). f. Pretreatment Standards for New Sources (PSNS)--section 307(b) of the CWA. Like PSES, PSNS are designed to prevent the discharge of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of a POTW. PSNS are to be issued at the same time as NSPS. New indirect dischargers have the opportunity to incorporate into their plants the best available demonstrated technologies. The Agency considers the same factors in promulgating PSNS as it considers in promulgating NSPS. g. Best Management Practices (BMPs). Section 304(e) of the CWA gives the Administrator the authority to publish regulations, in addition to the effluent limitations guidelines and standards listed above, to control plant site runoff, spillage or leaks, sludge or waste disposal, and drainage from raw material storage that the Administrator determines are associated with or ancillary to the industrial manufacturing or treatment process of the regulated point source category and that she (he) determines may contribute significant amounts of pollutants to waters of the United States. 2. Prior Regulations EPA promulgated interim final BPT regulations for the pharmaceutical manufacturing point source category on November 17, 1976 (41 FR 50676; 40 CFR part 439, Subparts A-E). The five subcategories of the pharmaceutical manufacturing industry (40 CFR 439) are: Subpart A--Fermentation Products Subcategory. Subpart B--Extraction Products Subcategory. Subpart C--Chemical Synthesis Subcategory. Subpart D-- Mixing, Compounding, and Formulating Subcategory. Subpart E-- Research Subcategory. The 1976 BPT regulations set monthly limitations for BOD5 and COD based on percent removal for all subcategories. No daily maximum effluent limitations were established for these parameters. The pH was set within the range of 6.0 to 9.0 standard units. The regulations also set maximum 30 day average total suspended solids (TSS) limitations for subcategories B, D, and E. No TSS limitations were established for subcategories A and C. Subpart A was amended (42 FR 6813) on February 4, 1977, to improve the language referring to separable mycelia and solvent recovery. The amendment also allowed the inclusion of spent beers (broths) in the calculation of raw waste loads for Subpart A in those instances where the spent beer is actually treated in the wastewater treatment system. On October 27, 1983, at 48 FR 49808, EPA promulgated revised BPT and BAT, PSES, and PSNS regulations for Subparts A-D covering the toxic pollutant cyanide and the conventional pollutants BOD5, TSS and pH and the nonconventional pollutant COD. The 1983 regulations kept intact the percent reduction regulations for BOD5 and COD established in 1976 but added floor concentration-based limitations for these parameters applicable to subcategories B and D. In addition, limitations for TSS based on each plant's BOD5 discharge were promulgated for subcategories A-D. EPA also promulgated BPT, BAT, PSES and PSNS for pH (6.0-9.0) and BAT concentration-based limitations controlling the discharge of cyanide from subcategory A-D plants. The Agency also proposed NSPS for BOD5, TSS and pH in the October 1983 notice, but did not publish final NSPS for these parameters. That proposal is being replaced by today's NSPS proposal. On December 16, 1986, at 51 FR 45094, EPA promulgated BCT effluent limitations for BOD5, TSS and pH for subcategories A-D. That final rule set BCT effluent limitations equal to the existing BPT effluent limitations for BOD5, TSS, and pH. 3. Litigation History The effluent limitations guidelines and standards for the pharmaceutical manufacturing industry have never been the subject of litigation. 4. Section 304(m) Requirements Section 304(m) of the Clean Water Act (33 U.S.C. 1314(m)), added by the Water Quality Act of 1987, requires EPA to establish schedules for (i) reviewing and revising existing effluent limitations guidelines and standards and (ii) promulgating new effluent guidelines. On January 2, 1990, EPA published an Effluent Guidelines Plan (55 FR 80), in which schedules were established for developing new and revised effluent guidelines for several industry categories. One of the industries for which the Agency established a schedule was the pharmaceutical manufacturing point source category. Natural Resources Defense Council, Inc. (NRDC) and Public Citizen, Inc. challenged the Effluent Guidelines Plan in a suit filed in U.S. District Court for the District of Columbia (NRDC et al. v. Reilly, Civ. No. 89-2980 (D.D.C.)). (The suit originally challenged EPA's failure to publish the plan by the statutory deadline.) The plaintiffs charged that EPA's plan did not meet the requirements of section 304(m). On January 31, 1992, EPA entered into a consent decree (the ``304(m) Decree''), which established schedules for, among other things, EPA's proposal and promulgation of approximately 20 effluent guidelines including those for the pharmaceutical manufacturing point source category. On May 18, 1994, the Agency published a second plan (see 59 FR 25859). The plan projected proposal and promulgation dates for several industrial categories including the pharmaceutical manufacturing category. B. Clean Air Act Title III of the 1990 Clean Air Act Amendments was enacted to reduce the amount of nationwide emissions of hazardous air pollutants. It comprehensively amended section 112 of the Clean Air Act (CAA). Section 112(b) lists the 189 chemicals, compounds, or groups of chemicals deemed by Congress to be hazardous air pollutants (HAPs). These toxic air pollutants are to be regulated by national emission standards for hazardous air pollutants (NESHAP). Section 112(c) requires the [[Page 21601]] Administrator to use this list of HAPs to develop and publish a list of source categories for which NESHAP will be developed. EPA must list all known categories and subcategories of ``major sources.'' The term major source is defined in paragraph 112(a)(1) to mean any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit, considering controls, in the aggregate 10 tons per year (tons/yr) or more of any HAP or 25 tons/yr or more of any combination of HAPs. The term stationary source, from section 111 of the CAA, means any building, structure, facility, or installation that emits or may emit any air pollutant. The term area source, as defined in section 112(a)(2), means any stationary source of HAPs that is not a major source. Notice of the initial list of categories of major and area sources of HAPs was published on July 16, 1992 (57 FR 31576), under authority of section 112(c). This notice listed pharmaceutical manufacturing as a category of major sources of HAPs. Notice of the schedule for the promulgation of emission standards for the listed categories, under authority of section 112(e), was given on December 3, 1993 (58 FR 63941). Under this notice, emission standards for the pharmaceutical production industry would be promulgated no later than November 15, 1997. Section 112(d) of the CAA directs the Administrator to promulgate emission standards for each category of HAP sources listed under section 112(c). Such standards are applicable to both new and existing sources and must require the maximum degree of reduction in emissions of the hazardous air pollutants subject to this section (including a prohibition on such emissions, where achievable) that the Administrator, taking into consideration the cost of achieving such emission reduction, and any non-air quality health and environmental impacts and energy requirements, determines is achievable for new and existing sources in the category or subcategory to which such emission standard applies. See 42 U.S.C. 7412(d)(2). Section 112(d)(3) provides that the maximum degree of reduction in emissions that is deemed achievable for new sources shall not be any less stringent than the emission control that is achieved in practice by the best controlled similar source. For existing sources, the standards may not be less stringent than the