Federal Register, Volume 60 Issue 84 (Tuesday, May 2, 1995)

[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.
BOD5--Five-Day Biochemical Oxygen Demand. A measure of
biochemical decomposition of organic matter in a water sample. It is
determined by measuring the dissolved oxygen consumed by microorganisms
to oxidize the organic contaminants in a water sample under standard
laboratory conditions of five days and 20 deg.C. BOD5 is not
related to the oxygen requirements in chemical combustion.
Boiler--Any enclosed combustion device that extracts useful energy
in the form of steam and is not an incinerator.
BPT--The best practicable control technology currently available,
as described in section 304(b)(1) of the Clean Water Act.
CAA--Clean Air Act. The Air Pollution Prevention and Control Act
(42 U.S.C. 7401 et seq.), as amended, inter alia, by the Clean Air Act
Amendments of 1990 (Pub. L. 101-549, 104 Stat. 2399).
Chemical Synthesis--The process(es) of using a chemical reaction or
a series of chemical reactions to manufacture pharmaceutically active
ingredients. The chemical synthesis process operations define
subcategory C (40 CFR 439, subpart C).
Clarifier--A treatment unit designed to remove suspended materials
from wastewater, typically by sedimentation.
Closed vent system--A system that is not open to the atmosphere and
is composed of piping, ductwork, [[Page 21594]] connections, and, if
necessary, flow-inducing devices that transport gas or vapor from an
emission point to a control device or back into the process.
CN--Abbreviation for total cyanide.
COD--Chemical oxygen demand (COD)--A nonconventional bulk parameter
that measures the total oxygen-consuming capacity of wastewater. This
parameter is a measure of materials in water or wastewater that are
biodegradable and materials that are resistant (refractory) to
biodegradation. Refractory compounds slowly exert demand on downstream
receiving water resources. Certain of the compounds measured by this
parameter have been found to have carcinogenic, mutagenic, and similar
adverse effects, either singly or in combination. It is expressed as
the amount of oxygen consumed by a chemical oxidant in a specific test.
Combustion device--An individual unit of equipment, including but
not limited to, an incinerator or boiler, used for the thermal
oxidation of organic hazardous air pollutant vapors.
Condensate--Any material that has condensed from a gaseous phase
into a liquid phase.
Continuous discharge--Discharge that occurs without interruption
throughout the operating hours of the facility.
Control Techniques Guidance (CTG)--A document prepared to provide
State and local air pollution authorities with an information base for
proceeding with analysis of Reasonably Available Control Technology
(RACT) to meet Clean Air Act statutory requirements.
Controlled-release discharge--A discharge that occurs at a rate
that is intentionally varied to accommodate fluctuations in receiving
stream assimilative capacity or for other reasons.
Conventional pollutants--The pollutants identified in section
304(a)(4) of the Clean Water Act and the regulations thereunder (i.e.,
biochemical oxygen demand (BOD5), total suspended solids (TSS),
oil and grease, fecal coliform and pH).
CWA--Clean Water Act. The Federal Water Pollution Control Act
Amendments of 1972 (33 U.S.C. 1251 et seq.), as amended, inter alia, by
the Clean Water Act of 1977 (Pub. L. 95-217) and the Water Quality Act
of 1987 (Pub. L. 100-4).
Daily discharge--The discharge of a pollutant measured during any
calendar day or any 24-hour period that reasonably represents a
calendar day for purposes of sampling. For pollutants with limitations
expressed in units of mass, the daily discharge is calculated as the
total mass of the pollutant discharged over the day. For pollutants
with limitations expressed in other units of measurement, the daily
discharge is calculated as the average measurement of the pollutant
over the day.
Direct discharger--A facility that discharges or may discharge
treated or untreated process wastewaters, non-contact cooling waters,
or non-process wastewaters (including stormwater runoff) into waters of
the United States.
Effluent--Wastewater discharges.
Effluent limitation--Any restriction, including schedules of
compliance, established by a State or the Administrator on quantities,
rates, and concentrations of chemical, physical, biological, and other
constituents which are discharged from point sources into waters of the
United States, the waters of the contiguous zone, or the ocean.
Emission--Passage of air pollutants into the atmosphere via a gas
stream or other means.
Emission point--Any location within a source from which air
pollutants are emitted, including an individual process vent, an
opening within a wastewater collection and treatment system, or an open
piece of process equipment.
EOP effluent--Final plant effluent discharged to waters of the
United States or to a POTW.
EOP treatment--End-of-pipe treatment facilities or systems used to
treat process wastewaters, non-process wastewaters (including
stormwater runoff) after the wastewaters have left the process area of
the facility and prior to discharge. End-of-pipe treatment generally
does not include facilities or systems where products or by-products
are separated from process wastewaters and returned to the process or
directed to air emission control devices.
EPA--The U.S. Environmental Protection Agency.
General Provisions--General Provisions for national emission
standards for hazardous air pollutants and other regulatory
requirements pursuant to section 112 of the Clean Air Act, as amended
November 15, 1990. The General Provisions, located in subpart A of part
63 of title 40 of the Code of Federal Regulations, codify procedures
and criteria to implement emission standards for stationary sources
that emit (or have the potential to emit) one or more of the 189
chemicals listed as hazardous air pollutants in section 112(b) of the
Clean Air Act as amended in 1990. EPA published the NESHAP General
Provisions in the Federal Register on March 16, 1993 (59 FR 12408). The
term General Provisions also refers to the General Provisions for the
effluent limitations guidelines and standards proposed today, to be
located at 40 CFR part 439.
Fermentation--A chemical change induced by a living organism or
enzyme, specifically bacteria or the microorganisms occurring in
unicellular plants such as yeast, molds, or fungi. Process operations
that utilize fermentation to manufacture pharmaceutically active
ingredients define subcategory A (40 CFR 439, subpart A).
HAP--Hazardous Air Pollutant. Any of the 189 chemicals listed under
section 112(b) of the Clean Air Act.
HON--Hazardous Organic NESHAP. As used in this notice, it refers to
the standard published by EPA for the Synthetic Organic Chemical
Manufacturing Industry (SOCMI) on April 22, 1994 (59 FR 19402).
Incinerator--An enclosed combustion device that is used for
destroying organic compounds. Auxiliary fuel may be used to heat waste
gas to combustion temperatures. Any energy recovery section present is
not physically formed into one manufactured or assembled unit with the
combustion section; rather, the energy recovery section is a separate
section following the combustion section and the two are joined by
ducts or connections carrying flue gas.
Indirect discharger--A facility that discharges or may discharge
wastewaters into a publicly owned treatment works.
Individual drain system--The system used to convey process
wastewater streams away from the pharmaceutical manufacturing process
equipment or tank, or process wastewater collection and treatment
system unit. The term includes all process drains and junction boxes,
together with their associated sewer lines and other junction boxes,
manholes, sumps and lift stations. The individual drain system is
designed to segregate the vapors within the system from other drain
systems. A separate storm sewer system, which is a drain and collection
system designed and operated for the purpose of collecting storm runoff
at a facility, and which is segregated from all other individual drain
systems, is excluded from this definition.
In-plant Control Technologies--These include controls or measures
applied within the manufacturing process to reduce or eliminate
pollutant and hydraulic loadings; these also include technologies, such
as steam stripping and cyanide destruction, applied directly to
wastewater generated by manufacturing processes. [[Page 21595]]
IU--Industrial User. Synonym for ``Indirect Discharger.''
Junction box--A manhole access point to a wastewater sewer system
or a lift station.
LTA--Long-term average. For purposes of proposed effluent
limitations guidelines and standards, average pollutant levels achieved
over a period of time by a plant, subcategory, or technology option.
LTAs were used in developing the limitations and standards in today's
proposed regulation.
MACT--Maximum Achievable Control Technology. Technology basis for
the national emission standards for hazardous air pollutants.
Major source--As defined in section 112(a) of the Clean Air Act,
major source is any stationary source or group of stationary sources
located within a contiguous area and under common control that emits or
has the potential to emit, considering controls, in the aggregate 10
tons per year or more of any hazardous air pollutant or 25 tons per
year or more of any combination of hazardous air pollutants.
Maximum daily discharge limitation--The highest allowable daily
discharge of a pollutant measured during a calendar day or any 24 hour
period that reasonably represents a calendar day for purposes of
sampling.
Mg--Megagram. One million (10\6\) grams, or one metric ton.
Metric ton--One thousand (10\3\) kilograms (abbreviated as kkg), or
one megagram. A metric ton is equal to 2,204.5 pounds.
Minimum level--The level at which an analytical system gives
recognizable signals and an acceptable calibration point.
Mixing/Compounding/Formulating--Processes through which
pharmaceutically active ingredients are put in dosage forms. Processes
involving mixing/compounding/formulating define subcategory D (40 CFR
439, subpart D).
Modification--As defined in section 112(a) of the Clean Air Act,
modification is any physical change in, or change in the method of
operation of, a major source which increases the actual emissions of
any hazardous air pollutant emitted by such source by more than a de
minimis amount or which results in the emission of any hazardous air
pollutant not previously emitted by more than a de minimis amount.
NESHAP--National Emission Standard for Hazardous Air Pollutants.
Emission standard promulgated that has been or will be promulgated
under section 112(d) of the Clean Air Act for hazardous air pollutants
listed in section 112(b) of the Clean Air Act.
New Source--As defined in 40 CFR 122.2, 122.29, and 403.3(k), a new
source is any building, structure, facility, or installation from which
there is or may be a discharge of pollutants, the construction of which
commenced (1) For purposes of compliance with New Source Performance
Standards, after the promulgation of such standards being proposed
today under CWA section 306; or (2) for the purposes of compliance with
Pretreatment Standards for New Sources, after the publication of
proposed standards under CWA section 307(c), if such standards are
thereafter promulgated in accordance with that section.
Nonconventional pollutants--Pollutants that are neither
conventional pollutants nor toxic pollutants.
Non-detect value--A concentration-based measurement reported below
the minimum level that can reliably be measured by the analytical
method for the pollutant.
Non-water quality environmental impact--An environmental impact of
a control or treatment technology, other than to surface waters.
NPDES--The National Pollutant Discharge Elimination System
authorized under section 402 of the CWA. The Clean Water Act requires
NPDES permits for discharge of pollutants from any point source into
waters of the United States.
NRDC--Natural Resources Defense Council.
NSPS--New Source Performance Standards. As used in this notice,
this term refers to standards for new sources under section 306 of the
CWA.
OMB--Office of Management and Budget.
Outfall--The mouth of conduit drains and other conduits from which
a plant discharges effluent into receiving waters.
Pharmaceutically active ingredient--Any substance considered to be
an active ingredient by Food and Drug Administration regulations (21
CFR 210.3(6)(7)).
Pilot-scale operation--The trial operation of processing equipment,
which is the intermediate stage between laboratory experimentation and
full-scale operation in the development of a new process or product.
Point of Generation--The location where the process wastewater
stream exits the pharmaceutical process equipment.
Point source category--A category of sources of water pollutants
that are included within the definition of ``point source'' in section
502(14) of the Clean Water Act.
Pollutant (to water)--Dredged spoil, solid waste, incinerator
residue, filter backwash, sewage, garbage, sewage sludge, munitions,
chemical wastes, biological materials, certain radioactive materials,
heat, wrecked or discarded equipment, rock, sand, cellar dirt, and
industrial, municipal, and agricultural waste discharged into water.
See CWA section 502(6); 40 CFR 122.2.
POTW or POTWs--Publicly owned treatment works, as defined at 40 CFR
403.3(o).
Pretreatment standard--A regulation specifying industrial
wastewater effluent quality required for discharge to a POTW.
Primary fuel--The fuel that provides the principal heat input to a
combustion device. To be considered primary, the fuel must be able to
sustain operation of the combustion device without the addition of
other fuels.
Priority pollutants--The toxic pollutants listed in 40 CFR part
403, Appendix A (printed immediately following 40 CFR 423.17).
Process changes--Alterations in process operating conditions,
equipment, or chemical use that reduce the formation of chemical
compounds that are pollutants and/or pollutant precursors.
Process emission point--A gas stream that contains hazardous air
pollutants discharged during operation of process equipment. Process
emission points include gas streams that are discharged directly to the
atmosphere, discharged to the atmosphere via vents or open process
equipment, or discharged after diversion through a product recovery
device.
Process unit--A piece of equipment, such as a chemical reactor or
fermentation tank, associated with pharmaceutical manufacturing
operations.
Process wastewater--Any water that, during manufacturing or
processing, comes into direct contact with or results from the
production or use of any raw material, intermediate product, finished
product, byproduct, or waste product. Process wastewater includes
surface runoff from the immediate process area that has the potential
to become contaminated.
(1) For purposes of this part, the following materials are excluded
from the definition of process wastewater:
1. Trimethyl silanol;
2. Any active anti-microbial materials;
3. Wastewater from imperfect fermentation batches; and
4. Process area spills. [[Page 21596]]
(2) For purposes of this part, the following waters and wastewaters
are excluded from the definition of process wastewater: noncontact
cooling water, utility wastewaters, general site surface runoff,
groundwater (e.g., contaminated groundwaters from on-site or off-site
groundwater remediation projects), and other water generated on site
that are not process wastewaters.
The discharge of such waters and wastewaters must be regulated
separately.
Process wastewater collection system--A piece of equipment,
structure, or transport mechanism used in conveying or storing a
process wastewater stream. Examples of process wastewater collection
system equipment include individual drain systems, wastewater tanks,
surface impoundments, and containers.
Process wastewater stream--When used in connection with CAA
obligations, any HAP-containing liquid that results from either direct
or indirect contact of water with organic compounds.
Process water--Water used to dilute, wash, or carry raw materials
or any other materials used in pharmaceutical manufacturing processes.
PSES--Pretreatment standards for existing sources of indirect
discharges, under section 307(b) of the CWA.
PSNS--Pretreatment standards for new sources of indirect
discharges, under sections 307(c) of the CWA.
RCRA--Resource Conservation and Recovery Act of 1976, as amended
(42 U.S.C. 6901, et seq.).
Research--Bench-scale activities or operations used in research
and/or product development of a pharmaceutical product. The Research
operations define subcategory E (40 CFR 439, Subpart E).
SIC--Standard Industrial Classification. A numerical categorization
system used by the U.S. Department of Commerce to denote segments of
industry. An SIC code refers to the principal product, or group of
products, produced or distributed, or to services rendered by an
operating establishment. SIC codes are used to group establishments by
the primary activity in which they are engaged.
Source Category--A category of major or area sources of hazardous
air pollutants.
Source Reduction--The reduction or elimination of waste generation
at the source, usually within a process. A source reduction practice is
any practice that (1) Reduces the amount of any hazardous substance,
pollutant, or contaminant entering any waste stream or otherwise
released into the environment (including fugitive emissions) prior to
recycling, treatment, or disposal; and (2) reduces the hazards to
public health and the environment associated with the release of such
substances, pollutants, or contaminants.
Stationary source--Any building, structure, facility, or
installation that emits or may emit any air pollutant. See CAA section
111(a)(3).
Support Document(s)--see section II for titles.
TDD--Technical Development Document
TEQ--Toxic Equivalent.
TSCA--Toxic Substances Control Act (15 U.S.C. 2601, et seq.).
TSS--Total Suspended Solids.
Toxic pollutants--the pollutants designated by EPA as toxic in 40
CFR 401.15.
Variability factor--The daily variability factor is the ratio of
the estimated 99th percentile of the distribution of daily values
divided by the expected value, or mean, of the distribution of the
daily data. The monthly variability factor is the estimated 95th
percentile of the monthly averages of the data divided by the expected
value of the monthly averages.
VOC--Volatile Organic Compound--means any organic compound,
excluding carbon monoxide, carbon dioxide, carbonic acid, metallic
carbides or carbonates, and ammonium carbonate, which participates in
atmospheric photochemical reactions other than those that the
Administrator designates as having negligible photochemical reactivity.
The Administrator has designated the following organic compounds as
negligibly reactive: methane; ethane; methylene chloride; methyl
chloroform; CFC-113; CFC-11; CFC-12; CFC-22; CFC-23; CFC-114; CFC-115;
HCFC-123; HFC-134a; HCFC-141b; HCFC-142b; HCFC-124; HFC-125; HFC-134;
HFC-143a; HFC-152a; and perfluorocarbon compounds which fall into these
classes: (i) Cyclic, branched, or linear, completely fluorinated
alkanes; (ii) cyclic, branched, or linear, completely fluorinated
ethers with no unsaturations; cyclic, branched, or linear, completely
fluorinated tertiary amines with no unsaturations; and (iv) sulfur
containing perfluorocarbons with no unsaturations and with sulfur bonds
only to carbon and fluorine. 40 CFR 51.100(s)(1).
Waters of the United States--the same meaning set forth in 40 CFR
122.2.
Zero discharge (ZD)--No discharge of wastewater to waters of the
United States or to a POTW.

