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

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 439

[FRL–5165–2]

RIN 2060–AC49

Effluent Limitations Guidelines,

Pretreatment Standards, and New

Source Performance Standards:

Pharmaceutical Manufacturing

Category

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

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 companyspecific 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
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 °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,
21594 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

connections, and, if necessary, flowinducing 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, noncontact 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.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 (106)

grams, or one metric ton.

Metric ton—One thousand (103)

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 concentrationbased 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 fullscale 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.
21596 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

(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
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 waterbased 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
21598 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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

1Same 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 passthrough 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
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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, nonwater 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 ‘‘costreasonableness’’ 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,
21600 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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 technologybased and are analogous to BAT effluent

limitations guidelines. See Section

IX.E.5.(ii) for discussion of EPA’s passthrough 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 passthrough 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
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 postclosure 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
21602 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 plantspecific 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
21604 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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 tabletmaking, 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’’).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 nonwater 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 mid1970s. 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
21606 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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 standalone 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 inplant 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.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 endof-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
21608 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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

Pollutants regulated

Effluent regulation

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. Orgs 1 ...................................................................................................... X X (4) (4)

1 Dimethyl sulfoxide, N,N-dimethyl acetamide, N,N-dimethyl formamide, ethylene glycol and formaldehyde.

2For 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

Pollutants regulated

Effluent regulation

BPT BCT BAT NSPS PSES PSNS

BOD5 ................................................................................................................................. X X X

TSS ................................................................................................................................... X X X

COD .................................................................................................................................. X X X

Nonconv. Vol. Orgs .......................................................................................................... X X X2 X2

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.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 coproposing 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 passthrough 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 coproposal, 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 solventladen 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
21610 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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-ofpipe 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).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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
21612 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

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-ofpipe 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
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 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 nonwater 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 onsite 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
21614 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

recently promulgated Hazardous

Organic NESHAP (HON) for the

Synthetic Organic Chemical

Manufacturing Industry (SOCMI), in

conjunction with Section 308

questionnaire responses, to evaluate the

1990 levels of air emissions from

wastewater for this industry. The results

of the analyses were used to estimate air

emission increases or decreases for the

regulatory options. The Agency

estimates that Option 1 would result in

a minimal increase in air emissions,

while Options 2 and 3 would decrease

air emissions by 5,300 and 6,350 metric

tons per year, respectively. Option 4

would achieve the same air emission

reduction as Option 3. In EPA’s view,

these beneficial non-water quality

environmental impacts militate in favor

of selecting a technology option

employing steam stripping or

distillation (i.e., Options 2, 3 or 4).

The Agency did not find that the age

of equipment and facilities involved

provided any basis for choosing among

the options. The Agency also evaluated

whether the engineering aspects of the

options were compatible with the

manufacturing processes employed and

potential process changes at facilities

with subcategory A and/or C operations.

EPA concluded that the engineering

aspects of all four options were

compatible with current manufacturing

processes and possible process changes

at these facilities, and the results of this

evaluation did not provide a basis for

selecting an option.

(2) Biological and Natural Extraction

and Mixing/Compounding/Formulating

Subcategories, Subparts B and D

EPA considered four regulatory

options to reduce the generation of

priority and nonconventional pollutants

by facilities with subcategory B and/or

D operations. In selecting and

evaluating these technology options for

BAT for these facilities, EPA examined

the 1990 questionnaire data supplied by

the fourteen facilities with subcategory

B and/or D operations only that

discharge directly into surface waters.

Among other things, EPA undertook to

characterize the process wastewater

from these facilities in order to identify

the best technologies available to treat

the pollutants of concern. The data

supplied by these facilities indicate that

the process wastewater of these direct

dischargers is significantly different, in

terms of the pollutants present and their

concentrations, from the process

wastewater of indirect discharging

facilities with subcategory B and/or D

operations. EPA is unable to account for

this marked difference, because the

processes employed by the direct and

indirect dischargers with subcategory B

and/or D operations seem to be the

same, and therefore EPA has some

doubts that these data depict the typical

wastestreams of direct dischargers with

subcategory B and/or D operations.

Although EPA proposes BAT limitations

for these facilities based on the

conclusions it drew from the data, EPA

also solicits comment on those

conclusions and invites additional data

concerning the processes and

wastewater characteristics (flow and

pollutant concentration) of these

facilities. See Section XIV, solicitation

number 7.0. Because new data for 1991–

1994 may establish greater similarities

between the process wastewaters of

direct and indirect dischargers with

operations than are evident today, EPA

is also considering and specifically

inviting comment on whether it should

promulgate BAT limitations based on

the model treatment technology selected

by EPA as the basis for its proposed

PSES limitations for facilities with

subcategory B and/or D operations. See

Section IX.E.5 for a discussion of the

reasoning underlying that proposal.

In addition, in the event a facility

with subcategory B and/or D operations

changes its mode of discharge and

decides to discharge its wastewater

directly to surface waters (rather than

through a POTW), EPA is considering

establishing BAT limitations for such

dischargers that reflect the wastewater

characteristics reported by the indirect

dischargers with subcategory B and/or D

operations. The possibility that an

indirect discharger may change its mode

of discharge and thus become subject to

BAT limitations rather than to PSES

further suggests to EPA that it should

consider the entire universe of data from

facilities with subcategory B and D

operations—not just those currently

with direct discharges—in setting BAT

limits. Therefore, EPA seeks comment

on whether it should promulgate BAT

limitations for this subcategory based on

steam stripping technology, which EPA

has determined is appropriate

technology for the wastestreams

reported by indirect dischargers in this

subcategory. See Section XIV,

solicitation number 7.0.

The four options considered by EPA

are as follows:

Option (1)—Advanced biological

treatment.

This option is identical to the

proposed technology basis for BPT for

facilities with subcategory B and/or D

operations.

Option (2)—In-plant steam stripping

plus advanced biological treatment.

This option adds in-plant steam

stripping to the technology described in

Option 1 for the purpose of removing

strippable organic pollutants prior to

dilution from commingled wastewater

streams and air stripping in treatment

basins and impoundments at the end of

the pipe.

Option (3)—In-plant steam stripping

with distillation plus advanced

biological treatment.

This option adds in-plant fractional

distillation to the technology described

in Option 2 for the fractional purpose of

achieving greater removal of difficult to

strip volatile organic pollutants (such as

methanol) prior to dilution from

commingled wastestreams and air

stripping in treatment basins and

impoundments at the end of the pipe.

Option (4)—Steam stripping with

distillation plus advanced biological

treatment plus end-of-pipe Granular

Activated Carbon (GAC) adsorption

technology.

This option adds Granular Activated

Carbon adsorption treatment to the

technology described in Option 3 for the

purpose of achieving additional removal

of the pollutant COD beyond that

achieved by Option 3.

EPA is proposing Option 1 as the

technology basis for BAT limitations for

facilities with subcategory B and/or D

operations because, on the basis of the

data submitted by the direct dischargers

in these subcategories, EPA determined

that this technology basis is the best

available technology economically

achievable for these pollutants.

However, as discussed above, EPA is

seriously considering and specifically

invites comment on setting BAT

limitations for these plants based on the

PSES model technology for facilities

with subcategory B and/or D operations.

In making the proposed BAT

determination, EPA analyzed data for

each facility identified through the 1989

Pharmaceutical Screener Questionnaire

and the 1990 Detailed Questionnaire as

engaging in subcategory B and/or D

operations. The results of the screener

questionnaire indicate that, nationwide,

14 pharmaceutical manufacturing plants

with direct discharges engage only in

subcategory B and/or D operations

(excluding subcategory E research

activities). These 14 facilities reported

to EPA in response to the 1990 detailed

questionnaire that they discharge BOD5,

TSS, COD, six solvents and no priority

pollutants. Of the six solvents, the

facilities reported discharging only two

in quantities exceeding a combined

subcategory total of 1000 lbs/year. EPA’s

analysis of the questionnaire data

indicates that the total nonconventional

pollutant loadings discharged, on

average, for each facility with

subcategory B and/or D operations in
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21615

1990 was 1,660 pounds/year. In

addition, these 14 facilities reported in

their questionnaire responses that they

emit from wastewater a total of 170

pounds/year of volatile organic

pollutants. Subsequent analysis by EPA

using its WATER7 model indicates that

these 14 facilities may actually emit

closer to 35,000 pounds/year from

wastewater. See Section 12 of TDD for

discussion of difference between

questionnaire results and WATER7

results. By way of comparison, facilities

with subcategory A and/or C operations

reported in the 1990 questionnaire that

they emit from wastewater a total of 3.2

million pounds/year of volatile organic

and priority pollutants, and the

WATER7 model projected 14 million

pounds/year of those pollutants from

wastewater.

Based on its evaluation of the data

available to it, EPA proposes to base

BAT limitations for facilities with

subcategory B and/or D operations on

advanced biological treatment (PSES

Option 1 minus cyanide destruction). In

view of the comparatively small

quantities of pollutants reported to be

discharged and emitted from wastewater

from the 14 existing facilities with

subcategory B and/or D operations only,

EPA has determined that the chosen

technology basis for the proposed BAT

limit is best suited to the type of

wastewater the data describe for direct

discharges in these subcategories. Other

technology options, which incorporate

steam stripping or steam stripping with

distillation technologies, are designed to

remove large quantities and many

varieties of solvents from process

wastewater. They are not optimal

treatment technologies for the type of

wastestreams reported by the 14 direct

dischargers in these subcategories,

because the 1990 data indicate that

these direct dischargers discharge only

6 solvents (in contrast to the 45 solvents

reported to be discharged by the

facilities with subcategory A and/or C

operations), and then in relatively small

amounts (an average of 1,660 pounds/

year for facilities with subcategory B

and/or D operations, compared to an

average of 14,600 pounds/year for

facilities with subcategory A and/or C

operations). Accordingly, based on the

data available to EPA for these facilities

from the 1990 questionnaire, EPA is not

proposing steam stripping or steam

stripping with distillation as part of the

technology basis for BAT for facilities

with subcategory B and/or D operations.

However, in the event that new data

for these facilities show that the

wastestreams of these facilities actually

resemble those of the indirect

dischargers in these subcategories, EPA

proposes to base the BAT limitations on

steam stripping technology, which EPA

has determined is the best available

technology for wastestreams of that

character. See Section IX.E.5.

Accordingly, EPA specifically invites

comments on establishing BAT

limitations equal to the proposed PSES

for those pollutants, including those

that EPA has determined pass through

as part of co-proposal (1). See Section

XIV, solicitation number 7. In addition,

if EPA promulgated BAT limitations

based on steam stripping or steam

stripping with distillation, EPA would

include BAT limitations on phenol,

acetonitrile and polyethylene glycol 600

(based on advanced biological

treatment), which are present in the

wastestreams of indirect dischargers but

which EPA does not propose to regulate

under either PSES co-proposal because

EPA has concluded that they do not

pass through POTWs.

The Agency has estimated that the

facilities with subcategory B and/or D

operations would incur total post-tax

annualized costs of $0.71 million in

complying with Option 1. The estimated

total post-tax annualized costs for

complying with other options are $1.5

million for Option 2, and $2.9 million

for Option 3. The Agency estimated that

none of the options would result in any

closures or unemployment. These

impacts, and the methodology behind

them, are explained in greater detail in

Section XI.B of this preamble and in the

Economic Impact Analysis. Based upon

these findings, EPA concluded that all

four options are economically

achievable. EPA selected Option 1

because it determined that option

represented that best available

technology from among all the

economically achievable options.

In evaluating the non-water quality

environmental impacts of the options,

specifically electrical power

consumption, the Agency found that the

annual incremental increase in

electrical power consumption for all

facilities to achieve Option 1 was 265

megawatts (MW) beyond current usage

(the same as for the proposed BPT

limits). This is equivalent to an increase

of approximately 0.005 percent of the

pharmaceutical industry’s purchased

electrical energy usage in 1990. The

incremental increases for electrical

power consumption for the remaining

options were: for Options 2 and 3, an

increase of 182 MW and 364 MW,

respectively, for all facilities for which

EPA estimated compliance costs; and

for Option 4 an increase of 911 MW for

all facilities for which EPA estimated

compliance costs. Further discussion of

these non-water quality environmental

impacts are presented in Section 12 of

the Technical Development Document.

The Agency considered other nonwater quality environmental impacts of

the proposed option, including the role

which this proposal may play in the

minimization, recycle, and disposal of

characteristic (ignitable) volatile organic

wastes. EPA has determined that

Options 2, 3 and 4 will generate 76

metric tons per year of condensates as

a result of the use of steam stripping or

steam stripping with distillation

technologies at direct discharging

plants. Based on the small increase in

condensate generation associated with

Options 2, 3 and 4 EPA has concluded

that the recovery opportunities or

incineration issues prompted by

condensate generation do not provide a

basis for choosing one of the technology

options as the basis for proposed BAT

limitations for facilities with

subcategory B and/or D operations. The

Agency also considered the effect of

these four options on the current levels

of air emissions from wastewater at

facilities with subcategory B and/or D

operations. To do this, EPA used the

WATER7 computer model to evaluate

the 1990 levels of air emissions from

wastewater for facilities with

subcategory B and/or D operations. The

results of the analyses were used to

estimate air emission increases or

decreases for the regulatory options. The

Agency estimates that Option 1 would

result in a minimal increase in air

emissions, while Options 2, 3 and 4

would decrease air emissions by 16

metric tons per year. EPA concluded

that the changes from current emission

levels are not significant enough to

justify selection of Options 2, 3 and 4.

EPA also concluded that the

engineering aspects of all four options

were compatible with current

manufacturing processes employed and

potential process changes at facilities

with subcategory B and/or D operations

and thus did not provide a basis for

selecting an option. Similarly, the age of

equipment and facilities involved did

not provide any basis for selecting

among the options.

The selection of Option 1 as BAT for

facilities with subcategory B and/or D

operations reflects, in large part, EPA’s

conclusion, based on currently available

data, that BPT level biological treatment

can degrade the relatively small load of

organic pollutants generated by these

facilities with a low occurrence of air

emissions during advanced biological

treatment. The Agency has noted,

however, that this industry is dynamic

with respect to its production processes.

Thus, volatile organic pollutant loading

data requested by EPA for 1991–1994
21616 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

may lead to a different conclusion

regarding the need for and feasibility of

controlling volatile organic pollutants.

See Section XIV, solicitation number 7.

d. Point of regulation. EPA considered

three different points of compliance

monitoring for facilities with

subcategory A and/or C operations in

establishing the proposed BAT effluent

limitations for control of strippable and

nonstrippable organic pollutants, and

cyanide and ammonia. These points are

located: (1) In-plant prior to dilution by

non-process wastewater, commingling

with other process wastewater streams

not containing the regulated pollutants

at treatable levels, and any conveyance,

equalization, or other treatment units

that are open to the atmosphere; (2) inplant after commingling with other

regulated process wastewater streams

but prior to open-air primary treatment;

and (3) at the final effluent point or endof-pipe.

EPA is proposing BAT limitations for

45 volatile and semivolatile pollutants

for facilities with subcategory B and/or

D operations based on advanced

biological treatment at the end of the

pipe because currently available data

does not support basing such limitations

on in-plant steam stripping or steam

stripping with distillation technologies.

For facilities with subcategory A and/or

C operations, EPA is proposing to set

BAT limitations based on advanced

biological treatment at the end of the

pipe for eight semivolatile organic

pollutants and COD because these

pollutants are not strippable. For these

facilities, EPA also proposes to enforce

limits on cyanide inside the discharger’s

facility at in-plant location (1). EPA is

proposing BAT limitations for 37

volatile and semivolatile pollutants plus

ammonia for facilities with subcategory

A and/or C operations based on in-plant

steam stripping followed by advanced

biological treatment at the end of the

pipe.

In the usual case, compliance

monitoring for NPDES permits occurs at

the end of the pipe. See 40 CFR

122.45(a). However, the NPDES

regulations also authorize permitting

authorities to impose in-plant

monitoring requirements on a case-bycase basis. 40 CFR 122.45(h). Those

regulations provides that when permit

effluent limitations or standards

imposed at the point of discharge are

impractical or infeasible, limitations or

standards may be imposed on internal

wastestreams before mixing with other

wastestreams or cooling waters. Id.

Under that regulation, the permit writer

must describe in the fact sheet the

exceptional circumstances that make

such limits necessary. Section

122.45(h)(2) lists examples of

exceptional circumstances that could

justify such in-plant monitoring

requirements. EPA also proposes to

provide in the regulations that the BAT

limitations set forth in the tables for

subcategories A and C do not apply for

any pollutant for which the permit

writer finds it necessary to specify inplant monitoring requirements under 40

CFR 122.44(i) and 122.45(h). EPA

proposes that limitations for those

pollutants would be established on a

best professional judgment basis

pursuant to 40 CFR 125.3. Permit

writers in such cases should use as

guidance the standards proposed as

PSES for the particular pollutants as set

forth at §§ 439.16(a)(1) and 439.36(a)(1)

of the proposed regulation, because the

proposed standards for those pollutants

reflect in-plant monitoring based or the

steam-stripping component of the BAT

technology.

In the event that EPA decides to

specify an in-plant monitoring location

for the 12 highly strippable volatile

organic pollutants, EPA would also

propose to establish different BAT

limitations corresponding to that

location. EPA would likely use as a

model the proposed pretreatment

standards for existing sources in these

subcategories for the reasons set forth

above.

In developing this proposal, EPA

considered establishing in-plant

monitoring locations for all 45 volatile

organic pollutants for facilities with

subcategory A and/or C operations. EPA

had several reasons for considering that

approach. First, EPA was concerned that

limits imposed at the end of the pipe for

these pollutants could be impractical or

infeasible to enforce. The limitations

being proposed for the 45 volatile

organic pollutants are based on BAT

model technology steam stripping

followed by advanced biological

treatment. Many of these proposed

limitations are only marginally above

the levels at which these pollutants can

be detected in the wastestreams.

Dilution of these regulated wastestreams

with other streams not containing the

regulated pollutants, followed by

incidental air stripping in primary and

secondary treatment units, would in

most cases cause the pollutants to be

present at or below detection by current

analytical methods. Thus, EPA was

concerned that neither the discharger

nor the permitting authority could

practicably or feasibly determine, at the

end of the pipe, whether the limits in

fact were being met. Second, EPA was

also concerned that monitoring for some

pollutants at the point of discharge

would be impractical and infeasible as

measures of the performance of the BAT

control technologies, because EPA

would have no way of knowing whether

reductions in wastewater discharges are

being achieved by application of the

control technology or by air emissions

in wastewater conveyance and

treatment facilities. Companies are not

required to install EPA’s model BAT

technology and can choose how they

wish to achieve the limitations in these

regulations. (EPA uses such information

to review existing effluent limitations

and to determine, consistent with

sections 304(b) and 304(m) of the Clean

Water Act, whether revisions are

necessary.) Third, in-plant monitoring

requirements could promote pollution

prevention opportunities for recycle and

reuse of volatile organic pollutants,

including nonhalogenated volatile

organic compounds (e.g., methanol),

derived from application of in-plant

technologies, like steam stripping.

These compounds are considered ‘‘clean

fuels.’’ See Section XII.B for a

discussion of ‘‘clean fuels.’’ Reuse of

these compounds as fuel could also help

reduce a discharger’s energy needs, a

factor EPA must consider under section

304(b) of the Clean Water Act.

In considering whether to establish

in-plant limitations for the 45 volatile

organic pollutants, EPA also weighed

the likelihood that wastewater

pollutants will be transferred to the air

in the course of primary or secondary

treatment. Based on its analyses using

the WATER7 model and questionnaire

response data, EPA believes that

wastewater from subcategory A and/or C

facilities can indeed produce significant

air emissions. EPA also believes that the

steam stripping component of the

proposed BAT technology will

significantly reduce the likelihood of

these emissions, because it achieves a

removal efficiency of 99% for most of

these pollutants. EPA further

emphasizes that air stripping is not part

of the proposed BAT technology.

Although EPA concluded that it has

the legal authority to establish in-plant

monitoring requirements, EPA has

determined as a matter of policy that

proposing such requirements today to

account for these emissions would be

premature because of the impending

rulemaking for this industry under the

Clean Air Act. As discussed in greater

detail in Section X below, EPA expects

to propose MACT standards for the

pharmaceutical industry on the basis of

the same steam stripper design

employed in this water rulemaking. EPA

also expects in the Clean Air Act

rulemaking to regulate all volatile

organic hazardous air pollutants (HAPs),

including many of the 45 volatile
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21617

organic pollutants covered by this

proposed rule. The least stringent

control option preliminarily identified

in Section X would require all

wastewater streams with a flow of 100

liters per minute or greater and a 1,000

ppmw or greater volatile organic HAP

concentration to be equipped with

controls. Thus, the Agency intends that

both rules ultimately will be based on

the same control technologies for the

same high concentration low volume

process wastewater streams that contain

the pollutants of concern. In short, EPA

expects that the non-water quality

environmental benefits that could be

achieved by establishing in-plant

monitoring requirements in this

rulemaking will be realized under the

statute that provides the most direct and

effective means for controlling the air

emissions at issue. By coordinating

these rulemakings to the extent that

external deadlines allow, EPA hopes to

address the multi-media issues

associated with the manufacture of

pharmaceuticals while using,

respectively, the statutory tools best

suited to the particular media being

protected.

EPA specifically solicits comment on

all issues pertaining to the

establishment of in-plant limitations on

a case-by-case basis, including the

burden imposed on permit writers, the

recommended limitations, and the

reasons EPA considered for setting

limitations in-plant on a national basis.

See Section XIV, solicitation numbers

7.2, 15.1–15.7. EPA also seeks comment

on EPA’s policy decision to defer at this

time to the Clean Air Act rulemaking.

See Section XIV, solicitation number

15.8.

4. NSPS

a. Introduction. The Agency today is

proposing New Source Performance

Standards (NSPS) for facilities with

subcategory A, B, C, and D operations in

the pharmaceutical manufacturing

industry. New plants have the

opportunity to incorporate the best

available demonstrated technologies,

including process changes, in-plant

controls, and end-of-pipe treatment

technologies. Current regulations

establish NSPS for cyanide based on

alkaline chlorination for all four

manufacturing subcategories. EPA

proposes to revise these standards for

facilities with subcategory A and/or C

operations and to repeal them for

facilities with subcategory B and/or D

operations.

b. Definitions of new source. EPA’s

NPDES regulations define the term

‘‘new source’’ at 40 CFR 122.2 and

122.29. Pursuant to those regulations, to

be a ‘‘new source’’ a source must:

(1) be constructed at a site at which

no other source is located;

(2) totally replace the process or

production equipment that causes the

discharge of pollutants at an existing

source; or

(3) have processes substantially

independent of an existing source at the

same site, considering the extent of

integration with the existing source and

the extent to which the new facility is

engaged in the same general type of

activity as the existing source. 40 CFR

122.29(b).

Any new source subject to part 439

that was a ‘‘new source’’ as defined

under 40 CFR 122.29 prior to the date

on which the New Source Performance

Standards proposed today are

promulgated will continue to be subject

to the current NSPS regulations for the

subpart to which the source is subject

until the expiration of the applicable

time period specified in 40 CFR

122.29(d)(1). After that time, the source

is no longer considered to be a new

source and will be required to achieve

the BPT, BCT and BAT effluent

limitations proposed in this rulemaking

applicable to the source for its

subcategory. EPA defines new source for

the purpose of NSPS in this rulemaking

as a source that commences

construction after promulgation of the

standards being proposed today, rather

than after proposal, because, in

accordance with the schedule

established in the 304(m) Consent

Decree, as modified, EPA does not

expect to promulgate final standards

within 120 days after proposal. See 40

CFR 122.2 (definition of New Source).

c. NSPS options and selection. (1)

Fermentation and chemical synthesis

subcategory, subparts A and C. EPA

today is proposing NSPS for 58 priority,

nonconventional, and conventional

pollutants for facilities with operations

in the fermentation and chemical

synthesis (A and C) subcategories. These

proposed standards are based on the

best available demonstrated control

technology, process, operating method,

or other alternative. In developing these

proposed standards, the Administrator

considered factors including the cost of

achieving effluent reductions, non-water

quality environmental impacts, and

energy requirements.

(i) Priority and nonconventional

pollutants. EPA today is proposing New

Source Performance Standards for 56

priority and nonconventional pollutants

for facilities with subcategory A and/or

C operations. In so doing, EPA

evaluated two technology options

described earlier in section IX.E.3.c.1.

The two options are: (1) In-plant

cyanide destruction and steam stripping

with distillation plus advanced

biological treatment; and (2) option 1

plus Granular Activated Carbon

adsorption treatment. EPA did not

consider a technology option based

primarily on steam stripping without

distillation because it is not as effective

as distillation in removing pollutants

such as methanol, that are difficult to

strip. EPA is proposing NSPS based on

the technology described in Option 1 for

subcategories A and C because EPA has

determined that it is the best available

demonstrated control technology for

treating and removing the pollutants of

concern for these subcategories. EPA

selected a more stringent NSPS

technology than its chosen BAT

technology because new sources have

the opportunity to segregate their

process wastewater in such a way as to

minimize the amount of wastewater that

will require steam stripping with

distillation, thereby reducing the

adverse energy impacts that prevented

EPA from selecting this technology as

BAT.

EPA considered the potential cost of

the proposed NSPS technology for new

plants, as well as the costs associated

with Option 2, which EPA did not

select. EPA concluded that costs

associated with any option would not be

so great as to present a barrier to entry,

because EPA anticipated no economic

impacts for existing source subcategory

A and C plants if they were to

implement the proposed NSPS

technology. The Agency also considered

energy requirements and other nonwater quality environmental impacts

when comparing the GAC technology

(Option 2) with Option 1. EPA

concluded that there would be only a

slight difference in the energy

requirements associated with Options 1

and 2. There are no significant

differences in the other non-water

quality environmental impacts between

the two options considered. EPA did not

select Option 2 as the proposed basis for

NSPS because, as noted above, EPA

does not have sufficient data to quantify

the amount of COD removed after

application of steam stripping with

distillation technology and therefore

could not determine whether granular

activated carbon technology is

appropriate to remove remaining COD

loads. See Section 16 of the TDD for

further discussion of NSPS for all four

subcategories.

EPA is proposing standards to control

COD based upon advanced biological

treatment, which is the BAT technology.

These proposed standards are based on

the performance of the ‘‘best’’
21618 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

performers with subcategory A and/or C

operations. EPA believes that a

substantial portion of the raw waste

load COD can be removed in plant, prior

to advanced biological treatment, by

application of steam stripping with

distillation technology—upon which the

proposed NSPS for priority pollutants

and the other nonconventional

pollutants are based. However, EPA

lacks sufficient data at this time to

quantify the removal of COD achievable

through in-plant steam stripping with

distillation, and in turn the further

removal of remaining COD load

achievable by advanced biological

treatment, and therefore is not able to

propose subcategory A and/or C NSPS

for COD based on that combination of

technologies. EPA solicits data and

comments concerning the establishment

of NSPS for COD for subcategories A

and C based on steam stripping with

distillation plus advanced biological

treatment. See Section XIV, solicitation

number 20.

(ii) Conventional pollutants. EPA

today is proposing NSPS for BOD5 and

TSS for the fermentation and chemical

synthesis subcategories (A and C). As

noted above for the proposed revised

BPT limitations, EPA is not proposing to

change the pH limitations incorporated

in the existing NSPS. Based upon data

available for this subcategory, the

technology basis for these proposed

standards—advanced biological

treatment—represents the best available

demonstrated level of performance (the

one best performer) for the control of

BOD5 and TSS in these subcategories.

EPA considered the cost of the

proposed technology basis for NSPS for

new plants. EPA concluded that such

costs are not so great as to present a

barrier to entry, as demonstrated by the

fact that one currently operating plant is

performing at the NSPS level using this

technology. The Agency considered

energy requirements and other nonwater quality environmental impacts

and found no basis for any different

standards than the proposed NSPS for

conventional pollutants.

(2) Biological and Natural Extraction

and Mixing/Compounding/Formulating

Subcategories, Subparts B and D. EPA

today is proposing New Source

Performance Standards (NSPS) for 56

priority, nonconventional and

conventional pollutants for facilities

with Biological and Natural Extraction

and Mixing/Compounding/Formulating

(B and D) subcategory operations. These

proposed standards are based on the

best available demonstrated control

technology, process, operating method,

or other alternative. In developing these

proposed standards, the Agency

considered factors including the cost of

achieving effluent reductions, non-water

quality environmental impacts, and

energy requirements.

(i) Priority and Nonconventional

Pollutants. EPA today is proposing New

Source Performance Standards for 54

priority and nonconventional pollutants

for facilities with subcategory B and D

operations. In developing NSPS for

these subcategories, EPA evaluated two

technology options described earlier in

Section IX.E.3.c.(2). The two options

are: (1) In-plant steam stripping with

distillation plus advanced biological

treatment; and (2) Option 1 plus

Granular Activated Carbon adsorption

treatment.

EPA is today proposing Option 1 as

the NSPS technology basis for

subcategories B and/or D. In making this

selection, EPA analyzed all of the

questionnaire data supplied by facilities

with subcategory B and/or D operations

and projected the types and volume of

volatile organic pollutants that would be

present in treatable levels in process

wastewaters from new facilities in these

subcategories. Although the 1990

questionnaire data indicated that

process wastewater from the 14 direct

dischargers contained fewer pollutants

in lower concentrations than the process

wastewater of indirect dischargers

(therefore justifying proposed effluent

limitations based on advanced

biological treatment alone, not

including steam stripping with

distillation), EPA has determined that

there is no basis to conclude that data

would adequately depict the wastewater

characteristics of a new direct

discharger. Thus, EPA relied instead on

the entire universe of facilities with

subcategory B and/or D operations,

irrespective of their direct or indirect

discharger status, on the theory that

these facilities are more plentiful and

hence statistically more significant.

Because EPA has no basis for

concluding that the wastewater

characteristics are related to the manner

of discharge, EPA saw no reason to

confine its NSPS analysis to the 14

existing direct dischargers and to ignore

the 67 indirect dischargers that reported

data. In evaluating all of the data

available to it for these subcategories

from the 1990 questionnaire, EPA

concluded that the vast majority of

facilities with subcategory B and/or D

operations have process wastewater

with a comparatively wide variety of

volatile organic pollutants in

comparatively high concentrations, as

reported by 67 of the 188 existing

indirect discharging plants with

subcategory B and/or D operations. EPA

considers wastestreams of these 67

plants to be more typical of the

wastestreams EPA expects to find in

new sources in this subcategory.

Therefore, EPA concluded that the

process wastewater of new facilities

with subcategory B and/or D operations

was more likely to resemble the more

typical subcategory B and/or D

wastestreams, not the atypical

wastestreams reported by the 14 existing

direct dischargers in those

subcategories. Based on that conclusion,

EPA selected, as the proposed

technology basis for NSPS for facilities

with subcategory B and/or D operations,

in-plant steam stripping with

distillation treatment followed by endof-pipe advanced biological treatment,

which EPA has concluded represents

the best available demonstrated

treatment technology. EPA selected a

more stringent NSPS technology than its

chosen BAT technology because new

sources have the opportunity to

segregate their process wastewater in

such a way as to minimize the amount

of wastewater that will require steam

stripping with distillation, thereby

reducing the adverse energy impacts

that prevented EPA from selecting this

technology as BAT. See Section 5 of the

TDD for further discussion of process

wastewaters that EPA projects would be

generated by facilities with subcategory

B and D operations.

EPA considered the potential cost of

the proposed NSPS technology for new

plants. EPA concluded that costs

associated with either option would not

be so great as to present a barrier to

entry. EPA predicted no economic

impacts (i.e., closures) for existing

source subcategory B and D plants if

they were to implement the equivalent

technology options considered as

possible BAT for those subcategories.

The Agency noted, however, that the

BAT technology option (based primarily

on steam stripping with distillation) was

inappropriate treatment for the small

reported quantities of volatile organic

loadings, because the resulting small

pollutant removals did not warrant the

additional cost of steam stripping with

distillation. See Section IX.E.3.c(2)

above.

The Agency also considered energy

requirements and other non-water

quality environmental impacts when

comparing the GAC technology (Option

2) with Option 1. EPA concluded that

there would be only a slight difference

in the energy requirements associated

with Options 1 and 2. There are no

significant differences in the other nonwater quality environmental impacts

between the two options considered.

EPA did not select Option 2 as the

proposed basis for NSPS because, as
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21619

noted above, EPA does not have

sufficient data to quantify the amount of

COD removed after application of steam

stripping with distillation technology

and therefore could not determine

whether granular activated carbon

technology is appropriate to remove

remaining COD loads. See Section 16 of

the TDD for further discussion of NSPS

for all four subcategories.

For reasons set forth above in the

discussion of the proposed NSPS for

facilities with subcategory A and/or C

operations, EPA is proposing NSPS for

the pollutant COD best performing

advanced biological treatment. EPA is

not proposing NSPS for COD based on

in-plant steam stripping with

distillation technology because it has

not been able to date to quantify the

removal of COD achievable through that

technology. See Section XIV of this

preamble, solicitation number 20.

(ii) Conventional Pollutants. EPA

today is proposing NSPS for BOD5 and

TSS for facilities with Biological and

Natural Extraction and Mixing/

Compounding/Formulating

subcategories (B and D). As noted above

for the proposed NSPS for facilities with

subcategory A and/or C operations, EPA

is not proposing to change the pH

limitations incorporated in the existing

NSPS for facilities with subcategory B

and D operations. Based upon data

available for this subcategory, the

technology basis selected for these

proposed standards—advanced

biological treatment—represents the

most stringent demonstrated level of

performance (the one best performer) for

the control of BOD5 and TSS in these

subcategories.

EPA considered the cost of the

proposed technology basis for the

proposed NSPS for new plants. EPA

concluded that such costs are not so

great as to present a barrier to entry, as

demonstrated by the fact that one

currently operating plant is performing

at the NSPS level using this technology.