average emission limitation achieved by the best performing 12 percent of existing sources in each category of 30 or more sources. Once this minimum control level (referred to as the floor) has been determined for new or existing sources for a category, the Administrator must set a standard based on maximum achievable control technology (MACT) that is no less stringent than the floor. The Administrator may set MACT standards that are more stringent than the floor if such standards are achievable considering the cost, environmental, and other impacts listed in section 112(d)(2). Such standards must then be met by all sources within the category. C. Resource Conservation and Recovery Act (RCRA) Subtitle C of RCRA, 42 U.S.C. 6921-39b, directs EPA to establish a comprehensive ``cradle to grave'' system regulating the generation, transport, storage, treatment and disposal of hazardous wastes. The hazardous wastes subject to this comprehensive management scheme include any solid waste, or combination of solid wastes, that because of its quantity, concentration, or physical, chemical, or infectious characteristics may cause or significantly contribute to an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness; or pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or otherwise managed. 42 U.S.C. 6903(5). RCRA defines ``solid waste'' to include any garbage, refuse, sludge from a waste treatment plant, water supply treatment plant, or air pollution control facility and other discarded material. 42 U.S.C. 6903(27). The Act does not specify what characteristics of a waste render it hazardous to human health or the environment; instead, it directs EPA to develop and promulgate criteria for identifying the characteristics of hazardous waste and for listing hazardous waste, taking into account toxicity, persistence, and degradability in nature, potential for accumulation in tissue, and other related factors such as flammability, corrosiveness, and other hazardous characteristics. 42 U.S.C. 6921. Pursuant to this directive, EPA has adopted a two track scheme for identifying hazardous wastes. So-called ``characteristic wastes,'' regulated under 40 CFR 261.20-.24, exhibit at least one of four specified characteristics: ignitability, corrosivity, reactivity, or toxicity. Such wastes are deemed automatically subject to regulation under RCRA subtitle C, and retain the designation of hazardous waste until they cease to exhibit any of the characteristics. See 40 CFR 261.3(d)(1). The other type of hazardous wastes, ``listed wastes,'' comprises wastes specifically classified as hazardous by EPA rule. See 40 CFR 261.11 (setting out criteria EPA considers in determining whether a solid waste should be a listed hazardous waste). Under EPA regulations, a listed hazardous waste retains that classification, even if has been treated in some fashion, until the waste has been demonstrated to be no longer hazardous. See 40 CFR 261.3(c)-(d) (the ``derived-from'' rule). Once a waste has been identified or listed by EPA, RCRA permits its disposal on the land if the waste has been treated to meet standards established by EPA pursuant to 42 U.S.C. 6924(m). Section 6924(m)(1) instructs EPA to specify those levels or methods of treatment, if any, that substantially diminish the toxicity of the waste or substantially reduce the likelihood of migration of hazardous constituents from the waste so that short-term and long-term threats to human health and the environment are minimized. EPA has concluded that requiring hazardous wastes to be treated in accordance with the best demonstrated available technology (``BDAT'') is sufficient to satisfy this criterion. See 51 FR 40,572, 40,578 (1986). These standards can apply even after a characteristic waste no longer exhibits a characteristic. 40 CFR 261.3(d)(1). In addition to meeting treatment standards before land disposal, hazardous wastes are also subject to cradle-to-grave control from point of generation to point of final disposition. Generators prepare manifests to assure proper tracking of all hazardous wastes. Facilities treating, storing or disposing of such wastes are subject to design and operating standards established by EPA. Such standards ordinarily are embodied in an operating permit issued by EPA to the facility. In addition to meeting design and operating standards, facilities must commit sufficient money to assure that the facility will be properly closed, or that proper post-closure care of the wastes will occur. D. Pollution Prevention Act of 1990 In the Pollution Prevention Act of 1990 (42 U.S.C. 13101 et seq.), Congress declared pollution prevention the national policy of the United States. The Pollution Prevention Act declares that pollution should be prevented or reduced whenever feasible; pollution that cannot be prevented should be recycled or reused in an [[Page 21602]] environmentally safe manner whenever feasible; pollution that cannot be prevented or recycled should be treated in an environmentally safe manner whenever feasible; and disposal or other release into the environment should be chosen only as a last resort and should be conducted in an environmentally safe manner. See 42 U.S.C. 13101(b). Today's proposed rule is consistent with this policy. The technology basis for the proposed NSPS and PSNS for facilities with subcategory A, B, C and/or D operations includes steam stripping with distillation. Today's proposed PSES for facilities with subcategory A, B, C and/or D operations, as well as today's proposed BAT limitations for facilities with subcategory A and/or C operations, are based on steam stripping. Both technologies allow for the recovery from wastewaters and possible reuse of organic solvents. As part of today's proposal, the Agency also investigated whether solvent use could be minimized and/or eliminated through process changes but concluded that such opportunities may be limited to specific process operations at some facilities. The Agency encourages research regarding solvent use reduction and/or elimination procedures for existing as well as future pharmaceutical manufacturing operations. The Agency solicits comment on process change (source reduction) opportunities for pharmaceutical manufacturing and products. See section XIV, solicitation number 12.0. E. Common Sense Initiative On August 19, 1994, the Administrator established the Common Sense Initiative (CSI) Council in accordance with the Federal Advisory Committee Act (U.S.C. App. 2, Section 9(c)) requirements. A principal goal of the CSI includes developing recommendations for optimal approaches to multi-media controls for six industrial sectors including Metal Plating and Finishing, Electronics and Computers, Auto Manufacturing, and Iron and Steel Manufacturing. The following are the six overall objectives of the CSI program, as stated in the ``Advisory Committee Charter.'' 1. Regulation. Review existing regulations for opportunities to get better environmental results at less cost. Improve new rules through increased coordination. 2. Pollution Prevention. Actively promote pollution prevention as the standard business practice and a central ethic of environmental protection. 3. Recordkeeping and Reporting. Make it easier to provide, use, and publicly disseminate relevant pollution and environmental information. 4. Compliance and Enforcement. Find innovative ways to assist companies that seek to comply and exceed legal requirements while consistently enforcing the law for those that do not achieve compliance. 5. Permitting. Improve permitting so that it works more efficiently, encourages innovation, and creates more opportunities for public participation. 