[Federal Register Volume 60, Number 84 (Tuesday, May 2, 1995)]
[Proposed Rules]
[Pages 21592-21679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5663]




[[Page 21591]]

_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 439



Effluent Limitations Guidelines, Pretreatment Standards, and New Source 
Performance Standards: Pharmaceutical Manufacturing Category; Proposed 
Rule

Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed 
Rules 
[[Page 21592]] 

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439

[FRL-5165-2]
RIN 2060-AC49


Effluent Limitations Guidelines, Pretreatment Standards, and New 
Source Performance Standards: Pharmaceutical Manufacturing Category

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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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.
    BOD<INF>5--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. BOD<INF>5 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 (BOD<INF>5), 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 (BOD<INF>5), 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 BOD<INF>5 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 BOD<INF>5, 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 BOD<INF>5), 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:
    <bullet> Subpart A--Fermentation Products Subcategory.
    <bullet> Subpart B--Extraction Products Subcategory.
    <bullet> Subpart C--Chemical Synthesis Subcategory.
    <bullet> Subpart D-- Mixing, Compounding, and Formulating 
Subcategory.
    <bullet> Subpart E-- Research Subcategory.
    The 1976 BPT regulations set monthly limitations for BOD<INF>5 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 BOD<INF>5, TSS and pH 
and the nonconventional pollutant COD. The 1983 regulations kept intact 
the percent reduction regulations for BOD<INF>5 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 BOD<INF>5 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 BOD<INF>5, 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 BOD<INF>5, TSS and pH for subcategories A-D. That final 
rule set BCT effluent limitations equal to the existing BPT effluent 
limitations for BOD<INF>5, 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 BOD<INF>5, 
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 BOD<INF>5, 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:
    <bullet> Water of reaction: Water formed during the chemical 
reaction.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> Equipment and floor washes: Water used to clean process 
equipment during unit shutdowns and floors during general housekeeping 
or for spill cleanup.
    <bullet> 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: BOD<INF>5, TSS, and pH. BOD<INF>5, the 
quantity of oxygen used in the aerobic stabilization of wastewater 
streams, is the most widely used measure of general organic pollution 
in wastewater. BOD<INF>5 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 BOD<INF>5 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 BOD<INF>5 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:
    BOD<INF>5 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  
----------------------------------------------------------------------------------------------------------------
BOD<INF>5................................................        X         X                   X                     
TSS.................................................        X         X                   X                     
COD.................................................        X                   X         X                     
CN..................................................        X                  X<SUP>2        X<SUP>2        X<SUP>2        X<SUP>2 
Ammonia.............................................                            X         X         X         X 
Nonconv Vol. Orgs...................................                            X         X        X<SUP>3        X<SUP>3 
Pri. Pol. Vol. Orgs.................................                            X         X         X         X 
Phenol..............................................                            X         X                     
Nonconv. Svol. Orgs<SUP>1................................                            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  
----------------------------------------------------------------------------------------------------------------
BOD<INF>5................................................        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 (BOD<INF>5) 
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 BOD<INF>5 
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 BOD<INF>5 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 BOD<INF>5 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-
through has not be demonstrated for these pollutants. In addition, as 
noted in Section C above, EPA is proposing two alternative pass-through 
for PSES for 33 priority and nonconventional pollutants. Under one of 
the proposed alternatives, EPA proposes to exclude 33 pollutants 
because EPA has some doubt as to whether these pollutants pass through. 
Under the other co-proposal, EPA proposes PSES for those pollutants 
based on a determination that they do pass through according to the 
data presently available to EPA.

D. Available Technologies

1. Pollution Prevention Technologies Considered
    EPA requested pollution prevention and process information 
regarding organic solvent use from pharmaceutical manufacturing 
facilities in its 1990 questionnaire. The responses indicate that while 
plants can make some process changes that would result in some source 
reduction, the opportunities to minimize or eliminate solvent use by 
changes in existing processes are limited, especially for facilities 
with subcategory A and/or C operations. Fermentation (A) and chemical 
synthesis (C) processes often involve complicated procedures which 
utilize solvents according to an exact recipe. In most cases, any 
change in the specific process or the amount of solvent used may result 
in a significant reduction in the yield of product obtained. 
Nonetheless, some Subcategory D (Mixing/Compounding/Formulating) 
facilities have utilized aqueous-based solvents instead of organic 
solvents to coat tablets, thereby eliminating solvent use for that 
operation. This approach is generally not applicable to all tablet 
coating operations because most coating materials are not soluble in 
aqueous solvents.
    Pharmaceutical plants sometimes cite an administrative, as well as 
a technical, impediment to pollution prevention. That is, once a 
pharmaceutical company gains approval from the Food and Drug 
Administration (FDA) to manufacture a pharmaceutically active 
ingredient or drug via a specific procedure, it may not deviate 
significantly from the approved procedure without additional FDA 
approval. Thus, if a company wishes to alter significantly an approved 
manufacturing procedure for any reason, including pollution prevention, 
it must submit a ``supplement'' application to FDA, which must be 
approved before the company can use the altered procedure.
    EPA understands that FDA historically needs to take a long period 
of time to process these requests for approval. However, since the 
enactment of the ``Prescription Drug User Fee Act of 1992,'' 21 U.S.C. 
379 et seq., Pub. L. 102-571, Oct. 29, 1992, the FDA has committed to 
using the revenues generated under that Act to expedite the 
prescription drug review and approval process, which include decisions 
on manufacturing supplements relating to pollution prevention-oriented 
process changes. EPA understands that the FDA hopes to eliminate its 
backlog of overdue manufacturing supplements by the end of Fiscal Year 
1995 and to achieve, by Fiscal Year 1997, its goal of reviewing and 
acting upon every complete manufacturing supplement within six months 
of submission. EPA believes that such expeditious processing of 
supplements will eliminate impediments that presently discourage 
pharmaceutical plants from making process changes necessary to achieve 
source reductions.
    In addition to evaluating opportunities for source reduction, EPA 
also examined potential treatment technologies to determine whether any 
might promote recovery, recycling, and reuse of chemicals in process 
wastewater generated by pharmaceutical manufacturing operations, such 
as solvents. After evaluating the various technologies available to 
treat solvent-laden wastewaters, EPA concluded that in-plant 
technologies such as steam stripping and steam stripping with 
distillation offered the best opportunity for recovery of solvents from 
wastewater. As discussed in greater [[Page 21610]] detail in Section 
IX.E.3 below, steam stripping technology and steam stripping with 
distillation technology are applied in-plant and minimize the dilution 
effects of commingling process wastewater streams and the transfer of 
volatile pollutants to air associated with other technologies. These 
technologies also allow the pharmaceutical manufacturing operation to 
recover the stripped solvents from the treatment process in an 
efficient and cost-effective manner from concentrated streams. These 
recovered solvents can then be recycled back into the process from 
which they were removed, reused in other manufacturing operations 
(e.g., in this industry or in other industries), or reused as ``clean 
fuel'' for boilers or other combustion devices. For further discussion 
of ``clean fuels,'' see section XII.B of this preamble.
2. In-Plant Technologies Considered
    EPA considered the following in-plant technologies to control 
solvent- and cyanide-laden wastewater generated by pharmaceutical 
manufacturing: (1) Steam stripping; (2) steam stripping with 
distillation; and (3) cyanide destruction. EPA concludes that steam 
stripping technology is the best technology available for removing high 
loadings and high concentrations of volatile organic pollutants from 
wastewater, and accordingly proposes BAT limitations for facilities 
with subcategory A and/or C operations on that technology basis. 
Fourteen plants reported using steam stripping technology and one 
facility reported using distillation technology for wastewater 
treatment in 1990. The demonstrated removal efficiencies for both 
technologies treating streams with high concentrations of highly 
strippable volatiles are greater than 99 percent. A detailed discussion 
of steam stripping and steam stripping with distillation (using 
fractional distillation columns with rectifying sections for difficult 
to strip volatile organic pollutants) and their use in the 
pharmaceutical manufacturing industry may be found in Section 7 of the 
TDD.
3. End-of-Pipe Technologies Considered
    The end-of-pipe treatment technologies currently employed by the 
industry include: preliminary or primary treatment (neutralization, 
equalization, and primary clarification); biological or equivalent 
treatment (aerated stabilization basins with and without settling 
basins, oxidation ponds, and activated sludge systems); and physical/
chemical treatment (multimedia filtration and chemically assisted 
clarification). In addition, EPA has designated as advanced biological 
treatment a treatment configuration consisting of primary treatment 
plus some form of activated sludge treatment, which achieves better 
than 90 percent BOD<INF>5 and 74 percent COD reduction from raw waste 
levels. EPA evaluated each of these available technologies in 
developing the limitations and standards proposed today. In addition to 
these technologies, the Agency also considered granular activated 
carbon (GAC) adsorption technology, which is an appropriate and 
available end-of-pipe treatment technology for pharmaceutical 
wastewater. All of the various technologies mentioned above are 
discussed in detail in Section 7 of the TDD.
    All 35 direct dischargers responding to EPA's detailed 
questionnaire reported having some form of primary treatment in place 
in 1990. Thirty-one facilities reported having some form of biological 
or secondary treatment in place, either air- or oxygen-activated sludge 
treatment followed by secondary clarification and, in some cases, 
multimedia filtration and polishing ponds. One plant reported using GAC 
technology as end-of-pipe technology, and one plant reported using GAC 
technology in-plant.