The Agency considered energy

requirements and other non-water

quality environmental impacts and

found no basis for proposing any

different standards than those based on

the selected NSPS for conventional

pollutants.

d. Point of Regulation. For the reasons

set forth in Section IX.E.3.d., above in

connection with BAT, EPA is proposing

to specify an end-of-pipe monitoring

location for its proposed NSPS

standards for facilities with A, B, C and/

or D operations (excluding cyanide, for

which EPA proposes in-plant

limitations for facilities with

subcategory A and/or C operations).

EPA seeks comments on all issues

pertaining to this proposal. See Section

XIV, solicitation number 15. EPA also

proposes to provide in the regulations

that the standards set forth in the NSPS

tables for subcategories A, B, C and D

do not apply for any pollutant for which

the permit writer finds it necessary to

specify in-plant monitoring

requirements under 40 CFR 122.44(i)

and 122.45(h). EPA proposes that NSPS

for those pollutants would be

established on a best professional

judgment basis pursuant to 40 CFR

125.3. Permit writers in such cases

should use as guidance the standards

proposed as PSNS for the particular

pollutants (as set forth at §§ 439.17(a)(1),

439.27(a)(1), 439.37(a)(1) and

439.47(a)(1) of the proposed regulation),

because those standards are based on

the steam stripping with distillation

technology that also represents the

NSPS technology. See Section XIV,

solicitation number 15.7.

5. PSES

Pretreatment Standards for Existing

Sources (PSES) are established to

prevent passthrough of pollutants from

POTWs to waters of the United States,

to prevent pollutants from interfering

with the operation of POTWs, and to

reduce non-water quality environmental

impacts (e.g., concerns for worker safety

and health, sludge contamination, and

air emissions). CWA Section 307(b). The

current PSES is based on cyanide

destruction, which does not remove

volatile organic pollutants. EPA is

proposing to establish PSES for this

industry to prevent passthrough from

POTWs of the same pollutants proposed

to be controlled by BAT for the

respective subcategories, except

polyethylene glycol 600, acetonitrile,

and phenol. Standards for existing

indirect discharging plants are based

upon the best available technologies

economically achievable, which may

include process changes, in-plant

controls, and end-of-pipe treatment

technologies. As discussed in section

5.a below, EPA is also proposing to

establish no PSES at this time for 33

volatile organic pollutants because there

is some doubt that these pollutants

actually pass through.

The Agency today is proposing to

establish pretreatment standards for

existing sources in the pharmaceutical

manufacturing point source category.

These standards would apply to plants

in the four manufacturing subcategories

of the industry. Currently, according to

the 1990 detailed survey questionnaire

responses, 259 plants report discharging

to POTWs, 88 of which conduct

predominantly A and C subcategory

operations and 171 conduct only B and

D operations. In 1993, EPA solicited

comments regarding PSES from nine

POTWs that treated significant

quantities of pharmaceutical

wastewater. EPA received responses

from six POTWs, each of which report

treating significant amounts of

pharmaceutical wastewater discharges.

The questionnaires asked the

respondents to comment on the need for

pretreatment standards for the

pharmaceutical manufacturing category

and other matters relating to discharges

from pharmaceutical plants. The six

POTWs that responded to the

questionnaire and their locations are:

The Onondaga County Department of

Drainage and Sanitation, Syracuse, NY;

the Greenville Utilities Commission,

Greenville, NC; the Bergen County

Utilities Authority, Little Ferry, NJ; the

North Shore Sanitary District, Gurnee,

IL; the Passaic Valley Sewerage

Commissioners, Newark, NJ; and the

Puerto Rico Aqueduct and Sewerage

Authority, Barceloneta, Puerto Rico.

Except as provided in 40 CFR 403.7

and 403.13, any existing indirect

discharger subject to subparts A, B, C or

D would be required to achieve the

proposed PSES for the subcategory to

which the facility is subject by a date

three years from promulgation of the

final rule.

a. Pass-Through Analysis. To

determine whether pollutants indirectly

discharged by plants in this industry

pass through POTWs, EPA reviewed

pharmaceutical manufacturing industry

treatment performance data, responses

to the detailed questionnaire,

performance data for POTWs, and

technical literature. In today’s notice,

EPA makes two alternative proposals

associated with PSES and its passthrough determinations. Under coproposal (1), for subcategories A and C,

EPA concludes that nine priority and 42

nonconventional organic pollutants plus

ammonia pass through POTWs.

Therefore, for all but five

nonconventional pollutants for which

EPA has not selected a treatment basis,

EPA proposes to establish categorical

pretreatment standards to regulate those

pollutants for subcategories A and C.

Similarly under that co-proposal, for

subcategories B and D, EPA proposes to

establish categorical pretreatment

standards to regulate the same

pollutants (minus ammonia and

cyanide, which EPA has determined are

not present in the wastewater of

facilities in those subcategories). Under

co-proposal (2), EPA proposes that 33

volatile pollutants do not pass through

and therefore does not propose PSES for

those pollutants for any subcategory.
21620 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

In determining whether to propose

pretreatment standards for the four

manufacturing subcategories, EPA first

identified the pollutants of concern

present in the wastewater characteristic

of the particular subcategories. EPA

determined from the available data that

as many as ten priority pollutants and

45 nonconventional pollutants could be

present, in varying amounts and

frequencies, in the wastestreams of

facilities in all four manufacturing

subcategories (excluding cyanide and

ammonia for subcategories B and D.) In

selecting the pollutants for analysis and

in performing the pass-through

determination, EPA made three

threshold decisions in view of the data

available to it.

First, with respect to subcategories B

and D, EPA used wastestream data

pertaining to indirect discharging

facilities rather than direct discharging

facilities, because, for reasons EPA is

unable to explain, the available data

indicated that the wastestreams of direct

dischargers were significantly different

from and hence unrepresentative of the

wastestreams for indirect dischargers in

those subcategories. Accordingly, EPA

concluded that it would be most

appropriate to identify the pollutants of

concern and ultimately evaluate the

need for pretreatment standards based

on the wastewater characteristic of the

indirect dischargers that would be

subject to such standards.

Second, based on that wastestream

data, EPA identified cyanide destruction

plus steam stripping followed by

advanced biological treatment for

subcategory A and/or C facilities and

advanced biological treatment for

subcategory B and/or D facilities as the

best available technology economically

achievable to remove the pollutants of

concern from those wastestreams. EPA

then used these technologies in its passthrough analysis as the basis for

comparing the removal efficiencies

accomplished through secondary

treatment by POTWs.

Third, EPA made pass through

determinations by pollutant for all four

manufacturing subcategories together,

because the data from indirect

dischargers data available to EPA

indicate that steam stripping is

applicable to all four subcategory

wastestreams at indirect discharging

facilities. Based on these decisions, EPA

then compared removal efficiencies

achievable by well-operated POTWs

employing secondary treatment with

those achievable by direct dischargers

employing the relevant technology for

those subcategories. In co-proposal (1),

EPA determined for subcategories A and

C that 52 pollutants pass through

POTWs and for subcategories B and D

that 50 pollutants pass through, based

on the information available to it at this

time.

For subcategories A and C, EPA also

concluded that ammonia passes through

because POTWs generally do not have

the nitrification capability that

comprises part of the technology basis

for the proposed BAT limitations for

those subcategories. With respect to

cyanide for subcategories A and C, EPA

found that this pollutant passes through

POTWs because the removal of cyanide

by BAT-level cyanide destruction units

at direct discharging plants with

subcategory A and C operations is

significantly greater than the

documented removals by POTWs with

advanced secondary treatment. These

findings regarding ammonia and

cyanide are not affected by alternative

co-proposals (1) and (2).

Based on the pass-through

determination in co-proposal (1), EPA

proposes to set pretreatment standards

for 45 priority and nonconventional

organic pollutants for all subcategories

in addition to cyanide and ammonia for

subcategories A and C. In determining

whether these volatile and semi-volatile

organic pollutants pass through POTWs,

EPA employed its traditional pass

through methodology as described

above. EPA determined that dischargers

in all subcategories could remove up to

99 percent or more of the volatile and

semi-volatile organic pollutants from

their wastestreams using the BAT

technology basis which includes inplant steam stripping for subcategory A

and/or C facilities.

Relying on data reported in the

Domestic Sewage Study, EPA then

ascertained the removal efficiencies

achieved by POTWs for those pollutants

using secondary treatment. In evaluating

removal efficiencies by POTWs for

volatile and semi-volatile pollutants,

EPA notes the fact that some of the

removal occurring after wastewater

leaves a manufacturing facility results

from volatilization of these pollutants in

the head works and unit operations

preceding biological treatment of the

POTWs. EPA has consistently refused in

these circumstances to regard transfers

of pollutants from wastewater to the air

as treatment. See, e.g., 59 FR at 50665

(Pesticides guidelines); 58 FR at 36885

(Organic Chemicals, Plastics and

Synthetic Fibers guidelines). Therefore,

because of this volatilization, the

quantity of a particular volatile or semivolatile pollutant actually available to

be removed by the POTW’s secondary

treatment works was less than the

quantity of that pollutant present in the

wastestream at the time it entered the

POTW collection system. Thus, the

POTW treated—and hence removed—a

smaller percentage of the pollutant than

it would have achieved through its

secondary treatment if volatilization en

route had not occurred. For a detailed

discussion of volatilization in the

context of EPA’s pass through

determinations for all pollutants in all

subcategories, see Section 17 of the

TDD.

The pass-through determinations

reflected in co-proposal (1) are

supported by POTWs that treat

wastewater generated by pharmaceutical

manufacturing facilities. In a letter sent

to EPA dated February 14, 1995, the

Association of Metropolitan Sewerage

Agencies (AMSA) urged EPA to

establish national pretreatment

standards for organic pollutants found

in pharmaceutical wastewater. A copy

of this letter is in the rulemaking docket.

AMSA argued that a decision by EPA

not to regulate these pollutants at the

national level would shift the financial,

technical and legal burden of regulation

to POTWs, which would need to

establish local limits for these pollutants

on a plant-by-plant, pollutant-bypollutant basis. Among other things,

AMSA asserted that many of its POTW

member organizations lack the on-site

technical expertise to develop limits for

the wide variety of volatile organic

pollutants of potential concern. It

further asserted that even where such

expertise exists, the costs associated

with establishing local limits in the

absence of federal standards would be

so significant that they would amount to

unfunded mandates. AMSA also noted

that pretreatment standards established

at the national level would facilitate the

enforcement of limits to protect against

volatility, exfiltration and flammability

concerns. AMSA concluded that

promulgation of national pretreatment

standards such as those contained in coproposal (1) would be the most

environmentally sound, timely, and cost

effective method of addressing these

pollutants of concern. EPA solicits

comment on these arguments in support

of co-proposal (1). See Section XIV,

solicitation number 24.4.

Under co-proposal (2), EPA is

considering a finding of no pass-through

for 33 priority and nonconventional

pollutants in all four subcategories. EPA

is soliciting comments and data with

respect to this finding. See Section XIV,

solicitation number 24.3. EPA has

developed co-proposal (2) because of

concerns expressed by industry

representatives that EPA’s pass-through

analysis under co-proposal (1) may not

be correct for some of the 33 volatile

organic pollutants such as methanol,
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21621

ethanol, and acetone. EPA believes that

the additional data and comments

received concerning the pass-through

analysis for these 33 volatile organic

pollutants will enable the Agency to

make a final pass-through determination

for these pollutants. EPA notes that coproposal (2) does not affect EPA’s passthrough findings regarding the 12 highly

strippable organic pollutants (and

cyanide and ammonia for subcategories

A and C) for which EPA proposes to

establish PSES independently.

EPA is not proposing pretreatment

standards for several pollutants found in

subcategory A, B, C and D facility

wastestreams for the following reasons.

(This part of the proposal is not affected

by the issues addressed in co-proposals

(1) and (2).) EPA has concluded for all

four manufacturing subcategories that

phenol does not pass through for the

reasons set forth in the Federal Register

Notices announcing the promulgation of

effluent limitation guidelines and

standards for the Pesticide Chemicals

and Organic Chemicals, Plastics and

Synthetic Fibers (OCPSF) industries.

See 59 FR 50638, 50664–65 (September

28, 1993); 58 FR 36872, 36885–86 (July

9, 1993). In addition, EPA does not have

sufficient data at this time to determine

whether acetonitrile and polyethylene

glycol 600 pass through POTWs and

therefore does not propose pretreatment

standards to control them. Similarly,

EPA lacks sufficient data to make a

pass-through determination for COD

generated by facilities with subcategory

A and/or C operations, although EPA is

concerned that certain refractory organic

waste materials measured as COD that

are generated by such facilities may pass

through POTWs. (EPA has made a

preliminary judgment that COD

generated by facilities with subcategory

B and/or D operations does not pass

through POTWs. EPA will review this

judgment based on new data as it

becomes available.) EPA therefore is

soliciting data and comments in order to

make a pass-through determination with

respect to acetonitrile, polyethylene

glycol 600, and COD. See Section XIV of

this preamble, solicitation numbers 26

and 27.3. In addition, as noted above,

EPA is not proposing pretreatment

standards for five nonconventional

organic pollutants (formaldehyde, N,Ndimethyl formamide, N,N dimethyl

acetamide, ethylene glycol, and

dimethyl sulfoxide) for any subcategory

because, although EPA has determined

that they pass through based on the

BAT-level technology, EPA has

concluded that the PSES technology (inplant steam stripping) is an

inappropriate basis for pretreatment

standards because these pollutants are

not strippable. Moreover, EPA currently

has insufficient data to select a

treatment technology that would be an

appropriate basis for such standards.

EPA is considering package biological

treatment of selected wastestreams for

this purpose and solicits comments and

data on this and other possible

technology bases for pretreatment

standards. See Section XIV, solicitation

numbers 27.1 and 27.2. EPA also solicits

comment and data regarding other

pollutants that may pass through or

interfere with POTWs, e.g., sulfates and

sulfides. See Section XIV, solicitation

number 28.

b. Options Considered. EPA

considered four technology options for

PSES under two different regulatory coproposal scenarios for facilities with

subcategory A, B, C, and D operations.

Under co-proposal (1), EPA would

propose PSES for 12 highly strippable

organic pollutants (plus cyanide at an

in-plant location (1) for subcategory A

and/or C facilities) and 33 less

strippable pollutants (plus ammonia for

subcategory A and/or facilities) at the

point of discharge to the POTW sewer.

In-plant location (1) is described in

IX.E.3.d, above. Under co-proposal (2),

EPA would propose PSES only for the

12 highly strippable organic pollutants,

plus cyanide at an in-plant location (1)

and ammonia at the point of discharge

to the POTW sewer for subcategory A

and/or C facilities. As discussed in

subsection a, above, EPA would not

propose any pretreatment standards for

the 33 less strippable organic pollutants

under co-proposal (2) because of issues

raised concerning EPA’s pass-through

analysis for those pollutants.

Under co-proposals (1) and (2), EPA

considered basing PSES on the

following four technology options for

facilities with subcategory A and/or C

operations for those pollutants found to

pass through:

Option (1) In-plant steam stripping

plus in-plant cyanide destruction.

Standards based on this option would

control up to eight priority and 38

nonconventional volatile organic

pollutants plus cyanide (depending on

the pass-through co-proposal

considered). Twelve pollutants plus

cyanide would be controlled at the inplant location (1) and 34 pollutants

(including ammonia) at the point of

discharge to the POTW sewer.

Option (2) In-plant steam stripping/

distillation plus in-plant cyanide

destruction.

Standards based on this option would

control up to eight priority and 38

nonconventional volatile organic

pollutants plus cyanide (depending on

the pass-through co-proposal

considered). Distillation affords

significantly greater removal of volatile

organic pollutants that are difficult to

strip, such as methanol. Under this

option, 22 volatile organic pollutants

plus cyanide would be controlled at the

in plant location (1) and 24 pollutants

(including ammonia) would be

controlled at the point of discharge to

the POTW sewer.

Option (3) In-plant steam stripping/

distillation plus in-plant cyanide

destruction plus advanced biological

treatment. The addition of advanced

biological treatment would achieve

additional volatiles removal beyond that

achieved by the technology described in

Option 2 as well as significant

reductions in discharge levels of COD.

Advanced biological treatment would

also reduce discharge levels of

nonstrippable organic pollutants that

are biodegradable.

Option (4) In-plant steam stripping/

distillation plus in-plant cyanide

destruction plus advanced biological

treatment plus granular activated

carbon (GAC) treatment. The addition of

granular activated carbon treatment to

the technology described in Option 3

would further reduce COD discharge

levels.

EPA considered the same four

technology options for PSES for

facilities with subcategory B and/or D

operations, excluding in-plant cyanide

destruction (cyanide and ammonia are

not regulated pollutants at subcategory

B and/or D facilities). EPA has selected

Option 1 for PSES under both coproposals for indirect discharging

facilities with subcategory A and/or C

operations. The Agency has evaluated

the costs of this option based on coproposal (1) and found that there would

be no closures among affected facilities

(for which costs were estimated by EPA)

as a result of these costs. Therefore EPA

determined the costs of Option 1 to be

economically achievable based on coproposal (1). EPA also found the other

options to be economically achievable.

EPA selected Option 1 because it

determined that this option represents

the best available technology among all

economically achievable options,

insofar as it achieves pollutant

reductions necessary to prevent passthrough of volatile organic pollutants,

allows for recovery and recycling of

volatile organic pollutants, and reduces

non-water quality environmental

impacts caused by air emissions of

pollutants from wastewater. See Section

XII.B of this preamble for a discussion

of the Administrator’s waste

minimization and combustion strategy.

Although Options 2, 3, and 4 would
21622 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

achieve essentially the same decrease in

the emission of wastewater pollutants to

the air as Option 1, the increase in

energy use requirements associated with

Options 2, 3, and 4 would be equivalent

to an increase of 31 percent above the

1990 pharmaceutical industry energy

use. For this reason, EPA selected

Option 1 over Options 2, 3, and 4.

EPA did not select Options 3 or 4

because EPA has not determined

whether refractory organic materials

measured as COD that are generated by

facilities with subcategory A and/or C

operations pass through POTWs and

therefore is not proposing standards

based on potentially unnecessary

technology. Moreover, as noted above in

EPA’s discussion of the proposed BAT

limitations for these subcategories, even

assuming COD does pass through, EPA

lacks data to estimate the COD

reductions achievable by steam

stripping and thus cannot compare COD

reductions achievable by Options 2, 3,

and 4.

EPA has also selected Option 1 as the

proposed technology basis for PSES

(minus cyanide destruction) for

facilities with subcategory B and/or D

operations. Under co-proposal (1), EPA

would propose PSES for 12 highly

strippable organic pollutants at in-plant

location (1) and 33 less strippable

pollutants at the point of discharge to

the POTW sewer. In-plant location (1) is

described in IX.E.3.d., above. Under coproposal (2), EPA would propose PSES

only for the 12 highly strippable organic

pollutants at in-plant location (1).

In selecting steam stripping (PSES

Option 1 minus cyanide destruction) as

the technology basis for the proposed

PSES for facilities with B and/or D

subcategory operations, EPA relied

upon the 1990 questionnaire data

supplied by 188 facilities with

subcategory B and/or D operations that

send their wastewater to POTWs for

treatment. For reasons that EPA is not

able to explain, these data show that the

wastestreams characteristic of indirect

dischargers with subcategory B and/or D

operations are significantly different (for

regulatory purposes) than the

wastestreams of direct dischargers with

subcategory B and/or D operations. See

Section IX.E.3.c(2) for discussion of

basis for proposed BAT limitations for

facilities with subcategory B and D

operations. In view of this reported

difference, EPA has based today’s

proposed pretreatment standards on a

different technology—steam stripping—

than the BAT limitations proposed for

the direct dischargers in this

subcategory, which are based on

advanced biological treatment.

The data supplied by the 188 indirect

facilities in this subcategory show that

these facilities discharge BOD5, TSS,

COD, 18 nonconventional pollutants

and four priority pollutants. See Section

9 of the TDD. EPA’s analysis of the

questionnaire data indicates that the

total nonconventional and priority

pollutant loadings discharged, on

average, for each indirect discharger

with subcategory B and D operations in

1990 was 14,600 pounds/year (in

contrast to the average of 1,660 pounds/

year reported by the 14 direct

dischargers in these subcategories). The

188 facilities also reported in their

questionnaire responses that they emit

from wastewater a total of 1.5 million

pounds/year of volatile organic

pollutants (in contrast to the emissions

totaling 170 pounds/year reported by

the direct dischargers). Subsequent

analysis by EPA using its WATER7

model indicates that these indirect

dischargers may actually emit closer to

3.3 million pounds/year from

wastewater (in contrast to the emissions

totaling 35,000 pounds/year for the

direct dischargers). See Section 12 of

TDD for discussion of difference

between questionnaire results and

WATER7 model results. Based on its

evaluation of the data available to it,

EPA proposes to base pretreatment

standards for facilities with subcategory

B and D operations on in-plant steam

stripping (Option 1). This technology is

designed to remove large quantities and

many varieties of solvents from process

wastewater. According to the data

supplied by the 188 indirect dischargers

with subcategory B and D operations,

EPA has concluded that the wastewater

characteristic of these facilities—with

its comparatively high volume and

concentration of solvents—is wellsuited to this form of treatment.

Accordingly, EPA has determined for

the reasons set forth above in

connection with establishing BAT

limitations for facilities with A and C

subcategory operations, see Section

IX.E.3.c(1) above, that in-plant steam

stripping is the most appropriate

technology basis for pretreatment

standards for facilities with subcategory

B and/or D operations. Even though

EPA’s 1990 data indicates that

subcategory B and/or D facilities

discharge only 22 priority and

nonconventional pollutants, EPA is

proposing to establish pretreatment

standards for 45 priority and

nonconventional pollutants because all

45 pollutants potentially can be

discharged to POTWs. (EPA is soliciting

comment on mechanisms by which

dischargers that do not use or generate

pollutants for which standards are

proposed can be exempted from

monitoring for those pollutants. See

Section XIV, solicitation number 38.) In

addition, EPA found that none of the 67

facilities (of the 188 indirect dischargers

with subcategory B and D operations)

that would incur costs as a result of the

proposed PSES limitations would close

as a result of this option. Therefore EPA

determined that the costs of the

pollutant reduction achieved by this

option were economically achievable.

In considering the various technology

options available as possible bases for

the proposed pretreatment standards for

these subcategories, EPA rejected

advanced biological treatment as a

viable technology option and therefore

did not consider it. Because indirect

discharging facilities with subcategory B

and/or D operations generate levels of

BOD5, TSS and COD comparable to

levels found in ordinary domestic

sewage, EPA concluded that biological

treatment afforded by POTWs is

adequate for these levels of pollutants.

Accordingly, EPA has determined that

BOD5, TSS and, preliminarily, COD

from facilities with subcategory B and/

or D operations do not pass through.

Thus, advanced biological treatment at

these facilities prior to POTW treatment

would be duplicative.

The Agency considered age, size,

processes, other engineering factors, and

non-water quality environmental

impacts in developing the proposed

PSES for all four subcategories. The

Agency did not identify any basis for

establishing different pretreatment

standards based on age, size, processes,

or other engineering factors. EPA has

concluded that the technology upon

which EPA proposes to base PSES for

facilities with subcategory B and/or D

operations would significantly decrease

air emissions and would be consistent

with the Administrator’s waste

minimization and combustion strategy.

See Section XII.B of this preamble for a

discussion of this strategy. EPA did not

choose Option 2 because, although this

option would result in approximately

the same decrease in air emissions as

Option 1, it would result in a significant

increase in total energy use over that

required under Option 1. (See section 16

of the TDD and the BAT discussion

above.)

c. Point of Regulation. EPA is

proposing to specify an in-plant

compliance monitoring location for each

of the 12 highly strippable volatile

organic pollutants for which EPA is

proposing PSES. (This is not affected by

the co-proposals addressing the 33 less

strippable pollutants.) This location is

described as in-plant location (1) in
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21623

section E.3.d., above. For facilities with

subcategory A and/or C operations, EPA

also proposes to require in-plant

monitoring for cyanide based upon

cyanide destruction technology.

EPA acknowledges that it reached a

different conclusion regarding the point

of regulation for direct dischargers with

subcategory A and/or C operations. As

discussed in section E.3.d., above, EPA

is proposing to specify end-of-pipe

monitoring requirements for the 12

highly strippable volatile organic

pollutants in deference to the

forthcoming Clean Air Act rule for this

industry, which will control air

emissions of these pollutants. EPA also

noted in that section, however, that the

permit writer has the authority under

the NPDES permit regulations to

establish limits in-plant on a case-bycase basis when it would be impractical

or infeasible to monitor for the

pollutants at the end of the pipe because

of dilution or other considerations.

Indeed, EPA observed that the BAT

limitations being proposed for the 12

highly strippable volatile organic

pollutants in subcategories A and C are

at levels that are only marginally above

the analytical minimum levels

established for these pollutants and

expressed its concern that dilution or air

stripping might make detection of the

pollutants infeasible at the end of the

pipe. Nevertheless, EPA concluded that

this concern could be addressed for

direct dischargers on a case-by-case

basis by the permit writer and therefore

proposed that establishing in-plant

compliance requirements on a national

level was not essential.

EPA is proposing to reach a different

conclusion for indirect dischargers. Like

the proposed BAT limitations, the

proposed pretreatment standards for

existing dischargers are only marginally

above the minimum levels established

for these pollutants. Similarly, EPA is

concerned that dilution with process

and non-process wastewater might

cause the pollutants to be undetectable

by current analytical methods. Under

EPA regulations, however, indirect

dischargers are prohibited from

substituting dilution for treatment,

except where dilution is expressly

authorized by an applicable

pretreatment standard. See 40 CFR

403.6(d). This prohibition theoretically

could be enforced by POTWs through

the establishment of local limitations at

in-plant locations on a pollutant-bypollutant, case-by-case basis in the same

way that a permit writer could do so for

direct dischargers. By establishing inplant monitoring requirements, the

POTW, like the permit writer, would be

able to determine whether compliance

is being achieved by dilution or by

treatment. The difference, however, is

this pollutant-by-pollutant, case-by-case

solution to the detection and dilution

problems may impose a financial and

technical burden on POTWs. There are

six times as many indirect dischargers

as direct dischargers, and unlike state

and EPA permit writers, POTWs

commonly lack the on-site technical

expertise to establish and justify inplant monitoring requirements on a

case-by-case basis. Even when such

expertise exists, EPA is concerned that

the accompanying burden and expense

would be significant. Therefore, EPA is

proposing to establish in-plant points of

regulation on a nationwide level.

EPA is proposing pretreatment

standards in large measure because of

the concern registered by some POTWs

that discharges containing substantial

concentrations of these volatile organic

pollutants may interfere with the

operation of the sewerage system and

the health and safety of employees of

the POTW system. EPA solicits

comment and supporting data regarding

whether this objective may be satisfied

by assuring that discharges to the POTW

sewer are near or at the level of

detection. See Section XIV, solicitation

number 24.0. In addition, as discussed

in Section X, EPA is developing a

separate rulemaking under the

requirements of Section 112 of the Clean

Air Act to address the air emissions

from pharmaceutical plants, including

the emissions of these 12 highly

strippable volatile organic pollutants.

EPA’s air rulemaking may complement

this proposal so that standards set at the

point of discharge to the POTW sewer

may satisfy EPA’s objectives in this

rulemaking. EPA expects to propose

these air emission standards next year.

As a result, EPA is also considering

whether to establish limits for the 12

highly strippable volatile organic

pollutants at the point of discharge to

the POTW sewer. See Section XIV,

solicitation number 24.5.

6. PSNS

Section 307(c) of the Act requires EPA

to promulgate pretreatment standards

for new sources (PSNS) at the same time

it promulgates new source performance

standards (NSPS). New indirect

discharging plants, like new direct

discharging plants, have the opportunity

to incorporate the best available

demonstrated technologies, including

process changes, in-plant controls, and

end-of-pipe treatment technologies.

Any new source subject to part 439

that was a ‘‘new source’’ as defined

under 40 CFR 122.29 prior to the date

on which the pretreatment standards for

new sources proposed today are

promulgated will continue to be subject

to the current PSNS regulations for the

subpart to which the source is subject

until the expiration of the applicable

time period specified in 40 CFR

122.29(d)(1). After that time, the source

is no longer considered to be a new

source and will be required to achieve

the PSES standards proposed in this

rulemaking applicable to the source for

its subcategory. EPA defines new source

for the purpose of PSNS in this

rulemaking as a source that commences

construction after promulgation of the

standards being proposed today, rather

than after proposal, because, in

accordance with the schedule

established in the 304(m) Consent

Decree, as modified, EPA does not

expect to promulgate final standards

within 120 days after proposal. See 40

CFR 122.2 (definition of New Source).

EPA considered three technology

options for PSNS under two different

regulatory co-proposal scenarios for

facilities with subcategory A and/or C

operations. Under co-proposal (1), EPA

would propose PSNS for 12 highly

strippable organic pollutants plus

cyanide at an in-plant location (1) and

33 less strippable pollutants plus

ammonia at the point of discharge to the

POTW sewer. Under co-proposal (2),

EPA would propose PSNS only for the

12 highly strippable organic pollutants,

plus cyanide at in-plant location (1) and

for ammonia at the end-of-pipe (3).

Under co-proposals (1) and (2), EPA

considered the following three

technology options for facilities with

subcategory A and/or C operations for

those pollutants found to pass through:

Option (1): In-plant steam stripping

with distillation plus in-plant cyanide

destruction.

Option (2): In-plant steam stripping

with distillation plus in-plant cyanide

destruction plus advanced biological

treatment.

Option (3): In-plant steam stripping

with distillation plus in-plant cyanide

destruction plus advanced biological

treatment plus granular activated carbon

(GAC) treatment.

Under co-proposals (1) and (2), EPA

considered the following two

technology options for facilities with

subcategory B and/or D operations for

those pollutants found to pass through:

Option (1): In-plant steam stripping

with distillation.

Option (2): In-plant steam stripping

with distillation plus granular activated

carbon (GAC) treatment.

EPA selected a more stringent PSNS

technology than its chosen PSES

technology because new sources have

the opportunity to segregate their
21624 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

process wastewater in such a way as to

minimize the amount of wastewater that

will require steam stripping with

distillation, thereby reducing the

adverse energy impacts that prevented

EPA from selecting this technology as

PSES.

EPA is proposing to set pretreatment

standards for new sources based on

PSNS Option 1 (steam stripping with

distillation plus cyanide destruction) for

priority and nonconventional pollutant

for indirect discharging facilities with

subcategory A and/or C operations.

Similarly, EPA is proposing to set

pretreatment standards for new sources

based on PSNS Option 1 (steam striping

with distillation) for facilities with

subcategory B and/or D operations.

EPA considered the cost of the

proposed PSNS technologies for new

plants. EPA has concluded that such

costs are not so great as to present a

barrier to entry, as demonstrated by the

fact that currently operating plants are

using these technologies. The Agency

also considered energy requirements

and other non-water quality

environmental impacts when comparing

the three PSNS technology options for

facilities with subcategroy A and/or C

operations and the two PSNS

technology options for facilities with

subcategory B and/or D operations. EPA

concluded that there would be only a

slight difference in the energy

requirements associated with Options 1,

2, and 3 for subcategory A and/or C

facilities and with Options 1 and 2 for

subcategory B and/or D facilities. There

are no significant differences in the

other non-water quality environmental

impacts between the options

considered.

7. BMP

EPA is not proposing any Best

Management Practices (BMPs) today for

the Pharmaceutical Manufacturing

Category. However, EPA is soliciting

comment on whether BMPs are

applicable to the pharmaceutical

manufacturing industry and, if so, what

they should include. See Section XIV,

solicitation number 31.0. See also the

TDD at Appendix B for specific BMPs

that EPA is considering adopting.

F. Determination of Long-Term

Averages, Variability Factors, and

Limitations

A detailed description of the

statistical methodology used for the

calculation of limitations is described in

the Statistical Support Document. A

summary of the methodology follows.

Limitations were based on actual

concentrations of constituents measured

in wastewaters treated by BAT

treatment systems when such data were

available. Limitations were transferred

based on engineering analysis when

actual monitoring data were

unavailable. For steam stripping and

distillation technology, engineering

analysis involved grouping constituents

on the basis of their Henry’s Law

Constant. For biological treatment, the

engineering analysis involved grouping

constituents on the basis of their

chemical structure and published data

on relative biodegradability.

The calculation of the BAT daily

limitations for constituents other than

cyanide was performed by the following

steps. The arithmetic long-term mean

concentration was calculated for each

facility dataset representing BAT

treatment technology, and the median of

the means was determined. A modified

delta-lognormal distribution, the

distribution model used by EPA in the

Organic Chemicals, Plastics and

Synthetic Fibers (OCPSF) and Pesticides

Manufacturing rulemakings, was fit to

daily concentration data from each

facility dataset that had enough detected

concentration values for parameter

estimation. Variability factors were then

computed for each of these datasets, and

the average variability factor was

determined. Finally, the daily maximum

limitation was calculated by

multiplying the median long-term mean

by the average variability factor. The

monthly average maximum limitation

was calculated similarly except that the

variability factor corresponding to the

95th percentile of the distribution of

monthly averages was used instead of

the 99th percentile of daily

concentration measurements. The

monthly average maximum limitation

calculation assumes four measurements

per month, or one per week.

The modified delta-lognormal

distribution models the data as a

mixture of non-detects and measured

values. This distribution was selected

because the data for most constituents

consisted of a mixture of measured

values and non-detects. The modified

delta-lognormal distribution assumes

that all non-detects have a value equal

to the detection limit and the detected

values follow a lognormal distribution.

A beta distribution rather than a deltalognormal was used to model cyanide

data. The BAT treatment for cyanide

requires the reprocessing of wastewater

if effluent cyanide concentrations

exceed 1 ppm. Therefore, the cyanide

data from a properly operated treatment

system should range between 0 and 1

ppm. Such data are appropriately

modelled by the beta distribution. The

parameters of the beta distribution were

estimated from the cyanide dataset by

the method of moments. Parameter

estimates were then substituted in the

beta distribution from which the daily

limitation (99th percentile) was

calculated. The monthly average

cyanide (based on 4 daily

measurements) limitation was estimated

in a similar fashion.

The calculation of the proposed BPT

limitations was based on measured

concentrations of BOD5, COD, and TSS

measured in wastewaters treated by BPT

systems. A 1-day and 30-day limitation

was determined for each BPT facility

dataset from a modified delta-lognormal

distribution that was fit to the data.