6. Environmental Technology. Give industry the incentives and flexibility to develop innovative technologies that meet and exceed environmental standards while cutting costs. The pharmaceutical manufacturing rulemaking effort was not among those included in the Common Sense Initiative. However, the Agency believes that the CSI objectives already have been incorporated into the pharmaceutical manufacturing industry rulemaking. Nonetheless, given the multimedia considerations affecting this rulemaking, the Agency will continue to pursue these objectives. The Agency particularly will focus on avenues for giving state and local authorities flexibility in implementing this rule, and giving the industry flexibility to develop innovative and cost-effective compliance strategies. In developing this rule, EPA took advantage of several opportunities to gain the involvement of various stakeholders. Section XIII.F of this preamble describes consultations with state, local, and tribal governments and other parties including the industry. EPA has internally coordinated among relevant program offices in developing this rule. Section X of this preamble describes coordination between the Office of Water and the Office of Air and Radiation concerning this proposed water and a related air rule that will be proposed at a later date. Also, Section XII of this preamble describes coordination between the Office of Water and the Office of Solid Waste and Emergency Response regarding the hazardous waste implications of this proposed water rule. See Section XIV of this preamble for pertinent comment and data solicitations. The effluent guideline development process for the pharmaceutical manufacturing industry will continue to implement the principles of the Common Sense Initiative. VI. Regulatory Development Under the Clean Water Act This section describes the Agency's approach for developing proposed effluent limitations guidelines and standards applicable to the pharmaceutical manufacturing industry under the CWA. In developing this rule, EPA first collected information about the industry, next identified potential control and treatment technology bases for the effluent limitations and standards EPA proposes to establish, and then, using methodologies, assumptions, and data described in the economic and regulatory impact analyses (See Section XI of this preamble), estimated and analyzed the total environmental and economic impacts of basing limitations and standards on various combinations of these control technologies. Finally, EPA selected the control technologies upon which it based the proposed effluent limitations and standards. A. Background The pharmaceutical manufacturing industry releases significant amounts of pollutants to surface waters, and POTWs, and ambient air. Section V of this notice discusses in greater detail the legal authorities available to EPA to address these pollutant releases. B. Goals EPA has several technical and policy goals regarding the development of the proposed effluent limitations guidelines and standards. These goals include: (1) Protecting the public health and the environment by attaining significant reductions in pharmaceutical manufacturing industry pollutant releases to water and other media; (2) minimizing the cost of complying with the rule; (3) promoting and facilitating coordinated compliance planning within the industry; (4) promoting and facilitating pollution prevention; and (5) taking into account the multimedia nature of pollution control. In light of the multimedia nature of the environmental releases from this industry, the Agency has closely coordinated this effluent guidelines rulemaking with the rulemaking and related activities of the Office of Air and Radiation (OAR) and the Office of Solid Waste and Emergency Response (OSWER). C. Technical Approach 1. Information Collection EPA's first step in developing these proposed regulations was to develop a plant-specific database, using information gathered under section 308 of the CWA, of all facilities potentially subject to the limitations and standards. See Section VIII below. Information and data were gathered by EPA from a number of sources, including EPA's wastewater sampling program, the 1989 [[Page 21603]] screener questionnaire, and the 1990 survey questionnaire. The information collected includes the processes and control technologies in use, current control levels, and pollutant releases. EPA also updated survey data through telephone calls and letters to specific facilities in an attempt to ensure that the database reasonably reflects the current status of the industry. The Agency recognizes that the industry is dynamic, and that processes and equipment change over time. Accordingly, EPA will consider information and data submitted in a timely manner by interested parties in response to this proposal for the purpose of updating the database prior to promulgation. EPA placed information collected about the industry into plant- specific databases. These databases consist mainly of the 1990 survey responses provided by 244 plants but also contain information from EPA's sampling program. EPA then estimated costs of implementing the proposed technology bases in order to analyze the economic impacts of achieving the proposed effluent limitations guidelines and standards. The Agency used the plant-specific databases and other components to calculate wastewater discharges and the costs of complying with the proposed effluent limitations and standards. This comprehensive information provides a strong basis for ensuring that the proposed regulations meet the statutory requirements, and allows consideration of other factors such as multimedia pollutant reduction. 2. Summary of Public Participation Beginning in 1989, EPA met on at least a biennial basis with industry representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA) to discuss the development of the screener and detailed questionnaires that EPA intended to distribute under section 308 of the CWA. The Agency received input from the industry representatives that was invaluable in the development of these information collection instruments. Following the completion of the screener and detailed questionnaires, EPA has continued to meet informally with PhRMA representatives to discuss progress in the rulemaking effort. EPA has also met informally with the Natural Resources Defense Council regarding this rulemaking and has made available to environmental groups and other members of the public the information that was provided to the industry. On May 23, 1994, EPA held a public meeting on the pharmaceutical rulemaking (see 59 FR 21740, April 26, 1994). Following the meeting EPA sent copies of revised meeting handout materials to all attendees and to interested parties who could not attend. In addition, by letter dated August 12, 1994, EPA provided written responses to questions submitted by PhRMA concerning issues raised at the public meeting. These documents are in the rulemaking docket. 3. Development of Effluent Limitations Control Technology Options After evaluating a variety of control and treatment technologies and their use in the industry, EPA selected BPT, BAT, BCT, PSES, NSPS, and PSNS control technology options upon which it bases this proposed rule. This process is described in Section IX of this notice. 