E. Rationale for Selection of Technology Bases for Proposed Regulations

1. BPT
    a. Introduction. EPA is today proposing revised BPT effluent 
limitations guidelines based on the Best Practicable Control Technology 
Currently Available (BPT) for BOD<INF>5, TSS, and COD for subcategories 
A, B, C, and D of the pharmaceutical manufacturing industry. EPA is 
also proposing to revise existing BPT limitations for cyanide for 
facilities with subcategory A and/or C operations and to repeal the 
existing BPT cyanide limitations for facilities with B and/or D 
operations. The Clean Water Act explicitly authorizes EPA to revise all 
effluent limitations guidelines, including those based on best 
practicable technology, at least annually if appropriate. See CWA 
section 304(b). In the 1987 amendments to the Clean Water Act, Congress 
further required EPA to establish a schedule for the annual review and 
revision of promulgated effluent guidelines in accordance with section 
304(b). See CWA section 304(m). Moreover, as discussed in Section 
V.A.4, above, EPA entered into a consent decree that requires EPA to 
propose and promulgate effluent guidelines for the pharmaceutical 
manufacturing industry, as appropriate, including those authorized by 
section 304(b) for existing dischargers. See 304(m) Decree at 4-5. 
Because BPT guidelines are among those listed in section 304(b), EPA 
thus is required by the 304(m) Decree to propose and take final action 
on BPT guidelines for this industry, unless not appropriate.
    EPA has determined that revising BPT limitations for the 
pharmaceutical manufacturing industry is indeed appropriate and 
important. The existing BPT guidelines for BOD<INF>5, TSS, COD and 
cyanide for this industry, which were most recently revised in 1983, 
are based on secondary treatment data collected in the mid-1970s and 
cyanide destruction technology data collected in the early 1980s. Data 
from the 1990 detailed questionnaire indicate that there have been 
significant improvements in secondary treatment and cyanide destruction 
technologies in the industry since that time. Accordingly, the 
technology underpinnings of the current BPT limitations no longer 
reflect the ``average of the best'' technology currently available. 
Moreover, substantial environmental benefits would ensue from more 
stringent BPT limitations. For example, there would be significant 
reductions in the levels of COD and cyanide in addition to BOD<INF>5 
and TSS from current levels if BPT were revised. EPA has determined 
that revising the BPT limitations to reflect the best practicable 
control technology currently available is appropriate at this time.
    b. Pollutants of concern. EPA is proposing to revise BPT effluent 
limitations controlling the discharge of BOD<INF>5, TSS, COD, and, for 
facilities with subcategory A and/or C operations, cyanide (CN). EPA 
has determined that cyanide is not a pollutant of concern for 
facilities with subcategory B and/or D operations. Limitations for the 
pollutant parameter, pH, are not being revised.
    c. Determination of technology basis of BPT. To determine the 
technology basis and performance level that constitutes BPT, EPA 
developed a database consisting of 1988 and 1989 effluent data supplied 
in response to the 1990 detailed questionnaire and its pretest form. 
The Agency determined that more than 29 of 35 direct dischargers and 23 
indirect dischargers utilized biological treatment (activated sludge 
treatment). In addition, 10 direct and indirect discharging plants 
reported some form of cyanide destruction technology in place. Other 
technologies utilized include wastewater incineration (12 plants), 
effluent filtration (6 plants), and polishing ponds (8 plants). 
[[Page 21611]] 
    d. Determination of performance level defining BPT. EPA used 1989 
and 1990 data supplied in the response to the 1990 detailed 
questionnaire regarding BOD<INF>5, TSS, and COD effluent and effluent 
concentrations and loadings in order to calculate long-term average 
concentrations for BOD<INF>5, TSS, and COD. EPA then used this 
information to determine the performance level defining proposed BPT 
for BOD<INF>5, TSS, and COD. EPA has determined that the level of 
performance necessary for a plant to be considered as a best performer 
with respect to advanced biological treatment was full compliance with 
the existing BPT limitations.
    In order to develop BPT limitations for BOD<INF>5, TSS, and COD for 
facilities with subcategory A and/or C and B and/or D operations, EPA 
first identified those plant datasets that indicated full compliance 
with the 1983 BPT regulation. BPT in the 1983 regulation was based on 
activated sludge treatment, which is considered a principal component 
of advanced biological treatment. Under the intent of the 1983 
regulation, facilities with subcategory A and/or C operations must 
achieve long-term average reductions of 90 and 74 percent in BOD<INF>5 
and COD, respectively, and average TSS concentrations equal to 1.7 
times their average influent BOD<INF>5 concentrations. As an initial 
matter, EPA did not consider plants for this rulemaking unless they 
were consistently achieving such long-term BOD<INF>5 and COD percent 
reductions and related TSS concentrations.
    Having identified the plants that are complying with the 1983 BPT 
requirements, EPA then undertook to determine which could be considered 
best performers in the two subcategory groups. To do this, EPA usually 
develops editing criteria to analyze available performance data. EPA 
concluded that no such editing criteria were necessary in this case, 
however, because performance data for the plants employing advanced 
biological treatment to fully comply with the intent of the 1983 BPT 
regulation showed that all were achieving similar good performance. 
Five thus emerged as best performers among facilities with subcategory 
A and/or C operations; for facilities with subcategory B and/or D 
operations, EPA identified two as best performers. The Agency then 
calculated long-term average performance concentrations for BOD<INF>5, 
TSS, and COD using datasets from the best performing A and C and B and 
D plants. The limitations derived from these concentrations represent 
the ``average of the best'' performance with respect to advanced 
biological treatment in the pharmaceutical manufacturing industry.
    With respect to the development of the BPT cyanide limitations for 
facilities with subcategory A and/or C operations, EPA identified ten 
facilities that used some form of cyanide destruction technology to 
destroy or oxidize the cyanide in their waste streams. The existing BPT 
limits for CN were based on alkaline chlorination technology. After 
evaluating the performance data characteristic of the various cyanide 
destruction technologies employed, EPA concluded that hydrogen peroxide 
oxidation appeared to meet the statutory requirements for BPT most 
effectively. In reaching this decision, EPA used influent and effluent 
cyanide data from one of these facilities to determine the 
effectiveness of this form of treatment in reducing cyanide 
concentrations. This facility achieved substantially more effective 
treatment than the other two facilities that used the same cyanide 
destruction technology. As a result, the proposed cyanide limitations 
for facilities with subcategory A and/or C operations are based on the 
performance of hydrogen peroxide oxidation technology. EPA is proposing 
to repeal the current BPT limitations for cyanide for facilities with 
subcategory B and/or D operations because cyanide is not a pollutant of 
concern for those operations. See Section 9 of the TDD for discussion 
of the cyanide content of raw wastewaters generated by facilities with 
subcategory B and/or D operations.
    The development of the variability factors used to determine BPT 
effluent limitations for BOD<INF>5, TSS, COD, and cyanide from the LTA 
is discussed in section IX.F below. A detailed explanation of the 
development of the proposed BPT effluent limitations is found in 
Section 2.2 of the statistical support document. Additional discussion 
of the basis for developing treatment effectiveness data for cyanide 
destruction is presented in Section 8 of the TDD.
2. BCT
    a. Methodology for determining revised BCT limits. EPA is today 
proposing revised BCT effluent limitations guidelines based on the Best 
Conventional Pollutant Control Technology (BCT) for four subcategories 
(A, B, C, and D) of the pharmaceutical manufacturing industry. These 
proposed guidelines, for the conventional pollutants BOD<INF>5 and TSS, 
are based on the average performance of the best plants in these 
subcategories that employ advanced biological treatment (the technology 
basis of the proposed BPT limitations). In developing and proposing 
revised BCT limits, EPA considered whether there are technologies that 
achieve greater removals of conventional pollutants than the proposed 
BPT, and whether those technologies are cost-reasonable according to 
the BCT cost test. In the four subcategories for which EPA proposes 
revised limitations today, EPA identified no technologies that achieve 
greater removals of conventional pollutants than those associated with 
the proposed BPT limits that are also cost-reasonable under the BCT 
cost test, and accordingly proposes BCT limits equal to the proposed 
BPT limits for those subcategories. The technologies considered for 
facilities with subcategory A and/or C operations included effluent 
filtration, polishing ponds, and the combination of effluent filtration 
and polishing ponds. EPA considered only effluent filtration for 
facilities with subcategory B and/or D operations.
    EPA's analysis had several steps. First, EPA considered how best to 
define the BPT ``baseline'' for these purposes. In performing the BCT 
cost tests, the BPT baseline serves as the starting point against which 
more stringent technologies are analyzed. EPA considered three possible 
baselines: (i) the revised BPT limits proposed in today's notice; (ii) 
the actual long-term average discharge of conventional pollutants from 
plants in this industry, based on EPA's 1990 survey data; and (iii) a 
level of control equal to the amount of discharge allowed under 
existing BPT regulations. Of these, the first is the most stringent and 
the third is the least stringent level of control. EPA has selected the 
proposed revised BPT limits because the revised BPT limitations reflect 
the average performance of the best facilities in the industry as 
required by the Clean Water Act. Moreover, dischargers would be 
required to meet these limitations irrespective of the BCT analysis and 
hence they provide a more realistic starting point against which to 
analyze potentially more stringent candidate BCT technologies.
    As the second step in determining whether to revise BCT limits, EPA 
identified candidate BCT technologies. Three candidate technologies 
were identified for facilities with subcategory A and/or C operations. 
Each incorporates advanced biological treatment plus one of the 
following: (1) Multimedia filtration; (2) polishing ponds; or (3) 
polishing ponds followed by multimedia filtration. The only option 
evaluated for facilities with subcategory B and/or D operations was 
[[Page 21612]] multimedia filtration. EPA was able to evaluate these 
candidate technologies for facilities with subcategory A and/or C 
operations and for facilities with subcategory B and/or D operations by 
estimating costs and pollutant removals on a plant-by-plant basis. The 
design parameters and other engineering assumptions for these cost and 
pollutant removal estimates applicable to both A and/or C and B and/or 
D facilities are explained in Section 10 of the TDD. Section 7 of the 
TDD also discusses EPA's evaluation and selection of the various 
candidate BCT technologies. The Agency solicits comment on the above 
described candidate technologies, and other candidate technologies that 
might be more cost-effective than multimedia filtration, polishing 
ponds, or the combination thereof. See Section XIV of this preamble, 
solicitation number 30.0.
    EPA found that all candidate technology options failed the BCT cost 
test in the two subcategory groups (A and C, and B and D). As a result, 
EPA is today proposing to set BCT equal to proposed BPT in these two 
subcategory groups. See the Section 14 of the TDD for a complete 
discussion of the BCT methodology as applied in each of the 
subcategories.
    b. Alternative methodology for developing BCT limits. EPA performed 
an alternative BCT analysis, in addition to the foregoing. This 
alternative analysis is based on the possibility that, notwithstanding 
today's proposal, BPT limits for this industry ultimately are not 
revised. In performing this analysis, EPA considered four candidate 
technology options for facilities with subcategory A and/or C 
operations and two candidate technology options for facilities with 
subcategory B and/or D operations. The technologies identified above 
plus advanced biological treatment is the first candidate technology 
option in each case. The analysis also uses, as its baseline, the level 
of control equal to the discharge allowed under the existing BPT 
regulations. This baseline was used in the development of the 1986 BCT 
limitations for the pharmaceutical manufacturing industry. EPA 
concluded from this alternative analysis that all candidate technology 
options fail the BCT cost test using the baseline for the 1986 
analysis. Section 14 of the TDD provides more discussion of all BCT 
cost test analyses.
3. BAT
    a. Introduction. EPA today is proposing both new and revised BAT 
effluent limitations guidelines based on the Best Available Technology 
Economically Achievable (BAT) for four subcategories (A, B, C, and D) 
of the pharmaceutical manufacturing industry. The BAT effluent 
limitations proposed today would control certain priority and 
nonconventional pollutants discharged from plants in these 
subcategories at an end-of-pipe location. In developing these proposed 
effluent limitations, EPA identified technologies appropriate for 
individual priority and nonconventional pollutants.
    b. Establishing BAT limits. EPA has identified 56 pollutants for 
possible control by BAT limitations for facilities with subcategory A 
and/or C operations. The proposed BAT limitations for these 
subcategories for cyanide and COD are identical to those established 
under BPT. EPA also is proposing limitations for ammonia for facilities 
with subcategory A and/or C operations based on incidental removal 
through steam stripping and advanced biological treatment. Of the 
remaining 53 priority and nonconventional pollutants for which 
limitations are being proposed today for facilities with subcategory A 
and/or C operations, 45 are volatile organic pollutants, which are 
treatable by steam stripping and steam stripping with distillation 
technologies. For facilities with subcategory A and/or C operations, 
EPA is today proposing BAT limitations for those pollutants based on 
steam stripping technology followed by end-of-pipe advanced biological 
treatment. The remaining eight pollutants are nonstrippable organic 
compounds, which are biodegradable. Consequently, EPA is proposing 
advanced biological treatment as the basis for BAT limitations for 
these pollutants for facilities with subcategory A and/or C operations.
    For facilities with subcategory B and/or D operations, EPA has 
identified 54 pollutants for control by the proposed BAT limitations 
based on advanced biological treatment (the technology selected as the 
basis for the proposed BPT). As discussed under BPT, cyanide is not a 
pollutant of concern for subcategory B and/or D operations and EPA is 
proposing to repeal the current BAT limitations for cyanide for 
facilities with subcategory B and/or D operations. EPA also has 
determined that ammonia is not a pollutant of concern for these 
subcategories. EPA is proposing to set BAT limitations for COD for 
facilities with subcategory B and/or D operations at the levels 
achieved by compliance with the proposed BPT limitations.
    c. Rationale for BAT limitations by subcategory. Section V.A.1 
summarizes the factors to be considered in establishing the BAT level 
of control. In general, BAT represents the performance of the best 
available technology economically achievable among plants with shared 
characteristics. Where existing pollution control technologies are 
uniformly inadequate, BAT may be transferred from a different 
subcategory or industrial category. BAT limitations may be based upon 
process changes, as well as upon measures that are not common industry 
practice.
    The Agency is today proposing BAT effluent limitations for 
facilities with subcategory A, B, C, and D operations. The rationale 
for the proposed effluent limitations in each subcategory is presented 
in the following paragraphs.
(1) Fermentation and Chemical Synthesis Subcategories, Subparts A and C
    The technology basis for the current BAT limitations is cyanide 
destruction plus end-of-pipe biological treatment.
    In establishing the proposed BAT effluent limitations, EPA 
considered four regulatory options to reduce the generation of priority 
and nonconventional pollutants by facilities with subcategory A and/or 
C operations. These options are as follows:
    Option (1)--In-plant cyanide destruction plus advanced biological 
treatment with nitrification.
    This option is identical to the technology selected as the basis 
for the proposed BPT limitations for facilities with subcategory A and/
or C operations, except that provisions for nitrification are added.
    Option (2)--In-plant cyanide destruction and steam stripping plus 
advanced biological treatment.
    This option adds in-plant steam stripping to the technology 
described in option 1 for the purpose of removing strippable volatile 
organic pollutants prior to dilution from commingled wastestreams and 
air stripping in treatment basins and impoundments at the end of the 
pipe. Steam stripping will also remove ammonia, thereby obviating the 
need to add nitrification to end-of-pipe biological treatment.
    Option (3)--In-plant cyanide destruction and steam stripping with 
distillation plus advanced biological treatment.
    This option adds in-plant fractional distillation to the technology 
described in Option 2 for the fractional purpose of achieving greater 
removal of difficult to strip volatile organic pollutants (such as 
methanol) prior to dilution from commingled wastestreams and air 
stripping in treatment basins and impoundments at the end of the pipe.
    Option (4)--In-plant cyanide destruction and steam stripping with 
[[Page 21613]] distillation plus advanced biological treatment plus 
end-of-pipe Granular Activated Carbon (GAC) adsorption technology.
    This option adds Granular Activated Carbon adsorption treatment to 
the technology described in Option 3 for the purpose of achieving 
additional removal of the pollutant parameter COD beyond that achieved 
by Option 3.
    EPA selected Option 2 as the proposed technology basis for BAT 
limitations for facilities with subcategory A and/or C operations 
because EPA believes this option represents the best available 
technology economically achievable, considering all statutory factors.
    The Agency found that the annual incremental increase in electrical 
power consumption for all facilities to achieve Option 2 was 13,200 MW. 
This increase is equivalent to an increase of approximately 0.25 
percent of the pharmaceutical industry's purchased electrical energy 
usage in 1990. Using the industry's 1990 purchased electrical energy 
usage as a baseline, the estimated incremental increases for electrical 
power consumption for the remaining options were, for Option 3, an 
increase of 13,800 MW and, for Option 4, an increase of 17,900 MW. With 
respect to energy needs associated with steam generation for steam 
stripping and distillation, the Agency found that Option 2 would result 
in 720,000 MW of incremental energy consumption, or approximately an 8 
percent increase above the industry's 1990 total energy consumption. 
For Option 3, EPA found that 2,220,000 MW of incremental energy 
consumption, or a 25 percent increase above the industry's 1990 total 
energy consumption, would be required. EPA did not select Option 3 as 
proposed BAT because of this large increase in energy consumption 
required for steam generation. This decision is consistent with the 
CWA's requirement that EPA take into account energy requirements in 
selecting BAT. While steam generation under Option 2 requires slightly 
higher energy consumption than the 1990 baseline, the Agency notes that 
the potential for solvent recovery and reuse will substantially offset 
these energy expenditures. See Section XII.B of this preamble for 
further discussion of ``clean fuels.'' Further discussion of these non-
water quality environmental and energy impacts also is presented in 
Sections 12 and 15 of the TDD.
    EPA also is proposing standards to control COD, based upon advanced 
biological treatment. These proposed BAT limitations are based on the 
performance of the ``best'' performers among facilities with 
subcategory A and/or C operations. EPA believes that a substantial 
portion of the raw waste load COD can be removed in plant, prior to 
advanced biological treatment, by application of steam stripping 
technology--upon which the proposed BAT limitations for priority 
pollutants and the other nonconventional pollutants are based. However, 
EPA lacks sufficient data at this time to quantify the removal of COD 
achievable through in-plant steam stripping, and in turn the further 
removal of remaining COD load achievable by advanced biological 
treatment, and therefore does not propose its subcategory A and/or C 
BAT limitations for COD based on that combination of technologies. EPA 
solicits data and comments concerning the establishment of EPA for COD 
for subcategories A and C based on steam stripping plus advanced 
biological treatment. See Section XIV, solicitation number 20.
    In estimating the energy consumption for steam generation 
associated with Option 3, EPA assumed, based on available data, that 
very high volumes of wastewater would need to be stripped and 
distilled, thus requiring high demands for steam. EPA believes that 
this assumption is very conservative because the Agency assumed from 
the 308 questionnaire responses that wastewater streams containing high 
concentrations of volatile organic pollutants could not be segregated 
from streams containing minimal or no concentrations of these 
pollutants. EPA believes that stream segregation is possible. EPA 
further expects that more recent data will show that the volume of 
wastewater that would be subject to steam stripping and distillation is 
substantially lower than the volume assumed in this proposal. Such 
lower volumes would also invariably result in higher concentrations of 
the volatile organic pollutants to be stripped. Considerably less 
steam, and hence considerably less energy, would be necessary to strip 
(Option 2) or distill (Option 3) such pollutants from low volume, high 
concentration wastewater. If more recent data fulfills this 
expectation, the Agency may reconsider Option 3 for A and/or C 
subcategory facilities. Therefore, EPA invites comments and data 
regarding the volume of wastewater that may require steam stripping and 
the pollutant concentrations in those wastestreams. See Section XIV, 
solicitation numbers 6.0 and 15.6. EPA also solicits comments on the 
use of distillation technology for the purpose of obtaining additional 
removal of pollutants such as methanol that are difficult to steam 
strip. See Section XIV, solicitation number 15.9.
    The Agency considered other non-water quality environmental impacts 
of the selected option, including the role which this proposal may play 
in the minimization, recycle, and disposal of characteristic 
(ignitable) volatile organic wastes. EPA has determined that Options 2 
and 3 will generate 52,200 and 61,000 metric tons per year of 
condensates, respectively (more than Option 1 because of the use of 
steam stripping and steam stripping with distillation technologies). 
The condensates may include both halogenated and nonhalogenated 
solvents. Plants may choose to purify these condensates and then 
recycle/reuse the purified solvents as raw materials or use the 
condensate streams as fuel for incinerators either on or off site. If 
plants choose the latter approach, EPA has determined that adequate 
commercial incinerator capacity exists. Although EPA believes that most 
facilities will either recycle or incinerate their steam stripping 
condensates on-site because, in many cases, adequate recycle or 
incineration capability exists on-site, the Agency has adopted the 
conservative approach in its BAT cost estimates by assuming all 
condensates will be disposed of by off-site incineration. Because 
Option 3 features distillation in addition to steam stripping and 
achieves greater organic pollutant removal, resulting in a higher 
volume of condensates, EPA determined that the estimated costs of off-
site incineration of the resulting condensates would be about 10 
percent higher for Option 3 than for Option 2. Because the cost 
differential between Options 2 and 3 represents only a small part of 
the total costs associated with Option 3, EPA did not regard it as a 
significant factor. Accordingly, EPA concluded that the generation of 
condensates as a result of steam stripping and steam stripping with 
distillation technology does not provide a basis for choosing between 
technology Options 2 and 3 as the basis for BAT limitations for 
facilities with subcategory A and/or C operations. A more complete 
discussion of the Agency's waste minimization and combustion strategy 
and its relationship to this industry and rulemaking is presented in 
Section XII.B of this preamble and in Section 7 of the TDD.
    The Agency also considered the effect of Options 1, 2, 3, and 4 on 
the current levels of air emissions from wastewaters at facilities with 
subcategory A and/or C operations. EPA used the WATER7 computer model 
employed by the EPA Office of Air and Radiation (OAR) in the 
[[Page 21614]] recently promulgated Hazardous Organic NESHAP (HON) for 
the Synthetic Organic Chemical Manufacturing Industry (SOCMI), in 
conjunction with Section 308 questionnaire responses, to evaluate the 
1990 levels of air emissions from wastewater for this industry. The 
results of the analyses were used to estimate air emission increases or 
decreases for the regulatory options. The Agency estimates that Option 
1 would result in a minimal increase in air emissions, while Options 2 
and 3 would decrease air emissions by 5,300 and 6,350 metric tons per 
year, respectively. Option 4 would achieve the same air emission 
reduction as Option 3. In EPA's view, these beneficial non-water 
quality environmental impacts militate in favor of selecting a 
technology option employing steam stripping or distillation (i.e., 
Options 2, 3 or 4).
    The Agency did not find that the age of equipment and facilities 
involved provided any basis for choosing among the options. The Agency 
also evaluated whether the engineering aspects of the options were 
compatible with the manufacturing processes employed and potential 
process changes at facilities with subcategory A and/or C operations. 
EPA concluded that the engineering aspects of all four options were 
compatible with current manufacturing processes and possible process 
changes at these facilities, and the results of this evaluation did not 
provide a basis for selecting an option.
(2) Biological and Natural Extraction and Mixing/Compounding/
Formulating Subcategories, Subparts B and D
    EPA considered four regulatory options to reduce the generation of 
priority and nonconventional pollutants by facilities with subcategory 
B and/or D operations. In selecting and evaluating these technology 
options for BAT for these facilities, EPA examined the 1990 
questionnaire data supplied by the fourteen facilities with subcategory 
B and/or D operations only that discharge directly into surface waters. 
Among other things, EPA undertook to characterize the process 
wastewater from these facilities in order to identify the best 
technologies available to treat the pollutants of concern. The data 
supplied by these facilities indicate that the process wastewater of 
these direct dischargers is significantly different, in terms of the 
pollutants present and their concentrations, from the process 
wastewater of indirect discharging facilities with subcategory B and/or 
D operations. EPA is unable to account for this marked difference, 
because the processes employed by the direct and indirect dischargers 
with subcategory B and/or D operations seem to be the same, and 
therefore EPA has some doubts that these data depict the typical 
wastestreams of direct dischargers with subcategory B and/or D 
operations. Although EPA proposes BAT limitations for these facilities 
based on the conclusions it drew from the data, EPA also solicits 
comment on those conclusions and invites additional data concerning the 
processes and wastewater characteristics (flow and pollutant 
concentration) of these facilities. See Section XIV, solicitation 
number 7.0. Because new data for 1991-1994 may establish greater 
similarities between the process wastewaters of direct and indirect 
dischargers with operations than are evident today, EPA is also 
considering and specifically inviting comment on whether it should 
promulgate BAT limitations based on the model treatment technology 
selected by EPA as the basis for its proposed PSES limitations for 
facilities with subcategory B and/or D operations. See Section IX.E.5 
for a discussion of the reasoning underlying that proposal.
    In addition, in the event a facility with subcategory B and/or D 
operations changes its mode of discharge and decides to discharge its 
wastewater directly to surface waters (rather than through a POTW), EPA 
is considering establishing BAT limitations for such dischargers that 
reflect the wastewater characteristics reported by the indirect 
dischargers with subcategory B and/or D operations. The possibility 
that an indirect discharger may change its mode of discharge and thus 
become subject to BAT limitations rather than to PSES further suggests 
to EPA that it should consider the entire universe of data from 
facilities with subcategory B and D operations--not just those 
currently with direct discharges--in setting BAT limits. Therefore, EPA 
seeks comment on whether it should promulgate BAT limitations for this 
subcategory based on steam stripping technology, which EPA has 
determined is appropriate technology for the wastestreams reported by 
indirect dischargers in this subcategory. See Section XIV, solicitation 
number 7.0.
    The four options considered by EPA are as follows:
    Option (1)--Advanced biological treatment.
    This option is identical to the proposed technology basis for BPT 
for facilities with subcategory B and/or D operations.
    Option (2)--In-plant steam stripping plus advanced biological 
treatment.
    This option adds in-plant steam stripping to the technology 
described in Option 1 for the purpose of removing strippable organic 
pollutants prior to dilution from commingled wastewater streams and air 
stripping in treatment basins and impoundments at the end of the pipe.
    Option (3)--In-plant steam stripping with distillation plus 
advanced biological treatment.
    This option adds in-plant fractional distillation to the technology 
described in Option 2 for the fractional purpose of achieving greater 
removal of difficult to strip volatile organic pollutants (such as 
methanol) prior to dilution from commingled wastestreams and air 
stripping in treatment basins and impoundments at the end of the pipe.
    Option (4)--Steam stripping with distillation plus advanced 
biological treatment plus end-of-pipe Granular Activated Carbon (GAC) 
adsorption technology.
    This option adds Granular Activated Carbon adsorption treatment to 
the technology described in Option 3 for the purpose of achieving 
additional removal of the pollutant COD beyond that achieved by Option 
3.
    EPA is proposing Option 1 as the technology basis for BAT 
limitations for facilities with subcategory B and/or D operations 
because, on the basis of the data submitted by the direct dischargers 
in these subcategories, EPA determined that this technology basis is 
the best available technology economically achievable for these 
pollutants. However, as discussed above, EPA is seriously considering 
and specifically invites comment on setting BAT limitations for these 
plants based on the PSES model technology for facilities with 
subcategory B and/or D operations. In making the proposed BAT 
determination, EPA analyzed data for each facility identified through 
the 1989 Pharmaceutical Screener Questionnaire and the 1990 Detailed 
Questionnaire as engaging in subcategory B and/or D operations. The 
results of the screener questionnaire indicate that, nationwide, 14 
pharmaceutical manufacturing plants with direct discharges engage only 
in subcategory B and/or D operations (excluding subcategory E research 
activities). These 14 facilities reported to EPA in response to the 
1990 detailed questionnaire that they discharge BOD<INF>5, TSS, COD, 
six solvents and no priority pollutants. Of the six solvents, the 
facilities reported discharging only two in quantities exceeding a 
combined subcategory total of 1000 lbs/year. EPA's analysis of the 
questionnaire data indicates that the total nonconventional pollutant 
loadings discharged, on average, for each facility with subcategory B 
and/or D operations in [[Page 21615]] 1990 was 1,660 pounds/year. In 
addition, these 14 facilities reported in their questionnaire responses 
that they emit from wastewater a total of 170 pounds/year of volatile 
organic pollutants. Subsequent analysis by EPA using its WATER7 model 
indicates that these 14 facilities may actually emit closer to 35,000 
pounds/year from wastewater. See Section 12 of TDD for discussion of 
difference between questionnaire results and WATER7 results. By way of 
comparison, facilities with subcategory A and/or C operations reported 
in the 1990 questionnaire that they emit from wastewater a total of 3.2 
million pounds/year of volatile organic and priority pollutants, and 
the WATER7 model projected 14 million pounds/year of those pollutants 
from wastewater.
    Based on its evaluation of the data available to it, EPA proposes 
to base BAT limitations for facilities with subcategory B and/or D 
operations on advanced biological treatment (PSES Option 1 minus 
cyanide destruction). In view of the comparatively small quantities of 
pollutants reported to be discharged and emitted from wastewater from 
the 14 existing facilities with subcategory B and/or D operations only, 
EPA has determined that the chosen technology basis for the proposed 
BAT limit is best suited to the type of wastewater the data describe 
for direct discharges in these subcategories. Other technology options, 
which incorporate steam stripping or steam stripping with distillation 
technologies, are designed to remove large quantities and many 
varieties of solvents from process wastewater. They are not optimal 
treatment technologies for the type of wastestreams reported by the 14 
direct dischargers in these subcategories, because the 1990 data 
indicate that these direct dischargers discharge only 6 solvents (in 
contrast to the 45 solvents reported to be discharged by the facilities 
with subcategory A and/or C operations), and then in relatively small 
amounts (an average of 1,660 pounds/year for facilities with 
subcategory B and/or D operations, compared to an average of 14,600 
pounds/year for facilities with subcategory A and/or C operations). 
Accordingly, based on the data available to EPA for these facilities 
from the 1990 questionnaire, EPA is not proposing steam stripping or 
steam stripping with distillation as part of the technology basis for 
BAT for facilities with subcategory B and/or D operations.
    However, in the event that new data for these facilities show that 
the wastestreams of these facilities actually resemble those of the 
indirect dischargers in these subcategories, EPA proposes to base the 
BAT limitations on steam stripping technology, which EPA has determined 
is the best available technology for wastestreams of that character. 
See Section IX.E.5. Accordingly, EPA specifically invites comments on 
establishing BAT limitations equal to the proposed PSES for those 
pollutants, including those that EPA has determined pass through as 
part of co-proposal (1). See Section XIV, solicitation number 7. In 
addition, if EPA promulgated BAT limitations based on steam stripping 
or steam stripping with distillation, EPA would include BAT limitations 
on phenol, acetonitrile and polyethylene glycol 600 (based on advanced 
biological treatment), which are present in the wastestreams of 
indirect dischargers but which EPA does not propose to regulate under 
either PSES co-proposal because EPA has concluded that they do not pass 
through POTWs.
    The Agency has estimated that the facilities with subcategory B 
and/or D operations would incur total post-tax annualized costs of 
$0.71 million in complying with Option 1. The estimated total post-tax 
annualized costs for complying with other options are $1.5 million for 
Option 2, and $2.9 million for Option 3. The Agency estimated that none 
of the options would result in any closures or unemployment. These 
impacts, and the methodology behind them, are explained in greater 
detail in Section XI.B of this preamble and in the Economic Impact 
Analysis. Based upon these findings, EPA concluded that all four 
options are economically achievable. EPA selected Option 1 because it 
determined that option represented that best available technology from 
among all the economically achievable options.
    In evaluating the non-water quality environmental impacts of the 
options, specifically electrical power consumption, the Agency found 
that the annual incremental increase in electrical power consumption 
for all facilities to achieve Option 1 was 265 megawatts (MW) beyond 
current usage (the same as for the proposed BPT limits). This is 
equivalent to an increase of approximately 0.005 percent of the 
pharmaceutical industry's purchased electrical energy usage in 1990. 
The incremental increases for electrical power consumption for the 
remaining options were: for Options 2 and 3, an increase of 182 MW and 
364 MW, respectively, for all facilities for which EPA estimated 
compliance costs; and for Option 4 an increase of 911 MW for all 
facilities for which EPA estimated compliance costs. Further discussion 
of these non-water quality environmental impacts are presented in 
Section 12 of the Technical Development Document.
    The Agency considered other non-water quality environmental impacts 
of the proposed option, including the role which this proposal may play 
in the minimization, recycle, and disposal of characteristic 
(ignitable) volatile organic wastes. EPA has determined that Options 2, 
3 and 4 will generate 76 metric tons per year of condensates as a 
result of the use of steam stripping or steam stripping with 
distillation technologies at direct discharging plants. Based on the 
small increase in condensate generation associated with Options 2, 3 
and 4 EPA has concluded that the recovery opportunities or incineration 
issues prompted by condensate generation do not provide a basis for 
choosing one of the technology options as the basis for proposed BAT 
limitations for facilities with subcategory B and/or D operations. The 
Agency also considered the effect of these four options on the current 
levels of air emissions from wastewater at facilities with subcategory 
B and/or D operations. To do this, EPA used the WATER7 computer model 
to evaluate the 1990 levels of air emissions from wastewater for 
facilities with subcategory B and/or D operations. The results of the 
analyses were used to estimate air emission increases or decreases for 
the regulatory options. The Agency estimates that Option 1 would result 
in a minimal increase in air emissions, while Options 2, 3 and 4 would 
decrease air emissions by 16 metric tons per year. EPA concluded that 
the changes from current emission levels are not significant enough to 
justify selection of Options 2, 3 and 4.
    EPA also concluded that the engineering aspects of all four options 
were compatible with current manufacturing processes employed and 
potential process changes at facilities with subcategory B and/or D 
operations and thus did not provide a basis for selecting an option. 
Similarly, the age of equipment and facilities involved did not provide 
any basis for selecting among the options.
    The selection of Option 1 as BAT for facilities with subcategory B 
and/or D operations reflects, in large part, EPA's conclusion, based on 
currently available data, that BPT level biological treatment can 
degrade the relatively small load of organic pollutants generated by 
these facilities with a low occurrence of air emissions during advanced 
biological treatment. The Agency has noted, however, that this industry 
is dynamic with respect to its production processes. Thus, volatile 
organic pollutant loading data requested by EPA for 1991-1994 
[[Page 21616]] may lead to a different conclusion regarding the need 
for and feasibility of controlling volatile organic pollutants. See 
Section XIV, solicitation number 7.
    d. Point of regulation. EPA considered three different points of 
compliance monitoring for facilities with subcategory A and/or C 
operations in establishing the proposed BAT effluent limitations for 
control of strippable and nonstrippable organic pollutants, and cyanide 
and ammonia. These points are located: (1) In-plant prior to dilution 
by non-process wastewater, commingling with other process wastewater 
streams not containing the regulated pollutants at treatable levels, 
and any conveyance, equalization, or other treatment units that are 
open to the atmosphere; (2) in-plant after commingling with other 
regulated process wastewater streams but prior to open-air primary 
treatment; and (3) at the final effluent point or end-of-pipe.
    EPA is proposing BAT limitations for 45 volatile and semivolatile 
pollutants for facilities with subcategory B and/or D operations based 
on advanced biological treatment at the end of the pipe because 
currently available data does not support basing such limitations on 
in-plant steam stripping or steam stripping with distillation 
technologies. For facilities with subcategory A and/or C operations, 
EPA is proposing to set BAT limitations based on advanced biological 
treatment at the end of the pipe for eight semivolatile organic 
pollutants and COD because these pollutants are not strippable. For 
these facilities, EPA also proposes to enforce limits on cyanide inside 
the discharger's facility at in-plant location (1). EPA is proposing 
BAT limitations for 37 volatile and semivolatile pollutants plus 
ammonia for facilities with subcategory A and/or C operations based on 
in-plant steam stripping followed by advanced biological treatment at 
the end of the pipe.
    In the usual case, compliance monitoring for NPDES permits occurs 
at the end of the pipe. See 40 CFR 122.45(a). However, the NPDES 
regulations also authorize permitting authorities to impose in-plant 
monitoring requirements on a case-by-case basis. 40 CFR 122.45(h). 
Those regulations provides that when permit effluent limitations or 
standards imposed at the point of discharge are impractical or 
infeasible, limitations or standards may be imposed on internal 
wastestreams before mixing with other wastestreams or cooling waters. 
Id. Under that regulation, the permit writer must describe in the fact 
sheet the exceptional circumstances that make such limits necessary. 
Section 122.45(h)(2) lists examples of exceptional circumstances that 
could justify such in-plant monitoring requirements. EPA also proposes 
to provide in the regulations that the BAT limitations set forth in the 
tables for subcategories A and C do not apply for any pollutant for 
which the permit writer finds it necessary to specify in-plant 
monitoring requirements under 40 CFR 122.44(i) and 122.45(h). EPA 
proposes that limitations for those pollutants would be established on 
a best professional judgment basis pursuant to 40 CFR 125.3. Permit 
writers in such cases should use as guidance the standards proposed as 
PSES for the particular pollutants as set forth at Secs. 439.16(a)(1) 
and 439.36(a)(1) of the proposed regulation, because the proposed 
standards for those pollutants reflect in-plant monitoring based or the 
steam-stripping component of the BAT technology.
    In the event that EPA decides to specify an in-plant monitoring 
location for the 12 highly strippable volatile organic pollutants, EPA 
would also propose to establish different BAT limitations corresponding 
to that location. EPA would likely use as a model the proposed 
pretreatment standards for existing sources in these subcategories for 
the reasons set forth above.
    In developing this proposal, EPA considered establishing in-plant 
monitoring locations for all 45 volatile organic pollutants for 
facilities with subcategory A and/or C operations. EPA had several 
reasons for considering that approach. First, EPA was concerned that 
limits imposed at the end of the pipe for these pollutants could be 
impractical or infeasible to enforce. The limitations being proposed 
for the 45 volatile organic pollutants are based on BAT model 
technology steam stripping followed by advanced biological treatment. 
Many of these proposed limitations are only marginally above the levels 
at which these pollutants can be detected in the wastestreams. Dilution 
of these regulated wastestreams with other streams not containing the 
regulated pollutants, followed by incidental air stripping in primary 
and secondary treatment units, would in most cases cause the pollutants 
to be present at or below detection by current analytical methods. 
Thus, EPA was concerned that neither the discharger nor the permitting 
authority could practicably or feasibly determine, at the end of the 
pipe, whether the limits in fact were being met. Second, EPA was also 
concerned that monitoring for some pollutants at the point of discharge 
would be impractical and infeasible as measures of the performance of 
the BAT control technologies, because EPA would have no way of knowing 
whether reductions in wastewater discharges are being achieved by 
application of the control technology or by air emissions in wastewater 
conveyance and treatment facilities. Companies are not required to 
install EPA's model BAT technology and can choose how they wish to 
achieve the limitations in these regulations. (EPA uses such 
information to review existing effluent limitations and to determine, 
consistent with sections 304(b) and 304(m) of the Clean Water Act, 
whether revisions are necessary.) Third, in-plant monitoring 
requirements could promote pollution prevention opportunities for 
recycle and reuse of volatile organic pollutants, including 
nonhalogenated volatile organic compounds (e.g., methanol), derived 
from application of in-plant technologies, like steam stripping. These 
compounds are considered ``clean fuels.'' See Section XII.B for a 
discussion of ``clean fuels.'' Reuse of these compounds as fuel could 
also help reduce a discharger's energy needs, a factor EPA must 
consider under section 304(b) of the Clean Water Act.
    In considering whether to establish in-plant limitations for the 45 
volatile organic pollutants, EPA also weighed the likelihood that 
wastewater pollutants will be transferred to the air in the course of 
primary or secondary treatment. Based on its analyses using the WATER7 
model and questionnaire response data, EPA believes that wastewater 
from subcategory A and/or C facilities can indeed produce significant 
air emissions. EPA also believes that the steam stripping component of 
the proposed BAT technology will significantly reduce the likelihood of 
these emissions, because it achieves a removal efficiency of 99% for 
most of these pollutants. EPA further emphasizes that air stripping is 
not part of the proposed BAT technology.
    Although EPA concluded that it has the legal authority to establish 
in-plant monitoring requirements, EPA has determined as a matter of 
policy that proposing such requirements today to account for these 
emissions would be premature because of the impending rulemaking for 
this industry under the Clean Air Act. As discussed in greater detail 
in Section X below, EPA expects to propose MACT standards for the 
pharmaceutical industry on the basis of the same steam stripper design 
employed in this water rulemaking. EPA also expects in the Clean Air 
Act rulemaking to regulate all volatile organic hazardous air 
pollutants (HAPs), including many of the 45 volatile 
[[Page 21617]] organic pollutants covered by this proposed rule. The 
least stringent control option preliminarily identified in Section X 
would require all wastewater streams with a flow of 100 liters per 
minute or greater and a 1,000 ppmw or greater volatile organic HAP 
concentration to be equipped with controls. Thus, the Agency intends 
that both rules ultimately will be based on the same control 
technologies for the same high concentration low volume process 
wastewater streams that contain the pollutants of concern. In short, 
EPA expects that the non-water quality environmental benefits that 
could be achieved by establishing in-plant monitoring requirements in 
this rulemaking will be realized under the statute that provides the 
most direct and effective means for controlling the air emissions at 
issue. By coordinating these rulemakings to the extent that external 
deadlines allow, EPA hopes to address the multi-media issues associated 
with the manufacture of pharmaceuticals while using, respectively, the 
statutory tools best suited to the particular media being protected.
    EPA specifically solicits comment on all issues pertaining to the 
establishment of in-plant limitations on a case-by-case basis, 
including the burden imposed on permit writers, the recommended 
limitations, and the reasons EPA considered for setting limitations in-
plant on a national basis. See Section XIV, solicitation numbers 7.2, 
15.1-15.7. EPA also seeks comment on EPA's policy decision to defer at 
this time to the Clean Air Act rulemaking. See Section XIV, 
solicitation number 15.8.
4. NSPS
    a. Introduction. The Agency today is proposing New Source 
Performance Standards (NSPS) for facilities with subcategory A, B, C, 
and D operations in the pharmaceutical manufacturing industry. New 
plants have the opportunity to incorporate the best available 
demonstrated technologies, including process changes, in-plant 
controls, and end-of-pipe treatment technologies. Current regulations 
establish NSPS for cyanide based on alkaline chlorination for all four 
manufacturing subcategories. EPA proposes to revise these standards for 
facilities with subcategory A and/or C operations and to repeal them 
for facilities with subcategory B and/or D operations.
    b. Definitions of new source. EPA's NPDES regulations define the 
term ``new source'' at 40 CFR 122.2 and 122.29. Pursuant to those 
regulations, to be a ``new source'' a source must:
    (1) be constructed at a site at which no other source is located;
    (2) totally replace the process or production equipment that causes 
the discharge of pollutants at an existing source; or
    (3) have processes substantially independent of an existing source 
at the same site, considering the extent of integration with the 
existing source and the extent to which the new facility is engaged in 
the same general type of activity as the existing source. 40 CFR 
122.29(b).
    Any new source subject to part 439 that was a ``new source'' as 
defined under 40 CFR 122.29 prior to the date on which the New Source 
Performance Standards proposed today are promulgated will continue to 
be subject to the current NSPS regulations for the subpart to which the 
source is subject until the expiration of the applicable time period 
specified in 40 CFR 122.29(d)(1). After that time, the source is no 
longer considered to be a new source and will be required to achieve 
the BPT, BCT and BAT effluent limitations proposed in this rulemaking 
applicable to the source for its subcategory. EPA defines new source 
for the purpose of NSPS in this rulemaking as a source that commences 
construction after promulgation of the standards being proposed today, 
rather than after proposal, because, in accordance with the schedule 
established in the 304(m) Consent Decree, as modified, EPA does not 
expect to promulgate final standards within 120 days after proposal. 
See 40 CFR 122.2 (definition of New Source).
    c. NSPS options and selection. (1) Fermentation and chemical 
synthesis subcategory, subparts A and C. EPA today is proposing NSPS 
for 58 priority, nonconventional, and conventional pollutants for 
facilities with operations in the fermentation and chemical synthesis 
(A and C) subcategories. These proposed standards are based on the best 
available demonstrated control technology, process, operating method, 
or other alternative. In developing these proposed standards, the 
Administrator considered factors including the cost of achieving 
effluent reductions, non-water quality environmental impacts, and 
energy requirements.
    (i) Priority and nonconventional pollutants. EPA today is proposing 
New Source Performance Standards for 56 priority and nonconventional 
pollutants for facilities with subcategory A and/or C operations. In so 
doing, EPA evaluated two technology options described earlier in 
section IX.E.3.c.1. The two options are: (1) In-plant cyanide 
destruction and steam stripping with distillation plus advanced 
biological treatment; and (2) option 1 plus Granular Activated Carbon 
adsorption treatment. EPA did not consider a technology option based 
primarily on steam stripping without distillation because it is not as 
effective as distillation in removing pollutants such as methanol, that 
are difficult to strip. EPA is proposing NSPS based on the technology 
described in Option 1 for subcategories A and C because EPA has 
determined that it is the best available demonstrated control 
technology for treating and removing the pollutants of concern for 
these subcategories. EPA selected a more stringent NSPS technology than 
its chosen BAT technology because new sources have the opportunity to 
segregate their process wastewater in such a way as to minimize the 
amount of wastewater that will require steam stripping with 
distillation, thereby reducing the adverse energy impacts that 
prevented EPA from selecting this technology as BAT.
    EPA considered the potential cost of the proposed NSPS technology 
for new plants, as well as the costs associated with Option 2, which 
EPA did not select. EPA concluded that costs associated with any option 
would not be so great as to present a barrier to entry, because EPA 
anticipated no economic impacts for existing source subcategory A and C 
plants if they were to implement the proposed NSPS technology. The 
Agency also considered energy requirements and other non-water quality 
environmental impacts when comparing the GAC technology (Option 2) with 
Option 1. EPA concluded that there would be only a slight difference in 
the energy requirements associated with Options 1 and 2. There are no 
significant differences in the other non-water quality environmental 
impacts between the two options considered. EPA did not select Option 2 
as the proposed basis for NSPS because, as noted above, EPA does not 
have sufficient data to quantify the amount of COD removed after 
application of steam stripping with distillation technology and 
therefore could not determine whether granular activated carbon 
technology is appropriate to remove remaining COD loads. See Section 16 
of the TDD for further discussion of NSPS for all four subcategories.
    EPA is proposing standards to control COD based upon advanced 
biological treatment, which is the BAT technology. These proposed 
standards are based on the performance of the ``best'' 
[[Page 21618]] performers with subcategory A and/or C operations. EPA 
believes that a substantial portion of the raw waste load COD can be 
removed in plant, prior to advanced biological treatment, by 
application of steam stripping with distillation technology--upon which 
the proposed NSPS for priority pollutants and the other nonconventional 
pollutants are based. However, EPA lacks sufficient data at this time 
to quantify the removal of COD achievable through in-plant steam 
stripping with distillation, and in turn the further removal of 
remaining COD load achievable by advanced biological treatment, and 
therefore is not able to propose subcategory A and/or C NSPS for COD 
based on that combination of technologies. EPA solicits data and 
comments concerning the establishment of NSPS for COD for subcategories 
A and C based on steam stripping with distillation plus advanced 
biological treatment. See Section XIV, solicitation number 20.
    (ii) Conventional pollutants. EPA today is proposing NSPS for 
BOD<INF>5 and TSS for the fermentation and chemical synthesis 
subcategories (A and C). As noted above for the proposed revised BPT 
limitations, EPA is not proposing to change the pH limitations 
incorporated in the existing NSPS. Based upon data available for this 
subcategory, the technology basis for these proposed standards--
advanced biological treatment--represents the best available 
demonstrated level of performance (the one best performer) for the 
control of BOD<INF>5 and TSS in these subcategories.
    EPA considered the cost of the proposed technology basis for NSPS 
for new plants. EPA concluded that such costs are not so great as to 
present a barrier to entry, as demonstrated by the fact that one 
currently operating plant is performing at the NSPS level using this 
technology. The Agency considered energy requirements and other non-
water quality environmental impacts and found no basis for any 
different standards than the proposed NSPS for conventional pollutants.
    (2) Biological and Natural Extraction and Mixing/Compounding/
Formulating Subcategories, Subparts B and D. EPA today is proposing New 
Source Performance Standards (NSPS) for 56 priority, nonconventional 
and conventional pollutants for facilities with Biological and Natural 
Extraction and Mixing/Compounding/Formulating (B and D) subcategory 
operations. These proposed standards are based on the best available 
demonstrated control technology, process, operating method, or other 
alternative. In developing these proposed standards, the Agency 
considered factors including the cost of achieving effluent reductions, 
non-water quality environmental impacts, and energy requirements.
    (i) Priority and Nonconventional Pollutants. EPA today is proposing 
New Source Performance Standards for 54 priority and nonconventional 
pollutants for facilities with subcategory B and D operations. In 
developing NSPS for these subcategories, EPA evaluated two technology 
options described earlier in Section IX.E.3.c.(2). The two options are: 
(1) In-plant steam stripping with distillation plus advanced biological 
treatment; and (2) Option 1 plus Granular Activated Carbon adsorption 
treatment.
    EPA is today proposing Option 1 as the NSPS technology basis for 
subcategories B and/or D. In making this selection, EPA analyzed all of 
the questionnaire data supplied by facilities with subcategory B and/or 
D operations and projected the types and volume of volatile organic 
pollutants that would be present in treatable levels in process 
wastewaters from new facilities in these subcategories. Although the 
1990 questionnaire data indicated that process wastewater from the 14 
direct dischargers contained fewer pollutants in lower concentrations 
than the process wastewater of indirect dischargers (therefore 
justifying proposed effluent limitations based on advanced biological 
treatment alone, not including steam stripping with distillation), EPA 
has determined that there is no basis to conclude that data would 
adequately depict the wastewater characteristics of a new direct 
discharger. Thus, EPA relied instead on the entire universe of 
facilities with subcategory B and/or D operations, irrespective of 
their direct or indirect discharger status, on the theory that these 
facilities are more plentiful and hence statistically more significant. 
Because EPA has no basis for concluding that the wastewater 
characteristics are related to the manner of discharge, EPA saw no 
reason to confine its NSPS analysis to the 14 existing direct 
dischargers and to ignore the 67 indirect dischargers that reported 
data. In evaluating all of the data available to it for these 
subcategories from the 1990 questionnaire, EPA concluded that the vast 
majority of facilities with subcategory B and/or D operations have 
process wastewater with a comparatively wide variety of volatile 
organic pollutants in comparatively high concentrations, as reported by 
67 of the 188 existing indirect discharging plants with subcategory B 
and/or D operations. EPA considers wastestreams of these 67 plants to 
be more typical of the wastestreams EPA expects to find in new sources 
in this subcategory. Therefore, EPA concluded that the process 
wastewater of new facilities with subcategory B and/or D operations was 
more likely to resemble the more typical subcategory B and/or D 
wastestreams, not the atypical wastestreams reported by the 14 existing 
direct dischargers in those subcategories. Based on that conclusion, 
EPA selected, as the proposed technology basis for NSPS for facilities 
with subcategory B and/or D operations, in-plant steam stripping with 
distillation treatment followed by end-of-pipe advanced biological 
treatment, which EPA has concluded represents the best available 
demonstrated treatment technology. EPA selected a more stringent NSPS 
technology than its chosen BAT technology because new sources have the 
opportunity to segregate their process wastewater in such a way as to 
minimize the amount of wastewater that will require steam stripping 
with distillation, thereby reducing the adverse energy impacts that 
prevented EPA from selecting this technology as BAT. See Section 5 of 
the TDD for further discussion of process wastewaters that EPA projects 
would be generated by facilities with subcategory B and D operations.
    EPA considered the potential cost of the proposed NSPS technology 
for new plants. EPA concluded that costs associated with either option 
would not be so great as to present a barrier to entry. EPA predicted 
no economic impacts (i.e., closures) for existing source subcategory B 
and D plants if they were to implement the equivalent technology 
options considered as possible BAT for those subcategories. The Agency 
noted, however, that the BAT technology option (based primarily on 
steam stripping with distillation) was inappropriate treatment for the 
small reported quantities of volatile organic loadings, because the 
resulting small pollutant removals did not warrant the additional cost 
of steam stripping with distillation. See Section IX.E.3.c(2) above.
    The Agency also considered energy requirements and other non-water 
quality environmental impacts when comparing the GAC technology (Option 
2) with Option 1. EPA concluded that there would be only a slight 
difference in the energy requirements associated with Options 1 and 2. 
There are no significant differences in the other non-water quality 
environmental impacts between the two options considered. EPA did not 
select Option 2 as the proposed basis for NSPS because, as 
[[Page 21619]] noted above, EPA does not have sufficient data to 
quantify the amount of COD removed after application of steam stripping 
with distillation technology and therefore could not determine whether 
granular activated carbon technology is appropriate to remove remaining 
COD loads. See Section 16 of the TDD for further discussion of NSPS for 
all four subcategories.
    For reasons set forth above in the discussion of the proposed NSPS 
for facilities with subcategory A and/or C operations, EPA is proposing 
NSPS for the pollutant COD best performing advanced biological 
treatment. EPA is not proposing NSPS for COD based on in-plant steam 
stripping with distillation technology because it has not been able to 
date to quantify the removal of COD achievable through that technology. 
See Section XIV of this preamble, solicitation number 20.
    (ii) Conventional Pollutants. EPA today is proposing NSPS for 
BOD<INF>5 and TSS for facilities with Biological and Natural Extraction 
and Mixing/Compounding/Formulating subcategories (B and D). As noted 
above for the proposed NSPS for facilities with subcategory A and/or C 
operations, EPA is not proposing to change the pH limitations 
incorporated in the existing NSPS for facilities with subcategory B and 
D operations. Based upon data available for this subcategory, the 
technology basis selected for these proposed standards--advanced 
biological treatment--represents the most stringent demonstrated level 
of performance (the one best performer) for the control of BOD<INF>5 
and TSS in these subcategories.
    EPA considered the cost of the proposed technology basis for the 
proposed NSPS for new plants. EPA concluded that such costs are not so 
great as to present a barrier to entry, as demonstrated by the fact 
that one currently operating plant is performing at the NSPS level 
using this technology. The Agency considered energy requirements and 
other non-water quality environmental impacts and found no basis for 
proposing any different standards than those based on the selected NSPS 
for conventional pollutants.
    d. Point of Regulation. For the reasons set forth in Section 
IX.E.3.d., above in connection with BAT, EPA is proposing to specify an 
end-of-pipe monitoring location for its proposed NSPS standards for 
facilities with A, B, C and/or D operations (excluding cyanide, for 
which EPA proposes in-plant limitations for facilities with subcategory 
A and/or C operations). EPA seeks comments on all issues pertaining to 
this proposal. See Section XIV, solicitation number 15. EPA also 
proposes to provide in the regulations that the standards set forth in 
the NSPS tables for subcategories A, B, C and D do not apply for any 
pollutant for which the permit writer finds it necessary to specify in-
plant monitoring requirements under 40 CFR 122.44(i) and 122.45(h). EPA 
proposes that NSPS for those pollutants would be established on a best 
professional judgment basis pursuant to 40 CFR 125.3. Permit writers in 
such cases should use as guidance the standards proposed as PSNS for 
the particular pollutants (as set forth at Secs. 439.17(a)(1), 
439.27(a)(1), 439.37(a)(1) and 439.47(a)(1) of the proposed 
regulation), because those standards are based on the steam stripping 
with distillation technology that also represents the NSPS technology. 
See Section XIV, solicitation number 15.7.
5. PSES
    Pretreatment Standards for Existing Sources (PSES) are established 
to prevent passthrough of pollutants from POTWs to waters of the United 
States, to prevent pollutants from interfering with the operation of 
POTWs, and to reduce non-water quality environmental impacts (e.g., 
concerns for worker safety and health, sludge contamination, and air 
emissions). CWA Section 307(b). The current PSES is based on cyanide 
destruction, which does not remove volatile organic pollutants. EPA is 
proposing to establish PSES for this industry to prevent passthrough 
from POTWs of the same pollutants proposed to be controlled by BAT for 
the respective subcategories, except polyethylene glycol 600, 
acetonitrile, and phenol. Standards for existing indirect discharging 
plants are based upon the best available technologies economically 
achievable, which may include process changes, in-plant controls, and 
end-of-pipe treatment technologies. As discussed in section 5.a below, 
EPA is also proposing to establish no PSES at this time for 33 volatile 
organic pollutants because there is some doubt that these pollutants 
actually pass through.
    The Agency today is proposing to establish pretreatment standards 
for existing sources in the pharmaceutical manufacturing point source 
category. These standards would apply to plants in the four 
manufacturing subcategories of the industry. Currently, according to 
the 1990 detailed survey questionnaire responses, 259 plants report 
discharging to POTWs, 88 of which conduct predominantly A and C 
subcategory operations and 171 conduct only B and D operations. In 
1993, EPA solicited comments regarding PSES from nine POTWs that 
treated significant quantities of pharmaceutical wastewater. EPA 
received responses from six POTWs, each of which report treating 
significant amounts of pharmaceutical wastewater discharges. The 
questionnaires asked the respondents to comment on the need for 
pretreatment standards for the pharmaceutical manufacturing category 
and other matters relating to discharges from pharmaceutical plants. 
The six POTWs that responded to the questionnaire and their locations 
are: The Onondaga County Department of Drainage and Sanitation, 
Syracuse, NY; the Greenville Utilities Commission, Greenville, NC; the 
Bergen County Utilities Authority, Little Ferry, NJ; the North Shore 
Sanitary District, Gurnee, IL; the Passaic Valley Sewerage 
Commissioners, Newark, NJ; and the Puerto Rico Aqueduct and Sewerage 
Authority, Barceloneta, Puerto Rico.
    Except as provided in 40 CFR 403.7 and 403.13, any existing 
indirect discharger subject to subparts A, B, C or D would be required 
to achieve the proposed PSES for the subcategory to which the facility 
is subject by a date three years from promulgation of the final rule.
    a. Pass-Through Analysis. To determine whether pollutants 
indirectly discharged by plants in this industry pass through POTWs, 
EPA reviewed pharmaceutical manufacturing industry treatment 
performance data, responses to the detailed questionnaire, performance 
data for POTWs, and technical literature. In today's notice, EPA makes 
two alternative proposals associated with PSES and its pass-through 
determinations. Under co-proposal (1), for subcategories A and C, EPA 
concludes that nine priority and 42 nonconventional organic pollutants 
plus ammonia pass through POTWs. Therefore, for all but five 
nonconventional pollutants for which EPA has not selected a treatment 
basis, EPA proposes to establish categorical pretreatment standards to 
regulate those pollutants for subcategories A and C. Similarly under 
that co-proposal, for subcategories B and D, EPA proposes to establish 
categorical pretreatment standards to regulate the same pollutants 
(minus ammonia and cyanide, which EPA has determined are not present in 
the wastewater of facilities in those subcategories). Under co-proposal 
(2), EPA proposes that 33 volatile pollutants do not pass through and 
therefore does not propose PSES for those pollutants for any 
subcategory. [[Page 21620]] 
    In determining whether to propose pretreatment standards for the 
four manufacturing subcategories, EPA first identified the pollutants 
of concern present in the wastewater characteristic of the particular 
subcategories. EPA determined from the available data that as many as 
ten priority pollutants and 45 nonconventional pollutants could be 
present, in varying amounts and frequencies, in the wastestreams of 
facilities in all four manufacturing subcategories (excluding cyanide 
and ammonia for subcategories B and D.) In selecting the pollutants for 
analysis and in performing the pass-through determination, EPA made 
three threshold decisions in view of the data available to it.
    First, with respect to subcategories B and D, EPA used wastestream 
data pertaining to indirect discharging facilities rather than direct 
discharging facilities, because, for reasons EPA is unable to explain, 
the available data indicated that the wastestreams of direct 
dischargers were significantly different from and hence 
unrepresentative of the wastestreams for indirect dischargers in those 
subcategories. Accordingly, EPA concluded that it would be most 
appropriate to identify the pollutants of concern and ultimately 
evaluate the need for pretreatment standards based on the wastewater 
characteristic of the indirect dischargers that would be subject to 
such standards.
    Second, based on that wastestream data, EPA identified cyanide 
destruction plus steam stripping followed by advanced biological 
treatment for subcategory A and/or C facilities and advanced biological 
treatment for subcategory B and/or D facilities as the best available 
technology economically achievable to remove the pollutants of concern 
from those wastestreams. EPA then used these technologies in its pass-
through analysis as the basis for comparing the removal efficiencies 
accomplished through secondary treatment by POTWs.
    Third, EPA made pass through determinations by pollutant for all 
four manufacturing subcategories together, because the data from 
indirect dischargers data available to EPA indicate that steam 
stripping is applicable to all four subcategory wastestreams at 
indirect discharging facilities. Based on these decisions, EPA then 
compared removal efficiencies achievable by well-operated POTWs 
employing secondary treatment with those achievable by direct 
dischargers employing the relevant technology for those subcategories. 
In co-proposal (1), EPA determined for subcategories A and C that 52 
pollutants pass through POTWs and for subcategories B and D that 50 
pollutants pass through, based on the information available to it at 
this time.
    For subcategories A and C, EPA also concluded that ammonia passes 
through because POTWs generally do not have the nitrification 
capability that comprises part of the technology basis for the proposed 
BAT limitations for those subcategories. With respect to cyanide for 
subcategories A and C, EPA found that this pollutant passes through 
POTWs because the removal of cyanide by BAT-level cyanide destruction 
units at direct discharging plants with subcategory A and C operations 
is significantly greater than the documented removals by POTWs with 
advanced secondary treatment. These findings regarding ammonia and 
cyanide are not affected by alternative co-proposals (1) and (2).
    Based on the pass-through determination in co-proposal (1), EPA 
proposes to set pretreatment standards for 45 priority and 
nonconventional organic pollutants for all subcategories in addition to 
cyanide and ammonia for subcategories A and C. In determining whether 
these volatile and semi-volatile organic pollutants pass through POTWs, 
EPA employed its traditional pass through methodology as described 
above. EPA determined that dischargers in all subcategories could 
remove up to 99 percent or more of the volatile and semi-volatile 
organic pollutants from their wastestreams using the BAT technology 
basis which includes in-plant steam stripping for subcategory A and/or 
C facilities.
    Relying on data reported in the Domestic Sewage Study, EPA then 
ascertained the removal efficiencies achieved by POTWs for those 
pollutants using secondary treatment. In evaluating removal 
efficiencies by POTWs for volatile and semi-volatile pollutants, EPA 
notes the fact that some of the removal occurring after wastewater 
leaves a manufacturing facility results from volatilization of these 
pollutants in the head works and unit operations preceding biological 
treatment of the POTWs. EPA has consistently refused in these 
circumstances to regard transfers of pollutants from wastewater to the 
air as treatment. See, e.g., 59 FR at 50665 (Pesticides guidelines); 58 
FR at 36885 (Organic Chemicals, Plastics and Synthetic Fibers 
guidelines). Therefore, because of this volatilization, the quantity of 
a particular volatile or semi-volatile pollutant actually available to 
be removed by the POTW's secondary treatment works was less than the 
quantity of that pollutant present in the wastestream at the time it 
entered the POTW collection system. Thus, the POTW treated--and hence 
removed--a smaller percentage of the pollutant than it would have 
achieved through its secondary treatment if volatilization en route had 
not occurred. For a detailed discussion of volatilization in the 
context of EPA's pass through determinations for all pollutants in all 
subcategories, see Section 17 of the TDD.
    The pass-through determinations reflected in co-proposal (1) are 
supported by POTWs that treat wastewater generated by pharmaceutical 
manufacturing facilities. In a letter sent to EPA dated February 14, 
1995, the Association of Metropolitan Sewerage Agencies (AMSA) urged 
EPA to establish national pretreatment standards for organic pollutants 
found in pharmaceutical wastewater. A copy of this letter is in the 
rulemaking docket. AMSA argued that a decision by EPA not to regulate 
these pollutants at the national level would shift the financial, 
technical and legal burden of regulation to POTWs, which would need to 
establish local limits for these pollutants on a plant-by-plant, 
pollutant-by-pollutant basis. Among other things, AMSA asserted that 
many of its POTW member organizations lack the on-site technical 
expertise to develop limits for the wide variety of volatile organic 
pollutants of potential concern. It further asserted that even where 
such expertise exists, the costs associated with establishing local 
limits in the absence of federal standards would be so significant that 
they would amount to unfunded mandates. AMSA also noted that 
pretreatment standards established at the national level would 
facilitate the enforcement of limits to protect against volatility, 
exfiltration and flammability concerns. AMSA concluded that 
promulgation of national pretreatment standards such as those contained 
in co-proposal (1) would be the most environmentally sound, timely, and 
cost effective method of addressing these pollutants of concern. EPA 
solicits comment on these arguments in support of co-proposal (1). See 
Section XIV, solicitation number 24.4.
    Under co-proposal (2), EPA is considering a finding of no pass-
through for 33 priority and nonconventional pollutants in all four 
subcategories. EPA is soliciting comments and data with respect to this 
finding. See Section XIV, solicitation number 24.3. EPA has developed 
co-proposal (2) because of concerns expressed by industry 
representatives that EPA's pass-through analysis under co-proposal (1) 
may not be correct for some of the 33 volatile organic pollutants such 
as methanol, [[Page 21621]] ethanol, and acetone. EPA believes that the 
additional data and comments received concerning the pass-through 
analysis for these 33 volatile organic pollutants will enable the 
Agency to make a final pass-through determination for these pollutants. 
EPA notes that co-proposal (2) does not affect EPA's pass-through 
findings regarding the 12 highly strippable organic pollutants (and 
cyanide and ammonia for subcategories A and C) for which EPA proposes 
to establish PSES independently.
    EPA is not proposing pretreatment standards for several pollutants 
found in subcategory A, B, C and D facility wastestreams for the 
following reasons. (This part of the proposal is not affected by the 
issues addressed in co-proposals (1) and (2).) EPA has concluded for 
all four manufacturing subcategories that phenol does not pass through 
for the reasons set forth in the Federal Register Notices announcing 
the promulgation of effluent limitation guidelines and standards for 
the Pesticide Chemicals and Organic Chemicals, Plastics and Synthetic 
Fibers (OCPSF) industries. See 59 FR 50638, 50664-65 (September 28, 
1993); 58 FR 36872, 36885-86 (July 9, 1993). In addition, EPA does not 
have sufficient data at this time to determine whether acetonitrile and 
polyethylene glycol 600 pass through POTWs and therefore does not 
propose pretreatment standards to control them. Similarly, EPA lacks 
sufficient data to make a pass-through determination for COD generated 
by facilities with subcategory A and/or C operations, although EPA is 
concerned that certain refractory organic waste materials measured as 
COD that are generated by such facilities may pass through POTWs. (EPA 
has made a preliminary judgment that COD generated by facilities with 
subcategory B and/or D operations does not pass through POTWs. EPA will 
review this judgment based on new data as it becomes available.) EPA 
therefore is soliciting data and comments in order to make a pass-
through determination with respect to acetonitrile, polyethylene glycol 
600, and COD. See Section XIV of this preamble, solicitation numbers 26 
and 27.3. In addition, as noted above, EPA is not proposing 
pretreatment standards for five nonconventional organic pollutants 
(formaldehyde, N,N-dimethyl formamide, N,N dimethyl acetamide, ethylene 
glycol, and dimethyl sulfoxide) for any subcategory because, although 
EPA has determined that they pass through based on the BAT-level 
technology, EPA has concluded that the PSES technology (in-plant steam 
stripping) is an inappropriate basis for pretreatment standards because 
these pollutants are not strippable. Moreover, EPA currently has 
insufficient data to select a treatment technology that would be an 
appropriate basis for such standards. EPA is considering package 
biological treatment of selected wastestreams for this purpose and 
solicits comments and data on this and other possible technology bases 
for pretreatment standards. See Section XIV, solicitation numbers 27.1 
and 27.2. EPA also solicits comment and data regarding other pollutants 
that may pass through or interfere with POTWs, e.g., sulfates and 
sulfides. See Section XIV, solicitation number 28.
    b. Options Considered. EPA considered four technology options for 
PSES under two different regulatory co-proposal scenarios for 
facilities with subcategory A, B, C, and D operations. Under co-
proposal (1), EPA would propose PSES for 12 highly strippable organic 
pollutants (plus cyanide at an in-plant location (1) for subcategory A 
and/or C facilities) and 33 less strippable pollutants (plus ammonia 
for subcategory A and/or facilities) at the point of discharge to the 
POTW sewer. In-plant location (1) is described in IX.E.3.d, above. 
Under co-proposal (2), EPA would propose PSES only for the 12 highly 
strippable organic pollutants, plus cyanide at an in-plant location (1) 
and ammonia at the point of discharge to the POTW sewer for subcategory 
A and/or C facilities. As discussed in subsection a, above, EPA would 
not propose any pretreatment standards for the 33 less strippable 
organic pollutants under co-proposal (2) because of issues raised 
concerning EPA's pass-through analysis for those pollutants.
    Under co-proposals (1) and (2), EPA considered basing PSES on the 
following four technology options for facilities with subcategory A 
and/or C operations for those pollutants found to pass through:
    Option (1) In-plant steam stripping plus in-plant cyanide 
destruction.
    Standards based on this option would control up to eight priority 
and 38 nonconventional volatile organic pollutants plus cyanide 
(depending on the pass-through co-proposal considered). Twelve 
pollutants plus cyanide would be controlled at the in-plant location 
(1) and 34 pollutants (including ammonia) at the point of discharge to 
the POTW sewer.
    Option (2) In-plant steam stripping/distillation plus in-plant 
cyanide destruction.
    Standards based on this option would control up to eight priority 
and 38 nonconventional volatile organic pollutants plus cyanide 
(depending on the pass-through co-proposal considered). Distillation 
affords significantly greater removal of volatile organic pollutants 
that are difficult to strip, such as methanol. Under this option, 22 
volatile organic pollutants plus cyanide would be controlled at the in 
plant location (1) and 24 pollutants (including ammonia) would be 
controlled at the point of discharge to the POTW sewer.
    Option (3) In-plant steam stripping/distillation plus in-plant 
cyanide destruction plus advanced biological treatment. The addition of 
advanced biological treatment would achieve additional volatiles 
removal beyond that achieved by the technology described in Option 2 as 
well as significant reductions in discharge levels of COD. Advanced 
biological treatment would also reduce discharge levels of 
nonstrippable organic pollutants that are biodegradable.
    Option (4) In-plant steam stripping/distillation plus in-plant 
cyanide destruction plus advanced biological treatment plus granular 
activated carbon (GAC) treatment. The addition of granular activated 
carbon treatment to the technology described in Option 3 would further 
reduce COD discharge levels.
    EPA considered the same four technology options for PSES for 
facilities with subcategory B and/or D operations, excluding in-plant 
cyanide destruction (cyanide and ammonia are not regulated pollutants 
at subcategory B and/or D facilities). EPA has selected Option 1 for 
PSES under both co-proposals for indirect discharging facilities with 
subcategory A and/or C operations. The Agency has evaluated the costs 
of this option based on co-proposal (1) and found that there would be 
no closures among affected facilities (for which costs were estimated 
by EPA) as a result of these costs. Therefore EPA determined the costs 
of Option 1 to be economically achievable based on co-proposal (1). EPA 
also found the other options to be economically achievable. EPA 
selected Option 1 because it determined that this option represents the 
best available technology among all economically achievable options, 
insofar as it achieves pollutant reductions necessary to prevent pass-
through of volatile organic pollutants, allows for recovery and 
recycling of volatile organic pollutants, and reduces non-water quality 
environmental impacts caused by air emissions of pollutants from 
wastewater. See Section XII.B of this preamble for a discussion of the 
Administrator's waste minimization and combustion strategy. Although 
Options 2, 3, and 4 would [[Page 21622]] achieve essentially the same 
decrease in the emission of wastewater pollutants to the air as Option 
1, the increase in energy use requirements associated with Options 2, 
3, and 4 would be equivalent to an increase of 31 percent above the 
1990 pharmaceutical industry energy use. For this reason, EPA selected 
Option 1 over Options 2, 3, and 4.
    EPA did not select Options 3 or 4 because EPA has not determined 
whether refractory organic materials measured as COD that are generated 
by facilities with subcategory A and/or C operations pass through POTWs 
and therefore is not proposing standards based on potentially 
unnecessary technology. Moreover, as noted above in EPA's discussion of 
the proposed BAT limitations for these subcategories, even assuming COD 
does pass through, EPA lacks data to estimate the COD reductions 
achievable by steam stripping and thus cannot compare COD reductions 
achievable by Options 2, 3, and 4.
    EPA has also selected Option 1 as the proposed technology basis for 
PSES (minus cyanide destruction) for facilities with subcategory B and/
or D operations. Under co-proposal (1), EPA would propose PSES for 12 
highly strippable organic pollutants at in-plant location (1) and 33 
less strippable pollutants at the point of discharge to the POTW sewer. 
In-plant location (1) is described in IX.E.3.d., above. Under co-
proposal (2), EPA would propose PSES only for the 12 highly strippable 
organic pollutants at in-plant location (1).
    In selecting steam stripping (PSES Option 1 minus cyanide 
destruction) as the technology basis for the proposed PSES for 
facilities with B and/or D subcategory operations, EPA relied upon the 
1990 questionnaire data supplied by 188 facilities with subcategory B 
and/or D operations that send their wastewater to POTWs for treatment. 
For reasons that EPA is not able to explain, these data show that the 
wastestreams characteristic of indirect dischargers with subcategory B 
and/or D operations are significantly different (for regulatory 
purposes) than the wastestreams of direct dischargers with subcategory 
B and/or D operations. See Section IX.E.3.c(2) for discussion of basis 
for proposed BAT limitations for facilities with subcategory B and D 
operations. In view of this reported difference, EPA has based today's 
proposed pretreatment standards on a different technology--steam 
stripping--than the BAT limitations proposed for the direct dischargers 
in this subcategory, which are based on advanced biological treatment.
    The data supplied by the 188 indirect facilities in this 
subcategory show that these facilities discharge BOD<INF>5, TSS, COD, 
18 nonconventional pollutants and four priority pollutants. See Section 
9 of the TDD. EPA's analysis of the questionnaire data indicates that 
the total nonconventional and priority pollutant loadings discharged, 
on average, for each indirect discharger with subcategory B and D 
operations in 1990 was 14,600 pounds/year (in contrast to the average 
of 1,660 pounds/year reported by the 14 direct dischargers in these 
subcategories). The 188 facilities also reported in their questionnaire 
responses that they emit from wastewater a total of 1.5 million pounds/
year of volatile organic pollutants (in contrast to the emissions 
totaling 170 pounds/year reported by the direct dischargers). 
Subsequent analysis by EPA using its WATER7 model indicates that these 
indirect dischargers may actually emit closer to 3.3 million pounds/
year from wastewater (in contrast to the emissions totaling 35,000 
pounds/year for the direct dischargers). See Section 12 of TDD for 
discussion of difference between questionnaire results and WATER7 model 
results. Based on its evaluation of the data available to it, EPA 
proposes to base pretreatment standards for facilities with subcategory 
B and D operations on in-plant steam stripping (Option 1). This 
technology is designed to remove large quantities and many varieties of 
solvents from process wastewater. According to the data supplied by the 
188 indirect dischargers with subcategory B and D operations, EPA has 
concluded that the wastewater characteristic of these facilities--with 
its comparatively high volume and concentration of solvents--is well-
suited to this form of treatment. Accordingly, EPA has determined for 
the reasons set forth above in connection with establishing BAT 
limitations for facilities with A and C subcategory operations, see 
Section IX.E.3.c(1) above, that in-plant steam stripping is the most 
appropriate technology basis for pretreatment standards for facilities 
with subcategory B and/or D operations. Even though EPA's 1990 data 
indicates that subcategory B and/or D facilities discharge only 22 
priority and nonconventional pollutants, EPA is proposing to establish 
pretreatment standards for 45 priority and nonconventional pollutants 
because all 45 pollutants potentially can be discharged to POTWs. (EPA 
is soliciting comment on mechanisms by which dischargers that do not 
use or generate pollutants for which standards are proposed can be 
exempted from monitoring for those pollutants. See Section XIV, 
solicitation number 38.) In addition, EPA found that none of the 67 
facilities (of the 188 indirect dischargers with subcategory B and D 
operations) that would incur costs as a result of the proposed PSES 
limitations would close as a result of this option. Therefore EPA 
determined that the costs of the pollutant reduction achieved by this 
option were economically achievable.
    In considering the various technology options available as possible 
bases for the proposed pretreatment standards for these subcategories, 
EPA rejected advanced biological treatment as a viable technology 
option and therefore did not consider it. Because indirect discharging 
facilities with subcategory B and/or D operations generate levels of 
BOD<INF>5, TSS and COD comparable to levels found in ordinary domestic 
sewage, EPA concluded that biological treatment afforded by POTWs is 
adequate for these levels of pollutants. Accordingly, EPA has 
determined that BOD<INF>5, TSS and, preliminarily, COD from facilities 
with subcategory B and/or D operations do not pass through. Thus, 
advanced biological treatment at these facilities prior to POTW 
treatment would be duplicative.
    The Agency considered age, size, processes, other engineering 
factors, and non-water quality environmental impacts in developing the 
proposed PSES for all four subcategories. The Agency did not identify 
any basis for establishing different pretreatment standards based on 
age, size, processes, or other engineering factors. EPA has concluded 
that the technology upon which EPA proposes to base PSES for facilities 
with subcategory B and/or D operations would significantly decrease air 
emissions and would be consistent with the Administrator's waste 
minimization and combustion strategy. See Section XII.B of this 
preamble for a discussion of this strategy. EPA did not choose Option 2 
because, although this option would result in approximately the same 
decrease in air emissions as Option 1, it would result in a significant 
increase in total energy use over that required under Option 1. (See 
section 16 of the TDD and the BAT discussion above.)
    c. Point of Regulation. EPA is proposing to specify an in-plant 
compliance monitoring location for each of the 12 highly strippable 
volatile organic pollutants for which EPA is proposing PSES. (This is 
not affected by the co-proposals addressing the 33 less strippable 
pollutants.) This location is described as in-plant location (1) in 
[[Page 21623]] section E.3.d., above. For facilities with subcategory A 
and/or C operations, EPA also proposes to require in-plant monitoring 
for cyanide based upon cyanide destruction technology.
    EPA acknowledges that it reached a different conclusion regarding 
the point of regulation for direct dischargers with subcategory A and/
or C operations. As discussed in section E.3.d., above, EPA is 
proposing to specify end-of-pipe monitoring requirements for the 12 
highly strippable volatile organic pollutants in deference to the 
forthcoming Clean Air Act rule for this industry, which will control 
air emissions of these pollutants. EPA also noted in that section, 
however, that the permit writer has the authority under the NPDES 
permit regulations to establish limits in-plant on a case-by-case basis 
when it would be impractical or infeasible to monitor for the 
pollutants at the end of the pipe because of dilution or other 
considerations. Indeed, EPA observed that the BAT limitations being 
proposed for the 12 highly strippable volatile organic pollutants in 
subcategories A and C are at levels that are only marginally above the 
analytical minimum levels established for these pollutants and 
expressed its concern that dilution or air stripping might make 
detection of the pollutants infeasible at the end of the pipe. 
Nevertheless, EPA concluded that this concern could be addressed for 
direct dischargers on a case-by-case basis by the permit writer and 
therefore proposed that establishing in-plant compliance requirements 
on a national level was not essential.
    EPA is proposing to reach a different conclusion for indirect 
dischargers. Like the proposed BAT limitations, the proposed 
pretreatment standards for existing dischargers are only marginally 
above the minimum levels established for these pollutants. Similarly, 
EPA is concerned that dilution with process and non-process wastewater 
might cause the pollutants to be undetectable by current analytical 
methods. Under EPA regulations, however, indirect dischargers are 
prohibited from substituting dilution for treatment, except where 
dilution is expressly authorized by an applicable pretreatment 
standard. See 40 CFR 403.6(d). This prohibition theoretically could be 
enforced by POTWs through the establishment of local limitations at in-
plant locations on a pollutant-by-pollutant, case-by-case basis in the 
same way that a permit writer could do so for direct dischargers. By 
establishing in-plant monitoring requirements, the POTW, like the 
permit writer, would be able to determine whether compliance is being 
achieved by dilution or by treatment. The difference, however, is this 
pollutant-by-pollutant, case-by-case solution to the detection and 
dilution problems may impose a financial and technical burden on POTWs. 
There are six times as many indirect dischargers as direct dischargers, 
and unlike state and EPA permit writers, POTWs commonly lack the on-
site technical expertise to establish and justify in-plant monitoring 
requirements on a case-by-case basis. Even when such expertise exists, 
EPA is concerned that the accompanying burden and expense would be 
significant. Therefore, EPA is proposing to establish in-plant points 
of regulation on a nationwide level.
    EPA is proposing pretreatment standards in large measure because of 
the concern registered by some POTWs that discharges containing 
substantial concentrations of these volatile organic pollutants may 
interfere with the operation of the sewerage system and the health and 
safety of employees of the POTW system. EPA solicits comment and 
supporting data regarding whether this objective may be satisfied by 
assuring that discharges to the POTW sewer are near or at the level of 
detection. See Section XIV, solicitation number 24.0. In addition, as 
discussed in Section X, EPA is developing a separate rulemaking under 
the requirements of Section 112 of the Clean Air Act to address the air 
emissions from pharmaceutical plants, including the emissions of these 
12 highly strippable volatile organic pollutants. EPA's air rulemaking 
may complement this proposal so that standards set at the point of 
discharge to the POTW sewer may satisfy EPA's objectives in this 
rulemaking. EPA expects to propose these air emission standards next 
year. As a result, EPA is also considering whether to establish limits 
for the 12 highly strippable volatile organic pollutants at the point 
of discharge to the POTW sewer. See Section XIV, solicitation number 
24.5.
6. PSNS
    Section 307(c) of the Act requires EPA to promulgate pretreatment 
standards for new sources (PSNS) at the same time it promulgates new 
source performance standards (NSPS). New indirect discharging plants, 
like new direct discharging plants, have the opportunity to incorporate 
the best available demonstrated technologies, including process 
changes, in-plant controls, and end-of-pipe treatment technologies.
    Any new source subject to part 439 that was a ``new source'' as 
defined under 40 CFR 122.29 prior to the date on which the pretreatment 
standards for new sources proposed today are promulgated will continue 
to be subject to the current PSNS regulations for the subpart to which 
the source is subject until the expiration of the applicable time 
period specified in 40 CFR 122.29(d)(1). After that time, the source is 
no longer considered to be a new source and will be required to achieve 
the PSES standards proposed in this rulemaking applicable to the source 
for its subcategory. EPA defines new source for the purpose of PSNS in 
this rulemaking as a source that commences construction after 
promulgation of the standards being proposed today, rather than after 
proposal, because, in accordance with the schedule established in the 
304(m) Consent Decree, as modified, EPA does not expect to promulgate 
final standards within 120 days after proposal. See 40 CFR 122.2 
(definition of New Source).
    EPA considered three technology options for PSNS under two 
different regulatory co-proposal scenarios for facilities with 
subcategory A and/or C operations. Under co-proposal (1), EPA would 
propose PSNS for 12 highly strippable organic pollutants plus cyanide 
at an in-plant location (1) and 33 less strippable pollutants plus 
ammonia at the point of discharge to the POTW sewer. Under co-proposal 
(2), EPA would propose PSNS only for the 12 highly strippable organic 
pollutants, plus cyanide at in-plant location (1) and for ammonia at 
the end-of-pipe (3).
    Under co-proposals (1) and (2), EPA considered the following three 
technology options for facilities with subcategory A and/or C 
operations for those pollutants found to pass through:
    Option (1): In-plant steam stripping with distillation plus in-
plant cyanide destruction.
    Option (2): In-plant steam stripping with distillation plus in-
plant cyanide destruction plus advanced biological treatment.
    Option (3): In-plant steam stripping with distillation plus in-
plant cyanide destruction plus advanced biological treatment plus 
granular activated carbon (GAC) treatment.
    Under co-proposals (1) and (2), EPA considered the following two 
technology options for facilities with subcategory B and/or D 
operations for those pollutants found to pass through:
    Option (1): In-plant steam stripping with distillation.
    Option (2): In-plant steam stripping with distillation plus 
granular activated carbon (GAC) treatment.
    EPA selected a more stringent PSNS technology than its chosen PSES 
technology because new sources have the opportunity to segregate their 
[[Page 21624]] process wastewater in such a way as to minimize the 
amount of wastewater that will require steam stripping with 
distillation, thereby reducing the adverse energy impacts that 
prevented EPA from selecting this technology as PSES.
    EPA is proposing to set pretreatment standards for new sources 
based on PSNS Option 1 (steam stripping with distillation plus cyanide 
destruction) for priority and nonconventional pollutant for indirect 
discharging facilities with subcategory A and/or C operations. 
Similarly, EPA is proposing to set pretreatment standards for new 
sources based on PSNS Option 1 (steam striping with distillation) for 
facilities with subcategory B and/or D operations.
    EPA considered the cost of the proposed PSNS technologies for new 
plants. EPA has concluded that such costs are not so great as to 
present a barrier to entry, as demonstrated by the fact that currently 
operating plants are using these technologies. The Agency also 
considered energy requirements and other non-water quality 
environmental impacts when comparing the three PSNS technology options 
for facilities with subcategroy A and/or C operations and the two PSNS 
technology options for facilities with subcategory B and/or D 
operations. EPA concluded that there would be only a slight difference 
in the energy requirements associated with Options 1, 2, and 3 for 
subcategory A and/or C facilities and with Options 1 and 2 for 
subcategory B and/or D facilities. There are no significant differences 
in the other non-water quality environmental impacts between the 
options considered.
7. BMP
    EPA is not proposing any Best Management Practices (BMPs) today for 
the Pharmaceutical Manufacturing Category. However, EPA is soliciting 
comment on whether BMPs are applicable to the pharmaceutical 
manufacturing industry and, if so, what they should include. See 
Section XIV, solicitation number 31.0. See also the TDD at Appendix B 
for specific BMPs that EPA is considering adopting.