These limitations were then averaged

across the datasets to determine the

overall 1-day and 30-day maximum

limitations. An intermediate step

involved adjusting the modeled

variability to account for day-to-day

correlation in concentrations of BOD5,

COD, and TSS. The adjustment was

based on a lag-1 autocorrelation time

series model estimated from adjacent

day observations, the same approach

adopted in the OCPSF rulemaking. For

datasets having an insufficient number

of adjacent day observations to estimate

an autocorrelation an average value was

assumed.

G. Costs

The Agency estimated the cost for the

pharmaceutical manufacturing industry

to achieve each of the effluent

limitations and standards proposed

today. These estimated costs are

summarized in this section and

discussed in more detail in section 10

of the Technical Development

Document. All cost estimates are

expressed in 1990 dollars (the year for

which EPA received questionnaire

responses and data submissions). The

cost components reported in this section

are engineering estimates of the capital

cost of purchasing and installing

equipment and the annual operating

and maintenance costs associated with

that equipment. The total annualized

cost, which is used to estimate

economic impacts, better describes the

actual compliance cost that a company

will incur because it allows for interest,

depreciation, and taxes. A summary of

the economic impact analysis for the

proposed regulation is contained in

Section XI.B of today’s notice. See also

the Economic Impact Analysis.

1. BPT

The Agency used a plant-specific

engineering cost assessment to estimate

the costs of achieving the proposed BPT

limitations. If a plant’s reported 1990

discharges of BOD5, TSS, COD and, in

the case of facilities with subcategory A
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21625

and/or C operations, cyanide were less

than the long-term average loads

achievable by the technology basis for

today’s proposed BPT limitations, the

plant was estimated to have no

compliance costs. If the resulting

pollutant loads exceeded the proposed

BPT long-term average loads, EPA

estimated costs for treatment system

upgrades and, in the case of cyanide, inplant hydrogen peroxide oxidation

technology. Based on this analysis, EPA

concluded that 20 pharmaceutical

manufacturing facilities would incur

costs to comply with the proposed BPT

limitations. EPA estimated the total

capital expenditures for complying with

the proposed BPT limitations to be

$15.3 million and the annual operating

and maintenance (O&M) costs to be $7.5

million. The estimated cost for

implementing the proposed BPT

limitations is summarized for the A and

C and B and D subcategories below in

Table IX.G.1.

2. BAT

EPA estimated the costs to comply

with today’s proposed BAT limitations

on priority and nonconventional

pollutants on plant-by-plant and

pollutant-by-pollutant basis. If the

loading data provided by the facility in

its Section 308 questionnaire response

indicated that its discharge was above

the proposed limitation target load for a

given pollutant, EPA developed cost

estimates for the control technology

EPA believes is appropriate for that

pollutant (e.g., steam stripping for all

strippable pollutants).

For direct dischargers with

subcategory A and C operations, BAT

costs include, where necessary, the

costs for in-plant steam stripping

followed by end-of-pipe advanced

biological treatment upgrades to comply

with the proposed limitations for

priority and nonconventional

pollutants. The operation and

maintenance costs include monitoring

of strippable pollutants in-plant and

nonstrippable biodegradable pollutants

at the end-of-pipe.

For direct dischargers with

subcategory B and D operations, BAT

costs include the costs for end-of-pipe

advanced biological treatment upgrades.

The upgrades are designed around

treating conventional pollutants to

specific targets, equivalent to BPT longterm mean performance. In a few cases,

additional compliance costs were

estimated for direct discharging

facilities with subcategory B and D

operations that already achieve these

conventional pollutant upgrade targets,

but require more closely controlled

treatment system operation to comply

with the priority and nonconventional

pollutant BAT limitations.

The BAT operation and maintenance

costs for subcategories B and D include

monitoring for priority and

nonconventional pollutants at the endof-pipe. EPA estimated the total capital

expenditures for complying with the

proposed BAT limitations to be $57.0

million, and the annual operating and

maintenance (O&M) costs to be $36.8

million. These costs are not incremental

and include the advanced biological

treatment upgrades also presented

under BPT. See Table IX.G.2–1 for a

breakdown of the costs by subcategory.

TABLE IX.G.1.—COST OF IMPLEMENTING PROPOSED BPT REGULATIONS

[In millions of 1990 dollars]

Subcategory No. of plants Capital costs Annual O&M

costs

Fermentation (A) and Chemical Synthesis (C) ............................................................................ 15 14.7 7.0

Biological and Natural Extraction (B) and Mixing/Compounding/Formulating (D) ...................... 5 0.6 0.5

TABLE IX.G.2.—COST OF IMPLEMENTING PROPOSED BAT REGULATIONS

[In millions of 1990 dollars]

Subcategory No. of plants Capital costs Annual O&M

costs

Fermentation (A) and Chemical Synthesis (C) ............................................................................ 23 56.4 35.7

Biological and Natural Extraction (B) and Mixing/Compounding/Formulating (D) ...................... 13 0.64 1.1

3. PSES

EPA developed PSES costs for

compliance with the proposed

pretreatment standards for strippable

priority and nonconventional pollutants

in the same manner that it developed

BAT compliance costs for these

pollutants. In developing these costs,

EPA based the number of pollutants

proposed to be regulated under PSES on

the pass-through findings of PSES coproposal (1), which include the 33 less

strippable volatile organic pollutants.

EPA did not include cost estimates for

nonstrippable nonconventional

pollutants in the PSES costs because

EPA is requesting comment on its

technology basis for controlling the

discharge of these pollutants. See

Section XIV, solicitation numbers 27.1

and 27.2. The estimated total capital

expenditure for complying with the

proposed PSES limitations are $91.8

million and the annual operating and

maintenance (O & M) costs are $54.1

million. See table IX.G.3 for a

breakdown of the costs by subcategory.

TABLE IX.G.3.—COST OF IMPLEMENTING PROPOSED PSES REGULATIONS

[In millions of 1990 dollars]

Subcategory No. of plants Capital costs Annual O&M

costs

Fermentation (A) and Chemical Synthesis (C) ............................................................................ 71 70.8 46.4

Biological and Natural Extraction (B) and Mixing/Compounding/Formulating (D) ...................... 75 21.0 7.7
21626 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

H. Pollutant Reductions

The Agency estimated the reduction

in the mass of pollutants that would be

discharged from pharmaceutical

manufacturing plants after the

implementation of the regulations being

proposed today. The reduction in

pollutant mass is attributable both to inplant treatment technologies and

improved end-of-pipe treatment. Inplant technologies such as steam

stripping achieve pollutant load

reductions by physical removal or

extraction of volatile organic pollutants.

Other technologies such as end-of-pipe

biological treatment and in-plant

cyanide destruction achieve pollutant

reduction by chemically or

biochemically altering the nature of the

pollutants (e.g., by converting them to

different substances like carbon dioxide

and water). Additional information on

the methodology used to estimate the

pollutant reductions resulting from the

implementation of the proposed effluent

limitations and standards is included in

Section 9 of the Technical Development

Document.

1. Conventional Pollutants

For each subcategory, the Agency

developed an estimate of the annual

average mass loadings of BOD5 and TSS

that would be discharged after the

implementation of the proposed BPT

limitations. Since EPA proposes to set

BCT limitations for conventional

pollutants equal to the proposed BPT

limitations for all subcategories, there

would be no further reduction in BOD5

and TSS achieved through BCT. Then

EPA subtracted these loadings from the

discharge loadings reported in the

Section 308 questionnaire responses for

1990. The resultant pollutant reductions

for BOD5 and TSS are summarized in

Table IX.H.1.

TABLE IX.H.1.—BPT, BOD5 AND TSS REDUCTIONS

Subcategories

BOD5

reduction

(lbs. per yr.)

TSS

reduction

(lbs. per yr.)

A and C .................................................................................................................................................................... 931,000 2,150,000

B and D .................................................................................................................................................................... 10,000 4,820

2. Priority Pollutants

For the ten priority pollutants EPA

proposes to regulate, EPA estimated the

removals achieved by the various BPT,

BAT, and PSES technologies based on

raw waste load data provided by plants

in their Section 308 questionnaire

responses. In estimating these pollutant

reductions, EPA did not include

pollutant reductions being achieved by

existing technology, including advanced

biological treatment, already in place.

The resultant priority pollutant

reductions are summarized in Table

IX.H.2.

TABLE IX.H.2.—BPT, BAT AND PSES PRIORITY POLLUTANT REDUCTIONS

Subcategories

BPT reduction

(cyanide)

(lbs. per yr.)

BAT reduction

(lbs. per yr.)

PSES

reduction

(lbs. per yr.)

A and C ........................................................................................................................................ 38 2,650,000 7,140,000

B and D ........................................................................................................................................ 1 N/A 0 694,000

1 Cyanide is not a pollutant of concern for facilities with subcategory B and D operations.

3. Nonconventional Pollutants

For the 45 nonconventional pollutants

(excluding COD) for which limitations

and standards are being proposed, EPA

estimated the removals achieved by the

various proposed BPT, BAT, and PSES

technology bases, using raw waste load

data provided by plants in their Section

308 questionnaire responses. In

estimating these pollutant reductions,

EPA did not include pollutant

reductions being achieved by

technology already in place, including

in many cases advanced biological

treatment. The resultant priority

pollutant reductions are summarized in

Table IX.H.3.

TABLE IX.H.3.—BPT, BAT AND PSES NONCONVENTIONAL POLLUTANT REDUCTIONS

Subcategories

BPT reduction

(lbs. per yr.)

COD only

BAT reduction

(lbs. per yr.)

PSES

reduction

(lbs. per yr.)

A and C ........................................................................................................................................ 9,840,000 16,800,000 30,900,000

B and D ........................................................................................................................................ 59,600 22,600 3,440,000

I. Regulatory Implementation

1. Applicability

The regulation proposed today is just

that—a proposed regulation. As such,

although it represents EPA’s best

judgment at this time, it is not intended

to be relied upon by permit writers in

establishing effluent limitations. Indeed,

because EPA solicits comment and data

(see specific solicitation numbers 1.2

and 1.3) regarding the proposed effluent

limitations and standards specified in

today’s notice as well as on the

technologies upon which they are

based, the proposed limitations and

standards and any conclusions set forth

in this notice are subject to change.

2. Upset and Bypass Provisions

A ‘‘bypass’’ is an intentional diversion

of waste streams from any portion of a

treatment facility. An ‘‘upset’’ is an

exceptional incident in which there is

unintentional and temporary

noncompliance with technology-based

permit effluent limitations because of

factors beyond the reasonable control of
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21627

the permittee. EPA’s regulations

concerning bypasses and upsets are set

forth at 40 CFR 122.41(m) and (n).

3. Variances and Modifications

The CWA requires application of the

effluent limitations established pursuant

to section 301 or the pretreatment

standards of section 307 to all direct and

indirect dischargers. However, the

statute provides for the modification of

these national requirements in a limited

number of circumstances. Moreover, the

Agency has established administrative

mechanisms to provide an opportunity

for relief from the application of

national effluent limitations guidelines

and pretreatment standards for

categories of existing sources for toxic,

conventional and nonconventional

pollutants.

a. Fundamentally Different Factors

Variances. EPA will develop effluent

limitations or standards different from

the otherwise applicable requirements if

an individual discharging facility is

fundamentally different with respect to

factors considered in establishing the

limitation or standards applicable to the

individual facility. Such a modification

is known as a ‘‘fundamentally different

factors’’ (FDF) variance.

Early on, EPA, by regulation,

provided for FDF modifications from

BPT effluent limitations, BAT

limitations for toxic and nonconventional pollutants and BCT

limitation for conventional pollutants

for direct dischargers. For indirect

dischargers, EPA provided for FDF

modifications from pretreatment

standards. FDF variances for toxic

pollutants were challenged judicially

and ultimately sustained by the

Supreme Court. Chemical

Manufacturers Ass’n v. NRDC, 479 U.S.

116 (1985).

Subsequently, in the Water Quality

Act of 1987, Congress added new

section 301(n) of the Act explicitly to

authorize modification of the otherwise

applicable BAT effluent limitations or

categorical pretreatment standards for

existing sources if a facility is

fundamentally different with respect to

the factors specified in section 304

(other than costs) from those considered

by EPA in establishing the effluent

limitations or pretreatment standard. No

FDF variance is available for new

sources subject to NSPS or PSNS.

Section 301(n) also defined the

conditions under which EPA may

establish alternative requirements.

Under section 301(n), an application for

approval of an FDF variance must be

based solely on (1) information

submitted during the rulemaking raising

the factors that are fundamentally

different or (2) information the

applicant did not have an opportunity

to submit. The alternate limitation or

standard must be no less stringent than

justified by the difference and not result

in markedly more adverse non-water

quality environmental impacts than the

national limitation or standard.

EPA regulations at 40 CFR Part 125

Subpart D, authorizing the Regional

Administrators to establish alternative

limitations and standards, further detail

the substantive criteria used to evaluate

FDF variance requests for direct

dischargers. Thus, 40 CFR 125.31(d)

identifies six factors (e.g., volume of

process wastewater, age and size of a

discharger’s facility) that may be

considered in determining if a facility is

fundamentally different. The Agency

must determine whether, on the basis of

one or more of these factors, the facility

in question is fundamentally different

from the facilities and factors

considered by the EPA in developing

the nationally applicable effluent

guidelines. The regulation also lists four

other factors (e.g., infeasibility of

installation within the time allowed or

a discharger’s ability to pay) that may

not provide a basis for an FDF variance.

In addition, under 40 CFR 125.31(b)(3),

a request for limitations less stringent

than the national limitation may be

approved only if compliance with the

national limitations would result in

either (a) a removal cost wholly out of

proportion to the removal cost

considered during development of the

national limitations, or (b) a non-water

quality environmental impact

(including energy requirements)

fundamentally more adverse than the

impact considered during development

of the national limits. EPA regulations

provide for an FDF variance for indirect

dischargers at 40 CFR 403.13. The

conditions for approval of a request to

modify applicable pretreatment

standards and factors considered are the

same as those for direct dischargers.

The legislative history of Section

301(n) underscores the necessity for the

FDF variance applicant to establish

eligibility for the variance. EPA’s

regulations at 40 CFR 125.32(b)(1) are

explicit in imposing this burden upon

the applicant. The applicant must show

that the factors relating to the discharge

controlled by the applicant’s permit

which are claimed to be fundamentally

different are, in fact, fundamentally

different from those factors considered

by the EPA in establishing the

applicable guidelines. The pretreatment

regulations incorporate a similar

requirement at 40 CFR 403.13(h)(9).

b. Economic Variances. Section 301(c)

of the CWA authorizes a variance from

the otherwise applicable BAT effluent

guidelines for nonconventional

pollutants due to economic factors. The

request for a variance from effluent

limitations developed from BAT

guidelines must normally be filed by the

discharger during the public notice

period for the draft permit. Other filing

time periods may apply, as specified in

40 CFR 122.21(l)(2). Specific guidance

for this type of variance is available

from EPA’s Office of Wastewater

Management.

c. Water Quality Variances. Section

301(g) of the CWA authorizes a variance

from BAT effluent guidelines for certain

nonconventional pollutants due to

localized environmental factors. These

pollutants include ammonia, chlorine,

color, iron, and total phenols.

d. Permit Modifications. Even after

EPA (or an authorized State) has issued

a final permit to a direct discharger, the

permit may still be modified under

certain conditions. (When a permit

modification is under consideration,

however, all other permit conditions

remain in effect.) A permit modification

may be triggered in several

circumstances. These could include a

regulatory inspection or information

submitted by the permittee that reveals

the need for modification. Any

interested person may request

modification of a permit modification be

made. There are two classifications of

modifications: major and minor. From a

procedural standpoint, they differ

primarily with respect to the public

notice requirements. Major

modifications require public notice

while minor modifications do not.

Virtually any modification that results

in less stringent conditions is treated as

a major modification, with provisions

for public notice and comment.

Conditions that would necessitate a

major modification of a permit are

described in 40 CFR 122.62. Minor

modifications are generally nonsubstantive changes. The conditions for

minor modification are described in 40

CFR 122.63.

e. Removal credits. As described

previously, many industrial facilities

discharge large quantities of pollutants

to POTWs where their wastewaters mix

with wastewater from other sources,

domestic sewage from private

residences and run-off from various

sources prior to treatment and discharge

by the POTW. Industrial discharges

frequently contain pollutants that are

generally not removed as effectively by

treatment at the POTWs as by the

industries themselves.

The introduction of pollutants to a

POTW from industrial discharges may

pose several problems. These include
21628 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

1The U.S. Court of Appeals for the District of

Columbia Circuit has remanded portions of these

regulations not pertinent here for modification or

additional justification. Leather Industries of

America, Inc. v. EPA, 40 F.3d 392 (D.C. Cir. 1994).

2Under Section 403.7, a POTW is authorized to

give removal credits only under certain conditions.

These include applying for, and obtaining, approval

from the Regional Administrator (or Director of a

State NPDES program with an approved

pretreatment program), a showing of consistent

pollutant removal and an approved pretreatment

program. See 40 CFR § 403.7(a)(3)(i), (ii), and (iii).

potential interference with the POTW’s

operation or pass-through of pollutants

if inadequately treated. As discussed,

Congress, in section 307(b) of the Act,

directed EPA to establish pretreatment

standards to prevent these potential

problems. Congress also recognized that,

in certain instances, POTWs could

provide some or all of the treatment of

an industrial user’s wastewater that

would be required pursuant to the

pretreatment standard. Consequently,

Congress established a discretionary

program for POTWs to grant ‘‘removal

credits’’ to their indirect dischargers.

The credit, in the form of a less stringent

pretreatment standard, allows an

increased concentration of a pollutant in

the flow from the indirect discharger’s

facility to the POTW.

Section 307(b) of the CWA establishes

a three-part test for obtaining removal

credit authority for a given pollutant.

Removal credits may be authorized only

if (1) The POTW ‘‘removes all or any

part of such toxic pollutant,’’ (2) the

POTW’s ultimate discharge would ‘‘not

violate that effluent limitation, or

standard which would be applicable to

that toxic pollutant if it were

discharged’’ directly rather than through

a POTW and (3) the POTW’s discharge

would ‘‘not prevent sludge use and

disposal by such [POTW] in accordance

with section [405] * * *.’’ Section

307(b).

EPA has promulgated removal credit

regulations in 40 CFR Part 403.7. The

United States Court of Appeals for the

Third Circuit has interpreted the statute

to require EPA to promulgate

comprehensive sewage sludge

regulations before any removal credits

could be authorized. NRDC v. EPA, 790

F.2d 289, 292 (3d Cir. 1986), cert.

denied. 479 U.S. 1084 (1987). Congress

made this explicit in the Water Quality

Act of 1987 which provided that EPA

could not authorize any removal credits

until it issued the sewage sludge use

and disposal regulations required by

section 405(d)(2)(a)(ii).

Section 405 of the CWA requires EPA

to promulgate regulations that establish

standards for sewage sludge when used

or disposed for various purposes. These

standards must include sewage sludge

management standards as well as

numerical limits for pollutants that may

be present in sewage sludge in

concentrations which may adversely

affect public health and the

environment. Section 405 requires EPA

to develop these standards in two

phases. On November 25, 1992, EPA

promulgated the Round One sewage

sludge regulations establishing

standards, including numerical

pollutant limits, for the use or disposal

of sewage sludge. 58 FR 9248 1. EPA

established pollutant limits for ten

metals when sewage sludge is applied to

land, for three metals when it is

disposed of on a surface disposal site

and for seven metals and a total

hydrocarbon operational standard, a

surrogate for organic pollutant

emissions, when sewage sludge is

incinerated. These requirements are

codified at 40 CFR Part 503.

The Phase One regulations partially

fulfilled the Agency’s commitment

under the terms of a consent decree that

settled a citizens suit to compel

issuance of the sludge regulations.

Gearhart, et al. v. Reilly, Civil No. 89–

6266–JO (D.Ore). Under the terms of

that decree, EPA must propose and take

final action on the Round Two sewage

sludge regulations by December 15,

2001.

At the same time EPA promulgated

the Round One regulations, EPA also

amended its pretreatment regulations to

provide that removal credits would be

available for certain pollutants regulated

in the sewage sludge regulations. See 58

FR 9386. The amendments to Part 403

provide that removal credits may be

made potentially available for the

following pollutants:

(1) If a POTW applies its sewage

sludge to the land for beneficial uses,

disposes of it on surface disposal sites

or incinerates it, removal credits may be

available, depending on which use or

disposal method is selected (so long as

the POTW complies with the

requirements in Part 503). When sewage

sludge is applied to land, removal

credits may be available for ten metals.

When sewage sludge is disposed of on

a surface disposal site, removal credits

may be available for three metals. When

the sewage sludge is incinerated,

removal credits may be available for

seven metals and for 57 organic

pollutants. See 40 CFR

403.7(a)(3)(iv)(A).

(2) In addition, when sewage sludge is

used on land or disposed of on a surface

disposal site or incinerated, removal

credits may also be available for

additional pollutants so long as the

concentration of the pollutant in sludge

does not exceed a concentration level

established in Part 403. When sewage

sludge is applied to land, removal

credits may be available for two

additional metals and 14 organic

pollutants. When the sewage sludge is

disposed of on a surface disposal site,

removal credits may be available for

seven additional metals and 13 organic

pollutants. When the sewage sludge is

incinerated, removal credits may be

available for three other metals. See 40

CFR 403.7(a)(3)(iv)(B).

(3) When a POTW disposes of its

sewage sludge in a municipal solid

waste landfill that meets the criteria of

40 CFR Part 258 (MSWLF), removal

credits may be available for any

pollutant in the POTW’s sewage sludge.

See 40 CFR 403.7(a)(3)(iv)(C). Thus,

given compliance with the requirements

of EPA’s removal credit regulations,2

following promulgation of the

pretreatment standards being proposed

here, removal credits may be authorized

for any pollutant subject to pretreatment

standards if the applying POTW

disposes of its sewage sludge in a

MSWLF that meets the requirements of

40 CFR Part 258. If the POTW uses or

disposes of its sewage sludge by land

application, surface disposal or

incineration, removal credits may be

available for the following metal

pollutants (depending on the method of

use or disposal): arsenic, cadmium,

chromium, copper, iron, lead, mercury,

molybdenum, nickel, selenium and

zinc. Given compliance with section

403.7, removal credits may be available

for the following organic pollutants

(depending on the method of use or

disposal) if the POTW uses or disposes

of its sewage sludge: benzene, 1,1-

dichloroethane, 1,2-dibromoethane,

ethylbenzene, methylene chloride,

toluene, tetrachloroethene, 1,1,1-

trichloroethane, 1,1,2-trichloroethane

and trans-1,2-dichloroethene.

Some facilities may be interested in

obtaining removal credit authorization

for other pollutants being considered for

regulation in this rulemaking for which

removal credit authorization would not

otherwise be available under Part 403.

Under sections 307(b) and 405 of the

CWA, EPA may authorize removal

credits only when EPA determines that,

if removal credits are authorized, that

the increased discharges of a pollutant

to POTWs resulting from removal

credits will not affect POTW sewage

sludge use or disposal adversely. As

discussed in the preamble to

amendment to the Part 403 regulations

(58 FR 9382–83), EPA has interpreted

these sections to authorize removal

credits for a pollutant only in one of two

circumstances. Removal credits may be
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21629

3 In the Round One sewage sludge regulation,

EPA concluded, on the basis of risk assessments,

that certain pollutants (see Appendix G to Part 403)

did not pose an unreasonable risk to human health

and the environment and did not require the

establishment of sewage sludge pollutant limits. As

discussed above, so long as the concentration of

these pollutant in sewage sludge are lower than a

prescribed level, removal credits are authorized for

such pollutants.

authorized for any categorical pollutant

(1) for which EPA have established a

numerical pollutant limit in Part 503; or

(2) which EPA has determined will not

threaten human health and the

environment when used or disposed of

in sewage sludge. The pollutants

described in paragraphs (1)–(3) above

include all those pollutants that EPA

either specifically regulated in Part 503

or evaluated for regulation and

determined would not adversely affect

sludge use and disposal.

Consequently, in the case of a

pollutant for which EPA did not

perform a risk assessment in developing

the Phase One sewage sludge

regulations, removal credit for

pollutants will only be available when

the Agency determines either a safe

level for the pollutant in sewage sludge

or that regulation of the pollutant is

unnecessary to protect public health

and the environment from the

reasonably anticipated adverse effects of

such a pollutant.3 Therefore, any person

seeking to add additional categorical

pollutants to the list for which removal

credits are now available would need to

submit information to the Agency to

support such a determination. The basis

for such a determination may include

information showing the absence of

risks for the pollutant (generally

established through an environmental

pathway risk assessment such as EPA

used for Phase One) or data establishing

the pollutant’s presence in sewage

sludge at low levels relative to risk

levels or both. Parties, however, may

submit whatever information they

conclude is sufficient to establish either

the absence of any potential for harm

from the presence of the pollutant in

sewage sludge or data demonstrating a

‘‘safe’’ level for the pollutant in sludge.

Following submission of such a

demonstration, EPA will review the data

and determine whether or not it should

propose to amend the list of pollutants

for which removal credits would be

available.

EPA has already begun the process of

evaluating a number of pollutants for

adverse potential to human health and

the environment when present in

sewage sludge. In May, 1993, pursuant

to the terms of the consent decree in the

Gearhart case, the Agency notified the

United States District Court for the

District of Oregon that, based on the

information then available at that time,

it intended to propose 31 pollutants for

regulation in the Round Two sewage

sludge regulations. These are acetic acid

(2,4-dichlorophenoxy), aluminum,

antimony, asbestos, barium, beryllium,

boron, butanone (2-), carbon disulfide,

cresol (p-), cyanides (soluble salts and

complexes), dioxins/dibenzofurans (all

monochloro to octochloro congeners),

endsulfan-II, fluoride, manganese,

methylene chloride, nitrate, nitrite,

pentachloronitrobenzene, phenol,

phthalate (bis-2-ethylexyl),

polychlorinated biphenyls (co-planar),

propanone (2-), silver, thallium, tin,

titanium, toluene,

trichlorophenoxyacetic acid (2, 4,5-),

trichlorphenoxypropionic acid ([2-

(2,4,5-)], and vanadium.

The Round Two regulations are not

scheduled for proposal until December,

1999 and promulgation in December

2001. However, given the necessary

factual showing, as detailed above, EPA

could conclude before the contemplated

proposal and promulgation dates that

regulation of some of these pollutants is

not necessary. In those circumstances,

EPA could propose that removal credits

should be authorized for such pollutants

before promulgation of the Round Two

sewage sludge regulations. However,

given the Agency’s commitment to

promulgation of effluent limitations and

guidelines under court-supervised

deadlines, it may not be possible to

complete review of removal credit

authorization requests by the time EPA

must promulgate these guidelines and

standards.

4. Relationship of Effluent Limitations

to NPDES Permits and Monitoring

Requirements

Effluent limitations act as a primary

mechanism to control the discharges of

pollutants to waters of the United

States. These limitations are applied to

individual facilities through NPDES

permits issued by the EPA or authorized

States under section 402 of the Clean

Water Act.

The Agency has developed the

limitations and standards for this

proposed rule to cover the discharge of

pollutants for this industrial category. In

specific cases, the NPDES permitting

authority may elect to establish

technology-based permit limits for

pollutants not covered by this proposed

regulation, on a case-by-case basis using

best professional judgment. See section

402(a)(1)(B) of the Clean Water Act; 40

CFR 125.3. In addition, if State water

quality standards or other provisions of

State or Federal law require limits on

pollutants not covered by this regulation

(or require more stringent limits on

covered pollutants), the permitting

authority must apply those limitations.

See, e.g., section 301(b)(1)(C) of the

Clean Water Act.

For determination of effluent limits

where there are multiple products or

multiple categories and subcategories,

the effluent guidelines would be applied

using a flow-weighted combination of

the appropriate guideline for each

category or subcategory. Where a facility

has added a new production facility in

conjunction with an existing production

facility, the effluent guidelines would

also be applied by using a flowweighted combination of the NSPS limit

for the new line and the BAT and BCT

standards to the existing lines to derive

the limitations. However, as stated

above, if State water quality standards

or other provisions of State or Federal

law require limits on pollutants not

covered by this regulation (or require

more stringent limits on covered

pollutants), the permitting authority

must apply those limitations regardless

of the limitation derived using the

production-weighted combinations.

The Agency does not consider certain

wastewaters or materials to be process

wastewaters; therefore, these proposed

effluent limitations guidelines and

standards would not apply to the

discharge of such wastewaters. Such

materials include, for example, any

active anti-microbial materials,

wastewater from imperfect fermentation

batches, or process area spills. Any

pharmaceutical manufacturing facility

wishing NPDES authorization to

discharge any materials and/or nonprocess wastestream(s) must specifically

disclose this in its permit application. If

the permitting authority wishes to

authorize this discharge, the permit

must specifically authorize the

discharge of the specified materials

and/or non-process wastestream(s). The

effluent limitations in the permit must

also reflect a separate analysis, done by

the permitting authority on a best

professional judgment basis, of the

levels of pollutants in such materials

and/or non-process wastestream(s) that

are commensurate with the application

of BPT, BCT, BAT, and PSES. Caution

should be exercised in permitting such

discharges. Treatment systems may not

be designed to accommodate these types

of materials and their discharge could

adversely affect the treatment systems

and receiving waters.

Working in conjunction with the

effluent limitations are the monitoring

conditions set out in an NPDES permit.

An integral part of the monitoring

conditions are the monitoring points.

The point at which a sample is collected
21630 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

can have a dramatic effect on the

monitoring results for that facility.

Therefore, it may be necessary to require

internal monitoring points in order to

assure compliance. Authority to address

internal waste streams is provided in 40

CFR 122.44(i)(1)(iii) and 122.45(h). In

some instances, today’s proposed rule

establishes internal monitoring points to

ensure compliance with the effluent

limitations guidelines and standards.

Permit writers may establish additional

internal monitoring points to the extent

consistent with EPA’s regulations.

5. Best Management Practices

EPA is not proposing in today’s notice

best management practices (BMPs)

pursuant to Section 304(e) of the Clean

Water Act. BMPs established under

Section 304(e) may be different from

effluent limitations guidelines and

standards principally because BMPs are

specific requirements for conduct, not

performance standards. When EPA sets

technology-based effluent limits, those

limits may be achieved by any

technology a discharger chooses.

However, when EPA establishes BMPs

under Section 304(e) of the CWA, and

those BMPs are incorporated into a

dischargers permit, the discharger must

perform those specific BMPs. The fact

that a discharger had met all its

technology-based effluent limits would

not be a defense, if the discharger were

charged with a permit violation for

failing to perform its BMPs.

BMPs for the pharmaceutical

manufacturing industry, which might

include spill prevention, control

provisions, and other aspects to prevent

the release of raw materials, solvents,

and process chemicals to wastewaters,

would control the release of

constituents listed in sections 307(a)

and 311(e) of the CWA, such as

methylene chloride, toluene,

chloroform, and chloromethane (methyl

chloride).

The EPA believes these BMPs are

important because: discharges of raw

materials, process chemicals and other

materials are not recognized process

wastewaters and contribute to

significant portions of untreated

wastewater loadings and to final

effluent discharge loadings of oxygen

demanding substances and priority and

nonconventional pollutants. Prevention

and control of discharges of materials

used in pharmaceutical manufacturing

processes will result in less demand for

make-up chemicals; energy efficiency

through recovery of process materials;

more effective and less costly

wastewater treatment system operations;

reduced formation of wastewater

treatment sludges; and reduced

atmospheric emissions of hazardous air

pollutants (HAPs) and other volatile

organic pollutants.

EPA is soliciting comment on whether

BMPs are applicable to pharmaceutical

manufacturing facilities in any or all

subcategories for which effluent

limitations guidelines and standards are

being proposed. The principal focus of

the BMPs are prevention and control of

losses of raw materials, process

chemicals and other process materials

from spills and equipment leaks. More

information related to the BMPs is

outlined in Section XIV regarding

solicitation of comments and data (see

specific solicitation number 31.0).

Appendix B of the Technical

Development Document presents details

on the specifics of BMPs that may be

appropriate.

6. Analytical Methods

Section 304(h) of the Clean Water Act

(CWA) directs the EPA to promulgate

guidelines establishing test procedures

(methods) for the analysis of pollutants.

These methods are used to determine

the presence and concentration of

pollutants in wastewater, and for

compliance monitoring. Dischargers

seeking NPDES permits must supply

information on the characteristics of

their effluent, analyzed in accordance

with approved test procedures, as part

of their permit applications. 40 CFR

122.21(g)(7). Similarly, holders of

NPDES permits are required to conduct

monitoring in accordance with such test

procedures. 40 CFR 122.41(j)(4).

Information and analysis performed in

accordance with these methods are also

required under the pretreatment

program, 40 CFR 403.12(d)(5)(vi), and as

a condition for receiving a conditional

removal credit under 40 CFR 403.7(d).

EPA has promulgated analytical

methods for monitoring discharges to

surface water at 40 CFR part 136, and

has promulgated methods for

parameters specific to a given industrial

category and for other purposes at parts

400–480 of the CFR. In today’s notice,

EPA also proposes to establish

appropriate analytical methods at 40

CFR part 439 to support regulation of

discharges in the pharmaceutical

manufacturing industrial point source

category. Those methods are presented

in ‘‘Analytical Methods for the

Determination of Pollutants in

Pharmaceutical Industry Wastewater,’’ a

compendium of analytical methods and

are incorporated herein by reference.

See Section XIV, solicitation number 33.

Methods 1624 and 1625 are two of the

previously promulgated methods

applicable to the determination of

volatile and semivolatile organic

pollutants in water and wastewater for

the proposed effluent guidelines. They

employ gas chromatography coupled to

a mass spectrometer (GC/MS) to

separate and quantify volatile and

semivolatile organic pollutants.