4. Analyses of Regulatory Alternatives EPA conducted a series of analyses to assess the economic and environmental impacts of various combinations of BPT, BCT, BAT, NSPS, PSES, and PSNS control options. EPA then compared the projected effluent loadings and air emissions resulting from each regulatory alternative to baseline pollutant releases estimated as of January 1, 1991, based on the 1990 survey data. EPA also estimated the costs of implementing the various control options and other environmental and economic impacts for each alternative above the baseline level of control which EPA determined as treatment technologies in place in 1990. EPA evaluated each alternative in order to determine the effectiveness of the control technologies represented and to ascertain the reductions in effluent loadings and air emissions below the baseline that each control technology option could attain. The Agency also determined the environmental effects of these technologies with a goal toward minimizing the cross-media transfer of pollutants between water and air. EPA also evaluated the possibility of basing BAT and PSES on process changes involving solvent use minimization or elimination. After evaluating information provided in response to the section 308 detailed questionnaire survey regarding pollution prevention measures on-going at pharmaceutical manufacturing facilities, the Agency concluded that no option involving solvent use elimination or minimization is technically available at this time. Nonetheless, the Agency is encouraging the industry to conduct research into eliminating or minimizing the use of solvents for existing processes and to design future manufacturing processes that eliminate or minimize the use of volatile solvents. See Section XIV, solicitation number 12.0. VII. Description of the Industry A. Pharmaceutical Manufacturing Facilities Presented below is a brief description of the pharmaceutical manufacturing industry. Other characteristics of the industry are detailed in Sections IX.B., IX.C., IX.D., and IX.E. of this notice and in Section 3 of the TDD. Based upon responses to EPA's 1989 Screener Survey of Pharmaceutical Manufacturing Facilities, the Agency estimates that there are 566 manufacturing facilities located in 39 States, Puerto Rico, and the Virgin Islands. The major pharmaceutical manufacturing areas in the U.S. are the Northeast, the Midwest, and Puerto Rico. B. Manufacturing Processes 1. Fermentation Fermentation is the usual method for producing most steroids and antibiotics. The fermentation process involves three basic steps: inoculum and seed preparation, fermentation or growth, and product recovery. Production of a pharmaceutically active ingredient begins with spores from the plant master stock. The spores are activated with water, nutrients, and warmth and are then propagated through the use of agar plates, test tubes, and flasks until enough mass is produced for transfer to the seed tank. Following adequate propagation in the seed tank, microorganisms from the seed tank are transferred to a fermenter tank along with the sterilized nutrients and the tank is then sparged with air to begin the fermentation or growth process. After a period ranging from 12 hours to a week, depending on the specific process, the fermenter batch whole broth is ready for filtration, which removes mycelia (i.e., the remains of the microorganisms). The filtered aqueous broth containing product and residual nutrients is then ready to enter the product recovery phase. There are three common methods of product recovery: solvent extraction, direct precipitation, and ion exchange or adsorption. The most common method, solvent extraction, involves the use of an organic solvent to remove or extract the pharmaceutically active ingredient or product from the aqueous broth. Numerous solvent extractions are usually necessary to remove an acceptable yield of product from the contaminant mixture. Another common recovery method, direct precipitation, involves the use of aqueous solutions of [[Page 21604]] heavy metals such as copper and zinc to precipitate the product as a metal salt from the aqueous broth, after which the broth is filtered and the product is extracted from the solid residue. Ion exchange or adsorption involves removal of the product from the broth using solid materials such as ion exchange resin, adsorptive resin or activated carbon to bond with the product. The product is extracted from the solid phase material using solvent extraction followed by solvent evaporation. 2. Biological and Natural Extraction Biological and natural extraction is used to manufacture pharmaceutically active ingredients whose molecular structure is too complex for chemical synthesis or fermentation methods. Extraction involves the collection and processing of large volumes of plant or animal matter to produce small quantities of product. Initially, this large volume material is subject to a large, usually organic solvent- based, extraction procedure to obtain a first product cut or extraction. This cut is purified in many successive extraction operations. At each stage of the extraction process, the volume of material used becomes smaller. In the end, the volume of product may be only a few thousandths of the mass of material handled in the earlier procedures. Generally, the yield from extraction procedures is very small and pharmaceutical companies use extraction only when they have no other alternative. Recently, pharmaceutical manufacturers have been developing bioengineered microorganisms that can produce pharmaceutically active ingredients. Pharmaceutical manufacturers sometimes use extraction procedures to obtain and purify these ingredients, but EPA understands generally that the amounts of water and solvents used in these procedures at this time are minimal. Nonetheless, EPA is soliciting information and data to better characterize wastewaters from these operations (see Section XIV at solicitation number 11.0). 3. Chemical Synthesis Chemical synthesis involves the use of a series of chemical reactions to produce pharmaceutically active ingredients, usually starting with common feedstock chemicals as raw materials. The product of each successive chemical reaction then becomes the reactant in the next chemical reaction until the final reaction step of the synthesis is reached when the pharmaceutically active ingredient product is generated. More pharmaceutically active ingredients are manufactured by chemical synthesis than by any other process. 4. Mixing/Compounding/Formulating Before active ingredients can be used as pharmaceuticals, they must be prepared in dosage forms. The primary dosage forms utilized by the industry include tablets, capsules, liquids and ointments. For example, in tablet-making, manufacturers blend pharmaceutically inactive materials filler (e.g., starch) and binder (e.g., corn starch) with the active ingredient(s) and form tablets using a tablet press machine. Mixing, compounding, and formulating operations are utilized by more plants than any other process operation. VIII. Summary of Data Gathering Efforts A. Technical and Economic Data 1. 1989 Screener Survey of the Pharmaceutical Industry In 1988, the Agency developed a short questionnaire for distribution to all known or suspected pharmaceutical manufacturers. The purpose of the questionnaire was to identify facilities that could be affected by future effluent limitations guidelines and standards applicable to the pharmaceutical manufacturing industry. The Information Collection Review (ICR) package for this questionnaire was sent to OMB in May 1989 and approved in June 1989. The questionnaire was sent to 1163 facilities in July of 1989. The Agency received 962 responses. 2. 