II. Background Documents

The rule proposed today is supported by several major documents:
(1) EPA's technical conclusions concerning the wastewater regulations
are detailed in the ``Development Document for Proposed Effluent
Limitations Guidelines and Standards for the Pharmaceutical
Manufacturing Point Source Category,'' hereafter referred to as the
Technical Development Document (TDD) (EPA 821-R-95-019), (2) the
Agency's economic analysis is found in the ``Economic Impact and
Regulatory Flexibility Analysis of Proposed Effluent Guidelines for the
Pharmaceutical Manufacturing Industry,'' hereafter called the Economic
Impact Analysis (EPA 821-R-95-018), (3) the regulatory impact analysis
(including the Agency's assessment of environmental benefits) is
detailed in the ``Regulatory Impact Assessment of Proposed Effluent
Guidelines for the Pharmaceutical Manufacturing Industry,'' hereafter
called the Regulatory Impact Assessment (EPA 821-R-95-017), (4) an
analysis of the incremental costs and pollutant removals for the
proposed effluent limitations guidelines and standards is presented in
``Cost-effectiveness Analysis of Proposed Effluent Limitations
Guidelines for the Pharmaceutical Manufacturing Industry,'' (EPA 821-R-
95-015), (5) analytical methods used in the development of the proposed
effluent limitations guidelines and standards are found in ``Analytical
Methods for the Determination of Pollutants in Pharmaceutical
Manufacturing Industry Wastewater,'' a compendium of analytical methods
(EPA 821-R-95-014), and (6) the statistical (EPA 821-R-95-016) support
for today's proposed effluent limitations guidelines and standards is
found in ``Statistical Support Document for the Proposed Effluent
Limitations Guidelines for the Pharmaceutical Manufacturing Industry.''

III. Legal Authority

This regulation is being proposed under the authority of sections
301, 304, 306, 307, 308, and 501 of the Clean Water Act, 33 U.S.C.
1311, 1314, 1316, 1317, 1318, and 1361.

IV. Summary and Scope of the Proposed Rule

In today's notice, EPA proposes effluent limitations guidelines and
standards for process wastewater generated by the pharmaceutical
manufacturing industry. Section IX of this notice discusses the
rationale for [[Page 21597]] the proposed guidelines and standards.
This summary section highlights the technology bases and other key
aspects of the proposed rule. The technology descriptions in this
section are presented in abbreviated form; more detailed descriptions
are included in the TDD.
Today's notice presents the Agency's proposed regulatory approach
and several others that EPA considered. The Agency's proposal is based
on comments received from interested parties during the development of
this proposed rule, and on detailed evaluation of the available data.
As indicated below in the discussion of the specifics of the proposal,
the Agency welcomes comment on all options, issues, rationale, and
proposed decisions and encourages commenters to submit additional data
during the comment period (see section XIV of this preamble). In
particular, the Agency welcomes comments on the treatment technologies
that EPA has selected as the basis for the limitations and standards
being proposed today. For example, EPA bases its proposed standards for
new sources primarily on steam stripping with distillation technology.
For most existing sources, EPA bases the proposed limitations and
standards primarily on steam stripping technology, which is less costly
and less energy intensive than distillation technology.
EPA expects a variety of human health, environmental, and economic
benefits to result from these reductions in effluent loadings and, in
some cases, air emissions. In particular, the benefits include: human
health and agricultural benefits due to reductions in emissions of
ozone precursors (i.e., reductions in VOC emissions); human health
benefits due to reductions in excess cancer risk; human health benefits
due to reductions in non-carcinogenic risk; ecological and recreational
benefits due to improved water quality; and benefits to publicly owned
treatment works (POTWs) from reductions in interference, passthrough,
and sludge contamination problems and improvements in worker health and
safety. EPA monetized the estimated benefits for reductions in air
emissions of ozone precursors and cancer risk reductions, but is unable
to quantify the dollar magnitude of benefits from the other benefit
categories. Therefore, the reported benefit estimate understates the
total benefits of the proposed rule. EPA estimates that the annual
benefits resulting from the proposed rule will range from $231,000 to
$7.6 million ($1994).
EPA has internally coordinated among relevant program offices in
developing this rule. Section X of this preamble describes close
coordination between the Office of Water and the Office of Air and
Radiation on this proposed water rule and an air rule that will be
proposed at a later date for the pharmaceutical manufacturing industry.
As explained in detail in Section X, the Agency intends that direct and
indirect dischargers will be able to employ a single steam stripper
design to achieve the requirements of both final rules. It is also the
Agency's intent, upon promulgation, that both rules will apply to
essentially the same high concentration, low volume process wastewater
streams in which the bulk of the volatile organic pollutants are
contained (see Section X for details). The practical effect of this
approach will be that only a relatively small portion (i.e.,
substantially less than half) of all process wastewaters will require
control of volatile organic pollutants (e.g., by steam stripping) to
achieve compliance with both rules. In the air rule, EPA also will
develop air emission standards for other emission points (e.g., process
vents, process area fugitive emissions, etc.). Also, Section XII of
this preamble describes coordination between the Office of Water and
the Office of Solid Waste and Emergency Response regarding the
hazardous waste implications of this proposed water rule, including
recovering ignitable nonhalogenated organics and reusing them as
``clean fuels.''
The Agency has worked with the Food and Drug Administration (FDA)
to explore pollution prevention opportunities to the maximum extent
feasible. EPA shared with FDA information and data gathered from the
industry in responses to EPA's detailed Section 308 questionnaire. This
was done to assist FDA in evaluating the environmental impacts of
revised drug manufacturing processes (as described in ``supplement''
applications) and of new drug manufacturing processes. These reviews
will ensure that opportunities for solvent use minimization/elimination
and water-based manufacturing processes (e.g., water-based tablet
coating) are considered and adopted within the constraints of
maintaining the efficacy of both existing and new pharmaceutical
products.
EPA has involved stakeholders and interested parties, including
state and local governments, in the process of developing this rule.
Since the inception of the project in 1986, there have been periodic
meetings with the industry and its trade association, the
Pharmaceutical Research and Manufacturers of America (PhRMA), to
discuss progress on the rulemaking. The Agency also has met with the
Natural Resources Defense Council (NRDC) to discuss progress on this
rulemaking. Because most of the facilities affected by this proposal
are indirect dischargers, the Agency conducted an outreach survey in
1990 to a limited number of POTWs substantially affected by one or more
pharmaceutical manufacturing facilities to solicit their input on the
need for this proposed rule and pertinent technical issues.
The Agency also held a public meeting on May 23, 1994. EPA
representatives of the Office of Water and the Office of Air and
Radiation outlined the underlying technical basis and options being
considered for this proposal, the efforts to coordinate the future air
rule and this proposed water rule, and took comments and questions from
the audience. The Agency also consulted recently with representatives
of selected POTWs regarding underlying technical aspects of this
proposal.
The Agency plans to have additional discussions with stakeholders
and interested parties during the comment period to minimize the
potential for unfunded mandates and to help ensure that the Agency has
the views of such parties and the best possible data upon which to base
a decision for the final rule. EPA's final rule may be based upon any
technologies, rationale or approaches that are a logical outgrowth of
this proposal, including any options discussed in this or subsequent
Federal Register documents.