F. Determination of Long-Term Averages, Variability Factors, and 
Limitations

    A detailed description of the statistical methodology used for the 
calculation of limitations is described in the Statistical Support 
Document. A summary of the methodology follows.
    Limitations were based on actual concentrations of constituents 
measured in wastewaters treated by BAT treatment systems when such data 
were available. Limitations were transferred based on engineering 
analysis when actual monitoring data were unavailable. For steam 
stripping and distillation technology, engineering analysis involved 
grouping constituents on the basis of their Henry's Law Constant. For 
biological treatment, the engineering analysis involved grouping 
constituents on the basis of their chemical structure and published 
data on relative biodegradability.
    The calculation of the BAT daily limitations for constituents other 
than cyanide was performed by the following steps. The arithmetic long-
term mean concentration was calculated for each facility dataset 
representing BAT treatment technology, and the median of the means was 
determined. A modified delta-lognormal distribution, the distribution 
model used by EPA in the Organic Chemicals, Plastics and Synthetic 
Fibers (OCPSF) and Pesticides Manufacturing rulemakings, was fit to 
daily concentration data from each facility dataset that had enough 
detected concentration values for parameter estimation. Variability 
factors were then computed for each of these datasets, and the average 
variability factor was determined. Finally, the daily maximum 
limitation was calculated by multiplying the median long-term mean by 
the average variability factor. The monthly average maximum limitation 
was calculated similarly except that the variability factor 
corresponding to the 95th percentile of the distribution of monthly 
averages was used instead of the 99th percentile of daily concentration 
measurements. The monthly average maximum limitation calculation 
assumes four measurements per month, or one per week.
    The modified delta-lognormal distribution models the data as a 
mixture of non-detects and measured values. This distribution was 
selected because the data for most constituents consisted of a mixture 
of measured values and non-detects. The modified delta-lognormal 
distribution assumes that all non-detects have a value equal to the 
detection limit and the detected values follow a lognormal 
distribution.
    A beta distribution rather than a delta-lognormal was used to model 
cyanide data. The BAT treatment for cyanide requires the reprocessing 
of wastewater if effluent cyanide concentrations exceed 1 ppm. 
Therefore, the cyanide data from a properly operated treatment system 
should range between 0 and 1 ppm. Such data are appropriately modelled 
by the beta distribution. The parameters of the beta distribution were 
estimated from the cyanide dataset by the method of moments. Parameter 
estimates were then substituted in the beta distribution from which the 
daily limitation (99th percentile) was calculated. The monthly average 
cyanide (based on 4 daily measurements) limitation was estimated in a 
similar fashion.
    The calculation of the proposed BPT limitations was based on 
measured concentrations of BOD<INF>5, COD, and TSS measured in 
wastewaters treated by BPT systems. A 1-day and 30-day limitation was 
determined for each BPT facility dataset from a modified delta-
lognormal distribution that was fit to the data. These limitations were 
then averaged across the datasets to determine the overall 1-day and 
30-day maximum limitations. An intermediate step involved adjusting the 
modeled variability to account for day-to-day correlation in 
concentrations of BOD<INF>5, COD, and TSS. The adjustment was based on 
a lag-1 autocorrelation time series model estimated from adjacent day 
observations, the same approach adopted in the OCPSF rulemaking. For 
datasets having an insufficient number of adjacent day observations to 
estimate an autocorrelation an average value was assumed.

G. Costs

    The Agency estimated the cost for the pharmaceutical manufacturing 
industry to achieve each of the effluent limitations and standards 
proposed today. These estimated costs are summarized in this section 
and discussed in more detail in section 10 of the Technical Development 
Document. All cost estimates are expressed in 1990 dollars (the year 
for which EPA received questionnaire responses and data submissions). 
The cost components reported in this section are engineering estimates 
of the capital cost of purchasing and installing equipment and the 
annual operating and maintenance costs associated with that equipment. 
The total annualized cost, which is used to estimate economic impacts, 
better describes the actual compliance cost that a company will incur 
because it allows for interest, depreciation, and taxes. A summary of 
the economic impact analysis for the proposed regulation is contained 
in Section XI.B of today's notice. See also the Economic Impact 
Analysis.
1. BPT
    The Agency used a plant-specific engineering cost assessment to 
estimate the costs of achieving the proposed BPT limitations. If a 
plant's reported 1990 discharges of BOD<INF>5, TSS, COD and, in the 
case of facilities with subcategory A [[Page 21625]] and/or C 
operations, cyanide were less than the long-term average loads 
achievable by the technology basis for today's proposed BPT 
limitations, the plant was estimated to have no compliance costs. If 
the resulting pollutant loads exceeded the proposed BPT long-term 
average loads, EPA estimated costs for treatment system upgrades and, 
in the case of cyanide, in-plant hydrogen peroxide oxidation 
technology. Based on this analysis, EPA concluded that 20 
pharmaceutical manufacturing facilities would incur costs to comply 
with the proposed BPT limitations. EPA estimated the total capital 
expenditures for complying with the proposed BPT limitations to be 
$15.3 million and the annual operating and maintenance (O&M) costs to 
be $7.5 million. The estimated cost for implementing the proposed BPT 
limitations is summarized for the A and C and B and D subcategories 
below in Table IX.G.1.
2. BAT
    EPA estimated the costs to comply with today's proposed BAT 
limitations on priority and nonconventional pollutants on plant-by-
plant and pollutant-by-pollutant basis. If the loading data provided by 
the facility in its Section 308 questionnaire response indicated that 
its discharge was above the proposed limitation target load for a given 
pollutant, EPA developed cost estimates for the control technology EPA 
believes is appropriate for that pollutant (e.g., steam stripping for 
all strippable pollutants).
    For direct dischargers with subcategory A and C operations, BAT 
costs include, where necessary, the costs for in-plant steam stripping 
followed by end-of-pipe advanced biological treatment upgrades to 
comply with the proposed limitations for priority and nonconventional 
pollutants. The operation and maintenance costs include monitoring of 
strippable pollutants in-plant and nonstrippable biodegradable 
pollutants at the end-of-pipe.
    For direct dischargers with subcategory B and D operations, BAT 
costs include the costs for end-of-pipe advanced biological treatment 
upgrades. The upgrades are designed around treating conventional 
pollutants to specific targets, equivalent to BPT long-term mean 
performance. In a few cases, additional compliance costs were estimated 
for direct discharging facilities with subcategory B and D operations 
that already achieve these conventional pollutant upgrade targets, but 
require more closely controlled treatment system operation to comply 
with the priority and nonconventional pollutant BAT limitations.
    The BAT operation and maintenance costs for subcategories B and D 
include monitoring for priority and nonconventional pollutants at the 
end-of-pipe. EPA estimated the total capital expenditures for complying 
with the proposed BAT limitations to be $57.0 million, and the annual 
operating and maintenance (O&M) costs to be $36.8 million. These costs 
are not incremental and include the advanced biological treatment 
upgrades also presented under BPT. See Table IX.G.2-1 for a breakdown 
of the costs by subcategory.

      Table IX.G.1.--Cost of Implementing Proposed BPT Regulations      
                      [In millions of 1990 dollars]                     
------------------------------------------------------------------------
                                                            Annual O&M  
       Subcategory         No. of plants   Capital costs       costs    
------------------------------------------------------------------------
Fermentation (A) and                                                    
 Chemical Synthesis (C).              15            14.7             7.0
Biological and Natural                                                  
 Extraction (B) and                                                     
 Mixing/Compounding/                                                    
 Formulating (D)........               5             0.6             0.5
------------------------------------------------------------------------


      Table IX.G.2.--Cost of Implementing Proposed BAT Regulations      
                      [In millions of 1990 dollars]                     
------------------------------------------------------------------------
                                                            Annual O&M  
       Subcategory         No. of plants   Capital costs       costs    
------------------------------------------------------------------------
Fermentation (A) and                                                    
 Chemical Synthesis (C).              23           56.4             35.7
Biological and Natural                                                  
 Extraction (B) and                                                     
 Mixing/Compounding/                                                    
 Formulating (D)........              13            0.64             1.1
------------------------------------------------------------------------

3. PSES
    EPA developed PSES costs for compliance with the proposed 
pretreatment standards for strippable priority and nonconventional 
pollutants in the same manner that it developed BAT compliance costs 
for these pollutants. In developing these costs, EPA based the number 
of pollutants proposed to be regulated under PSES on the pass-through 
findings of PSES co-proposal (1), which include the 33 less strippable 
volatile organic pollutants. EPA did not include cost estimates for 
nonstrippable nonconventional pollutants in the PSES costs because EPA 
is requesting comment on its technology basis for controlling the 
discharge of these pollutants. See Section XIV, solicitation numbers 
27.1 and 27.2. The estimated total capital expenditure for complying 
with the proposed PSES limitations are $91.8 million and the annual 
operating and maintenance (O & M) costs are $54.1 million. See table 
IX.G.3 for a breakdown of the costs by subcategory.

      Table IX.G.3.--Cost of Implementing Proposed PSES Regulations     
                      [In millions of 1990 dollars]                     
------------------------------------------------------------------------
                                                            Annual O&M  
       Subcategory         No. of plants   Capital costs       costs    
------------------------------------------------------------------------
 Fermentation (A) and                                                   
 Chemical Synthesis (C).              71            70.8            46.4
Biological and Natural                                                  
 Extraction (B) and                                                     
 Mixing/Compounding/                                                    
 Formulating (D)........              75            21.0             7.7
------------------------------------------------------------------------


[[Page 21626]]

H. Pollutant Reductions

    The Agency estimated the reduction in the mass of pollutants that 
would be discharged from pharmaceutical manufacturing plants after the 
implementation of the regulations being proposed today. The reduction 
in pollutant mass is attributable both to in-plant treatment 
technologies and improved end-of-pipe treatment. In-plant technologies 
such as steam stripping achieve pollutant load reductions by physical 
removal or extraction of volatile organic pollutants. Other 
technologies such as end-of-pipe biological treatment and in-plant 
cyanide destruction achieve pollutant reduction by chemically or 
biochemically altering the nature of the pollutants (e.g., by 
converting them to different substances like carbon dioxide and water). 
Additional information on the methodology used to estimate the 
pollutant reductions resulting from the implementation of the proposed 
effluent limitations and standards is included in Section 9 of the 
Technical Development Document.
1. Conventional Pollutants
    For each subcategory, the Agency developed an estimate of the 
annual average mass loadings of BOD<INF>5 and TSS that would be 
discharged after the implementation of the proposed BPT limitations. 
Since EPA proposes to set BCT limitations for conventional pollutants 
equal to the proposed BPT limitations for all subcategories, there 
would be no further reduction in BOD<INF>5 and TSS achieved through 
BCT. Then EPA subtracted these loadings from the discharge loadings 
reported in the Section 308 questionnaire responses for 1990. The 
resultant pollutant reductions for BOD<INF>5 and TSS are summarized in 
Table IX.H.1.

               Table IX.H.1.--BPT, BOD<INF>5 and TSS Reductions              
------------------------------------------------------------------------
                                           BOD<INF>5reduction   TSS reduction
              Subcategories               (lbs. per yr.)  (lbs. per yr.)
------------------------------------------------------------------------
A and C.................................         931,000       2,150,000
B and D.................................          10,000           4,820
------------------------------------------------------------------------

2. Priority Pollutants
    For the ten priority pollutants EPA proposes to regulate, EPA 
estimated the removals achieved by the various BPT, BAT, and PSES 
technologies based on raw waste load data provided by plants in their 
Section 308 questionnaire responses. In estimating these pollutant 
reductions, EPA did not include pollutant reductions being achieved by 
existing technology, including advanced biological treatment, already 
in place. The resultant priority pollutant reductions are summarized in 
Table IX.H.2.

     Table IX.H.2.--BPT, BAT and PSES Priority Pollutant Reductions     
------------------------------------------------------------------------
                           BPT reduction                                
      Subcategories          (cyanide)     BAT reduction  PSES reduction
                          (lbs. per yr.)  (lbs. per yr.)  (lbs. per yr.)
------------------------------------------------------------------------
A and C.................              38       2,650,000       7,140,000
B and D.................          \1\N/A               0        694,000 
------------------------------------------------------------------------
\1\Cyanide is not a pollutant of concern for facilities with subcategory
  B and D operations.                                                   

3. Nonconventional Pollutants
    For the 45 nonconventional pollutants (excluding COD) for which 
limitations and standards are being proposed, EPA estimated the 
removals achieved by the various proposed BPT, BAT, and PSES technology 
bases, using raw waste load data provided by plants in their Section 
308 questionnaire responses. In estimating these pollutant reductions, 
EPA did not include pollutant reductions being achieved by technology 
already in place, including in many cases advanced biological 
treatment. The resultant priority pollutant reductions are summarized 
in Table IX.H.3.

  Table IX.H.3.--BPT, BAT and PSES Nonconventional Pollutant Reductions 
------------------------------------------------------------------------
                           BPT reduction                                
      Subcategories       (lbs. per yr.)   BAT reduction  PSES reduction
                             COD only     (lbs. per yr.)  (lbs. per yr.)
------------------------------------------------------------------------
 A and C................       9,840,000      16,800,000      30,900,000
B and D.................          59,600          22,600       3,440,000
------------------------------------------------------------------------

I. Regulatory Implementation

1. Applicability
    The regulation proposed today is just that--a proposed regulation. 
As such, although it represents EPA's best judgment at this time, it is 
not intended to be relied upon by permit writers in establishing 
effluent limitations. Indeed, because EPA solicits comment and data 
(see specific solicitation numbers 1.2 and 1.3) regarding the proposed 
effluent limitations and standards specified in today's notice as well 
as on the technologies upon which they are based, the proposed 
limitations and standards and any conclusions set forth in this notice 
are subject to change.
2. Upset and Bypass Provisions
    A ``bypass'' is an intentional diversion of waste streams from any 
portion of a treatment facility. An ``upset'' is an exceptional 
incident in which there is unintentional and temporary noncompliance 
with technology-based permit effluent limitations because of factors 
beyond the reasonable control of [[Page 21627]] the permittee. EPA's 
regulations concerning bypasses and upsets are set forth at 40 CFR 
122.41(m) and (n).
3. Variances and Modifications
    The CWA requires application of the effluent limitations 
established pursuant to section 301 or the pretreatment standards of 
section 307 to all direct and indirect dischargers. However, the 
statute provides for the modification of these national requirements in 
a limited number of circumstances. Moreover, the Agency has established 
administrative mechanisms to provide an opportunity for relief from the 
application of national effluent limitations guidelines and 
pretreatment standards for categories of existing sources for toxic, 
conventional and nonconventional pollutants.
    a. Fundamentally Different Factors Variances. EPA will develop 
effluent limitations or standards different from the otherwise 
applicable requirements if an individual discharging facility is 
fundamentally different with respect to factors considered in 
establishing the limitation or standards applicable to the individual 
facility. Such a modification is known as a ``fundamentally different 
factors'' (FDF) variance.
    Early on, EPA, by regulation, provided for FDF modifications from 
BPT effluent limitations, BAT limitations for toxic and non-
conventional pollutants and BCT limitation for conventional pollutants 
for direct dischargers. For indirect dischargers, EPA provided for FDF 
modifications from pretreatment standards. FDF variances for toxic 
pollutants were challenged judicially and ultimately sustained by the 
Supreme Court. Chemical Manufacturers Ass'n v. NRDC, 479 U.S. 116 
(1985).
    Subsequently, in the Water Quality Act of 1987, Congress added new 
section 301(n) of the Act explicitly to authorize modification of the 
otherwise applicable BAT effluent limitations or categorical 
pretreatment standards for existing sources if a facility is 
fundamentally different with respect to the factors specified in 
section 304 (other than costs) from those considered by EPA in 
establishing the effluent limitations or pretreatment standard. No FDF 
variance is available for new sources subject to NSPS or PSNS. Section 
301(n) also defined the conditions under which EPA may establish 
alternative requirements. Under section 301(n), an application for 
approval of an FDF variance must be based solely on (1) information 
submitted during the rulemaking raising the factors that are 
fundamentally different or (2) information the applicant did not have 
an opportunity to submit. The alternate limitation or standard must be 
no less stringent than justified by the difference and not result in 
markedly more adverse non-water quality environmental impacts than the 
national limitation or standard.
    EPA regulations at 40 CFR Part 125 Subpart D, authorizing the 
Regional Administrators to establish alternative limitations and 
standards, further detail the substantive criteria used to evaluate FDF 
variance requests for direct dischargers. Thus, 40 CFR 125.31(d) 
identifies six factors (e.g., volume of process wastewater, age and 
size of a discharger's facility) that may be considered in determining 
if a facility is fundamentally different. The Agency must determine 
whether, on the basis of one or more of these factors, the facility in 
question is fundamentally different from the facilities and factors 
considered by the EPA in developing the nationally applicable effluent 
guidelines. The regulation also lists four other factors (e.g., 
infeasibility of installation within the time allowed or a discharger's 
ability to pay) that may not provide a basis for an FDF variance. In 
addition, under 40 CFR 125.31(b)(3), a request for limitations less 
stringent than the national limitation may be approved only if 
compliance with the national limitations would result in either (a) a 
removal cost wholly out of proportion to the removal cost considered 
during development of the national limitations, or (b) a non-water 
quality environmental impact (including energy requirements) 
fundamentally more adverse than the impact considered during 
development of the national limits. EPA regulations provide for an FDF 
variance for indirect dischargers at 40 CFR 403.13. The conditions for 
approval of a request to modify applicable pretreatment standards and 
factors considered are the same as those for direct dischargers.
    The legislative history of Section 301(n) underscores the necessity 
for the FDF variance applicant to establish eligibility for the 
variance. EPA's regulations at 40 CFR 125.32(b)(1) are explicit in 
imposing this burden upon the applicant. The applicant must show that 
the factors relating to the discharge controlled by the applicant's 
permit which are claimed to be fundamentally different are, in fact, 
fundamentally different from those factors considered by the EPA in 
establishing the applicable guidelines. The pretreatment regulations 
incorporate a similar requirement at 40 CFR 403.13(h)(9).
    b. Economic Variances. Section 301(c) of the CWA authorizes a 
variance from the otherwise applicable BAT effluent guidelines for 
nonconventional pollutants due to economic factors. The request for a 
variance from effluent limitations developed from BAT guidelines must 
normally be filed by the discharger during the public notice period for 
the draft permit. Other filing time periods may apply, as specified in 
40 CFR 122.21(l)(2). Specific guidance for this type of variance is 
available from EPA's Office of Wastewater Management.
    c. Water Quality Variances. Section 301(g) of the CWA authorizes a 
variance from BAT effluent guidelines for certain nonconventional 
pollutants due to localized environmental factors. These pollutants 
include ammonia, chlorine, color, iron, and total phenols.
    d. Permit Modifications. Even after EPA (or an authorized State) 
has issued a final permit to a direct discharger, the permit may still 
be modified under certain conditions. (When a permit modification is 
under consideration, however, all other permit conditions remain in 
effect.) A permit modification may be triggered in several 
circumstances. These could include a regulatory inspection or 
information submitted by the permittee that reveals the need for 
modification. Any interested person may request modification of a 
permit modification be made. There are two classifications of 
modifications: major and minor. From a procedural standpoint, they 
differ primarily with respect to the public notice requirements. Major 
modifications require public notice while minor modifications do not. 
Virtually any modification that results in less stringent conditions is 
treated as a major modification, with provisions for public notice and 
comment. Conditions that would necessitate a major modification of a 
permit are described in 40 CFR 122.62. Minor modifications are 
generally non-substantive changes. The conditions for minor 
modification are described in 40 CFR 122.63.
    e. Removal credits. As described previously, many industrial 
facilities discharge large quantities of pollutants to POTWs where 
their wastewaters mix with wastewater from other sources, domestic 
sewage from private residences and run-off from various sources prior 
to treatment and discharge by the POTW. Industrial discharges 
frequently contain pollutants that are generally not removed as 
effectively by treatment at the POTWs as by the industries themselves.
    The introduction of pollutants to a POTW from industrial discharges 
may pose several problems. These include [[Page 21628]] potential 
interference with the POTW's operation or pass-through of pollutants if 
inadequately treated. As discussed, Congress, in section 307(b) of the 
Act, directed EPA to establish pretreatment standards to prevent these 
potential problems. Congress also recognized that, in certain 
instances, POTWs could provide some or all of the treatment of an 
industrial user's wastewater that would be required pursuant to the 
pretreatment standard. Consequently, Congress established a 
discretionary program for POTWs to grant ``removal credits'' to their 
indirect dischargers. The credit, in the form of a less stringent 
pretreatment standard, allows an increased concentration of a pollutant 
in the flow from the indirect discharger's facility to the POTW.
    Section 307(b) of the CWA establishes a three-part test for 
obtaining removal credit authority for a given pollutant. Removal 
credits may be authorized only if (1) The POTW ``removes all or any 
part of such toxic pollutant,'' (2) the POTW's ultimate discharge would 
``not violate that effluent limitation, or standard which would be 
applicable to that toxic pollutant if it were discharged'' directly 
rather than through a POTW and (3) the POTW's discharge would ``not 
prevent sludge use and disposal by such [POTW] in accordance with 
section [405] * * *.'' Section 307(b).
    EPA has promulgated removal credit regulations in 40 CFR Part 
403.7. The United States Court of Appeals for the Third Circuit has 
interpreted the statute to require EPA to promulgate comprehensive 
sewage sludge regulations before any removal credits could be 
authorized. NRDC v. EPA, 790 F.2d 289, 292 (3d Cir. 1986), cert. 
denied. 479 U.S. 1084 (1987). Congress made this explicit in the Water 
Quality Act of 1987 which provided that EPA could not authorize any 
removal credits until it issued the sewage sludge use and disposal 
regulations required by section 405(d)(2)(a)(ii).
    Section 405 of the CWA requires EPA to promulgate regulations that 
establish standards for sewage sludge when used or disposed for various 
purposes. These standards must include sewage sludge management 
standards as well as numerical limits for pollutants that may be 
present in sewage sludge in concentrations which may adversely affect 
public health and the environment. Section 405 requires EPA to develop 
these standards in two phases. On November 25, 1992, EPA promulgated 
the Round One sewage sludge regulations establishing standards, 
including numerical pollutant limits, for the use or disposal of sewage 
sludge. 58 FR 9248<SUP>1. EPA established pollutant limits for ten 
metals when sewage sludge is applied to land, for three metals when it 
is disposed of on a surface disposal site and for seven metals and a 
total hydrocarbon operational standard, a surrogate for organic 
pollutant emissions, when sewage sludge is incinerated. These 
requirements are codified at 40 CFR Part 503.

    \1\The U.S. Court of Appeals for the District of Columbia 
Circuit has remanded portions of these regulations not pertinent 
here for modification or additional justification. Leather 
Industries of America, Inc. v. EPA, 40 F.3d 392 (D.C. Cir. 1994).
---------------------------------------------------------------------------

    The Phase One regulations partially fulfilled the Agency's 
commitment under the terms of a consent decree that settled a citizens 
suit to compel issuance of the sludge regulations. Gearhart, et al. v. 
Reilly, Civil No. 89-6266-JO (D.Ore). Under the terms of that decree, 
EPA must propose and take final action on the Round Two sewage sludge 
regulations by December 15, 2001.
    At the same time EPA promulgated the Round One regulations, EPA 
also amended its pretreatment regulations to provide that removal 
credits would be available for certain pollutants regulated in the 
sewage sludge regulations. See 58 FR 9386. The amendments to Part 403 
provide that removal credits may be made potentially available for the 
following pollutants:
    (1) If a POTW applies its sewage sludge to the land for beneficial 
uses, disposes of it on surface disposal sites or incinerates it, 
removal credits may be available, depending on which use or disposal 
method is selected (so long as the POTW complies with the requirements 
in Part 503). When sewage sludge is applied to land, removal credits 
may be available for ten metals. When sewage sludge is disposed of on a 
surface disposal site, removal credits may be available for three 
metals. When the sewage sludge is incinerated, removal credits may be 
available for seven metals and for 57 organic pollutants. See 40 CFR 
403.7(a)(3)(iv)(A).
    (2) In addition, when sewage sludge is used on land or disposed of 
on a surface disposal site or incinerated, removal credits may also be 
available for additional pollutants so long as the concentration of the 
pollutant in sludge does not exceed a concentration level established 
in Part 403. When sewage sludge is applied to land, removal credits may 
be available for two additional metals and 14 organic pollutants. When 
the sewage sludge is disposed of on a surface disposal site, removal 
credits may be available for seven additional metals and 13 organic 
pollutants. When the sewage sludge is incinerated, removal credits may 
be available for three other metals. See 40 CFR 403.7(a)(3)(iv)(B).
    (3) When a POTW disposes of its sewage sludge in a municipal solid 
waste landfill that meets the criteria of 40 CFR Part 258 (MSWLF), 
removal credits may be available for any pollutant in the POTW's sewage 
sludge. See 40 CFR 403.7(a)(3)(iv)(C). Thus, given compliance with the 
requirements of EPA's removal credit regulations,<SUP>2 following 
promulgation of the pretreatment standards being proposed here, removal 
credits may be authorized for any pollutant subject to pretreatment 
standards if the applying POTW disposes of its sewage sludge in a MSWLF 
that meets the requirements of 40 CFR Part 258. If the POTW uses or 
disposes of its sewage sludge by land application, surface disposal or 
incineration, removal credits may be available for the following metal 
pollutants (depending on the method of use or disposal): arsenic, 
cadmium, chromium, copper, iron, lead, mercury, molybdenum, nickel, 
selenium and zinc. Given compliance with section 403.7, removal credits 
may be available for the following organic pollutants (depending on the 
method of use or disposal) if the POTW uses or disposes of its sewage 
sludge: benzene, 1,1-dichloroethane, 1,2-dibromoethane, ethylbenzene, 
methylene chloride, toluene, tetrachloroethene, 1,1,1-trichloroethane, 
1,1,2-trichloroethane and trans-1,2-dichloroethene.

    \2\Under Section 403.7, a POTW is authorized to give removal 
credits only under certain conditions. These include applying for, 
and obtaining, approval from the Regional Administrator (or Director 
of a State NPDES program with an approved pretreatment program), a 
showing of consistent pollutant removal and an approved pretreatment 
program. See 40 CFR Sec. 403.7(a)(3)(i), (ii), and (iii).
---------------------------------------------------------------------------

    Some facilities may be interested in obtaining removal credit 
authorization for other pollutants being considered for regulation in 
this rulemaking for which removal credit authorization would not 
otherwise be available under Part 403. Under sections 307(b) and 405 of 
the CWA, EPA may authorize removal credits only when EPA determines 
that, if removal credits are authorized, that the increased discharges 
of a pollutant to POTWs resulting from removal credits will not affect 
POTW sewage sludge use or disposal adversely. As discussed in the 
preamble to amendment to the Part 403 regulations (58 FR 9382-83), EPA 
has interpreted these sections to authorize removal credits for a 
pollutant only in one of two circumstances. Removal credits may be 
[[Page 21629]] authorized for any categorical pollutant (1) for which 
EPA have established a numerical pollutant limit in Part 503; or (2) 
which EPA has determined will not threaten human health and the 
environment when used or disposed of in sewage sludge. The pollutants 
described in paragraphs (1)-(3) above include all those pollutants that 
EPA either specifically regulated in Part 503 or evaluated for 
regulation and determined would not adversely affect sludge use and 
disposal.
    Consequently, in the case of a pollutant for which EPA did not 
perform a risk assessment in developing the Phase One sewage sludge 
regulations, removal credit for pollutants will only be available when 
the Agency determines either a safe level for the pollutant in sewage 
sludge or that regulation of the pollutant is unnecessary to protect 
public health and the environment from the reasonably anticipated 
adverse effects of such a pollutant.<SUP>3 Therefore, any person 
seeking to add additional categorical pollutants to the list for which 
removal credits are now available would need to submit information to 
the Agency to support such a determination. The basis for such a 
determination may include information showing the absence of risks for 
the pollutant (generally established through an environmental pathway 
risk assessment such as EPA used for Phase One) or data establishing 
the pollutant's presence in sewage sludge at low levels relative to 
risk levels or both. Parties, however, may submit whatever information 
they conclude is sufficient to establish either the absence of any 
potential for harm from the presence of the pollutant in sewage sludge 
or data demonstrating a ``safe'' level for the pollutant in sludge. 
Following submission of such a demonstration, EPA will review the data 
and determine whether or not it should propose to amend the list of 
pollutants for which removal credits would be available.