1990 Pharmaceutical Manufacturing Industry Survey In early 1989, EPA began to develop a questionnaire to gather the technical and financial information necessary for this rulemaking. EPA met with industry representatives during the questionnaire development process in an effort to keep the industry informed of the Agency's plans and to solicit informed comments on questionnaire design. Before pretesting the questionnaire, EPA sent a preliminary version of the questionnaire to the Pharmaceutical Manufacturers Association (now known as the Pharmaceutical Research and Manufacturers of America) for distribution and review by representatives of member companies. The Agency then incorporated all appropriate comments of the industry representatives into a pretest version of the questionnaire. In 1990, EPA sent pretest versions of the questionnaire to eight facilities for response and comment. Along with their responses, the pretest candidates provided information on the amount of time required to complete the questionnaire and suggestions for improving the questionnaire as an information gathering instrument. The pretest suggestions were used to develop a final version of the questionnaire, which was part of an ICR package that was sent to OMB for approval in May 1990. In August of that year, OMB cleared part A (technical section) of the questionnaire and some questions in part B (economic and financial) but denied clearance for most of the part B plant-specific financial and economic questions. In order to accommodate OMB's and industry's concerns about the need for responses to plant-specific economic and financial questions, the Agency developed a certification procedure. This procedure allowed industry respondents to certify that future pharmaceutical category regulations would not impact their facility above a certain dollar amount. A respondent making the certification was not required to respond to most of the part B questions. In May 1991, the Agency submitted a revised ICR package to OMB, including the certification option discussed above. OMB approved the questionnaire and EPA sent the final questionnaire to 280 facilities in September 1991. EPA received responses from 244 of the 304 facilities still engaged in pharmaceutical manufacturing with solvent use. 3. Sampling and Analytical Program Between 1986 and 1991, EPA conducted a sampling program at 13 pharmaceutical manufacturing facilities to: (1) Characterize the pollutants in the wastewater being discharged directly to surface waters and indirectly to POTWs; (2) generate pollutant treatment system performance data from facilities with well-operated advanced biological treatment systems (those systems attaining better than BPT annual average effluent quality); and (3) obtain treatability data from steam stripping units. Prior to 1986, the Agency had focused on five conventional pollutants and 126 priority pollutants in the pharmaceutical manufacturing industry's wastewater. Beginning in 1986, the Agency expanded the analysis of pharmaceutical wastewater and wastewater treatment plant sludges to determine the presence and levels of all the pollutants on the ``Industrial Technology Division (ITD) List of Analytes'' (hereinafter, the ``List of Analytes''). [[Page 21605]] During the sampling program, EPA gathered analytical data to characterize the wastewater from five direct dischargers and eight indirect dischargers. Treatment system performance data were gathered from three advanced biological treatment systems and two biological pretreatment systems. Treatment unit performance data documenting the performance of five steam stripping columns were also gathered. The performance of one resin adsorption column and one cyanide destruction unit was also documented. a. Bench-, Pilot-, and Full-Scale Studies. Between October and December 1991, EPA conducted bench-scale and pilot-scale tests to study: (1) Air stripping technology (with ammonia capture) for ammonia removal from pharmaceutical plant final effluent; and (2) steam stripping technology for removal of volatile organic pollutants from pharmaceutical plant process wastewaters. EPA conducted the air stripping and steam stripping pilot studies at a pharmaceutical manufacturing facility with fermentation, chemical synthesis, formulation, and research operations. The objective of the air stripping study was to examine the feasibility of obtaining at least 90 percent ammonia removal using air stripping technology. A portion of the total facility effluent was used as the feed to the pilot-scale air stripping study. The objectives of the steam stripping study were to demonstrate the achievement of the lowest practical concentrations of volatile organic pollutants in the treated effluent, using the available bench- and pilot-scale steam stripping test equipment, and to collect sufficient data to document these concentrations using the available bench- and pilot-scale data. On-site pilot-scale testing was conducted for two of the three streams. EPA elected not to run pilot-scale tests on one of the streams because the stream flow from that process area was insufficient for pilot-scale testing during the study time period. Performance data for this third process wastewater stream were collected using bench-scale equipment. In September 1993, EPA conducted an on-site treatment performance study using a pharmaceutical manufacturing facility's existing distillation column that treated wastewaters containing methanol. The objective of the study was to achieve the lowest practical concentrations of methanol (within the operating constraints of the facility) in the treated effluent and to collect sufficient data to document these concentrations. All of the studies are discussed in more detail in sections 5 and 8 of the TDD. B. Air Emission Data In July 1993, pursuant to section 114 of the Clean Air Act, EPA distributed questionnaires seeking data on air emissions to 396 pharmaceutical manufacturing facilities. The scope of the survey included all manufacturing operations that were covered by the SIC Code Nos. 2833, 2834, and 2836 and that also emitted hazardous air pollutants. Research facilities were not included. The questionnaire requested production data, process flow diagrams, emissions data, emission control technology data, and information on source reduction measures. EPA will use this data and information in developing standards to be promulgated under the Clean Air Act for the pharmaceutical manufacturing industry. EPA will compare these data and information, to the extent it is appropriate, to the data and information collected under the Clean Water Act to ensure that the best and most consistent data are used in both rulemaking efforts. See Section X below. IX. Development of Effluent Limitations Guidelines and Standards A. Industry Subcategorization 1. Introduction In developing today's proposed rule, EPA considered whether different effluent limitations and standards were appropriate for different groups of plants or subcategories within the pharmaceutical manufacturing industry. Factors considered included: processes employed, effluent characteristics, costs, age of equipment and facilities, size, location, engineering aspects of the application of various types of control techniques, process changes, and non-water quality environmental impacts. In determining which subcategories were appropriate for this proposed rule, EPA, using recently available data, evaluated the scheme for establishing subcategories regulated under the current effluent limitations guidelines and standards applicable to this industry. 2. Current Subcategorization The current subcategorization of this industry dates back to 1976 and was developed using data from the mid-1970s. The current subcategories are as follows: Subpart A Fermentation Subpart B Biological and Natural Extraction Subpart C Chemical Synthesis Subpart D Mixing/Compounding/Formulating Subpart E Pharmaceutical Research 3. Rationale for Maintaining the Current Subcategorization Prior to finalizing the 1983 regulation, the Agency evaluated the original subcategorization scheme developed for the 1976 interim final regulations. This evaluation is discussed in section 4 of the 1983 technical development document and in the preamble to the final regulation at 48 FR 49808 (October 27, 1983). The Agency concluded at that time that the original subcategorization scheme based on manufacturing process type was the most appropriate one for the Pharmaceutical Manufacturing Point Source Category. In determining whether this scheme is appropriate for the rule being proposed today, the Agency evaluated the wastewater and production data obtained from the detailed questionnaire responses as well as plant sampling data in light of the current scheme. The Agency compared the wastewater flow and pollutant characteristics data (influent and effluent BOD5, TSS, and COD) obtained from the 1990 detailed questionnaire responses with the data presented in Section 4 of the 1983 TDD. EPA concluded that the similarities and data trends reported for both subcategory A and C and subcategory B and D facilities were identical to those reported in 1983 for analogous data. Consequently, the Agency concluded that the current subcategorization scheme continues to be appropriate for today's proposed rule. As was the case with the 1983 final regulation, the limitations and standards being proposed today for subcategory A are identical to those proposed for subcategory C and those limitations and standards being proposed for subcategory B are identical to those being proposed for subcategory D. The Agency invites comments regarding this regulatory scheme. The subcategorization analysis is discussed in more detail in section 4 of the TDD for this rulemaking. See Section XIV, solicitation number 4.0. 