A. Effluent Limitations Guidelines and Standards

1. Subcategorization
EPA is proposing to maintain the subcategorization scheme under the
existing effluent limitations guidelines and standards for this
industry (in part 439). The rationale for maintaining the existing
subcategorization scheme is detailed in section IX.A.
2. Best Practicable Control Technology Currently Available (BPT)
EPA is proposing to revise the BPT effluent limitations guidelines
for biochemical oxygen demand (BOD5), COD, and total suspended
solids (TSS) for four subcategories of the pharmaceutical manufacturing
industry. These proposed revisions are based on the application of
advanced biological treatment. EPA also is proposing to revise the BPT
effluent limitations guidelines for CN (Total Cyanide) for facilities
with subcategory A and/or C operations, based on in-plant cyanide
destruction technology. As discussed in [[Page 21598]] Section IX.E.,
below, EPA also is proposing to repeal the existing BPT cyanide
limitations for facilities with subcategory B and/or D operations. The
proposed BPT effluent limitations are defined by the performance of the
average of the best plants in the subcategory. The development of
proposed BPT effluent limitations is discussed in section IX.E.1 of
this notice and in Section 8 of the TDD.
3. Best Conventional Pollutant Control Technology (BCT)
EPA is proposing to revise the BCT effluent limitations guidelines
for BOD5 and TSS for four subcategories of the pharmaceutical
manufacturing industry. In all cases, the proposed BCT effluent
limitations are equal to the proposed BPT effluent limitations. The
development of proposed BCT effluent limitations is further explained
in section IX.E.2.
4. Best Available Technology Economically Achievable (BAT)
The Agency is proposing to revise the BAT effluent limitations
guidelines for four subcategories of the pharmaceutical manufacturing
industry to control priority and nonconventional pollutants. Table
IV.A-1 is a summary of the technology basis for the proposed BAT
effluent limitations for each subcategory.

Table IV.A-1.--Proposed Technology Basis for BAT Effluent Limitations
----------------------------------------------------------------------------------------------------------------
Proposed subpart Name of subcategory Proposed technology basis
----------------------------------------------------------------------------------------------------------------
A................... Fermentation........................... In-plant steam stripping and cyanide destruction
followed by advanced biological treatment.
B................... Natural Extraction..................... Advanced biological treatment.
C................... Chemical Synthesis..................... In-plant steam stripping and cyanide destruction
followed by advanced biological treatment.
D................... Mixing/Compounding/Formulating......... Advanced biological treatment.\1\
----------------------------------------------------------------------------------------------------------------
\1\Same technology basis as for proposed BPT limitations.

The pollutants that EPA proposes to regulate and the points of
monitoring to establish compliance with the limitations vary for each
subcategory and are described in sections IX.C and IX.E.3.
5. New Source Performance Standards (NSPS)
a. Priority and Nonconventional Pollutants. EPA is proposing
revised NSPS for four subcategories of the pharmaceutical manufacturing
industry. For facilities with subcategory A and/or C and B and/or D
operations, EPA is proposing NSPS to be more stringent than the
proposed BAT effluent limitations and is basing those standards
primarily on steam stripping with distillation technology. The
development of proposed NSPS for priority and nonconventional
pollutants is discussed in section IX.E.4.
b. Conventional Pollutants. EPA is proposing to revise NSPS
pertaining to discharges of BOD5, COD and TSS for four
subcategories of the pharmaceutical manufacturing industry at a level
equal to the discharge characteristics of the best performing plant. A
summary of the pollutants and subcategories proposed to be regulated is
presented in section IX.C. The development of proposed NSPS for
conventional pollutants and COD is discussed in section IX.E.4.
6. Pretreatment Standards for Existing Sources (PSES)
EPA is proposing to revise PSES for four subcategories of the
pharmaceutical manufacturing industry for the priority and
nonconventional pollutants to be controlled by technologies summarized
in Table IV.A-2. EPA also co-proposes two different pass-through
determinations for 33 less strippable volatile organic pollutants. PSES
are further discussed in section IX.E.5.

Table IV.A-2.--Proposed Technology Basis for PSES Effluent Limitations
----------------------------------------------------------------------------------------------------------------
Proposed subpart Name of subcategory Proposed technology basis
----------------------------------------------------------------------------------------------------------------
A................... Fermentation........................... In-plant cyanide destruction; in-plant steam
stripping.
B.................. Natural Extraction..................... In-plant steam stripping.
C................... Chemical Synthesis..................... In-plant cyanide destruction; in-plant steam
stripping.
D.................. Mixing/Compounding/Formulating......... In-plant steam stripping.
----------------------------------------------------------------------------------------------------------------

7. Pretreatment Standards for New Sources (PSNS)
EPA is proposing to revise PSNS for four subcategories of the
pharmaceutical manufacturing industry for the same priority and
nonconventional pollutants controlled by the proposed PSES, but based
on steam stripping with distillation technology. As under PSES, EPA co-
proposes two different pass-through determinations for 33 less
strippable volatile organic pollutants. PSNS are further discussed in
section IX.E.6.
8. Best Management Practices (BMPs)
The Agency is not proposing today BMPs for the pharmaceutical
manufacturing point source category. However, the Agency is soliciting
comment on whether BMPs are applicable to pharmaceutical manufacturing
facilities and, if so, what they should be. See Section XIV of this
preamble, solicitation number 31.

B. Scope of the Proposed Rule

The rule proposed today covers four subcategories of the
pharmaceutical manufacturing point source category. As discussed in
Section IX.A.4, below, EPA does not propose to revise the effluent
limitations guidelines applicable to Subcategory E (Pharmaceutical
Research) facilities and subcategory E operations at facilities with
subcategory A through D operations. These activities will be covered by
the existing BPT effluent limitations regulations for this
[[Page 21599]] subcategory and subject to BAT and BCT limitations,
where appropriate, set on a case-by-case basis using best professional
judgment (BPJ).
Pharmaceutical manufacturers use many different raw materials and
manufacturing processes to create a wide range of products. These
products include medicinal and feed grades of all organic chemicals
having therapeutic value, whether obtained by chemical synthesis,
fermentation, extraction from naturally occurring plant or animal
substances, or by refining a technical grade product.
The pharmaceutical products, processes and activities covered by
this proposal include:
a. Biological products covered by the U.S. Department of Commerce,
Bureau of the Census Standard Industrial Classification (SIC) Code No.
2836, with the exception of diagnostic substances. (Products covered by
SIC Code No. 2836 were formerly covered under the 1977 SIC Code No.
2831.)
b. Medicinal chemicals and botanical products covered by SIC Code
No. 2833;
c. Pharmaceutical products covered by SIC Code No. 2834;
d. All fermentation, biological and natural extraction, chemical
synthesis and formulation products considered to be pharmaceutically
active ingredients by the Food and Drug Administration that are not
covered by SIC Code Nos. 2833, 2834, and 2836;
e. Multiple end-use products derived from pharmaceutical
manufacturing operations (e.g., components of formulations,
intermediates, or final products, provided that the primary use of the
product is intended for pharmaceutical purposes);
f. Products not covered by SIC Code Nos. 2833, 2834, and 2836 if
they are manufactured by a pharmaceutical manufacturer by processes
that generate wastewaters that in turn closely correspond to those of
pharmaceutical products;
g. Cosmetic preparations covered by SIC Code No. 2844 that function
as a skin treatment. (This group of preparations does not include
products such as lipsticks or perfumes that serve to enhance appearance
or to provide a pleasing odor, but do not provide skin care. In
general, this also excludes deodorants, manicure preparations, and
shaving preparations that do not function primarily as a skin
treatment.); and
h. Pharmaceutical research that includes biological,
microbiological, and chemical research, product development, clinical
and pilot-scale activities. (This does not include farms that breed,
raise, and/or hold animals for research at another site. This also does
not include ordinary feedlot or farm operations utilizing feed that
contains pharmaceutically active ingredients.) Pilot-scale and product
development operations conducted at research facilities would be
subject to the specific manufacturing subcategory limitations and
standards corresponding to the subcategory wastewater that the research
facility's wastewater resembles. For example, a pilot chemical
synthesis operation that generates wastewater that is similar to
wastewater generated by chemical synthesis manufacturing would be
subject to the subcategory C limitations and standards.
A number of products and/or activities such as surgical and medical
manufacturing and medical laboratory activity are not part of the
pharmaceutical manufacturing category. A descriptive listing of the
products and activities that are specifically excluded from the
pharmaceuticals manufacturing category may be found in section 2 of the
TDD.