Detected pollutants are quantified by

isotope dilution. For volatile organic

pollutants, samples of water or solids

suspended in water are purged by a

stream of inert gas into the gaseous

phase where they are concentrated into

a trap. Subsequent heating of the trap

introduces the concentrated volatile

organics into a GC/MS for separation

and quantification. The sensitivity of

these methods are sufficient to detect

and quantify volatile and semivolatile

organics at parts per billion (ppb) levels

in environmental samples. EPA also

solicits comment on whether it may be

appropriate to allow facilities to use

analytical methods for organic

pollutants other than those used to

generate data upon which this proposal

is based. See Section XIV, solicitation

number 38.3.

Many of the non-conventional

pollutants that may be released from the

pharmaceutical manufacturing industry

are not included in methods previously

promulgated for monitoring effluents

from other industries. For this reason it

has been necessary to develop methods

for these pollutants. Some are amenable

to extraction from aqueous solution and

can be analyzed by GC/MS after

extraction and concentration. Method

1665 has been developed for these

analytes. Others may be concentrated by

purging from aqueous solution and

trapping in a column containing sorbent

material. For these substances, purgeand-trap followed by GC/MS analysis as

described in Method 1666 was

developed. Some highly water soluble

analytes, however, could not be

extracted from aqueous solution and

could not be efficiently purged from

water. For this reason, it was necessary

to develop a direct aqueous injection

technique for GC/MS analysis by

Method 1666. A subset of these highly

water soluble substances, all containing

nitrogen, were found not to

chromatograph well on the column

used. For this reason, a third technique,

Method 1668, was developed using a

different GC column and detection by

electrolytic conductivity. Formaldehyde

is not extractable from water and can

not be readily analyzed by either purgeand-trap GC/MS or direct aqueous

injection. For this reason a fourth

approach, Method 1667, was developed

for formaldehyde and the other

aldehydes included in the analyte list.

A complete description of these
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21631

methods can be found in the Methods

Compendium mentioned previously.

Methods 410.1 and 410.2 are two of

several methods allowed for

determination of chemical oxygen

demand (COD) in water and wastewater.

Other methods allowed for the

determination of COD in this industry

are those in 40 CFR part 136 that use

analytical technologies equivalent to the

technologies used in EPA methods

410.1 and 410.2, specifically oxidation

by potassium dichromate and titration

with ferrous ammonium sulfate, as

described below. Method 410.2 is

specific for levels of COD less than 50

mg/L, and Method 410.1 for levels

greater than 50 mg/L. Other methods for

COD that are intended for brines (e.g.,

EPA method 410.3) and that are

interfered with by color (e.g., EPA

method 410.4) and the methods in 40

CFR part 136 equivalent to these

methods are allowed for monitoring

pharmaceutical manufacturing

wastewaters.

X. Regulation of the Pharmaceutical

Manufacturing Industry Under the

Clean Air Act Amendments of 1990

Section 112 of the Clean Air Act

Amendments of 1990 (CAAA) requires

EPA to develop National Emission

Standards for Hazardous Air Pollutants

(NESHAP) based on maximum

achievable control technology (MACT)

for sources that emit 10 or more tons per

year of a single hazardous air pollutant

(HAP) or 25 or more tons per year of a

mixture of HAP. The CAAA contain a

list of 189 pollutants identified as HAPs.

It also establishes a schedule for issuing

these standards over a ten-year period.

Pharmaceutical plants are among the

source categories for which MACT

standards must be promulgated by

November 15, 1997.

EPA’s Office of Water, which is

developing the effluent limitations and

standards being proposed today, has

been working closely with EPA’s Office

of Air and Radiation since the beginning

of this effluent guidelines effort in order

to ensure that the present rulemaking is

consistent, within the constraints of the

governing statutes, with the air

emissions standards EPA will be

promulgating for the pharmaceutical

manufacturing industry. As noted in

Section V.A above, EPA’s promulgation

of this effluent guideline—including the

date of this proposal—is subject to a

court-ordered schedule, which at this

time requires EPA to issue this

regulation in final form by August 1996.

Meanwhile, EPA has established

November 15, 1997, as the date by

which it will promulgate air emissions

standards for this industry. See Section

V.B above. In determining priorities for

promulgating standards for this and

other industries, EPA was required by

section 112(e) of the Clean Air Act to

consider several factors, including

anticipated adverse effects on public

health and the environment. Thus, the

promulgation date for the

pharmaceutical industry NESHAP

reflects EPA’s consideration of these

statutory criteria, as well as resource

limitations that reinforced the Agency’s

need to rank its rulemakings in priority

order. Despite the different schedules

and resource constraints necessitating

separate rulemakings under the Clean

Water Act and Clean Air Act for the

pharmaceutical manufacturing industry,

EPA is making every effort to reconcile

these activities.

Consistent with this intent, EPA is

providing the following information to

put the affected public on notice that

EPA is developing regulations and

guidance to reduce air emissions from

wastewater operations at

pharmaceutical manufacturing facilities

under the Clean Air Act. Section X of

this notice also sketches in preliminary

form the approach EPA is considering to

regulate such air emissions and

provides preliminary cost and emission

reduction information associated with

that approach. By this notice, EPA

solicits comment on the possible

combined effect of the proposed Clean

Water Act regulation and the tentative

Clean Air Act approach for the

pharmaceutical manufacturing industry.

See Section XIV, solicitation number 32.

This notice is also intended to provide

the industry with an opportunity to plan

for integrated least-cost multimedia

compliance.

A. Preliminary Development of Air

Emissions Standards

EPA is in the early stages of

developing the MACT standard for

pharmaceutical plants; the standards

will require the control of several

different emission points, including

organic air emissions from wastewater

operations. EPA recently promulgated a

similar MACT standard for organic HAP

emissions from the Synthetic Organic

Chemical Manufacturing Industry

(SOCMI). This rule, often referred to as

the Hazardous Organic NESHAP or

HON, was published on April 22, 1994

(59 FR 19402). On January 7, 1993, EPA

published amendments to the Benzene

Waste Operations NESHAP, which

controls benzene emissions from

wastewater operations based upon

Clean Air Act authority predating the

1990 amendments (40 CFR part 61

subpart FF).

The control approach that EPA is

considering for the pharmaceutical

manufacturing industry is similar to the

approach EPA used in the SOCMI HON

and the Benzene Waste Operations

NESHAP to control organic air

emissions from wastewater collection

and treatment operations. That

approach consists first of identifying a

subset of wastewater streams that

require control through a combination

of wastewater flowrate and

concentration action levels, and second,

the control requirements for these

affected streams. The flowrate and

concentration of each wastewater stream

would be determined to reflect the

characteristics at the point of generation

of the wastewater stream.

The point of generation is defined to

be where each individual wastewater

stream exits production process

equipment prior to any form of

wastewater treatment. The

characteristics of a wastewater stream at

the point of generation are used to

determine which streams to control

because this is where the organic

concentration is the highest and the

flow is the lowest. The use of the point

of generation characteristics in this way

results in the identification of the most

cost effective streams for control. If the

characteristics of the streams were

determined at some point downstream

of the point of generation, there would

be losses of organics due to air

emissions and an increase in the

wastewater flowrate due to mixing with

other wastewater streams, both of which

would result in the subsequent control

of the stream being less cost effective. In

addition, if wastewater treatment were

allowed before the point of generation,

the treatment unit, such as an air

stripper, would not be required to have

air emission control.

The flowrate action level is generally

expressed as the liters per minute of

wastewater flow. Values of flowrate

used in previous regulatory analyses

range from 0.02 to 10 liters per minute.

The concentration action level is

based on the ‘‘volatile organic’’

concentration of the wastewater stream

rather than the total concentration. EPA

has developed a test method, Method

305 in Appendix A of 40 CFR part 63,

to determine the volatile organic HAP

concentration for use with wastewater

MACT standards. The purpose of this

test method is to determine a relative

measure of the emission potential of a

typically controlled wastewater stream

by measuring essentially all of an

organic HAP compound that is likely to

be emitted in significant quantities

while measuring essentially none of an

organic HAP compound that is unlikely
21632 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

to be emitted. Previous regulatory

analyses have used an action level of

10,000 ppmw at any flowrate and

coupled with a range of action levels

from 10 to 1,000 ppmw tied to a

flowrate cutoff as described above.

Examples of the use of these action

levels in recent rules include the

Benzene Waste Operations NESHAP,

which has action levels of 0.02 liters per

minute and 10 ppmw benzene, and the

HON, which has a 10,000 ppmw volatile

organic HAP concentration action level

at any flow rate coupled with an action

level pair of 10 liters per minute and

1,000 ppmw volatile organic HAP

concentration.

The control requirements for affected

wastewater streams include managing

the identified wastewater streams in

controlled units during collection and

treatment to remove or destroy the

organics. This control approach

includes: (1) Suppression or control of

air emissions from the point of

wastewater generation to the treatment

device by installing controls on the

sewer system, tanks, and containers

used to transport the wastewater; (2)

treatment of the wastewater to remove

or destroy the organics; (3) control of air

emissions from the treatment device

(e.g., the non-condensible air emissions

from the stripper condenser); and (4)

control or recycling of the organics

removed by the treatment device (e.g.,

the condensed residuals collected by the

stripper condenser). See also Section

XII.B of this preamble for discussion of

the Administrator’s strategy for waste

minimization and combustion

(incineration) of ignitable organic

wastes.

The treatment device used as the basis

for the HON is a steam stripper, the

same device proposed as the primary

technology basis for today’s proposed

limits and standards. The HON

requirements are performance

standards, so that any device that

achieves the desired performance can be

used. In addition, the HON allows

several compliance alternatives

including the use of open biological

treatment units to treat the wastewater

if a controlled collection and treatment

system is used up to the unit and the

unit can be demonstrated to achieve the

required level of biological degradation.

The HON requires the use of the

procedures outlined in Appendix C of

40 CFR part 63 to demonstrate that the

organics are being degraded by the

biological treatment unit and not

emitted to the air.

The CAAA also requires EPA to

establish Control Techniques Guideline

(CTG) documents for the States to use to

develop VOC emissions control plans

for ozone nonattainment areas.

Industrial wastewater, which includes

the pharmaceutical manufacturing

industry, is one of the source categories

for which EPA is developing a CTG

document (see the draft document

entitled ‘‘Control of Volatile Organic

Compound Emissions from Industrial

Wastewater,’’ EPA–453/D–92–056,

September 1992; available in the public

docket for this Clean Water Act

rulemaking). Based on this guidance,

certain States will write rules for VOC

emissions from wastewater operations at

pharmaceutical plants located in ozone

nonattainment areas. These rules are

expected to be similar to the MACT

standards, except they would control

additional wastewater streams based on

their potential for VOC emissions rather

than HAP emissions. The concentration

action level used in the draft CTG is

based on the volatile organic

concentration, which is determined by

Method 25D in Appendix A of 40 CFR

part 60.

The volatile organic HAP and flowrate

action levels for the MACT standard for

pharmaceutical plants have not yet been

determined. For this notice, EPA has

conducted a preliminary analysis of the

impacts of a set of control options

(action levels) for direct and indirect

dischargers of A and C, and B and D

effluent guideline subcategory

production process wastewaters based

on the approaches used in the HON.

EPA emphasizes that this analysis is

still preliminary. Wastewater data from

the recent Section 308 pharmaceutical

industry questionnaire responses were

used in the analysis; however, a number

of assumptions were made. See the draft

document entitled ‘‘Control of Volatile

Organic Compound Emissions from

Industrial Wastewater, EPA–453/D–92–

056, September 1992, for presentation of

the assumptions and methodology used

for this preliminary analysis. During the

development of the MACT standard,

this analysis will be refined based on

new information and comments from

the public.

Tables X.A.1 and X.A.2 summarize

the results of this preliminary analysis.

Two sets of preliminary results are

presented based on two ways to

evaluate the existing data for effluent

guideline subcategory A, B, C, and D

plants. The actual results of a rule based

on any of the control options could be

very different than these preliminary

impacts. Table X.A.1 presents results

based on applying the controls

described above to wastewater streams

that are equal to or greater than the

identified action levels as the streams

were reported in the Section 308

questionnaire responses. This database

reflects the characteristics of combined

process area wastewater streams, not the

point of generation of the wastewater.

Table X.A.2 presents results based on

the same criteria, but the Section 308

questionnaire wastewater data have

been disaggregated in an attempt to

simulate the characteristics at the point

of generation. This disaggregation was

performed in the manner described in

Appendix B of the draft CTG document.

The control options (action levels),

which encompass different

combinations of volatile organic HAP

(VOHAP) and wastewater stream

flowrates, identified in both tables are

ones that were considered in the

development of the HON. All of the

control options would require control of

any wastewater stream that has 10,000

ppmw or greater volatile organic HAP

concentration. The least stringent

control option identified would require

all wastewater streams with a flow of 10

liters per minute or greater and a 1,000

ppmw or greater volatile organic HAP

concentration be equipped with

controls. Wastewater streams below

these criteria would not require control.

Other more stringent control options

would have lower action levels and

require more wastewater streams to be

controlled. The most stringent control

option shown would require all streams

with a flow of 1.0 liters per minute or

greater and a 100 ppmw or greater

volatile organic HAP concentration be

controlled.

The analysis will be refined, and

these results, along with other statutory

criteria in the Clean Air Act, will be

considered before a MACT standard for

the pharmaceutical manufacturing

industry is proposed. Information on the

controls that may be required for

wastewater streams exceeding the action

levels, however, is provided in today’s

notice to allow pharmaceutical

manufacturing facility owners and

operators to consider these additional

controls in their planning and to allow

the public to comment on the combined

effect of the MACT standard and today’s

proposed effluent limitations

guidelines.

It is the Agency’s intent for both the

effluent guidelines being proposed

today and the MACT standards to be

proposed at a later date that upon

promulgation the in-plant technology

basis of both rules will be applicable to

essentially the same high concentration

low volume process wastewater streams

in which the bulk of the volatile organic

pollutants are contained, as represented

preliminarily by Tables X.A.1 and

X.A.2. The practical effect of this

approach will be that only a relatively

small portion (i.e., substantially less
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21633

than half) of all process wastewaters

will require control by a treatment

device (e.g., steam stripping) to achieve

both rules. EPA has been informed by

the industry that additional data will be

submitted (some data have been

submitted) in order to characterize, in

greater detail than available in

responses to the Section 308

questionnaire, the individual process

wastewater streams at the point of

generation. This additional data and any

other information available to EPA will

be considered prior to promulgation in

identifying the small portion of process

wastewater streams that would require

control of volatile organic pollutants

under both the effluent guideline and

the MACT standard for this industry.

The methodology to be used in

analyzing these data will likely be the

same as presented above and the

preliminary results of which are

presented in the following tables.

TABLE X.A.1.—PRELIMINARY IMPACTS OF CONTROL OPTIONS FOR A, B, C, AND D SUBCATEGORY PHARMACEUTICAL

PLANTS BASED ON PROCESS AREA STREAMS

Control Option

VOHAP conc.1

cutoff

(PPMW)

Flow cutoff

(LPM)

Total flow controlled by option

(percent)

HAP

emissions

(MG/yr)

HAP emission

reduction

(percent)

Total annual

cost

($M/yr)

HAP cost effectiveness

($/MG HAP

ER2)

Baseline ........................ ....................... ....................... ....................... 12,500 ....................... ....................... .......................

1 .................................... 1,000 10 46 1,650 87 19.0 1,750

2 .................................... 800 5 47 1,640 87 19.8 1,830

3 .................................... 500 1 72 1,520 88 26.1 2,380

4 .................................... 200 1 75 1,510 88 27.6 2,520

5 .................................... 100 1 80 1,500 88 29.5 2,680

Notes:

1 ‘‘VOHAP CONC. CUTOFF’’ means the volatile organic HAP concentration determined by Method 305 in 40 CFR Part 63, Appendix A.

2 ‘‘$/MG HAP ER’’ means the dollars per megagram of HAP emission reduction by the given control option, which is determined by dividing the

annual cost of the option by the annual emission reduction.

• All options include an action level of 10,000 ppmw volatile organic HAP concentration at any flowrate.

• Total industry wastewater flow equals 75,300 liters per minute.

TABLE X.A.2.—PRELIMINARY IMPACTS OF CONTROL OPTIONS FOR A, B, C, AND D SUBCATEGORY PHARMACEUTICAL

PLANTS BASED ON DISAGGREGATED STREAMS

Control Option

VOHAP conc.1

cutoff

(PPMW)

Flow cutoff

(LPM)

Total flow controlled by option

(percent)

HAP

emissions

(MG/yr)

HAP emission

reduction

(percent)

Total annual

cost

($M/yr)

HAP cost effectiveness

(R/MG HAP

ER2)

Baseline ........................ ....................... ....................... ....................... 12,500 ....................... ....................... .......................

1 .................................... 1,000 10 7 2,790 78 6.6 680

2 .................................... 800 5 10 2,440 80 8.0 800

3 .................................... 500 1 16 2,120 83 10.6 1,020

4 .................................... 200 1 25 1,680 87 13.7 1,270

5 .................................... 100 1 29 1,630 87 15.9 1,460

Notes:

1 ‘‘VOHAP CONC.’’ means the volatile organic HAP concentration determined by Method 305 in 40 CFR Part 63 Appendix A.

2 ‘‘$/MG HAP ER’’ means the dollars per megagram of HAP emission reduction by the given control option, which is determined by dividing the

annual cost of the option by the annual emission reduction.

• All options include an action level of 10,000 ppmw volatile organic HAP concentration at any flowrate.

• Total industry wastewater flow equals 75,300 liters per minute.

B. Potential Interaction of Proposed

Effluent Limitations Guidelines and

Future Air Emission Standards

Because both the effluent limitations

guidelines and standards being

proposed today and the future MACT

standards for this industry are likely to

regulate similar pollutants and to reflect

similar technology bases, EPA

acknowledges that there is considerable

interest in the industry concerning the

potential interaction of these

rulemakings. In this section, EPA

addresses various issues that thus far

have come to EPA’s attention.

The effluent limitations guidelines

and standards proposed today for

nonconventional and priority pollutants

are based on actual performance data

obtained for specific pollutants over a

range of influent concentrations. The

future MACT standards for HAPs

emissions from pharmaceutical

wastewater, like the HON, probably will

employ data on Volatile Organic HAP

concentration and flow rate of the

wastewater stream to determine

applicability of its standards to covered

sources. Like the HON, the

pharmaceuticals NESHAP will probably

authorize percent reduction standards,

effluent concentration limitations and

mass removal requirements as options

for measuring compliance.

EPA considered proposing percent

reduction limitations and standards in

this water rulemaking, but for the

following reasons has determined that

such limitations and standards would

not adequately control the discharge of

wastewater pollutants of concern,

particularly volatile pollutants. First, in

EPA’s view, effluent limitations

guidelines and standards based on

percent reduction do not reflect the

performance of the best available

technology in removing wastewater

pollutants for the pharmaceutical

manufacturing industry. EPA’s analysis

of actual performance data shows that

the proposed concentration-based

effluent limitations and standards can

be met, regardless of variations in the

influent concentrations of the target

volatile compounds, using welldesigned and well-operated technology.

Second, percent reduction effluent

limitations, as previously promulgated

under the Clean Water Act for this

industry, may discourage source
21634 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

reduction programs (programs whose

goal is to reduce raw waste loadings of

volatiles) because plants with high raw

waste loadings of volatiles can more

easily comply with percent reduction

regulations than plants with moderate

or low volatile loadings. Finally, the

percent reduction approach for effluent

limitations guidelines and standards

imposes special burdens on permit

writers and facilities. The percent

reduction approach would require the

gathering and evaluation of long-term

raw waste data from each facility in

order to develop plant-specific

limitations on individual pollutants,

and to demonstrate continuing

compliance with the limitations.

The Agency solicits comments and

data on potential alternative formats for

effluent limitations guidelines and

standards, such as percent removal

limitations and standards and minimum

treatment threshold concentrations for

individual wastewater streams. See

Section XIV of this preamble,

solicitation number 32.4.

Another issue arises in connection

with the design of the steam stripper

being proposed as a technology basis for

various limitations and standards in

today’s rule. Today’s notice proposes

performance standards, based on a

specific steam stripper design, that

correspond to the wastestreams being

treated. EPA also expects that the MACT

standards for this industry also will be

a performance standard based on a

specific steam stripper design. However,

the control approach contained in the

air rule will include four components:

(1) Suppression or control of air

emissions from the point of generation

to the treatment device by installing

controls on the sewer system, tanks, and

containers used to transport the

wastewater; (2) a treatment device (such

as a steam stripper); (3) control of air

emissions from the treatment device

itself (e.g., the non-condensible air

emissions from the steam stripper

condensor); and (4) control or recycling

of the organics removed by the

treatment device (e.g., the condensed

residuals collected by the steam stripper

condensor). The treatment device itself

is a major component of the air

emissions control approach for

wastewater. It is the Agency’s intent that

a facility that installs steam stripping for

the purpose of complying with this

proposed rule also will achieve the

requirements of the MACT standards to

be developed for this industry. By the

time public comments on the effluent

guideline are being considered, EPA

will have a better understanding of the

stripper design that will serve as the

basis for the MACT standards to be

proposed for this industry. This

understanding, as well as the public

comments on the water rule, will be

considered in formulating the final

effluent guideline as it pertains to

stripper design. The Agency’s intent is

that the same stripper design will be

able to achieve the requirements of both

final rules, and will be applicable both

to direct dischargers (BAT) and indirect

dischargers (PSES). It is possible,

however, that the stripper design upon

which today’s proposed water rule is

based could change before promulgation

based upon additional data and any

comments received. Any information or

comment on this subject is welcomed.

See Section XIV, solicitation number

32.3. EPA also will develop air emission

standards for other emission points (e.g.,

process vents, process area fugitive

emissions, etc.).

A third issue relates to the possibility

that the future MACT standard for the

pharmaceutical manufacturing industry

will allow plants to use an enclosed

collection system to suppress emissions

while transporting the wastewaters

containing volatile pollutants to a

central treatment unit, which in turn

can be controlled for air emissions. In

today’s notice, EPA has selected inplant steam stripping for controlling

volatile organic pollutants. Under this

proposal, plants would be required to

treat all wastewater streams that contain

regulated volatile organic pollutants at

concentrations greater than the longterm average concentrations established

for these regulated pollutants. However,

a plant could choose to meet the

proposed effluent limitations guidelines

and standards by combining all such

streams and treating the combined

wastestreams at a central treatment unit

prior to their dilution by wastestreams

that do not contain volatile organic

pollutants. This approach to the

treatment of wastestreams containing

volatile organic pollutants not only

would satisfy the proposed regulations,

but also appears to be more efficient

than treating individual wastestreams at

the wastewater generation source.

However, in certain cases individual

plants may find that streams containing

recoverable quantities of individual

volatile organic pollutants (e.g.,

methanol) may be more cost-effectively

managed as segregated binary streams

(i.e., water and one solvent), rather than

mixing them with streams containing all

other volatile organic pollutants

generated at the facility, prior to either

steam stripping or steam stripping/

distillation. EPA solicits data and

comment on this option. See Section

XIV of this preamble, solicitation

number 32.5.

A fourth issue concerns the

possibility that the future MACT

standards will allow the use of open

biological treatment units to treat

organic compounds with limited

volatility (e.g., methanol) from enclosed

primary treatment systems, provided

that a facility-specific emission limit or

a 95 percent destruction of the organic

HAP by biodegradation is achieved. In

demonstrating the destruction, losses

due to air emissions and effluent

discharge would not be considered

destruction. EPA did not select this

technology as BAT for subcategories A

and C because all known A and C direct

discharger plants have open biological

treatment systems and no air emissions

data were available from plants with

biological treatment systems that

demonstrate 95 percent biodegradation

of volatiles. In addition, the use of

biodegradation for volatiles treatment

eliminates the potential for their

recovery and reuse. Nevertheless, EPA

solicits comment on whether it is

appropriate and feasible, considering

recycle opportunities and control of air

emissions, to develop a separate

subcategory for the effluent limitations

guidelines and standards with alternate

limits that would allow for end-of-pipe

biological treatment in place of or in

combination with in-plant steam

stripping for volatile organic pollutants.

See Section XIV of this preamble,

solicitation number 32.6.

XI. Impacts of Regulatory Options

Considered in this Rulemaking

The purpose of this section is to

analyze the projected economic impacts

and non-water quality environmental

impacts associated with the various

technology options considered as

possible bases for the limitations and

standards proposed in today’s notice.

A. Regulatory Options

In developing the proposed effluent

limitations and standards set forth in

today’s notice, EPA developed

technology options based upon a variety

of different technologies and

combinations of technologies. EPA

developed technology options for direct

dischargers and indirect dischargers,

and for different industry subcategory

groupings, i.e., facilities with

subcategory A and C operations and

facilities with subcategory B and D

operations. For direct dischargers, EPA

proposes limitations and standards

based on options for Best Practicable

Control Technology Currently Available

(BPT), Best Conventional Pollutant

Control Technology (BCT), Best
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21635

Available Technology Economically

Achievable (BAT), and New Source

Performance Standards (NSPS) options.

For indirect dischargers, EPA proposed

Pretreatment Standards for Existing

Sources (PSES) and Pretreatment

Standards for New Sources (PSNS),

based on a variety of technology options

considered. Table XI.A–1 presents the

technology options considered in this

rulemaking. The economic impact

analysis discussed below reflects each

of these options.

TABLE XI.A–1.—TECHNOLOGY OPTIONS CONSIDERED IN THE ECONOMIC IMPACT ANALYSIS

Type of option Name Description

Direct Dischargers

Best Practicable Technology

(BPT).

BPT–A/C#1

BPT–A/C#2

Current biological treatment

Cyanide destruction + advanced biological treatment.

BPT–A/C#3 Cyanide destruction + advanced biological treatment + effluent filtration.

BPT–A/C#4 Cyanide destruction + advanced biological treatment + polishing pond.

BPT–A/C#5 Cyanide destruction + advanced biological treatment + effluent filtration + polishing pond.

BPT–B/D#1 Current biological treatment.

BPT–B/D#2 Advanced biological treatment.

BPT–B/D#3 Advanced biological treatment + effluent filtration.

Best Conventional Technology

(BCT)*.

BCT–A/C#1

BCT–A/C#2

Advanced biological treatment + effluent filtration.

Advanced biological treatment + polishing pond.

BCT–A/C#3 Advanced biological treatment + effluent filtration + polishing pond.

BCT–B/D#1 Advanced biological treatment.

BCT–B/D#2 Advanced biological treatment + effluent filtration.

Best Available Technology (BAT) BAT–A/C#1 Cyanide destruction + advanced biological treatment with nitrification, where necessary.

BAT–A/C#2 Cyanide destruction + in-plant steam stripping + advanced biological treatment.

BAT–A/C#3 In-plant cyanide destruction + in-plant steam stripping/distillation + advanced biological

treatment.

BAT–A/C#4 In-plant cyanide destruction + in-plant steam stripping/distillation + advanced biological

treatment + granular activated carbon.

BAT–B/D#1 Advanced biological treatment.

BAT–B/D#2 In-plant steam stripping + advanced biological treatment.

BAT–B/D#3 In-plant steam stripping/distillation + advanced biological treatment.

BAT–B/D#4 In-plant steam stripping/distillation + advanced biological treatment + granular activated

carbon.

New Source Performance Standard (NSPS).NSPS–A/C#1 In-plant cyanide destruction + in-plant steam stripping/distillation + advanced biological

treatment.

NSPS–A/C#2 In-plant cyanide destruction + in-plant steam stripping/distillation + advanced biological

treatment + granular activated carbon.

NSPS–B/D#1 Advanced biological treatment + in-plant steam stripping/distillation.

NSPS–B/D#2 In-plant steam stripping/distillation + advanced biological treatment + granular activated

carbon.

Indirect Dischargers

Pretreatment Standards for Existing Sources (PSES).PSES–A/C#1

PSES–A/C#2

In-plant steam stripping + cyanide destruction.

In-plant steam stripping/distillation + in-plant cyanide destruction.

PSES–A/C#3 In-plant steam stripping/distillation + in-plant cyanide destruction + end-of-pipe advanced

biological treatment.

PSES–A/C#4 In-plant steam stripping/distillation + in-plant cyanide destruction + advanced biological

treatment + granular activated carbon.

PSES–B/D#1 In-plant steam stripping.

PSES–B/D#2 In-plant steam stripping/distillation.

PSES–B/D#3 In-plant steam stripping/distillation + granular activated carbon.

Pretreatment Standard for New

Sources (PSNS).

PSNS–A/C#1

PSNS–A/C#2

In-plant steam stripping/distillation + in-plant cyanide destruction.

In-plant steam stripping/distillation + in-plant cyanide destruction + end-of-pipe advanced

biological treatment.

PSNS–A/C#3 In-plant steam stripping/distillation + in-plant cyanide destruction + end-of-pipe advanced

biological treatment + granular activated carbon.

PSNS–B/D#1 In-plant steam stripping/distillation.

PSNS–B/D#2 In-plant steam stripping/distillation + granular activated carbon.

*In the Development Document, BCT–A/C#1, #2, and #3 in this table actually correspond to Options 3, 4, and 5, and BCT–B/D#1 and #2 in

this table actually correspond to Options 2 and 3. The options not listed in this table were never considered in the EIA because they are equal to

or less stringent than the requirements of the selected BPT options, and thus no incremental costs are incurred.

EPA has selected the following

technology options as bases for the

effluent limitations and standards

proposed in today’s notice:

• For direct discharging A/C

facilities, BPT–A/C#2 is the technology

basis for conventional pollutants and

BAT–A/C#2 is the technology basis for

priority and nonconventional

pollutants.

• For direct discharging B/D facilities,

BPT–B/D#2 is the technology basis for

conventional pollutants and BAT–B/

D#1 is the technology basis for

nonconventional pollutants.

• NSPS–A/C#1 is the technology

basis for new A/C facilities that are

direct dischargers.
21636 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

4The Development Document presents costs in

1990 dollars. These costs are inflated to 1994

dollars in this preamble using a factor of 1.143

derived from Engineering News Record

‘‘Construction Cost Index.’’

• NSPS–B/D#1 is the technology basis

for new B/D facilities that are direct

dischargers (this option is identical to

BAT–B/D#3).

• PSES–A/C#1 is the technology basis

for A/C facilities that are indirect

dischargers.

• PSES–B/D#1 is the technology basis

for B/D facilities that are indirect

dischargers.

• PSNS–A/C#1 is the technology

basis for new A/C facilities that are

indirect dischargers (this option is

identical to PSES–A/C#2).

• PSNS–B/D#1 is the technology basis

for new B/D facilities that are indirect

dischargers (this option is identical to

PSES–B/D#2).

B. Economic Impact Considerations

1. Introduction

EPA’s economic impact assessment is

documented in the report titled

‘‘Economic Impact Analysis of Proposed

Effluent Limitations Guidelines and

Standards for the Pharmaceutical

Manufacturing Industry’’ (hereinafter

EIA). This report estimates the

economic effect of compliance with the

proposed regulation in terms of

annualized costs, facility closures,

changes in rate of return on assets and

the interest coverage ratio at the

company level, and profit losses at the

company level. In addition, impacts on

affected communities, foreign trade,

specific demographic groups, and new

sources also are considered. Finally, a

Regulatory Flexibility Analysis detailing

the impacts on small businesses within

the pharmaceutical industry is included

in the EIA. The methodologies for these

analyses are detailed in the EIA. The

major source of information for this EIA

is the 1990 Detailed Questionnaire,

which was conducted under the

authority of Section 308 of the Clean

Water Act.

2. Projected Facility Economic Impacts

The annual costs of regulatory

compliance may have a negative effect

on facility earnings. Facility closures are

identified when the salvage value (i.e.,

liquidation value) of the facility exceeds

the present value of its future earnings.

A post-compliance facility closure

analysis was performed for all

technology options.

a. Annual Costs. The aggregate posttax annualized costs for all the

regulatory options are given in Tables

XI.B.2–1 through XI.B.2–3. The

annualized costs for the selected options

for this proposed rulemaking are shown

in Table XI.B.2–4. The aggregate posttax annualized costs were estimated at

$30.6 million (1994 $) for facilities with

subcategory A and C operations to

implement BAT Option 2 (BAT–A/C#2),

$0.8 million (1994 $) for facilities with

subcategory B and D operations to

implement BAT Option 1 (BAT–B/D#1),

$39.5 million (1994 $) for facilities with

subcategory A and C operations to

implement PSES Option 1 (PSES–A/

C#1), and $9.1 million (1994 $) for

facilities with subcategory B and D

operations to implement PSES Option 1

(PSES–B/D#1), for a total of $80.0

million (1994 $) for the selected

options.4

TABLE XI.B.2–1.—ESTIMATED COMPLIANCE COSTS FOR A/C DIRECT DISCHARGERS

[Millions of 1994 dollars]

Option No. Total capital

costs

Total O&M

costs

Total post-tax

annualized

costs

Average annual

cost per

facility 1

BPT Option Costs

BPT–A/C#1 ..................................................................................................... 0 0 0 0

BPT–A/C#2 ..................................................................................................... 16.9 8.1 6.5 0.3

BPT–A/C#3 ..................................................................................................... 25.0 8.6 7.7 0.3

BPT–A/C#4 ..................................................................................................... 42.8 24.9 19.0 0.8

BPT–A/C#5 ..................................................................................................... 50.5 26.8 21.0 0.9

BCT Option Costs

BCT–A/C#1 ..................................................................................................... 19.3 3.4 4.1 0.17

BCT–A/C#2 ..................................................................................................... 37.1 18.9 15.0 0.62

BCT–A/C#3 ..................................................................................................... 44.8 21.8 17.5 0.73

BAT Option Costs

BAT–A/C#1 ..................................................................................................... 17.2 9.8 7.5 0.3

BAT–A/C#2 ..................................................................................................... 64.5 40.8 30.6 1.3

BAT–A/C#3 ..................................................................................................... 77.8 66.3 46.8 1.9

BAT–A/C#4 ..................................................................................................... 106.1 130.6 87.0 3.6

Footnotes:

1Total Post–Tax Annualized Costs divided by the total number of A/C direct discharge facilities.

b. Post-compliance Facility Closures.

The selected options result in no

closures of any facilities. When the most

stringent options are considered, one

direct discharging facility with

subcategory A and C operations is

predicted to close under BAT–A/C#4,

and one indirect discharging facility

with subcategory B and D operations is

predicted to close under PSES–B/D#3.