4. Subcategory Regulation Not Revised EPA is not proposing new or revised effluent limitations and standards for the Pharmaceutical Research Subcategory (Subcategory E). Rather, research activities falling within this subcategory will continue to be subject to the BPT regulations established for that subcategory in the 1983 regulations for this industry. The 1983 regulations did not establish BCT, BAT, NSPS, PSES, or PSNS effluent limitations and standards for the research subcategory, and today's proposed revisions to 40 [[Page 21606]] CFR part 439 will not change this. However, process wastewater generated by research activities falling within this subcategory will continue to be subject to BCT and BAT limitations, as appropriate, established on a best professional judgment (BPJ) basis. In addition, indirect dischargers will be subject to local limits, as appropriate. In its preamble to the 1983 regulations, EPA explained that it was specifically excluding subcategory E pharmaceutical research from all limitations and standards in the regulation other than BPT limitations because these operations do not involve production and wastewater generation in appreciable quantities on a regular basis. See 48 FR 49808, 49816 (Oct. 27, 1983). EPA also noted that research activities conducted at mixed and single subcategory plants (A, B, C, and D only) would be covered by that regulation. In today's Notice, EPA proposes to exclude subcategory E research operations from all limitations and standards in the proposed rule, other than the existing BPT limitations, at both stand alone and mixed subcategory plants. However, in order to clarify the scope of Subcategory E as described in the 1983 preamble, EPA proposes to define Subcategory E research operations specifically as bench-scale activities related to the development of pharmaceutical products. Bench-scale activities, in contrast to pilot- scale operations, do not involve production or wastewater generation in appreciable quantities on a regular basis and therefore describe the activities historically encompassed within Subcategory E, Pharmaceutical Research. Consequently, under this proposal, bench-scale research activities that generate process wastewater at manufacturing facilities or at stand-alone Subcategory E facilities will be covered by the current subcategory E BPT limitations on BOD5, COD, TSS and pH. This means that if a facility engaging in bench-scale research operations also engages in pharmaceutical manufacturing operations covered by subcategories A, B, C, or D, the process wastewater from the bench- scale research operations would be subject only to subcategory E regulations (and on a case-by-case basis BCT and BAT limitations based on BPJ, as appropriate). Conversely, if a facility engages in research operations on a pilot-scale level, then the wastewater generated by those operations would be subject to the standards and limitations applicable to the manufacturing subcategory (A, B, C, or D) that the wastewater most resembles. See 40 CFR 439.50 et seq. The proposal that subcategory E applies to all bench-scale research operations irrespective of their proximity to pharmaceutical manufacturing process operations represents a change from the interpretation expressed by EPA in the preamble to the 1983 rule. In that preamble, EPA indicated that research activities conducted at mixed and single subcategory plants (A, B, C, and D only) would be covered by the regulations corresponding to the particular subcategory. Accordingly, the Agency is soliciting comment on whether facilities with both subcategory E and subcategory A, B, C, or D process operations should be subject to the standards and limitations corresponding to the manufacturing subcategory (A, B, C, or D) and not to subcategory E BPT limitations as proposed here. See Section XIV, solicitation number 5.2. B. Water Use, Wastewater Discharge and Characterization This section describes current water use and wastewater recycling practices, discharge practices and the general characteristics of wastewater at the plants that manufacture pharmaceuticals in the United States. A more detailed presentation can be found in Section 5 of the TDD. Almost all pharmaceutical manufacturing processes require the use of water, although use and discharge practices and the characteristics of the wastewater will vary depending on the process operations at individual facilities. 1. Water Use and Wastewater Generation a. Water Use. EPA estimates the average daily wastewater generation by the pharmaceutical manufacturing industry to be 266 million gallons, based on the responses to questions in part A section 4 of the 1990 Pharmaceutical Manufacturing Survey. Pharmaceutical manufacturers use water for process operations and for other nonprocess purposes such as noncontact cooling and sanitation. The water is used or generated in pharmaceutical manufacturing process operations in several ways, thereby generating process wastewater: Water of reaction: Water formed during the chemical reaction. Process solvent: Water used to transport or support the chemicals involved in the reaction process; this water is usually removed from the process through a separation step, such as centrifugation, decantation, drying, or stripping. Process stream washes: Water added to a process stream (i.e., the carrier, spent acid, or spent base) that has been separated from the reaction mixture, in order to purify the stream by washing away impurities in the stream. Product washes: Water added to the reaction medium to purify an intermediate or final product by washing away the impurities (this water is subsequently removed through a separations step); or water used to wash the crude product after it has been removed from the reaction medium. Spent Acid/Caustic: Spent acid and caustic streams, which may consist primarily of water, that are discharged from the process during the separation steps following the reaction step in which acid and basic reagents are used to facilitate, catalyze, or participate in the reactions. Condensed steam: Steam used as a sterilizing medium and in steam strippers for solvent recovery and wastewater treatment. Other sources of process wastewater associated with pharmaceutical manufacturing operations include: Air pollution control scrubber blowdown: Water or acidic or basic compounds used in air emission control scrubbers to control fumes from reaction vessels, storage tanks, incinerators, and other process equipment. Equipment and floor washes: Water used to clean process equipment during unit shutdowns and floors during general housekeeping or for spill cleanup. Pump seal water: Direct contact water used to cool packing material and lubricate pumps. In addition to process wastewater, non-process wastewater may be generated during pharmaceutical manufacturing. This non-process wastewater may include noncontact cooling water (used in heat exchangers), noncontact ancillary water (e.g., boiler blowdown, bottle washing), sanitary wastewater, and wastewater from other sources such as stormwater. b. Water Conservation. In response to the 1990 detailed survey questionnaire, 137 of the 244 responding pharmaceutical manufacturers reported implementing water conservation measures with regard to process wastewater. Such water conservation measures include: careful monitoring of water use, installation of automatic monitoring and alarm systems on in-plant discharges, implementation of alternative production processes requiring less water, conversion from barometric to surface condensers, reuse of wastewater from other manufacturing processes, reuse of noncontact water as process makeup water, and treatment of contact cooling water to allow reuse. [[Page 21607]] 2. Wastewater Discharge Based on the responses to the screener and detailed survey questionnaires and other information, EPA has learned that of the 304 potentially affected facilities, 35 facilities discharge their wastewater directly to surface waters of the United States, 259 discharge to a POTW, three discharge directly to surface water as well as to a POTW, and seven do not discharge to a POTW or to surface waters. EPA estimates that the average daily volume of pharmaceutical process wastewater discharged via a POTW or directly from the manufacturing facility to surface waters of the U.S. is 84 and 20 million gallons, respectively. 