V. Background

A. Clean Water Act

1. Statutory Requirements of Regulations
The objective of the Clean Water Act (CWA) is to ``restore and
maintain the chemical, physical, and biological integrity of the
Nation's waters''. Section 101(a) of the CWA. To assist in achieving
this objective, EPA issues effluent limitations guidelines,
pretreatment standards, and new source performance standards for
industrial dischargers. These guidelines and standards are summarized
below:
a. Best Practicable Control Technology Currently Available (BPT)--
section 304(b)(1) of the CWA. BPT effluent limitations guidelines apply
to all discharges from existing direct dischargers. BPT guidelines are
based on the average of the best performance achieved by plants in a
category or subcategory utilizing currently available technology. In
establishing BPT, EPA considers the cost of achieving effluent
reductions in relation to the effluent reduction benefits, the age of
equipment and facilities, the processes employed, process changes
required, engineering aspects of the control technologies, non-water
quality environmental impacts (including energy requirements), and
other factors as the EPA Administrator deems appropriate. Section
304(b)(1)(B) of the CWA. Where existing performance is uniformly
inadequate within a category or subcategory, BPT may be transferred
from a different subcategory or category.
b. Best Conventional Pollutant Control Technology (BCT)--section
304(b)(4) of the CWA. The 1977 amendments to the CWA established BCT as
an additional level of control for discharges of conventional
pollutants from existing industrial point sources. Section 304(a)(4)
designates the following as conventional pollutants: biochemical oxygen
demanding pollutants (measured as BOD5), total suspended solids
(TSS), fecal coliform, pH, and any additional pollutants defined by the
Administrator as conventional. The Administrator designated oil and
grease as an additional conventional pollutant on July 30, 1979 (44 FR
44501). See 40 CFR 401.16. In addition to other factors specified in
section 304(b)(4)(B), the CWA requires that BCT limitations be
established in light of a two part ``cost-reasonableness'' test. EPA
issued a methodology for the development of BCT limitations on July 9,
1986 (51 FR 24974).
c. Best Available Technology Economically Achievable (BAT)--section
304(b)(2) of the CWA. In general, BAT effluent limitations guidelines
represent the best economically achievable performance of plants in the
industrial subcategory or category, based on available technology. The
CWA establishes BAT as a principal means of controlling the direct
discharge of toxic and nonconventional pollutants to waters of the
United States. The factors considered in assessing BAT include the age
of equipment and facilities involved, the process employed, potential
process changes, and non-water quality environmental impacts, including
energy requirements. The Agency retains considerable discretion in
assigning the weight to be accorded these factors. As with BPT, where
existing performance is uniformly inadequate within a category or
subcategory, BAT may be transferred from a different category or
subcategory. BAT may be based upon process changes or internal
controls, even when these technologies are not common industry
practice.
d. New Source Performance Standards (NSPS)--section 306 of the CWA.
NSPS are based on the best available demonstrated treatment technology.
New plants have the opportunity to install the best and most efficient
production processes and wastewater treatment technologies. As a
result, NSPS should represent the most stringent controls attainable
through the application of the best available control technology for
all pollutants (i.e., conventional, nonconventional, and toxic
pollutants). In establishing NSPS, [[Page 21600]] EPA is directed to
take into consideration the cost of achieving the effluent reduction
and any non-water quality environmental impacts and energy
requirements.
e. Pretreatment Standards for Existing Sources (PSES)--section
307(b) of the CWA. PSES are designed to prevent the discharge of
pollutants that pass through, interfere with, or are otherwise
incompatible with the operation of publicly owned treatment works
(POTWs). The CWA authorizes EPA to establish pretreatment standards for
pollutants that pass through POTWs or interfere with treatment
processes or sludge disposal methods at POTWs. Pretreatment standards
are technology-based and are analogous to BAT effluent limitations
guidelines. See Section IX.E.5.(ii) for discussion of EPA's pass-
through methodology.
The General Pretreatment Regulations, which set forth the framework
for the implementation of categorical pretreatment standards, are found
at 40 CFR part 403. Those regulations contain a definition of pass-
through that addresses localized rather than national instances of
pass-through and establish pretreatment standards that apply to all
nondomestic dischargers. For national instances of pass-through, EPA
performs an analysis based on the procedures set forth at 52 FR 1586
(January 14, 1987).
f. Pretreatment Standards for New Sources (PSNS)--section 307(b) of
the CWA. Like PSES, PSNS are designed to prevent the discharge of
pollutants that pass through, interfere with, or are otherwise
incompatible with the operation of a POTW. PSNS are to be issued at the
same time as NSPS. New indirect dischargers have the opportunity to
incorporate into their plants the best available demonstrated
technologies. The Agency considers the same factors in promulgating
PSNS as it considers in promulgating NSPS.
g. Best Management Practices (BMPs). Section 304(e) of the CWA
gives the Administrator the authority to publish regulations, in
addition to the effluent limitations guidelines and standards listed
above, to control plant site runoff, spillage or leaks, sludge or waste
disposal, and drainage from raw material storage that the Administrator
determines are associated with or ancillary to the industrial
manufacturing or treatment process of the regulated point source
category and that she (he) determines may contribute significant
amounts of pollutants to waters of the United States.
2. Prior Regulations
EPA promulgated interim final BPT regulations for the
pharmaceutical manufacturing point source category on November 17, 1976
(41 FR 50676; 40 CFR part 439, Subparts A-E). The five subcategories of
the pharmaceutical manufacturing industry (40 CFR 439) are:
Subpart A--Fermentation Products Subcategory.
Subpart B--Extraction Products Subcategory.
Subpart C--Chemical Synthesis Subcategory.
Subpart D-- Mixing, Compounding, and Formulating
Subcategory.
Subpart E-- Research Subcategory.
The 1976 BPT regulations set monthly limitations for BOD5 and
COD based on percent removal for all subcategories. No daily maximum
effluent limitations were established for these parameters. The pH was
set within the range of 6.0 to 9.0 standard units. The regulations also
set maximum 30 day average total suspended solids (TSS) limitations for
subcategories B, D, and E. No TSS limitations were established for
subcategories A and C. Subpart A was amended (42 FR 6813) on February
4, 1977, to improve the language referring to separable mycelia and
solvent recovery. The amendment also allowed the inclusion of spent
beers (broths) in the calculation of raw waste loads for Subpart A in
those instances where the spent beer is actually treated in the
wastewater treatment system.
On October 27, 1983, at 48 FR 49808, EPA promulgated revised BPT
and BAT, PSES, and PSNS regulations for Subparts A-D covering the toxic
pollutant cyanide and the conventional pollutants BOD5, TSS and pH
and the nonconventional pollutant COD. The 1983 regulations kept intact
the percent reduction regulations for BOD5 and COD established in
1976 but added floor concentration-based limitations for these
parameters applicable to subcategories B and D. In addition,
limitations for TSS based on each plant's BOD5 discharge were
promulgated for subcategories A-D. EPA also promulgated BPT, BAT, PSES
and PSNS for pH (6.0-9.0) and BAT concentration-based limitations
controlling the discharge of cyanide from subcategory A-D plants. The
Agency also proposed NSPS for BOD5, TSS and pH in the October 1983
notice, but did not publish final NSPS for these parameters. That
proposal is being replaced by today's NSPS proposal.
On December 16, 1986, at 51 FR 45094, EPA promulgated BCT effluent
limitations for BOD5, TSS and pH for subcategories A-D. That final
rule set BCT effluent limitations equal to the existing BPT effluent
limitations for BOD5, TSS, and pH.
3. Litigation History
The effluent limitations guidelines and standards for the
pharmaceutical manufacturing industry have never been the subject of
litigation.
4. Section 304(m) Requirements
Section 304(m) of the Clean Water Act (33 U.S.C. 1314(m)), added by
the Water Quality Act of 1987, requires EPA to establish schedules for
(i) reviewing and revising existing effluent limitations guidelines and
standards and (ii) promulgating new effluent guidelines. On January 2,
1990, EPA published an Effluent Guidelines Plan (55 FR 80), in which
schedules were established for developing new and revised effluent
guidelines for several industry categories. One of the industries for
which the Agency established a schedule was the pharmaceutical
manufacturing point source category.
Natural Resources Defense Council, Inc. (NRDC) and Public Citizen,
Inc. challenged the Effluent Guidelines Plan in a suit filed in U.S.
District Court for the District of Columbia (NRDC et al. v. Reilly,
Civ. No. 89-2980 (D.D.C.)). (The suit originally challenged EPA's
failure to publish the plan by the statutory deadline.) The plaintiffs
charged that EPA's plan did not meet the requirements of section
304(m). On January 31, 1992, EPA entered into a consent decree (the
``304(m) Decree''), which established schedules for, among other
things, EPA's proposal and promulgation of approximately 20 effluent
guidelines including those for the pharmaceutical manufacturing point
source category.
On May 18, 1994, the Agency published a second plan (see 59 FR
25859). The plan projected proposal and promulgation dates for several
industrial categories including the pharmaceutical manufacturing
category.

B. Clean Air Act

Title III of the 1990 Clean Air Act Amendments was enacted to
reduce the amount of nationwide emissions of hazardous air pollutants.
It comprehensively amended section 112 of the Clean Air Act (CAA).
Section 112(b) lists the 189 chemicals, compounds, or groups of
chemicals deemed by Congress to be hazardous air pollutants (HAPs).
These toxic air pollutants are to be regulated by national emission
standards for hazardous air pollutants (NESHAP). Section 112(c)
requires the [[Page 21601]] Administrator to use this list of HAPs to
develop and publish a list of source categories for which NESHAP will
be developed. EPA must list all known categories and subcategories of
``major sources.''
The term major source is defined in paragraph 112(a)(1) to mean any
stationary source or group of stationary sources located within a
contiguous area and under common control that emits or has the
potential to emit, considering controls, in the aggregate 10 tons per
year (tons/yr) or more of any HAP or 25 tons/yr or more of any
combination of HAPs. The term stationary source, from section 111 of
the CAA, means any building, structure, facility, or installation that
emits or may emit any air pollutant. The term area source, as defined
in section 112(a)(2), means any stationary source of HAPs that is not a
major source.
Notice of the initial list of categories of major and area sources
of HAPs was published on July 16, 1992 (57 FR 31576), under authority
of section 112(c). This notice listed pharmaceutical manufacturing as a
category of major sources of HAPs. Notice of the schedule for the
promulgation of emission standards for the listed categories, under
authority of section 112(e), was given on December 3, 1993 (58 FR
63941). Under this notice, emission standards for the pharmaceutical
production industry would be promulgated no later than November 15,
1997.
Section 112(d) of the CAA directs the Administrator to promulgate
emission standards for each category of HAP sources listed under
section 112(c). Such standards are applicable to both new and existing
sources and must require the maximum degree of reduction in emissions
of the hazardous air pollutants subject to this section (including a
prohibition on such emissions, where achievable) that the
Administrator, taking into consideration the cost of achieving such
emission reduction, and any non-air quality health and environmental
impacts and energy requirements, determines is achievable for new and
existing sources in the category or subcategory to which such emission
standard applies. See 42 U.S.C. 7412(d)(2).
Section 112(d)(3) provides that the maximum degree of reduction in
emissions that is deemed achievable for new sources shall not be any
less stringent than the emission control that is achieved in practice
by the best controlled similar source. For existing sources, the
standards may not be less stringent than the average emission
limitation achieved by the best performing 12 percent of existing
sources in each category of 30 or more sources.
Once this minimum control level (referred to as the floor) has been
determined for new or existing sources for a category, the
Administrator must set a standard based on maximum achievable control
technology (MACT) that is no less stringent than the floor. The
Administrator may set MACT standards that are more stringent than the
floor if such standards are achievable considering the cost,
environmental, and other impacts listed in section 112(d)(2). Such
standards must then be met by all sources within the category.

C. Resource Conservation and Recovery Act (RCRA)

Subtitle C of RCRA, 42 U.S.C. 6921-39b, directs EPA to establish a
comprehensive ``cradle to grave'' system regulating the generation,
transport, storage, treatment and disposal of hazardous wastes. The
hazardous wastes subject to this comprehensive management scheme
include any solid waste, or combination of solid wastes, that because
of its quantity, concentration, or physical, chemical, or infectious
characteristics may cause or significantly contribute to an increase in
mortality or an increase in serious irreversible, or incapacitating
reversible, illness; or pose a substantial present or potential hazard
to human health or the environment when improperly treated, stored,
transported, or disposed of, or otherwise managed. 42 U.S.C. 6903(5).
RCRA defines ``solid waste'' to include any garbage, refuse, sludge
from a waste treatment plant, water supply treatment plant, or air
pollution control facility and other discarded material. 42 U.S.C.
6903(27). The Act does not specify what characteristics of a waste
render it hazardous to human health or the environment; instead, it
directs EPA to develop and promulgate criteria for identifying the
characteristics of hazardous waste and for listing hazardous waste,
taking into account toxicity, persistence, and degradability in nature,
potential for accumulation in tissue, and other related factors such as
flammability, corrosiveness, and other hazardous characteristics. 42
U.S.C. 6921. Pursuant to this directive, EPA has adopted a two track
scheme for identifying hazardous wastes. So-called ``characteristic
wastes,'' regulated under 40 CFR 261.20-.24, exhibit at least one of
four specified characteristics: ignitability, corrosivity, reactivity,
or toxicity. Such wastes are deemed automatically subject to regulation
under RCRA subtitle C, and retain the designation of hazardous waste
until they cease to exhibit any of the characteristics. See 40 CFR
261.3(d)(1).
The other type of hazardous wastes, ``listed wastes,'' comprises
wastes specifically classified as hazardous by EPA rule. See 40 CFR
261.11 (setting out criteria EPA considers in determining whether a
solid waste should be a listed hazardous waste). Under EPA regulations,
a listed hazardous waste retains that classification, even if has been
treated in some fashion, until the waste has been demonstrated to be no
longer hazardous. See 40 CFR 261.3(c)-(d) (the ``derived-from'' rule).
Once a waste has been identified or listed by EPA, RCRA permits its
disposal on the land if the waste has been treated to meet standards
established by EPA pursuant to 42 U.S.C. 6924(m). Section 6924(m)(1)
instructs EPA to specify those levels or methods of treatment, if any,
that substantially diminish the toxicity of the waste or substantially
reduce the likelihood of migration of hazardous constituents from the
waste so that short-term and long-term threats to human health and the
environment are minimized. EPA has concluded that requiring hazardous
wastes to be treated in accordance with the best demonstrated available
technology (``BDAT'') is sufficient to satisfy this criterion. See 51
FR 40,572, 40,578 (1986). These standards can apply even after a
characteristic waste no longer exhibits a characteristic. 40 CFR
261.3(d)(1).
In addition to meeting treatment standards before land disposal,
hazardous wastes are also subject to cradle-to-grave control from point
of generation to point of final disposition. Generators prepare
manifests to assure proper tracking of all hazardous wastes. Facilities
treating, storing or disposing of such wastes are subject to design and
operating standards established by EPA. Such standards ordinarily are
embodied in an operating permit issued by EPA to the facility. In
addition to meeting design and operating standards, facilities must
commit sufficient money to assure that the facility will be properly
closed, or that proper post-closure care of the wastes will occur.