No other options were determined to

result in any other facility closures.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21637

TABLE XI.B.2–2.—ESTIMATED COMPLIANCE COSTS FOR B/D DIRECT DISCHARGERS

[Millions of 1994 dollars]

Option No. Total capital

costs

Total O&M

costs

Total post-tax

annualized

costs

Average annual

cost per

facility 1

BPT Option Costs

BPT–B/D#1 ............................................................................................... 0 0 0 0

BPT–B/D#2 ............................................................................................... 0.69 0.59 0.42 0.030

BPT–B/D#3 ............................................................................................... 3.4 0.86 0.87 0.062

BCT Option Costs

BCT–B/D#1 ............................................................................................... 0.64 0.51 0.37 0.026

BCT–B/D#2 ............................................................................................... 3.3 0.78 0.82 0.058

BAT Option Costs

BAT–B/D#1 ............................................................................................... 0.74 1.3 0.81 0.058

BAT–B/D#2 ............................................................................................... 2.0 1.1 0.84 0.060

BAT–B/D#3 ............................................................................................... 3.4 2.2 1.7 0.12

BAT–B/D#4 ............................................................................................... 11.8 3.5 3.3 0.24

Footnotes:

1Total Post-Tax Annualized Costs divided by the total number of B/D direct discharge facilities.

TABLE XI.B.2–3.—ESTIMATED COMPLIANCE COSTS FOR INDIRECT DISCHARGERS (PSES)

[Millions of 1994 dollars]

Option No. Total capital

costs

Total O&M

costs

Total post-tax

annualized

costs

Average annual

cost per

facility 1

A/C Facilities

PSES–A/C#1 .................................................................................................. 80.9 53.1 39.5 0.4

PSES–A/C#2 .................................................................................................. 103.0 93.6 65.3 0.7

PSES–A/C#3 .................................................................................................. 164.6 120.9 87.8 1.0

PSES–A/C#4 .................................................................................................. 213.7 203.0 140.6 1.6

B/D Facilities

PSES–B/D#1 .................................................................................................. 28.8 10.2 9.1 0.06

PSES–B/D#2 .................................................................................................. 34.8 19.4 15.0 0.10

PSES–B/D#3 .................................................................................................. 70.8 112.2 72.5 0.5

Footnotes:

1Total Post-Tax Annualized Costs divided by the total number of indirect discharge facilities.

TABLE XI.B.2–4.—ESTIMATED COMPLIANCE COSTS FOR SELECTED REGULATORY OPTIONS

[Millions of 1994 dollars]

Option No. Total capital

costs

Total O&M

costs

Total post-tax

annualized

costs

Average annual

cost per

facility 1

BAT–A/C#2 ..................................................................................................... 64.5 40.8 30.6 1.3

BAT–B/D#1 ..................................................................................................... 0.7 1.3 0.8 0.06

PSES–A/C#1 .................................................................................................. 80.9 53.1 39.5 0.4

PSES–B/D#1 .................................................................................................. 28.8 10.2 9.1 0.06

Total 2 ...................................................................................................... 174.9 105.4 80.0 0.29

Footnotes:

1Total Post-Tax Annualized Costs divided by the total number of facilities for each subcategory.

2Total number of facilities includes seven non-discharging facilities.

3. Projected Owner Company-Level

Economic Impacts

Firm failures are identified when the

return on assets and the interest

coverage ratio, common financial

indicators, fall below benchmarks for

the industry.

Table XI.B.3.b2–1 presents the results

of the postcompliance analysis under

the selected regulatory options. This

analysis determined that none of the

firms owning direct discharging

facilities with subcategory A and C or B

and D operations are expected to
21638 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

experience significant impacts (i.e., firm

failure) as a result of implementing the

selected regulatory options. In addition,

only two firms with indirect discharging

facilities with subcategory A and C

operations and one firm owning an

indirect discharging facility with

subcategory B and D operations would

be expected to experience significant

impacts as a result of compliance costs.

Thus, a total of three firms are projected

to fail under the conservative

assumption of no costs being passed

through to consumers. Overall, these

firms represent 3.8 percent of all firms

with indirect discharging facilities with

subcategory A and C operations, 1.4

percent of firms with subcategory B and

D operations, and 2.3 percent of all

regulated firms. As indicated by the

Profitability Analysis, 15 firms (11

percent of firms in the postcompliance

analysis) are anticipated to have major

impacts short of firm failure (i.e., will

experience a change in ROA of greater

than 5 percent). Impacts are most likely

overstated, however, because this

analysis assumes that firms cannot pass

any increased costs through to

consumers. If half the costs can be

passed through to consumers there

would be no firm failures.

TABLE XI.B.3.b2–1.—PROJECTED FIRM FAILURE: 1 POST COMPLIANCE ANALYSIS 2

Total No.

of firms

Regulatory impact on firms

No significant impact Significant impact

No. Percent No. Percent

Firms with A/C Direct Facilities .................................................................................... 15 15 100.0 0 0.0

Firms with B/D Direct Facilities .................................................................................... 7 7 100.0 0 0.0

Firms with A/C Indirect Facilities .................................................................................. 53 51 96.2 2 3.8

Firms with B/D Indirect Facilities .................................................................................. 72 71 98.6 1 1.4

All Firms 3 ..................................................................................................................... 133 130 97.7 3 2.3

Note: Analysis excludes three firms because of lack of financial data. 1Firm failure is defined when a firm’s return on assets or interest coverage ratio falls below industry benchmarks. This analysis assumes no

costs can be passed through to consumers. 2This scenario analyzes impacts from regulating A/C Direct Facilities under options BAT–A/C#2 and BPT–A/C#2, B/D Direct Facilities under

options BAT–B/D#1 and BPT–B/D#2, A/C Indirect Facilities under option PSES–A/C#1, and B/D Indirect Facilities under option PSES–B/D#1. 3 Number of firms for All Firms may be less than the total firms by subcategory because some firms have more than one type of facility. Total

number of All Firms includes firms that have nondischarging facilities.

4. Projected Employment Losses and

Gains and Community-Level Economic

Impacts

Based on facility closures and firm

failures, the employment losses analysis

sums the number of jobs lost in the

postcompliance scenario and compares

these losses to community employment

measures. Job gains are calculated based

on the cost of manufacturing, installing,

and operating compliance equipment.

No employment losses were projected

to occur as a result of regulatory options

for direct dischargers. For indirect

dischargers, however, total projected

primary employment losses resulting

from the selected regulatory options

were 78 full time equivalent (FTE)

positions among indirect discharging

facilities with subcategory A and C

operations and 13 FTEs among indirect

discharging facilities with subcategory B

and D operations, for a total of 91 FTEs

or 0.07 percent of total employment for

the affected portion of the industry.

Secondary employment losses were

predicted to be 541 FTEs.

None of these losses is expected to

result in a change of employment rates

of more than 1 percent in the affected

communities.

Employment losses are offset to some

extent by the need to hire workers to

manufacture, install, and maintain the

pollution control equipment. Primary

employment gains are expected to total

68 annual FTEs for manufacturing

equipment, 10 annual FTEs for

installing equipment, and 0 to 889

annual FTEs for operating and

maintaining equipment for a total of 78

to 967 annual FTE gains. The sum of

primary and secondary gains is

calculated to range from 218 FTEs to

2,890 FTEs. Net gains and losses thus

range from a loss of 323 FTEs to a gain

of 2,349 FTEs.

5. Projected Foreign Trade Impacts

The impact of effluent guidelines on

pharmaceutical exports and the U.S.

balance of trade was found to be

negligible. The one firm/facility

predicted to close as a result of the

effluent guidelines had pharmaceutical

exports totaling $0.09 million (1994 $).

The loss of these exports would have

virtually no effect on U.S.

pharmaceutical exports, which,

according to the U.S. Department of

Commerce, totalled $5.7 billion in 1991.

6. Regulatory Flexibility Analysis

a. Purpose of the Regulatory

Flexibility Analysis. The Regulatory

Flexibility Act requires the federal

government to consider the impacts on

small entities as part of rulemaking

procedures. The goal of the analysis is

to ensure that small entities potentially

affected by a new regulation will not be

disproportionately burdened. Small

entities have limited resources, and it is

the responsibility of the regulating

federal agency to avoid, if possible,

disproportionately or unnecessarily

burdening such entities.

b. Projected Impacts on Small

Businesses. (i) Size Distribution. Small

firms make up 76 percent of the 190

firms in the survey universe. The largest

percentage of firms are in the 100 to 499

employees size group (37 percent of all

firms in the survey universe).

(ii) Recordkeeping and Reporting

Requirements. The proposed effluent

guidelines for the pharmaceutical

industry are revisions to existing

effluent guidelines and, accordingly,

most of the recordkeeping and reporting

requirements to which the industry

would be subject are not new

requirements. There are some new

monitoring requirements. The new

monitoring costs total $10.3 million

(1994 $) annually, and are 15 percent of

the total annual compliance cost for the

selected options. Large firms incur the

largest proportion of the new

monitoring costs (61 percent of total

monitoring costs).

(iii) Other Federal Requirements. EPA

is aware of no federal rules that

duplicate, overlap, or conflict with the

proposed effluent guidelines for the

pharmaceutical industry.

(iv) Significant Alternatives to the

Proposed Rule. No significant

alternatives to the proposed rule will

substantially reduce impacts on small

entities, thus the Agency believes the
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21639

stated objectives of the Clean Water Act

are met with this proposed rule and the

impacts to small firms have been

considered, where possible.

(v) Projected Impacts on Small Firms.

Projected Impacts on small firms

measured as firm failure are as follows.

Two of the three firms that were

projected to fail in the firm-level

analysis under the selected regulatory

options have fewer than 750 employees,

although only 2 percent of small firms

in the postcomplaince analysis are

affected in this manner. In addition, 14

of 15 firms found to experience a

significant decline in ROA (over 5

percent) have fewer than 750

employees. These firms represent about

14 percent of all small firms in the postcompliance analysis.

When cash flow is analyzed, however,

impacts seem less disproportionate.

Except in the 19 to 99 employees group,

the total present value of compliance

costs as a percentage of the present

value of net income is smaller among

small firms than among large firms.

Over all small firms (or all large firms),

the present value of compliance costs is

less than 1 percent of the present value

of net income.

The above analyses indicate that

although small firms do bear a large

portion of the impacts such as firm

failures, these impacts are felt by a very

small percentage of all small firms.

Additionally, the percentages of the

present value of compliance costs to the

present value of net income are

expected to be smaller, on average,

among small firms than among large

firms; thus, impacts to small firms are

not expected to be disproportionate to

those for large firms.

7. Projected Distributional Impacts

a. Impacts on Drug Prices. Assuming

that all costs are passed on to consumers

and that price increases will reflect 100

percent of the cost increases to

manufacturers, the following

observations can be made. For all the

selected regulatory options, the ratio of

compliance costs to total

pharmaceutical costs was 1.6 percent.

Most facilities would incur compliance

costs less than 1 percent of total

pharmaceutical costs. Only three

facilities (1 percent of all facilities)

would incur compliance costs greater

than 10 percent of total pharmaceutical

costs.

b. Impacts on Specific Demographic

Groups. When possible uses for

products produced by a sampling of

highly affected facilities (those where

compliance costs exceed 10 percent of

total pharmaceutical costs) were

investigated, it appeared that children,

women, and the elderly were likely to

be the major consumers of many of

these products. It was further

determined that individuals who lack

any health insurance, those who are

covered by government insurance, and

those who are covered by nonworkrelated medical insurance might be least

likely to have drug coverage. These

groups include Hispanics, young adults,

African Americans, young children, and

the elderly. Thus, young adult women,

children, and the elderly are likely to be

the most heavily affected by potential

cost increases, if such increases can be

passed through to consumers.

Because on average any potential

price increases are likely to be very low

(1.6 percent), impacts on mass

consumers of drugs such as HMOs,

governments, and, indirectly, thirdparty insurers should be minimal.

8. Projected Impacts on New Sources

The projected selected options for

new sources are NSPS–A/C#1, NSPS–B/

D#1, PSNS–A/C#1, and PSNS–B/D#1. In

all cases, the requirements for new

sources are more stringent than those for

existing sources. However, the

difference in cost between new source

requirements and existing source

requirements for typical facilities are

relatively small when compared to the

average facility costs of production. In

most cases, existing facilities would be

required to retrofit in-plant steam

stripping systems, whereas new sources

would have to install in-plant steam

stripping/distillation systems. Because

designing in pollution control

equipment in a new source is typically

less expensive than retrofitting the same

equipment in an existing source, the

cost differential between the selected

requirements for existing sources and

those higher existing source options that

are technically equivalent to new source

requirements should be an upper limit

on the differential annual cost faced by

new sources. Where this differential is

not substantial relative to the typical

costs of doing business in this industry,

no significant barrier to entry is likely

to exist.

The average per-facility compliance

costs were investigated to determine

what the cost differentials would be

between proposed new source and

existing source requirements. The

average per-facility cost differentials

ranged from about a $39,000 to a

$674,000 difference (1994 $) (for A/C

direct dischargers), depending on the

type of facility. The maximum $674,000

difference generates the highest

percentage of compliance cost

differential to pharmaceuticals

manufacturing cost—about 1.4 percent

of total manufacturing costs and about

3.0 percent of pharmaceutical

manufacturing costs. Since this cost

differential is likely to be less than that

assumed here, this small premium

estimated to be paid by new sources is

not likely to have much impact on the

decision to enter the market.

Furthermore, these same options, when

applied to existing sources, were found

to have nearly identical impacts on

existing sources as the selected options

for existing sources. Thus no significant

barriers to entry are estimated to result

from the proposed new source

requirements.

9. Regulatory Impact Assessment

The Agency has prepared a regulatory

impact assessment (RIA) for the

proposed regulatory alternative. The

RIA responds to the requirements in

Executive Order 12866 to assess both

the costs and benefits to society of

significant regulatory actions.

Significant regulatory actions are those

that impose an annual cost to the

economy of $100 million or more, or

have certain other regulatory, policy or

economic impacts. The RIA is detailed

in ‘‘Regulatory Impact Assessment of

the Proposed Effluent Guidelines for the

Pharmaceutical Manufacturing

Industry’’ (see Section II for availability

of this and other supporting

documents). This RIA was submitted to

OMB for review as required by

Executive Order 12866.

The RIA analyzes the effects of

current air and water emissions and

assesses the benefits of reductions in

these emissions resulting from the

proposed regulation. EPA expects a

variety of human health, environmental,

and economic benefits to result from

these reductions in effluent loadings

and air emissions. In particular, the

benefits assessment addresses the

following benefit categories: human

health and agricultural benefits due to

reductions in emissions of ozone

precursors (i.e., reductions in VOC

emissions); human health benefits due

to reductions in excess cancer risk;

human health benefits due to reductions

in non-carcinogenic risk; ecological and

recreational benefits due to improved

water quality; and benefits to publicly

owned treatment works (POTWs) from

reductions in interference, pass through,

and sludge contamination problems and

improvements in worker health and

safety. EPA monetizes the estimated

benefits for reductions in air emissions

of ozone precursors and cancer risk

reductions, but is unable to quantify the

dollar magnitude of benefits from the

other benefit categories. Air benefits are

estimated separately for Section 308
21640 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

survey air emissions data and for air

emissions estimated by the WATER7

model which estimates the maximum

emissions.

a. Human Health/Agricultural

Benefits from Reductions in Emissions

of Ozone Precursors. The proposed

effluent guidelines are expected to

result in reductions in ambient ozone

concentrations due to reductions in

VOC emissions. Controlling VOC

emissions is beneficial because VOCs

are precursors to ozone, which

negatively affects human health and the

environment.

(1) Human Health Benefits.

The RIA estimates that the annual

human health benefits resulting from

reductions in VOC emissions due to the

proposed rule range from $31,000 to

$1.9 million (1994 $). EPA monetizes

these benefits using a benefits-transferbased approach. Specifically, the

estimated reductions in VOC emissions

in nonattainment areas (1,396 Mg) are

multiplied by an existing estimate of the

range of the value of a unit reduction in

VOC emissions ($22/Mg to $1,382/Mg,

1994 $). This range is taken from an

existing study that evaluated the human

health benefits of ozone reductions in

nonattainment areas.

(2) Welfare Benefits from Increased

Agricultural Crop Yields.

Studies of the relationship between

ambient ozone concentrations and

greenhouse-controlled ozone

concentrations and agricultural crop

yields demonstrate that ozone

negatively affects crop yields.

Reductions in crop yields in turn affects

agricultural production, crop prices, and

incomes of agricultural producers, and

thus affects social welfare. Thus,

reductions in ozone concentrations that

lead to improved crop yields will

generate welfare benefits.

The RIA estimates that the annual

agricultural-related economic welfare

benefits from reductions in VOC

emissions range from $186,000 to

$315,000 (1994 $). To generate these

welfare benefit estimates, EPA applies

an existing estimate of the benefits per

unit reduction in VOC emissions ($134/

Mg to $226/Mg, 1994 $) to the total

expected reduction in VOC emissions in

nonattainment areas. The existing value

estimates were developed using

economic models that estimate the net

change in social welfare resulting from

higher crop yields as a result of lower

ambient ozone levels in rural areas.

b. Human Health Benefits Due To

Cancer Risk Reduction. The benefits

from the proposed rule include human

health benefits from reductions in

excess cancer risk. EPA expects the

proposed rule to reduce loadings of

toxic substances that otherwise would

volatilize and pose a cancer risk to

humans, resulting in reductions in

excess cancer risk in exposed

populations from inhalation of VOCs. In

addition, EPA expects that reduced

loadings to surface waters will improve

water quality and thus reduce cancer

risk to the exposed populations from

consumption of contaminated drinking

water and fish tissue.

Based on the cancer risk assessment

conducted for the RIA, EPA estimates

that the proposed guidelines will result

in 0.02 to 0.35 excess cancer cases

avoided per year nationwide. The

estimated value of the human health

benefits from these cancer risk

reductions ranges from $14,000 to $5.4

million (1994 $) annually. EPA

developed these benefit estimates by

applying an existing estimate of the

value of a statistical life to the estimated

number of excess cancer cases avoided.

The estimated range of the value of a

statistical life used in this analysis is

$0.7 million to $15.4 million (1994 $).

This estimated range is based on a

review of literature pertaining to the

value of life.

c. Human Health Benefits from

Reductions in Noncarcinogenic Risk.

Exposure to toxic substances poses risk

of systemic and other effects to humans,

including effects on the circulatory,

respiratory or digestive systems and

neurological and developmental effects.

The proposed rule might generate

human health benefits by reducing

exposure to these substances, thus

reducing the risks of these associated

effects.

As in the case of the cancer risk

assessment, systemic risks from

exposure to air emissions and

consumption of contaminated fish

tissue and drinking water are evaluated.

Modeled pollutant concentration levels

are compared to human health criteria

or estimated toxic effect levels. Based on

this analysis, reductions in air

emissions might result in reduced

systemic risk, with benefits ranging

from reduced risk to zero individuals

(since estimated baseline risks are low)

to reduced risk to 126,000 individuals

due to reduced exposure to two toxic

pollutants. No systemic risk reductions

are expected to result from reduced

exposure to contaminated fish tissue or

drinking water. Sufficient data to

quantify these benefits further are not

available.

d. Ecological and Recreational

Benefits Due to Improved Water Quality.

EPA expects the proposed effluent

guidelines to generate environmental

benefits by improving water quality.

There are a wide range of benefits

associated with the maintenance and

improvement of water quality. These

benefits include use values (e.g.,

recreational fishing), ecological values

(e.g., provision of habitat), and passive

use values. For example, water

pollution might affect the quality of the

fish and wildlife habitat provided by

water resources, thus affecting the

species using these resources. This in

turn might affect the quality of

recreational experiences of users, such

as anglers fishing in the affected

streams. In the RIA, EPA considers the

value of the recreational benefits

resulting from the proposed rule, but

does not evaluate the other types of

ecological and environmental benefits

due to data limitations.

To estimate the benefits from the

improvements in water quality expected

to result from this rule, instream

concentration estimates are modeled

and then compared to EPA’s freshwater

acute and chronic aquatic life criteria to

evaluate whether these discharges pose

risk to aquatic organisms. The projected

reductions in toxic loadings to surface

waters are significant. Pollutant

loadings are estimated to decline by 57

percent, from 39.9 million pounds per

year under current conditions to 17.1

million pounds per year under the

proposed rule. The analysis comparing

instream concentration levels to aquatic

life water quality criteria estimates that

current discharge loadings result in

excursions of aquatic water quality

criteria at two locations. The analysis

also indicates that no excursions are

expected to occur at these two sites

under the proposed rule.

EPA estimates that the annual

recreational benefits associated with the

expected changes in water quality are

on the order of thousands of dollars.

EPA evaluates these recreational

benefits, applying a simple model that

considers the change in consumer

welfare likely to result from improved

catch rates by recreational anglers at

these two sites. EPA assumes that catch

rates improve due to larger fish

populations that are assumed to result

from improved water quality.

e. Benefits from Reductions in

Loadings Discharged to POTWs. The

RIA considers three potential sources of

benefits to POTWs from the proposed

regulation: Reductions in the likelihood

of interference, pass through, and

sewage sludge contamination problems,

reductions in health and safety risks to

POTW workers, and reductions in costs

potentially incurred by POTWs in

analyzing toxic pollutants and

determining whether to, and the

appropriate level at which to, set local

limits. Although the benefits from
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21641

reducing these effects at POTWs might

be substantial, the RIA does not quantify

these benefits due to data limitations.

First, regarding potential interference,

pass through and sewage sludge

contamination problems, the proposed

rule is expected to help reduce these

problems by reducing toxic loadings in

the industry’s effluent and reducing

shock releases. Anecdotal evidence from

POTW responses to an EPA survey and

analytic results indicate that such

effects can occur. In addition, based on

an analysis comparing POTW influent

levels to available data on inhibition

levels, inhibition problems are projected

to occur at six POTWs for seven

pollutants under current conditions.

Inhibition problems are projected to

occur at five POTWs for three pollutants

after the proposed rule. Sufficient data

are not available to further quantify this

benefit category.

Furthermore, toxic substances in

effluent discharges to POTWs pose

health risks to POTW workers. The

proposed rule is expected to reduce

these risks, thus generating human

health benefits. Based on the assessment

of the risk posed to POTW workers from

exposure to toxic pollutants, the

proposed rule is estimated to reduce

occupational risk at six POTWs. Data

are not available to monetize this benefit

category.

Finally, in implementing local

programs to control pollutants

discharged to their systems, authorized

POTWs often must set numerical limits

on toxic loadings in discharges to the

POTW, based on national categorical

pretreatment standards or local limits

determined by the POTW. In setting

these local limits, POTWs sometimes

need to undertake analyses to determine

which pollutants warrant local limits

and at what numerical level.

Conducting these analyses is expensive,

costing on the order of hundreds of

thousands of dollars. Several POTWs

contacted as part of EPA’s survey of

POTWs indicated that they will benefit

from the establishment of national

pretreatment standards by avoiding

these analytical costs. In addition, they

indicated that the pretreatment

standards will bolster the legal authority

of the limits they set. EPA solicits

comments on this issue. See Section

XIV, solicitation number 24.4.

f. Summary of Benefits. EPA estimates

that the annual benefits resulting from

the proposed rule will range from

$231,000 to $7.6 million (1994 $). Table

XI.B.9.f summarizes these benefits by

category. The range reflects the

uncertainty in evaluating the effects of

the proposed rule and in placing a

dollar value on these effects. As

indicated in the table, these benefit

ranges do not reflect many of the benefit

categories expected to result under the

proposed rule, including human health

benefits associated with potential

reductions in chronic effects from ozone

exposure, human health benefits

associated with reductions in acute

effects in attainment areas, agriculturerelated benefits from reductions in

emissions of ozone precursors in

attainment areas, ecological and

recreational benefits from improvements

in water quality, benefits from avoided

interference and pass through problems

and improved worker health and safety

at POTWs, and human health benefits

from potential reductions in systemic

risk. Therefore the reported benefit

estimate understates the total benefits of

the proposed rule.

TABLE XI.B.9.f.—POTENTIAL ECONOMIC BENEFITS FROM THE PROPOSED EFFLUENT GUIDELINES FOR THE

PHARMACEUTICAL INDUSTRY

Benefit category

Thousands of

1994 dollars

per year

Reductions in Emissions of Ozone Precursors:1

Human Health ........................................................................................................................................................................... 31–1,929.

Agricultural ................................................................................................................................................................................ 186–315.

Cancer Risk Reductions ................................................................................................................................................................... 14–5,401.

Non-carcinogenic Risk Reductions .................................................................................................................................................. Unquantified.

Ecological and Recreational Benefits .............................................................................................................................................. Unquantified.

POTW Reductions in Interference and Sludge Inhibition ................................................................................................................ Unquantified.

Total quantifiable benefits ..................................................................................................................................................... 231–7,646.

1The estimates presented only include benefits associated with reductions in acute health effects and improvements in agricultural yields in

nonattainment areas. Potential welfare benefits associated with forest yield, materials damage, and visibility are not addressed in this analysis.

g. Costs to Society. A major

component of social cost (beyond the

cost to industry of compliance) is the

cost to government of providing the tax

deductions on pollution control costs to

industry. In addition, there are other

monetary and nonmonetary outlays

made by government. Government

administrative costs and costs of

reallocating displaced workers are two

additional monetary costs.

Nonmonetary costs include losses in

consumers’ or producers’ surpluses in

product markets, discomfort or

inconvenience, loss of time, and

slowing the rate of innovation. The

social costs estimated here, which

include compliance costs to industry

and the costs of government tax

subsidies, therefore, are a very large

portion of, but not the true total social

cost of the proposed regulation. The

costs reported here are thus only a close

estimate of this true cost.

The estimate of total annual social

costs for all selected options is shown

in Table XI.B.9.g. Total social costs

resulting from the proposed effluent

guideline are estimated to be $123.9

million (1994 $).

TABLE XI.B.9.g.—SOCIAL COSTS FOR SELECTED REGULATORY OPTIONS

[Millions of 1994 dollars]

Option No. Total capital

costs

Total O&M

costs

Total

annualized

costs 1

BAT–A/C#2 ................................................................................................................................... 64.5 40.8 47.6

BAT–B/D#1 ................................................................................................................................... 0.7 1.3 1.3
21642 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

TABLE XI.B.9.g.—SOCIAL COSTS FOR SELECTED REGULATORY OPTIONS—Continued

[Millions of 1994 dollars]

Option No. Total capital

costs

Total O&M

costs

Total

annualized

costs 1

PSES–A/C#1 ................................................................................................................................ 80.9 53.1 61.6

PSES–B/D#1 ................................................................................................................................ 28.8 10.2 13.3

Total 2 .................................................................................................................................... 174.9 105.4 123.9

Footnotes:

1The total annualized costs of compliance are calculated prior to accounting for the tax deductibility of the pollution control costs.

2Total number of facilities includes seven non-discharging facilities.

Note: These numbers are for all facilities and do not reflect closures predicted by the analyses in this report.

h. Benefit-Cost Comparison. Because

not all of the benefits resulting from the

regulatory alternative can be valued in

terms of dollars, a complete cost-benefit

comparison cannot be performed. The

social cost of the alternatives considered

in the proposed rule, discussed in the

preceding section is estimated to be

$123.9 million (1994 $). The sum of

total benefits that can be valued in

dollar terms ranges from $0.2 to $7.6

million per year (1994 $) (see Table

XI.B.9.h).

TABLE XI.B.9.h.—COMPARISON OF ANNUAL BENEFITS AND COSTS FOR THE PHARMACEUTICAL RULEMAKING

[Thousands of 1994 dollars]

Benefits

Cancer risk reductions ......................................................................................................................................................................... 14–5,401

Reductions in emissions of ozone precursors .................................................................................................................................... 31–1,929

Human health ...................................................................................................................................................................................... 186–315

Agricultural benefits ............................................................................................................................................................................. .......................

Total quantifiable benefits ............................................................................................................................................................ 231–7,646

Costs

Total Annual Costs to Industry ............................................................................................................................................................ 80,000

Total Annual Social Costs ................................................................................................................................................................... 123,900

XII. Relationship of Proposed Effluent

Guidelines to EPA’s Hazardous Waste

Initiatives

A. Relationship to Rulemaking

Activities Under RCRA

1. Introduction and Overview of Land

Ban Regulations

EPA’s Office of Solid Waste Phase 3

proposed land disposal restriction

regulations under the Resource

Conservation and Recovery Act (RCRA)

for certain hazardous wastes streams

common to the pharmaceutical

manufacturing industry on February 16,

1995. These regulations will be codified

at 40 CFR Part 268 after they are

finalized (scheduled for January 1996).

The proposed RCRA regulations

signed on February 16, 1995 cover

decharacterized ignitable (I), corrosive

(C), reactive (R) and toxic (TC) wastes

(i.e., wastes that initially exhibit a

characteristic but, as a result of dilution,

no longer do so when they are land

disposed) that are managed in surface

impoundments whose ultimate

discharge is regulated under the Clean

Water Act. These regulations also

potentially apply to decharacterized

wastes disposed in Class I

nonhazardous deep injection wells

regulated under the Safe Drinking Water

Act’s Underground Injection Control

program. The definitions of these waste

streams are listed in Table XII.A. The

September 1992 Third decision in

Chemical Waste Management v. EPA,

976 F.2d 2 (D.C. Cir. 1992) requires EPA

to assure that decharacterized wastes

disposed in surface impoundments are

treated to the same extent they would be

if disposed in surface disposal units.

However, the opinion specifically

allows this showing of equivalent

treatment to be measured at the eventual

discharge point, so that treatment

occurring in the wastewater treatment

system (including the surface

impoundment) can be taken into

account.

2. The Land Disposal Restrictions

Program

a. Introduction to RCRA Land

Disposal Restrictions. The Hazardous

and Solid Waste Amendments (HSWA)

to RCRA, enacted on November 8, 1984,

largely prohibit the land disposal of

untreated hazardous wastes. Once a

hazardous waste is prohibited from land

disposal, the statute provides only two

options for legal land disposal: Meet the

treatment standard for the waste prior to

land disposal, or dispose of the waste in

a land disposal unit that has been found

to satisfy the statutory no migration test.

A no migration unit is one from which

there will be no migration of hazardous

constituents for as long as the waste

remains hazardous. RCRA sections 3004

(d),(e),(g)(5).

The treatment standards may be

expressed as either constituent

concentration levels or as specific

methods of treatment. These standards

must substantially diminish the toxicity

of the waste or substantially reduce the

likelihood of migration of hazardous

constituents from the waste so that

short-term and long-term threats to

human health and the environment are

minimized. RCRA section 3004(m)(1).

For purposes of the restrictions, the

RCRA program defines land disposal to

include any placement of hazardous

waste in a landfill, surface

impoundment, waste pile, injection

well, land treatment facility, salt dome

formation, salt bed formation, or

underground mine or cave. Discharge of

wastewater streams containing

hazardous wastes to surface

impoundments is considered temporary

land disposal. RCRA section 3004(k).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21643

EPA has implemented these

requirements by requiring treatment

standards for hazardous wastes to be

based on performance of Best

Demonstrated Available Technology

(BDAT).

b. Regulation of Characteristic

Wastes. On May 8, 1990, EPA

promulgated land disposal prohibitions

and treatment standards for hazardous

wastes that exhibited one or more of the

following characteristics: ignitability,

corrosivity, reactivity, or EP toxicity (40

CFR 261.21–261.24). These regulations

established treatment standards for the

characteristic wastes in one of four

forms: (1) A concentration level equal

to, or greater than, the characteristic

level; (2) a concentration level less than

the characteristic level; (3) a specified

treatment technology (e.g., for ignitable

wastes containing high levels of total

organic carbon); and (4) a treatment

standard of ‘‘deactivation’’ which

allowed the use of any technology,

including dilution, to remove the

characteristic.

Such treatment frequently occurs in

centralized wastewater management

systems subject to regulation under the

Clean Water Act or Safe Drinking Water

Act. Furthermore, the deactivation can

occur as a result of mixing wastewaters

together (for example, to equalize

wastewater flow into a centralized

wastewater management unit). This

mixing, however, is a type of dilution,

and dilution is normally an

impermissible means of achieving a

land disposal regulation (LDR)

treatment standard. EPA addressed at

length the question of whether dilution

incidental to such centralized

wastewater management should be

allowed. See generally 55 FR 22653–59

(June 1, 1990). The Agency found,

generally, that mixing waste streams to

eliminate certain characteristics was

appropriate and permissible for

corrosive wastewaters and, in some

cases, reactive or ignitable wastewaters.

Furthermore, EPA stated that the

dilution prohibition did not normally

apply to characteristic wastewaters that

are managed in treatment trains,

including surface impoundments,

whose ultimate discharge is regulated

under the pretreatment and NPDES

programs under sections 307(b) and 402

of the CWA, or in Class I underground

injection well systems regulated under

the Safe Drinking Water Act (SDWA).

The Agency stated that the treatment

requirements and associated dilution

rules under the CWA are generally

consistent with the dilution rules under

RCRA, and that the Agency should rely

on the existing CWA provisions. The

Agency also singled out certain

particularly toxic wastewaters to which

the dilution prohibition still applies

notwithstanding management in CWA

systems. 40 CFR 268.3(b). Similarly,

EPA stated that a regulatory program

had been established under the SDWA

to prevent underground injection that

endangers drinking water sources.

c. The Third Third Court Decision.

On September 25, 1992, the United

States Court of Appeals for the District

of Columbia Circuit ruled on the various

petitions for review filed against the

1990 land disposal rule, also known as

the Third Third rule. See Chemical

Waste Management v. EPA, 976 F.2d 2,

cert. denied, 113 S.Ct. 1961 (1993). The

court issued three principal holdings of

the case with respect to characteristic

wastes. First, EPA may require

treatment under RCRA section 3004(m)

to more stringent levels than those at

which wastes are identified as

hazardous, Id. at 12–14. Second, section

3004(m) requires that treatment

standards address both short-term and

long-term potential harms posed by

hazardous wastes, and consequently

must result in destruction and removal

of hazardous constituents as well as

removal of the characteristic property,

Id. at 16, 17, 23. As a consequence,

dilution without destruction or removal

of hazardous constituents is permissible

as an exclusive method of treatment

only for those characteristic wastes that

do not contain hazardous constituents

‘‘in sufficient concentrations to pose a

threat to human health or the

environment’’ (i.e., the minimize threat

level in section 3004(m)). Id. at 16.