3. Wastewater Characterization The pharmaceutical manufacturing industry generates process wastewaters containing a variety of pollutants. Most of this process wastewater receives some treatment, either in-plant at the process unit prior to commingling with other facility wastewaters or in an end-of- pipe wastewater treatment system. Pharmaceutical manufacturers discharge wastewater containing conventional, priority, and nonconventional pollutants. These pollutants are discussed in Section IX.C below. a. Conventional Pollutants: BOD5, TSS, and pH. BOD5, the quantity of oxygen used in the aerobic stabilization of wastewater streams, is the most widely used measure of general organic pollution in wastewater. BOD5 discharges from facilities with subcategory A and/or C operations are significantly higher than those discharges from facilities with subcategory B and/or D operations because fermentation and chemical synthesis process operations generate substantially greater concentrations of organic material (on average ten times higher untreated BOD5 concentrations) than extraction or mixing, compounding, and formulating processes. TSS is the portion of the total solids that can be filtered out of a solution using a 1-micron filter. (Total solids in wastewater is defined as the residue remaining after evaporation at just above the boiling point.) Discharges of TSS for this industry are generally proportional to the amount of BOD5 discharged and, as a result, A and/or C subcategory facilities discharge significantly more TSS than do B and/or D facilities. The pollutant parameter, pH, is a measure of the acidity or alkalinity of an aqueous solution. It is defined as the logarithm of the reciprocal of the hydronium-ion concentration of a solution. A pH of 7.0 indicates neutrality or a balance between free hydronium and free hydroxyl ions. A pH above 7.0 indicates that a solution is alkaline; a pH below 7.0 indicates that a solution is acidic. Untreated wastewaters from the pharmaceutical manufacturing industry range from being highly alkaline (pH 12 or higher) to highly acidic (pH 2 or lower). The pollutant parameter, pH, is currently controlled within the range of 6.0 to 9.0 by promulgated effluent limitations guidelines and standards for all five subcategories of the pharmaceutical manufacturing industry. EPA does not propose to modify the promulgated pH limitations by this rulemaking. Therefore, pH is not included in the following discussion of pollutant parameters. b. Priority Pollutants. Questionnaire respondents reported discharging 13 different priority pollutants. The annual mass loading of untreated priority pollutants released to the environment from pharmaceutical wastewater (including pollutants emitted to the air from wastewaters) range from 3.6 million pounds per year to 400 pounds per year. The most significant priority pollutants discharged by the industry are methylene chloride, toluene, chloroform, and chloromethane. EPA sampling data at various direct and indirect discharging facilities indicate over 57 different priority pollutants were detected in pharmaceutical wastewaters at various concentrations. Many of the priority pollutants detected during sampling programs were pesticides unrelated to process operations and priority pollutant metals detected at concentrations incapable of being treated by available technologies. In general, facilities with subcategory A and/or C operations reported discharging a greater variety of priority pollutants and at greater loads than facilities with Subcategory B and/or D operations. The Subcategory B and/or D direct dischargers reported that they did not discharge any priority pollutant load, while the Subcategory B and/ or D indirect dischargers reported discharging some priority pollutant load. See Section 9 of the TDD for a presentation of the current priority pollutant discharge loads by subcategory group. c. Nonconventional Pollutants. Questionnaire respondents reported discharging 105 different nonconventional pollutants, not including COD. The annual mass loadings of nonconventional pollutants released to the environment from pharmaceutical wastewaters (including air emissions from wastewaters) range from 15.4 million pounds per year to one pound per year. The most significant nonconventional pollutants discharged by the industry are methanol, ethanol, isopropanol, and acetone. EPA sampling data at various direct and indirect discharging facilities indicate over 59 different volatile and semivolatile organic compounds were detected in pharmaceutical wastewaters at various concentrations. In general, facilities with subcategory A and/or C operations reported discharging a greater variety of nonconventional pollutants and at greater loads than Subcategory B and/or D operations. In addition, the Subcategory B and/or D direct dischargers reported discharging fewer nonconventional pollutants at lower loads than the Subcategory B and/or D indirect dischargers. See Section 9 of the TDD for a presentation of the current nonconventional pollutant discharge loads by subcategory group. C. Selection of Pollutant Parameters 1. Pollutants Regulated a. Introduction. This section lists the pollutants covered by today's proposed rule in groups of conventional, priority, and nonconventional pollutants. For this proposed rule, EPA considered each pollutant identified in questionnaire responses and in EPA's sampling programs. In selecting the pollutants for control, EPA took into account their respective discharge loadings, frequency of occurrence, treatability, and environmental significance. In addition, EPA considered whether appropriate analytical methods were available or could be readily developed to detect and quantify the presence of these pollutants in wastewater. Finally, EPA investigated whether bulk parameters (e.g., COD) could be substituted for groups of individual pollutants. EPA concluded preliminarily that no known bulk parameters could be substituted as indicator pollutants for the individual pollutants to be regulated by these proposed effluent limitations and standards. EPA is soliciting comment on this finding. See section XIV of this preamble at solicitation number 37.0. Table IX.C-1 and Table IX.C-2 list the pollutants to be regulated by the various proposed effluent limitations and standards. A complete discussion of the pollutant selection/exclusion process may be found in section 6 of the TDD. Conventional Pollutants: BOD5 and TSS Priority Pollutants: Benzene Chlorobenzene Chloroform [[Page 21608]] Chloromethane Cyanide o-Dichlorobenzene* 1,2-Dichloroethane* Methylene Chloride Phenol Toluene Nonconventional Pollutants: Acetone* Acetonitrile Ammonia (aqueous) n-Amyl Acetate* Amyl Alcohol* Aniline* 2-Butanone (MEK)* n-Butyl Acetate* n-Butyl Alcohol* tert-Butyl Alcohol* COD (Chemical Oxygen Demand) Cyclohexane Diethyl Ether* Diethylamine* N,N-Dimethylacetamide Dimethylamine* N,N-Dimethylaniline* N,N-Dimethylformamide Dimethyl Sulfoxide 1,4-Dioxane* Ethanol* Ethyl Acetate* Ethylene Glycol Formaldehyde Formamide* Furfural* n-Heptane n-Hexane Isobutyraldehyde* Isopropanol* Isopropyl Acetate* Isopropyl Ether* Methanol* Methylamine* Methyl Cellosolve (2-Methoxyethanol) Methyl Formate* Methyl Isobutyl Ketone (MIBK)* 2-Methyl Pyridine* Petroleum Naphtha* Polyethylene Glycol 600 n-Propanol* Pyridine* Tetrahydrofuran* Trichlorofluoromethane Triethylamine* Xylenes *Under co-proposal (2) these pollutants will not be regulated. Table IX.C-1. Pollutants Regulated in Proposed Effluent Limitations Guidelines and Standards for Facilities With subcategory A and/or C Operations ---------------------------------------------------------------------------------------------------------------- Effluent regulation Pollutants regulated ----------------------------------------------------------- BPT BCT BAT NSPS PSES PSNS ---------------------------------------------------------------------------------------------------------------- BOD5................................................ X X X TSS................................................. X X X COD................................................. X X X CN.................................................. X X2 X2 X2 X2 Ammonia............................................. X X X X Nonconv Vol. Orgs................................... X X X3 X3 Pri. Pol. Vol. Orgs................................. X X X X Phenol.............................................. X X Nonconv. Svol. Orgs1................................ X X (\4\) (\4\) ---------------------------------------------------------------------------------------------------------------- \1\Dimethyl sulfoxide, N,N-dimethyl acetamide, N,N-dimethyl formamide, ethylene glycol and formaldehyde. \2\For purposes of proposal, CN limits for BAT, NSPS, PSES, and PSNS are the same as BPT. \3\Does not include two pollutants which do not pass through (acetonitrile and polyethylene glycol 600). \4\Limits are not being proposed at this time for these pollutants. Table IX.C-2. Pollutants Regulated in Proposed Effluent Limitations Guidelines and Standards for Facilities With Subcategory B and D Operations ---------------------------------------------------------------------------------------------------------------- Effluent regulation Pollutants regulated ----------------------------------------------------------- BPT BCT BAT NSPS PSES PSNS ---------------------------------------------------------------------------------------------------------------- BOD5................................................ X X X TSS................................................. X X X COD................................................. X X X Nonconv. Vol. Orgs.................................. X X X\2\ X\2\ Pri. Pol. Vol. Orgs................................. X X X X Phenol.............................................. X X Nonconv. Svol Orgs\1\............................... X X (\3\) (\3\) ---------------------------------------------------------------------------------------------------------------- \1\Dimethyl sulfoxide, N,N-dimethyl acetamide, N,N-dimethyl formamide, ethylene glycol and formaldehyde. \2\Does not include two pollutants which do not pass through (acetonitrile and polyethylene glycol 600). \3\Limits are not being proposed at this time for these pollutants. b. Conventional pollutants. Biochemical oxygen demand (BOD5) and total suspended solids (TSS) are conventional pollutants that have been regulated in this industry by previous BPT and BCT effluent limitations guidelines. These parameters are important because they quantify the biodegradable organic matter and suspended solids generated by all plants in all subcategories of the pharmaceutical industry. EPA estimates that 3.3 million pounds per year of BOD5 and 6.4 million pounds per year of TSS are discharged by the 35 facilities EPA has identified as direct dischargers. Most direct discharger plants have some level of secondary biological treatment in- place designed to treat BOD5 and TSS. EPA is proposing to establish NSPS and to revise the BPT and BCT effluent limitations for these pollutants in all subcategories. EPA does not propose to set limitations for BOD5 and TSS applicable to indirect dischargers because EPA has determined that these pollutants can be adequately treated by POTWs. EPA is not proposing to use them as indicators for other pollutants in this industrial category, although this will be given further evaluation. [[Page 21609]] c. Priority pollutants. The priority pollutants selected for control include cyanide, phenol and various solvents used by the industry. EPA estimates that direct and indirect discharging facilities discharge 0.5 and 1.8 million pounds per year, respectively, of the 10 priority pollutants addressed in this proposal. EPA is proposing to promulgate BPT, BAT, NSPS, PSES, and PSNS for some or all of these pollutants in subcategories A, B, C, and D. d. Nonconventional pollutants. Nonconventional pollutants include ammonia, COD (Chemical Oxygen Demand), and various volatile and semivolatile organic compounds that are used for the most part as solvents by the industry. EPA estimates that 0.8 and 0.5 million pounds per year of ammonia and 32 and 78 million pounds per year of COD are discharged by direct and indirect discharging facilities, respectively. With respect to COD, EPA is proposing to revise existing BPT limitations and promulgate new BAT limitations and NSPS for subcategories A, B, C, and/or D. With respect to ammonia, EPA is proposing to promulgate BAT, NSPS, PSES, and PSNS for subcategories A and/or C. EPA has determined that ammonia is not a pollutant of concern in wastewaters of facilities with subcategory B and/or D operations and hence does not propose limits for ammonia for those subcategories. See Section 5 of the TDD. See Section XIV, solicitation numbers 20.0 and 23.0. For PSES, EPA is co-proposing a finding of no pass-through for 33 priority and nonconventional pollutants. 2. Pollutants Not Regulated EPA is not proposing effluent limitations or standards for 85 priority and nonconventional pollutants identified as potentially present in pharmaceutical wastewaters. In Section 6 of the TDD, EPA describes for each pollutant or group of pollutants the reasons each is excluded from this proposal. EPA bases its decision to exclude these pollutants or groups of pollutants on one or more of the following reasons: (1) The pollutant or group of pollutants is deemed not present in pharmaceutical wastewaters, because it was not detected in the effluent with the use of analytical methods promulgated pursuant to section 304(h) of the Clean Water Act or with other state-of-the-art methods; (2) The pollutant or group of pollutants is present only in trace amounts and is neither causing nor likely to cause toxic effects in humans or aquatic life; (3) The pollutant or group of pollutants is detected in the effluent from only one or a small number of sources; (4) The pollutant or group of pollutants is effectively controlled by the technologies used as a basis for limitations on other pollutants, including those limitations and standards proposed today; or (5) Insufficient data are available to establish effluent limitations or standards for that pollutant or group of pollutants. In addition, EPA proposes to control phenol discharged by direct dischargers (through BAT and NSPS) but not by indirect dischargers (through PSES and PSNS) because pass-through has not been demonstrated for phenol. See the discussion on the analysis of pollutant pass- through in Section IX.E.5.a. of this preamble. EPA also is proposing to exclude two nonconventional pollutants from control by PSES and PSNS regulations (acetonitrile and polyethylene glycol 600) because pass- [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-5663. Public record. Not legal advice.