D. Pollution Prevention Act of 1990

In the Pollution Prevention Act of 1990 (42 U.S.C. 13101 et seq.),
Congress declared pollution prevention the national policy of the
United States. The Pollution Prevention Act declares that pollution
should be prevented or reduced whenever feasible; pollution that cannot
be prevented should be recycled or reused in an
[[Page 21602]] environmentally safe manner whenever feasible; pollution
that cannot be prevented or recycled should be treated in an
environmentally safe manner whenever feasible; and disposal or other
release into the environment should be chosen only as a last resort and
should be conducted in an environmentally safe manner. See 42 U.S.C.
13101(b).
Today's proposed rule is consistent with this policy. The
technology basis for the proposed NSPS and PSNS for facilities with
subcategory A, B, C and/or D operations includes steam stripping with
distillation. Today's proposed PSES for facilities with subcategory A,
B, C and/or D operations, as well as today's proposed BAT limitations
for facilities with subcategory A and/or C operations, are based on
steam stripping. Both technologies allow for the recovery from
wastewaters and possible reuse of organic solvents. As part of today's
proposal, the Agency also investigated whether solvent use could be
minimized and/or eliminated through process changes but concluded that
such opportunities may be limited to specific process operations at
some facilities. The Agency encourages research regarding solvent use
reduction and/or elimination procedures for existing as well as future
pharmaceutical manufacturing operations. The Agency solicits comment on
process change (source reduction) opportunities for pharmaceutical
manufacturing and products. See section XIV, solicitation number 12.0.

E. Common Sense Initiative

On August 19, 1994, the Administrator established the Common Sense
Initiative (CSI) Council in accordance with the Federal Advisory
Committee Act (U.S.C. App. 2, Section 9(c)) requirements. A principal
goal of the CSI includes developing recommendations for optimal
approaches to multi-media controls for six industrial sectors including
Metal Plating and Finishing, Electronics and Computers, Auto
Manufacturing, and Iron and Steel Manufacturing. The following are the
six overall objectives of the CSI program, as stated in the ``Advisory
Committee Charter.''
1. Regulation. Review existing regulations for opportunities to get
better environmental results at less cost. Improve new rules through
increased coordination.
2. Pollution Prevention. Actively promote pollution prevention as
the standard business practice and a central ethic of environmental
protection.
3. Recordkeeping and Reporting. Make it easier to provide, use, and
publicly disseminate relevant pollution and environmental information.
4. Compliance and Enforcement. Find innovative ways to assist
companies that seek to comply and exceed legal requirements while
consistently enforcing the law for those that do not achieve
compliance.
5. Permitting. Improve permitting so that it works more
efficiently, encourages innovation, and creates more opportunities for
public participation.
6. Environmental Technology. Give industry the incentives and
flexibility to develop innovative technologies that meet and exceed
environmental standards while cutting costs.
The pharmaceutical manufacturing rulemaking effort was not among
those included in the Common Sense Initiative. However, the Agency
believes that the CSI objectives already have been incorporated into
the pharmaceutical manufacturing industry rulemaking. Nonetheless,
given the multimedia considerations affecting this rulemaking, the
Agency will continue to pursue these objectives. The Agency
particularly will focus on avenues for giving state and local
authorities flexibility in implementing this rule, and giving the
industry flexibility to develop innovative and cost-effective
compliance strategies. In developing this rule, EPA took advantage of
several opportunities to gain the involvement of various stakeholders.
Section XIII.F of this preamble describes consultations with state,
local, and tribal governments and other parties including the industry.
EPA has internally coordinated among relevant program offices in
developing this rule. Section X of this preamble describes coordination
between the Office of Water and the Office of Air and Radiation
concerning this proposed water and a related air rule that will be
proposed at a later date. Also, Section XII of this preamble describes
coordination between the Office of Water and the Office of Solid Waste
and Emergency Response regarding the hazardous waste implications of
this proposed water rule. See Section XIV of this preamble for
pertinent comment and data solicitations. The effluent guideline
development process for the pharmaceutical manufacturing industry will
continue to implement the principles of the Common Sense Initiative.

VI. Regulatory Development Under the Clean Water Act

This section describes the Agency's approach for developing
proposed effluent limitations guidelines and standards applicable to
the pharmaceutical manufacturing industry under the CWA. In developing
this rule, EPA first collected information about the industry, next
identified potential control and treatment technology bases for the
effluent limitations and standards EPA proposes to establish, and then,
using methodologies, assumptions, and data described in the economic
and regulatory impact analyses (See Section XI of this preamble),
estimated and analyzed the total environmental and economic impacts of
basing limitations and standards on various combinations of these
control technologies. Finally, EPA selected the control technologies
upon which it based the proposed effluent limitations and standards.

A. Background

The pharmaceutical manufacturing industry releases significant
amounts of pollutants to surface waters, and POTWs, and ambient air.
Section V of this notice discusses in greater detail the legal
authorities available to EPA to address these pollutant releases.

B. Goals

EPA has several technical and policy goals regarding the
development of the proposed effluent limitations guidelines and
standards. These goals include: (1) Protecting the public health and
the environment by attaining significant reductions in pharmaceutical
manufacturing industry pollutant releases to water and other media; (2)
minimizing the cost of complying with the rule; (3) promoting and
facilitating coordinated compliance planning within the industry; (4)
promoting and facilitating pollution prevention; and (5) taking into
account the multimedia nature of pollution control.
In light of the multimedia nature of the environmental releases
from this industry, the Agency has closely coordinated this effluent
guidelines rulemaking with the rulemaking and related activities of the
Office of Air and Radiation (OAR) and the Office of Solid Waste and
Emergency Response (OSWER).

C. Technical Approach

1. Information Collection
EPA's first step in developing these proposed regulations was to
develop a plant-specific database, using information gathered under
section 308 of the CWA, of all facilities potentially subject to the
limitations and standards. See Section VIII below. Information and data
were gathered by EPA from a number of sources, including EPA's
wastewater sampling program, the 1989 [[Page 21603]] screener
questionnaire, and the 1990 survey questionnaire. The information
collected includes the processes and control technologies in use,
current control levels, and pollutant releases. EPA also updated survey
data through telephone calls and letters to specific facilities in an
attempt to ensure that the database reasonably reflects the current
status of the industry. The Agency recognizes that the industry is
dynamic, and that processes and equipment change over time.
Accordingly, EPA will consider information and data submitted in a
timely manner by interested parties in response to this proposal for
the purpose of updating the database prior to promulgation.
EPA placed information collected about the industry into plant-
specific databases. These databases consist mainly of the 1990 survey
responses provided by 244 plants but also contain information from
EPA's sampling program. EPA then estimated costs of implementing the
proposed technology bases in order to analyze the economic impacts of
achieving the proposed effluent limitations guidelines and standards.
The Agency used the plant-specific databases and other components to
calculate wastewater discharges and the costs of complying with the
proposed effluent limitations and standards. This comprehensive
information provides a strong basis for ensuring that the proposed
regulations meet the statutory requirements, and allows consideration
of other factors such as multimedia pollutant reduction.
2. Summary of Public Participation
Beginning in 1989, EPA met on at least a biennial basis with
industry representatives from the Pharmaceutical Research and
Manufacturers of America (PhRMA) to discuss the development of the
screener and detailed questionnaires that EPA intended to distribute
under section 308 of the CWA. The Agency received input from the
industry representatives that was invaluable in the development of
these information collection instruments. Following the completion of
the screener and detailed questionnaires, EPA has continued to meet
informally with PhRMA representatives to discuss progress in the
rulemaking effort. EPA has also met informally with the Natural
Resources Defense Council regarding this rulemaking and has made
available to environmental groups and other members of the public the
information that was provided to the industry.
On May 23, 1994, EPA held a public meeting on the pharmaceutical
rulemaking (see 59 FR 21740, April 26, 1994). Following the meeting EPA
sent copies of revised meeting handout materials to all attendees and
to interested parties who could not attend. In addition, by letter
dated August 12, 1994, EPA provided written responses to questions
submitted by PhRMA concerning issues raised at the public meeting.
These documents are in the rulemaking docket.
3. Development of Effluent Limitations Control Technology Options
After evaluating a variety of control and treatment technologies
and their use in the industry, EPA selected BPT, BAT, BCT, PSES, NSPS,
and PSNS control technology options upon which it bases this proposed
rule. This process is described in Section IX of this notice.
4. Analyses of Regulatory Alternatives
EPA conducted a series of analyses to assess the economic and
environmental impacts of various combinations of BPT, BCT, BAT, NSPS,
PSES, and PSNS control options. EPA then compared the projected
effluent loadings and air emissions resulting from each regulatory
alternative to baseline pollutant releases estimated as of January 1,
1991, based on the 1990 survey data. EPA also estimated the costs of
implementing the various control options and other environmental and
economic impacts for each alternative above the baseline level of
control which EPA determined as treatment technologies in place in
1990. EPA evaluated each alternative in order to determine the
effectiveness of the control technologies represented and to ascertain
the reductions in effluent loadings and air emissions below the
baseline that each control technology option could attain. The Agency
also determined the environmental effects of these technologies with a
goal toward minimizing the cross-media transfer of pollutants between
water and air.
EPA also evaluated the possibility of basing BAT and PSES on
process changes involving solvent use minimization or elimination.
After evaluating information provided in response to the section 308
detailed questionnaire survey regarding pollution prevention measures
on-going at pharmaceutical manufacturing facilities, the Agency
concluded that no option involving solvent use elimination or
minimization is technically available at this time. Nonetheless, the
Agency is encouraging the industry to conduct research into eliminating
or minimizing the use of solvents for existing processes and to design
future manufacturing processes that eliminate or minimize the use of
volatile solvents. See Section XIV, solicitation number 12.0.

VII. Description of the Industry

A. Pharmaceutical Manufacturing Facilities

Presented below is a brief description of the pharmaceutical
manufacturing industry. Other characteristics of the industry are
detailed in Sections IX.B., IX.C., IX.D., and IX.E. of this notice and
in Section 3 of the TDD. Based upon responses to EPA's 1989 Screener
Survey of Pharmaceutical Manufacturing Facilities, the Agency estimates
that there are 566 manufacturing facilities located in 39 States,
Puerto Rico, and the Virgin Islands. The major pharmaceutical
manufacturing areas in the U.S. are the Northeast, the Midwest, and
Puerto Rico.