    \3\In the Round One sewage sludge regulation, EPA concluded, on 
the basis of risk assessments, that certain pollutants (see Appendix 
G to Part 403) did not pose an unreasonable risk to human health and 
the environment and did not require the establishment of sewage 
sludge pollutant limits. As discussed above, so long as the 
concentration of these pollutant in sewage sludge are lower than a 
prescribed level, removal credits are authorized for such 
pollutants.
---------------------------------------------------------------------------

    EPA has already begun the process of evaluating a number of 
pollutants for adverse potential to human health and the environment 
when present in sewage sludge. In May, 1993, pursuant to the terms of 
the consent decree in the Gearhart case, the Agency notified the United 
States District Court for the District of Oregon that, based on the 
information then available at that time, it intended to propose 31 
pollutants for regulation in the Round Two sewage sludge regulations. 
These are acetic acid (2,4-dichlorophenoxy), aluminum, antimony, 
asbestos, barium, beryllium, boron, butanone (2-), carbon disulfide, 
cresol (p-), cyanides (soluble salts and complexes), dioxins/
dibenzofurans (all monochloro to octochloro congeners), endsulfan-II, 
fluoride, manganese, methylene chloride, nitrate, nitrite, 
pentachloronitrobenzene, phenol, phthalate (bis-2-ethylexyl), 
polychlorinated biphenyls (co-planar), propanone (2-), silver, 
thallium, tin, titanium, toluene, trichlorophenoxyacetic acid (2, 4,5-
), trichlorphenoxypropionic acid ([2-(2,4,5-)], and vanadium.
    The Round Two regulations are not scheduled for proposal until 
December, 1999 and promulgation in December 2001. However, given the 
necessary factual showing, as detailed above, EPA could conclude before 
the contemplated proposal and promulgation dates that regulation of 
some of these pollutants is not necessary. In those circumstances, EPA 
could propose that removal credits should be authorized for such 
pollutants before promulgation of the Round Two sewage sludge 
regulations. However, given the Agency's commitment to promulgation of 
effluent limitations and guidelines under court-supervised deadlines, 
it may not be possible to complete review of removal credit 
authorization requests by the time EPA must promulgate these guidelines 
and standards.
4. Relationship of Effluent Limitations to NPDES Permits and Monitoring 
Requirements
    Effluent limitations act as a primary mechanism to control the 
discharges of pollutants to waters of the United States. These 
limitations are applied to individual facilities through NPDES permits 
issued by the EPA or authorized States under section 402 of the Clean 
Water Act.
    The Agency has developed the limitations and standards for this 
proposed rule to cover the discharge of pollutants for this industrial 
category. In specific cases, the NPDES permitting authority may elect 
to establish technology-based permit limits for pollutants not covered 
by this proposed regulation, on a case-by-case basis using best 
professional judgment. See section 402(a)(1)(B) of the Clean Water Act; 
40 CFR 125.3. In addition, if State water quality standards or other 
provisions of State or Federal law require limits on pollutants not 
covered by this regulation (or require more stringent limits on covered 
pollutants), the permitting authority must apply those limitations. 
See, e.g., section 301(b)(1)(C) of the Clean Water Act.
    For determination of effluent limits where there are multiple 
products or multiple categories and subcategories, the effluent 
guidelines would be applied using a flow-weighted combination of the 
appropriate guideline for each category or subcategory. Where a 
facility has added a new production facility in conjunction with an 
existing production facility, the effluent guidelines would also be 
applied by using a flow-weighted combination of the NSPS limit for the 
new line and the BAT and BCT standards to the existing lines to derive 
the limitations. However, as stated above, if State water quality 
standards or other provisions of State or Federal law require limits on 
pollutants not covered by this regulation (or require more stringent 
limits on covered pollutants), the permitting authority must apply 
those limitations regardless of the limitation derived using the 
production-weighted combinations.
    The Agency does not consider certain wastewaters or materials to be 
process wastewaters; therefore, these proposed effluent limitations 
guidelines and standards would not apply to the discharge of such 
wastewaters. Such materials include, for example, any active anti-
microbial materials, wastewater from imperfect fermentation batches, or 
process area spills. Any pharmaceutical manufacturing facility wishing 
NPDES authorization to discharge any materials and/or non-process 
wastestream(s) must specifically disclose this in its permit 
application. If the permitting authority wishes to authorize this 
discharge, the permit must specifically authorize the discharge of the 
specified materialsP and/or non-process wastestream(s). The effluent 
limitations in the permit must also reflect a separate analysis, done 
by the permitting authority on a best professional judgment basis, of 
the levels of pollutants in such materials and/or non-process 
wastestream(s) that are commensurate with the application of BPT, BCT, 
BAT, and PSES. Caution should be exercised in permitting such 
discharges. Treatment systems may not be designed to accommodate these 
types of materials and their discharge could adversely affect the 
treatment systems and receiving waters.
    Working in conjunction with the effluent limitations are the 
monitoring conditions set out in an NPDES permit. An integral part of 
the monitoring conditions are the monitoring points. The point at which 
a sample is collected [[Page 21630]] can have a dramatic effect on the 
monitoring results for that facility. Therefore, it may be necessary to 
require internal monitoring points in order to assure compliance. 
Authority to address internal waste streams is provided in 40 CFR 
122.44(i)(1)(iii) and 122.45(h). In some instances, today's proposed 
rule establishes internal monitoring points to ensure compliance with 
the effluent limitations guidelines and standards. Permit writers may 
establish additional internal monitoring points to the extent 
consistent with EPA's regulations.
5. Best Management Practices
    EPA is not proposing in today's notice best management practices 
(BMPs) pursuant to Section 304(e) of the Clean Water Act. BMPs 
established under Section 304(e) may be different from effluent 
limitations guidelines and standards principally because BMPs are 
specific requirements for conduct, not performance standards. When EPA 
sets technology-based effluent limits, those limits may be achieved by 
any technology a discharger chooses. However, when EPA establishes BMPs 
under Section 304(e) of the CWA, and those BMPs are incorporated into a 
dischargers permit, the discharger must perform those specific BMPs. 
The fact that a discharger had met all its technology-based effluent 
limits would not be a defense, if the discharger were charged with a 
permit violation for failing to perform its BMPs.
    BMPs for the pharmaceutical manufacturing industry, which might 
include spill prevention, control provisions, and other aspects to 
prevent the release of raw materials, solvents, and process chemicals 
to wastewaters, would control the release of constituents listed in 
sections 307(a) and 311(e) of the CWA, such as methylene chloride, 
toluene, chloroform, and chloromethane (methyl chloride).
    The EPA believes these BMPs are important because: discharges of 
raw materials, process chemicals and other materials are not recognized 
process wastewaters and contribute to significant portions of untreated 
wastewater loadings and to final effluent discharge loadings of oxygen 
demanding substances and priority and nonconventional pollutants. 
Prevention and control of discharges of materials used in 
pharmaceutical manufacturing processes will result in less demand for 
make-up chemicals; energy efficiency through recovery of process 
materials; more effective and less costly wastewater treatment system 
operations; reduced formation of wastewater treatment sludges; and 
reduced atmospheric emissions of hazardous air pollutants (HAPs) and 
other volatile organic pollutants.
    EPA is soliciting comment on whether BMPs are applicable to 
pharmaceutical manufacturing facilities in any or all subcategories for 
which effluent limitations guidelines and standards are being proposed. 
The principal focus of the BMPs are prevention and control of losses of 
raw materials, process chemicals and other process materials from 
spills and equipment leaks. More information related to the BMPs is 
outlined in Section XIV regarding solicitation of comments and data 
(see specific solicitation number 31.0). Appendix B of the Technical 
Development Document presents details on the specifics of BMPs that may 
be appropriate.
6. Analytical Methods
    Section 304(h) of the Clean Water Act (CWA) directs the EPA to 
promulgate guidelines establishing test procedures (methods) for the 
analysis of pollutants. These methods are used to determine the 
presence and concentration of pollutants in wastewater, and for 
compliance monitoring. Dischargers seeking NPDES permits must supply 
information on the characteristics of their effluent, analyzed in 
accordance with approved test procedures, as part of their permit 
applications. 40 CFR 122.21(g)(7). Similarly, holders of NPDES permits 
are required to conduct monitoring in accordance with such test 
procedures. 40 CFR 122.41(j)(4). Information and analysis performed in 
accordance with these methods are also required under the pretreatment 
program, 40 CFR 403.12(d)(5)(vi), and as a condition for receiving a 
conditional removal credit under 40 CFR 403.7(d).
    EPA has promulgated analytical methods for monitoring discharges to 
surface water at 40 CFR part 136, and has promulgated methods for 
parameters specific to a given industrial category and for other 
purposes at parts 400-480 of the CFR. In today's notice, EPA also 
proposes to establish appropriate analytical methods at 40 CFR part 439 
to support regulation of discharges in the pharmaceutical manufacturing 
industrial point source category. Those methods are presented in 
``Analytical Methods for the Determination of Pollutants in 
Pharmaceutical Industry Wastewater,'' a compendium of analytical 
methods and are incorporated herein by reference. See Section XIV, 
solicitation number 33.
    Methods 1624 and 1625 are two of the previously promulgated methods 
applicable to the determination of volatile and semivolatile organic 
pollutants in water and wastewater for the proposed effluent 
guidelines. They employ gas chromatography coupled to a mass 
spectrometer (GC/MS) to separate and quantify volatile and semivolatile 
organic pollutants. Detected pollutants are quantified by isotope 
dilution. For volatile organic pollutants, samples of water or solids 
suspended in water are purged by a stream of inert gas into the gaseous 
phase where they are concentrated into a trap. Subsequent heating of 
the trap introduces the concentrated volatile organics into a GC/MS for 
separation and quantification. The sensitivity of these methods are 
sufficient to detect and quantify volatile and semivolatile organics at 
parts per billion (ppb) levels in environmental samples. EPA also 
solicits comment on whether it may be appropriate to allow facilities 
to use analytical methods for organic pollutants other than those used 
to generate data upon which this proposal is based. See Section XIV, 
solicitation number 38.3.
    Many of the non-conventional pollutants that may be released from 
the pharmaceutical manufacturing industry are not included in methods 
previously promulgated for monitoring effluents from other industries. 
For this reason it has been necessary to develop methods for these 
pollutants. Some are amenable to extraction from aqueous solution and 
can be analyzed by GC/MS after extraction and concentration. Method 
1665 has been developed for these analytes. Others may be concentrated 
by purging from aqueous solution and trapping in a column containing 
sorbent material. For these substances, purge-and-trap followed by GC/
MS analysis as described in Method 1666 was developed. Some highly 
water soluble analytes, however, could not be extracted from aqueous 
solution and could not be efficiently purged from water. For this 
reason, it was necessary to develop a direct aqueous injection 
technique for GC/MS analysis by Method 1666. A subset of these highly 
water soluble substances, all containing nitrogen, were found not to 
chromatograph well on the column used. For this reason, a third 
technique, Method 1668, was developed using a different GC column and 
detection by electrolytic conductivity. Formaldehyde is not extractable 
from water and can not be readily analyzed by either purge-and-trap GC/
MS or direct aqueous injection. For this reason a fourth approach, 
Method 1667, was developed for formaldehyde and the other aldehydes 
included in the analyte list. A complete description of these 
[[Page 21631]] methods can be found in the Methods Compendium mentioned 
previously.
    Methods 410.1 and 410.2 are two of several methods allowed for 
determination of chemical oxygen demand (COD) in water and wastewater. 
Other methods allowed for the determination of COD in this industry are 
those in 40 CFR part 136 that use analytical technologies equivalent to 
the technologies used in EPA methods 410.1 and 410.2, specifically 
oxidation by potassium dichromate and titration with ferrous ammonium 
sulfate, as described below. Method 410.2 is specific for levels of COD 
less than 50 mg/L, and Method 410.1 for levels greater than 50 mg/L. 
Other methods for COD that are intended for brines (e.g., EPA method 
410.3) and that are interfered with by color (e.g., EPA method 410.4) 
and the methods in 40 CFR part 136 equivalent to these methods are 
allowed for monitoring pharmaceutical manufacturing wastewaters.

X. Regulation of the Pharmaceutical Manufacturing Industry Under the 
Clean Air Act Amendments of 1990

    Section 112 of the Clean Air Act Amendments of 1990 (CAAA) requires 
EPA to develop National Emission Standards for Hazardous Air Pollutants 
(NESHAP) based on maximum achievable control technology (MACT) for 
sources that emit 10 or more tons per year of a single hazardous air 
pollutant (HAP) or 25 or more tons per year of a mixture of HAP. The 
CAAA contain a list of 189 pollutants identified as HAPs. It also 
establishes a schedule for issuing these standards over a ten-year 
period. Pharmaceutical plants are among the source categories for which 
MACT standards must be promulgated by November 15, 1997.
    EPA's Office of Water, which is developing the effluent limitations 
and standards being proposed today, has been working closely with EPA's 
Office of Air and Radiation since the beginning of this effluent 
guidelines effort in order to ensure that the present rulemaking is 
consistent, within the constraints of the governing statutes, with the 
air emissions standards EPA will be promulgating for the pharmaceutical 
manufacturing industry. As noted in Section V.A above, EPA's 
promulgation of this effluent guideline--including the date of this 
proposal--is subject to a court-ordered schedule, which at this time 
requires EPA to issue this regulation in final form by August 1996. 
Meanwhile, EPA has established November 15, 1997, as the date by which 
it will promulgate air emissions standards for this industry. See 
Section V.B above. In determining priorities for promulgating standards 
for this and other industries, EPA was required by section 112(e) of 
the Clean Air Act to consider several factors, including anticipated 
adverse effects on public health and the environment. Thus, the 
promulgation date for the pharmaceutical industry NESHAP reflects EPA's 
consideration of these statutory criteria, as well as resource 
limitations that reinforced the Agency's need to rank its rulemakings 
in priority order. Despite the different schedules and resource 
constraints necessitating separate rulemakings under the Clean Water 
Act and Clean Air Act for the pharmaceutical manufacturing industry, 
EPA is making every effort to reconcile these activities.
    Consistent with this intent, EPA is providing the following 
information to put the affected public on notice that EPA is developing 
regulations and guidance to reduce air emissions from wastewater 
operations at pharmaceutical manufacturing facilities under the Clean 
Air Act. Section X of this notice also sketches in preliminary form the 
approach EPA is considering to regulate such air emissions and provides 
preliminary cost and emission reduction information associated with 
that approach. By this notice, EPA solicits comment on the possible 
combined effect of the proposed Clean Water Act regulation and the 
tentative Clean Air Act approach for the pharmaceutical manufacturing 
industry. See Section XIV, solicitation number 32. This notice is also 
intended to provide the industry with an opportunity to plan for 
integrated least-cost multimedia compliance.

A. Preliminary Development of Air Emissions Standards

    EPA is in the early stages of developing the MACT standard for 
pharmaceutical plants; the standards will require the control of 
several different emission points, including organic air emissions from 
wastewater operations. EPA recently promulgated a similar MACT standard 
for organic HAP emissions from the Synthetic Organic Chemical 
Manufacturing Industry (SOCMI). This rule, often referred to as the 
Hazardous Organic NESHAP or HON, was published on April 22, 1994 (59 FR 
19402). On January 7, 1993, EPA published amendments to the Benzene 
Waste Operations NESHAP, which controls benzene emissions from 
wastewater operations based upon Clean Air Act authority predating the 
1990 amendments (40 CFR part 61 subpart FF).
    The control approach that EPA is considering for the pharmaceutical 
manufacturing industry is similar to the approach EPA used in the SOCMI 
HON and the Benzene Waste Operations NESHAP to control organic air 
emissions from wastewater collection and treatment operations. That 
approach consists first of identifying a subset of wastewater streams 
that require control through a combination of wastewater flowrate and 
concentration action levels, and second, the control requirements for 
these affected streams. The flowrate and concentration of each 
wastewater stream would be determined to reflect the characteristics at 
the point of generation of the wastewater stream.
    The point of generation is defined to be where each individual 
wastewater stream exits production process equipment prior to any form 
of wastewater treatment. The characteristics of a wastewater stream at 
the point of generation are used to determine which streams to control 
because this is where the organic concentration is the highest and the 
flow is the lowest. The use of the point of generation characteristics 
in this way results in the identification of the most cost effective 
streams for control. If the characteristics of the streams were 
determined at some point downstream of the point of generation, there 
would be losses of organics due to air emissions and an increase in the 
wastewater flowrate due to mixing with other wastewater streams, both 
of which would result in the subsequent control of the stream being 
less cost effective. In addition, if wastewater treatment were allowed 
before the point of generation, the treatment unit, such as an air 
stripper, would not be required to have air emission control.
    The flowrate action level is generally expressed as the liters per 
minute of wastewater flow. Values of flowrate used in previous 
regulatory analyses range from 0.02 to 10 liters per minute.
    The concentration action level is based on the ``volatile organic'' 
concentration of the wastewater stream rather than the total 
concentration. EPA has developed a test method, Method 305 in Appendix 
A of 40 CFR part 63, to determine the volatile organic HAP 
concentration for use with wastewater MACT standards. The purpose of 
this test method is to determine a relative measure of the emission 
potential of a typically controlled wastewater stream by measuring 
essentially all of an organic HAP compound that is likely to be emitted 
in significant quantities while measuring essentially none of an 
organic HAP compound that is unlikely [[Page 21632]] to be emitted. 
Previous regulatory analyses have used an action level of 10,000 ppmw 
at any flowrate and coupled with a range of action levels from 10 to 
1,000 ppmw tied to a flowrate cutoff as described above.
    Examples of the use of these action levels in recent rules include 
the Benzene Waste Operations NESHAP, which has action levels of 0.02 
liters per minute and 10 ppmw benzene, and the HON, which has a 10,000 
ppmw volatile organic HAP concentration action level at any flow rate 
coupled with an action level pair of 10 liters per minute and 1,000 
ppmw volatile organic HAP concentration.
    The control requirements for affected wastewater streams include 
managing the identified wastewater streams in controlled units during 
collection and treatment to remove or destroy the organics. This 
control approach includes: (1) Suppression or control of air emissions 
from the point of wastewater generation to the treatment device by 
installing controls on the sewer system, tanks, and containers used to 
transport the wastewater; (2) treatment of the wastewater to remove or 
destroy the organics; (3) control of air emissions from the treatment 
device (e.g., the non-condensible air emissions from the stripper 
condenser); and (4) control or recycling of the organics removed by the 
treatment device (e.g., the condensed residuals collected by the 
stripper condenser). See also Section XII.B of this preamble for 
discussion of the Administrator's strategy for waste minimization and 
combustion (incineration) of ignitable organic wastes.
    The treatment device used as the basis for the HON is a steam 
stripper, the same device proposed as the primary technology basis for 
today's proposed limits and standards. The HON requirements are 
performance standards, so that any device that achieves the desired 
performance can be used. In addition, the HON allows several compliance 
alternatives including the use of open biological treatment units to 
treat the wastewater if a controlled collection and treatment system is 
used up to the unit and the unit can be demonstrated to achieve the 
required level of biological degradation. The HON requires the use of 
the procedures outlined in Appendix C of 40 CFR part 63 to demonstrate 
that the organics are being degraded by the biological treatment unit 
and not emitted to the air.
    The CAAA also requires EPA to establish Control Techniques 
Guideline (CTG) documents for the States to use to develop VOC 
emissions control plans for ozone nonattainment areas. Industrial 
wastewater, which includes the pharmaceutical manufacturing industry, 
is one of the source categories for which EPA is developing a CTG 
document (see the draft document entitled ``Control of Volatile Organic 
Compound Emissions from Industrial Wastewater,'' EPA-453/D-92-056, 
September 1992; available in the public docket for this Clean Water Act 
rulemaking). Based on this guidance, certain States will write rules 
for VOC emissions from wastewater operations at pharmaceutical plants 
located in ozone nonattainment areas. These rules are expected to be 
similar to the MACT standards, except they would control additional 
wastewater streams based on their potential for VOC emissions rather 
than HAP emissions. The concentration action level used in the draft 
CTG is based on the volatile organic concentration, which is determined 
by Method 25D in Appendix A of 40 CFR part 60.
    The volatile organic HAP and flowrate action levels for the MACT 
standard for pharmaceutical plants have not yet been determined. For 
this notice, EPA has conducted a preliminary analysis of the impacts of 
a set of control options (action levels) for direct and indirect 
dischargers of A and C, and B and D effluent guideline subcategory 
production process wastewaters based on the approaches used in the HON. 
EPA emphasizes that this analysis is still preliminary. Wastewater data 
from the recent Section 308 pharmaceutical industry questionnaire 
responses were used in the analysis; however, a number of assumptions 
were made. See the draft document entitled ``Control of Volatile 
Organic Compound Emissions from Industrial Wastewater, EPA-453/D-92-
056, September 1992, for presentation of the assumptions and 
methodology used for this preliminary analysis. During the development 
of the MACT standard, this analysis will be refined based on new 
information and comments from the public.
    Tables X.A.1 and X.A.2 summarize the results of this preliminary 
analysis. Two sets of preliminary results are presented based on two 
ways to evaluate the existing data for effluent guideline subcategory 
A, B, C, and D plants. The actual results of a rule based on any of the 
control options could be very different than these preliminary impacts. 
Table X.A.1 presents results based on applying the controls described 
above to wastewater streams that are equal to or greater than the 
identified action levels as the streams were reported in the Section 
308 questionnaire responses. This database reflects the characteristics 
of combined process area wastewater streams, not the point of 
generation of the wastewater. Table X.A.2 presents results based on the 
same criteria, but the Section 308 questionnaire wastewater data have 
been disaggregated in an attempt to simulate the characteristics at the 
point of generation. This disaggregation was performed in the manner 
described in Appendix B of the draft CTG document.
    The control options (action levels), which encompass different 
combinations of volatile organic HAP (VOHAP) and wastewater stream 
flowrates, identified in both tables are ones that were considered in 
the development of the HON. All of the control options would require 
control of any wastewater stream that has 10,000 ppmw or greater 
volatile organic HAP concentration. The least stringent control option 
identified would require all wastewater streams with a flow of 10 
liters per minute or greater and a 1,000 ppmw or greater volatile 
organic HAP concentration be equipped with controls. Wastewater streams 
below these criteria would not require control. Other more stringent 
control options would have lower action levels and require more 
wastewater streams to be controlled. The most stringent control option 
shown would require all streams with a flow of 1.0 liters per minute or 
greater and a 100 ppmw or greater volatile organic HAP concentration be 
controlled.
    The analysis will be refined, and these results, along with other 
statutory criteria in the Clean Air Act, will be considered before a 
MACT standard for the pharmaceutical manufacturing industry is 
proposed. Information on the controls that may be required for 
wastewater streams exceeding the action levels, however, is provided in 
today's notice to allow pharmaceutical manufacturing facility owners 
and operators to consider these additional controls in their planning 
and to allow the public to comment on the combined effect of the MACT 
standard and today's proposed effluent limitations guidelines.
    It is the Agency's intent for both the effluent guidelines being 
proposed today and the MACT standards to be proposed at a later date 
that upon promulgation the in-plant technology basis of both rules will 
be applicable to essentially the same high concentration low volume 
process wastewater streams in which the bulk of the volatile organic 
pollutants are contained, as represented preliminarily by Tables X.A.1 
and X.A.2. The practical effect of this approach will be that only a 
relatively small portion (i.e., substantially less [[Page 21633]] than 
half) of all process wastewaters will require control by a treatment 
device (e.g., steam stripping) to achieve both rules. EPA has been 
informed by the industry that additional data will be submitted (some 
data have been submitted) in order to characterize, in greater detail 
than available in responses to the Section 308 questionnaire, the 
individual process wastewater streams at the point of generation. This 
additional data and any other information available to EPA will be 
considered prior to promulgation in identifying the small portion of 
process wastewater streams that would require control of volatile 
organic pollutants under both the effluent guideline and the MACT 
standard for this industry. The methodology to be used in analyzing 
these data will likely be the same as presented above and the 
preliminary results of which are presented in the following tables.

         Table X.A.1.--Preliminary Impacts of Control Options for A, B, C, and D Subcategory Pharmaceutical Plants Based on Process Area Streams        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Total flow                                                       HAP cost   
                                          VOHAP conc.\1\    Flow cutoff    controlled by   HAP emissions   HAP emission    Total annual    effectiveness
             Control Option                cutoff (PPMW)       (LPM)          option          (MG/yr)        reduction     cost ($M/yr)      ($/MG HAP  
                                                                             (percent)                       (percent)                        ER\2\)    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline................................  ..............  ..............  ..............          12,500  ..............  ..............  ..............
1.......................................           1,000              10              46           1,650              87            19.0           1,750
2.......................................             800               5              47           1,640              87            19.8           1,830
3.......................................             500               1              72           1,520              88            26.1           2,380
4.......................................             200               1              75           1,510              88            27.6           2,520
5.......................................             100               1              80           1,500              88            29.5           2,680
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:                                                                                                                                                  
\1\``VOHAP CONC. CUTOFF'' means the volatile organic HAP concentration determined by Method 305 in 40 CFR Part 63, Appendix A.                          
\2\``$/MG HAP ER'' means the dollars per megagram of HAP emission reduction by the given control option, which is determined by dividing the annual cost
  of the option by the annual emission reduction.                                                                                                       
<bullet> All options include an action level of 10,000 ppmw volatile organic HAP concentration at any flowrate.                                         
<bullet> Total industry wastewater flow equals 75,300 liters per minute.                                                                                


        Table X.A.2.--Preliminary Impacts of Control Options for A, B, C, and D Subcategory Pharmaceutical Plants Based on Disaggregated Streams        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Total flow                                                       HAP cost   
                                          VOHAP conc.\1\    Flow cutoff    controlled by   HAP emissions   HAP emission    Total annual    effectiveness
             Control Option                cutoff (PPMW)       (LPM)          option          (MG/yr)        reduction     cost ($M/yr)      (R/MG HAP  
                                                                             (percent)                       (percent)                        ER\2\)    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline................................  ..............  ..............  ..............          12,500  ..............  ..............  ..............
1.......................................           1,000              10               7           2,790              78             6.6             680
2.......................................             800               5              10           2,440              80             8.0             800
3.......................................             500               1              16           2,120              83            10.6           1,020
4.......................................             200               1              25           1,680              87            13.7           1,270
5.......................................             100               1              29           1,630              87            15.9           1,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:                                                                                                                                                  
\1\``VOHAP CONC.'' means the volatile organic HAP concentration determined by Method 305 in 40 CFR Part 63 Appendix A.                                  
\2\``$/MG HAP ER'' means the dollars per megagram of HAP emission reduction by the given control option, which is determined by dividing the annual cost
  of the option by the annual emission reduction.                                                                                                       
<bullet> All options include an action level of 10,000 ppmw volatile organic HAP concentration at any flowrate.                                         
<bullet> Total industry wastewater flow equals 75,300 liters per minute.                                                                                

B. Potential Interaction of Proposed Effluent Limitations Guidelines 
and Future Air Emission Standards

    Because both the effluent limitations guidelines and standards 
being proposed today and the future MACT standards for this industry 
are likely to regulate similar pollutants and to reflect similar 
technology bases, EPA acknowledges that there is considerable interest 
in the industry concerning the potential interaction of these 
rulemakings. In this section, EPA addresses various issues that thus 
far have come to EPA's attention.
    The effluent limitations guidelines and standards proposed today 
for nonconventional and priority pollutants are based on actual 
performance data obtained for specific pollutants over a range of 
influent concentrations. The future MACT standards for HAPs emissions 
from pharmaceutical wastewater, like the HON, probably will employ data 
on Volatile Organic HAP concentration and flow rate of the wastewater 
stream to determine applicability of its standards to covered sources. 
Like the HON, the pharmaceuticals NESHAP will probably authorize 
percent reduction standards, effluent concentration limitations and 
mass removal requirements as options for measuring compliance.
    EPA considered proposing percent reduction limitations and 
standards in this water rulemaking, but for the following reasons has 
determined that such limitations and standards would not adequately 
control the discharge of wastewater pollutants of concern, particularly 
volatile pollutants. First, in EPA's view, effluent limitations 
guidelines and standards based on percent reduction do not reflect the 
performance of the best available technology in removing wastewater 
pollutants for the pharmaceutical manufacturing industry. EPA's 
analysis of actual performance data shows that the proposed 
concentration-based effluent limitations and standards can be met, 
regardless of variations in the influent concentrations of the target 
volatile compounds, using well-designed and well-operated technology. 
Second, percent reduction effluent limitations, as previously 
promulgated under the Clean Water Act for this industry, may discourage 
source [[Page 21634]] reduction programs (programs whose goal is to 
reduce raw waste loadings of volatiles) because plants with high raw 
waste loadings of volatiles can more easily comply with percent 
reduction regulations than plants with moderate or low volatile 
loadings. Finally, the percent reduction approach for effluent 
limitations guidelines and standards imposes special burdens on permit 
writers and facilities. The percent reduction approach would require 
the gathering and evaluation of long-term raw waste data from each 
facility in order to develop plant-specific limitations on individual 
pollutants, and to demonstrate continuing compliance with the 
limitations.
    The Agency solicits comments and data on potential alternative 
formats for effluent limitations guidelines and standards, such as 
percent removal limitations and standards and minimum treatment 
threshold concentrations for individual wastewater streams. See Section 
XIV of this preamble, solicitation number 32.4.
    Another issue arises in connection with the design of the steam 
stripper being proposed as a technology basis for various limitations 
and standards in today's rule. Today's notice proposes performance 
standards, based on a specific steam stripper design, that correspond 
to the wastestreams being treated. EPA also expects that the MACT 
standards for this industry also will be a performance standard based 
on a specific steam stripper design. However, the control approach 
contained in the air rule will include four components: (1) Suppression 
or control of air emissions from the point of generation to the 
treatment device by installing controls on the sewer system, tanks, and 
containers used to transport the wastewater; (2) a treatment device 
(such as a steam stripper); (3) control of air emissions from the 
treatment device itself (e.g., the non-condensible air emissions from 
the steam stripper condensor); and (4) control or recycling of the 
organics removed by the treatment device (e.g., the condensed residuals 
collected by the steam stripper condensor). The treatment device itself 
is a major component of the air emissions control approach for 
wastewater. It is the Agency's intent that a facility that installs 
steam stripping for the purpose of complying with this proposed rule 
also will achieve the requirements of the MACT standards to be 
developed for this industry. By the time public comments on the 
effluent guideline are being considered, EPA will have a better 
understanding of the stripper design that will serve as the basis for 
the MACT standards to be proposed for this industry. This 
understanding, as well as the public comments on the water rule, will 
be considered in formulating the final effluent guideline as it 
pertains to stripper design. The Agency's intent is that the same 
stripper design will be able to achieve the requirements of both final 
rules, and will be applicable both to direct dischargers (BAT) and 
indirect dischargers (PSES). It is possible, however, that the stripper 
design upon which today's proposed water rule is based could change 
before promulgation based upon additional data and any comments 
received. Any information or comment on this subject is welcomed. See 
Section XIV, solicitation number 32.3. EPA also will develop air 
emission standards for other emission points (e.g., process vents, 
process area fugitive emissions, etc.).
    A third issue relates to the possibility that the future MACT 
standard for the pharmaceutical manufacturing industry will allow 
plants to use an enclosed collection system to suppress emissions while 
transporting the wastewaters containing volatile pollutants to a 
central treatment unit, which in turn can be controlled for air 
emissions. In today's notice, EPA has selected in-plant steam stripping 
for controlling volatile organic pollutants. Under this proposal, 
plants would be required to treat all wastewater streams that contain 
regulated volatile organic pollutants at concentrations greater than 
the long-term average concentrations established for these regulated 
pollutants. However, a plant could choose to meet the proposed effluent 
limitations guidelines and standards by combining all such streams and 
treating the combined wastestreams at a central treatment unit prior to 
their dilution by wastestreams that do not contain volatile organic 
pollutants. This approach to the treatment of wastestreams containing 
volatile organic pollutants not only would satisfy the proposed 
regulations, but also appears to be more efficient than treating 
individual wastestreams at the wastewater generation source. However, 
in certain cases individual plants may find that streams containing 
recoverable quantities of individual volatile organic pollutants (e.g., 
methanol) may be more cost-effectively managed as segregated binary 
streams (i.e., water and one solvent), rather than mixing them with 
streams containing all other volatile organic pollutants generated at 
the facility, prior to either steam stripping or steam stripping/
distillation. EPA solicits data and comment on this option. See Section 
XIV of this preamble, solicitation number 32.5.
    A fourth issue concerns the possibility that the future MACT 
standards will allow the use of open biological treatment units to 
treat organic compounds with limited volatility (e.g., methanol) from 
enclosed primary treatment systems, provided that a facility-specific 
emission limit or a 95 percent destruction of the organic HAP by 
biodegradation is achieved. In demonstrating the destruction, losses 
due to air emissions and effluent discharge would not be considered 
destruction. EPA did not select this technology as BAT for 
subcategories A and C because all known A and C direct discharger 
plants have open biological treatment systems and no air emissions data 
were available from plants with biological treatment systems that 
demonstrate 95 percent biodegradation of volatiles. In addition, the 
use of biodegradation for volatiles treatment eliminates the potential 
for their recovery and reuse. Nevertheless, EPA solicits comment on 
whether it is appropriate and feasible, considering recycle 
opportunities and control of air emissions, to develop a separate 
subcategory for the effluent limitations guidelines and standards with 
alternate limits that would allow for end-of-pipe biological treatment 
in place of or in combination with in-plant steam stripping for 
volatile organic pollutants. See Section XIV of this preamble, 
solicitation number 32.6.

XI. Impacts of Regulatory Options Considered in this Rulemaking

    The purpose of this section is to analyze the projected economic 
impacts and non-water quality environmental impacts associated with the 
various technology options considered as possible bases for the 
limitations and standards proposed in today's notice.

A. Regulatory Options

    In developing the proposed effluent limitations and standards set 
forth in today's notice, EPA developed technology options based upon a 
variety of different technologies and combinations of technologies. EPA 
developed technology options for direct dischargers and indirect 
dischargers, and for different industry subcategory groupings, i.e., 
facilities with subcategory A and C operations and facilities with 
subcategory B and D operations. For direct dischargers, EPA proposes 
limitations and standards based on options for Best Practicable Control 
Technology Currently Available (BPT), Best Conventional Pollutant 
Control Technology (BCT), Best [[Page 21635]] Available Technology 
Economically Achievable (BAT), and New Source Performance Standards 
(NSPS) options. For indirect dischargers, EPA proposed Pretreatment 
Standards for Existing Sources (PSES) and Pretreatment Standards for 
New Sources (PSNS), based on a variety of technology options 
considered. Table XI.A-1 presents the technology options considered in 
this rulemaking. The economic impact analysis discussed below reflects 
each of these options.

                  Table XI.A-1.--Technology Options Considered in the Economic Impact Analysis                  
----------------------------------------------------------------------------------------------------------------
             Type of option                       Name                             Description                  
----------------------------------------------------------------------------------------------------------------
                                               Direct Dischargers                                               
                                                                                                                
----------------------------------------------------------------------------------------------------------------
Best Practicable Technology (BPT).......  BPT-A/C#1             Current biological treatment                    
                                          BPT-A/C#2             Cyanide destruction + advanced biological       
                                                                 treatment.                                     
                                          BPT-A/C#3             Cyanide destruction + advanced biological       
                                                                 treatment + effluent filtration.               
                                          BPT-A/C#4             Cyanide destruction + advanced biological       
                                                                 treatment + polishing pond.                    
                                          BPT-A/C#5             Cyanide destruction + advanced biological       
                                                                 treatment + effluent filtration + polishing    
                                                                 pond.                                          
                                          BPT-B/D#1             Current biological treatment.                   
                                          BPT-B/D#2             Advanced biological treatment.                  
                                          BPT-B/D#3             Advanced biological treatment + effluent        
                                                                 filtration.                                    
Best Conventional Technology (BCT)*.....  BCT-A/C#1             Advanced biological treatment + effluent        
                                          BCT-A/C#2              filtration.                                    
                                                                Advanced biological treatment + polishing pond. 
                                          BCT-A/C#3             Advanced biological treatment + effluent        
                                                                 filtration + polishing pond.                   
                                          BCT-B/D#1             Advanced biological treatment.                  
                                          BCT-B/D#2             Advanced biological treatment + effluent        
                                                                 filtration.                                    
Best Available Technology (BAT).........  BAT-A/C#1             Cyanide destruction + advanced biological       
                                                                 treatment with nitrification, where necessary. 
                                          BAT-A/C#2             Cyanide destruction + in-plant steam stripping +
                                                                 advanced biological treatment.                 
                                          BAT-A/C#3             In-plant cyanide destruction + in-plant steam   
                                                                 stripping/distillation + advanced biological   
                                                                 treatment.                                     
                                          BAT-A/C#4             In-plant cyanide destruction + in-plant steam   
                                                                 stripping/distillation + advanced biological   
                                                                 treatment + granular activated carbon.         
                                          BAT-B/D#1             Advanced biological treatment.                  
                                          BAT-B/D#2             In-plant steam stripping + advanced biological  
                                                                 treatment.                                     
                                          BAT-B/D#3             In-plant steam stripping/distillation + advanced
                                                                 biological treatment.                          
                                          BAT-B/D#4             In-plant steam stripping/distillation + advanced
                                                                 biological treatment + granular activated      
                                                                 carbon.                                        
New Source Performance Standard (NSPS)..  NSPS-A/C#1            In-plant cyanide destruction + in-plant steam   
                                                                 stripping/distillation + advanced biological   
                                                                 treatment.                                     
                                          NSPS-A/C#2            In-plant cyanide destruction + in-plant steam   
                                                                 stripping/distillation + advanced biological   
                                                                 treatment + granular activated carbon.         
                                          NSPS-B/D#1            Advanced biological treatment + in-plant steam  
                                                                 stripping/distillation.                        
                                          NSPS-B/D#2            In-plant steam stripping/distillation + advanced
                                                                 biological treatment + granular activated      
                                                                 carbon.                                        
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                              Indirect Dischargers                                              
                                                                                                                
----------------------------------------------------------------------------------------------------------------
Pretreatment Standards for Existing       PSES-A/C#1            In-plant steam stripping + cyanide destruction. 
 Sources (PSES).                          PSES-A/C#2            In-plant steam stripping/distillation + in-plant
                                                                 cyanide destruction.                           
                                          PSES-A/C#3            In-plant steam stripping/distillation + in-plant
                                                                 cyanide destruction + end-of-pipe advanced     
                                                                 biological treatment.                          
                                          PSES-A/C#4            In-plant steam stripping/distillation + in-plant
                                                                 cyanide destruction + advanced biological      
                                                                 treatment + granular activated carbon.         
                                          PSES-B/D#1            In-plant steam stripping.                       
                                          PSES-B/D#2            In-plant steam stripping/distillation.          
                                          PSES-B/D#3            In-plant steam stripping/distillation + granular
                                                                 activated carbon.                              
Pretreatment Standard for New Sources     PSNS-A/C#1            In-plant steam stripping/distillation + in-plant
 (PSNS).                                  PSNS-A/C#2             cyanide destruction.                           
                                                                In-plant steam stripping/distillation + in-plant
                                                                 cyanide destruction + end-of-pipe advanced     
                                                                 biological treatment.                          
                                          PSNS-A/C#3            In-plant steam stripping/distillation + in-plant
                                                                 cyanide destruction + end-of-pipe advanced     
                                                                 biological treatment + granular activated      
                                                                 carbon.                                        
                                          PSNS-B/D#1            In-plant steam stripping/distillation.          
                                          PSNS-B/D#2            In-plant steam stripping/distillation + granular
                                                                 activated carbon.                              
----------------------------------------------------------------------------------------------------------------
*In the Development Document, BCT-A/C#1, #2, and #3 in this table actually correspond to Options 3, 4, and 5,   
  and BCT-B/D#1 and #2 in this table actually correspond to Options 2 and 3. The options not listed in this     
  table were never considered in the EIA because they are equal to or less stringent than the requirements of   
  the selected BPT options, and thus no incremental costs are incurred.                                         

    EPA has selected the following technology options as bases for the 
effluent limitations and standards proposed in today's notice:
    <bullet> For direct discharging A/C facilities, BPT-A/C#2 is the 
technology basis for conventional pollutants and BAT-A/C#2 is the 
technology basis for priority and nonconventional pollutants.
    <bullet> For direct discharging B/D facilities, BPT-B/D#2 is the 
technology basis for conventional pollutants and BAT-B/D#1 is the 
technology basis for nonconventional pollutants.
    <bullet> NSPS-A/C#1 is the technology basis for new A/C facilities 
that are direct dischargers. [[Page 21636]] 
    <bullet> NSPS-B/D#1 is the technology basis for new B/D facilities 
that are direct dischargers (this option is identical to BAT-B/D#3).
    <bullet> PSES-A/C#1 is the technology basis for A/C facilities that 
are indirect dischargers.
    <bullet> PSES-B/D#1 is the technology basis for B/D facilities that 
are indirect dischargers.
    <bullet> PSNS-A/C#1 is the technology basis for new A/C facilities 
that are indirect dischargers (this option is identical to PSES-A/C#2).
    <bullet> PSNS-B/D#1 is the technology basis for new B/D facilities 
that are indirect dischargers (this option is identical to PSES-B/D#2).

B. Economic Impact Considerations

1. Introduction
    EPA's economic impact assessment is documented in the report titled 
``Economic Impact Analysis of Proposed Effluent Limitations Guidelines 
and Standards for the Pharmaceutical Manufacturing Industry'' 
(hereinafter EIA). This report estimates the economic effect of 
compliance with the proposed regulation in terms of annualized costs, 
facility closures, changes in rate of return on assets and the interest 
coverage ratio at the company level, and profit losses at the company 
level. In addition, impacts on affected communities, foreign trade, 
specific demographic groups, and new sources also are considered. 
Finally, a Regulatory Flexibility Analysis detailing the impacts on 
small businesses within the pharmaceutical industry is included in the 
EIA. The methodologies for these analyses are detailed in the EIA. The 
major source of information for this EIA is the 1990 Detailed 
Questionnaire, which was conducted under the authority of Section 308 
of the Clean Water Act.
2. Projected Facility Economic Impacts
    The annual costs of regulatory compliance may have a negative 
effect on facility earnings. Facility closures are identified when the 
salvage value (i.e., liquidation value) of the facility exceeds the 
present value of its future earnings. A post-compliance facility 
closure analysis was performed for all technology options.
    a. Annual Costs. The aggregate post-tax annualized costs for all 
the regulatory options are given in Tables XI.B.2-1 through XI.B.2-3. 
The annualized costs for the selected options for this proposed 
rulemaking are shown in Table XI.B.2-4. The aggregate post-tax 
annualized costs were estimated at $30.6 million (1994 $) for 
facilities with subcategory A and C operations to implement BAT Option 
2 (BAT-A/C#2), $0.8 million (1994 $) for facilities with subcategory B 
and D operations to implement BAT Option 1 (BAT-B/D#1), $39.5 million 
(1994 $) for facilities with subcategory A and C operations to 
implement PSES Option 1 (PSES-A/C#1), and $9.1 million (1994 $) for 
facilities with subcategory B and D operations to implement PSES Option 
1 (PSES-B/D#1), for a total of $80.0 million (1994 $) for the selected 
options.<SUP>4

                     Table XI.B.2-1.--Estimated Compliance Costs for A/C Direct Dischargers                     
                                           [Millions of 1994 dollars]                                           
----------------------------------------------------------------------------------------------------------------
                                                                                  Total post-tax  Average annual
                   Option No.                      Total capital     Total O&M      annualized       cost per   
                                                       costs           costs           costs        facility\1\ 
----------------------------------------------------------------------------------------------------------------
                                                BPT Option Costs                                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BPT-A/C#1.......................................             0                0               0             0   
BPT-A/C#2.......................................            16.9             8.1             6.5            0.3 
BPT-A/C#3.......................................            25.0             8.6             7.7            0.3 
BPT-A/C#4.......................................            42.8            24.9            19.0            0.8 
BPT-A/C#5.......................................            50.5            26.8            21.0            0.9 
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                BCT Option Costs                                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BCT-A/C#1.......................................            19.3             3.4             4.1            0.17
BCT-A/C#2.......................................            37.1            18.9            15.0            0.62
BCT-A/C#3.......................................            44.8            21.8            17.5            0.73
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                BAT Option Costs                                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BAT-A/C#1.......................................            17.2             9.8             7.5            0.3 
BAT-A/C#2.......................................            64.5            40.8            30.6            1.3 
BAT-A/C#3.......................................            77.8            66.3            46.8            1.9 
BAT-A/C#4.......................................           106.1           130.6            87.0            3.6 
----------------------------------------------------------------------------------------------------------------
Footnotes:                                                                                                      
\1\Total Post-Tax Annualized Costs divided by the total number of A/C direct discharge facilities.              

    b. Post-compliance Facility Closures. The selected options result 
in no closures of any facilities. When the most stringent options are 
considered, one
direct discharging facility with subcategory A and C operations is 
predicted to close under BAT-A/C#4, and one indirect discharging 
facility
with subcategory B and D operations is predicted to close under PSES-B/
D#3. No other options were determined to result in any other facility 
closures.

    \4\The Development Document presents costs in 1990 dollars. 
These costs are inflated to 1994 dollars in this preamble using a 
factor of 1.143 derived from Engineering News Record ``Construction 
Cost Index.''

