Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards: Pharmaceutical Manufacturing Category
Federal RegisterMay 2, 1995
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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 X2 X2 X2 X2
Ammonia............................................. X X X X
Nonconv Vol. Orgs................................... X X X3 X3
Pri. Pol. Vol. Orgs................................. X X X X
Phenol.............................................. X X
Nonconv. Svol. Orgs1................................ X X (\4\) (\4\)
----------------------------------------------------------------------------------------------------------------
\1\Dimethyl sulfoxide, N,N-dimethyl acetamide, N,N-dimethyl formamide, ethylene glycol and formaldehyde.
\2\For purposes of proposal, CN limits for BAT, NSPS, PSES, and PSNS are the same as BPT.
\3\Does not include two pollutants which do not pass through (acetonitrile and polyethylene glycol 600).
\4\Limits are not being proposed at this time for these pollutants.
Table IX.C-2. Pollutants Regulated in Proposed Effluent Limitations Guidelines and Standards for Facilities With
Subcategory B and D Operations
----------------------------------------------------------------------------------------------------------------
Effluent regulation
Pollutants regulated -----------------------------------------------------------
BPT BCT BAT NSPS PSES PSNS
----------------------------------------------------------------------------------------------------------------
BOD5................................................ X X X
TSS................................................. X X X
COD................................................. X X X
Nonconv. Vol. Orgs.................................. X X X\2\ X\2\
Pri. Pol. Vol. Orgs................................. X X X X
Phenol.............................................. X X
Nonconv. Svol Orgs\1\............................... X X (\3\) (\3\)
----------------------------------------------------------------------------------------------------------------
\1\Dimethyl sulfoxide, N,N-dimethyl acetamide, N,N-dimethyl formamide, ethylene glycol and formaldehyde.
\2\Does not include two pollutants which do not pass through (acetonitrile and polyethylene glycol 600).
\3\Limits are not being proposed at this time for these pollutants.
b. Conventional pollutants. Biochemical oxygen demand (BOD5)
and total suspended solids (TSS) are conventional pollutants that have
been regulated in this industry by previous BPT and BCT effluent
limitations guidelines. These parameters are important because they
quantify the biodegradable organic matter and suspended solids
generated by all plants in all subcategories of the pharmaceutical
industry. EPA estimates that 3.3 million pounds per year of BOD5
and 6.4 million pounds per year of TSS are discharged by the 35
facilities EPA has identified as direct dischargers. Most direct
discharger plants have some level of secondary biological treatment in-
place designed to treat BOD5 and TSS. EPA is proposing to
establish NSPS and to revise the BPT and BCT effluent limitations for
these pollutants in all subcategories. EPA does not propose to set
limitations for BOD5 and TSS applicable to indirect dischargers
because EPA has determined that these pollutants can be adequately
treated by POTWs. EPA is not proposing to use them as indicators for
other pollutants in this industrial category, although this will be
given further evaluation. [[Page 21609]]
c. Priority pollutants. The priority pollutants selected for
control include cyanide, phenol and various solvents used by the
industry. EPA estimates that direct and indirect discharging facilities
discharge 0.5 and 1.8 million pounds per year, respectively, of the 10
priority pollutants addressed in this proposal. EPA is proposing to
promulgate BPT, BAT, NSPS, PSES, and PSNS for some or all of these
pollutants in subcategories A, B, C, and D.
d. Nonconventional pollutants. Nonconventional pollutants include
ammonia, COD (Chemical Oxygen Demand), and various volatile and
semivolatile organic compounds that are used for the most part as
solvents by the industry. EPA estimates that 0.8 and 0.5 million pounds
per year of ammonia and 32 and 78 million pounds per year of COD are
discharged by direct and indirect discharging facilities, respectively.
With respect to COD, EPA is proposing to revise existing BPT
limitations and promulgate new BAT limitations and NSPS for
subcategories A, B, C, and/or D. With respect to ammonia, EPA is
proposing to promulgate BAT, NSPS, PSES, and PSNS for subcategories A
and/or C. EPA has determined that ammonia is not a pollutant of concern
in wastewaters of facilities with subcategory B and/or D operations and
hence does not propose limits for ammonia for those subcategories. See
Section 5 of the TDD. See Section XIV, solicitation numbers 20.0 and
23.0. For PSES, EPA is co-proposing a finding of no pass-through for 33
priority and nonconventional pollutants.
2. Pollutants Not Regulated
EPA is not proposing effluent limitations or standards for 85
priority and nonconventional pollutants identified as potentially
present in pharmaceutical wastewaters. In Section 6 of the TDD, EPA
describes for each pollutant or group of pollutants the reasons each is
excluded from this proposal. EPA bases its decision to exclude these
pollutants or groups of pollutants on one or more of the following
reasons:
(1) The pollutant or group of pollutants is deemed not present in
pharmaceutical wastewaters, because it was not detected in the effluent
with the use of analytical methods promulgated pursuant to section
304(h) of the Clean Water Act or with other state-of-the-art methods;
(2) The pollutant or group of pollutants is present only in trace
amounts and is neither causing nor likely to cause toxic effects in
humans or aquatic life;
(3) The pollutant or group of pollutants is detected in the
effluent from only one or a small number of sources;
(4) The pollutant or group of pollutants is effectively controlled
by the technologies used as a basis for limitations on other
pollutants, including those limitations and standards proposed today;
or
(5) Insufficient data are available to establish effluent
limitations or standards for that pollutant or group of pollutants.
In addition, EPA proposes to control phenol discharged by direct
dischargers (through BAT and NSPS) but not by indirect dischargers
(through PSES and PSNS) because pass-through has not been demonstrated
for phenol. See the discussion on the analysis of pollutant pass-
through in Section IX.E.5.a. of this preamble. EPA also is proposing to
exclude two nonconventional pollutants from control by PSES and PSNS
regulations (acetonitrile and polyethylene glycol 600) because pass-
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 th
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