B. Manufacturing Processes

1. Fermentation
Fermentation is the usual method for producing most steroids and
antibiotics. The fermentation process involves three basic steps:
inoculum and seed preparation, fermentation or growth, and product
recovery. Production of a pharmaceutically active ingredient begins
with spores from the plant master stock. The spores are activated with
water, nutrients, and warmth and are then propagated through the use of
agar plates, test tubes, and flasks until enough mass is produced for
transfer to the seed tank. Following adequate propagation in the seed
tank, microorganisms from the seed tank are transferred to a fermenter
tank along with the sterilized nutrients and the tank is then sparged
with air to begin the fermentation or growth process. After a period
ranging from 12 hours to a week, depending on the specific process, the
fermenter batch whole broth is ready for filtration, which removes
mycelia (i.e., the remains of the microorganisms). The filtered aqueous
broth containing product and residual nutrients is then ready to enter
the product recovery phase.
There are three common methods of product recovery: solvent
extraction, direct precipitation, and ion exchange or adsorption. The
most common method, solvent extraction, involves the use of an organic
solvent to remove or extract the pharmaceutically active ingredient or
product from the aqueous broth. Numerous solvent extractions are
usually necessary to remove an acceptable yield of product from the
contaminant mixture. Another common recovery method, direct
precipitation, involves the use of aqueous solutions of
[[Page 21604]] heavy metals such as copper and zinc to precipitate the
product as a metal salt from the aqueous broth, after which the broth
is filtered and the product is extracted from the solid residue. Ion
exchange or adsorption involves removal of the product from the broth
using solid materials such as ion exchange resin, adsorptive resin or
activated carbon to bond with the product. The product is extracted
from the solid phase material using solvent extraction followed by
solvent evaporation.
2. Biological and Natural Extraction
Biological and natural extraction is used to manufacture
pharmaceutically active ingredients whose molecular structure is too
complex for chemical synthesis or fermentation methods. Extraction
involves the collection and processing of large volumes of plant or
animal matter to produce small quantities of product. Initially, this
large volume material is subject to a large, usually organic solvent-
based, extraction procedure to obtain a first product cut or
extraction. This cut is purified in many successive extraction
operations. At each stage of the extraction process, the volume of
material used becomes smaller. In the end, the volume of product may be
only a few thousandths of the mass of material handled in the earlier
procedures. Generally, the yield from extraction procedures is very
small and pharmaceutical companies use extraction only when they have
no other alternative.
Recently, pharmaceutical manufacturers have been developing
bioengineered microorganisms that can produce pharmaceutically active
ingredients. Pharmaceutical manufacturers sometimes use extraction
procedures to obtain and purify these ingredients, but EPA understands
generally that the amounts of water and solvents used in these
procedures at this time are minimal. Nonetheless, EPA is soliciting
information and data to better characterize wastewaters from these
operations (see Section XIV at solicitation number 11.0).
3. Chemical Synthesis
Chemical synthesis involves the use of a series of chemical
reactions to produce pharmaceutically active ingredients, usually
starting with common feedstock chemicals as raw materials. The product
of each successive chemical reaction then becomes the reactant in the
next chemical reaction until the final reaction step of the synthesis
is reached when the pharmaceutically active ingredient product is
generated. More pharmaceutically active ingredients are manufactured by
chemical synthesis than by any other process.
4. Mixing/Compounding/Formulating
Before active ingredients can be used as pharmaceuticals, they must
be prepared in dosage forms. The primary dosage forms utilized by the
industry include tablets, capsules, liquids and ointments. For example,
in tablet-making, manufacturers blend pharmaceutically inactive
materials filler (e.g., starch) and binder (e.g., corn starch) with the
active ingredient(s) and form tablets using a tablet press machine.
Mixing, compounding, and formulating operations are utilized by more
plants than any other process operation.

VIII. Summary of Data Gathering Efforts

A. Technical and Economic Data

1. 1989 Screener Survey of the Pharmaceutical Industry
In 1988, the Agency developed a short questionnaire for
distribution to all known or suspected pharmaceutical manufacturers.
The purpose of the questionnaire was to identify facilities that could
be affected by future effluent limitations guidelines and standards
applicable to the pharmaceutical manufacturing industry. The
Information Collection Review (ICR) package for this questionnaire was
sent to OMB in May 1989 and approved in June 1989. The questionnaire
was sent to 1163 facilities in July of 1989. The Agency received 962
responses.
2. 1990 Pharmaceutical Manufacturing Industry Survey
In early 1989, EPA began to develop a questionnaire to gather the
technical and financial information necessary for this rulemaking. EPA
met with industry representatives during the questionnaire development
process in an effort to keep the industry informed of the Agency's
plans and to solicit informed comments on questionnaire design. Before
pretesting the questionnaire, EPA sent a preliminary version of the
questionnaire to the Pharmaceutical Manufacturers Association (now
known as the Pharmaceutical Research and Manufacturers of America) for
distribution and review by representatives of member companies. The
Agency then incorporated all appropriate comments of the industry
representatives into a pretest version of the questionnaire. In 1990,
EPA sent pretest versions of the questionnaire to eight facilities for
response and comment. Along with their responses, the pretest
candidates provided information on the amount of time required to
complete the questionnaire and suggestions for improving the
questionnaire as an information gathering instrument.
The pretest suggestions were used to develop a final version of the
questionnaire, which was part of an ICR package that was sent to OMB
for approval in May 1990. In August of that year, OMB cleared part A
(technical section) of the questionnaire and some questions in part B
(economic and financial) but denied clearance for most of the part B
plant-specific financial and economic questions. In order to
accommodate OMB's and industry's concerns about the need for responses
to plant-specific economic and financial questions, the Agency
developed a certification procedure. This procedure allowed industry
respondents to certify that future pharmaceutical category regulations
would not impact their facility above a certain dollar amount. A
respondent making the certification was not required to respond to most
of the part B questions.
In May 1991, the Agency submitted a revised ICR package to OMB,
including the certification option discussed above. OMB approved the
questionnaire and EPA sent the final questionnaire to 280 facilities in
September 1991. EPA received responses from 244 of the 304 facilities
still engaged in pharmaceutical manufacturing with solvent use.
3. Sampling and Analytical Program
Between 1986 and 1991, EPA conducted a sampling program at 13
pharmaceutical manufacturing facilities to: (1) Characterize the
pollutants in the wastewater being discharged directly to surface
waters and indirectly to POTWs; (2) generate pollutant treatment system
performance data from facilities with well-operated advanced biological
treatment systems (those systems attaining better than BPT annual
average effluent quality); and (3) obtain treatability data from steam
stripping units.
Prior to 1986, the Agency had focused on five conventional
pollutants and 126 priority pollutants in the pharmaceutical
manufacturing industry's wastewater. Beginning in 1986, the Agency
expanded the analysis of pharmaceutical wastewater and wastewater
treatment plant sludges to determine the presence and levels of all the
pollutants on the ``Industrial Technology Division (ITD) List of
Analytes'' (hereinafter, the ``List of Analytes''). [[Page 21605]]
During the sampling program, EPA gathered analytical data to
characterize the wastewater from five direct dischargers and eight
indirect dischargers. Treatment system performance data were gathered
from three advanced biological treatment systems and two biological
pretreatment systems. Treatment unit performance data documenting the
performance of five steam stripping columns were also gathered. The
performance of one resin adsorption column and one cyanide destruction
unit was also documented.
a. Bench-, Pilot-, and Full-Scale Studies. Between October and
December 1991, EPA conducted bench-scale and pilot-scale tests to
study: (1) Air stripping technology (with ammonia capture) for ammonia
removal from pharmaceutical plant final effluent; and (2) steam
stripping technology for removal of volatile organic pollutants from
pharmaceutical plant process wastewaters.
EPA conducted the air stripping and steam stripping pilot studies
at a pharmaceutical manufacturing facility with fermentation, chemical
synthesis, formulation, and research operations. The objective of the
air stripping study was to examine the feasibility of obtaining at
least 90 percent ammonia removal using air stripping technology. A
portion of the total facility effluent was used as the feed to the
pilot-scale air stripping study.
The objectives of the steam stripping study were to demonstrate the
achievement of the lowest practical concentrations of volatile organic
pollutants in the treated effluent, using the available bench- and
pilot-scale steam stripping test equipment, and to collect sufficient
data to document these concentrations using the available bench- and
pilot-scale data. On-site pilot-scale testing was conducted for two of
the three streams. EPA elected not to run pilot-scale tests on one of
the streams because the stream flow from that process area was
insufficient for pilot-scale testing during the study time period.
Performance data for this third process wastewater stream were
collected using bench-scale equipment.
In September 1993, EPA conducted an on-site treatment performance
study using a pharmaceutical manufacturing facility's existing
distillation column that treated wastewaters containing methanol. The
objective of the study was to achieve the lowest practical
concentrations of methanol (within the operating constraints of the
facility) in the treated effluent and to collect sufficient data to
document these concentrations. All of the studies are discussed in more
detail in sections 5 and 8 of the TDD.

B. Air Emission Data

In July 1993, pursuant to section 114 of the Clean Air Act, EPA
distributed questionnaires seeking data on air emissions to 396
pharmaceutical manufacturing facilities. The scope of the survey
included all manufacturing operations that were covered by the SIC Code
Nos. 2833, 2834, and 2836 and that also emitted hazardous air
pollutants. Research facilities were not included. The questionnaire
requested production data, process flow diagrams, emissions data,
emission control technology data, and information on source reduction
measures. EPA will use this data and information in developing
standards to be promulgated under the Clean Air Act for the
pharmaceutical manufacturing industry. EPA will compare these data and
information, to the extent it is appropriate, to the data and
information collected under the Clean Water Act to ensure that the best
and most consistent data are used in both rulemaking efforts. See
Section X below.

IX. Development of Effluent Limitations Guidelines and Standards

A. Industry Subcategorization

1. Introduction
In developing today's proposed rule, EPA considered whether
different effluent limitations and standards were appropriate for
different groups of plants or subcategories within the pharmaceutical
manufacturing industry. Factors considered included: processes
employed, effluent characteristics, costs, age of equipment and
facilities, size, location, engineering aspects of the application of
various types of control techniques, process changes, and non-water
quality environmental impacts. In determining which subcategories were
appropriate for this proposed rule, EPA, using recently available data,
evaluated the scheme for establishing subcategories regulated under the
current effluent limitations guidelines and standards applicable to
this industry.
2. Current Subcategorization
The current subcategorization of this industry dates back to 1976
and was developed using data from the mid-1970s. The current
subcategories are as follows:

Subpart A Fermentation
Subpart B Biological and Natural Extraction
Subpart C Chemical Synthesis
Subpart D Mixing/Compounding/Formulating
Subpart E Pharmaceutical Research