                                                                                                                
[[Page 21637]]                                                                                                  
                     Table XI.B.2-2.--Estimated Compliance Costs for B/D Direct Dischargers                     
                                           [Millions of 1994 dollars]                                           
----------------------------------------------------------------------------------------------------------------
                                                                                  Total post-tax  Average annual
                   Option No.                      Total capital     Total O&M      annualized       cost per   
                                                       costs           costs           costs        facility\1\ 
----------------------------------------------------------------------------------------------------------------
                                                BPT Option Costs                                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BPT-B/D#1.......................................            0               0               0              0    
BPT-B/D#2.......................................            0.69            0.59            0.42           0.030
BPT-B/D#3.......................................            3.4             0.86            0.87           0.062
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                BCT Option Costs                                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BCT-B/D#1.......................................            0.64            0.51            0.37           0.026
BCT-B/D#2.......................................            3.3             0.78            0.82           0.058
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                BAT Option Costs                                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BAT-B/D#1.......................................            0.74            1.3             0.81           0.058
BAT-B/D#2.......................................            2.0             1.1             0.84           0.060
BAT-B/D#3.......................................            3.4             2.2             1.7            0.12 
BAT-B/D#4.......................................           11.8             3.5             3.3            0.24 
----------------------------------------------------------------------------------------------------------------
Footnotes:                                                                                                      
\1\Total Post-Tax Annualized Costs divided by the total number of B/D direct discharge facilities.              


                   Table XI.B.2-3.--Estimated Compliance Costs for Indirect Dischargers (PSES)                  
                                           [Millions of 1994 dollars]                                           
----------------------------------------------------------------------------------------------------------------
                                                                                  Total post-tax  Average annual
                   Option No.                      Total capital     Total O&M      annualized       cost per   
                                                       costs           costs           costs        facility\1\ 
----------------------------------------------------------------------------------------------------------------
                                                 A/C Facilities                                                 
                                                                                                                
----------------------------------------------------------------------------------------------------------------
PSES-A/C#1......................................            80.9            53.1            39.5            0.4 
PSES-A/C#2......................................           103.0            93.6            65.3            0.7 
PSES-A/C#3......................................           164.6           120.9            87.8            1.0 
PSES-A/C#4......................................           213.7           203.0           140.6            1.6 
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                 B/D Facilities                                                 
                                                                                                                
----------------------------------------------------------------------------------------------------------------
PSES-B/D#1......................................            28.8            10.2             9.1            0.06
PSES-B/D#2......................................            34.8            19.4            15.0            0.10
PSES-B/D#3......................................            70.8           112.2            72.5            0.5 
----------------------------------------------------------------------------------------------------------------
Footnotes:                                                                                                      
\1\Total Post-Tax Annualized Costs divided by the total number of indirect discharge facilities.                


                   Table XI.B.2-4.--Estimated Compliance Costs for Selected Regulatory Options                  
                                           [Millions of 1994 dollars]                                           
----------------------------------------------------------------------------------------------------------------
                                                                                  Total post-tax  Average annual
                   Option No.                      Total capital     Total O&M      annualized       cost per   
                                                       costs           costs           costs        facility\1\ 
----------------------------------------------------------------------------------------------------------------
BAT-A/C#2.......................................            64.5            40.8            30.6            1.3 
BAT-B/D#1.......................................             0.7             1.3             0.8            0.06
PSES-A/C#1......................................            80.9            53.1            39.5            0.4 
PSES-B/D#1......................................            28.8            10.2             9.1            0.06
                                                 ---------------------------------------------------------------
    Total\2\....................................           174.9           105.4            80.0            0.29
----------------------------------------------------------------------------------------------------------------
Footnotes:                                                                                                      
\1\Total Post-Tax Annualized Costs divided by the total number of facilities for each subcategory.              
\2\Total number of facilities includes seven non-discharging facilities.                                        

3. Projected Owner Company-Level Economic Impacts
    Firm failures are identified when the return on assets and the 
interest coverage ratio, common financial indicators, fall below 
benchmarks for the industry.
    Table XI.B.3.b2-1 presents the results of the postcompliance 
analysis under the selected regulatory options. This analysis 
determined that none of the firms owning direct discharging facilities 
with subcategory A and C or B and D operations are expected to 
[[Page 21638]] experience significant impacts (i.e., firm failure) as a 
result of implementing the selected regulatory options. In addition, 
only two firms with indirect discharging facilities with subcategory A 
and C operations and one firm owning an indirect discharging facility 
with subcategory B and D operations would be expected to experience 
significant impacts as a result of compliance costs. Thus, a total of 
three firms are projected to fail under the conservative assumption of 
no costs being passed through to consumers. Overall, these firms 
represent 3.8 percent of all firms with indirect discharging facilities 
with subcategory A and C operations, 1.4 percent of firms with 
subcategory B and D operations, and 2.3 percent of all regulated firms. 
As indicated by the Profitability Analysis, 15 firms (11 percent of 
firms in the postcompliance analysis) are anticipated to have major 
impacts short of firm failure (i.e., will experience a change in ROA of 
greater than 5 percent). Impacts are most likely overstated, however, 
because this analysis assumes that firms cannot pass any increased 
costs through to consumers. If half the costs can be passed through to 
consumers there would be no firm failures.

     Table XI.B.3.b2-1.--Projected Firm Failure:\1\ Post Compliance     
                               Analysis\2\                              
------------------------------------------------------------------------
                                      Regulatory impact on firms        
                             -------------------------------------------
                   Total No.     No significant      Significant impact 
                    of firms         impact        ---------------------
                             ----------------------                     
                                 No.      Percent      No.      Percent 
------------------------------------------------------------------------
Firms with A/C                                                          
 Direct                                                                 
 Facilities......         15         15      100.0          0        0.0
Firms with B/D                                                          
 Direct                                                                 
 Facilities......          7          7      100.0          0        0.0
Firms with A/C                                                          
 Indirect                                                               
 Facilities......         53         51       96.2          2        3.8
Firms with B/D                                                          
 Indirect                                                               
 Facilities......         72         71       98.6          1        1.4
All Firms\3\.....        133        130       97.7          3        2.3
------------------------------------------------------------------------
Note: Analysis excludes three firms because of lack of financial data.  
                                                                        
\1\Firm failure is defined when a firm's return on assets or interest   
  coverage ratio falls below industry benchmarks. This analysis assumes 
  no costs can be passed through to consumers.                          
\2\This scenario analyzes impacts from regulating A/C Direct Facilities 
  under options BAT-A/C#2 and BPT-A/C#2, B/D Direct Facilities under    
  options BAT-B/D#1 and BPT-B/D#2, A/C Indirect Facilities under option 
  PSES-A/C#1, and B/D Indirect Facilities under option PSES-B/D#1.      
\3\Number of firms for All Firms may be less than the total firms by    
  subcategory because some firms have more than one type of facility.   
  Total number of All Firms includes firms that have nondischarging     
  facilities.                                                           

4. Projected Employment Losses and Gains and Community-Level Economic 
Impacts
    Based on facility closures and firm failures, the employment losses 
analysis sums the number of jobs lost in the postcompliance scenario 
and compares these losses to community employment measures. Job gains 
are calculated based on the cost of manufacturing, installing, and 
operating compliance equipment.
    No employment losses were projected to occur as a result of 
regulatory options for direct dischargers. For indirect dischargers, 
however, total projected primary employment losses resulting from the 
selected regulatory options were 78 full time equivalent (FTE) 
positions among indirect discharging facilities with subcategory A and 
C operations and 13 FTEs among indirect discharging facilities with 
subcategory B and D operations, for a total of 91 FTEs or 0.07 percent 
of total employment for the affected portion of the industry. Secondary 
employment losses were predicted to be 541 FTEs.
    None of these losses is expected to result in a change of 
employment rates of more than 1 percent in the affected communities.
    Employment losses are offset to some extent by the need to hire 
workers to manufacture, install, and maintain the pollution control 
equipment. Primary employment gains are expected to total 68 annual 
FTEs for manufacturing equipment, 10 annual FTEs for installing 
equipment, and 0 to 889 annual FTEs for operating and maintaining 
equipment for a total of 78 to 967 annual FTE gains. The sum of primary 
and secondary gains is calculated to range from 218 FTEs to 2,890 FTEs. 
Net gains and losses thus range from a loss of 323 FTEs to a gain of 
2,349 FTEs.
5. Projected Foreign Trade Impacts
    The impact of effluent guidelines on pharmaceutical exports and the 
U.S. balance of trade was found to be negligible. The one firm/facility 
predicted to close as a result of the effluent guidelines had 
pharmaceutical exports totaling $0.09 million (1994 $). The loss of 
these exports would have virtually no effect on U.S. pharmaceutical 
exports, which, according to the U.S. Department of Commerce, totalled 
$5.7 billion in 1991.
6. Regulatory Flexibility Analysis
    a. Purpose of the Regulatory Flexibility Analysis. The Regulatory 
Flexibility Act requires the federal government to consider the impacts 
on small entities as part of rulemaking procedures. The goal of the 
analysis is to ensure that small entities potentially affected by a new 
regulation will not be disproportionately burdened. Small entities have 
limited resources, and it is the responsibility of the regulating 
federal agency to avoid, if possible, disproportionately or 
unnecessarily burdening such entities.
    b. Projected Impacts on Small Businesses. (i) Size Distribution. 
Small firms make up 76 percent of the 190 firms in the survey universe. 
The largest percentage of firms are in the 100 to 499 employees size 
group (37 percent of all firms in the survey universe).
    (ii) Recordkeeping and Reporting Requirements. The proposed 
effluent guidelines for the pharmaceutical industry are revisions to 
existing effluent guidelines and, accordingly, most of the 
recordkeeping and reporting requirements to which the industry would be 
subject are not new requirements. There are some new monitoring 
requirements. The new monitoring costs total $10.3 million (1994 $) 
annually, and are 15 percent of the total annual compliance cost for 
the selected options. Large firms incur the largest proportion of the 
new monitoring costs (61 percent of total monitoring costs).
    (iii) Other Federal Requirements. EPA is aware of no federal rules 
that duplicate, overlap, or conflict with the proposed effluent 
guidelines for the pharmaceutical industry.
    (iv) Significant Alternatives to the Proposed Rule. No significant 
alternatives to the proposed rule will substantially reduce impacts on 
small entities, thus the Agency believes the [[Page 21639]] stated 
objectives of the Clean Water Act are met with this proposed rule and 
the impacts to small firms have been considered, where possible.
    (v) Projected Impacts on Small Firms. Projected Impacts on small 
firms measured as firm failure are as follows. Two of the three firms 
that were projected to fail in the firm-level analysis under the 
selected regulatory options have fewer than 750 employees, although 
only 2 percent of small firms in the postcomplaince analysis are 
affected in this manner. In addition, 14 of 15 firms found to 
experience a significant decline in ROA (over 5 percent) have fewer 
than 750 employees. These firms represent about 14 percent of all small 
firms in the post-compliance analysis.
    When cash flow is analyzed, however, impacts seem less 
disproportionate. Except in the 19 to 99 employees group, the total 
present value of compliance costs as a percentage of the present value 
of net income is smaller among small firms than among large firms. Over 
all small firms (or all large firms), the present value of compliance 
costs is less than 1 percent of the present value of net income.
    The above analyses indicate that although small firms do bear a 
large portion of the impacts such as firm failures, these impacts are 
felt by a very small percentage of all small firms. Additionally, the 
percentages of the present value of compliance costs to the present 
value of net income are expected to be smaller, on average, among small 
firms than among large firms; thus, impacts to small firms are not 
expected to be disproportionate to those for large firms.
7. Projected Distributional Impacts
    a. Impacts on Drug Prices. Assuming that all costs are passed on to 
consumers and that price increases will reflect 100 percent of the cost 
increases to manufacturers, the following observations can be made. For 
all the selected regulatory options, the ratio of compliance costs to 
total pharmaceutical costs was 1.6 percent. Most facilities would incur 
compliance costs less than 1 percent of total pharmaceutical costs. 
Only three facilities (1 percent of all facilities) would incur 
compliance costs greater than 10 percent of total pharmaceutical costs.
    b. Impacts on Specific Demographic Groups. When possible uses for 
products produced by a sampling of highly affected facilities (those 
where compliance costs exceed 10 percent of total pharmaceutical costs) 
were investigated, it appeared that children, women, and the elderly 
were likely to be the major consumers of many of these products. It was 
further determined that individuals who lack any health insurance, 
those who are covered by government insurance, and those who are 
covered by nonwork-related medical insurance might be least likely to 
have drug coverage. These groups include Hispanics, young adults, 
African Americans, young children, and the elderly. Thus, young adult 
women, children, and the elderly are likely to be the most heavily 
affected by potential cost increases, if such increases can be passed 
through to consumers.
    Because on average any potential price increases are likely to be 
very low (1.6 percent), impacts on mass consumers of drugs such as 
HMOs, governments, and, indirectly, third-party insurers should be 
minimal.
8. Projected Impacts on New Sources
    The projected selected options for new sources are NSPS-A/C#1, 
NSPS-B/D#1, PSNS-A/C#1, and PSNS-B/D#1. In all cases, the requirements 
for new sources are more stringent than those for existing sources. 
However, the difference in cost between new source requirements and 
existing source requirements for typical facilities are relatively 
small when compared to the average facility costs of production. In 
most cases, existing facilities would be required to retrofit in-plant 
steam stripping systems, whereas new sources would have to install in-
plant steam stripping/distillation systems. Because designing in 
pollution control equipment in a new source is typically less expensive 
than retrofitting the same equipment in an existing source, the cost 
differential between the selected requirements for existing sources and 
those higher existing source options that are technically equivalent to 
new source requirements should be an upper limit on the differential 
annual cost faced by new sources. Where this differential is not 
substantial relative to the typical costs of doing business in this 
industry, no significant barrier to entry is likely to exist.
    The average per-facility compliance costs were investigated to 
determine what the cost differentials would be between proposed new 
source and existing source requirements. The average per-facility cost 
differentials ranged from about a $39,000 to a $674,000 difference 
(1994 $) (for A/C direct dischargers), depending on the type of 
facility. The maximum $674,000 difference generates the highest 
percentage of compliance cost differential to pharmaceuticals 
manufacturing costabout 1.4 percent of total manufacturing costs and 
about 3.0 percent of pharmaceutical manufacturing costs. Since this 
cost differential is likely to be less than that assumed here, this 
small premium estimated to be paid by new sources is not likely to have 
much impact on the decision to enter the market. Furthermore, these 
same options, when applied to existing sources, were found to have 
nearly identical impacts on existing sources as the selected options 
for existing sources. Thus no significant barriers to entry are 
estimated to result from the proposed new source requirements.
9. Regulatory Impact Assessment
    The Agency has prepared a regulatory impact assessment (RIA) for 
the proposed regulatory alternative. The RIA responds to the 
requirements in Executive Order 12866 to assess both the costs and 
benefits to society of significant regulatory actions. Significant 
regulatory actions are those that impose an annual cost to the economy 
of $100 million or more, or have certain other regulatory, policy or 
economic impacts. The RIA is detailed in ``Regulatory Impact Assessment 
of the Proposed Effluent Guidelines for the Pharmaceutical 
Manufacturing Industry'' (see Section II for availability of this and 
other supporting documents). This RIA was submitted to OMB for review 
as required by Executive Order 12866.
    The RIA analyzes the effects of current air and water emissions and 
assesses the benefits of reductions in these emissions resulting from 
the proposed regulation. EPA expects a variety of human health, 
environmental, and economic benefits to result from these reductions in 
effluent loadings and air emissions. In particular, the benefits 
assessment addresses the following benefit categories: 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, pass through, 
and sludge contamination problems and improvements in worker health and 
safety. EPA monetizes 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. Air benefits are estimated separately for Section 308 
[[Page 21640]] survey air emissions data and for air emissions 
estimated by the WATER7 model which estimates the maximum emissions.
    a. Human Health/Agricultural Benefits from Reductions in Emissions 
of Ozone Precursors. The proposed effluent guidelines are expected to 
result in reductions in ambient ozone concentrations due to reductions 
in VOC emissions. Controlling VOC emissions is beneficial because VOCs 
are precursors to ozone, which negatively affects human health and the 
environment.
    (1) Human Health Benefits.
    The RIA estimates that the annual human health benefits resulting 
from reductions in VOC emissions due to the proposed rule range from 
$31,000 to $1.9 million (1994 $). EPA monetizes these benefits using a 
benefits-transfer-based approach. Specifically, the estimated 
reductions in VOC emissions in nonattainment areas (1,396 Mg) are 
multiplied by an existing estimate of the range of the value of a unit 
reduction in VOC emissions ($22/Mg to $1,382/Mg, 1994 $). This range is 
taken from an existing study that evaluated the human health benefits 
of ozone reductions in nonattainment areas.
    (2) Welfare Benefits from Increased Agricultural Crop Yields.
    Studies of the relationship between ambient ozone concentrations 
and greenhouse-controlled ozone concentrations and agricultural crop 
yields demonstrate that ozone negatively affects crop yields. 
Reductions in crop yields in turn affects agricultural production, crop 
prices, and incomes of agricultural producers, and thus affects social 
welfare. Thus, reductions in ozone concentrations that lead to improved 
crop yields will generate welfare benefits.
    The RIA estimates that the annual agricultural-related economic 
welfare benefits from reductions in VOC emissions range from $186,000 
to $315,000 (1994 $). To generate these welfare benefit estimates, EPA 
applies an existing estimate of the benefits per unit reduction in VOC 
emissions ($134/Mg to $226/Mg, 1994 $) to the total expected reduction 
in VOC emissions in nonattainment areas. The existing value estimates 
were developed using economic models that estimate the net change in 
social welfare resulting from higher crop yields as a result of lower 
ambient ozone levels in rural areas.
    b. Human Health Benefits Due To Cancer Risk Reduction. The benefits 
from the proposed rule include human health benefits from reductions in 
excess cancer risk. EPA expects the proposed rule to reduce loadings of 
toxic substances that otherwise would volatilize and pose a cancer risk 
to humans, resulting in reductions in excess cancer risk in exposed 
populations from inhalation of VOCs. In addition, EPA expects that 
reduced loadings to surface waters will improve water quality and thus 
reduce cancer risk to the exposed populations from consumption of 
contaminated drinking water and fish tissue.
    Based on the cancer risk assessment conducted for the RIA, EPA 
estimates that the proposed guidelines will result in 0.02 to 0.35 
excess cancer cases avoided per year nationwide. The estimated value of 
the human health benefits from these cancer risk reductions ranges from 
$14,000 to $5.4 million (1994 $) annually. EPA developed these benefit 
estimates by applying an existing estimate of the value of a 
statistical life to the estimated number of excess cancer cases 
avoided. The estimated range of the value of a statistical life used in 
this analysis is $0.7 million to $15.4 million (1994 $). This estimated 
range is based on a review of literature pertaining to the value of 
life.
    c. Human Health Benefits from Reductions in Noncarcinogenic Risk. 
Exposure to toxic substances poses risk of systemic and other effects 
to humans, including effects on the circulatory, respiratory or 
digestive systems and neurological and developmental effects. The 
proposed rule might generate human health benefits by reducing exposure 
to these substances, thus reducing the risks of these associated 
effects.
    As in the case of the cancer risk assessment, systemic risks from 
exposure to air emissions and consumption of contaminated fish tissue 
and drinking water are evaluated. Modeled pollutant concentration 
levels are compared to human health criteria or estimated toxic effect 
levels. Based on this analysis, reductions in air emissions might 
result in reduced systemic risk, with benefits ranging from reduced 
risk to zero individuals (since estimated baseline risks are low) to 
reduced risk to 126,000 individuals due to reduced exposure to two 
toxic pollutants. No systemic risk reductions are expected to result 
from reduced exposure to contaminated fish tissue or drinking water. 
Sufficient data to quantify these benefits further are not available.
    d. Ecological and Recreational Benefits Due to Improved Water 
Quality. EPA expects the proposed effluent guidelines to generate 
environmental benefits by improving water quality. There are a wide 
range of benefits associated with the maintenance and improvement of 
water quality. These benefits include use values (e.g., recreational 
fishing), ecological values (e.g., provision of habitat), and passive 
use values. For example, water pollution might affect the quality of 
the fish and wildlife habitat provided by water resources, thus 
affecting the species using these resources. This in turn might affect 
the quality of recreational experiences of users, such as anglers 
fishing in the affected streams. In the RIA, EPA considers the value of 
the recreational benefits resulting from the proposed rule, but does 
not evaluate the other types of ecological and environmental benefits 
due to data limitations.
    To estimate the benefits from the improvements in water quality 
expected to result from this rule, instream concentration estimates are 
modeled and then compared to EPA's freshwater acute and chronic aquatic 
life criteria to evaluate whether these discharges pose risk to aquatic 
organisms. The projected reductions in toxic loadings to surface waters 
are significant. Pollutant loadings are estimated to decline by 57 
percent, from 39.9 million pounds per year under current conditions to 
17.1 million pounds per year under the proposed rule. The analysis 
comparing instream concentration levels to aquatic life water quality 
criteria estimates that current discharge loadings result in excursions 
of aquatic water quality criteria at two locations. The analysis also 
indicates that no excursions are expected to occur at these two sites 
under the proposed rule.
    EPA estimates that the annual recreational benefits associated with 
the expected changes in water quality are on the order of thousands of 
dollars. EPA evaluates these recreational benefits, applying a simple 
model that considers the change in consumer welfare likely to result 
from improved catch rates by recreational anglers at these two sites. 
EPA assumes that catch rates improve due to larger fish populations 
that are assumed to result from improved water quality.
    e. Benefits from Reductions in Loadings Discharged to POTWs. The 
RIA considers three potential sources of benefits to POTWs from the 
proposed regulation: Reductions in the likelihood of interference, pass 
through, and sewage sludge contamination problems, reductions in health 
and safety risks to POTW workers, and reductions in costs potentially 
incurred by POTWs in analyzing toxic pollutants and determining whether 
to, and the appropriate level at which to, set local limits. Although 
the benefits from [[Page 21641]] reducing these effects at POTWs might 
be substantial, the RIA does not quantify these benefits due to data 
limitations.
    First, regarding potential interference, pass through and sewage 
sludge contamination problems, the proposed rule is expected to help 
reduce these problems by reducing toxic loadings in the industry's 
effluent and reducing shock releases. Anecdotal evidence from POTW 
responses to an EPA survey and analytic results indicate that such 
effects can occur. In addition, based on an analysis comparing POTW 
influent levels to available data on inhibition levels, inhibition 
problems are projected to occur at six POTWs for seven pollutants under 
current conditions. Inhibition problems are projected to occur at five 
POTWs for three pollutants after the proposed rule. Sufficient data are 
not available to further quantify this benefit category.
    Furthermore, toxic substances in effluent discharges to POTWs pose 
health risks to POTW workers. The proposed rule is expected to reduce 
these risks, thus generating human health benefits. Based on the 
assessment of the risk posed to POTW workers from exposure to toxic 
pollutants, the proposed rule is estimated to reduce occupational risk 
at six POTWs. Data are not available to monetize this benefit category.
    Finally, in implementing local programs to control pollutants 
discharged to their systems, authorized POTWs often must set numerical 
limits on toxic loadings in discharges to the POTW, based on national 
categorical pretreatment standards or local limits determined by the 
POTW. In setting these local limits, POTWs sometimes need to undertake 
analyses to determine which pollutants warrant local limits and at what 
numerical level. Conducting these analyses is expensive, costing on the 
order of hundreds of thousands of dollars. Several POTWs contacted as 
part of EPA's survey of POTWs indicated that they will benefit from the 
establishment of national pretreatment standards by avoiding these 
analytical costs. In addition, they indicated that the pretreatment 
standards will bolster the legal authority of the limits they set. EPA 
solicits comments on this issue. See Section XIV, solicitation number 
24.4.
    f. Summary of Benefits. EPA estimates that the annual benefits 
resulting from the proposed rule will range from $231,000 to $7.6 
million (1994 $). Table XI.B.9.f summarizes these benefits by category. 
The range reflects the uncertainty in evaluating the effects of the 
proposed rule and in placing a dollar value on these effects. As 
indicated in the table, these benefit ranges do not reflect many of the 
benefit categories expected to result under the proposed rule, 
including human health benefits associated with potential reductions in 
chronic effects from ozone exposure, human health benefits associated 
with reductions in acute effects in attainment areas, agriculture-
related benefits from reductions in emissions of ozone precursors in 
attainment areas, ecological and recreational benefits from 
improvements in water quality, benefits from avoided interference and 
pass through problems and improved worker health and safety at POTWs, 
and human health benefits from potential reductions in systemic risk. 
Therefore the reported benefit estimate understates the total benefits 
of the proposed rule.

 Table XI.B.9.f.--Potential Economic Benefits From the Proposed Effluent
               Guidelines for the Pharmaceutical Industry               
------------------------------------------------------------------------
                                                      Thousands of 1994 
                 Benefit category                     dollars per year  
------------------------------------------------------------------------
Reductions in Emissions of Ozone Precursors:\1\                         
    Human Health..................................  31-1,929.           
    Agricultural..................................  186-315.            
Cancer Risk Reductions............................  14-5,401.           
Non-carcinogenic Risk Reductions..................  Unquantified.       
Ecological and Recreational Benefits..............  Unquantified.       
POTW Reductions in Interference and Sludge          Unquantified.       
 Inhibition.                                                            
      Total quantifiable benefits.................  231-7,646.          
------------------------------------------------------------------------
\1\The estimates presented only include benefits associated with        
  reductions in acute health effects and improvements in agricultural   
  yields in nonattainment areas. Potential welfare benefits associated  
  with forest yield, materials damage, and visibility are not addressed 
  in this analysis.                                                     

    g. Costs to Society. A major component of social cost (beyond the 
cost to industry of compliance) is the cost to government of providing 
the tax deductions on pollution control costs to industry. In addition, 
there are other monetary and nonmonetary outlays made by government. 
Government administrative costs and costs of reallocating displaced 
workers are two additional monetary costs. Nonmonetary costs include 
losses in consumers' or producers' surpluses in product markets, 
discomfort or inconvenience, loss of time, and slowing the rate of 
innovation. The social costs estimated here, which include compliance 
costs to industry and the costs of government tax subsidies, therefore, 
are a very large portion of, but not the true total social cost of the 
proposed regulation. The costs reported here are thus only a close 
estimate of this true cost.
    The estimate of total annual social costs for all selected options 
is shown in Table XI.B.9.g. Total social costs resulting from the 
proposed effluent guideline are estimated to be $123.9 million (1994 
$).

      Table XI.B.9.g.--Social Costs for Selected Regulatory Options     
                       [Millions of 1994 dollars]                       
------------------------------------------------------------------------
                                                               Total    
       Option No.          Total capital     Total O&M      annualized  
                               costs           costs         costs\1\   
------------------------------------------------------------------------
BAT-A/C#2...............            64.5            40.8            47.6
BAT-B/D#1...............             0.7             1.3            1.3 
[[Page 21642]]                                                          
                                                                        
PSES-A/C#1..............            80.9            53.1            61.6
PSES-B/D#1..............            28.8            10.2            13.3
                         -----------------------------------------------
    Total\2\............           174.9           105.4          123.9 
------------------------------------------------------------------------
Footnotes:                                                              
\1\The total annualized costs of compliance are calculated prior to     
  accounting for the tax deductibility of the pollution control costs.  
\2\Total number of facilities includes seven non-discharging facilities.
                                                                        
Note: These numbers are for all facilities and do not reflect closures  
  predicted by the analyses in this report.                             

    h. Benefit-Cost Comparison. Because not all of the benefits 
resulting from the regulatory alternative can be valued in terms of 
dollars, a complete cost-benefit comparison cannot be performed. The 
social cost of the alternatives considered in the proposed rule, 
discussed in the preceding section is estimated to be $123.9 million 
(1994 $). The sum of total benefits that can be valued in dollar terms 
ranges from $0.2 to $7.6 million per year (1994 $) (see Table 
XI.B.9.h).

    Table XI.B.9.h.--Comparison of Annual Benefits and Costs for the    
                        Pharmaceutical Rulemaking                       
                       [Thousands of 1994 dollars]                      
                                                                        
                                                                        
                        Benefits                                        
                                                                        
Cancer risk reductions..................................        14-5,401
Reductions in emissions of ozone precursors.............        31-1,929
Human health............................................         186-315
Agricultural benefits...................................  ..............
    Total quantifiable benefits.........................       231-7,646
                                                                        
                          Costs                                         
                                                                        
Total Annual Costs to Industry..........................          80,000
Total Annual Social Costs...............................         123,900

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
    EPA's Office of Solid Waste Phase 3 proposed land disposal 
restriction regulations under the Resource Conservation and Recovery 
Act (RCRA) for certain hazardous wastes streams common to the 
pharmaceutical manufacturing industry on February 16, 1995. These 
regulations will be codified at 40 CFR Part 268 after they are 
finalized (scheduled for January 1996).
    The proposed RCRA regulations signed on February 16, 1995 cover 
decharacterized ignitable (I), corrosive (C), reactive (R) and toxic 
(TC) wastes (i.e., wastes that initially exhibit a characteristic but, 
as a result of dilution, no longer do so when they are land disposed) 
that are managed in surface impoundments whose ultimate discharge is 
regulated under the Clean Water Act. These regulations also potentially 
apply to decharacterized wastes disposed in Class I nonhazardous deep 
injection wells regulated under the Safe Drinking Water Act's 
Underground Injection Control program. The definitions of these waste 
streams are listed in Table XII.A. The September 1992 Third decision in 
Chemical Waste Management v. EPA, 976 F.2d 2 (D.C. Cir. 1992) requires 
EPA to assure that decharacterized wastes disposed in surface 
impoundments are treated to the same extent they would be if disposed 
in surface disposal units. However, the opinion specifically allows 
this showing of equivalent treatment to be measured at the eventual 
discharge point, so that treatment occurring in the wastewater 
treatment system (including the surface impoundment) can be taken into 
account.
2. The Land Disposal Restrictions Program
    a. Introduction to RCRA Land Disposal Restrictions. The Hazardous 
and Solid Waste Amendments (HSWA) to RCRA, enacted on November 8, 1984, 
largely prohibit the land disposal of untreated hazardous wastes. Once 
a hazardous waste is prohibited from land disposal, the statute 
provides only two options for legal land disposal: Meet the treatment 
standard for the waste prior to land disposal, or dispose of the waste 
in a land disposal unit that has been found to satisfy the statutory no 
migration test. A no migration unit is one from which there will be no 
migration of hazardous constituents for as long as the waste remains 
hazardous. RCRA sections 3004 (d),(e),(g)(5).
    The treatment standards may be expressed as either constituent 
concentration levels or as specific methods of treatment. These 
standards must 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. RCRA section 
3004(m)(1). For purposes of the restrictions, the RCRA program defines 
land disposal to include any placement of hazardous waste in a 
landfill, surface impoundment, waste pile, injection well, land 
treatment facility, salt dome formation, salt bed formation, or 
underground mine or cave. Discharge of wastewater streams containing 
hazardous wastes to surface impoundments is considered temporary land 
disposal. RCRA section 3004(k). [[Page 21643]] EPA has implemented 
these requirements by requiring treatment standards for hazardous 
wastes to be based on performance of Best Demonstrated Available 
Technology (BDAT).
    b. Regulation of Characteristic Wastes. On May 8, 1990, EPA 
promulgated land disposal prohibitions and treatment standards for 
hazardous wastes that exhibited one or more of the following 
characteristics: ignitability, corrosivity, reactivity, or EP toxicity 
(40 CFR 261.21-261.24). These regulations established treatment 
standards for the characteristic wastes in one of four forms: (1) A 
concentration level equal to, or greater than, the characteristic 
level; (2) a concentration level less than the characteristic level; 
(3) a specified treatment technology (e.g., for ignitable wastes 
containing high levels of total organic carbon); and (4) a treatment 
standard of ``deactivation'' which allowed the use of any technology, 
including dilution, to remove the characteristic.
    Such treatment frequently occurs in centralized wastewater 
management systems subject to regulation under the Clean Water Act or 
Safe Drinking Water Act. Furthermore, the deactivation can occur as a 
result of mixing wastewaters together (for example, to equalize 
wastewater flow into a centralized wastewater management unit). This 
mixing, however, is a type of dilution, and dilution is normally an 
impermissible means of achieving a land disposal regulation (LDR) 
treatment standard. EPA addressed at length the question of whether 
dilution incidental to such centralized wastewater management should be 
allowed. See generally 55 FR 22653-59 (June 1, 1990). The Agency found, 
generally, that mixing waste streams to eliminate certain 
characteristics was appropriate and permissible for corrosive 
wastewaters and, in some cases, reactive or ignitable wastewaters. 
Furthermore, EPA stated that the dilution prohibition did not normally 
apply to characteristic wastewaters that are managed in treatment 
trains, including surface impoundments, whose ultimate discharge is 
regulated under the pretreatment and NPDES programs under sections 
307(b) and 402 of the CWA, or in Class I underground injection well 
systems regulated under the Safe Drinking Water Act (SDWA). The Agency 
stated that the treatment requirements and associated dilution rules 
under the CWA are generally consistent with the dilution rules under 
RCRA, and that the Agency should rely on the existing CWA provisions. 
The Agency also singled out certain particularly toxic wastewaters to 
which the dilution prohibition still applies notwithstanding management 
in CWA systems. 40 CFR 268.3(b). Similarly, EPA stated that a 
regulatory program had been established under the SDWA to prevent 
underground injection that endangers drinking water sources.
    c. The Third Third Court Decision.
    On September 25, 1992, the United States Court of Appeals for the 
District of Columbia Circuit ruled on the various petitions for review 
filed against the 1990 land disposal rule, also known as the Third 
Third rule. See Chemical Waste Management v. EPA, 976 F.2d 2, cert. 
denied, 113 S.Ct. 1961 (1993). The court issued three principal 
holdings of the case with respect to characteristic wastes. First, EPA 
may require treatment under RCRA section 3004(m) to more stringent 
levels than those at which wastes are identified as hazardous, Id. at 
12-14. Second, section 3004(m) requires that treatment standards 
address both short-term and long-term potential harms posed by 
hazardous wastes, and consequently must result in destruction and 
removal of hazardous constituents as well as removal of the 
characteristic property, Id. at 16, 17, 23. As a consequence, dilution 
without destruction or removal of hazardous constituents is permissible 
as an exclusive method of treatment only for those characteristic 
wastes that do not contain hazardous constituents ``in sufficient 
concentrations to pose a threat to human health or the environment'' 
(i.e., the minimize threat level in section 3004(m)). Id. at 16. Third, 
situations where characteristic hazardous wastes are diluted, lose 
their characteristic(s) and are then managed in centralized wastewater 
management land disposal units (i.e., subtitle D surface impoundments 
or Class I nonhazardous injection wells) are legal only if it can be 
demonstrated that hazardous constituents are removed or destroyed to 
the same extent they would be pursuant to otherwise-applicable RCRA 
treatment standards. Id. at 7.
    As a consequence of these holdings, the court held that the 
deactivation standard for ignitable and corrosive wastes did not fully 
comply with RCRA section 3004(m). This was because that standard could 
be achieved by dilution, and dilution fails to destroy or remove the 
underlying hazardous constituents that can be present in the wastes. 
Id.
3. Phase 3 and the Pharmaceutical Effluent Guidelines
    The RCRA regulations EPA proposed on February 16, 1995 are known as 
the Phase 3 rule. In response to the D.C. Circuit court decision 
requiring treatment beyond decharacterization or dilution for 
ignitable, corrosive, reactive and characteristically toxic wastes, the 
proposed rule addresses underlying hazardous constituents of these 
wastes.
    EPA believes that the practices of disposal of spent solvents used 
extensively in pharmaceutical processes for cleaning out batch units 
result in the discharge of significant amounts of characteristically 
ignitable (D001) hazardous waste. Many of these streams are disposed in 
surface impoundments and will be covered by the Phase 3 proposal.
    The Phase 3 rule sets out EPA's general approach to have the RCRA 
standards be the same as BAT under the CWA. This is because the BAT 
standards reflect an industry-specific evaluation of best treatment for 
that industry's wastewater. Thus, the RCRA technology-based standards 
will typically match those of the Clean Water Act. This approach works 
well for the pharmaceutical manufacturing industry because the Clean 
Water Act rule effluent limitations guidelines and standards are being 
revised contemporaneously with the Phase 3 LDR rules, and thus reflect 
current BAT.

   Table XII.A.--Ignitable/Corrosive/Reactive/Toxicity Characteristic   
                   Wastes D001, D002, D003 and D004-32                  
                                                                        
                                                                        
D001...............................  IGNITABLE.                         
    D001...........................  Liquid--flash point<60 C--High TOC--
                                      261.21(a)(1).                     
    D001...........................  Liquid--flash point<60 C--Low TOC--
                                      261.21(a)(1).                     
    D001...........................  Nonliquid--burns vigorously/       
                                      persistently--261.21(a)(2).       
    D001...........................  Ignitable compressed gas--49 CFR   
                                      173.300--261.21(a)(3).            
    D001...........................  Oxidizer--49 CFR 173.151--         
                                      261.21(a)(4).                     
D002...............................  CORROSIVE.                         
    D002...........................  pH<2--261.22(a)(1).                
    D002...........................  pH>10--261.22(a)(1).               
[[Page 21644]]                                                          
                                                                        
    D002...........................  Corrodes steel--261.22(a)(2).      
D003...............................  REACTIVE.                          
    D003...........................  Violent change without detonating--
                                      261.23(a)(1).                     
    D003...........................  Violent reaction with water--      
                                      261.23(a)(2).                     
    D003...........................  Generates toxic gases--            
                                      261.23(a)(3).                     
    D003...........................  Contains CN or S--261.23(a)(4).    
    D003...........................  Capable of detonating under stress--
                                      261.23(a)(5).                     
    D003...........................  Capable of detonating              
                                      spontaneously--261.23(a)(6).      
    D003...........................  Forbidden, Class A or Class B      
                                      explosive--261.23(a)(7).          
D004-D043..........................  TOXICITY CHARACTERISTIC (TC)       
                                      WASTES.                           
    D004...........................  Arsenic.                           
    D005...........................  Barium.                            
    D006...........................  Cadmium.                           
    D007...........................  Chromium.                          
    D008...........................  Lead.                              
    D009...........................  Mercury.                           
    D010...........................  Selenium.                          
    D011...........................  Silver.                            
    D012...........................  Endrin.                            
    D013...........................  Lindane.                           
    D014...........................  Methoxychlor.                      
    D015...........................  Toxaphene.                         
    D016...........................  2,4-D.                             
    D017...........................  Silvex.                            
    D018...........................  Benzene.                           
    D019...........................  Carbon tetrachloride.              
    D020...........................  Chlordane.                         
    D021...........................  Chlorobenzene.                     
    D022...........................  Chloroform.                        
    D023...........................  o-Cresol.                          
    D024...........................  m-Cresol.                          
    D025...........................  p-Cresol.                          
    D026...........................  Cresol.                            
    D027...........................  1,4-Dichlorobenzene.               
    D028...........................  1,2-Dichloroethylene.              
    D029...........................  1,1-Dichloroethylene.              
    D030...........................  2,4-Dinitrotoluene.                
    D031...........................  Heptachlor and epoxide.            
    D032...........................  Hexachlorobenzene.                 
    D033...........................  Hexachlorobutadiene.               
    D034...........................  Hexachloroethane.                  
    D035...........................  Methyl ethyl ketone.               
    D036...........................  Nitrobenzene.                      
    D037...........................  Pentachlorophenol.                 
    D038...........................  Pyridine.                          
    D039...........................  Tetrachloroethylene.               
    D040...........................  Trichloroethylene.                 
    D041...........................  2,4,5-Trichlorophenol.             
    D042...........................  2,4,6-Trichlorophenol.             
    D043...........................  Vinyl chloride.                    

B. Coordination With Waste Minimization and Combustion Strategy

    In May 1994, the Administrator announced a Draft Hazardous Waste 
Minimization and Combustion Strategy that is pertinent to this 
rulemaking for the pharmaceutical manufacturing industry. The Draft 
Strategy provides the central framework for EPA's federal effort to 
maximize the source reduction and recycling of hazardous wastes under 
RCRA. The Draft Strategy focuses on a number of specific goals, 
including reducing the amount and toxicity of hazardous waste that is 
generated, particularly when such reductions would benefit more than 
one environmental medium. The Draft Strategy also encompasses a number 
of other features, including public outreach, public involvement and 
environmental justice, permitting, enforcement, risk assessments, and 
good science.
1. Waste Minimization
    The Draft Strategy has both short-term and a longer-term phases. In 
the short-term, EPA will address the source reduction and 
environmentally sound recycling of halogenated (and metal-bearing) 
combustible wastes. The longer-term effort will encompass all RCRA 
hazardous wastes, taking a more comprehensive approach to how wastes 
are generated and managed, and the role waste minimization can play as 
a preferred ``mode of management'' over other forms of waste management 
(e.g., treatment, storage, and disposal). This source reduction (waste 
minimization) strategy should reduce the long-term demand for 
combustion and other waste management facilities. Section VI of this 
preamble presents EPA's efforts toward increasing opportunities for 
source reduction (e.g., process changes) in the pharmaceutical 
manufacturing industry.
    The Agency also has released a draft report by the EPA Office of 
Solid Waste's Definition of Solid Waste Task [[Page 21645]] Force. This 
report, Reengineering RCRA for Recycling, presents recommendations of 
the Task Force to improve the regulation of hazardous waste recycling 
under RCRA. One of the recommendations of the Task Force was that 
provision should be made to exempt ``clean'' waste-derived fuels from 
the regulatory requirements of RCRA for hazardous wastes. ``Clean 
fuels'' are fuels with ``de minimis'' levels of halogens (primarily 
chlorine in this case) or toxic metals, especially fuels that are 
characteristically hazardous only because of ignitability. EPA has 
initiated a rulemaking effort to address the recommendations of the 
Task Force, including the recommendation on ``clean fuels.''
    In the case of the pharmaceutical manufacturing industry, the 
volatile organic pollutants that are generated in the largest 
quantities are non-halogenated volatile organic pollutants, including 
methanol, ethanol, isopropanol, and acetone. Implementation of in-plant 
steam stripping or steam stripping with distillation technology affords 
the opportunity to recover these potentially ``clean fuels'' for 
recycle in industrial boilers, such as those on-site at pharmaceutical 
manufacturing facilities.
    Implementation of in-plant steam stripping or steam stripping with 
distillation technology also affords the opportunity to recover 
halogenated volatile organic pollutants (e.g., methylene chloride) for 
recycle in the pharmaceutical manufacturing process. Recovered 
chlorinated solvents that are not of sufficient quality for reuse in 
pharmaceutical manufacturing processes may be sold for reuse in other 
industries.
2. Combustion
    The Draft Strategy also addresses rigorous controls on hazardous 
waste combustion facilities using best available technologies to ensure 
that these facilities do not impose unacceptable risk to human health 
and the environment. EPA's regulatory activities are scheduled to be 
directed toward upgrading technical standards for residual wastes and 
emissions from hazardous waste combustion facilities, including 
incinerators, cement kilns, light-weight aggregate kilns, and smelter 
furnaces, as well as boilers and industrial furnaces.
    EPA estimates that approximately 115,000 metric tons per year of 
solvents (halogenated and nonhalogenated) would be recovered from in-
plant steam stripping technology at pharmaceutical manufacturing 
facilities. There is currently adequate capacity at commercial 
incinerators to combust the entire mass of solvents (in excess of 1 
million metric tons per year) if none was recovered and recycled. 
However, it is the Agency's policy, as stated in the Draft Waste 
Minimization and Combustion Strategy, that the most appropriate mode of 
management for solvents removed from pharmaceutical manufacturing 
wastewaters by steam stripping is recycle of ``clean fuels'' in 
boilers, recycle in the process, or recycle at other facilities.