Third, situations where characteristic

hazardous wastes are diluted, lose their

characteristic(s) and are then managed

in centralized wastewater management

land disposal units (i.e., subtitle D

surface impoundments or Class I

nonhazardous injection wells) are legal

only if it can be demonstrated that

hazardous constituents are removed or

destroyed to the same extent they would

be pursuant to otherwise-applicable

RCRA treatment standards. Id. at 7.

As a consequence of these holdings,

the court held that the deactivation

standard for ignitable and corrosive

wastes did not fully comply with RCRA

section 3004(m). This was because that

standard could be achieved by dilution,

and dilution fails to destroy or remove

the underlying hazardous constituents

that can be present in the wastes. Id.

3. Phase 3 and the Pharmaceutical

Effluent Guidelines

The RCRA regulations EPA proposed

on February 16, 1995 are known as the

Phase 3 rule. In response to the D.C.

Circuit court decision requiring

treatment beyond decharacterization or

dilution for ignitable, corrosive, reactive

and characteristically toxic wastes, the

proposed rule addresses underlying

hazardous constituents of these wastes.

EPA believes that the practices of

disposal of spent solvents used

extensively in pharmaceutical processes

for cleaning out batch units result in the

discharge of significant amounts of

characteristically ignitable (D001)

hazardous waste. Many of these streams

are disposed in surface impoundments

and will be covered by the Phase 3

proposal.

The Phase 3 rule sets out EPA’s

general approach to have the RCRA

standards be the same as BAT under the

CWA. This is because the BAT

standards reflect an industry-specific

evaluation of best treatment for that

industry’s wastewater. Thus, the RCRA

technology-based standards will

typically match those of the Clean Water

Act. This approach works well for the

pharmaceutical manufacturing industry

because the Clean Water Act rule

effluent limitations guidelines and

standards are being revised

contemporaneously with the Phase 3

LDR rules, and thus reflect current BAT.

TABLE XII.A.—IGNITABLE/CORROSIVE/REACTIVE/TOXICITY CHARACTERISTIC WASTES D001, D002, D003 AND D004–32

D001 .......................................................................................................... IGNITABLE.

D001 ................................................................................................... Liquid—flash point<60 C—High TOC—261.21(a)(1).

D001 ................................................................................................... Liquid—flash point<60 C—Low TOC—261.21(a)(1).

D001 ................................................................................................... Nonliquid—burns vigorously/persistently—261.21(a)(2).

D001 ................................................................................................... Ignitable compressed gas—49 CFR 173.300—261.21(a)(3).

D001 ................................................................................................... Oxidizer—49 CFR 173.151—261.21(a)(4).

D002 .......................................................................................................... CORROSIVE.

D002 ................................................................................................... pH<2—261.22(a)(1).

D002 ................................................................................................... pH>10—261.22(a)(1).
21644 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

TABLE XII.A.—IGNITABLE/CORROSIVE/REACTIVE/TOXICITY CHARACTERISTIC WASTES D001, D002, D003 AND D004–32—

Continued

D002 ................................................................................................... Corrodes steel—261.22(a)(2).

D003 .......................................................................................................... REACTIVE.

D003 ................................................................................................... Violent change without detonating—261.23(a)(1).

D003 ................................................................................................... Violent reaction with water—261.23(a)(2).

D003 ................................................................................................... Generates toxic gases—261.23(a)(3).

D003 ................................................................................................... Contains CN or S—261.23(a)(4).

D003 ................................................................................................... Capable of detonating under stress—261.23(a)(5).

D003 ................................................................................................... Capable of detonating spontaneously—261.23(a)(6).

D003 ................................................................................................... Forbidden, Class A or Class B explosive—261.23(a)(7).

D004–D043 ............................................................................................... TOXICITY CHARACTERISTIC (TC) WASTES.

D004 ................................................................................................... Arsenic.

D005 ................................................................................................... Barium.

D006 ................................................................................................... Cadmium.

D007 ................................................................................................... Chromium.

D008 ................................................................................................... Lead.

D009 ................................................................................................... Mercury.

D010 ................................................................................................... Selenium.

D011 ................................................................................................... Silver.

D012 ................................................................................................... Endrin.

D013 ................................................................................................... Lindane.

D014 ................................................................................................... Methoxychlor.

D015 ................................................................................................... Toxaphene.

D016 ................................................................................................... 2,4-D.

D017 ................................................................................................... Silvex.

D018 ................................................................................................... Benzene.

D019 ................................................................................................... Carbon tetrachloride.

D020 ................................................................................................... Chlordane.

D021 ................................................................................................... Chlorobenzene.

D022 ................................................................................................... Chloroform.

D023 ................................................................................................... o-Cresol.

D024 ................................................................................................... m-Cresol.

D025 ................................................................................................... p-Cresol.

D026 ................................................................................................... Cresol.

D027 ................................................................................................... 1,4-Dichlorobenzene.

D028 ................................................................................................... 1,2-Dichloroethylene.

D029 ................................................................................................... 1,1-Dichloroethylene.

D030 ................................................................................................... 2,4-Dinitrotoluene.

D031 ................................................................................................... Heptachlor and epoxide.

D032 ................................................................................................... Hexachlorobenzene.

D033 ................................................................................................... Hexachlorobutadiene.

D034 ................................................................................................... Hexachloroethane.

D035 ................................................................................................... Methyl ethyl ketone.

D036 ................................................................................................... Nitrobenzene.

D037 ................................................................................................... Pentachlorophenol.

D038 ................................................................................................... Pyridine.

D039 ................................................................................................... Tetrachloroethylene.

D040 ................................................................................................... Trichloroethylene.

D041 ................................................................................................... 2,4,5-Trichlorophenol.

D042 ................................................................................................... 2,4,6-Trichlorophenol.

D043 ................................................................................................... Vinyl chloride.

B. Coordination With Waste

Minimization and Combustion Strategy

In May 1994, the Administrator

announced a Draft Hazardous Waste

Minimization and Combustion Strategy

that is pertinent to this rulemaking for

the pharmaceutical manufacturing

industry. The Draft Strategy provides

the central framework for EPA’s federal

effort to maximize the source reduction

and recycling of hazardous wastes

under RCRA. The Draft Strategy focuses

on a number of specific goals, including

reducing the amount and toxicity of

hazardous waste that is generated,

particularly when such reductions

would benefit more than one

environmental medium. The Draft

Strategy also encompasses a number of

other features, including public

outreach, public involvement and

environmental justice, permitting,

enforcement, risk assessments, and good

science.

1. Waste Minimization

The Draft Strategy has both short-term

and a longer-term phases. In the shortterm, EPA will address the source

reduction and environmentally sound

recycling of halogenated (and metalbearing) combustible wastes. The

longer-term effort will encompass all

RCRA hazardous wastes, taking a more

comprehensive approach to how wastes

are generated and managed, and the role

waste minimization can play as a

preferred ‘‘mode of management’’ over

other forms of waste management (e.g.,

treatment, storage, and disposal). This

source reduction (waste minimization)

strategy should reduce the long-term

demand for combustion and other waste

management facilities. Section VI of this

preamble presents EPA’s efforts toward

increasing opportunities for source

reduction (e.g., process changes) in the

pharmaceutical manufacturing industry.

The Agency also has released a draft

report by the EPA Office of Solid

Waste’s Definition of Solid Waste Task
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21645

Force. This report, Reengineering RCRA

for Recycling, presents

recommendations of the Task Force to

improve the regulation of hazardous

waste recycling under RCRA. One of the

recommendations of the Task Force was

that provision should be made to

exempt ‘‘clean’’ waste-derived fuels

from the regulatory requirements of

RCRA for hazardous wastes. ‘‘Clean

fuels’’ are fuels with ‘‘de minimis’’

levels of halogens (primarily chlorine in

this case) or toxic metals, especially

fuels that are characteristically

hazardous only because of ignitability.

EPA has initiated a rulemaking effort to

address the recommendations of the

Task Force, including the

recommendation on ‘‘clean fuels.’’

In the case of the pharmaceutical

manufacturing industry, the volatile

organic pollutants that are generated in

the largest quantities are nonhalogenated volatile organic pollutants,

including methanol, ethanol,

isopropanol, and acetone.

Implementation of in-plant steam

stripping or steam stripping with

distillation technology affords the

opportunity to recover these potentially

‘‘clean fuels’’ for recycle in industrial

boilers, such as those on-site at

pharmaceutical manufacturing facilities.

Implementation of in-plant steam

stripping or steam stripping with

distillation technology also affords the

opportunity to recover halogenated

volatile organic pollutants (e.g.,

methylene chloride) for recycle in the

pharmaceutical manufacturing process.

Recovered chlorinated solvents that are

not of sufficient quality for reuse in

pharmaceutical manufacturing

processes may be sold for reuse in other

industries.

2. Combustion

The Draft Strategy also addresses

rigorous controls on hazardous waste

combustion facilities using best

available technologies to ensure that

these facilities do not impose

unacceptable risk to human health and

the environment. EPA’s regulatory

activities are scheduled to be directed

toward upgrading technical standards

for residual wastes and emissions from

hazardous waste combustion facilities,

including incinerators, cement kilns,

light-weight aggregate kilns, and smelter

furnaces, as well as boilers and

industrial furnaces.

EPA estimates that approximately

115,000 metric tons per year of solvents

(halogenated and nonhalogenated)

would be recovered from in-plant steam

stripping technology at pharmaceutical

manufacturing facilities. There is

currently adequate capacity at

commercial incinerators to combust the

entire mass of solvents (in excess of 1

million metric tons per year) if none

was recovered and recycled. However, it

is the Agency’s policy, as stated in the

Draft Waste Minimization and

Combustion Strategy, that the most

appropriate mode of management for

solvents removed from pharmaceutical

manufacturing wastewaters by steam

stripping is recycle of ‘‘clean fuels’’ in

boilers, recycle in the process, or recycle

at other facilities.

XIII. Administrative Requirements

A. Changes In Format and Name

EPA is not proposing any changes in

format to part 439 of the Code of Federal

Regulations.

B. Docket and Public Record

The Record for this rulemaking is

available for public review at EPA

Headquarters, 401 M Street SW,

Washington, DC 20460. The Record

supporting the effluent limitations

guidelines in part 439 is located in the

Office of Water Docket, Room L102 (in

the basement of Waterside Mall). The

Docket is staffed by an EPA contractor,

Labat-Anderson, Inc., and interested

parties are encouraged to call for an

appointment. The telephone number for

the Water Docket is (202) 260–3027.

EPA notes that many documents in

the record supporting these proposed

rules have been claimed as confidential

business information and, therefore, are

not included in the record that is

available to the public in the Water

Docket. To support the rulemaking, EPA

is presenting certain information in

aggregated form or is masking plant

identities to preserve confidentiality

claims. Further, the Agency has

withheld from disclosure some data not

claimed as confidential business

information because release of this

information could indirectly reveal

information claimed to be confidential.

C. Clean Water Act Procedural

Requirements

As required by the Clean Water Act,

EPA will conduct a public hearing on

the pretreatment standards portion of

the proposed rule. The location and

time of this public hearing will be

announced in a future notice.

D. Executive Order 12866

Under Executive Order 12866, (58 FR

51735 (October 4, 1993)) requires EPA

and other agencies to assess the

potential costs and benefits of all

significant regulatory actions, and

submit these actions to the Office of

Management and Budget (OMB).

Significant regulatory actions are those

that impose a cost on the economy of

$100 million or more annually or have

certain other regulatory, policy, or

economic impacts. Today’s rule meets

the criteria of a significant regulatory

action as set forth in section 3(f) of the

Executive Order. The regulatory

analysis for this proposed rule is

presented in ‘‘Regulatory Impact

Assessment of Proposed Effluent

Guidelines for the Pharmaceutical

Industry.’’ This analysis (referred to as

the RIA) is summarized in section XI.B.

Today’s proposed rule and the RIA were

submitted to the OMB for review.

E. Regulatory Flexibility Act

The Regulatory Flexibility Act, 5

U.S.C. 601 et. seq., requires EPA and

other agencies to prepare an initial

regulatory flexibility analysis for

regulations that have a significant

impact on a substantial number of small

entities. EPA projects that today’s

proposed rule, if promulgated, could

affect small businesses. The initial

regulatory flexibility analysis for these

proposed rules is incorporated into the

economic impact analysis and is

discussed in section XI.B. Reporting and

other compliance requirements are

summarized in sections IX.I and

detailed in the TDD. While the Agency

has not identified any duplicative,

overlapping, or conflicting Federal

rules, a discussion of other related

rulemakings is presented in sections

V.B, V.C, V.D, X.A, X.B, XII.A, and

XII.B.

F. Reduction of Unfunded Mandates

and Consultation with State, Local, and

Tribal Governments

Executive Order No. 12875

supplements Executive Order No. 12866

[Sec. 1(b)(9)], and is intended ‘‘to reduce

the imposition of unfunded mandates

upon State, local, and tribal

governments.’’ Facilities in the

pharmaceutical manufacturing industry

are not associated with tribal

governments, and the burden to states

and local authorities is expected to be

minimal, if not decreased, by the

implementation of this rule.

These proposed requirements, when

promulgated, will be implemented via

the existing regulatory structure and no

additional burden is expected beyond

that previously estimated by EPA for the

NPDES and general pretreatment

programs. In the absence of effluent

limitations guidelines and pretreatment

standards, establishing BAT, BCT,

NSPS, PSES, and PSNS permit

limitations are to be developed on a

case-by-case ‘‘Best Professional

Judgment’’ (BPJ) basis. In addition,

NPDES permits for all direct dischargers
21646 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

and POTWs must incorporate state

water quality standards where

necessary. Once these revised

pharmaceutical effluent guidelines and

standards are in place, regulatory

burdens on the states and local POTWs

in developing pollutant control

requirements that heretofore have not

been addressed for this industry,

particularly for volatile organic

pollutants and other wastewater

discharge characteristics, will be

reduced. For example, the Agency is

aware that certain POTWs have

expended considerable resources for

outside contractors (e.g., engineering

consultants) to secure technical support

in developing the basis for local limits

or other special requirements, for POTW

maintenance and equipment

replacement, and for special treatment

systems. These requirements were

needed to prevent pollutant pass

through, interference, or sludge

contamination attributable to

pharmaceutical facility discharges.

In compliance with E.O. 12875, EPA

has involved state and local

governments in the process of

developing this rule. Since the

inception of the project in 1986, there

have been periodic meetings with the

industry and its trade association, the

Pharmaceutical Research and

Manufacturers of America (PhRMA), to

discuss progress on the rulemaking. The

Agency also has met with the Natural

Resources Defense Council (NRDC) to

discuss progress on this rulemaking.

Because most of the facilities affected by

this proposal are indirect dischargers,

the Agency conducted an outreach

survey to a limited number of POTWs

substantially affected by one or more

pharmaceutical manufacturing facilities

to solicit their input on the need for this

proposed rule and pertinent technical

issues. The Agency has worked with the

Food and Drug Administration (FDA) to

explore pollution prevention

opportunities to the maximum extent

feasible. As described previously in this

preamble, EPA shared with FDA

information and data gathered from the

industry in responses to EPA’s detailed

Section 308 questionnaire. This was

done to assist FDA in evaluating the

environmental impacts of revised drug

manufacturing processes (as described

in ‘‘supplement’’ applications) and of

new drug manufacturing processes.

These reviews will ensure that

opportunities for solvent use

minimization/elimination and waterbased manufacturing processes (e.g.,

water-based tablet coating) are

considered and adopted within the

constraints of maintaining the efficacy

of both existing and new

pharmaceutical products.

The Agency also held a public

meeting on May 23, 1994. EPA

representatives of the Office of Water

and the Office of Air and Radiation

outlined the underlying technical basis

and options being considered for this

proposal, the efforts to coordinate the

future air rule and this proposed water

rule, and took comments and questions

from the audience. The Agency also

consulted with representatives of

selected POTWs regarding underlying

technical aspects of this proposal.

The Agency will continue this process

of consulting with state, local, and other

affected parties after proposal in order

to further minimize the potential for

unfunded mandates that may result

from this rule.

G. Paperwork Reduction Act

The proposed effluent guidelines and

standards for the pharmaceutical

manufacturing industry contain no

information collection activities beyond

those required for the NPDES permit

program and the general pretreatment

program. Therefore, an information

collection request (ICR) has not been

submitted to the Office of Management

and Budget (OMB) for review and

approval under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq.

OMB has approved the existing

information collection requirements

associated with NPDES discharge

permit applications and the general

pretreatment program under the

provisions of the Paperwork Reduction

Act.

The collection of information required

for NPDES discharge permit

applications has an estimated reporting

burden averaging 12 hours per response

and an estimated annual recordkeeping

burden averaging two hours per

respondent. These estimates include

time for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information.

XIV. Solicitation of Data and Comments

A. Introduction and General Solicitation

EPA invites and encourages public

participation in this rulemaking. The

Agency asks that comments address any

perceived deficiencies in the record of

this proposal and that suggested

revisions or corrections be supported by

data.

The Agency invites all parties to

coordinate their data collection

activities with EPA to facilitate

mutually beneficial and cost-effective

data submissions. EPA is interested in

participating in study plans, data

collection and documentation. Please

refer to the ‘‘For Further Information’’

section at the beginning of this preamble

for technical contacts at EPA.

When responding to these comment

solicitations, please identify for each

comment or data submission the

comment solicitation number or

numbers that the comment or data

submission addresses. Commenters

should also submit an electronic version

on diskette if possible.

B. Specific Data and Comment

Solicitations

EPA has solicited comments and data

on many individual topics throughout

this preamble. The Agency incorporates

each of these solicitations here, and

reiterates its interest in receiving data

and comments on the issues addressed

by those solicitations. EPA particularly

requests comments and data on the

following issues:

1.0 General

1.1 Comments on Options and

Technologies Evaluated

The Agency solicits comments on all

of the technologies and technology

options identified in today’s proposal.

1.2 Comments on Options/

Technologies Selected for Proposal

The Agency solicits comments on the

options and technologies and

compliance monitoring points selected

for proposal today, and the technical,

policy, and legal bases expressed by

EPA in support of such selections.

1.3 Comments on Proposed Effluent

Limitations and Standards

The Agency solicits comments on the

effluent limitations and standards

proposed today.

1.4 Comments on the Methodology

Used to Develop Steam Stripper- and

Steam Stripper With Distillation-Based

Limitations and Standards

The Agency solicits comment

regarding its methodology for

developing the proposed limitations and

standards based on available steam

stripper and steam stripper/distillation

performance data.

2.0 Adequacy of the 308

Questionnaire Database

The Agency has collected a significant

amount of technical and economic data

from pharmaceutical manufacturing

facilities. Nonetheless, the Agency is

open to suggestions regarding any

additional data collections that may be
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21647

required. The Agency also solicits

information, comments, and data on the

following technical areas:

a. Data characterizing in-facility

process wastewater streams bearing

pollutants proposed to be regulated,

including ammonia concentration in the

wastewater stream, stream pH, stream

TDS and TSS, and information on the

ionic species in the stream.

b. Information on new steam strippers

installed since 1990 for the treatment of

pharmaceutical process wastewater.

c. Information on the storage capacity

used by facilities prior to steam

stripping.

d. Information on steam generation

and cost, including how much steam is

generated on-site and at what cost, how

much steam is purchased from off-site

sources and at what cost, steam

condition, and steam pressure used by

the facility.

e. Information on scaling in steam

strippers including information

concerning the issues, problems, and

solutions to scaling.

f. Information on the operation and

maintenance costs for running steam

strippers at pharmaceutical

manufacturing facilities.

3.0 Basis for Pollutant Loading

Estimates

EPA requests information from plants

that completed Table 3–2 of the ‘‘1990

Pharmaceutical Manufacturing Survey’’

but did not indicate a technical basis for

their loadings estimates (i.e., air

emissions from wastewater, discharges

to surface waters/sewers etc.). The

Agency requests that facilities specify

the method and underlying assumptions

used in making air emission and water

discharge estimates for individual

pollutants, the loading estimate values

either estimated or measured, and the

uncertainty associated with the method

used to estimate these quantities.

4.0 Subcategorization

EPA is proposing to maintain the

existing subcategorization scheme. The

rationale for maintaining this scheme is

discussed in Section IX.A.3 of this

preamble.

4.1 Comments on Maintaining the

Existing Subcategorization Scheme

EPA solicits comments regarding the

decision to maintain the existing

scheme.

4.2 Alternative Regulatory Schemes

The Agency also solicits suggestions

for alternative regulatory schemes.

5.0 Definition of Research Operations

5.1 Definition

Research operations are defined and

discussed in section IX.A.4 of this

preamble. EPA solicits comments

regarding the definition of research

operations for the pharmaceutical

manufacturing category.

5.2 Research Operation Wastewater in

Combination With Other Subcategory

Wastewater

EPA solicits comment on whether

wastewaters generated from bench-scale

pharmaceutical research operations at

facilities with other pharmaceutical

subcategory wastewaters (A, B, C, D)

should be subject to the proposed

subcategory A, B, C, and/or D standards

and limitations rather than the existing

BPT limitations for subcategory E.

6.0 Characterization of Individual

Process Wastewater Streams

The Agency anticipates that at most

facilities, a greater mass of volatile

organic pollutants will be concentrated

in specific wastewater streams rather

than being evenly distributed in all

wastewater streams. Nonetheless, EPA

has assumed for purposes of this

proposal that wastewater streams with

volatile organic pollutants at

concentrations above the distillation

treatability target concentrations would

require steam stripping. Because of a

lack of detailed and consistent flow and

pollutant characterization data in the

plant responses to the section 308

questionnaire, EPA assumed, when

estimating costs associated with the

steam stripping and steam stripping

with distillation options, that facilities

would be treating all or most of the

process wastewater generated by their

individual plants. EPA believes that this

is not a realistic assumption and that the

costs developed for in-plant steam

stripping and steam stripping with

distillation are substantially overstated.

As a practical matter, EPA anticipates

that plants will attempt to segregate and

treat the most concentrated volatile

pollutant-bearing wastewater streams

from those not requiring treatment, thus

reducing the amount of wastewater that

will be treated. Since amount of flow

entering a steam stripper or steam

stripper with distillation unit is a

significant cost component in the design

of these units (i.e., the greater the flow

the greater the cost), reductions in input

flows should result in significant cost

reductions.

6.1 Data on Flow and Organic

Pollutant Distribution

In order to obtain better estimates of

the volume and pollutant

characterization of wastewaters

requiring treatment, EPA solicits data

from plants in the industry on the

distribution of volatile organic

pollutants in process wastewater

streams. These data should specify: (1)

The number and measured or estimated

volume of individual process

wastewater streams; (2) the types of

organics in these waste streams and the

ranges of organic pollutant

concentrations either measured or

estimated in these streams (e.g., <1

mg/l, 1–10 mg/l, 10–100 mg/l, 100–

1,000 mg/l, >1,000 mg/l); and (3) the ten

organic pollutants found or expected to

be found in these streams in the highest

concentrations. In any cases where these

data are estimates, the underlying

assumptions for these estimates will

need to be specified. In cases where

plants undertake to generate data from

process wastewater flow measurements

and pollutant analyses, the

measurement and analytical methods

used to generate these data also will

need to be specified. The Agency

strongly suggests that any such plants

which choose to generate these data

should contact EPA staff (please refer to

the FOR FURTHER INFORMATION section of

this preamble) for guidance on details of

the scope and methods of data

collection and supporting

documentation.

6.2 Wastewater Stream Segregation

EPA anticipates that plants would

segregate volatile bearing wastewater

from non-volatile bearing wastewater.

EPA solicits comments supported by

data concerning whether stream

segregation of volatile bearing streams

from non-volatile bearing streams is

feasible and/or practical.

7.0 BAT Limitations for Direct

Discharging Facilities With Subcategory

B and D Operations Based on Steam

Stripping or Steam Stripping With

Distillation

In section IX.E.3.c(2) of this preamble,

EPA speculated that pollutant loading

data from years other than 1990 may

indicate that in-plant steam stripping

technology or in-plant steam stripping

with distillation technology is an

appropriate basis for BAT regulations

for facilities with subcategory B and/or

D operations. Accordingly, EPA solicits

volatile pollutant loading data from

direct discharging facilities with

subcategory B and D operations for
21648 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

years other than 1990 (i.e., 1991–1994,

or any later period if available).

7.1 Feasibility and Appropriateness of

Such Limits

EPA also solicits comment concerning

the feasibility and appropriateness of

setting BAT limitations on volatile

organic pollutants for facilities with

subcategory B and/or D operations

based on steam stripping or steam

stripping with distillation.

7.2 Point of Regulation for BAT

Limitations and NSPS Standards Based

on In-Plant Technologies

EPA also solicits comment on the

point of regulation for any BAT

limitations and NSPS standards based

on in-plant technologies.

7.3 Limitations if Facilities Change

Their Mode of Discharge

EPA also solicits comment on the

issue of whether it should promulgate

separate BAT limitations, based on inplant technologies, for facilities with

subcategory B and/or D operations that

change their mode of discharge from

indirect to direct (in view of EPA’s

proposal today to base PSES on steam

stripping for these subcategories).

8.0 Definition of Process Wastewater

The Agency is proposing a definition

of process wastewater for the effluent

limitations guidelines regulation set out

at 40 CFR section 122.2. The definition

specifically includes any water which,

during manufacturing or processing,

comes into direct contact with or results

from the production or use of any raw

material, intermediate product, finished

product, by-product, or waste product.

The types of wastewaters considered to

be process wastewater are set out in the

proposed regulation at § 439.01(m), and

discussed in detail in section 5 of the

TDD. EPA solicits comment on the

wastewaters being defined as process

wastewater.

9.0 Prohibited Discharges

The Agency is proposing to prohibit

the discharge of certain materials to

POTWs or waters of the United States

without an NPDES permit or individual

control mechanism authorizing such

discharge. See proposed regulation at

§§ 439.10, 439.20, 439.30 and 439.40. A

list of these materials is set forth at

§ 439.01(m)(1) of the proposed

regulation. The Agency believes that

discharge and loss of these materials is

inappropriate from the standpoint of

productivity loss, pollution prevention,

adverse impacts on wastewater

treatment (i.e., in POTWs) and worker

safety and health.

9.1 List of Prohibited Materials

EPA solicits comment on the specific

proposed list of materials prohibited for

discharge. EPA is separately soliciting

comment on whether BMPs are

appropriate for application to control

the discharge of these materials through

leaks, spills, and intentional diversions

(see solicitation number 31 in this

section of the preamble).

9.2 Non-Process Wastewaters

EPA solicits comment on the

following waters and wastewaters

proposed to be excluded from the

definition of process wastewater:

noncontact cooling water, utility

wastewaters, general site surface runoff,

groundwater (e.g., contaminated

groundwaters from on-site or off-site

groundwater remediation projects), and

other nonprocess water generated on

site. EPA also solicits comment on the

proposal that the discharge of such

waters and wastewaters be regulated

separately.

9.3 Costs of Complying With the

Prohibitions

EPA solicits comment on the potential

costs of complying with the proposed

prohibition of the discharge of materials

used in or generated by pharmaceutical

manufacturing processes.

10.0 TOC Limits as Alternative to

COD Limits

EPA is aware of suggestions that, in

some instances, the TOC (Total Organic

Carbon) test may be an appropriate

substitute for the COD test and that,

therefore, TOC limits should be

promulgated instead of or as an

alternative to COD limits. Industrial

commenters on analytical methods have

indicated that the approved method for

determining COD in wastewater does

not completely correct for abnormally

high chloride (a direct interferant)

concentrations found in some

wastewaters.

EPA solicits all influent and effluent

TOC and COD concentration data points

that are descriptive of the same

wastewater stream but the Agency is

especially interested in those

concentration data that are descriptive

of wastewaters with high chloride

concentrations.

11.0 Wastewaters From Bioengineered

Materials

The Agency recognizes that there has

been considerable development of

bioengineered materials that may be

incorporated in pharmaceutical

products. The Agency is concerned

about the release of these bioengineered

materials in pharmaceutical

wastewaters. EPA solicits comment and

data that characterize wastewater from

the development of bioengineered

materials.

12.0 Source Reduction Activities

The Agency solicits information and

data on any efforts (ongoing or planned)

concerning source reduction activities at

pharmaceutical manufacturing facilities,

as discussed in Section IX of this

preamble.

12.1 Pollution Prevention and

Combustion Strategy

EPA solicits comments on the waste

minimization and combustion strategy

discussed in Section XII.B of this

preamble as it may be applied in this

industry. See also solicitation number

22 below.

13.0 Water-Based Tablet Coating

Processes

EPA is aware that certain facilities

engaging in subcategory D operations

(compounding/mixing/formulating)

have opportunities to make process

changes that can result in lower

wastewater discharges and air emissions

of volatile pollutants. Specifically,

facilities may utilize an aqueous-based

tablet coating process as opposed to a

volatile organic solvent-based tablet

coating process. EPA realizes that this

substitution is not feasible for all

coating processes. Nonetheless, EPA

solicits data from plants in the industry

on any changes or substitutions made to

solvent-based tablet coating processes.

14.0 Concentration Versus Percent

Reduction and Mass-Based Limitations

The Agency today is proposing

concentration-based effluent limitations

and standards as the most appropriate

basis for controlling the discharge of

conventional, priority, and

nonconventional pollutants from the

pharmaceutical manufacturing industry.

Industry representatives have

commented that alternative formats for

these limitations and standards

controlling volatile pollutants may be

appropriate, including percent removal

with base concentrations as provided for

in the HON.

14.1 Concentration-Based Format

The Agency solicits comment on the

concentration-based format for

limitations being proposed today.

14.2 Implementation of an Alternative

Percent Reduction Limitation

The Agency solicits comment on

alternative percent reduction-based

limitations, as used for some of the

existing effluent limitations and the
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21649

HON, and how this approach would be

implemented. See solicitation number

32.4.

14.3 Implementation of a Mass-Based

Limitation

The Agency solicits comment on

alternative mass-based limitations and

how this approach would be

implemented.

15.0 In-Plant Limitations for Volatile

Organic Pollutant Control

For PSES and PSNS, the Agency is

proposing to require compliance

monitoring in-plant for certain

pollutants (e.g., chloroform, methylene

chloride, and toluene) that due to

dilution would be found at the end-ofpipe at levels below the current

analytical limits of detection. The longterm average concentrations upon

which the applicable standards are

based are, for many pollutants, near the

analytical limits of detection established

for these pollutants in wastewater. The

Agency is concerned that measurements

made at end-of-pipe, after dilution with

process and non-process wastewaters,

will not adequately reflect the

performance of the PSES or PSNS level

treatment due to uncertainty associated

with pollutant concentration

measurements near established limits of

detection. EPA has a similar concern for

the proposed BAT technology for

facilities with subcategory A and/or C

operations and the NSPS technology for

all manufacturing subcategories.

During development of these

proposed regulations, industry

representatives asserted that requiring

compliance monitoring in-plant on

internal streams may reduce their

flexibility in compliance and require

installation of specific in-plant

treatment technologies. Based upon

available data, the Agency believes that

even if in-plant monitoring is required,

pharmaceutical facilities will retain

considerable flexibility in choosing

specific compliance strategies that may

be implemented at individual facilities,

including available in-plant treatment

technologies. EPA also believes in-plant

limitations will enhance opportunities

for recovery and reuse of solvents and

may allow for the generation of ‘‘clean

fuels,’’ as described in section XI.C of

this preamble.

15.1 Feasibility of End-of-Pipe Limits

in Measuring Compliance

EPA solicits comments and data on

whether requiring compliance

monitoring at the end-of-pipe could

practically or feasibly be used to

determine whether the proposed BAT,

PSES, NSPS and PSNS limitations and

standards are being met.

15.2 Feasibility of End-of-Pipe Limits

in Measuring Technology Performance

EPA solicits comments and data on

whether requiring compliance

monitoring at the end-of-pipe could

practically or feasibly be used to

measure the performance of the process

technologies that form the basis of

EPA’s proposed BAT, PSES, NSPS and

PSNS regulation.

15.3 Extent That In-Plant Control

Enhances Recovery/Reuse

The Agency solicits comments and

specific supporting data on the extent to

which recovery and reuse opportunities

may be enhanced by in-plant control.

15.4 Compliance Strategy With InPlant Monitoring Points

The Agency solicits comments on

whether compliance strategies are either

enhanced or limited by the use of inplant monitoring points.

15.5 Air Emissions

The Agency solicits comment on the

extent to which air emissions may be

controlled by in-plant limits and

standards for volatile organic pollutants

based on steam stripping or steam

stripping with distillation.

15.6 Minimum Concentration and

Flow Thresholds

EPA is aware that it may not be

efficient or cost effective for plants to

steam strip or distill wastewater streams

containing low concentrations of

volatile organic pollutants.

Consequently, EPA solicits suggestions

for concentration and flow thresholds

for identifying wastewater streams

containing volatile organic pollutants

which would be subject to in-plant

steam stripping or steam stripping with

distillation.

15.7 Setting In-Plant Limitations on

Case-by-Case Basis

The Agency solicits comment on the

burden imposed on permit writers to

establish in-plant BAT limitations and

NSPS on a case-by-case basis for the 45

volatile organic pollutants for which

EPA is proposing to specify end-of-pipe

limitations and standards. EPA also

seeks comment on its proposal that the

end-of-pipe BAT limitations and NSPS

standards for particular pollutants

would not apply if a permit writer finds

in-plant limitations or standards to be

necessary for those pollutants; EPA also

seeks comment on the recommendation

that the permit writer consult the

appropriate PSES or PSNS table in

setting the necessary in-plant

limitations and standards on a best

professional judgment basis. EPA also

seeks comment on the utility of relying

on EPA’s existing NPDES permit

regulations to address issues associated

with pollutants that are not detectable at

the end of the pipe.