3. Rationale for Maintaining the Current Subcategorization
Prior to finalizing the 1983 regulation, the Agency evaluated the
original subcategorization scheme developed for the 1976 interim final
regulations. This evaluation is discussed in section 4 of the 1983
technical development document and in the preamble to the final
regulation at 48 FR 49808 (October 27, 1983). The Agency concluded at
that time that the original subcategorization scheme based on
manufacturing process type was the most appropriate one for the
Pharmaceutical Manufacturing Point Source Category. In determining
whether this scheme is appropriate for the rule being proposed today,
the Agency evaluated the wastewater and production data obtained from
the detailed questionnaire responses as well as plant sampling data in
light of the current scheme. The Agency compared the wastewater flow
and pollutant characteristics data (influent and effluent BOD5,
TSS, and COD) obtained from the 1990 detailed questionnaire responses
with the data presented in Section 4 of the 1983 TDD. EPA concluded
that the similarities and data trends reported for both subcategory A
and C and subcategory B and D facilities were identical to those
reported in 1983 for analogous data. Consequently, the Agency concluded
that the current subcategorization scheme continues to be appropriate
for today's proposed rule. As was the case with the 1983 final
regulation, the limitations and standards being proposed today for
subcategory A are identical to those proposed for subcategory C and
those limitations and standards being proposed for subcategory B are
identical to those being proposed for subcategory D. The Agency invites
comments regarding this regulatory scheme. The subcategorization
analysis is discussed in more detail in section 4 of the TDD for this
rulemaking. See Section XIV, solicitation number 4.0.
4. Subcategory Regulation Not Revised
EPA is not proposing new or revised effluent limitations and
standards for the Pharmaceutical Research Subcategory (Subcategory E).
Rather, research activities falling within this subcategory will
continue to be subject to the BPT regulations established for that
subcategory in the 1983 regulations for this industry. The 1983
regulations did not establish BCT, BAT, NSPS, PSES, or PSNS effluent
limitations and standards for the research subcategory, and today's
proposed revisions to 40 [[Page 21606]] CFR part 439 will not change
this. However, process wastewater generated by research activities
falling within this subcategory will continue to be subject to BCT and
BAT limitations, as appropriate, established on a best professional
judgment (BPJ) basis. In addition, indirect dischargers will be subject
to local limits, as appropriate.
In its preamble to the 1983 regulations, EPA explained that it was
specifically excluding subcategory E pharmaceutical research from all
limitations and standards in the regulation other than BPT limitations
because these operations do not involve production and wastewater
generation in appreciable quantities on a regular basis. See 48 FR
49808, 49816 (Oct. 27, 1983). EPA also noted that research activities
conducted at mixed and single subcategory plants (A, B, C, and D only)
would be covered by that regulation. In today's Notice, EPA proposes to
exclude subcategory E research operations from all limitations and
standards in the proposed rule, other than the existing BPT
limitations, at both stand alone and mixed subcategory plants. However,
in order to clarify the scope of Subcategory E as described in the 1983
preamble, EPA proposes to define Subcategory E research operations
specifically as bench-scale activities related to the development of
pharmaceutical products. Bench-scale activities, in contrast to pilot-
scale operations, do not involve production or wastewater generation in
appreciable quantities on a regular basis and therefore describe the
activities historically encompassed within Subcategory E,
Pharmaceutical Research.
Consequently, under this proposal, bench-scale research activities
that generate process wastewater at manufacturing facilities or at
stand-alone Subcategory E facilities will be covered by the current
subcategory E BPT limitations on BOD5, COD, TSS and pH. This means
that if a facility engaging in bench-scale research operations also
engages in pharmaceutical manufacturing operations covered by
subcategories A, B, C, or D, the process wastewater from the bench-
scale research operations would be subject only to subcategory E
regulations (and on a case-by-case basis BCT and BAT limitations based
on BPJ, as appropriate). Conversely, if a facility engages in research
operations on a pilot-scale level, then the wastewater generated by
those operations would be subject to the standards and limitations
applicable to the manufacturing subcategory (A, B, C, or D) that the
wastewater most resembles. See 40 CFR 439.50 et seq.
The proposal that subcategory E applies to all bench-scale research
operations irrespective of their proximity to pharmaceutical
manufacturing process operations represents a change from the
interpretation expressed by EPA in the preamble to the 1983 rule. In
that preamble, EPA indicated that research activities conducted at
mixed and single subcategory plants (A, B, C, and D only) would be
covered by the regulations corresponding to the particular subcategory.
Accordingly, the Agency is soliciting comment on whether facilities
with both subcategory E and subcategory A, B, C, or D process
operations should be subject to the standards and limitations
corresponding to the manufacturing subcategory (A, B, C, or D) and not
to subcategory E BPT limitations as proposed here. See Section XIV,
solicitation number 5.2.

B. Water Use, Wastewater Discharge and Characterization

This section describes current water use and wastewater recycling
practices, discharge practices and the general characteristics of
wastewater at the plants that manufacture pharmaceuticals in the United
States. A more detailed presentation can be found in Section 5 of the
TDD. Almost all pharmaceutical manufacturing processes require the use
of water, although use and discharge practices and the characteristics
of the wastewater will vary depending on the process operations at
individual facilities.
1. Water Use and Wastewater Generation
a. Water Use. EPA estimates the average daily wastewater generation
by the pharmaceutical manufacturing industry to be 266 million gallons,
based on the responses to questions in part A section 4 of the 1990
Pharmaceutical Manufacturing Survey. Pharmaceutical manufacturers use
water for process operations and for other nonprocess purposes such as
noncontact cooling and sanitation.
The water is used or generated in pharmaceutical manufacturing
process operations in several ways, thereby generating process
wastewater:
Water of reaction: Water formed during the chemical
reaction.
Process solvent: Water used to transport or support the
chemicals involved in the reaction process; this water is usually
removed from the process through a separation step, such as
centrifugation, decantation, drying, or stripping.
Process stream washes: Water added to a process stream
(i.e., the carrier, spent acid, or spent base) that has been separated
from the reaction mixture, in order to purify the stream by washing
away impurities in the stream.
Product washes: Water added to the reaction medium to
purify an intermediate or final product by washing away the impurities
(this water is subsequently removed through a separations step); or
water used to wash the crude product after it has been removed from the
reaction medium.
Spent Acid/Caustic: Spent acid and caustic streams, which
may consist primarily of water, that are discharged from the process
during the separation steps following the reaction step in which acid
and basic reagents are used to facilitate, catalyze, or participate in
the reactions.
Condensed steam: Steam used as a sterilizing medium and in
steam strippers for solvent recovery and wastewater treatment.
Other sources of process wastewater associated with pharmaceutical
manufacturing operations include:
Air pollution control scrubber blowdown: Water or acidic
or basic compounds used in air emission control scrubbers to control
fumes from reaction vessels, storage tanks, incinerators, and other
process equipment.
Equipment and floor washes: Water used to clean process
equipment during unit shutdowns and floors during general housekeeping
or for spill cleanup.
Pump seal water: Direct contact water used to cool packing
material and lubricate pumps.
In addition to process wastewater, non-process wastewater may be
generated during pharmaceutical manufacturing. This non-process
wastewater may include noncontact cooling water (used in heat
exchangers), noncontact ancillary water (e.g., boiler blowdown, bottle
washing), sanitary wastewater, and wastewater from other sources such
as stormwater.
b. Water Conservation. In response to the 1990 detailed survey
questionnaire, 137 of the 244 responding pharmaceutical manufacturers
reported implementing water conservation measures with regard to
process wastewater. Such water conservation measures include: careful
monitoring of water use, installation of automatic monitoring and alarm
systems on in-plant discharges, implementation of alternative
production processes requiring less water, conversion from barometric
to surface condensers, reuse of wastewater from other manufacturing
processes, reuse of noncontact water as process makeup water, and
treatment of contact cooling water to allow reuse. [[Page 21607]]
2. Wastewater Discharge
Based on the responses to the screener and detailed survey
questionnaires and other information, EPA has learned that of the 304
potentially affected facilities, 35 facilities discharge their
wastewater directly to surface waters of the United States, 259
discharge to a POTW, three discharge directly to surface water as well
as to a POTW, and seven do not discharge to a POTW or to surface
waters. EPA estimates that the average daily volume of pharmaceutical
process wastewater discharged via a POTW or directly from the
manufacturing facility to surface waters of the U.S. is 84 and 20
million gallons, respectively.
3. Wastewater Characterization
The pharmaceutical manufacturing industry generates process
wastewaters containing a variety of pollutants. Most of this process
wastewater receives some treatment, either in-plant at the process unit
prior to commingling with other facility wastewaters or in an end-of-
pipe wastewater treatment system. Pharmaceutical manufacturers
discharge wastewater containing conventional, priority, and
nonconventional pollutants. These pollutants are discussed in Section
IX.C below.
a. Conventional Pollutants: BOD5, TSS, and pH. BOD5, the
quantity of oxygen used in the aerobic stabilization of wastewater
streams, is the most widely used measure of general organic pollution
in wastewater. BOD5 discharges from facilities with subcategory A
and/or C operations are significantly higher than those discharges from
facilities with subcategory B and/or D operations because fermentation
and chemical synthesis process operations generate substantially
greater concentrations of organic material (on average ten times higher
untreated BOD5 concentrations) than extraction or mixing,
compounding, and formulating processes.
TSS is the portion of the total solids that can be filtered out of
a solution using a 1-micron filter. (Total solids in wastewater is
defined as the residue remaining after evaporation at just above the
boiling point.) Discharges of TSS for this industry are generally
proportional to the amount of BOD5 discharged and, as a result, A
and/or C subcategory facilities discharge significantly more TSS than
do B and/or D facilities.
The pollutant parameter, pH, is a measure of the acidity or
alkalinity of an aqueous solution. It is defined as the logarithm of
the reciprocal of the hydronium-ion concentration of a solution. A pH
of 7.0 indicates neutrality or a balance between free hydronium and
free hydroxyl ions. A pH above 7.0 indicates that a solution is
alkaline; a pH below 7.0 indicates that a solution is acidic. Untreated
wastewaters from the pharmaceutical manufacturing industry range from
being highly alkaline (pH 12 or higher) to highly acidic (pH 2 or
lower). The pollutant parameter, pH, is currently controlled within the
range of 6.0 to 9.0 by promulgated effluent limitations guidelines and
standards for all five subcategories of the pharmaceutical
manufacturing industry. EPA does not propose to modify the promulgated
pH limitations by this rulemaking. Therefore, pH is not included in the
following discussion of pollutant parameters.
b. Priority Pollutants. Questionnaire respondents reported
discharging 13 different priority pollutants. The annual mass loading
of untreated priority pollutants released to the environment from
pharmaceutical wastewater (including pollutants emitted to the air from
wastewaters) range from 3.6 million pounds per year to 400 pounds per
year. The most significant priority pollutants discharged by the
industry are methylene chloride, toluene, chloroform, and
chloromethane. EPA sampling data at various direct and indirect
discharging facilities indicate over 57 different priority pollutants
were detected in pharmaceutical wastewaters at various concentrations.
Many of the priority pollutants detected during sampling programs were
pesticides unrelated to process operations and priority pollutant
metals detected at concentrations incapable of being treated by
available technologies.
In general, facilities with subcategory A and/or C operations
reported discharging a greater variety of priority pollutants and at
greater loads than facilities with Subcategory B and/or D operations.
The Subcategory B and/or D direct dischargers reported that they did
not discharge any priority pollutant load, while the Subcategory B and/
or D indirect dischargers reported discharging some priority pollutant
load. See Section 9 of the TDD for a presentation of the current
priority pollutant discharge loads by subcategory group.
c. Nonconventional Pollutants. Questionnaire respondents reported
discharging 105 different nonconventional pollutants, not including
COD. The annual mass loadings of nonconventional pollutants released to
the environment from pharmaceutical wastewaters (including air
emissions from wastewaters) range from 15.4 million pounds per year to
one pound per year. The most significant nonconventional pollutants
discharged by the industry are methanol, ethanol, isopropanol, and
acetone. EPA sampling data at various direct and indirect discharging
facilities indicate over 59 different volatile and semivolatile organic
compounds were detected in pharmaceutical wastewaters at various
concentrations.
In general, facilities with subcategory A and/or C operations
reported discharging a greater variety of nonconventional pollutants
and at greater loads than Subcategory B and/or D operations. In
addition, the Subcategory B and/or D direct dischargers reported
discharging fewer nonconventional pollutants at lower loads than the
Subcategory B and/or D indirect dischargers. See Section 9 of the TDD
for a presentation of the current nonconventional pollutant discharge
loads by subcategory group.

C. Selection of Pollutant Parameters

1. Pollutants Regulated
a. Introduction. This section lists the pollutants covered by
today's proposed rule in groups of conventional, priority, and
nonconventional pollutants. For this proposed rule, EPA considered each
pollutant identified in questionnaire responses and in EPA's sampling
programs. In selecting the pollutants for control, EPA took into
account their respective discharge loadings, frequency of occurrence,
treatability, and environmental significance. In addition, EPA
considered whether appropriate analytical methods were available or
could be readily developed to detect and quantify the presence of these
pollutants in wastewater. Finally, EPA investigated whether bulk
parameters (e.g., COD) could be substituted for groups of individual
pollutants. EPA concluded preliminarily that no known bulk parameters
could be substituted as indicator pollutants for the individual
pollutants to be regulated by these proposed effluent limitations and
standards. EPA is soliciting comment on this finding. See section XIV
of this preamble at solicitation number 37.0. Table IX.C-1 and Table
IX.C-2 list the pollutants to be regulated by the various proposed
effluent limitations and standards. A complete discussion of the
pollutant selection/exclusion process may be found in section 6 of the
TDD.