XIII. Administrative Requirements

A. Changes In Format and Name

    EPA is not proposing any changes in format to part 439 of the Code 
of Federal Regulations.

B. Docket and Public Record

    The Record for this rulemaking is available for public review at 
EPA Headquarters, 401 M Street SW, Washington, DC 20460. The Record 
supporting the effluent limitations guidelines in part 439 is located 
in the Office of Water Docket, Room L102 (in the basement of Waterside 
Mall). The Docket is staffed by an EPA contractor, Labat-Anderson, 
Inc., and interested parties are encouraged to call for an appointment. 
The telephone number for the Water Docket is (202) 260-3027.
    EPA notes that many documents in the record supporting these 
proposed rules 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.

C. Clean Water Act Procedural Requirements

    As required by the Clean Water Act, EPA will conduct a public 
hearing on the pretreatment standards portion of the proposed rule. The 
location and time of this public hearing will be announced in a future 
notice.

D. Executive Order 12866

    Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) 
requires EPA and other agencies to assess the potential costs and 
benefits of all significant regulatory actions, and submit these 
actions to the Office of Management and Budget (OMB). Significant 
regulatory actions are those that impose a cost on the economy of $100 
million or more annually or have certain other regulatory, policy, or 
economic impacts. Today's rule meets the criteria of a significant 
regulatory action as set forth in section 3(f) of the Executive Order. 
The regulatory analysis for this proposed rule is presented in 
``Regulatory Impact Assessment of Proposed Effluent Guidelines for the 
Pharmaceutical Industry.'' This analysis (referred to as the RIA) is 
summarized in section XI.B. Today's proposed rule and the RIA were 
submitted to the OMB for review.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601 et. seq., requires EPA 
and other agencies to prepare an initial regulatory flexibility 
analysis for regulations that have a significant impact on a 
substantial number of small entities. EPA projects that today's 
proposed rule, if promulgated, could affect small businesses. The 
initial regulatory flexibility analysis for these proposed rules is 
incorporated into the economic impact analysis and is discussed in 
section XI.B. Reporting and other compliance requirements are 
summarized in sections IX.I and detailed in the TDD. While the Agency 
has not identified any duplicative, overlapping, or conflicting Federal 
rules, a discussion of other related rulemakings is presented in 
sections V.B, V.C, V.D, X.A, X.B, XII.A, and XII.B.

F. Reduction of Unfunded Mandates and Consultation with State, Local, 
and Tribal Governments

    Executive Order No. 12875 supplements Executive Order No. 12866 
[Sec. 1(b)(9)], and is intended ``to reduce the imposition of unfunded 
mandates upon State, local, and tribal governments.'' Facilities in the 
pharmaceutical manufacturing industry are not associated with tribal 
governments, and the burden to states and local authorities is expected 
to be minimal, if not decreased, by the implementation of this rule.
    These proposed requirements, when promulgated, will be implemented 
via the existing regulatory structure and no additional burden is 
expected beyond that previously estimated by EPA for the NPDES and 
general pretreatment programs. In the absence of effluent limitations 
guidelines and pretreatment standards, establishing BAT, BCT, NSPS, 
PSES, and PSNS permit limitations are to be developed on a case-by-case 
``Best Professional Judgment'' (BPJ) basis. In addition, NPDES permits 
for all direct dischargers [[Page 21646]] and POTWs must incorporate 
state water quality standards where necessary. Once these revised 
pharmaceutical effluent guidelines and standards are in place, 
regulatory burdens on the states and local POTWs in developing 
pollutant control requirements that heretofore have not been addressed 
for this industry, particularly for volatile organic pollutants and 
other wastewater discharge characteristics, will be reduced. For 
example, the Agency is aware that certain POTWs have expended 
considerable resources for outside contractors (e.g., engineering 
consultants) to secure technical support in developing the basis for 
local limits or other special requirements, for POTW maintenance and 
equipment replacement, and for special treatment systems. These 
requirements were needed to prevent pollutant pass through, 
interference, or sludge contamination attributable to pharmaceutical 
facility discharges.
    In compliance with E.O. 12875, EPA has involved 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 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 has worked with the Food and 
Drug Administration (FDA) to explore pollution prevention opportunities 
to the maximum extent feasible. As described previously in this 
preamble, 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.
    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 with representatives of 
selected POTWs regarding underlying technical aspects of this proposal.
    The Agency will continue this process of consulting with state, 
local, and other affected parties after proposal in order to further 
minimize the potential for unfunded mandates that may result from this 
rule.

G. Paperwork Reduction Act

    The proposed effluent guidelines and standards for the 
pharmaceutical manufacturing industry contain no information collection 
activities beyond those required for the NPDES permit program and the 
general pretreatment program. Therefore, an information collection 
request (ICR) has not been submitted to the Office of Management and 
Budget (OMB) for review and approval under the provisions of the 
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
    OMB has approved the existing information collection requirements 
associated with NPDES discharge permit applications and the general 
pretreatment program under the provisions of the Paperwork Reduction 
Act.
    The collection of information required for NPDES discharge permit 
applications has an estimated reporting burden averaging 12 hours per 
response and an estimated annual recordkeeping burden averaging two 
hours per respondent. These estimates include time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.

XIV. Solicitation of Data and Comments

A. Introduction and General Solicitation

    EPA invites and encourages public participation in this rulemaking. 
The Agency asks that comments address any perceived deficiencies in the 
record of this proposal and that suggested revisions or corrections be 
supported by data.
    The Agency invites all parties to coordinate their data collection 
activities with EPA to facilitate mutually beneficial and cost-
effective data submissions. EPA is interested in participating in study 
plans, data collection and documentation. Please refer to the ``For 
Further Information'' section at the beginning of this preamble for 
technical contacts at EPA.
    When responding to these comment solicitations, please identify for 
each comment or data submission the comment solicitation number or 
numbers that the comment or data submission addresses. Commenters 
should also submit an electronic version on diskette if possible.

B. Specific Data and Comment Solicitations

    EPA has solicited comments and data on many individual topics 
throughout this preamble. The Agency incorporates each of these 
solicitations here, and reiterates its interest in receiving data and 
comments on the issues addressed by those solicitations. EPA 
particularly requests comments and data on the following issues:

1.0  General

1.1  Comments on Options and Technologies Evaluated

    The Agency solicits comments on all of the technologies and 
technology options identified in today's proposal.

1.2  Comments on Options/Technologies Selected for Proposal

    The Agency solicits comments on the options and technologies and 
compliance monitoring points selected for proposal today, and the 
technical, policy, and legal bases expressed by EPA in support of such 
selections.

1.3  Comments on Proposed Effluent Limitations and Standards

    The Agency solicits comments on the effluent limitations and 
standards proposed today.

1.4  Comments on the Methodology Used to Develop Steam Stripper- and 
Steam Stripper With Distillation-Based Limitations and Standards

    The Agency solicits comment regarding its methodology for 
developing the proposed limitations and standards based on available 
steam stripper and steam stripper/distillation performance data.

2.0  Adequacy of the 308 Questionnaire Database

    The Agency has collected a significant amount of technical and 
economic data from pharmaceutical manufacturing facilities. 
Nonetheless, the Agency is open to suggestions regarding any additional 
data collections that may be [[Page 21647]] required. The Agency also 
solicits information, comments, and data on the following technical 
areas:
    a. Data characterizing in-facility process wastewater streams 
bearing pollutants proposed to be regulated, including ammonia 
concentration in the wastewater stream, stream pH, stream TDS and TSS, 
and information on the ionic species in the stream.
    b. Information on new steam strippers installed since 1990 for the 
treatment of pharmaceutical process wastewater.
    c. Information on the storage capacity used by facilities prior to 
steam stripping.
    d. Information on steam generation and cost, including how much 
steam is generated on-site and at what cost, how much steam is 
purchased from off-site sources and at what cost, steam condition, and 
steam pressure used by the facility.
    e. Information on scaling in steam strippers including information 
concerning the issues, problems, and solutions to scaling.
    f. Information on the operation and maintenance costs for running 
steam strippers at pharmaceutical manufacturing facilities.

3.0  Basis for Pollutant Loading Estimates

    EPA requests information from plants that completed Table 3-2 of 
the ``1990 Pharmaceutical Manufacturing Survey'' but did not indicate a 
technical basis for their loadings estimates (i.e., air emissions from 
wastewater, discharges to surface waters/sewers etc.). The Agency 
requests that facilities specify the method and underlying assumptions 
used in making air emission and water discharge estimates for 
individual pollutants, the loading estimate values either estimated or 
measured, and the uncertainty associated with the method used to 
estimate these quantities.

4.0  Subcategorization

    EPA is proposing to maintain the existing subcategorization scheme. 
The rationale for maintaining this scheme is discussed in Section 
IX.A.3 of this preamble.

4.1  Comments on Maintaining the Existing Subcategorization Scheme

    EPA solicits comments regarding the decision to maintain the 
existing scheme.

4.2  Alternative Regulatory Schemes

    The Agency also solicits suggestions for alternative regulatory 
schemes.

5.0  Definition of Research Operations

5.1  Definition

    Research operations are defined and discussed in section IX.A.4 of 
this preamble. EPA solicits comments regarding the definition of 
research operations for the pharmaceutical manufacturing category.

5.2  Research Operation Wastewater in Combination With Other 
Subcategory Wastewater

    EPA solicits comment on whether wastewaters generated from bench-
scale pharmaceutical research operations at facilities with other 
pharmaceutical subcategory wastewaters (A, B, C, D) should be subject 
to the proposed subcategory A, B, C, and/or D standards and limitations 
rather than the existing BPT limitations for subcategory E.

6.0  Characterization of Individual Process Wastewater Streams

    The Agency anticipates that at most facilities, a greater mass of 
volatile organic pollutants will be concentrated in specific wastewater 
streams rather than being evenly distributed in all wastewater streams. 
Nonetheless, EPA has assumed for purposes of this proposal that 
wastewater streams with volatile organic pollutants at concentrations 
above the distillation treatability target concentrations would require 
steam stripping. Because of a lack of detailed and consistent flow and 
pollutant characterization data in the plant responses to the section 
308 questionnaire, EPA assumed, when estimating costs associated with 
the steam stripping and steam stripping with distillation options, that 
facilities would be treating all or most of the process wastewater 
generated by their individual plants. EPA believes that this is not a 
realistic assumption and that the costs developed for in-plant steam 
stripping and steam stripping with distillation are substantially 
overstated. As a practical matter, EPA anticipates that plants will 
attempt to segregate and treat the most concentrated volatile 
pollutant-bearing wastewater streams from those not requiring 
treatment, thus reducing the amount of wastewater that will be treated. 
Since amount of flow entering a steam stripper or steam stripper with 
distillation unit is a significant cost component in the design of 
these units (i.e., the greater the flow the greater the cost), 
reductions in input flows should result in significant cost reductions.

6.1  Data on Flow and Organic Pollutant Distribution

    In order to obtain better estimates of the volume and pollutant 
characterization of wastewaters requiring treatment, EPA solicits data 
from plants in the industry on the distribution of volatile organic 
pollutants in process wastewater streams. These data should specify: 
(1) The number and measured or estimated volume of individual process 
wastewater streams; (2) the types of organics in these waste streams 
and the ranges of organic pollutant concentrations either measured or 
estimated in these streams (e.g., <1   mg/l, 1-10 mg/l, 10-100 mg/l, 
100-1,000 mg/l, >1,000 mg/l); and (3) the ten organic pollutants found 
or expected to be found in these streams in the highest concentrations. 
In any cases where these data are estimates, the underlying assumptions 
for these estimates will need to be specified. In cases where plants 
undertake to generate data from process wastewater flow measurements 
and pollutant analyses, the measurement and analytical methods used to 
generate these data also will need to be specified. The Agency strongly 
suggests that any such plants which choose to generate these data 
should contact EPA staff (please refer to the FOR FURTHER INFORMATION 
section of this preamble) for guidance on details of the scope and 
methods of data collection and supporting documentation.

6.2  Wastewater Stream Segregation

    EPA anticipates that plants would segregate volatile bearing 
wastewater from non-volatile bearing wastewater. EPA solicits comments 
supported by data concerning whether stream segregation of volatile 
bearing streams from non-volatile bearing streams is feasible and/or 
practical.

7.0  BAT Limitations for Direct Discharging Facilities With 
Subcategory B and D Operations Based on Steam Stripping or Steam 
Stripping With Distillation

    In section IX.E.3.c(2) of this preamble, EPA speculated that 
pollutant loading data from years other than 1990 may indicate that in-
plant steam stripping technology or in-plant steam stripping with 
distillation technology is an appropriate basis for BAT regulations for 
facilities with subcategory B and/or D operations. Accordingly, EPA 
solicits volatile pollutant loading data from direct discharging 
facilities with subcategory B and D operations for [[Page 21648]] years 
other than 1990 (i.e., 1991-1994, or any later period if available).

7.1  Feasibility and Appropriateness of Such Limits

    EPA also solicits comment concerning the feasibility and 
appropriateness of setting BAT limitations on volatile organic 
pollutants for facilities with subcategory B and/or D operations based 
on steam stripping or steam stripping with distillation.

7.2  Point of Regulation for BAT Limitations and NSPS Standards Based 
on In-Plant Technologies

    EPA also solicits comment on the point of regulation for any BAT 
limitations and NSPS standards based on in-plant technologies.

7.3  Limitations if Facilities Change Their Mode of Discharge

    EPA also solicits comment on the issue of whether it should 
promulgate separate BAT limitations, based on in-plant technologies, 
for facilities with subcategory B and/or D operations that change their 
mode of discharge from indirect to direct (in view of EPA's proposal 
today to base PSES on steam stripping for these subcategories).

8.0  Definition of Process Wastewater

    The Agency is proposing a definition of process wastewater for the 
effluent limitations guidelines regulation set out at 40 CFR section 
122.2. The definition specifically includes any water which, during 
manufacturing or processing, comes into direct contact with or results 
from the production or use of any raw material, intermediate product, 
finished product, by-product, or waste product. The types of 
wastewaters considered to be process wastewater are set out in the 
proposed regulation at Sec. 439.01(m), and discussed in detail in 
section 5 of the TDD. EPA solicits comment on the wastewaters being 
defined as process wastewater.

9.0  Prohibited Discharges

    The Agency is proposing to prohibit the discharge of certain 
materials to POTWs or waters of the United States without an NPDES 
permit or individual control mechanism authorizing such discharge. See 
proposed regulation at Secs. 439.10, 439.20, 439.30 and 439.40. A list 
of these materials is set forth at Sec. 439.01(m)(1) of the proposed 
regulation. The Agency believes that discharge and loss of these 
materials is inappropriate from the standpoint of productivity loss, 
pollution prevention, adverse impacts on wastewater treatment (i.e., in 
POTWs) and worker safety and health.

9.1  List of Prohibited Materials

    EPA solicits comment on the specific proposed list of materials 
prohibited for discharge. EPA is separately soliciting comment on 
whether BMPs are appropriate for application to control the discharge 
of these materials through leaks, spills, and intentional diversions 
(see solicitation number 31 in this section of the preamble).

9.2  Non-Process Wastewaters

    EPA solicits comment on the following waters and wastewaters 
proposed to be 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 nonprocess water 
generated on site. EPA also solicits comment on the proposal that the 
discharge of such waters and wastewaters be regulated separately.

9.3  Costs of Complying With the Prohibitions

    EPA solicits comment on the potential costs of complying with the 
proposed prohibition of the discharge of materials used in or generated 
by pharmaceutical manufacturing processes.

10.0  TOC Limits as Alternative to COD Limits

    EPA is aware of suggestions that, in some instances, the TOC (Total 
Organic Carbon) test may be an appropriate substitute for the COD test 
and that, therefore, TOC limits should be promulgated instead of or as 
an alternative to COD limits. Industrial commenters on analytical 
methods have indicated that the approved method for determining COD in 
wastewater does not completely correct for abnormally high chloride (a 
direct interferant) concentrations found in some wastewaters.
    EPA solicits all influent and effluent TOC and COD concentration 
data points that are descriptive of the same wastewater stream but the 
Agency is especially interested in those concentration data that are 
descriptive of wastewaters with high chloride concentrations.

11.0  Wastewaters From Bioengineered Materials

    The Agency recognizes that there has been considerable development 
of bioengineered materials that may be incorporated in pharmaceutical 
products. The Agency is concerned about the release of these 
bioengineered materials in pharmaceutical wastewaters. EPA solicits 
comment and data that characterize wastewater from the development of 
bioengineered materials.

12.0  Source Reduction Activities

    The Agency solicits information and data on any efforts (ongoing or 
planned) concerning source reduction activities at pharmaceutical 
manufacturing facilities, as discussed in Section IX of this preamble.

12.1  Pollution Prevention and Combustion Strategy

    EPA solicits comments on the waste minimization and combustion 
strategy discussed in Section XII.B of this preamble as it may be 
applied in this industry. See also solicitation number 22 below.

13.0  Water-Based Tablet Coating Processes

    EPA is aware that certain facilities engaging in subcategory D 
operations (compounding/mixing/formulating) have opportunities to make 
process changes that can result in lower wastewater discharges and air 
emissions of volatile pollutants. Specifically, facilities may utilize 
an aqueous-based tablet coating process as opposed to a volatile 
organic solvent-based tablet coating process. EPA realizes that this 
substitution is not feasible for all coating processes. Nonetheless, 
EPA solicits data from plants in the industry on any changes or 
substitutions made to solvent-based tablet coating processes.

14.0  Concentration Versus Percent Reduction and Mass-Based 
Limitations

    The Agency today is proposing concentration-based effluent 
limitations and standards as the most appropriate basis for controlling 
the discharge of conventional, priority, and nonconventional pollutants 
from the pharmaceutical manufacturing industry. Industry 
representatives have commented that alternative formats for these 
limitations and standards controlling volatile pollutants may be 
appropriate, including percent removal with base concentrations as 
provided for in the HON.

14.1  Concentration-Based Format

    The Agency solicits comment on the concentration-based format for 
limitations being proposed today.

14.2  Implementation of an Alternative Percent Reduction Limitation

    The Agency solicits comment on alternative percent reduction-based 
limitations, as used for some of the existing effluent limitations and 
the [[Page 21649]] HON, and how this approach would be implemented. See 
solicitation number 32.4.

14.3  Implementation of a Mass-Based Limitation

    The Agency solicits comment on alternative mass-based limitations 
and how this approach would be implemented.

15.0  In-Plant Limitations for Volatile Organic Pollutant Control

    For PSES and PSNS, the Agency is proposing to require compliance 
monitoring in-plant for certain pollutants (e.g., chloroform, methylene 
chloride, and toluene) that due to dilution would be found at the end-
of-pipe at levels below the current analytical limits of detection. The 
long-term average concentrations upon which the applicable standards 
are based are, for many pollutants, near the analytical limits of 
detection established for these pollutants in wastewater. The Agency is 
concerned that measurements made at end-of-pipe, after dilution with 
process and non-process wastewaters, will not adequately reflect the 
performance of the PSES or PSNS level treatment due to uncertainty 
associated with pollutant concentration measurements near established 
limits of detection. EPA has a similar concern for the proposed BAT 
technology for facilities with subcategory A and/or C operations and 
the NSPS technology for all manufacturing subcategories.
    During development of these proposed regulations, industry 
representatives asserted that requiring compliance monitoring in-plant 
on internal streams may reduce their flexibility in compliance and 
require installation of specific in-plant treatment technologies. Based 
upon available data, the Agency believes that even if in-plant 
monitoring is required, pharmaceutical facilities will retain 
considerable flexibility in choosing specific compliance strategies 
that may be implemented at individual facilities, including available 
in-plant treatment technologies. EPA also believes in-plant limitations 
will enhance opportunities for recovery and reuse of solvents and may 
allow for the generation of ``clean fuels,'' as described in section 
XI.C of this preamble.

15.1  Feasibility of End-of-Pipe Limits in Measuring Compliance

    EPA solicits comments and data on whether requiring compliance 
monitoring at the end-of-pipe could practically or feasibly be used to 
determine whether the proposed BAT, PSES, NSPS and PSNS limitations and 
standards are being met.

15.2  Feasibility of End-of-Pipe Limits in Measuring Technology 
Performance

    EPA solicits comments and data on whether requiring compliance 
monitoring at the end-of-pipe could practically or feasibly be used to 
measure the performance of the process technologies that form the basis 
of EPA's proposed BAT, PSES, NSPS and PSNS regulation.

15.3  Extent That In-Plant Control Enhances Recovery/Reuse

    The Agency solicits comments and specific supporting data on the 
extent to which recovery and reuse opportunities may be enhanced by in-
plant control.

15.4  Compliance Strategy With In-Plant Monitoring Points

    The Agency solicits comments on whether compliance strategies are 
either enhanced or limited by the use of in-plant monitoring points.

15.5  Air Emissions

    The Agency solicits comment on the extent to which air emissions 
may be controlled by in-plant limits and standards for volatile organic 
pollutants based on steam stripping or steam stripping with 
distillation.

15.6  Minimum Concentration and Flow Thresholds

    EPA is aware that it may not be efficient or cost effective for 
plants to steam strip or distill wastewater streams containing low 
concentrations of volatile organic pollutants. Consequently, EPA 
solicits suggestions for concentration and flow thresholds for 
identifying wastewater streams containing volatile organic pollutants 
which would be subject to in-plant steam stripping or steam stripping 
with distillation.

15.7  Setting In-Plant Limitations on Case-by-Case Basis

    The Agency solicits comment on the burden imposed on permit writers 
to establish in-plant BAT limitations and NSPS on a case-by-case basis 
for the 45 volatile organic pollutants for which EPA is proposing to 
specify end-of-pipe limitations and standards. EPA also seeks comment 
on its proposal that the end-of-pipe BAT limitations and NSPS standards 
for particular pollutants would not apply if a permit writer finds in-
plant limitations or standards to be necessary for those pollutants; 
EPA also seeks comment on the recommendation that the permit writer 
consult the appropriate PSES or PSNS table in setting the necessary in-
plant limitations and standards on a best professional judgment basis. 
EPA also seeks comment on the utility of relying on EPA's existing 
NPDES permit regulations to address issues associated with pollutants 
that are not detectable at the end of the pipe.

15.8  Deference to Clean Air Act Rulemaking

    The Agency seeks comment on all aspects of EPA's policy 
determination in this proposal to defer to the Clean Air Act rulemaking 
for the pharmaceuticals industry with respect to the control of 
volatile air emissions from certain pharmaceutical wastestreams.

15.9  Comments on Steam Stripping With Distillation

    The Agency requests comments and data on whether steam stripping 
with distillation should be the technology basis for effluent 
limitations and standards for volatile organic pollutants, particularly 
those that are difficult to strip, such as methanol and ethanol.

15.10  Comments on the Proposed End-of-Pipe Limits for Highly 
Strippable Volatile Organic Pollutants

    The Agency solicits comments supported by data regarding whether it 
is appropriate to develop limitations requiring compliance monitoring 
at the end of the pipe for highly strippable volatile organic 
pollutants such as methylene chloride and chloroform.

16.0  WATER7 Model

    In analyzing responses to the mass balance question (section 3-2 of 
the 308 questionnaire), EPA has determined that many of the loading 
estimates (i.e., to air, to water etc.) provided for individual 
pollutants were not accompanied with explanations of how the estimates 
were made. The Agency is concerned that the 308 mass balance responses 
may underestimate the amount of pollutant air emissions from wastewater 
and overestimate the amount of pollutant biodegradation and/or 
destruction. Consequently, EPA has used the WATER7 computer model in 
conjunction with other 308 response data to develop pollutant-by-
pollutant air emission estimates. The WATER7 program was used 
previously to estimate air emissions from wastewater for the SOCMI HON 
(see 59 FR 19402).

16.1  Technical Validity of the WATER7 Model

    EPA solicits comments on the technical validity of the WATER7 model 
and its use in estimating pollutant releases at pharmaceutical 
facilities. [[Page 21650]] 

16.2  Other Models for Estimating Air and Water Loadings

    The Agency also welcomes suggestions regarding the use of other 
computer models for estimating air and water loadings at pharmaceutical 
plants.

17.1  Alternative Technologies to Steam Stripping or Steam Stripping 
With Distillation Technology

    For volatile organic pollutants, EPA is proposing to base its BAT 
limitations for facilities with subcategory A and/or C operations and 
PSES limitations for all manufacturing subcategories on steam stripping 
technology. EPA also proposed to base NSPS and PSNS regulations for all 
manufacturing subcategories for those pollutants on in-plant steam 
stripping with distillation technology. The Agency believes that steam 
stripping technology is the best available technology and that steam 
stripping with distillation technology is the best demonstrated 
technology for removing volatile pollutants from wastewater that also 
offer the opportunity for recovery and recycle of solvents.
    EPA solicits comments accompanied by data regarding other 
technologies designed to remove volatile organic pollutants from 
wastewater. Information on alternative technologies should be 
accompanied by influent and effluent data that demonstrate removal.

18.0  Materials of Construction for Steam Stripper and Distillation 
Columns

    EPA has used stainless steel as its construction material in steam 
stripper and distillation column capital cost estimates. Nonetheless, 
the Agency recognizes that certain corrosive (low pH) streams may 
require the use of construction materials made of corrosion resistant 
alloys such as Hastalloy to allow long-term operation of steam 
strippers and distillation columns.

18.1  Process Wastewater Characteristics Requiring Special Alloys

    The Agency solicits comments and data on the characteristics of any 
process wastewater streams that may require that steam strippers and/or 
distillation columns be constructed of highly specialized alloys such 
as Hastalloy.

18.2  Existing Materials of Construction

    The Agency requests information regarding the construction 
materials used to build all the steam strippers and distillation units 
currently in-place within the industry.

19.0  Streams Containing Volatile Organic Pollutants That Also 
Contain Significant Amounts of Dissolved Solids

    EPA wants to ensure that the final limitations and standards for 
volatile organics based on steam stripping or steam stripping with 
distillation technology adequately reflect the dissolved solids content 
of representative industry wastestreams. The Agency is aware that 
certain waste streams that contain large concentrations of certain 
inorganic salts may cause scaling problems within packed columns that 
may reduce column performance. Consequently, EPA solicits comments 
supported by data concerning the strippability of wastestreams 
containing high concentrations of inorganic salts (dissolved solids).

20.0  COD Removal Through Steam Stripping and Steam Stripping With 
Distillation

    As indicated earlier in this preamble, the Agency does not have 
removal data for COD achievable through steam stripping and steam 
stripping with distillation technology.

20.1  COD Removal Data

    EPA solicits any influent and effluent COD data across a steam 
stripper and/or distillation unit for any available time period. The 
COD influent and effluent data should also include influent stream 
characteristics data (i.e., organic constituent concentrations) if 
possible. EPA also solicits COD data for any facilities that also have 
a biological treatment system following a steam stripper or 
distillation unit for which COD data are available or may be gathered.

20.2  COD Regulation Beyond BPT

    EPA is proposing BAT limitations and NSPS for COD for all 
manufacturing subcategories based on advanced biological treatment (the 
BPT-level technology). EPA is not proposing COD limitations and 
standards based on steam stripping or steam stripping with distillation 
because EPA is unable at this time to quantify the COD loading 
reductions attainable through those technologies in addition to 
advanced biological treatment. EPA solicits comments and data 
concerning whether BAT limitations and NSPS for COD based on in-plant 
steam stripping or steam stripping with distillation in addition to 
advanced biological treatment are necessary or appropriate for 
facilities with subcategory A and/or C operations. EPA also solicits 
comments and data on the advisability of adding granular activated 
carbon adsorption technology to the steam stripping-based technologies 
for additional removal of COD. EPA also solicits comments and data 
concerning BAT limitations and NSPS for COD for facilities with 
subcategory B and D operations.

21.0  Clean Up of Steam Stripping and Distillation Overheads, i.e., 
Condensates

21.1  Additional Treatment Required for Clean Up

    EPA is aware that the overhead materials recovered from steam 
stripping and distillation may need to be ``cleaned up'' prior to 
reuse. EPA solicits information on the technologies that are currently 
being used to purify overheads from steam stripping and distillation.

21.2  Costs of Overhead Recovery for Reuse

    EPA solicits information and data regarding the costs of cleaning 
up or purifying overheads for reuse in manufacturing operations along 
with information on the cost of virgin solvent materials.

22.0  Clean Fuels

    EPA is aware that some facilities use distillation/steam stripping 
overheads as boiler feed. The Agency solicits data and comment 
concerning the use of such overheads as ``clean fuels'' from plants 
which are using overheads as boiler feed and from plants which plan to 
do so in the future.

23.0  Regulation of Ammonia at BAT and PSES

    EPA is proposing effluent limitations and standards controlling the 
discharge of the pollutant ammonia for facilities with subcategory A 
and/or C operations because it is a pollutant of concern and is 
discharged at treatable concentration levels. Data are available 
demonstrating that ammonia passes through POTWs, and that ammonia is 
not adequately treated at direct dischargers. The control technology 
basis for BAT ammonia limitations is incidental removal through in-
plant steam stripping and advanced biological treatment upgraded for 
nitrification. The control technology basis for PSES ammonia 
limitations is removal through in-plant steam stripping. Industry 
representatives have commented that ammonia discharges from direct 
dischargers should be controlled through water quality standards. 
Industry representatives have also commented that the adoption of 
technology-based limitations and standards for ammonia would result in 
[[Page 21651]] significant cross-media transfers and energy use.

23.1  Degree to Which Ammonia Passes Through POTWs

    EPA solicits comments and data on the degree to which ammonia 
generated by pharmaceutical manufacturing facilities passes through 
POTWs.

23.2  Degree to Which Ammonia is Treated at Direct Dischargers

    EPA solicits comments and data on the degree to which ammonia is 
adequately treated at direct discharging facilities.

23.3  Achievability of the Proposed Ammonia Limitations

    EPA solicits comments and data on the achievability of the Agency's 
proposed ammonia limitations.

23.4  Proposed Ammonia Control Technologies

    EPA solicits comments on the underlying control technologies 
proposed for ammonia treatment.

23.5  Nutrient Balance of Downstream Biotreatment

    EPA solicits comments on the extent to which ammonia removal may 
adversely affect the nutrient balance of process wastewaters treated in 
biological treatment systems.

23.6  Other Factors

    EPA solicits comments on the costs, effluent reduction benefits, 
water quality benefits, and any other factors that may be related to 
the proposed ammonia limitations and standards.

24.0  Impact of Pharmaceutical Wastewaters on POTW Operations

    EPA has received information and data indicating that 
pharmaceutical manufacturing process wastewaters discharged to POTWs 
contain significant concentrations of volatile organic pollutants. 
These concentrations can result in slug loads of volatile organic 
pollutants and other wastewater constituents that, in turn, may cause 
significant air emissions in the headworks of these POTWs and may be a 
threat to worker safety and health. The Agency's proposed PSES are 
intended to reduce the concentration of volatile organic pollutants in 
pharmaceutical discharges. EPA solicits comments and supporting data on 
these findings and on the question whether these objectives can be 
satisfied by assuring that discharges to the POTW sewer are near or at 
the level of detection.

24.1  PSES Removal of Volatile Organic Pollutants

    The Agency solicits comments and data that address the extent to 
which EPA's proposed PSES may reduce the concentration of volatile 
organic pollutants in pharmaceutical plant discharges to POTWs.

24.2  Regulatory Approach

    The Agency solicits comment on the appropriate regulatory approach 
for facilities that discharge pharmaceutical manufacturing wastewater 
to privately owned treatment works. The Agency specifically requests 
comment on whether such discharges are best regulated under today's 
proposed regulations, are best regulated under effluent limitations 
guidelines and standards for centralized waste treatment facilities, 40 
CFR Part 437, or are best regulated on a case-by-case basis using best 
professional judgment.

24.3  Comments on the Finding of No Pass-Through for 33 Volatile 
Organic Pollutants Under PSES Co-Proposal (2)

    The Agency solicits comments and data regarding its finding under 
PSES co-proposal (2) that the specified 33 volatile organic pollutants 
do not pass through.

24.4  Need for Pretreatment Standards for 33 Less Strippable Volatile 
Organic Pollutants

    The Agency proposes as PSES and PSNS pass-through co-proposal (1) 
to establish PSES and PSNS for 33 less strippable volatile organic 
pollutants. Co-proposal (1) is supported by the Association of 
Metropolitan Sewerage Agencies, which in letter to EPA dated February 
14, 1995, asserted that the promulgation of national pretreatment 
standards for these pollutants would be the most environmentally sound, 
timely and cost-effective method of addressing those pollutants. See 
Section IX.E.5.a. EPA solicits comments on EPA's two pass-through co-
proposals and on the asserted benefits to POTWs associated with co-
proposal (1).
    Industry data supplied to the Agency indicate preliminarily that 
only 10 percent of the indirect sources account for 80 to 90 percent of 
the total discharge of these pollutants to POTWs and that problems 
associated with discharges to POTWs are specific and local. EPA 
solicits comments and supporting data on the extent to which indirect 
discharges present a national problem warranting regulation at the 
national, as opposed to local, level and whether mechanisms other than 
those considered as the technology basis for PSES and PSNS are possible 
alternatives for addressing the problem.

24.5  Effect of Forthcoming Clean Air Rule

    EPA is developing a separate rulemaking (under the requirements of 
Section 112 of the Clean Air Act) to address the air emissions from 
pharmaceutical plants, including the emissions of most of these 12 
volatile organic pollutants. EPA's air rulemaking may complement this 
proposal so that standards set at the point of discharge to the POTW 
sewer may satisfy EPA's objectives in this rulemaking. EPA expects to 
propose these air emission standards next year. As a result, EPA is 
also considering whether to establish the limits for the 12 highly 
strippable organic pollutants at the point of discharge to the POTW 
sewer and solicits comments and supporting data on this question.

25.0  Pretreatment of Methanol

25.1  Biodegradation of Non-Halogenated Volatile Organic Pollutants 
Without Causing Air Emissions

    Industry representatives have stated that EPA's pretreatment 
standards requiring removal of methanol and other non-halogenated 
volatile organic pollutants (e.g., acetone, ethanol, and isopropanol) 
are not necessary because these pollutants are adequately biodegraded 
by POTWs. Industry maintains that these pollutants have low predicted 
air emissions from industrial direct discharge systems and, at the 
lower temperatures and concentrations found in POTW systems, would have 
even lower potential to be emitted from POTWs.
    EPA solicits comments and supporting data regarding the ability of 
POTWs to biodegrade non-halogenated volatile organic pollutants without 
significant air emissions.

25.2  BOD<INF>5 Removal Efficiency at POTWs

    Industry also asserts that removal of these non-halogenated 
volatile organic pollutants (a portion of which are measured as 
BOD<INF>5) may have adverse impacts on the BOD<INF>5 removal efficiency 
of biological treatment systems at POTWs receiving pharmaceutical 
manufacturing process wastewaters. EPA solicits comments and supporting 
data on whether pretreatment of these pollutants will adversely affect 
the BOD<INF>5 removal efficiency of POTWs.

25.3  Financial Impact on POTWs

    The industry has asserted that pretreatment of methanol and other 
non-halogenated volatile organic [[Page 21652]] pollutants by 
pharmaceutical manufacturing facilities will have an adverse financial 
impact on POTWs.
    EPA solicits comments and supporting data on whether pretreatment 
for removal of these pollutants, and thereby reduced BOD<INF>5 raw 
waste loads to POTWs, will have adverse financial impacts on POTW 
revenues.

26.0  Pass-Through of COD at POTWs

    EPA will be conducting a POTW pass-through analysis for the 
pollutant COD because EPA is concerned that certain refractory organic 
waste materials from subcategory A and C operations measured as COD may 
pass-through the treatment afforded by POTWs.

26.1  Data on COD Pass-Through

    EPA is soliciting data on COD removal (influent and effluent data) 
from POTWs that treat wastewater from pharmaceutical plants engaging in 
subcategory A and C operations.

26.2  Appropriate Procedure for Conducting the COD Pass-Through 
Analysis

    EPA also solicits comments on the appropriate procedure for 
conducting a pass-through analysis for the pollutant COD.

27.0  Pretreatment Standards for Nonstrippable Organic Pollutants

27.1  Package Biotreatment for Five Nonstrippable Organic Pollutants

    As noted in Section IX.E.5.a of this preamble, EPA has determined 
that five nonstrippable biodegradable organic pollutants (N,N dimethyl 
formamide, dimethyl sulfoxide, N,N-dimethyl acetamide, formaldehyde and 
ethylene glycol) pass through POTWs. EPA is considering developing 
pretreatment standards for these pollutants based on package biological 
treatment. EPA solicits comments and data regarding whether 
pretreatment standards based on package biological treatment for the 
five nonstrippable organic pollutants should be promulgated.

27.2  Other Treatment Technologies for Nonstrippable Organic Pollutants

    EPA solicits data and information regarding the ability of other 
technologies to reduce wastewater concentrations of the five 
nonstrippable organic pollutants identified in the comment solicitation 
above.

27.3  POTW Pass Through for Acetonitrile and PEG 600

    EPA solicits data and information concerning whether acetonitrile 
and polyethylene glycol 600 pass through POTWs.

28.0  PSES for Additional Pollutants

    Although today's proposed PSES would control 45 volatile organic 
pollutants (as well as cyanide and ammonia for subcategories A and C), 
the Agency is concerned that additional pollutants currently being 
discharged by pharmaceutical plants may either pass through POTWs or 
interfere with their operation.
    Consequently, EPA solicits comments and data concerning other 
pollutants discharged by pharmaceutical plants in all manufacturing 
subcategories that may pass through and/or interfere with POTWs, such 
as sulfates and sulfide (hydrogen sulfide) which are capable of causing 
significant worker safety problems and corrosion.

29.0  Revision of BPT

    EPA is proposing to revise the existing BPT effluent limitations, 
which are outdated and no longer represent the average of the best 
performers in the pharmaceutical manufacturing industry. In developing 
the proposed revised BPT effluent limitations, EPA has identified the 
average of the best performers with advanced biological treatment.

29.1  Advanced Biological Treatment

    EPA solicits comments and data with respect to whether EPA has 
appropriately selected advanced biological treatment as the technology 
basis for the proposed BPT conventional pollutant limitations.

29.2  Methodology Used to Select Best Performers

    EPA solicits comments on the methodology used to select the best 
performing facilities with advanced biological treatment and to develop 
the limitations based on performance data from these facilities.

29.3  Statutory Authority and Other Factors

    EPA solicits comments and data with respect to the authority under 
the Clean Water Act to revise BPT, and on costs, effluent reduction 
benefits, water quality benefits, and any other factors that may be 
related to the proposed BPT revisions.

30.0  Revision of BCT

    EPA is proposing to revise the existing BCT effluent limitations 
that were promulgated in July 1986 (51 FR 24974). EPA identified no 
technologies that achieve greater removals of conventional pollutants 
than those associated with the proposed revised BPT limitations that 
are also cost-reasonable.

30.1  Proposed Baseline for BCT Cost Test

    EPA solicits comments on the baseline used for this proposal (i.e., 
revised BPT limits being proposed today) beyond which candidate 
technologies were identified, and the alternative baseline identified 
(i.e., existing BPT limitations).

30.2  Candidate Technologies for BCT

    EPA solicits comments on the candidate technologies considered for 
BCT in this analysis and any others not identified that may be 
appropriate.

30.3  BCT Results

    EPA solicits comments on the finding that none of the candidate BCT 
technologies beyond BPT were cost-reasonable.

30.4  Other Factors

    EPA solicits comments with respect to costs, effluent reduction 
benefits, and any other factors that may be related to the proposed BCT 
revisions.

31.0  Applicability and Scope of Best Management Practices

    Section 304(e) of the CWA gives the Administrator the authority to 
publish regulations 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 processes of the regulated point 
source category and that she (he) determines may contribute significant 
amounts of pollutants to waters of the United States. Examples of BMP 
regulations include the requirement that dikes be constructed in 
process areas and required employee training in spill prevention and 
control.

31.1  Establishment of BMPs

    EPA solicits comments regarding whether BMP regulations should be 
established for the pharmaceutical manufacturing industry.

31.2  BMPs and Costs

    The Agency also solicits suggestions on possible BMPs to be 
prescribed by regulation, accompanied by facility implementation cost 
estimates that may be appropriate for this industrial category.