15.8 Deference to Clean Air Act

Rulemaking

The Agency seeks comment on all

aspects of EPA’s policy determination in

this proposal to defer to the Clean Air

Act rulemaking for the pharmaceuticals

industry with respect to the control of

volatile air emissions from certain

pharmaceutical wastestreams.

15.9 Comments on Steam Stripping

With Distillation

The Agency requests comments and

data on whether steam stripping with

distillation should be the technology

basis for effluent limitations and

standards for volatile organic pollutants,

particularly those that are difficult to

strip, such as methanol and ethanol.

15.10 Comments on the Proposed Endof-Pipe Limits for Highly Strippable

Volatile Organic Pollutants

The Agency solicits comments

supported by data regarding whether it

is appropriate to develop limitations

requiring compliance monitoring at the

end of the pipe for highly strippable

volatile organic pollutants such as

methylene chloride and chloroform.

16.0 WATER7 Model

In analyzing responses to the mass

balance question (section 3–2 of the 308

questionnaire), EPA has determined that

many of the loading estimates (i.e., to

air, to water etc.) provided for

individual pollutants were not

accompanied with explanations of how

the estimates were made. The Agency is

concerned that the 308 mass balance

responses may underestimate the

amount of pollutant air emissions from

wastewater and overestimate the

amount of pollutant biodegradation

and/or destruction. Consequently, EPA

has used the WATER7 computer model

in conjunction with other 308 response

data to develop pollutant-by-pollutant

air emission estimates. The WATER7

program was used previously to

estimate air emissions from wastewater

for the SOCMI HON (see 59 FR 19402).

16.1 Technical Validity of the

WATER7 Model

EPA solicits comments on the

technical validity of the WATER7 model

and its use in estimating pollutant

releases at pharmaceutical facilities.
21650 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

16.2 Other Models for Estimating Air

and Water Loadings

The Agency also welcomes

suggestions regarding the use of other

computer models for estimating air and

water loadings at pharmaceutical plants.

17.1 Alternative Technologies to

Steam Stripping or Steam Stripping

With Distillation Technology

For volatile organic pollutants, EPA is

proposing to base its BAT limitations for

facilities with subcategory A and/or C

operations and PSES limitations for all

manufacturing subcategories on steam

stripping technology. EPA also

proposed to base NSPS and PSNS

regulations for all manufacturing

subcategories for those pollutants on inplant steam stripping with distillation

technology. The Agency believes that

steam stripping technology is the best

available technology and that steam

stripping with distillation technology is

the best demonstrated technology for

removing volatile pollutants from

wastewater that also offer the

opportunity for recovery and recycle of

solvents.

EPA solicits comments accompanied

by data regarding other technologies

designed to remove volatile organic

pollutants from wastewater. Information

on alternative technologies should be

accompanied by influent and effluent

data that demonstrate removal.

18.0 Materials of Construction for

Steam Stripper and Distillation

Columns

EPA has used stainless steel as its

construction material in steam stripper

and distillation column capital cost

estimates. Nonetheless, the Agency

recognizes that certain corrosive (low

pH) streams may require the use of

construction materials made of

corrosion resistant alloys such as

Hastalloy to allow long-term operation

of steam strippers and distillation

columns.

18.1 Process Wastewater

Characteristics Requiring Special Alloys

The Agency solicits comments and

data on the characteristics of any

process wastewater streams that may

require that steam strippers and/or

distillation columns be constructed of

highly specialized alloys such as

Hastalloy.

18.2 Existing Materials of Construction

The Agency requests information

regarding the construction materials

used to build all the steam strippers and

distillation units currently in-place

within the industry.

19.0 Streams Containing Volatile

Organic Pollutants That Also Contain

Significant Amounts of Dissolved Solids

EPA wants to ensure that the final

limitations and standards for volatile

organics based on steam stripping or

steam stripping with distillation

technology adequately reflect the

dissolved solids content of

representative industry wastestreams.

The Agency is aware that certain waste

streams that contain large

concentrations of certain inorganic salts

may cause scaling problems within

packed columns that may reduce

column performance. Consequently,

EPA solicits comments supported by

data concerning the strippability of

wastestreams containing high

concentrations of inorganic salts

(dissolved solids).

20.0 COD Removal Through Steam

Stripping and Steam Stripping With

Distillation

As indicated earlier in this preamble,

the Agency does not have removal data

for COD achievable through steam

stripping and steam stripping with

distillation technology.

20.1 COD Removal Data

EPA solicits any influent and effluent

COD data across a steam stripper and/

or distillation unit for any available time

period. The COD influent and effluent

data should also include influent stream

characteristics data (i.e., organic

constituent concentrations) if possible.

EPA also solicits COD data for any

facilities that also have a biological

treatment system following a steam

stripper or distillation unit for which

COD data are available or may be

gathered.

20.2 COD Regulation Beyond BPT

EPA is proposing BAT limitations and

NSPS for COD for all manufacturing

subcategories based on advanced

biological treatment (the BPT-level

technology). EPA is not proposing COD

limitations and standards based on

steam stripping or steam stripping with

distillation because EPA is unable at

this time to quantify the COD loading

reductions attainable through those

technologies in addition to advanced

biological treatment. EPA solicits

comments and data concerning whether

BAT limitations and NSPS for COD

based on in-plant steam stripping or

steam stripping with distillation in

addition to advanced biological

treatment are necessary or appropriate

for facilities with subcategory A and/or

C operations. EPA also solicits

comments and data on the advisability

of adding granular activated carbon

adsorption technology to the steam

stripping-based technologies for

additional removal of COD. EPA also

solicits comments and data concerning

BAT limitations and NSPS for COD for

facilities with subcategory B and D

operations.

21.0 Clean Up of Steam Stripping and

Distillation Overheads, i.e.,

Condensates

21.1 Additional Treatment Required

for Clean Up

EPA is aware that the overhead

materials recovered from steam

stripping and distillation may need to

be ‘‘cleaned up’’ prior to reuse. EPA

solicits information on the technologies

that are currently being used to purify

overheads from steam stripping and

distillation.

21.2 Costs of Overhead Recovery for

Reuse

EPA solicits information and data

regarding the costs of cleaning up or

purifying overheads for reuse in

manufacturing operations along with

information on the cost of virgin solvent

materials.

22.0 Clean Fuels

EPA is aware that some facilities use

distillation/steam stripping overheads

as boiler feed. The Agency solicits data

and comment concerning the use of

such overheads as ‘‘clean fuels’’ from

plants which are using overheads as

boiler feed and from plants which plan

to do so in the future.

23.0 Regulation of Ammonia at BAT

and PSES

EPA is proposing effluent limitations

and standards controlling the discharge

of the pollutant ammonia for facilities

with subcategory A and/or C operations

because it is a pollutant of concern and

is discharged at treatable concentration

levels. Data are available demonstrating

that ammonia passes through POTWs,

and that ammonia is not adequately

treated at direct dischargers. The control

technology basis for BAT ammonia

limitations is incidental removal

through in-plant steam stripping and

advanced biological treatment upgraded

for nitrification. The control technology

basis for PSES ammonia limitations is

removal through in-plant steam

stripping. Industry representatives have

commented that ammonia discharges

from direct dischargers should be

controlled through water quality

standards. Industry representatives have

also commented that the adoption of

technology-based limitations and

standards for ammonia would result in
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21651

significant cross-media transfers and

energy use.

23.1 Degree to Which Ammonia Passes

Through POTWs

EPA solicits comments and data on

the degree to which ammonia generated

by pharmaceutical manufacturing

facilities passes through POTWs.

23.2 Degree to Which Ammonia is

Treated at Direct Dischargers

EPA solicits comments and data on

the degree to which ammonia is

adequately treated at direct discharging

facilities.

23.3 Achievability of the Proposed

Ammonia Limitations

EPA solicits comments and data on

the achievability of the Agency’s

proposed ammonia limitations.

23.4 Proposed Ammonia Control

Technologies

EPA solicits comments on the

underlying control technologies

proposed for ammonia treatment.

23.5 Nutrient Balance of Downstream

Biotreatment

EPA solicits comments on the extent

to which ammonia removal may

adversely affect the nutrient balance of

process wastewaters treated in

biological treatment systems.

23.6 Other Factors

EPA solicits comments on the costs,

effluent reduction benefits, water

quality benefits, and any other factors

that may be related to the proposed

ammonia limitations and standards.

24.0 Impact of Pharmaceutical

Wastewaters on POTW Operations

EPA has received information and

data indicating that pharmaceutical

manufacturing process wastewaters

discharged to POTWs contain

significant concentrations of volatile

organic pollutants. These concentrations

can result in slug loads of volatile

organic pollutants and other wastewater

constituents that, in turn, may cause

significant air emissions in the

headworks of these POTWs and may be

a threat to worker safety and health. The

Agency’s proposed PSES are intended to

reduce the concentration of volatile

organic pollutants in pharmaceutical

discharges. EPA solicits comments and

supporting data on these findings and

on the question whether these objectives

can be satisfied by assuring that

discharges to the POTW sewer are near

or at the level of detection.

24.1 PSES Removal of Volatile Organic

Pollutants

The Agency solicits comments and

data that address the extent to which

EPA’s proposed PSES may reduce the

concentration of volatile organic

pollutants in pharmaceutical plant

discharges to POTWs.

24.2 Regulatory Approach

The Agency solicits comment on the

appropriate regulatory approach for

facilities that discharge pharmaceutical

manufacturing wastewater to privately

owned treatment works. The Agency

specifically requests comment on

whether such discharges are best

regulated under today’s proposed

regulations, are best regulated under

effluent limitations guidelines and

standards for centralized waste

treatment facilities, 40 CFR Part 437, or

are best regulated on a case-by-case

basis using best professional judgment.

24.3 Comments on the Finding of No

Pass-Through for 33 Volatile Organic

Pollutants Under PSES Co-Proposal (2)

The Agency solicits comments and

data regarding its finding under PSES

co-proposal (2) that the specified 33

volatile organic pollutants do not pass

through.

24.4 Need for Pretreatment Standards

for 33 Less Strippable Volatile Organic

Pollutants

The Agency proposes as PSES and

PSNS pass-through co-proposal (1) to

establish PSES and PSNS for 33 less

strippable volatile organic pollutants.

Co-proposal (1) is supported by the

Association of Metropolitan Sewerage

Agencies, which in letter to EPA dated

February 14, 1995, asserted that the

promulgation of national pretreatment

standards for these pollutants would be

the most environmentally sound, timely

and cost-effective method of addressing

those pollutants. See Section IX.E.5.a.

EPA solicits comments on EPA’s two

pass-through co-proposals and on the

asserted benefits to POTWs associated

with co-proposal (1).

Industry data supplied to the Agency

indicate preliminarily that only 10

percent of the indirect sources account

for 80 to 90 percent of the total

discharge of these pollutants to POTWs

and that problems associated with

discharges to POTWs are specific and

local. EPA solicits comments and

supporting data on the extent to which

indirect discharges present a national

problem warranting regulation at the

national, as opposed to local, level and

whether mechanisms other than those

considered as the technology basis for

PSES and PSNS are possible alternatives

for addressing the problem.

24.5 Effect of Forthcoming Clean Air

Rule

EPA is developing a separate

rulemaking (under the requirements of

Section 112 of the Clean Air Act) to

address the air emissions from

pharmaceutical plants, including the

emissions of most of these 12 volatile

organic pollutants. EPA’s air rulemaking

may complement this proposal so that

standards set at the point of discharge

to the POTW sewer may satisfy EPA’s

objectives in this rulemaking. EPA

expects to propose these air emission

standards next year. As a result, EPA is

also considering whether to establish

the limits for the 12 highly strippable

organic pollutants at the point of

discharge to the POTW sewer and

solicits comments and supporting data

on this question.

25.0 Pretreatment of Methanol

25.1 Biodegradation of NonHalogenated Volatile Organic Pollutants

Without Causing Air Emissions

Industry representatives have stated

that EPA’s pretreatment standards

requiring removal of methanol and other

non-halogenated volatile organic

pollutants (e.g., acetone, ethanol, and

isopropanol) are not necessary because

these pollutants are adequately

biodegraded by POTWs. Industry

maintains that these pollutants have low

predicted air emissions from industrial

direct discharge systems and, at the

lower temperatures and concentrations

found in POTW systems, would have

even lower potential to be emitted from

POTWs.

EPA solicits comments and

supporting data regarding the ability of

POTWs to biodegrade non-halogenated

volatile organic pollutants without

significant air emissions.

25.2 BOD5 Removal Efficiency at

POTWs

Industry also asserts that removal of

these non-halogenated volatile organic

pollutants (a portion of which are

measured as BOD5) may have adverse

impacts on the BOD5 removal efficiency

of biological treatment systems at

POTWs receiving pharmaceutical

manufacturing process wastewaters.

EPA solicits comments and supporting

data on whether pretreatment of these

pollutants will adversely affect the

BOD5 removal efficiency of POTWs.

25.3 Financial Impact on POTWs

The industry has asserted that

pretreatment of methanol and other

non-halogenated volatile organic
21652 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

pollutants by pharmaceutical

manufacturing facilities will have an

adverse financial impact on POTWs.

EPA solicits comments and

supporting data on whether

pretreatment for removal of these

pollutants, and thereby reduced BOD5

raw waste loads to POTWs, will have

adverse financial impacts on POTW

revenues.

26.0 Pass-Through of COD at POTWs

EPA will be conducting a POTW passthrough analysis for the pollutant COD

because EPA is concerned that certain

refractory organic waste materials from

subcategory A and C operations

measured as COD may pass-through the

treatment afforded by POTWs.

26.1 Data on COD Pass-Through

EPA is soliciting data on COD

removal (influent and effluent data)

from POTWs that treat wastewater from

pharmaceutical plants engaging in

subcategory A and C operations.

26.2 Appropriate Procedure for

Conducting the COD Pass-Through

Analysis

EPA also solicits comments on the

appropriate procedure for conducting a

pass-through analysis for the pollutant

COD.

27.0 Pretreatment Standards for

Nonstrippable Organic Pollutants

27.1 Package Biotreatment for Five

Nonstrippable Organic Pollutants

As noted in Section IX.E.5.a of this

preamble, EPA has determined that five

nonstrippable biodegradable organic

pollutants (N,N dimethyl formamide,

dimethyl sulfoxide, N,N-dimethyl

acetamide, formaldehyde and ethylene

glycol) pass through POTWs. EPA is

considering developing pretreatment

standards for these pollutants based on

package biological treatment. EPA

solicits comments and data regarding

whether pretreatment standards based

on package biological treatment for the

five nonstrippable organic pollutants

should be promulgated.

27.2 Other Treatment Technologies for

Nonstrippable Organic Pollutants

EPA solicits data and information

regarding the ability of other

technologies to reduce wastewater

concentrations of the five nonstrippable

organic pollutants identified in the

comment solicitation above.

27.3 POTW Pass Through for

Acetonitrile and PEG 600

EPA solicits data and information

concerning whether acetonitrile and

polyethylene glycol 600 pass through

POTWs.

28.0 PSES for Additional Pollutants

Although today’s proposed PSES

would control 45 volatile organic

pollutants (as well as cyanide and

ammonia for subcategories A and C), the

Agency is concerned that additional

pollutants currently being discharged by

pharmaceutical plants may either pass

through POTWs or interfere with their

operation.

Consequently, EPA solicits comments

and data concerning other pollutants

discharged by pharmaceutical plants in

all manufacturing subcategories that

may pass through and/or interfere with

POTWs, such as sulfates and sulfide

(hydrogen sulfide) which are capable of

causing significant worker safety

problems and corrosion.

29.0 Revision of BPT

EPA is proposing to revise the

existing BPT effluent limitations, which

are outdated and no longer represent the

average of the best performers in the

pharmaceutical manufacturing industry.

In developing the proposed revised BPT

effluent limitations, EPA has identified

the average of the best performers with

advanced biological treatment.

29.1 Advanced Biological Treatment

EPA solicits comments and data with

respect to whether EPA has

appropriately selected advanced

biological treatment as the technology

basis for the proposed BPT conventional

pollutant limitations.

29.2 Methodology Used to Select Best

Performers

EPA solicits comments on the

methodology used to select the best

performing facilities with advanced

biological treatment and to develop the

limitations based on performance data

from these facilities.

29.3 Statutory Authority and Other

Factors

EPA solicits comments and data with

respect to the authority under the Clean

Water Act to revise BPT, and on costs,

effluent reduction benefits, water

quality benefits, and any other factors

that may be related to the proposed BPT

revisions.

30.0 Revision of BCT

EPA is proposing to revise the

existing BCT effluent limitations that

were promulgated in July 1986 (51 FR

24974). EPA identified no technologies

that achieve greater removals of

conventional pollutants than those

associated with the proposed revised

BPT limitations that are also costreasonable.

30.1 Proposed Baseline for BCT Cost

Test

EPA solicits comments on the

baseline used for this proposal (i.e.,

revised BPT limits being proposed

today) beyond which candidate

technologies were identified, and the

alternative baseline identified (i.e.,

existing BPT limitations).

30.2 Candidate Technologies for BCT

EPA solicits comments on the

candidate technologies considered for

BCT in this analysis and any others not

identified that may be appropriate.

30.3 BCT Results

EPA solicits comments on the finding

that none of the candidate BCT

technologies beyond BPT were costreasonable.

30.4 Other Factors

EPA solicits comments with respect to

costs, effluent reduction benefits, and

any other factors that may be related to

the proposed BCT revisions.

31.0 Applicability and Scope of Best

Management Practices

Section 304(e) of the CWA gives the

Administrator the authority to publish

regulations to control plant site runoff,

spillage or leaks, sludge or waste

disposal, and drainage from raw

material storage that the Administrator

determines are associated with or

ancillary to the industrial

manufacturing or treatment processes of

the regulated point source category and

that she (he) determines may contribute

significant amounts of pollutants to

waters of the United States. Examples of

BMP regulations include the

requirement that dikes be constructed in

process areas and required employee

training in spill prevention and control.

31.1 Establishment of BMPs

EPA solicits comments regarding

whether BMP regulations should be

established for the pharmaceutical

manufacturing industry.

31.2 BMPs and Costs

The Agency also solicits suggestions

on possible BMPs to be prescribed by

regulation, accompanied by facility

implementation cost estimates that may

be appropriate for this industrial

category.

31.3 Suggested Specific BMPs

The Agency solicits comments on the

suggested specific BMPs presented in

Appendix B of the Technical

Development Document.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21653

32.0 MACT Standards Versus Effluent

Guidelines

The proposed BAT and PSES effluent

limitations guidelines will control

volatile organic pollutants of which 22

are hazardous air pollutants (HAPs),

that are released to the environment

primarily in wastewater discharges and

air emissions. The mass of HAPs being

controlled by the effluent limitations

guidelines and standards is about 40

percent of the total mass of volatile

organic pollutants being controlled. It is

the Agency’s intent for both the effluent

guidelines being proposed today and the

MACT standards to be proposed at a

later date that upon promulgation the

in-plant technology basis of both rules

will be applicable to essentially the

same high concentration low volume

process wastewater streams in which

the bulk of the volatile organic

pollutants are contained.

Industry representatives commented

that air emissions from pharmaceutical

manufacturing facilities should be

controlled by a NESHAP rulemaking

rather than by BAT limitations and

PSES. Industry representatives also

commented that the Agency should

integrate the development of these two

rules, which now are progressing on

separate schedules. Industry

representatives commented further that

the effluent guidelines should include

the same elements of flexibility (e.g.,

allow for demonstration of equivalence

of biological treatment to steam

stripping) and format of the limitations

as included in the HON (e.g., percent

removal). Industry representatives also

indicated that the HON will allow for

emission-suppressed transport of

volatile organic pollutant-containing

wastewaters to central treatment

facilities.

32.1 Should the Water and Air

Regulations Be Integrated

In view of these preliminary concerns,

the Agency solicits comments and data

with respect to whether it is necessary

or appropriate for the two rules to be

integrated and, if so, how.

32.2 List of Organic Pollutants Covered

EPA solicits comments on whether it

is necessary or appropriate for the two

rules to cover the same list of volatile

organic pollutants.

32.3 Steam Stripping Design and

Operating Parameters

EPA solicits comments on whether

the design and operating parameters for

steam stripping technology as applied in

the two rules should be the same and,

if so, how (within the constraints of the

governing statutes).

32.4 Percent Removal Standard With a

Base Concentration

EPA solicits comments on whether

EPA should adopt, as an alternative to

the proposed concentration-based

limitations and standards, effluent

limitations guidelines and standards

based on percent removal standards, as

proposed in the HON for the Specialty

Organic Chemical Manufacturing

Industry (SOCMI). See solicitation

numbers 14.0–14.3.

32.5 Central Treatment for Volatiles

Removal

EPA solicits comments on whether

central treatment (i.e., steam stripping

or an equivalent technology prior to

end-of-pipe biological treatment) is or

should be an acceptable compliance

approach for the effluent guidelines.

32.6 Alternate Limitations for End-ofPipe Biological Treatment

EPA solicits comments on whether

the effluent guidelines should include

alternative limitations which would

allow for end-of-pipe biological

treatment of hard-piped volatile organic

pollutants (in place of in-plant steam

stripping or steam stripping with

distillation technology).

32.7 Control of Air Emissions Using

Alternate Limitations

EPA solicits comments on whether an

alternative approach (as described in

comment number 32.6) would present

the same control of air emissions as

achieved by in-plant steam stripping

and steam stripping with distillation

technology.

32.8 Energy Use for and Air Emissions

From Generation of Steam Used for

Steam Stripping and Steam Stripping

with Distillation

EPA solicits comments and data on

the increase in energy required to

generate steam used for steam stripping

and distillation, and on the increase in

air emissions created by steam

generation facilities (industrial boilers).

32.9 Comments on Evaluating the

Record of This Rulemaking in the

Context of the MACT Rule

The Agency requests comments on

whether it is appropriate for the Office

of Air and Radiation to evaluate the

basis for the proposed effluent

limitations and standards as part of its

development of MACT standards for the

pharmaceutical manufacturing industry.

33.0 Analytical Methods

A complete discussion of the new

analytical methods being proposed in

conjunction with these proposed

regulations may be found in section 18

of the Technical Development

Document.

33.1 Analytical Methods Proposed

Today

The methods being proposed today

involve the use of isotope dilution gas

chromatography/mass spectrometry

(GC/MS), derivatization followed by

high pressure liquid chromatography

(HPLC), and GC followed by detection

in an electrochemical cell optimized for

nitrogen containing compounds (GC/

ELCD). EPA solicits comments with

respect to these techniques (see

discussion in Section IX of this

preamble, and the supporting

compendium of analytical methods

entitled ‘‘Analytical Methods for the

Determination of Pollutants in

Pharmaceutical Manufacturing Industry

Wastewater;’’ see Section II of this

preamble) and any suggestions

regarding alternative techniques as well.

33.2 Limitations Set at the Minimum

Level of the Method

EPA solicits comments on those

limitations whose long-term average

basis is equal to the minimum level

established for the limited pollutant.

33.3 Statistical Methods for

Establishing Limitations

EPA solicits alternative statistical

methodologies for developing

limitations based on all non-detect data

which may be more appropriate than

the statistical methodology employed by

EPA.

33.4 Analytical Methods for Alcohols

EPA has proposed analytical methods

for quantifying various low-molecular

weight alcohols (e.g., methanol and

ethanol) in wastewater. See ‘‘Analytical

Methods for the Determination of

Pollutants in Pharmaceutical

Wastewater’’, EPA 821–R–95–015. EPA

invites comments on the proposed

methods for determining alcohols in

wastewater from industrial laboratories,

public sector laboratories and

individual researchers familiar with

similar analytical methods.

33.5 Matrix Interferences and

Analytical Methods

EPA is interested in identifying

solutions to matrix interference

problems connected with the analysis of

pharmaceutical manufacturing industry

wastewater streams. EPA is also

interested in any extraction,

concentration or other analytical

techniques that may offer solutions to

matrix interference problems.
21654 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

33.6 Analytical Method for the

Determination of Polyethylene Glycol

600 in Wastewater

EPA has determined that GC/MS

methods have not been found to be

useful in the determination of

polyethylene glycol 600 in wastewater.

EPA invites suggestions concerning the

analysis of this pollutant in wastewater.

33.7 COD Determinations in Samples

With High Chloride Content

EPA is aware that the standard

method determinations of COD in

samples with high chloride content

(e.g., brackish wastewater) need to be

pretreated to remove chloride prior to

the oxidation step in the COD

determination. EPA requests comments

regarding the techniques used to remove

chlorides prior to the oxidation step and

their adequacy in preventing

interference with the COD

determinations. EPA also solicits data

and information with respect to any

analytical method studies involving

COD determinations in wastewaters

with high chloride concentrations.

34.0 Surface Impoundments

EPA is concerned about the transfer of

volatile organic pollutants from surface

impoundments located at

pharmaceutical manufacturing facilities

to groundwater and air. EPA solicits

comment and data on the monitoring of

surface impoundments, including

leachate data and air emissions data.

35.0 Regulatory Impact Analysis

EPA solicits comments concerning the

methodology employed to estimate costs

and benefits in the Regulatory Impact

Analysis developed for these regulations

and the conclusions EPA reached by

applying those methodologies.

36.0 Economic Impact Analysis

EPA solicits comments on the

methodology employed to measure the

economic impacts of the proposed

regulations.

36.1 Definition of Small Entities

The Agency solicits comment on the

definition of small entity used in this

analysis, the analytical procedures for

assessing impacts on small entities, and

the opportunities to minimize the

impacts on small entities, as described

in the Economic Impact Analysis and

Regulatory Flexibility Analysis of

Proposed Effluent Guidelines for the

Pharmaceutical Manufacturing Industry.

37.0 Use of Bulk Parameters to

Represent Pollutants of Concern

EPA solicits comments and data on

the use of bulk parameters such as COD

to represent the presence and

treatability of pollutants of concern,

such as the broad range of organic

compounds present in pharmaceutical

manufacturing process wastewaters,

particularly chemical synthesis process

wastewaters. See also solicitation

numbers 10.0, 20.0, 26.0, 27.0, and 28.0.

38.0 Reducing Monitoring

Requirements

The Agency solicits comment on ways

to reduce the monitoring requirements

associated with the proposed

rulemaking.

38.1 Subcategory D Facilities

The Agency is aware that many

facilities with subcategory D operations

do not use or generate the pollutants for

which regulations are being proposed

today. Consequently, these facilities

should not be required to monitor for

these pollutants. EPA solicits comment

on any appropriate mechanism for

reducing monitoring requirements for

these facilities.

38.2 Pollutants Not Used or Generated

Similarly, facilities with operations in

other subcategories may not use or

generate specific pollutants for which

regulations are being proposed. EPA

solicits comment on any appropriate

mechanism for reducing monitoring

requirements for these pollutants at

such facilities.

38.3 Use of Alternate Analytical

Methods

EPA also solicits comments on

whether circumstances may exist under

which it may be appropriate to allow

facilities to use analytical methods for

organic pollutants other than those used

to generate data upon which this

proposal is based. Such circumstances

may include ‘‘screening’’ to confirm the

absence of pollutants where solvents are

not used in pharmaceutical

manufacturing processes (i.e.,

subcategory D, mixing/ compounding/

formulating). These alternate methods

might include Methods 624 and 625 as

alternatives to Methods 1624 and 1625.

39.0 Privately Owned Treatment

Plants

EPA solicits comment on the issue

whether part 439 should apply to

process wastewater pollutants

introduced into privately owned

treatment works.

List of Subjects in 40 CFR Part 439

Environmental Protection Air

pollution control, pharmaceutical

manufacturing Pollution prevention,

Wastewater treatment.

Dated: February 28, 1995.

Carol M. Browner,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I, part 439 of

the Code of Federal Regulations is

proposed to be amended as follows:

PART 439—PHARMACEUTICAL

MANUFACTURING POINT SOURCE

CATEGORY

1. The authority citation for part 439

is revised to read as follows:

Authority: Sections 301, 304, 306, 307, and

501 of the Clean Water Act, (33 U.S.C. 1311,

1314, 1316, 1317, and 1361).

2. The Table of Contents for part 439

is amended by adding §§ 439.3 and

439.4 and the entire table of contents is

published for the convenience of the

reader.

Sec.

439.0 Applicability.

439.1 General definitions.

439.2 Monitoring requirements.

439.3 Dilution prohibition.

439.4 [Reserved]

Subpart A—Fermentation Subcategory

439.10 Applicability; description of the

fermentation products subcategory.

439.11 Specialized definitions.

439.12 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best practicable

control technology currently available

(BPT).

439.13 Effluent limitations representing the

degree of effluent reduction attainable by

the best conventional pollutant control

technology (BCT).

439.14 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best available

technology economically achievable

(BAT).

439.15 New source performance standards

(NSPS).

439.16 Pretreatment standards for existing

sources (PSES).

439.17 Pretreatment standards for new

sources (PSNS).

439.18 [Reserved]

Subpart B—Extraction Subcategory

439.20 Applicability; description of the

extraction products subcategory.

439.21 Specialized definitions.

439.22 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best practicable

control technology currently available

(BPT).

439.23 Effluent limitations representing the

degree of effluent reduction attainable by

the best conventional pollutant control

technology (BCT).

439.24 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best available

technology economically achievable

(BAT).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21655

439.25 New source performance standards

(NSPS).

439.26 Pretreatment standards for existing

sources (PSES).

439.27 Pretreatment standards for new

sources (PSNS).

439.28 [Reserved]

Subpart C—Chemical Synthesis

Subcategory

439.30 Applicability; description of the

chemical synthesis products

subcategory.

439.31 Specialized definitions.

439.32 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best practicable

control technology currently available

(BPT).

439.33 Effluent limitations representing the

degree of effluent reduction attainable by

the best conventional pollutant control

technology (BCT).

439.34 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best available

technology economically achievable

(BAT).

439.35 New source performance standards

(NSPS).

439.36 Pretreatment standards for existing

sources (PSES).

439.37 Pretreatment standards for new

sources (PSNS).

439.38 [Reserved]

Subpart D—Mixing, Compounding and

Formulating Subcategory

439.40 Applicability; description of the

mixing, compounding and formulating

subcategory.

439.41 Specialized definitions.

439.42 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best practicable

control technology currently available

(BPT).

439.43 Effluent limitations representing the

degree of effluent reduction attainable by

the best conventional pollutant control

technology (BCT).

439.44 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best available

technology economically achievable

(BAT).

439.45 New source performance standards

(NSPS).

439.46 Pretreatment standards for existing

sources (PSES).

439.47 Pretreatment standards for new

sources (PSNS).

439.48 [Reserved]

Subpart E—Research Subcategory

439.50 Applicability; description of the

research subcategory.

439.51 Specialized definitions.

439.52 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best practicable

control technology currently available

(BPT).

439.53 Effluent limitations representing the

degree of effluent reduction attainable by

the best conventional pollutant control

technology (BCT). [Reserved]

439.54 Effluent limitations representing the

degree of effluent reduction attainable by

the application of best available

technology economically achievable

(BAT). [Reserved]

439.55 New source performance standards

(NSPS). [Reserved]

439.56 Pretreatment standards for existing

sources (PSES). [Reserved]

439.57 Pretreatment standards for new

sources (PSNS). [Reserved]

439.58 [Reserved]

3. Sections 439.0 through 439.2 are

revised and §§ 439.3 and 439.4 are

added to read as follows:

General Provisions

§ 439.0 Applicability.

This part applies to any

pharmaceutical manufacturing facility

that discharges or may discharge

process wastewater pollutants to the

waters of the United States, or that

introduces or may introduce process

wastewater pollutants into a publicly

owned treatment works. This part does

not apply to process wastewater

pollutants introduced into privately

owned treatment works.

§ 439.1 General definitions.

In addition to the definitions set forth

in 40 CFR part 401, the following

definitions shall apply to this part:

(a) Annual average. The mean

concentration, mass loading or

production-normalized mass loading of

a pollutant over a period of 365

consecutive days (or such other period

of time determined by the permitting

authority to be sufficiently long to

encompass expected variability of the

concentration, mass loading, or

production-normalized mass loading at

the relevant point of measurement).

(b) Bench-scale operation. Laboratory

testing of materials, methods, or

processes on a small scale, such as on

a laboratory worktable.

(c) Chemical oxygen demand (COD).

A bulk parameter that measures the total

oxygen-consuming capacity of

wastewater. This parameter is a measure

of materials in water or wastewater that

are biodegradable and materials that are

resistant (refractory) to biodegradation.

Refractory compounds slowly exert

demand on downstream receiving water

resources. Certain of the compounds

measured by this parameter have been

found to have adverse effects, either

singly or in combination. It is expressed

as the amount of oxygen consumed by

a chemical oxidant in a specific test.

(d) Conventional pollutants. The

pollutants identified in Section

304(a)(4) of the CWA and the

regulations thereunder, 40 CFR 401.16

(i.e., biochemical oxygen demand

(BOD5), total suspended solids (TSS), oil

and grease, pH, and fecal coliform).

(e) End-of-pipe effluent. Final plan

effluent discharged to waters of the

United States or to a POTW.

(f) In-plant monitoring points. (1) For

regulated organic pollutants, monitoring

point(s) prior to dilution by non-process

wastewater, commingling with other

process wastewaters not containing the

regulated organic pollutants at treatable

levels, and any conveyance,

equalization, or other wastewater

treatment units that are open to the

atmosphere.

(2) For cyanide, monitoring point(s)

prior to dilution or mixing with any

noncyanide-bearing wastewater.