Conventional Pollutants:
BOD5 and TSS
Priority Pollutants:
Benzene
Chlorobenzene
Chloroform [[Page 21608]]
Chloromethane
Cyanide
o-Dichlorobenzene*
1,2-Dichloroethane*
Methylene Chloride
Phenol
Toluene
Nonconventional Pollutants:
Acetone*
Acetonitrile
Ammonia (aqueous)
n-Amyl Acetate*
Amyl Alcohol*
Aniline*
2-Butanone (MEK)*
n-Butyl Acetate*
n-Butyl Alcohol*
tert-Butyl Alcohol*
COD (Chemical Oxygen Demand)
Cyclohexane
Diethyl Ether*
Diethylamine*
N,N-Dimethylacetamide
Dimethylamine*
N,N-Dimethylaniline*
N,N-Dimethylformamide
Dimethyl Sulfoxide
1,4-Dioxane*
Ethanol*
Ethyl Acetate*
Ethylene Glycol
Formaldehyde
Formamide*
Furfural*
n-Heptane
n-Hexane
Isobutyraldehyde*
Isopropanol*
Isopropyl Acetate*
Isopropyl Ether*
Methanol*
Methylamine*
Methyl Cellosolve (2-Methoxyethanol)
Methyl Formate*
Methyl Isobutyl Ketone (MIBK)*
2-Methyl Pyridine*
Petroleum Naphtha*
Polyethylene Glycol 600
n-Propanol*
Pyridine*
Tetrahydrofuran*
Trichlorofluoromethane
Triethylamine*
Xylenes

*Under co-proposal (2) these pollutants will not be regulated.

Table IX.C-1. Pollutants Regulated in Proposed Effluent Limitations Guidelines and Standards for Facilities With
subcategory A and/or C Operations
----------------------------------------------------------------------------------------------------------------
Effluent regulation
Pollutants regulated -----------------------------------------------------------
BPT BCT BAT NSPS PSES PSNS
----------------------------------------------------------------------------------------------------------------
BOD5................................................ X X X
TSS................................................. X X X
COD................................................. X X X
CN.................................................. X X^{2 X^{2 X^{2 X^{2
Ammonia............................................. X X X X
Nonconv Vol. Orgs................................... X X X^{3 X^{3
Pri. Pol. Vol. Orgs................................. X X X X
Phenol.............................................. X X
Nonconv. Svol. Orgs^{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
----------------------------------------------------------------------------------------------------------------
BOD5................................................ X X X
TSS................................................. X X X
COD................................................. X X X
Nonconv. Vol. Orgs.................................. X X X\2\ X\2\
Pri. Pol. Vol. Orgs................................. X X X X
Phenol.............................................. X X
Nonconv. Svol Orgs\1\............................... X X (\3\) (\3\)
----------------------------------------------------------------------------------------------------------------
\1\Dimethyl sulfoxide, N,N-dimethyl acetamide, N,N-dimethyl formamide, ethylene glycol and formaldehyde.
\2\Does not include two pollutants which do not pass through (acetonitrile and polyethylene glycol 600).
\3\Limits are not being proposed at this time for these pollutants.

b. Conventional pollutants. Biochemical oxygen demand (BOD5)
and total suspended solids (TSS) are conventional pollutants that have
been regulated in this industry by previous BPT and BCT effluent
limitations guidelines. These parameters are important because they
quantify the biodegradable organic matter and suspended solids
generated by all plants in all subcategories of the pharmaceutical
industry. EPA estimates that 3.3 million pounds per year of BOD5
and 6.4 million pounds per year of TSS are discharged by the 35
facilities EPA has identified as direct dischargers. Most direct
discharger plants have some level of secondary biological treatment in-
place designed to treat BOD5 and TSS. EPA is proposing to
establish NSPS and to revise the BPT and BCT effluent limitations for
these pollutants in all subcategories. EPA does not propose to set
limitations for BOD5 and TSS applicable to indirect dischargers
because EPA has determined that these pollutants can be adequately
treated by POTWs. EPA is not proposing to use them as indicators for
other pollutants in this industrial category, although this will be
given further evaluation. [[Page 21609]]
c. Priority pollutants. The priority pollutants selected for
control include cyanide, phenol and various solvents used by the
industry. EPA estimates that direct and indirect discharging facilities
discharge 0.5 and 1.8 million pounds per year, respectively, of the 10
priority pollutants addressed in this proposal. EPA is proposing to
promulgate BPT, BAT, NSPS, PSES, and PSNS for some or all of these
pollutants in subcategories A, B, C, and D.
d. Nonconventional pollutants. Nonconventional pollutants include
ammonia, COD (Chemical Oxygen Demand), and various volatile and
semivolatile organic compounds that are used for the most part as
solvents by the industry. EPA estimates that 0.8 and 0.5 million pounds
per year of ammonia and 32 and 78 million pounds per year of COD are
discharged by direct and indirect discharging facilities, respectively.
With respect to COD, EPA is proposing to revise existing BPT
limitations and promulgate new BAT limitations and NSPS for
subcategories A, B, C, and/or D. With respect to ammonia, EPA is
proposing to promulgate BAT, NSPS, PSES, and PSNS for subcategories A
and/or C. EPA has determined that ammonia is not a pollutant of concern
in wastewaters of facilities with subcategory B and/or D operations and
hence does not propose limits for ammonia for those subcategories. See
Section 5 of the TDD. See Section XIV, solicitation numbers 20.0 and
23.0. For PSES, EPA is co-proposing a finding of no pass-through for 33
priority and nonconventional pollutants.
2. Pollutants Not Regulated
EPA is not proposing effluent limitations or standards for 85
priority and nonconventional pollutants identified as potentially
present in pharmaceutical wastewaters. In Section 6 of the TDD, EPA
describes for each pollutant or group of pollutants the reasons each is
excluded from this proposal. EPA bases its decision to exclude these
pollutants or groups of pollutants on one or more of the following
reasons:
(1) The pollutant or group of pollutants is deemed not present in
pharmaceutical wastewaters, because it was not detected in the effluent
with the use of analytical methods promulgated pursuant to section
304(h) of the Clean Water Act or with other state-of-the-art methods;
(2) The pollutant or group of pollutants is present only in trace
amounts and is neither causing nor likely to cause toxic effects in
humans or aquatic life;
(3) The pollutant or group of pollutants is detected in the
effluent from only one or a small number of sources;
(4) The pollutant or group of pollutants is effectively controlled
by the technologies used as a basis for limitations on other
pollutants, including those limitations and standards proposed today;
or
(5) Insufficient data are available to establish effluent
limitations or standards for that pollutant or group of pollutants.
In addition, EPA proposes to control phenol discharged by direct
dischargers (through BAT and NSPS) but not by indirect dischargers
(through PSES and PSNS) because pass-through has not been demonstrated
for phenol. See the discussion on the analysis of pollutant pass-
through in Section IX.E.5.a. of this preamble. EPA also is proposing to
exclude two nonconventional pollutants from control by PSES and PSNS
regulations (acetonitrile and polyethylene glycol 600) because pass-
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 BOD5 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 BOD5, 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 BOD5, 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 BOD5
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 BOD5, 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 BOD5, TSS, and COD effluent and effluent
concentrations and loadings in order to calculate long-term average
concentrations for BOD5, TSS, and COD. EPA then used this
information to determine the performance level defining proposed BPT
for BOD5, 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 BOD5, 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 BOD5
and COD, respectively, and average TSS concentrations equal to 1.7
times their average influent BOD5 concentrations. As an initial
matter, EPA did not consider plants for this rulemaking unless they
were consistently achieving such long-term BOD5 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 BOD5,
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 BOD5, 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 BOD5 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 BOD5, 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
BOD5 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 BOD5 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
BOD5 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 BOD5
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 BOD5, 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
BOD5, 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 BOD5, 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 BOD5, 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 BOD5, 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 BOD5, 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 BOD5 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 BOD5 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 BOD5 and TSS are summarized in
Table IX.H.1.

Table IX.H.1.--BPT, BOD5 and TSS Reductions
------------------------------------------------------------------------
BOD5reduction 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^{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).
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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,^{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).
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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.^{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.
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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.
All options include an action level of 10,000 ppmw volatile organic HAP concentration at any flowrate.
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.
All options include an action level of 10,000 ppmw volatile organic HAP concentration at any flowrate.
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:
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.
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.
NSPS-A/C#1 is the technology basis for new A/C facilities
that are direct dischargers. [[Page 21636]]
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).
PSES-A/C#1 is the technology basis for A/C facilities that
are indirect dischargers.
PSES-B/D#1 is the technology basis for B/D facilities that
are indirect dischargers.
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).
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.^{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 BOD5 Removal Efficiency at POTWs

Industry also asserts that removal of these non-halogenated
volatile organic pollutants (a portion of which are measured as
BOD5) may have adverse impacts on the BOD5 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 BOD5 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 BOD5 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 (BOD5), 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 (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
BOD5............................................. 405.1 (^{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 (^{a)
Chlorobenzene.................................... 1624B 10
Chloroform....................................... 1624B 10
Chloromethane.................................... 1624B 50
Cyanide (Total).................................. 335.1, 335.2, 335.3 (^{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(^{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(^{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(^{b) 3,180
Pyridine......................................... 1665 5
Tetrahydrofuran.................................. 1666 20
Toluene.......................................... 1624 10
Trichlorofluoromethane........................... 1666 10
Triethlyamine.................................... 1666, 1671 50,000
TSS.............................................. 160.2 (^{a)
m,p-Xylene....................................... 1666 10
o-Xylene......................................... 1666 5
----------------------------------------------------------------------------------------------------------------
(^{a)--As specified in 40 CFR Part 136.
(^{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.............................................................. (^{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
(^{c)............... Xylenes..................................................................... 1
C-002-(a)......... BOD5........................................................................ 7
[[Page 21658]]

C-009-(a)......... TSS......................................................................... 7
----------------------------------------------------------------------------------------------------------------
(^{a) These are synthetic CASRN's designed for use with the Environmental Monitoring Methods Index (EMMI).
(^{b) Monitoring fequency for cyanide is once per treated batch.
(^{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).

------------------------------------------------------------------------
BPT effluent
limitations
micrograms per liter
(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
------------------------------------------------------------------------
BOD5............................................ 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 BOD5 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).

(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 (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).

[[Page 21660]]
------------------------------------------------------------------------
New source
performance
standards micrograms
per liter (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
(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
------------------------------------------------------------------------
BOD5.................................... 62 29
COD..................................... 781 538
TSS..................................... 87 43
pH...................................... (^{a) (^{a)
------------------------------------------------------------------------
(^{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).

(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 (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
(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
(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).

------------------------------------------------------------------------
BPT effluent
limitations
milligrams per liter
(mg/L)
Pollutant or pollutant parameter ---------------------
Maximum
for any Monthly
one day average
------------------------------------------------------------------------
BOD5.............................................. 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 BOD5 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 (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
(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
------------------------------------------------------------------------
BOD5.............................................. 34 10
COD............................................... 60 24
TSS............................................... 40 12
pH................................................ (^{a) (^{a)
------------------------------------------------------------------------
(^{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).

(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 (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
(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).]

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).

(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
------------------------------------------------------------------------
BOD5.............................................. 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 BOD5 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).

(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 (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).

------------------------------------------------------------------------
New source
performance
standards micrograms
per liter (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.

[[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
------------------------------------------------------------------------
BOD5.............................................. 62 29
COD............................................... 781 538
TSS............................................... 87 43
pH................................................ (^{a) (^{a)
------------------------------------------------------------------------
(^{a)Within the range of 6.0 to 9.0 standard units.

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).

(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).]

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).]

(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
(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
------------------------------------------------------------------------

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).

(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 BOD5 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 (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.

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

COD..................................... 60 24
TSS..................................... 40 12
pH...................................... (^{a) (^{a)
------------------------------------------------------------------------
(^{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).

(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 (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
(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).]

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 BOD5
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 BOD5 in any calendar month shall specifically not
reflect not less than 90 percent reduction in the long term daily
average raw waste content of BOD5 multiplied by a variability
factor of 3.0. However, a plant shall not be required to attain a 30-
day average BOD5 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 BOD5 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 BOD5 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
BOD5 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}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}