31.3  Suggested Specific BMPs

    The Agency solicits comments on the suggested specific BMPs 
presented in Appendix B of the Technical Development Document. 
[[Page 21653]] 

32.0  MACT Standards Versus Effluent Guidelines

    The proposed BAT and PSES effluent limitations guidelines will 
control volatile organic pollutants of which 22 are hazardous air 
pollutants (HAPs), that are released to the environment primarily in 
wastewater discharges and air emissions. The mass of HAPs being 
controlled by the effluent limitations guidelines and standards is 
about 40 percent of the total mass of volatile organic pollutants being 
controlled. It is the Agency's intent for both the effluent guidelines 
being proposed today and the MACT standards to be proposed at a later 
date that upon promulgation the in-plant technology basis of both rules 
will be applicable to essentially the same high concentration low 
volume process wastewater streams in which the bulk of the volatile 
organic pollutants are contained.
    Industry representatives commented that air emissions from 
pharmaceutical manufacturing facilities should be controlled by a 
NESHAP rulemaking rather than by BAT limitations and PSES. Industry 
representatives also commented that the Agency should integrate the 
development of these two rules, which now are progressing on separate 
schedules. Industry representatives commented further that the effluent 
guidelines should include the same elements of flexibility (e.g., allow 
for demonstration of equivalence of biological treatment to steam 
stripping) and format of the limitations as included in the HON (e.g., 
percent removal). Industry representatives also indicated that the HON 
will allow for emission-suppressed transport of volatile organic 
pollutant-containing wastewaters to central treatment facilities.

32.1  Should the Water and Air Regulations Be Integrated

    In view of these preliminary concerns, the Agency solicits comments 
and data with respect to whether it is necessary or appropriate for the 
two rules to be integrated and, if so, how.

32.2  List of Organic Pollutants Covered

    EPA solicits comments on whether it is necessary or appropriate for 
the two rules to cover the same list of volatile organic pollutants.

32.3  Steam Stripping Design and Operating Parameters

    EPA solicits comments on whether the design and operating 
parameters for steam stripping technology as applied in the two rules 
should be the same and, if so, how (within the constraints of the 
governing statutes).

32.4  Percent Removal Standard With a Base Concentration

    EPA solicits comments on whether EPA should adopt, as an 
alternative to the proposed concentration-based limitations and 
standards, effluent limitations guidelines and standards based on 
percent removal standards, as proposed in the HON for the Specialty 
Organic Chemical Manufacturing Industry (SOCMI). See solicitation 
numbers 14.0-14.3.

32.5  Central Treatment for Volatiles Removal

    EPA solicits comments on whether central treatment (i.e., steam 
stripping or an equivalent technology prior to end-of-pipe biological 
treatment) is or should be an acceptable compliance approach for the 
effluent guidelines.

32.6  Alternate Limitations for End-of-Pipe Biological Treatment

    EPA solicits comments on whether the effluent guidelines should 
include alternative limitations which would allow for end-of-pipe 
biological treatment of hard-piped volatile organic pollutants (in 
place of in-plant steam stripping or steam stripping with distillation 
technology).

32.7  Control of Air Emissions Using Alternate Limitations

    EPA solicits comments on whether an alternative approach (as 
described in comment number 32.6) would present the same control of air 
emissions as achieved by in-plant steam stripping and steam stripping 
with distillation technology.

32.8  Energy Use for and Air Emissions From Generation of Steam Used 
for Steam Stripping and Steam Stripping with Distillation

    EPA solicits comments and data on the increase in energy required 
to generate steam used for steam stripping and distillation, and on the 
increase in air emissions created by steam generation facilities 
(industrial boilers).

32.9  Comments on Evaluating the Record of This Rulemaking in the 
Context of the MACT Rule

    The Agency requests comments on whether it is appropriate for the 
Office of Air and Radiation to evaluate the basis for the proposed 
effluent limitations and standards as part of its development of MACT 
standards for the pharmaceutical manufacturing industry.

33.0  Analytical Methods

    A complete discussion of the new analytical methods being proposed 
in conjunction with these proposed regulations may be found in section 
18 of the Technical Development Document.

33.1  Analytical Methods Proposed Today

    The methods being proposed today involve the use of isotope 
dilution gas chromatography/mass spectrometry (GC/MS), derivatization 
followed by high pressure liquid chromatography (HPLC), and GC followed 
by detection in an electrochemical cell optimized for nitrogen 
containing compounds (GC/ELCD). EPA solicits comments with respect to 
these techniques (see discussion in Section IX of this preamble, and 
the supporting compendium of analytical methods entitled ``Analytical 
Methods for the Determination of Pollutants in Pharmaceutical 
Manufacturing Industry Wastewater;'' see Section II of this preamble) 
and any suggestions regarding alternative techniques as well.

33.2  Limitations Set at the Minimum Level of the Method

    EPA solicits comments on those limitations whose long-term average 
basis is equal to the minimum level established for the limited 
pollutant.

33.3  Statistical Methods for Establishing Limitations

    EPA solicits alternative statistical methodologies for developing 
limitations based on all non-detect data which may be more appropriate 
than the statistical methodology employed by EPA.

33.4  Analytical Methods for Alcohols

    EPA has proposed analytical methods for quantifying various low-
molecular weight alcohols (e.g., methanol and ethanol) in wastewater. 
See ``Analytical Methods for the Determination of Pollutants in 
Pharmaceutical Wastewater'', EPA 821-R-95-015. EPA invites comments on 
the proposed methods for determining alcohols in wastewater from 
industrial laboratories, public sector laboratories and individual 
researchers familiar with similar analytical methods.

33.5  Matrix Interferences and Analytical Methods

    EPA is interested in identifying solutions to matrix interference 
problems connected with the analysis of pharmaceutical manufacturing 
industry wastewater streams. EPA is also interested in any extraction, 
concentration or other analytical techniques that may offer solutions 
to matrix interference problems. [[Page 21654]] 

33.6  Analytical Method for the Determination of Polyethylene Glycol 
600 in Wastewater

    EPA has determined that GC/MS methods have not been found to be 
useful in the determination of polyethylene glycol 600 in wastewater. 
EPA invites suggestions concerning the analysis of this pollutant in 
wastewater.

33.7  COD Determinations in Samples With High Chloride Content

    EPA is aware that the standard method determinations of COD in 
samples with high chloride content (e.g., brackish wastewater) need to 
be pretreated to remove chloride prior to the oxidation step in the COD 
determination. EPA requests comments regarding the techniques used to 
remove chlorides prior to the oxidation step and their adequacy in 
preventing interference with the COD determinations. EPA also solicits 
data and information with respect to any analytical method studies 
involving COD determinations in wastewaters with high chloride 
concentrations.

34.0  Surface Impoundments

    EPA is concerned about the transfer of volatile organic pollutants 
from surface impoundments located at pharmaceutical manufacturing 
facilities to groundwater and air. EPA solicits comment and data on the 
monitoring of surface impoundments, including leachate data and air 
emissions data.

35.0  Regulatory Impact Analysis

    EPA solicits comments concerning the methodology employed to 
estimate costs and benefits in the Regulatory Impact Analysis developed 
for these regulations and the conclusions EPA reached by applying those 
methodologies.

36.0  Economic Impact Analysis

    EPA solicits comments on the methodology employed to measure the 
economic impacts of the proposed regulations.

36.1  Definition of Small Entities

    The Agency solicits comment on the definition of small entity used 
in this analysis, the analytical procedures for assessing impacts on 
small entities, and the opportunities to minimize the impacts on small 
entities, as described in the Economic Impact Analysis and Regulatory 
Flexibility Analysis of Proposed Effluent Guidelines for the 
Pharmaceutical Manufacturing Industry.

37.0  Use of Bulk Parameters to Represent Pollutants of Concern

    EPA solicits comments and data on the use of bulk parameters such 
as COD to represent the presence and treatability of pollutants of 
concern, such as the broad range of organic compounds present in 
pharmaceutical manufacturing process wastewaters, particularly chemical 
synthesis process wastewaters. See also solicitation numbers 10.0, 
20.0, 26.0, 27.0, and 28.0.

38.0  Reducing Monitoring Requirements

    The Agency solicits comment on ways to reduce the monitoring 
requirements associated with the proposed rulemaking.

38.1  Subcategory D Facilities

    The Agency is aware that many facilities with subcategory D 
operations do not use or generate the pollutants for which regulations 
are being proposed today. Consequently, these facilities should not be 
required to monitor for these pollutants. EPA solicits comment on any 
appropriate mechanism for reducing monitoring requirements for these 
facilities.

38.2  Pollutants Not Used or Generated

    Similarly, facilities with operations in other subcategories may 
not use or generate specific pollutants for which regulations are being 
proposed. EPA solicits comment on any appropriate mechanism for 
reducing monitoring requirements for these pollutants at such 
facilities.

38.3  Use of Alternate Analytical Methods

    EPA also solicits comments on whether circumstances may exist under 
which it may be appropriate to allow facilities to use analytical 
methods for organic pollutants other than those used to generate data 
upon which this proposal is based. Such circumstances may include 
``screening'' to confirm the absence of pollutants where solvents are 
not used in pharmaceutical manufacturing processes (i.e., subcategory 
D, mixing/ compounding/formulating). These alternate methods might 
include Methods 624 and 625 as alternatives to Methods 1624 and 1625.

39.0  Privately Owned Treatment Plants

    EPA solicits comment on the issue whether part 439 should apply to 
process wastewater pollutants introduced into privately owned treatment 
works.

List of Subjects in 40 CFR Part 439

    Environmental Protection Air pollution control, pharmaceutical 
manufacturing Pollution prevention, Wastewater treatment.

    Dated: February 28, 1995.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I, part 
439 of the Code of Federal Regulations is proposed to be amended as 
follows:

PART 439--PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY

    1. The authority citation for part 439 is revised to read as 
follows:

    Authority: Sections 301, 304, 306, 307, and 501 of the Clean 
Water Act, (33 U.S.C. 1311, 1314, 1316, 1317, and 1361).

    2. The Table of Contents for part 439 is amended by adding 
Secs. 439.3 and 439.4 and the entire table of contents is published for 
the convenience of the reader.

Sec.
439.0  Applicability.
439.1  General definitions.
439.2  Monitoring requirements.
439.3  Dilution prohibition.
439.4  [Reserved]

Subpart A--Fermentation Subcategory

439.10  Applicability; description of the fermentation products 
subcategory.
439.11  Specialized definitions.
439.12  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best practicable control 
technology currently available (BPT).
439.13  Effluent limitations representing the degree of effluent 
reduction attainable by the best conventional pollutant control 
technology (BCT).
439.14  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).
439.15  New source performance standards (NSPS).
439.16  Pretreatment standards for existing sources (PSES).
439.17  Pretreatment standards for new sources (PSNS).
439.18  [Reserved]

Subpart B--Extraction Subcategory

439.20  Applicability; description of the extraction products 
subcategory.
439.21  Specialized definitions.
439.22  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best practicable control 
technology currently available (BPT).
439.23  Effluent limitations representing the degree of effluent 
reduction attainable by the best conventional pollutant control 
technology (BCT).
439.24  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT). [[Page 21655]] 
439.25  New source performance standards (NSPS).
439.26  Pretreatment standards for existing sources (PSES).
439.27  Pretreatment standards for new sources (PSNS).
439.28  [Reserved]

Subpart C--Chemical Synthesis Subcategory

439.30  Applicability; description of the chemical synthesis 
products subcategory.
439.31  Specialized definitions.
439.32  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best practicable control 
technology currently available (BPT).
439.33  Effluent limitations representing the degree of effluent 
reduction attainable by the best conventional pollutant control 
technology (BCT).
439.34  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).
439.35  New source performance standards (NSPS).
439.36  Pretreatment standards for existing sources (PSES).
439.37  Pretreatment standards for new sources (PSNS).
439.38  [Reserved]

Subpart D--Mixing, Compounding and Formulating Subcategory

439.40  Applicability; description of the mixing, compounding and 
formulating subcategory.
439.41  Specialized definitions.
439.42  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best practicable control 
technology currently available (BPT).
439.43  Effluent limitations representing the degree of effluent 
reduction attainable by the best conventional pollutant control 
technology (BCT).
439.44  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).
439.45  New source performance standards (NSPS).
439.46  Pretreatment standards for existing sources (PSES).
439.47  Pretreatment standards for new sources (PSNS).
439.48  [Reserved]

Subpart E--Research Subcategory

439.50  Applicability; description of the research subcategory.
439.51  Specialized definitions.
439.52  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best practicable control 
technology currently available (BPT).
439.53  Effluent limitations representing the degree of effluent 
reduction attainable by the best conventional pollutant control 
technology (BCT). [Reserved]
439.54  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT). [Reserved]
439.55  New source performance standards (NSPS). [Reserved]
439.56  Pretreatment standards for existing sources (PSES). 
[Reserved]
439.57  Pretreatment standards for new sources (PSNS). [Reserved]
439.58  [Reserved]


    3. Sections 439.0 through 439.2 are revised and Secs. 439.3 and 
439.4 are added to read as follows:

General Provisions


Sec. 439.0  Applicability.

    This part applies to any pharmaceutical manufacturing facility that 
discharges or may discharge process wastewater pollutants to the waters 
of the United States, or that introduces or may introduce process 
wastewater pollutants into a publicly owned treatment works. This part 
does not apply to process wastewater pollutants introduced into 
privately owned treatment works.


Sec. 439.1  General definitions.

    In addition to the definitions set forth in 40 CFR part 401, the 
following definitions shall apply to this part:
    (a) 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).
    (b) Bench-scale operation. Laboratory testing of materials, 
methods, or processes on a small scale, such as on a laboratory 
worktable.
    (c) Chemical oxygen demand (COD). A 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 adverse effects, either singly or in combination. It is expressed 
as the amount of oxygen consumed by a chemical oxidant in a specific 
test.
    (d) Conventional pollutants. The pollutants identified in Section 
304(a)(4) of the CWA and the regulations thereunder, 40 CFR 401.16 
(i.e., biochemical oxygen demand (BOD<INF>5), total suspended solids 
(TSS), oil and grease, pH, and fecal coliform).
    (e) End-of-pipe effluent. Final plan effluent discharged to waters 
of the United States or to a POTW.
    (f) In-plant monitoring points. (1) For regulated organic 
pollutants, monitoring point(s) prior to dilution by non-process 
wastewater, commingling with other process wastewaters not containing 
the regulated organic pollutants at treatable levels, and any 
conveyance, equalization, or other wastewater treatment units that are 
open to the atmosphere.
    (2) For cyanide, monitoring point(s) prior to dilution or mixing 
with any noncyanide-bearing wastewater.
    (g) Minimum level. The level at which an analytical system gives 
recognizable signals and an acceptable calibration point. The following 
minimum levels (for water samples only) and analytical methods apply to 
pollutants in this part:

----------------------------------------------------------------------------------------------------------------
                                                                                                 Minimum level  
                                                                                                 micrograms per 
                    Pollutant                                        Method                    liter (<greek-m>g/
                                                                                                       L)       
----------------------------------------------------------------------------------------------------------------
Acetone..........................................  1624B                                                      50
Acetonitrile.....................................  1666, 1671                                              5,000
Ammonia (aqueous)................................  350.1, 350.2, 350.3                                        30
n-Amyl Acetate...................................  1666                                                        5
Amyl Alcohol.....................................  1666                                                      500
Aniline..........................................  1665                                                        2
Benzene..........................................  1624B                                                      10
BOD<INF>5.............................................  405.1                                                     (<SUP>a)
2-Butanone.......................................  1624B                                                      50
n-Butyl Acetate..................................  1666                                                        5
n-Butyl Alcohol..................................  1666                                                      500
[[Page 21656]]                                                                                                  
                                                                                                                
tert-Butyl Alcohol...............................  1666                                                      100
Chemical Oxygen Demand (COD).....................  410.1, 410.2, 410.3, 410.4                                (<SUP>a)
Chlorobenzene....................................  1624B                                                      10
Chloroform.......................................  1624B                                                      10
Chloromethane....................................  1624B                                                      50
Cyanide (Total)..................................  335.1, 335.2, 335.3                                       (<SUP>a)
Cyclohexane......................................  1666                                                        5
1,2-Dichlorobenzene..............................  1625B                                                      10
1,2-Dichloroethane...............................  1624B                                                      10
Diethylamine.....................................  1666, 1671                                             50,000
Diethyl Ether....................................  1624B                                                      50
N-N-Diethylacetamide.............................  1665                                                       50
N,N-Dimethylaniline..............................  1665                                                       10
Dimethylamine....................................  1666, 1671                                             50,000
N,N-Dimethylformamide............................  1665                                                        5
Dimethylsulforxide...............................  1666, 1671                                             20,000
1,4-Dioxane......................................  1624B                                                      50
Ethanol..........................................  1666, 1671(<SUP>b)                                           3,180
Ethyl Acetate....................................  1666                                                       10
Ethylene Glycol..................................  1666, 1671                                            100,000
Formaldehyde.....................................  1667                                                       50
Formamide........................................  1666, 1671                                            100,000
Furfural.........................................  1666, 1677                                                 50
n-Heptane........................................  1666                                                       10
n-Hexane.........................................  1666                                                       10
Isobutyraldehyde.................................  1666, 1667                                                 10
Isopropanol......................................  1666                                                      200
Isopropyl Acetate................................  1666                                                       10
Isopropyl Ether..................................  1666                                                        5
Methanol.........................................  1666, 1671(<SUP>a)                                           3,180
Methylamine......................................  1666, 1671                                             50,000
Methyl Cellosolve................................  1666, 1671                                             20,000
Methylene Chloride...............................  1624B                                                      10
Methyl Formate...................................  1666                                                      100
Methyl Isobutyl Ketone (MIBK)....................  1666                                                       10
2-Methylpyridine.................................  1624B, 1665                                                 5
Petroleum Naptha (as n-pentane)..................  1666                                                       10
Phenol...........................................  1625                                                       10
Polyethylene Glucol 600..........................  1673                                                    1,000
n-Propanol.......................................  1666, 1671(<SUP>b)                                           3,180
Pyridine.........................................  1665                                                        5
Tetrahydrofuran..................................  1666                                                       20
Toluene..........................................  1624                                                       10
Trichlorofluoromethane...........................  1666                                                       10
Triethlyamine....................................  1666, 1671                                             50,000
TSS..............................................  160.2                                                     (<SUP>a)
m,p-Xylene.......................................  1666                                                       10
o-Xylene.........................................  1666                                                        5
----------------------------------------------------------------------------------------------------------------
(<SUP>a)--As specified in 40 CFR Part 136.                                                                           
(<SUP>b)--Method 1671 is modified ASTM Method D3695-88.                                                              

    (h) New source. As defined in EPA's regulations at 40 CFR 122.2 and 
122.29.
    (i) Nonconventional pollutants. Pollutants that are neither 
conventional pollutants nor toxic pollutants.
    (j) Non-detect (ND) value. A concentration-based measurement 
reported below the minimum level (see paragraph (g) of this section) 
that can be reliably measured by the analytical method for the 
pollutant.
    (k) 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.
    (l) POTW. Publicly owned treatment works, as defined at 40 CFR 
403.3(o).
    (m) 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 runnoff from the immediate process area that has the potential 
to become contaminated.
    (1) For the purposes of this part, the following materials are 
excluded from the definition of process wastewater, and the discharge 
of such materials must be regulated separately.
    (i) Trimethyl silanol;
    (ii) Any active anti-microbial materials;
    (iii) Wastewater from imperfect fermentation batches; and
    (iv) Process area spills.
    (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 nonprocess water generated 
on site. The discharge of such waters and [[Page 21657]] wastewaters 
must be regulated separately.
    (n) Toxic pollutants. The pollutants designated by EPA as toxic in 
40 CFR 401.15.
    (o) Xylenes. The sum of o-xylene, p-xylene, and m-xylene.


Sec. 439.2  Monitoring requirements.

    Permit compliance monitoring is required for each regulated 
pollutant generated or used at a pharmaceutical manufacturing facility. 
Routine compliance monitoring is not required for regulated pollutants 
not generated or used at the facility. Except for cyanide, for which a 
separate procedure is established in subparts A and C, determination 
that regulated pollutants are not generated or used should be based on 
a review of all raw materials used, and an assessment of all chemical 
processes used, considering resulting products and by-products. The 
determination that a regulated pollutant is not generated or used must 
be confirmed by annual chemical analyses of wastewater from each 
monitoring location. Such confirmation is provided by an analytical 
measurement of a non-detect value. Compliance monitoring for all 
regulated pollutants generated or used is required at each of the 
monitoring locations specified in this part for those pollutants or at 
such locations specified pursuant to 40 CFR 122.45.

----------------------------------------------------------------------------------------------------------------
                                                                                                    Monitoring  
                                                                                                     frequency  
      CAS No.                                         Pollutant                                   (frequency per
                                                                                                       week)    
----------------------------------------------------------------------------------------------------------------
67-64-1...........  Acetone.....................................................................               1
75-05-8...........  Acetonitrile................................................................               1
1336-21-6.........  Ammonia.....................................................................               1
628-63-7..........  n-Amyl Acetate..............................................................               1
71-41-0...........  Amyl Alcohol................................................................               1
62-53-3...........  Aniline.....................................................................               1
71-43-2...........  Benzene.....................................................................               1
78-93-3...........  2-Butanone..................................................................               1
123-86-4..........  n-Butyl Acetate.............................................................               1
71-36-3...........  n-Butyl Alcohol.............................................................               1
75-65-0...........  tert-Butyl Alcohol..........................................................               1
C-004-(r).........  Chemical Oxygen Demand (COD)................................................               7
108-90-7..........  Chloabenzene................................................................               1
67-66-3...........  Chloroform..................................................................               1
74-87-3...........  Chloromethane...............................................................               1
57-12-5...........  Cyanide, Total..............................................................            (<SUP>b)1
110-82-7..........  Cyclohexane.................................................................               1
95-50-1...........  1,2-Dichlorobenzene.........................................................               1
107-06-2..........  1,2-Dichloroethane..........................................................               1
109-89-7..........  Diethylamine................................................................               1
60-29-7...........  Diethyl ether...............................................................               1
127-19-5..........  N,N-Dimethylacetamide.......................................................               1
121-69-7..........  N,N-Dimethylaniline.........................................................               1
124-40-3..........  Dimethylamine...............................................................               1
68-12-2...........  N,N-Dimethylformamide.......................................................               1
67-68-5...........  Dimethylsulfoxide...........................................................               1
123-91-1..........  1,4-Dioxane.................................................................               1
64-17-5...........  Ethanol.....................................................................               1
141-78-6..........  Ethyl acetate...............................................................               1
107-21-1..........  Ethylene glycol.............................................................               1
50-00-1...........  Formaldehyde................................................................               1
75-12-7...........  Formamide...................................................................               1
98-01-1...........  Furfural....................................................................               1
142-82-5..........  n-Heptane...................................................................               1
110-54-3..........  n-Hexane....................................................................               1
78-84-2...........  Isobutyraldehyde............................................................               1
67-63-0...........  Isopropanol.................................................................               1
108-21-4..........  Isopropyl acetate...........................................................               1
108-20-3..........  Isopropyl ether.............................................................               1
67-56-1...........  Methanol....................................................................               1
74-89-5...........  Methylamine.................................................................               1
109-86-4..........  Methyl Cellosolve...........................................................               1
75-09-2...........  Methylene Chloride..........................................................               1
107-31-3..........  Methyl formate..............................................................               1
108-10-1..........  Methyl Isobutyl Ketone......................................................               1
109-06-8..........  2-Methylpyridine............................................................               1
8030-30-6.........  Petroleum Naphtha...........................................................               1
108-95-2..........  Phenol......................................................................               1
25322-68-3........  Polyethylene Glycol 600.....................................................               1
71-23-8...........  n-Propanol..................................................................               1
110-86-1..........  Pyridine....................................................................               1
109-99-9..........  Tetrahydrofuran.............................................................               1
108-88-3..........  Toluene.....................................................................               1
75-69-4...........  Trichlorodluoromethane......................................................               1
121-44-8..........  Triethylamine...............................................................               1
(<SUP>c)...............  Xylenes.....................................................................               1
C-002-(a).........  BOD<INF>5........................................................................               7
[[P<INF>age 21658]]                                                                                                  
                                                                                                                
C-009-(a).........  TSS.........................................................................               7
----------------------------------------------------------------------------------------------------------------
(<SUP>a) These are synthetic CASRN's designed for use with the Environmental Monitoring Methods Index (EMMI).        
(<SUP>b) Monitoring fequency for cyanide is once per treated batch.                                                  
(<SUP>c) M-Xylene 108-38-3, o-Xylene 95-47- 6, p-Xylene 106-42-3.                                                    

Sec. 439.3  Dilution prohibition.

    Dilution may not be practiced to meet the effluent limitations and 
standards specified in this part.


Sec. 439.4  [Reserved]

Subpart A--Fermentation Subcategory

    4. Sections 439.10 through 439.14 are revised to read as follows:


Sec. 439.10  Applicability; description of the fermentation 
subcategory; prohibition.

    (a) The provisions of this subpart are applicable to discharges 
resulting from the manufacture of pharmaceuticals by fermentation. 
Fermentation operations are defined as process operations that utilize 
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 to produce a specified product. Fermentation 
operations include pilot-scale research operations not covered by the 
provisions of subpart E, Research Subcategory.
    (b) The discharge of nonprocess wastewater and materials excluded 
from the definition of process wastewater at Sec. 439.1 is not covered 
by this subpart. Discharge of such nonprocess wastewater and excluded 
materials into publicly owned treatment works or waters of the United 
States by a source subject to this subpart without an NPDES permit or 
individual control mechanism authorizing such discharge is prohibited.


Sec. 439.11  Specialized definitions.

    For the purpose of this subpart:
    (a) Except as provided in paragraph (b) of this section, the 
general definitions, abbreviations, and methods of analysis set forth 
in 40 CFR part 401 and Sec. 439.1 shall apply to this subpart.
    (b) The term ``product'' shall mean pharmaceutical products derived 
from fermentation processes.


Sec. 439.12  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available (BPT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available.
    (1) Subpart A (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                                        BPT effluent    
                                                         limitations    
                                                    micrograms per liter
                                                       (<greek-m>g/L)   
          Pollutant or pollutant property          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
Cyanide (Total)...................................        766        406
------------------------------------------------------------------------

    (2) Subpart A (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                                       BPT effluent     
                                                  limitations milligrams
                                                     per liter (mg/L)   
         Pollutant or pollutant property         -----------------------
                                                    Maximum             
                                                    for any     Monthly 
                                                    one day     average 
------------------------------------------------------------------------
BOD<INF>5............................................         137          58
TSS.............................................         318         110
COD.............................................        1100         628
------------------------------------------------------------------------

    (3) The pH shall be within the range of 6.0-9.0 standard units.
    (b) Permittees not using or generating cyanide are deemed to comply 
with the monitoring requirements specified in paragraph (a) of this 
section for cyanide if they certify to the permit issuing authority 
that they are not using or generating this pollutant.


Sec. 439.13  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best conventional 
pollutant control technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the degree of effluent reduction 
attainable by the application of the best conventional pollutant 
control technology: The limitations shall be the same as those 
specified for the conventional pollutants BOD<INF>5 and TSS in 
Sec. 439.12 for the best practicable control technology currently 
available.


Sec. 439.14  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best available 
technology economically achievable.
    (1) Subpart A (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                                        BAT effluent    
                                                         limitations    
                                                    micrograms per liter
                                                       (<greek-m>g/L)   
          Pollutant or pollutant property          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
Cyanide (Total)...................................        766        406
------------------------------------------------------------------------

    (2) Subpart A (For End-of-Pipe Effluent). The limitations in the 
following table do not apply for any pollutant(s) for which the permit 
writer finds it necessary to specify in-plant monitoring requirements 
pursuant to 40 CFR 122.44(i) and 122.45(h). Limitations for those 
pollutant(s) would be established on a best professional judgment basis 
pursuant to 40 CFR 125.3.

                                                                        
[[Page 21659]]                                                          
------------------------------------------------------------------------
                                             BAT effluent limitations   
                                           micrograms per liter (<greek-
                                                     m>NDg/L)           
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................              ND              ND
Acetonitrile............................              ND              ND
Ammonia.................................           4,850           3,230
n-Amyl Acetate..........................             105              45
Amyl Alcohol............................             668              ND
Aniline.................................              10              10
Benzene.................................              ND              ND
2-Butanone (MEK)........................             202              86
n-Butyl Acetate.........................              87              37
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................             668             284
Chemical Oxygen Demand (COD)............       1,100,000         628,000
Chlorobenzene...........................              ND              ND
Chloroform..............................              ND              ND
Chloromethane...........................              ND              ND
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................             100              35
Diethylamine............................              ND              ND
Diethyl Ether...........................             574             244
Dimethylamine...........................              ND              ND
N,N-Dimethylacetamide...................              ND              ND
N,N-Dimethylaniline.....................              50              50
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................             220              94
Ethanol.................................              ND              ND
Ethyl Acetate...........................             105              45
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................           2,670           1,140
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................           1,370             581
Isopropanol.............................              ND              ND
Isopropyl Acetate.......................              87              37
Isopropyl Ether.........................             574             244
Methanol................................              ND              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methyl Formate..........................             105              ND
Methylene Chloride......................              ND              ND
Methyl Isobutyl Ketone (MIBK)...........              ND              ND
2-Methylpyridine........................              50              50
Petroleum Naphtha.......................              ND              ND
Phenol..................................              25              14
Polyethylene Clycol 600.................           4,870           2,070
n-Propanol..............................              ND              ND
Pyridine................................              10              10
Tetrahydrofuran.........................             910             264
Toluene.................................              ND              ND
Trichlorofluoromethane..................              ND              ND
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    (b) Permittees not using or generating cyanide are deemed to comply 
with the monitoring requirements specified in paragraph (a) of this 
section for cyanide if they certify to the permit issuing authority 
that they are not using or generating this pollutant.
    5. Section 439.15 is amended by revising paragraph (a) introductory 
text and paragraph (b) and by adding paragraph (c) to read as follows:


Sec. 439.15  New source performance standards (NSPS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following new source performance standards until 
the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the effluent 
limitations specified in Secs. 439.12, 439.13, and 439.14.
* * * * *
    (b) Except as provided in paragraph (a) of this section, any new 
source subject to this subpart must achieve the following new source 
performance standards.
    (1) Subpart A (For In-Plant Monitoring Points).

                                                                        
[[Page 21660]]                                                          
------------------------------------------------------------------------
                                                         New source     
                                                         performance    
                                                    standards micrograms
                                                     per liter (<greek- 
          Pollutant or pollutant property                  m>g/L)       
                                                   ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
Cyanide (Total)...................................        766        406
------------------------------------------------------------------------

    (2) Subpart A (For End-of Pipe Effluent). The standards in the 
following table do not apply for any pollutant(s) for which the permit 
writer finds it necessary to specify in-plant monitoring requirements 
pursuant to 40 CFR 122.44(i) and 122.45(h). Standards for those 
pollutant(s) would be established on a best professional judgment basis 
pursuant to 40 CFR 125.3.

------------------------------------------------------------------------
                                              New source performance    
                                          standards micrograms per liter
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................              ND              ND
Acetonitrile............................              ND              ND
Ammonia.................................           4,850           3,230
n-Amyl Acetate..........................              14               6
Amyl Alcohol............................              ND              ND
Aniline.................................              10               4
Benzene.................................              ND              ND
2-Butanone (MEK)........................             144              61
n-Butyl Acetate.........................              11              ND
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................              ND              ND
Chlorobenzene...........................              ND              ND
Chloroform..............................              ND              ND
Chloromethane...........................              ND              ND
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................              13              ND
Diethylamine............................              ND              ND
Diethyl Ether...........................              74              ND
Dimethylamine...........................              ND              ND
N,N-Dimethylacetamide...................              ND              ND
N,N-Dimethylaniline.....................              50              45
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................              ND              ND
Ethanol.................................              ND              ND
Ethyl Acetate...........................              14              ND
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................              53              ND
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................             304             129
Isopropanol.............................              ND              ND
Isopropyl Acetate.......................              11              ND
Isopropyl Ether.........................              74              32
Methanol................................              ND              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methyl Formate..........................              ND              ND
Methylene Chloride......................              ND              ND
Methyl Isobutyl Ketone (MIBK)...........              ND              ND
2-Methylpyridine........................              50              45
Petroleum Naphtha.......................              ND              ND
Phenol..................................              25              14
Polyethylene Glycol 600.................           4,870           2,070
n-Propanol..............................              ND              ND
Pyridine................................              10              10
Tetrahydrofuran.........................             910             264
Toluene.................................              ND              ND
Trichlorofluoromethane..................              ND              ND
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    (3) Subpart A For End-of-Pipe Effluent).

                                                                        
[[Page 21661]]                                                          
------------------------------------------------------------------------
                                              New source performance    
                                          standards milligrams per liter
                                                      (mg/L)            
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
BOD<INF>5....................................              62              29
COD.....................................             781             538
TSS.....................................              87              43
pH......................................             (<SUP>a)             (<SUP>a)
------------------------------------------------------------------------
(<SUP>a)Within the range of 6.0 to 9.0 standard units.                       

    (c) Permittees not using or generating cyanide are deemed to comply 
with the monitoring requirements specified in paragraph (a) of this 
section for cyanide if they certify to the permit issuing authority 
that they are not using or generating this pollutant.
    6. Section 439.16 is revised to read as follows:


Sec. 439.16  Pretreatment standards for existing sources (PSES).

    (a) Except as provided in 40 CFR 403.7 and 403.13, any existing 
source subject to this subpart that introduces pollutants into a 
publicly owned treatment works must comply with 40 CFR part 403 by 
[date 3 years from the promulgation date of the final rule] and achieve 
the following pretreatment standards for existing sources.
    (1) Subpart A (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Benzene.................................             796             268
Chlorobenzene...........................             796             268
Chloroform..............................              ND              ND
Chloromethane...........................             796             268
Cyanide.................................             766             406
Cyclohexane.............................             796             268
n-Heptane...............................             796             268
n-Hexane................................             796             268
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Toluene.................................             198             148
Trichlorofluoromethane..................             796             268
Xylenes.................................             796             268
------------------------------------------------------------------------

    (2) Subpart A (For End-of-Pipe Monitoring Points).

    [Note: With respect to pollutants in this table, EPA proposes 
pretreatment standards for
    existing sources only for ammonia under co-proposal (2).]

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................          31,400           9,690
Ammonia.................................          12,900          10,900
n-Amyl Acetate..........................          23,900           8,050
Amyl Alcohol............................         607,000         205,000
Aniline.................................      10,900,000       3,690,000
2-Butanone (MEK)........................       1,440,000         430,000
n-Butyl Acetate.........................          23,900           8,050
n-Butyl Alcohol.........................      10,900,000       3,690,000
tert-Butyl Alcohol......................         607,000         205,000
o-Dichlorobenzene.......................          23,900           8,050
1,2-Dichloroethane......................          23,900           8,050
Diethylamine............................              ND              ND
Diethyl Ether...........................          23,900           8,050
Dimethylamine...........................         607,000         205,000
N,N-Dimethylaniline.....................         607,000         205,000
1,4-Dioxane.............................      10,900,000       3,690,000
Ethanol.................................       2,200,000         784,000
Ethyl Acetate...........................          23,900           8,050
Formamide...............................         607,000         205,000
Furfural................................         607,000         205,000
Isobutyraldehyde........................          23,900           8,050
[[Page 21662]]                                                          
                                                                        
Isopropanol.............................         597,000         198,000
Isopropyl Acetate.......................          23,900           8,050
Isopropyl Ether.........................          23,900           8,050
Methanol................................      11,700,000       3,800,000
Methylamine.............................         607,000         205,000
Methyl Formate..........................          23,900           8,050
Methyl Isobutyl Ketone (MIBK)...........          23,900           8,050
2-Methylpyridine........................         607,000         205,000
Petroleum Naphtha.......................      10,900,000       3,690,000
n-Propanol..............................       2,790,000         941,000
Pyridine................................           1,000           1,000
Tetrahydrofuran.........................           9,210           3,360
Triethylamine...........................              ND              ND
------------------------------------------------------------------------

    (b) Indirect dischargers not using or generating cyanide are deemed 
to comply with the monitoring requirements specified in paragraph (a) 
of this section for cyanide if they certify to the control authority 
that they are not using or generating this pollutant.
    7. Section 439.17 is amended by revising paragraph (a) introductory 
text and paragraph (b) and by adding paragraph (c) to read as follows:


Sec. 439.17  Pretreatment standards for new sources (PSNS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following pretreatment standards for new sources 
until the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the standards 
specified in Sec. 439.16.
* * * * *
    (b) Except as provided in 40 CFR 403.7 and paragraph (a) of this 
section, any new source subject to this subpart that introduces 
pollutants into a publicly owned treatment works must comply with 40 
CFR part 403 and achieve the following pretreatment standards for new 
sources.
    (1) Subpart A (For In-Plant Monitoring).

    [Note: With respect to pollutants in this table, EPA does not 
propose pretreatment standards for new sources for pollutants with 
an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone*................................           1,190             600
Amyl Alcohol*...........................           8,690           3,220
Benzene.................................             573             212
n-Butyl Alcohol*........................           8,690           3,220
tert-Butyl Alcohol*.....................           8,690           3,220
Chlorobenzene...........................             573             212
Chloroform..............................              ND              ND
Chloromethane...........................             573             212
Cyanide.................................             766             406
Cyclohexane.............................             573             212
Diethylamine*...........................              ND              ND
Diethyl Ether*..........................           2,230             826
Dimethylamine*..........................              ND              ND
Ethanol*................................           8,690           3,220
Formamide*..............................              ND              ND
n-Heptane...............................             573             212
n-Hexane................................             573             212
Isopropanol*............................           8,690           3,220
Methanol*...............................           8,320              ND
Methylamine*............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Methyl Formate*.........................           2,230             826
n-Propanol*.............................           8,690           3,220
Toluene.................................             184             135
Trichlorofluoromethane..................             573             212
Triethylamine*..........................              ND              ND
Xylenes.................................             573             212
------------------------------------------------------------------------

    (2) Subpart A (For End-of-Pipe Monitoring Points).

    [[Page 21663]] [Note: With respect to pollutants in this table, 
EPA does not propose pretreatment standards for new sources for 
pollutants with an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Ammonia.................................          12,900          10,900
n-Amyl Acetate*.........................           2,230             826
Aniline*................................           8,690           3,220
2-Butanone (MEK)*.......................         161,000          57,900
n-Butyl Acetate*........................           2,230             826
o-Dichlorobenzene*......................           2,230             826
1,2-Dichloroethane*.....................           2,230             826
N,N-Dimethylaniline*....................           8,690           3,220
1,4-Dioxane*............................           8,690           3,220
Ethyl Acetate*..........................           2,230             826
Furfural*...............................           8,690           3,220
Isobutyraldehyde*.......................           2,230             826
Isopropyl Acetate*......................           2,230             826
Isopropyl Ether*........................           2,230             826
Methyl Isobutyl Ketone (MIBK)*..........           2,230             826
2-Methylpyridine*.......................           8,690           3,220
Petroleum Naphtha*......................           8,690           3,220
Pyridine*...............................           1,000           1,000
Tetrahydrofuran*........................           9,210           3,360
------------------------------------------------------------------------

    (c) Indirect dischargers not using or generating cyanide are deemed 
to comply with the monitoring requirements specified in paragraph (a) 
of this section for cyanide if they certify to the control authority 
that they are not using or generating this pollutant.


Sec. 439.18  [Reserved]

Subpart B--Extraction Subcategory

    8. Sections 439.20 through 439.24 are revised to read as follows:


Sec. 439.20  Applicability; description of the extraction subcategory; 
prohibition.

    (a) The provisions of this subpart are applicable to discharges 
resulting from the manufacture of pharmaceutical products by biological 
and natural extraction operations. Biological and natural extraction 
operations are defined as process operations that utilize the chemical 
and physical extraction of pharmaceutically active ingredients from 
natural sources such as plant roots and leaves, animal glands, and 
parasitic fungi. Biological and natural extraction operations include 
pilot-scale research operations not covered by the provisions of 
subpart E, Research Subcategory.
    (b) The discharge of nonprocess wastewater and materials excluded 
from the definition of process wastewater at Sec. 439.1 is not covered 
by this subpart. Discharge of such nonprocess wastewater and excluded 
materials into publicly owned treatment works or waters of the United 
States by a source subject to this subpart without an NPDES permit or 
individual control mechanism authorizing such discharge is prohibited.


Sec. 439.21  Specialized definitions.

    (a) Except as provided paragraph (b) of this section, the general 
definitions, abbreviations, and methods of analysis set forth in 40 CFR 
part 401 and Sec. 439.1 shall apply to this subpart.
    (b) The term ``product'' shall mean any biological and natural 
extraction product. This subcategory shall include blood fractions, 
vaccines, serums, animal bile derivatives, endocrine products, and 
isolation of medicinal products, such as alkaloids, from botanical 
drugs and herbs.


Sec. 439.22  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available (BPT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available.
    (1) Subpart B (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                                        BPT effluent    
                                                         limitations    
                                                    milligrams per liter
                                                           (mg/L)       
         Pollutant or pollutant parameter          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
BOD<INF>5..............................................         37         11
TSS...............................................         80         27
COD...............................................        145         60
------------------------------------------------------------------------

    (2) The pH shall be within the range of 6.0-9.0 standard units.
    (b) [Reserved]


Sec. 439.23  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best conventional 
pollutant control technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the degree of effluent reduction 
attainable by the application of the best conventional pollutant 
control technology: The limitations shall be the same as those 
specified for conventional pollutants BOD<INF>5 and TSS in Sec. 439.22 
for the best practicable control technology currently available.


Sec. 439.24  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of 
[[Page 21664]] effluent reduction attainable by the application of the 
best available technology economically achievable.
    (1) Subpart B (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                             BAT effluent limitations   
                                           micrograms per Liter (<greek-
                                                      m>g/L)            
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................             413             178
Acetonitrile............................              ND              ND
n-Amyl Acetate..........................           3,000           1,280
Amyl Alcohol............................           3,980           1,690
Aniline.................................              10              10
Benzene.................................              40              17
2-Butanone (MEK)........................             202              86
n-Butyl Acetate.........................             500             500
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................           3,980           1,690
Chemical Oxygen Demand (COD)............         145,000          59,900
Chlorobenzene...........................              ND              ND
Chloroform..............................              22              13
Chloromethane...........................             206              87
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................             438             152
Diethylamine............................              ND              ND
Diethyl Ether...........................           4,870           2,070
N,N-Dimethylacetamide...................              ND              ND
Dimethylamine...........................              ND              ND
N,N-Dimethylaniline.....................              50              50
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................             220              94
Ethanol.................................              ND              ND
Ethyl Acetate...........................           3,000           1,280
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................           3,000           1,280
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................           1,370             581
Isopropanol.............................           1,120             476
Isopropyl Acetate.......................             500             500
Isopropyl Ether.........................           4,870           2,070
Methanol................................           6,660              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................           1,420             357
Methyl Formate..........................           3,000           1,280
Methyl Isobutyl Ketone (MIBK)...........             119              51
2-Methylpyridine........................              50              50
Petroleum Naphtha.......................              40              17
Phenol..................................              25              14
Polyethylene Glycol 600.................           4,870           2,070
n-Propanol..............................           3,980              ND
Pyridine................................              10              10
Tetrahydrofuran.........................          15,000           4,350
Toluene.................................              40              17
Trichlorofluoromethane..................             599             322
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    (2) [Reserved]
    (b) [Reserved]
    9. Section 439.25 is amended by revising paragraph (a) introductory 
text and paragraph (b) to read as follows:


Sec. 439.25  New source performance standards (NSPS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following new source performance standards until 
the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the effluent 
limitations [[Page 21665]] specified in Secs. 439.22, 439.23, and 
439.24.
* * * * *
    (b) Except as provided in paragraph (a) of this section any new 
source subject to this subpart must achieve the following new source 
performance standards.
    (1) Subpart B (For End-of-Pipe Effluent) The standards in the 
following table do not apply for any pollutant(s) for which the permit 
writer finds it necessary to specify in-plant monitoring requirements 
pursuant to 40 CFR 122.44(i) and 122.45(h). Standards for those 
pollutant(s) would be established on a best professional judgment basis 
pursuant to 40 CFR 125.3.

------------------------------------------------------------------------
                                              New source performance    
                                          standards micrograms per liter
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................              ND              ND
Acetonitrile............................              ND              ND
Ammonia.................................           4,850           3,230
n-Amyl Acetate..........................              14               6
Amyl Alcohol............................              ND              ND
Aniline104 Benzene......................              ND            10/4
2-Butanone (MEK)........................             144              61
n-Butyl Acetate.........................              11              ND
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................              ND              ND
Chlorobenzene...........................              ND              ND
Chloroform..............................              ND              ND
Chloromethane...........................              ND              ND
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................              13              ND
Diethylamine............................              ND              ND
Diethyl Ether...........................              74              ND
Dimethylamine...........................              ND              ND
N,N-Dimethylacetamide...................              ND              ND
N,N-Dimethylaniline.....................              50              45
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................              ND              ND
Ethanol.................................              ND              ND
Ethyl Acetate...........................              14              ND
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................              53              ND
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................             304             129
Isopropanol.............................              ND              ND
Isopropyl Acetate.......................              11              ND
Isopropyl Ether.........................              74              32
Methanol................................              ND              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methyl Formate..........................              ND              ND
Methylene Chloride......................              ND              ND
Methyl Isobutyl Ketone (MIBK)...........              ND              ND
2-Methylpyridine........................              50              45
Petroleum Naphtha.......................              ND              ND
Phenol..................................              25              14
Polyethylene Glycol 600.................           4,870           2,070
n-Propanol..............................              ND              ND
Pyridine................................              10              10
Tetrahydrofuran.........................             910             264
Toluene.................................              ND              ND
Trichlorofluoromethane..................              ND              ND
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    [[Page 21666]] (2) Subpart B (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                                         New source     
                                                         performance    
                                                    standards milligrams
                                                      per liter (mg/L)  
         Pollutant or pollutant parameter          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
BOD<INF>5..............................................         34         10
COD...............................................         60         24
TSS...............................................         40         12
pH................................................        (<SUP>a)       (<SUP>a) 
------------------------------------------------------------------------
(<SUP>a)Within the range of 6.0 to 9.0 standard units.                       

    10. Section 439.26 is revised to read as follows:


Sec. 439.26  Pretreatment standards for existing sources (PSES).

    (a) Except as provided in 40 CFR 403.7 and 403.13, any existing 
source subject to this subpart that introduces pollutants into a 
publicly owned treatment works must comply with 40 CFR part 403 and by 
[date 3 years from the promulgation date of the final rule] achieve the 
following pretreatment standards for existing sources.
    (1) Subpart B (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Benzene.................................             796             268
Chlorobenzene...........................             796             268
Chloroform..............................              ND              ND
Chloromethane...........................             796             268
Cyclohexane.............................             796             268
n-Heptane...............................             796             268
n-Hexane................................             796             268
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Toluene.................................             198             148
Trichlorofluoromethane..................             796             268
Xylenes.................................             796             268
------------------------------------------------------------------------

    (2) Subpart B (For End-of-Pipe Monitoring Points).


    (Note: Under co-proposal (2), EPA does not propose pretreatment 
standards for existing sources for these pollutants.)

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................          31,400           9,690
n-Amyl Acetate..........................          23,900           8,050
Amyl Alcohol............................         607,000         205,000
Aniline.................................      10,900,000       3,690,000
2-Butanone (MEK)........................       1,440,000         430,000
n-Butyl Acetate.........................          23,900           8,050
n-Butyl Alcohol.........................      10,900,000       3,690,000
tert-Butyl Alcohol......................         607,000         205,000
o-Dichlorobenzene.......................          23,900           8,050
1,2-Dichloroethane......................          23,900           8,050
Diethylamine............................              ND              ND
Diethyl Ether...........................          23,900           8,050
Dimethylamine...........................         607,000         205,000
N,N-Dimethylaniline.....................         607,000         205,000
1,4-Dioxane.............................      10,900,000       3,690,000
Ethanol.................................       2,200,000         784,000
Ethyl Acetate...........................          23,900           8,050
Formamide...............................         607,000         205,000
Furfural................................         607,000         205,000
Isobutyraldehyde........................          23,900           8,050
Isopropanol.............................         597,000         198,000
Isopropyl Acetate.......................          23,900           8,050
Isopropyl Ether.........................          23,900           8,050
Methanol................................      11,700,000       3,800,000
Methylamine.............................         607,000         205,000
Methyl Formate..........................          23,900           8,050
Methyl Isobutyl Ketone (MIBK)...........          23,900           8,050
2-Methylpyridine........................         607,000         205,000
Petroleum Naphtha.......................      10,900,000       3,690,000
n-Propanol..............................       2,790,000         941,000
Pyridine................................           1,000           1,000
[[Page 21667]]                                                          
                                                                        
Tetrahydrofuran.........................           9,210           3,360
Triethylamine...........................              ND              ND
------------------------------------------------------------------------

    (b) [Reserved]
    11. Section 439.27 is amended by revising paragraph (a) 
introductory text and paragraph (b) to read as follows:


Sec. 439.27  Pretreatment standards for new sources (PSNS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following pretreatment standards for new sources 
until the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the standards 
specified in Sec. 439.26.
* * * * *
    (b) Except as provided in 40 CFR 403.7 and paragraph (a) of this 
section, any new source subject to this subpart that introduces 
pollutants into a publicly owned treatment works must comply with 40 
CFR part 403 and achieve the following pretreatment standards for new 
sources.
    (1) Subpart B (For In-Plant Monitoring Points).

    [Note: With respect to pollutants in this table, EPA does not 
propose pretreatment standards for new sources for pollutants with 
an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone*................................           1,190             600
Amyl Alcohol*...........................           8,690           3,220
Benzene.................................             573             212
n-Butyl Alcohol*........................           8,690           3,220
tert-Butyl Alcohol*.....................           8,690           3,220
Chlorobenzene...........................             573             212
Chloroform..............................              ND              ND
Chloromethane...........................             573             212
Cyclohexane.............................             573             212
Diethylamine*...........................              ND              ND
Diethyl Ether*..........................           2,230             826
Dimethylamine*..........................              ND              ND
Ethanol*................................           8,690           3,220
Formamide*..............................              ND              ND
n-Heptane...............................             573             212
n-Hexane................................             573             212
Isopropanol*............................           8,690           3,220
Methanol*...............................           8,320              ND
Methylamine*............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Methyl Formate*.........................           2,230             826
n-Propanol*.............................           8,690           3,220
Toluene.................................             184             135
Trichlorofluoromethane..................             573             212
Triethylamine*..........................              ND              ND
Xylenes.................................             573             212
------------------------------------------------------------------------

    (2) Subpart B (For End-of-Pipe Monitoring Points).

    [Note: With respect to pollutants in this table, EPA does not 
propose pretreatment standards for new sources for pollutants with 
an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
n-Amyl Acetate*.........................           2,230             826
Aniline*................................           8,690           3,220
2-Butanone (MEK)*.......................         161,000          57,900
n-Butyl Acetate*........................           2,230             826
o-Dichlorobenzene*......................           2,230             826
1,2-Dichloroethane*.....................           2,230             826
[[Page 21668]]                                                          
                                                                        
N,N-Dimethylaniline*....................           8,690           3,220
1,4-Dioxane*............................           8,690           3,220
Ethyl Acetate*..........................           2,230             826
Furfural*...............................           8,690           3,220
Isobutyraldehyde*.......................           2,230             826
Isopropyl Acetate*......................           2,230             826
Isopropyl Ether*........................           2,230             826
Methyl Isobutyl Ketone (MIBK)*..........           2,230             826
2-Methylpyridine*.......................           8,690           3,220
Petroleum Naphtha*......................           8,690           3,220
Pyridine*...............................           1,000           1,000
Tetrahydrofuran*........................           9,210           3,360
------------------------------------------------------------------------

Sec. 439.28  [Reserved]

Subpart C--Chemical Synthesis Subcategory

    12. Sections 439.30 through 439.34 are revised to read as follows:


Sec. 439.30  Applicability; description of the chemical synthesis 
subcategory; prohibition.

    (a) The provisions of this subpart are applicable to discharges 
resulting from the manufacture of pharmaceutical products by chemical 
synthesis operations. Chemical synthesis is defined as the process(es) 
of using a chemical reaction or series of chemical reactions to produce 
a specified product. Chemical synthesis operations include pilot-scale 
research operations not covered by the provisions of subpart E, 
Research Subcategory.
    (b) The discharge of non-process wastewater and materials excluded 
from the definition of process wastewater at Sec. 439.1 is not covered 
by this subpart. Discharge of such non-process wastewater and excluded 
materials into publicly owned treatment works or waters of the United 
States by a source subject to this subpart without an NPDES permit or 
individual control mechanism authorizing such discharge is prohibited.


Sec. 439.31  Specialized definitions.

    For the purpose of this subpart:
    (a) Except as provided in paragraph (b) of this section, the 
general definitions, abbreviations, and methods of analysis set forth 
in 40 CFR part 401 and Sec. 439.1 shall apply to this subpart.
    (b) The term ``product'' shall mean any pharmaceutical product 
derived from chemical synthesis processes.


Sec. 439.32  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available (BPT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available.
    (1) Subpart C (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                                        BPT effluent    
                                                         limitations    
                                                    micrograms per liter
                                                       (<greek-m>g/L)   
          Pollutant or pollutant property          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
Cyanide (Total)...................................        766        406
------------------------------------------------------------------------

    (2) Subpart C (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                                        BPT effluent    
                                                         limitations    
                                                    micrograms per liter
                                                           (mg/L)       
          Pollutant or pollutant property          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
BOD<INF>5..............................................        137         58
TSS...............................................        318        110
COD...............................................       1100        628
------------------------------------------------------------------------

    3) The pH shall be within the range of 6.0-9.0 standard units.
    (b) Permittees not using or generating cyanide are deemed to comply 
with the monitoring requirements specified in paragraph (a) of this 
section for cyanide if they certify to the permit issuing authority 
that they are not using or generating this pollutant.


Sec. 439.33  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best conventional 
pollutant control technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the degree of effluent reduction 
attainable by the application of the best conventional pollutant 
control technology: The limitations shall be the same as those 
specified for conventional pollutants BOD<INF>5 and TSS in Sec. 439.32 
for the best practicable control technology currently available.


Sec. 439.34  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best available 
technology economically achievable.
    (1) Subpart C (For In-Plant Monitoring Points)

------------------------------------------------------------------------
                                                        BAT effluent    
                                                         limitations    
                                                    micrograms per liter
                                                       (<greek-m>g/L)   
          Pollutant or pollutant property          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
Cyanide (Total)...................................        766        406
------------------------------------------------------------------------

    (2) Subpart C (For End-of-Pipe Effluent). The limitations in the 
following table do not apply for any pollutant(s) for which the permit 
writer finds it necessary to specify in-plant monitoring requirements 
pursuant to 40 CFR 122.44(i) and 122.45(h). Limitations for those 
pollutant(s) would be established on a best professional 
[[Page 21669]] judgment basis pursuant to 40 CFR 125.3.

------------------------------------------------------------------------
                                             BAT effluent limitations   
                                           micrograms per liter (<greek-
                                                      m>g/L)            
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................              ND              ND
Acetonitrile............................              ND              ND
Ammonia.................................           4,850           3,230
n-Amyl Acetate..........................             105              45
Amyl Alcohol............................             668              ND
Aniline.................................              10              10
Benzene.................................              ND              ND
2-Butanone (MEK)........................             202              86
n-Butyl Acetate.........................              87              37
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................             668             284
Chemical Oxygen Demand (COD)............       1,100,000         628,000
Chlorobenzene...........................              ND              ND
Chloroform..............................              ND              ND
Chloromethane...........................              ND              ND
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................             100              35
Diethylamine............................              ND              ND
Diethyl Ether...........................             574             244
Dimethylamine...........................              ND              ND
N,N-Dimethylacetamide...................              ND              ND
N,N-Dimethylaniline.....................              50              50
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................             220              94
Ethanol.................................              ND              ND
Ethyl Acetate...........................             105              45
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................           2,670           1,140
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................           1,370             581
Isopropanol.............................              ND              ND
Isopropyl Acetate.......................              87              37
Isopropyl Ether.........................             574             244
Methanol................................              ND              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methyl Formate..........................             105              ND
Methylene Chloride......................              ND              ND
Methyl Isobutyl Ketone (MIBK)...........              ND              ND
2-Methylpyridine........................              50              50
Petroleum Naphtha.......................              ND              ND
Phenol..................................              25              14
Polyethylene glycol 600.................           4,870           2,070
n-Propanol..............................              ND              ND
Pyridine................................              10              10
Tetrahydrofuran.........................             910             264
Toluene.................................              ND              ND
Trichlorofluoromethane..................              ND              ND
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    (b) Permittees not using or generating cyanide are deemed to comply 
with the monitoring requirements specified in paragraph (a) of this 
section for cyanide if they certify to the permit issuing authority 
that they are not using or generating this pollutant.
    13. Section 439.35 is amended by revising paragraph (a) 
introductory text and paragraph (b) and by adding paragraph (c) to read 
as follows:


Sec. 439.35  New source performance standards (NSPS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following new source performance standards until 
the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the effluent 
limitations [[Page 21670]] specified in Secs. 439.32, 439.33, and 
439.34.
* * * * *
    (b) Except as provided in paragraph (a) of this section, any new 
source subject to this subpart must achieve the following new source 
performance standards.
    (1) Subpart C (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                                         New source     
                                                         performance    
                                                    standards micrograms
                                                     per liter (<greek- 
          Pollutant or pollutant property                  m>g/L)       
                                                   ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
Cyanide (Total)...................................        766        406
------------------------------------------------------------------------

    (2) Subpart C (For End-of-Pipe Effluent). The standards in the 
following table do not apply for any pollutant(s) for which the permit 
writer finds it necessary to specify in-plant monitoring requirements 
pursuant to 40 CFR 122.44(i) and 122.45(h). Standards for those 
pollutant(s) would be established on a best professional judgment basis 
pursuant to 40 CFR 125.3.

------------------------------------------------------------------------
                                              New source performance    
                                          standards micrograms per liter
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................              ND              ND
Acetonitrile............................              ND              ND
Ammonia.................................           4,850           3,230
n-Amyl Acetate..........................              14               6
Amyl Alcohol............................              ND              ND
Aniline.................................              10               4
Benzene.................................              ND              ND
2-Butanone (MEK)........................             144              61
n-Butyl Acetate.........................              11              ND
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................              ND              ND
Chlorobenzene...........................              ND              ND
Chloroform..............................              ND              ND
Chloromethane...........................              ND              ND
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................              13              ND
Diethylamine............................              ND              ND
Diethyl Ether...........................              74              ND
Dimethylamine...........................              ND              ND
N,N-Dimethylacetamide...................              ND              ND
N,N-Dimethylaniline.....................              50              45
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................              ND              ND
Ethanol.................................              ND              ND
Ethyl Acetate...........................              14              ND
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................              53              ND
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................             304             129
Isopropanol.............................              ND              ND
Isopropyl Acetate.......................              11              ND
Isopropyl Ether.........................              74              32
Methanol................................              ND              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methyl Formate..........................              ND              ND
Methylene Chloride......................              ND              ND
Methyl Isobutyl Ketone (MIBK)...........              ND              ND
2-Methylpyridine........................              50              45
Petroleum Naphtha.......................              ND              ND
Phenol..................................              25              14
Polyethylene Glycol 600.................           4,870           2,070
n-Propanol..............................              ND              ND
Pyridine................................              10              10
Tetrahydrofuran.........................             910             264
Toluene.................................              ND              ND
Trichlorofluoromethane..................              ND              ND
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------


[[Page 21671]]

    (3) Subpart C (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                                         New source     
                                                         performance    
                                                    standards milligrams
                                                      per liter (mg/L)  
          Pollutant or pollutant property          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
BOD<INF>5..............................................         62         29
COD...............................................        781        538
TSS...............................................         87         43
pH................................................        (<SUP>a)        (<SUP>a)
------------------------------------------------------------------------
(<SUP>a)Within the range of 6.0 to 9.0 standard units.                       

    (c) Permittees not using or generating cyanide are deemed to comply 
with the monitoring requirements specified in paragraph (a) of this 
section for cyanide if they certify to the permit issuing authority 
that they are not using or generating this pollutant.
    14. Section 439.36 is revised to read as follows:


Sec. 439.36  Pretreatment standards for existing sources (PSES).

    (a) Except as provided in 40 CFR 403.7 and 403.13, any existing 
source subject to this subpart that introduces pollutants into a 
publicly owned treatment works must comply with 40 CFR part 403 and by 
[date 3 years from the promulgation date of the final rule] achieve the 
following pretreatment standards for existing sources.
    (1) Subpart C (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Benzene.................................             796             268
Chlorobenzene...........................             796             268
Chloroform..............................              ND              ND
Chloromethane...........................             796             268
Cyanide.................................             766             406
Cyclohexane.............................             796             268
n-Heptane...............................             796             268
n-Hexane................................             796             268
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Toluene.................................             198             148
Trichlorofluoromethane..................             796             268
Xylenes.................................             796             268
------------------------------------------------------------------------

    (2) Subpart C (For End-of-Pipe Monitoring Points).

    [Note: With respect to the pollutants in this table, EPA 
proposes pretreatment standards for existing sources only for 
ammonia under co-proposal (2).]

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................          31,400           9,690
Ammonia.................................          12,900          10,900
n-Amyl Acetate..........................          23,900           8,050
Amyl Alcohol............................         607,000         205,000
Aniline.................................      10,900,000       3,690,000
2-Butanone (MEK)........................       1,440,000         430,000
n-Butyl Acetate.........................          23,900           8,050
n-Butyl Alcohol.........................      10,900,000       3,690,000
tert-Butyl Alcohol......................         607,000         205,000
o-Dichlorobenzene.......................          23,900           8,050
1,2-Dichloroethane......................          23,900           8,050
Diethylamine............................              ND              ND
Diethyl Ether...........................          23,900           8,050
Dimethylamine...........................         607,000         205,000
N,N-Dimethylaniline.....................         607,000         205,000
1,4-Dioxane.............................      10,900,000       3,690,000
Ethanol.................................       2,200,000         784,000
Ethyl Acetate...........................          23,900           8,050
Formamide...............................         607,000         205,000
Furfural................................         607,000         205,000
Isobutyraldehyde........................          23,900           8,050
Isopropanol.............................         597,000         198,000
Isopropyl Acetate.......................          23,900          8,050 
[[Page 21672]]                                                          
                                                                        
Isopropyl Ether.........................          23,900           8,050
Methanol................................      11,700,000       3,800,000
Methylamine.............................         607,000         205,000
Methyl Formate..........................          23,900           8,050
Methyl Isobutyl Ketone (MIBK)...........          23,900           8,050
2-Methylpyridine........................         607,000         205,000
Petroleum Naphtha.......................      10,900,000       3,690,000
n-Propanol..............................       2,790,000         941,000
Pyridine................................           1,000           1,000
Tetrahydrofuran.........................           9,210           3,360
Triethylamine...........................              ND              ND
------------------------------------------------------------------------

    (b) Indirect dischargers not using or generating cyanide are deemed 
to comply with the monitoring requirements specified in paragraph (a) 
of this section for cyanide if they certify to the control authority 
that they are not using or generating this pollutant.
    15. Section 439.37 is amended by revising paragraph (a) 
introductory text and paragraph (b) and by adding paragraph (c) to read 
as follows:


Sec. 439.37  Pretreatment standards for new sources (PSNS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following pretreatment standards for new sources 
until the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the standards 
specified in Sec. 439.36.
* * * * *
    (b) Except as provided in 40 CFR 403.7 and paragraph (a) of this 
section, any new source subject to this subpart that introduces 
pollutants into a publicly owned treatment works must comply with 40 
CFR part 403 and achieve the following pretreatment standards for new 
sources.
    (1) Subpart C (For In-Plant Monitoring Points).

    [Note: With respect to pollutants in this table, EPA does not 
propose pretreatment standards for new sources for pollutants with 
an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone*................................           1,190             600
Amyl Alcohol*...........................           8,690           3,220
Benzene.................................             573             212
n-Butyl Alcohol*........................           8,690           3,220
tert-Butyl Alcohol*.....................           8,690           3,220
Chlorobenzene...........................             573             212
Chloroform..............................              ND              ND
Chloromethane...........................             573             212
Cyanide.................................             766             406
Cyclohexane.............................             573             212
Diethylamine*...........................              ND              ND
Diethyl Ether*..........................           2,230             826
Dimethylamine*..........................              ND              ND
Ethanol*................................           8,690           3,220
Formamide*..............................              ND              ND
n-Heptane...............................             573             212
n-Hexane................................             573             212
Isopropanol*............................           8,690           3,220
Methanol*...............................           8,320              ND
Methylamine*............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Methyl Formate*.........................           2,230             826
n-Propanol*.............................           8,690           3,220
Toluene.................................             184             135
Trichlorofluoromethane..................             573             212
Triethylamine*..........................              ND              ND
Xylenes.................................             573             212
------------------------------------------------------------------------

    (2) Subpart C (For End-of-Pipe Monitoring Points).

    [[Page 21673]] [Note: With respect to pollutants in this table, 
EPA does not propose pretreatment standards for new sources for 
pollutants with an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Ammonia.................................          12,900          10,900
n-Amyl Acetate*.........................           2,230             826
Aniline*................................           8,690           3,220
2-Butanone (MEK)*.......................         161,000          57,900
n-Butyl Acetate*........................           2,230             826
o-Dichlorobenzene*......................           2,230             826
1,2-Dichloroethane*.....................           2,230             826
N,N-Dimethylaniline*....................           8,690           3,220
1,4-Dioxane*............................           8,690           3,220
Ethyl Acetate*..........................           2,230             826
Furfural*...............................           8,690           3,220
Isobutyraldehyde*.......................           2,230             826
Isopropyl Acetate*......................           2,230             826
Isopropyl Ether*........................           2,230             826
Methyl Isobutyl Ketone (MIBK)*..........           2,230             826
2-Methylpyridine*.......................           8,690           3,220
Petroleum Naphtha*......................           8,690           3,220
Pyridine*...............................           1,000           1,000
Tetrahydrofuran*........................           9,210           3,360
------------------------------------------------------------------------

    (c) Indirect dischargers not using or generating cyanide are deemed 
to comply with the monitoring requirements specified in paragraph (a) 
of this section for cyanide if they certify to the control authority 
that they are not using or generating this pollutant.


Sec. 439.38  [Reserved]

Subpart D--Mixing, Compounding and Formulating Subcategory

    16. Sections 439.40 through 439.44 are revised to read as follows:


Sec. 439.40  Applicability; description of the mixing, compounding and 
formulating subcategory; prohibition.

    (a) The provisions of this subpart are applicable to discharges 
resulting from the mixing, compounding and formulating operations of 
pharmaceutical products. Mixing, compounding, and formulating 
operations are defined as processes through which pharmaceutical 
products are put in dosage forms. Mixing, compounding, and formulating 
operations include pilot-scale research operations not covered by the 
provisions of subpart E, Research Subcategory.
    (b) The discharge of non-process wastewaters and materials excluded 
from the definition of process wastewater at Sec. 439.1 is not covered 
by this subpart. Discharge of such non-process wastewater and excluded 
materials into publicly owned treatment works or waters of the United 
States, by a source subject to this subpart, without an NPDES permit or 
individual control mechanism authorizing such discharge is prohibited.


Sec. 439.41  Specialized definitions.

    For the purpose of this subpart:
    (a) Except as provided below, the general definitions, 
abbreviations, and methods of analysis set forth in 40 CFR part 401 and 
Sec. 439.1 shall apply to this subpart.
    (b) The term ``product'' shall mean products from plants that 
blend, mix, compound, and formulate pharmaceutical ingredients. 
Pharmaceutical preparations for human and veterinary use such as 
ampules, tablets, capsules, vials, ointments, medicinal powders, 
solutions, and suspensions are included.


Sec. 439.42  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available (BPT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available.
    (1) Subpart D (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                                        BPT effluent    
                                                         limitations    
                                                    milligrams per liter
                                                           (mg/L)       
         Pollutant or pollutant parameter          ---------------------
                                                     Maximum            
                                                     for any    Monthly 
                                                     one day    average 
------------------------------------------------------------------------
BOD<INF>5..............................................         37         11
TSS...............................................         80         27
COD...............................................        145         60
------------------------------------------------------------------------

    (2) The pH shall be within the range of 6.0-9.0 standard units.
    (b) [Reserved]


Sec. 439.43  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best conventional 
pollutant control technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the degree of effluent reduction 
attainable by the application of the best conventional pollutant 
control technology. The limitations shall be the same as those 
specified for conventional pollutants BOD<INF>5 and TSS in Sec. 439.42 
for the best practicable control technology currently available.


Sec. 439.44  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of 
[[Page 21674]] effluent reduction attainable by the application of the 
best available technology economically achievable.
    (1) Subpart D (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                             BAT effluent limitations   
                                           micrograms per liter (<greek-
                                                      m>g/L)            
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................             413             178
Acetonitrile............................              ND              ND
n-Amyl Acetate..........................           3,000           1,280
Amyl Alcohol............................           3,980           1,690
Aniline.................................              10              10
Benzene.................................              40              17
2-Butanone (MEK)........................             202              86
n-Butyl Acetate.........................             500             500
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................           3,980           1,690
Chemical Oxygen Demand (COD)............         145,000          59,900
Chlorobenzene...........................              ND              ND
Chloroform..............................              22              13
Chloromethane...........................             206              87
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................             438             152
Diethylamine............................              ND              ND
Diethyl Ether...........................           4,870           2,070
N,N-Dimethylacetamide...................              ND              ND
Dimethylamine...........................              ND              ND
N,N-Dimethylaniline.....................              50              50
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................             220              94
Ethanol.................................              ND              ND
Ethyl Acetate...........................           3,000           1,280
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................           3,000           1,280
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................           1,370             581
Isopropanol.............................           1,120             476
Isopropyl Acetate.......................             500             500
Isopropyl Ether.........................           4,870           2,070
Methanol................................           6,660              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................           1,420             357
Methyl Formate..........................           3,000           1,280
Methyl Isobutyl Ketone (MIBK)...........             119              51
2-Methylpyridine........................              50              50
Petroleum Naphtha.......................              40              17
Phenol..................................              25              14
Polyethylene Glycol 600.................           4,870           2,070
n-Propanol..............................           3,980              ND
Pyridine................................              10              10
Tetrahydrofuran.........................          15,000           4,350
Toluene.................................              40              17
Trichlorofluoromethane..................             599             322
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    (2) [Reserved]
    (b) [Reserved]
    17. Section 439.45 is amended by revising paragraph (a) 
introductory text and paragraph (b) to read as follows:


Sec. 439.45  New source performance standards (NSPS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following new source performance standards until 
the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the effluent 
limitations specified in Secs. 439.42, 439.43, and 439.44.
* * * * *
    (b) Except as provided in paragraph (a) of this section, any new 
source subject to this subpart must achieve the following new source 
performance standards. [[Page 21675]] 
    (1) Subpart D (For End-of-Pipe Monitoring Points). The standards in 
the following table do not apply for any pollutant(s) for which the 
permit writer finds it necessary to specify in-plant monitoring 
requirements pursuant to 40 CFR 122.44(i) and 122.45(h). Standards for 
those pollutant(s) would be established on a best professional judgment 
basis pursuant to 40 CFR 125.3.

------------------------------------------------------------------------
                                              New source performance    
                                          standards micrograms per liter
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................              ND              ND
Acetonitrile............................              ND              ND
Ammonia.................................           4,850           3,230
n-Amyl Acetate..........................              14               6
Amyl Alcohol............................              ND              ND
Aniline.................................              10               4
Benzene.................................              ND              ND
2-Butanone (MEK)........................             144              61
n-Butyl Acetate.........................              11              ND
n-Butyl Alcohol.........................              ND              ND
tert-Butyl Alcohol......................              ND              ND
Chlorobenzene...........................              ND              ND
Chloroform..............................              ND              ND
Chloromethane...........................              ND              ND
Cyclohexane.............................              ND              ND
o-Dichlorobenzene.......................              ND              ND
1,2-Dichloroethane......................              13              ND
Diethylamine............................              ND              ND
Diethyl Ether...........................              74              ND
Dimethylamine...........................              ND              ND
N,N-Dimethylacetamide...................              ND              ND
N,N-Dimethylaniline.....................              50              45
N,N-Dimethylformamide...................              45              19
Dimethyl Sulfoxide......................              ND              ND
1,4-Dioxane.............................              ND              ND
Ethanol.................................              ND              ND
Ethyl Acetate...........................              14              ND
Ethylene Glycol.........................              ND              ND
Formaldehyde............................           1,480             623
Formamide...............................              ND              ND
Furfural................................              53              ND
n-Heptane...............................              ND              ND
n-Hexane................................              ND              ND
Isobutyraldehyde........................             304             129
Isopropanol.............................              ND              ND
Isopropyl Acetate.......................              11              ND
Isopropyl Ether.........................              74              32
Methanol................................              ND              ND
Methylamine.............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methyl Formate..........................              ND              ND
Methylene Chloride......................              ND              ND
Methyl Isobutyl Ketone (MIBK)...........              ND              ND
2-Methylpyridine........................              50              45
Petroleum Naphtha.......................              ND              ND
Phenol..................................              25              14
Polyethylene Glycol 600.................           4,870           2,070
n-Propanol..............................              ND              ND
Pyridine................................              10              10
Tetrahydrofuran.........................             910             264
Toluene.................................              ND              ND
Trichlorofluoromethane..................              ND              ND
Triethylamine...........................              ND              ND
Xylenes.................................              ND              ND
------------------------------------------------------------------------

    (2) Subpart D (For End-of-Pipe Effluent).

------------------------------------------------------------------------
                                              New source performance    
                                          standards milligrams per liter
                                                      (mg/L)            
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
BOD<INF>5....................................              34             10 
[[P<INF>age 21676]]                                                          
                                                                        
COD.....................................              60              24
TSS.....................................              40              12
pH......................................             (<SUP>a)            (<SUP>a) 
------------------------------------------------------------------------
(<SUP>a) Within the range of 6.0-9.0 standard units.                         

    18. Section 439.46 is revised to read as follows:


Sec. 439.46  Pretreatment standards for existing sources (PSES).

    (a) Except as provided in 40 CFR 403.7 and 403.13, any existing 
source subject to this subpart that introduces pollutants into a 
publicly owned treatment works must comply with 40 CFR part 403 and by 
[date 3 years from the promulgation date of the final rule] achieve the 
following pretreatment standards for existing sources.
    (1) Subpart D (For In-Plant Monitoring Points).

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Benzene.................................             796             268
Chlorobenzene...........................             796             268
Chloroform..............................              ND              ND
Chloromethane...........................             796             268
Cyclohexane.............................             796             268
n-Heptane...............................             796             268
n-Hexane................................             796             268
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Toluene.................................             198             148
Trichlorofluoromethane..................             796             268
Xylenes.................................             796             268
------------------------------------------------------------------------


    (2) Subpart D (For End-of-Pipe Monitoring Points).

    [Note: Under co-proposal (2), EPA does not propose pretreatment 
standards for existing sources for these pollutants.]

------------------------------------------------------------------------
                                            Pretreatment standards for  
                                            existing sources micrograms 
                                             per liter (<greek-m>g/L)   
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone.................................          31,400           9,690
n-Amyl Acetate..........................          23,900           8,050
Amyl Alcohol............................         607,000         205,000
Aniline.................................      10,900,000       3,690,000
2-Butanone (MEK)........................       1,440,000         430,000
n-Butyl Acetate.........................          23,900           8,050
n-Butyl Alcohol.........................      10,900,000       3,690,000
tert-Butyl Alcohol......................         607,000         205,000
o-Dichlorobenzene.......................          23,900           8,050
1,2-Dichloroethane......................          23,900           8,050
Diethylamine............................              ND              ND
Diethyl Ether...........................          23,900           8,050
Dimethylamine...........................         607,000         205,000
N,N-Dimethylaniline.....................         607,000         205,000
1,4-Dioxane.............................      10,900,000       3,690,000
Ethanol.................................       2,200,000         784,000
Ethyl Acetate...........................          23,900           8,050
Formamide...............................         607,000         205,000
Furfural................................         607,000         205,000
Isobutyraldehyde........................          23,900           8,050
Isopropanol.............................         597,000         198,000
Isopropyl Acetate.......................          23,900           8,050
Isopropyl Ether.........................          23,900           8,050
Methanol................................      11,700,000       3,800,000
Methylamine.............................         607,000         205,000
Methyl Formate..........................          23,900           8,050
[[Page 21677]]                                                          
                                                                        
Methyl Isobutyl Ketone (MIBK)...........          23,900           8,050
2-Methylpyridine........................         607,000         205,000
Petroleum Naphtha.......................      10,900,000       3,690,000
n-Propanol..............................       2,790,000         941,000
Pyridine................................           1,000           1,000
Tetrahydrofuran.........................           9,210           3,360
Triethylamine...........................              ND              ND
------------------------------------------------------------------------

    (b) [Reserved]
    19. Section 439.47 is amended by revising paragraph (a) 
introductory text and paragraph (b) to read as follows:


Sec. 439.47  Pretreatment standards for new sources (PSNS).

    (a) Any new source subject to this subpart that was a ``new 
source'' under 40 CFR 122.29 prior to [promulgation date of the final 
rule] must achieve the following pretreatment standards for new sources 
until the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the standards 
specified in Sec. 439.46.
* * * * *
    (b) Except as provided in 40 CFR 403.7 and paragraph (a) of this 
section, any new source subject to this subpart that introduces 
pollutants into a publicly owned treatment works must comply with 40 
CFR part 403 and achieve the following pretreatment standards for new 
sources.
    (1) Subpart D (For In-Plant Monitoring Points).

    [Note: With respect to pollutants in this table, EPA does not 
propose pretreatment standards for new sources for pollutants with 
an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
Acetone*................................           1,190             600
Amyl Alcohol*...........................           8,690           3,220
Benzene.................................             573             212
n-Butyl Alcohol*........................           8,690           3,220
tert-Butyl Alcohol*.....................           8,690           3,220
Chlorobenzene...........................             573             212
Chloroform..............................              ND              ND
Chloromethane...........................             573             212
Cyclohexane.............................             573             212
Diethylamine*...........................              ND              ND
Diethyl Ether*..........................           2,230             826
Dimethylamine*..........................              ND              ND
Ethanol*................................           8,690           3,220
Formamide*..............................              ND              ND
n-Heptane...............................             573             212
n-Hexane................................             573             212
Isopropanol*............................           8,690           3,220
Methanol*...............................           8,320              ND
Methylamine*............................              ND              ND
Methyl Cellosolve.......................              ND              ND
Methylene Chloride......................             809             279
Methyl Formate*.........................           2,230             826
n-Propanol*.............................           8,690           3,220
Toluene.................................             184             135
Trichlorofluoromethane..................             573             212
Triethylamine*..........................              ND              ND
Xylenes.................................             573             212
------------------------------------------------------------------------

    (2) Subpart D (For End-of-Pipe Monitoring Points).

    [Note: With respect to pollutants in this table, EPA does not 
propose pretreatment standards for new sources for pollutants with 
an asterisk (*) under co-proposal (2).]

------------------------------------------------------------------------
                                          Pretreatment standards for new
                                           sources micrograms per liter 
                                                  (<greek-m>g/L)        
     Pollutant or pollutant property     -------------------------------
                                            Maximum for       Monthly   
                                            any one day       average   
------------------------------------------------------------------------
n-Amyl Acetate*.........................           2,230             826
[[Page 21678]]                                                          
                                                                        
Aniline*................................           8,690           3,220
2-Butanone (MEK)*.......................         161,000          57,900
n-Butyl Acetate*........................           2,230             826
o-Dichlorobenzene*......................           2,230             826
1,2--Dichloroethane*....................           2,230             826
N,N-Dimethylaniline*....................           8,690           3,220
1,4-Dioxane*............................           8,690           3,220
Ethyl Acetate*..........................           2,230             826
Furfural*...............................           8,690           3,220
Isobutyraldehyde*.......................           2,230             826
Isopropyl Acetate*......................           2,230             826
Isopropyl Ether*........................           2,230             826
Methyl Isobutyl Ketone (MIBK)*..........           2,230             826
2-Methylpyridine*.......................           8,690           3,220
Petroleum Naphtha*......................           8,690           3,220
Pyridine*...............................           1,000           1,000
Tetrahydrofuran*........................           9,210           3,360
------------------------------------------------------------------------

Sec. 439.48  [Reserved]

Subpart E--Research Subcategory

    20. Sections 439.50 through 439.52 are revised to read as follows:


Sec. 439.50  Applicability; description of the research subcategory; 
prohibition.

    (a) The provisions of this subpart are applicable to discharges 
resulting from bench-scale pharmaceutical research operations and 
product development activities. This subpart does not apply to pilot- 
or full-scale operations that generate wastewaters using fermentation, 
extraction, chemical synthesis, or mixing, compounding and formulating. 
Such operations are covered under subparts A, B, C, and D, 
respectively.
    (b) The discharge of non-process wastewaters and materials excluded 
from the definition of process wastewater at Sec. 439.1 is not covered 
by this subpart. Discharges of such non-process wastewater and excluded 
materials into publicly owned treatment works or waters of the United 
States, by a source subject to this subpart without an NPDES permit or 
individual control mechanism authorizing such discharge is prohibited.


Sec. 439.51  Specialized definitions.

    For the purpose of this subpart:
    (a) Except as provided below, the general definitions, 
abbreviations, and methods of analysis set forth in 40 CFR part 401 and 
Sec. 439.1 shall apply to this subpart.
    (b) The term ``product'' shall mean any product or service 
resulting from pharmaceutical research, which includes microbiological, 
biological, and chemical operations.


Sec. 439.52  Effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available (BPT).

    (a) Except as provided in 40 CFR 125.30 through 125.32, any 
existing point source subject to this subpart must achieve the 
following effluent limitations representing the degree of effluent 
reduction attainable by the application of the best practicable control 
technology currently available.
    (1) The allowable discharge for the pollutant parameters BOD<INF>5 
and COD shall be expressed in mass per unit time and shall represent 
the specified wastewater treatment efficiency in terms of a residual 
discharge associated with an influent to the waste treatment plant 
corresponding to the maximum production period for a given 
pharmaceutical plant as defined in paragraph (a)(4) of this section.
    (2) The allowable effluent discharge limitation for the daily 
average mass of BOD<INF>5 in any calendar month shall specifically not 
reflect not less than 90 percent reduction in the long term daily 
average raw waste content of BOD<INF>5 multiplied by a variability 
factor of 3.0. However, a plant shall not be required to attain a 30-
day average BOD<INF>5 effluent limitation of less than the equivalent 
of 45 mg/L.
    (3) The allowable effluent discharge limitation for the daily 
average mass of COD in any calendar month shall specifically not 
reflect not less than 74 percent reduction in the long term daily 
average raw waste content of COD multiplied by a variability factor of 
2.2. However, a plant shall not be required to attain a 30-day average 
COD effluent limitation of less than the equivalent of 220 mg/L.
    (4) The long term daily average raw waste load for the pollutant 
parameters BOD<INF>5 and COD is defined as the average daily mass of 
each pollutant influent to the wastewater treatment system over a 12 
consecutive month period within the most recent 36 months, which shall 
include the greatest production effort.
    (5) To assure equity in regulation of discharges from sources 
covered by this subpart of the point source category, calculation of 
raw waste loads of BOD<INF>5 and COD for the purpose of determining 
NPDES permit limitations (i.e., the base numbers to which the percent 
reductions are applied) shall exclude any waste load associated with 
solvents in those raw waste loads, except the residual amounts of 
solvents remaining after the practice of solvent recovery and/or 
separate disposal or reuse. These practices of removal, disposal, or 
reuse include recovery of solvents from waste streams and incineration 
of concentrated solvent waste streams (including tar still bottoms). 
This subpart does not prohibit inclusion of such wastes in the raw 
waste loads in fact, nor does it mandate any specific practice, but 
rather describes the rationale for determining permit conditions. These 
limits may be achieved by any one of several programs and practices or 
a combination thereof.
    (6) The allowable effluent discharge limitation for the daily 
average mass of TSS in any calendar month shall be 1.7 times the 
BOD<INF>5 limitation determined in paragraph (a)(2) of this section.
    (7) The pH shall be within the range of 6.0-9.0 standard 
units. [[Page 21679]] 


(b)  [Reserved]


439.53  Effluent limitations representing the degree of effluent 
reduction attainable by the best conventional pollutant control 
technology (BCT). [Reserved]


439.54  Effluent limitations representing the degree of effluent 
reduction attainable by the application of best available technology 
economically achievable (BAT). [Reserved]


439.55  New source performance standards (NSPS). [Reserved]


439.56  Pretreatment standards for existing sources (PSES). [Reserved]


439.57  Pretreatment standards for new sources (PSNS). [Reserved]


439.58  [Reserved]

[FR Doc. 95-5663 Filed 5-1-95; 8:45 am]
BILLING CODE 6560-50-P