(g) Minimum level. The level at which

an analytical system gives recognizable

signals and an acceptable calibration

point. The following minimum levels

(for water samples only) and analytical

methods apply to pollutants in this part:

Pollutant Method

Minimum level

micrograms per

liter (μg/L)

Acetone ....................................................................................................................... 1624B 50

Acetonitrile ................................................................................................................... 1666, 1671 5,000

Ammonia (aqueous) .................................................................................................... 350.1, 350.2, 350.3 30

n-Amyl Acetate ............................................................................................................ 1666 5

Amyl Alcohol ............................................................................................................... 1666 500

Aniline .......................................................................................................................... 1665 2

Benzene ...................................................................................................................... 1624B 10

BOD5 ........................................................................................................................... 405.1 (a)

2-Butanone .................................................................................................................. 1624B 50

n-Butyl Acetate ............................................................................................................ 1666 5

n-Butyl Alcohol ............................................................................................................ 1666 500
21656 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant Method

Minimum level

micrograms per

liter (μg/L)

tert-Butyl Alcohol ......................................................................................................... 1666 100

Chemical Oxygen Demand (COD) ............................................................................. 410.1, 410.2, 410.3, 410.4 (a)

Chlorobenzene ............................................................................................................ 1624B 10

Chloroform ................................................................................................................... 1624B 10

Chloromethane ............................................................................................................ 1624B 50

Cyanide (Total) ............................................................................................................ 335.1, 335.2, 335.3 (a)

Cyclohexane ................................................................................................................ 1666 5

1,2-Dichlorobenzene ................................................................................................... 1625B 10

1,2-Dichloroethane ...................................................................................................... 1624B 10

Diethylamine ................................................................................................................ 1666, 1671 50,000

Diethyl Ether ................................................................................................................ 1624B 50

N-N-Diethylacetamide ................................................................................................. 1665 50

N,N-Dimethylaniline ..................................................................................................... 1665 10

Dimethylamine ............................................................................................................. 1666, 1671 50,000

N,N-Dimethylformamide .............................................................................................. 1665 5

Dimethylsulforxide ....................................................................................................... 1666, 1671 20,000

1,4-Dioxane ................................................................................................................. 1624B 50

Ethanol ........................................................................................................................ 1666, 1671(b) 3,180

Ethyl Acetate ............................................................................................................... 1666 10

Ethylene Glycol ........................................................................................................... 1666, 1671 100,000

Formaldehyde ............................................................................................................. 1667 50

Formamide .................................................................................................................. 1666, 1671 100,000

Furfural ........................................................................................................................ 1666, 1677 50

n-Heptane .................................................................................................................... 1666 10

n-Hexane ..................................................................................................................... 1666 10

Isobutyraldehyde ......................................................................................................... 1666, 1667 10

Isopropanol .................................................................................................................. 1666 200

Isopropyl Acetate ........................................................................................................ 1666 10

Isopropyl Ether ............................................................................................................ 1666 5

Methanol ...................................................................................................................... 1666, 1671(a) 3,180

Methylamine ................................................................................................................ 1666, 1671 50,000

Methyl Cellosolve ........................................................................................................ 1666, 1671 20,000

Methylene Chloride ..................................................................................................... 1624B 10

Methyl Formate ........................................................................................................... 1666 100

Methyl Isobutyl Ketone (MIBK) ................................................................................... 1666 10

2-Methylpyridine .......................................................................................................... 1624B, 1665 5

Petroleum Naptha (as n-pentane) .............................................................................. 1666 10

Phenol ......................................................................................................................... 1625 10

Polyethylene Glucol 600 ............................................................................................. 1673 1,000

n-Propanol ................................................................................................................... 1666, 1671(b) 3,180

Pyridine ....................................................................................................................... 1665 5

Tetrahydrofuran ........................................................................................................... 1666 20

Toluene ....................................................................................................................... 1624 10

Trichlorofluoromethane ............................................................................................... 1666 10

Triethlyamine ............................................................................................................... 1666, 1671 50,000

TSS ............................................................................................................................. 160.2 (a)

m,p-Xylene .................................................................................................................. 1666 10

o-Xylene ...................................................................................................................... 1666 5

(a)—As specified in 40 CFR Part 136.

(b)—Method 1671 is modified ASTM Method D3695–88.

(h) New source. As defined in EPA’s

regulations at 40 CFR 122.2 and 122.29.

(i) Nonconventional pollutants.

Pollutants that are neither conventional

pollutants nor toxic pollutants.

(j) Non-detect (ND) value. A

concentration-based measurement

reported below the minimum level (see

paragraph (g) of this section) that can be

reliably measured by the analytical

method for the pollutant.

(k) Pilot-scale operation. The trial

operation of processing equipment,

which is the intermediate stage between

laboratory experimentation and fullscale operation in the development of a

new process or product.

(l) POTW. Publicly owned treatment

works, as defined at 40 CFR 403.3(o).

(m) Process wastewater. Any water

that, during manufacturing or

processing, comes into direct contact

with or results from the production or

use of any raw material, intermediate

product, finished product, byproduct, or

waste product. Process wastewater

includes surface runnoff from the

immediate process area that has the

potential to become contaminated.

(1) For the purposes of this part, the

following materials are excluded from

the definition of process wastewater,

and the discharge of such materials

must be regulated separately.

(i) Trimethyl silanol;

(ii) Any active anti-microbial

materials;

(iii) Wastewater from imperfect

fermentation batches; and

(iv) Process area spills.

(2) For purposes of this part, the

following waters and wastewaters are

excluded from the definition of process

wastewater: noncontact cooling water,

utility wastewaters, general site surface

runoff, groundwater (e.g., contaminated

groundwaters from on-site or off-site

groundwater remediation projects), and

other nonprocess water generated on

site. The discharge of such waters and
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21657

wastewaters must be regulated

separately.

(n) Toxic pollutants. The pollutants

designated by EPA as toxic in 40 CFR

401.15.

(o) Xylenes. The sum of o-xylene, pxylene, and m-xylene.

§ 439.2 Monitoring requirements.

Permit compliance monitoring is

required for each regulated pollutant

generated or used at a pharmaceutical

manufacturing facility. Routine

compliance monitoring is not required

for regulated pollutants not generated or

used at the facility. Except for cyanide,

for which a separate procedure is

established in subparts A and C,

determination that regulated pollutants

are not generated or used should be

based on a review of all raw materials

used, and an assessment of all chemical

processes used, considering resulting

products and by-products. The

determination that a regulated pollutant

is not generated or used must be

confirmed by annual chemical analyses

of wastewater from each monitoring

location. Such confirmation is provided

by an analytical measurement of a nondetect value. Compliance monitoring for

all regulated pollutants generated or

used is required at each of the

monitoring locations specified in this

part for those pollutants or at such

locations specified pursuant to 40 CFR

122.45.

CAS No. Pollutant

Monitoring

frequency

(frequency

per week)

67–64–1 .......... Acetone .................................................................................................................................................................. 1

75–05–8 .......... Acetonitrile ............................................................................................................................................................. 1

1336–21–6 ...... Ammonia ................................................................................................................................................................ 1

628–63–7 ........ n-Amyl Acetate ...................................................................................................................................................... 1

71–41–0 .......... Amyl Alcohol .......................................................................................................................................................... 1

62–53–3 .......... Aniline .................................................................................................................................................................... 1

71–43–2 .......... Benzene ................................................................................................................................................................. 1

78–93–3 .......... 2-Butanone ............................................................................................................................................................ 1

123–86–4 ........ n-Butyl Acetate ...................................................................................................................................................... 1

71–36–3 .......... n-Butyl Alcohol ....................................................................................................................................................... 1

75–65–0 .......... tert-Butyl Alcohol .................................................................................................................................................... 1

C–004–(r) ........ Chemical Oxygen Demand (COD) ........................................................................................................................ 7

108–90–7 ........ Chloabenzene ........................................................................................................................................................ 1

67–66–3 .......... Chloroform ............................................................................................................................................................. 1

74–87–3 .......... Chloromethane ...................................................................................................................................................... 1

57–12–5 .......... Cyanide, Total ........................................................................................................................................................ (b)1

110–82–7 ........ Cyclohexane .......................................................................................................................................................... 1

95–50–1 .......... 1,2-Dichlorobenzene .............................................................................................................................................. 1

107–06–2 ........ 1,2-Dichloroethane ................................................................................................................................................. 1

109–89–7 ........ Diethylamine .......................................................................................................................................................... 1

60–29–7 .......... Diethyl ether ........................................................................................................................................................... 1

127–19–5 ........ N,N-Dimethylacetamide ......................................................................................................................................... 1

121–69–7 ........ N,N-Dimethylaniline ............................................................................................................................................... 1

124–40–3 ........ Dimethylamine ....................................................................................................................................................... 1

68–12–2 .......... N,N-Dimethylformamide ......................................................................................................................................... 1

67–68–5 .......... Dimethylsulfoxide ................................................................................................................................................... 1

123–91–1 ........ 1,4-Dioxane ............................................................................................................................................................ 1

64–17–5 .......... Ethanol ................................................................................................................................................................... 1

141–78–6 ........ Ethyl acetate .......................................................................................................................................................... 1

107–21–1 ........ Ethylene glycol ....................................................................................................................................................... 1

50–00–1 .......... Formaldehyde ........................................................................................................................................................ 1

75–12–7 .......... Formamide ............................................................................................................................................................. 1

98–01–1 .......... Furfural ................................................................................................................................................................... 1

142–82–5 ........ n-Heptane .............................................................................................................................................................. 1

110–54–3 ........ n-Hexane ............................................................................................................................................................... 1

78–84–2 .......... Isobutyraldehyde .................................................................................................................................................... 1

67–63–0 .......... Isopropanol ............................................................................................................................................................ 1

108–21–4 ........ Isopropyl acetate ................................................................................................................................................... 1

108–20–3 ........ Isopropyl ether ....................................................................................................................................................... 1

67–56–1 .......... Methanol ................................................................................................................................................................ 1

74–89–5 .......... Methylamine ........................................................................................................................................................... 1

109–86–4 ........ Methyl Cellosolve ................................................................................................................................................... 1

75–09–2 .......... Methylene Chloride ................................................................................................................................................ 1

107–31–3 ........ Methyl formate ....................................................................................................................................................... 1

108–10–1 ........ Methyl Isobutyl Ketone .......................................................................................................................................... 1

109–06–8 ........ 2-Methylpyridine ..................................................................................................................................................... 1

8030–30–6 ...... Petroleum Naphtha ................................................................................................................................................ 1

108–95–2 ........ Phenol .................................................................................................................................................................... 1

25322–68–3 .... Polyethylene Glycol 600 ........................................................................................................................................ 1

71–23–8 .......... n-Propanol ............................................................................................................................................................. 1

110–86–1 ........ Pyridine .................................................................................................................................................................. 1

109–99–9 ........ Tetrahydrofuran ..................................................................................................................................................... 1

108–88–3 ........ Toluene .................................................................................................................................................................. 1

75–69–4 .......... Trichlorodluoromethane ......................................................................................................................................... 1

121–44–8 ........ Triethylamine ......................................................................................................................................................... 1

(c) ..................... Xylenes .................................................................................................................................................................. 1

C–002–(a) ....... BOD5 ...................................................................................................................................................................... 7
21658 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

CAS No. Pollutant

Monitoring

frequency

(frequency

per week)

C–009–(a) ....... TSS ........................................................................................................................................................................ 7

(a) These are synthetic CASRN’s designed for use with the Environmental Monitoring Methods Index (EMMI).

(b) Monitoring fequency for cyanide is once per treated batch.

(c) M-Xylene 108–38–3, o-Xylene 95–47– 6, p-Xylene 106–42–3.

§ 439.3 Dilution prohibition.

Dilution may not be practiced to meet

the effluent limitations and standards

specified in this part.

§ 439.4 [Reserved]

Subpart A—Fermentation Subcategory

4. Sections 439.10 through 439.14 are

revised to read as follows:

§ 439.10 Applicability; description of the

fermentation subcategory; prohibition.

(a) The provisions of this subpart are

applicable to discharges resulting from

the manufacture of pharmaceuticals by

fermentation. Fermentation operations

are defined as process operations that

utilize a chemical change induced by a

living organism or enzyme, specifically,

bacteria, or the microorganisms

occurring in unicellular plants such as

yeast, molds, or fungi to produce a

specified product. Fermentation

operations include pilot-scale research

operations not covered by the

provisions of subpart E, Research

Subcategory.

(b) The discharge of nonprocess

wastewater and materials excluded from

the definition of process wastewater at

§ 439.1 is not covered by this subpart.

Discharge of such nonprocess

wastewater and excluded materials into

publicly owned treatment works or

waters of the United States by a source

subject to this subpart without an

NPDES permit or individual control

mechanism authorizing such discharge

is prohibited.

§ 439.11 Specialized definitions.

For the purpose of this subpart:

(a) Except as provided in paragraph

(b) of this section, the general

definitions, abbreviations, and methods

of analysis set forth in 40 CFR part 401

and § 439.1 shall apply to this subpart.

(b) The term ‘‘product’’ shall mean

pharmaceutical products derived from

fermentation processes.

§ 439.12 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best practicable

control technology currently available

(BPT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best practicable

control technology currently available.

(1) Subpart A (For In-Plant

Monitoring Points).

Pollutant or pollutant

property

BPT effluent limitations micrograms per

liter (μg/L)

Maximum

for any

one day

Monthly

average

Cyanide (Total) ......... 766 406

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

Effluent).

Pollutant or pollutant property

BPT effluent limitations

milligrams per liter

(mg/L)

Maximum

for any

one day

Monthly

average

BOD5 ..................... 137 58

TSS ....................... 318 110

COD ...................... 1100 628

(3) The pH shall be within the range

of 6.0–9.0 standard units.

(b) Permittees not using or generating

cyanide are deemed to comply with the

monitoring requirements specified in

paragraph (a) of this section for cyanide

if they certify to the permit issuing

authority that they are not using or

generating this pollutant.

§ 439.13 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best conventional

pollutant control technology (BCT).

Except as provided in 40 CFR 125.30

through 125.32, any existing point

source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best conventional

pollutant control technology: The

limitations shall be the same as those

specified for the conventional pollutants

BOD5 and TSS in § 439.12 for the best

practicable control technology currently

available.

§ 439.14 Effluent limitations representing

the degree of effluent reduction attainable

by the application of best available

technology economically achievable (BAT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best available

technology economically achievable.

(1) Subpart A (For In-Plant

Monitoring Points).

Pollutant or pollutant

property

BAT effluent limitations micrograms per

liter (μg/L)

Maximum

for any

one day

Monthly

average

Cyanide (Total) ......... 766 406

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

Effluent). The limitations in the

following table do not apply for any

pollutant(s) for which the permit writer

finds it necessary to specify in-plant

monitoring requirements pursuant to 40

CFR 122.44(i) and 122.45(h).

Limitations for those pollutant(s) would

be established on a best professional

judgment basis pursuant to 40 CFR

125.3.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21659

Pollutant or pollutant property

BAT effluent limitations

micrograms per liter (μNDg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... ND ND

Acetonitrile ............................................................................................................................................................... ND ND

Ammonia .................................................................................................................................................................. 4,850 3,230

n-Amyl Acetate ......................................................................................................................................................... 105 45

Amyl Alcohol ............................................................................................................................................................ 668 ND

Aniline ...................................................................................................................................................................... 10 10

Benzene ................................................................................................................................................................... ND ND

2-Butanone (MEK) ................................................................................................................................................... 202 86

n-Butyl Acetate ......................................................................................................................................................... 87 37

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... 668 284

Chemical Oxygen Demand (COD) .......................................................................................................................... 1,100,000 628,000

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... ND ND

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 100 35

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 574 244

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 50

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. 220 94

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 105 45

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 2,670 1,140

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 1,370 581

Isopropanol .............................................................................................................................................................. ND ND

Isopropyl Acetate ..................................................................................................................................................... 87 37

Isopropyl Ether ......................................................................................................................................................... 574 244

Methanol .................................................................................................................................................................. ND ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methyl Formate ........................................................................................................................................................ 105 ND

Methylene Chloride .................................................................................................................................................. ND ND

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ ND ND

2-Methylpyridine ....................................................................................................................................................... 50 50

Petroleum Naphtha .................................................................................................................................................. ND ND

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Clycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ ND ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 910 264

Toluene .................................................................................................................................................................... ND ND

Trichlorofluoromethane ............................................................................................................................................ ND ND

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND

(b) Permittees not using or generating

cyanide are deemed to comply with the

monitoring requirements specified in

paragraph (a) of this section for cyanide

if they certify to the permit issuing

authority that they are not using or

generating this pollutant.

5. Section 439.15 is amended by

revising paragraph (a) introductory text

and paragraph (b) and by adding

paragraph (c) to read as follows:

§ 439.15 New source performance

standards (NSPS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following new source performance

standards until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the effluent limitations

specified in §§ 439.12, 439.13, and

439.14.

* * * * *

(b) Except as provided in paragraph

(a) of this section, any new source

subject to this subpart must achieve the

following new source performance

standards.

(1) Subpart A (For In-Plant

Monitoring Points).
21660 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant or pollutant

property

New source performance standards

micrograms per liter

(μg/L)

Maximum

for any

one day

Monthly

average

Cyanide (Total) ......... 766 406

(2) Subpart A (For End-of Pipe

Effluent). The standards in the following

table do not apply for any pollutant(s)

for which the permit writer finds it

necessary to specify in-plant monitoring

requirements pursuant to 40 CFR

122.44(i) and 122.45(h). Standards for

those pollutant(s) would be established

on a best professional judgment basis

pursuant to 40 CFR 125.3.

Pollutant or pollutant property

New source performance

standards micrograms per liter

(μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... ND ND

Acetonitrile ............................................................................................................................................................... ND ND

Ammonia .................................................................................................................................................................. 4,850 3,230

n-Amyl Acetate ......................................................................................................................................................... 14 6

Amyl Alcohol ............................................................................................................................................................ ND ND

Aniline ...................................................................................................................................................................... 10 4

Benzene ................................................................................................................................................................... ND ND

2-Butanone (MEK) ................................................................................................................................................... 144 61

n-Butyl Acetate ......................................................................................................................................................... 11 ND

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... ND ND

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... ND ND

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 13 ND

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 74 ND

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 45

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. ND ND

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 14 ND

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 53 ND

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 304 129

Isopropanol .............................................................................................................................................................. ND ND

Isopropyl Acetate ..................................................................................................................................................... 11 ND

Isopropyl Ether ......................................................................................................................................................... 74 32

Methanol .................................................................................................................................................................. ND ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methyl Formate ........................................................................................................................................................ ND ND

Methylene Chloride .................................................................................................................................................. ND ND

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ ND ND

2-Methylpyridine ....................................................................................................................................................... 50 45

Petroleum Naphtha .................................................................................................................................................. ND ND

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Glycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ ND ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 910 264

Toluene .................................................................................................................................................................... ND ND

Trichlorofluoromethane ............................................................................................................................................ ND ND

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND

(3) Subpart A For End-of-Pipe Effluent).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21661

Pollutant or pollutant property

New source performance

standards milligrams per liter

(mg/L)

Maximum for

any one day

Monthly

average

BOD5 ........................................................................................................................................................................ 62 29

COD ......................................................................................................................................................................... 781 538

TSS .......................................................................................................................................................................... 87 43

pH ............................................................................................................................................................................. (a) (a)

(a) Within the range of 6.0 to 9.0 standard units.

(c) Permittees not using or generating

cyanide are deemed to comply with the

monitoring requirements specified in

paragraph (a) of this section for cyanide

if they certify to the permit issuing

authority that they are not using or

generating this pollutant.

6. Section 439.16 is revised to read as

follows:

§ 439.16 Pretreatment standards for

existing sources (PSES).

(a) Except as provided in 40 CFR

403.7 and 403.13, any existing source

subject to this subpart that introduces

pollutants into a publicly owned

treatment works must comply with 40

CFR part 403 by [date 3 years from the

promulgation date of the final rule] and

achieve the following pretreatment

standards for existing sources.

(1) Subpart A (For In-Plant

Monitoring Points).

Pollutant or pollutant property

Pretreatment standards

for existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Benzene ................................................................................................................................................................... 796 268

Chlorobenzene ......................................................................................................................................................... 796 268

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 796 268

Cyanide .................................................................................................................................................................... 766 406

Cyclohexane ............................................................................................................................................................ 796 268

n-Heptane ................................................................................................................................................................ 796 268

n-Hexane .................................................................................................................................................................. 796 268

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Toluene .................................................................................................................................................................... 198 148

Trichlorofluoromethane ............................................................................................................................................ 796 268

Xylenes .................................................................................................................................................................... 796 268

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

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

Pollutant or pollutant property

Pretreatment standards

for existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... 31,400 9,690

Ammonia .................................................................................................................................................................. 12,900 10,900

n-Amyl Acetate ......................................................................................................................................................... 23,900 8,050

Amyl Alcohol ............................................................................................................................................................ 607,000 205,000

Aniline ...................................................................................................................................................................... 10,900,000 3,690,000

2-Butanone (MEK) ................................................................................................................................................... 1,440,000 430,000

n-Butyl Acetate ......................................................................................................................................................... 23,900 8,050

n-Butyl Alcohol ......................................................................................................................................................... 10,900,000 3,690,000

tert-Butyl Alcohol ...................................................................................................................................................... 607,000 205,000

o-Dichlorobenzene ................................................................................................................................................... 23,900 8,050

1,2-Dichloroethane ................................................................................................................................................... 23,900 8,050

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 23,900 8,050

Dimethylamine ......................................................................................................................................................... 607,000 205,000

N,N-Dimethylaniline ................................................................................................................................................. 607,000 205,000

1,4-Dioxane .............................................................................................................................................................. 10,900,000 3,690,000

Ethanol ..................................................................................................................................................................... 2,200,000 784,000

Ethyl Acetate ............................................................................................................................................................ 23,900 8,050

Formamide ............................................................................................................................................................... 607,000 205,000

Furfural ..................................................................................................................................................................... 607,000 205,000

Isobutyraldehyde ...................................................................................................................................................... 23,900 8,050
21662 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant or pollutant property

Pretreatment standards

for existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Isopropanol .............................................................................................................................................................. 597,000 198,000

Isopropyl Acetate ..................................................................................................................................................... 23,900 8,050

Isopropyl Ether ......................................................................................................................................................... 23,900 8,050

Methanol .................................................................................................................................................................. 11,700,000 3,800,000

Methylamine ............................................................................................................................................................. 607,000 205,000

Methyl Formate ........................................................................................................................................................ 23,900 8,050

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ 23,900 8,050

2-Methylpyridine ....................................................................................................................................................... 607,000 205,000

Petroleum Naphtha .................................................................................................................................................. 10,900,000 3,690,000

n-Propanol ................................................................................................................................................................ 2,790,000 941,000

Pyridine .................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran ........................................................................................................................................................ 9,210 3,360

Triethylamine ............................................................................................................................................................ ND ND

(b) Indirect dischargers not using or

generating cyanide are deemed to

comply with the monitoring

requirements specified in paragraph (a)

of this section for cyanide if they certify

to the control authority that they are not

using or generating this pollutant.

7. Section 439.17 is amended by

revising paragraph (a) introductory text

and paragraph (b) and by adding

paragraph (c) to read as follows:

§ 439.17 Pretreatment standards for new

sources (PSNS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following pretreatment standards for

new sources until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the standards specified in

§ 439.16.

* * * * *

(b) Except as provided in 40 CFR

403.7 and paragraph (a) of this section,

any new source subject to this subpart

that introduces pollutants into a

publicly owned treatment works must

comply with 40 CFR part 403 and

achieve the following pretreatment

standards for new sources.

(1) Subpart A (For In-Plant

Monitoring).

[Note: With respect to pollutants in this

table, EPA does not propose pretreatment

standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards

for new sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone * .................................................................................................................................................................. 1,190 600

Amyl Alcohol* .......................................................................................................................................................... 8,690 3,220

Benzene ................................................................................................................................................................... 573 212

n-Butyl Alcohol* ....................................................................................................................................................... 8,690 3,220

tert-Butyl Alcohol* .................................................................................................................................................... 8,690 3,220

Chlorobenzene ......................................................................................................................................................... 573 212

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 573 212

Cyanide .................................................................................................................................................................... 766 406

Cyclohexane ............................................................................................................................................................ 573 212

Diethylamine * .......................................................................................................................................................... ND ND

Diethyl Ether* .......................................................................................................................................................... 2,230 826

Dimethylamine * ....................................................................................................................................................... ND ND

Ethanol* ................................................................................................................................................................... 8,690 3,220

Formamide * ............................................................................................................................................................. ND ND

n-Heptane ................................................................................................................................................................ 573 212

n-Hexane .................................................................................................................................................................. 573 212

Isopropanol* ............................................................................................................................................................ 8,690 3,220

Methanol* ................................................................................................................................................................ 8,320 ND

Methylamine * ........................................................................................................................................................... ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Methyl Formate * ...................................................................................................................................................... 2,230 826

n-Propanol* .............................................................................................................................................................. 8,690 3,220

Toluene .................................................................................................................................................................... 184 135

Trichlorofluoromethane ............................................................................................................................................ 573 212

Triethylamine * .......................................................................................................................................................... ND ND

Xylenes .................................................................................................................................................................... 573 212

(2) Subpart A (For End-of-Pipe Monitoring Points).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21663

[Note: With respect to pollutants in this table, EPA does not propose pretreatment standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

Ammonia .................................................................................................................................................................. 12,900 10,900

n-Amyl Acetate* ....................................................................................................................................................... 2,230 826

Aniline* ..................................................................................................................................................................... 8,690 3,220

2-Butanone (MEK)* .................................................................................................................................................. 161,000 57,900

n-Butyl Acetate* ....................................................................................................................................................... 2,230 826

o-Dichlorobenzene* .................................................................................................................................................. 2,230 826

1,2-Dichloroethane* ................................................................................................................................................. 2,230 826

N,N-Dimethylaniline* ................................................................................................................................................ 8,690 3,220

1,4-Dioxane* ............................................................................................................................................................ 8,690 3,220

Ethyl Acetate* .......................................................................................................................................................... 2,230 826

Furfural* ................................................................................................................................................................... 8,690 3,220

Isobutyraldehyde* .................................................................................................................................................... 2,230 826

Isopropyl Acetate* .................................................................................................................................................... 2,230 826

Isopropyl Ether* ....................................................................................................................................................... 2,230 826

Methyl Isobutyl Ketone (MIBK)* ............................................................................................................................... 2,230 826

2-Methylpyridine* ..................................................................................................................................................... 8,690 3,220

Petroleum Naphtha* ................................................................................................................................................. 8,690 3,220

Pyridine* ................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran* ...................................................................................................................................................... 9,210 3,360

(c) Indirect dischargers not using or

generating cyanide are deemed to

comply with the monitoring

requirements specified in paragraph (a)

of this section for cyanide if they certify

to the control authority that they are not

using or generating this pollutant.

§ 439.18 [Reserved]

Subpart B—Extraction Subcategory

8. Sections 439.20 through 439.24 are

revised to read as follows:

§ 439.20 Applicability; description of the

extraction subcategory; prohibition.

(a) The provisions of this subpart are

applicable to discharges resulting from

the manufacture of pharmaceutical

products by biological and natural

extraction operations. Biological and

natural extraction operations are

defined as process operations that

utilize the chemical and physical

extraction of pharmaceutically active

ingredients from natural sources such as

plant roots and leaves, animal glands,

and parasitic fungi. Biological and

natural extraction operations include

pilot-scale research operations not

covered by the provisions of subpart E,

Research Subcategory.

(b) The discharge of nonprocess

wastewater and materials excluded from

the definition of process wastewater at

§ 439.1 is not covered by this subpart.

Discharge of such nonprocess

wastewater and excluded materials into

publicly owned treatment works or

waters of the United States by a source

subject to this subpart without an

NPDES permit or individual control

mechanism authorizing such discharge

is prohibited.

§ 439.21 Specialized definitions.

(a) Except as provided paragraph (b)

of this section, the general definitions,

abbreviations, and methods of analysis

set forth in 40 CFR part 401 and § 439.1

shall apply to this subpart.

(b) The term ‘‘product’’ shall mean

any biological and natural extraction

product. This subcategory shall include

blood fractions, vaccines, serums,

animal bile derivatives, endocrine

products, and isolation of medicinal

products, such as alkaloids, from

botanical drugs and herbs.

§ 439.22 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best practicable

control technology currently available

(BPT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best practicable

control technology currently available.

(1) Subpart B (For End-of-Pipe

Effluent).

Pollutant or pollutant

parameter

BPT effluent limitations milligrams per

liter (mg/L)

Maximum

for any

one day

Monthly

average

BOD5 ......................... 37 11

TSS ........................... 80 27

COD .......................... 145 60

(2) The pH shall be within the range

of 6.0–9.0 standard units.

(b) [Reserved]

§ 439.23 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best conventional

pollutant control technology (BCT).

Except as provided in 40 CFR 125.30

through 125.32, any existing point

source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best conventional

pollutant control technology: The

limitations shall be the same as those

specified for conventional pollutants

BOD5 and TSS in § 439.22 for the best

practicable control technology currently

available.

§ 439.24 Effluent limitations representing

the degree of effluent reduction attainable

by the application of best available

technology economically achievable (BAT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of
21664 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

effluent reduction attainable by the

application of the best available

technology economically achievable.

(1) Subpart B (For End-of-Pipe Effluent).

Pollutant or pollutant property

BAT effluent limitations

micrograms per Liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... 413 178

Acetonitrile ............................................................................................................................................................... ND ND

n-Amyl Acetate ......................................................................................................................................................... 3,000 1,280

Amyl Alcohol ............................................................................................................................................................ 3,980 1,690

Aniline ...................................................................................................................................................................... 10 10

Benzene ................................................................................................................................................................... 40 17

2-Butanone (MEK) ................................................................................................................................................... 202 86

n-Butyl Acetate ......................................................................................................................................................... 500 500

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... 3,980 1,690

Chemical Oxygen Demand (COD) .......................................................................................................................... 145,000 59,900

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... 22 13

Chloromethane ......................................................................................................................................................... 206 87

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 438 152

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 4,870 2,070

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 50

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. 220 94

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 3,000 1,280

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 3,000 1,280

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 1,370 581

Isopropanol .............................................................................................................................................................. 1,120 476

Isopropyl Acetate ..................................................................................................................................................... 500 500

Isopropyl Ether ......................................................................................................................................................... 4,870 2,070

Methanol .................................................................................................................................................................. 6,660 ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 1,420 357

Methyl Formate ........................................................................................................................................................ 3,000 1,280

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ 119 51

2-Methylpyridine ....................................................................................................................................................... 50 50

Petroleum Naphtha .................................................................................................................................................. 40 17

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Glycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ 3,980 ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 15,000 4,350

Toluene .................................................................................................................................................................... 40 17

Trichlorofluoromethane ............................................................................................................................................ 599 322

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND

(2) [Reserved]

(b) [Reserved]

9. Section 439.25 is amended by

revising paragraph (a) introductory text

and paragraph (b) to read as follows:

§ 439.25 New source performance

standards (NSPS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following new source performance

standards until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the effluent limitations
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21665

specified in §§ 439.22, 439.23, and

439.24.

* * * * *

(b) Except as provided in paragraph

(a) of this section any new source

subject to this subpart must achieve the

following new source performance

standards.

(1) Subpart B (For End-of-Pipe

Effluent) The standards in the following

table do not apply for any pollutant(s)

for which the permit writer finds it

necessary to specify in-plant monitoring

requirements pursuant to 40 CFR

122.44(i) and 122.45(h). Standards for

those pollutant(s) would be established

on a best professional judgment basis

pursuant to 40 CFR 125.3.

Pollutant or pollutant property

New source performance

standards micrograms per liter

(μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... ND ND

Acetonitrile ............................................................................................................................................................... ND ND

Ammonia .................................................................................................................................................................. 4,850 3,230

n-Amyl Acetate ......................................................................................................................................................... 14 6

Amyl Alcohol ............................................................................................................................................................ ND ND

Aniline104 Benzene ................................................................................................................................................. ND 10/4

2-Butanone (MEK) ................................................................................................................................................... 144 61

n-Butyl Acetate ......................................................................................................................................................... 11 ND

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... ND ND

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... ND ND

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 13 ND

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 74 ND

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 45

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. ND ND

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 14 ND

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 53 ND

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 304 129

Isopropanol .............................................................................................................................................................. ND ND

Isopropyl Acetate ..................................................................................................................................................... 11 ND

Isopropyl Ether ......................................................................................................................................................... 74 32

Methanol .................................................................................................................................................................. ND ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methyl Formate ........................................................................................................................................................ ND ND

Methylene Chloride .................................................................................................................................................. ND ND

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ ND ND

2-Methylpyridine ....................................................................................................................................................... 50 45

Petroleum Naphtha .................................................................................................................................................. ND ND

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Glycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ ND ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 910 264

Toluene .................................................................................................................................................................... ND ND

Trichlorofluoromethane ............................................................................................................................................ ND ND

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND
21666 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

(2) Subpart B (For End-of-Pipe

Effluent).

Pollutant or pollutant

parameter

New source performance standards milligrams per liter

(mg/L)

Maximum

for any

one day

Monthly

average

BOD5 ......................... 34 10

COD .......................... 60 24

TSS ........................... 40 12

Pollutant or pollutant

parameter

New source performance standards milligrams per liter

(mg/L)

Maximum

for any

one day

Monthly

average

pH ............................. (a) (a)

(a) Within the range of 6.0 to 9.0 standard

units.

10. Section 439.26 is revised to read

as follows:

§ 439.26 Pretreatment standards for

existing sources (PSES).

(a) Except as provided in 40 CFR

403.7 and 403.13, any existing source

subject to this subpart that introduces

pollutants into a publicly owned

treatment works must comply with 40

CFR part 403 and by [date 3 years from

the promulgation date of the final rule]

achieve the following pretreatment

standards for existing sources.

(1) Subpart B (For In-Plant Monitoring

Points).

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Benzene ................................................................................................................................................................... 796 268

Chlorobenzene ......................................................................................................................................................... 796 268

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 796 268

Cyclohexane ............................................................................................................................................................ 796 268

n-Heptane ................................................................................................................................................................ 796 268

n-Hexane .................................................................................................................................................................. 796 268

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Toluene .................................................................................................................................................................... 198 148

Trichlorofluoromethane ............................................................................................................................................ 796 268

Xylenes .................................................................................................................................................................... 796 268

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

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

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... 31,400 9,690

n-Amyl Acetate ......................................................................................................................................................... 23,900 8,050

Amyl Alcohol ............................................................................................................................................................ 607,000 205,000

Aniline ...................................................................................................................................................................... 10,900,000 3,690,000

2-Butanone (MEK) ................................................................................................................................................... 1,440,000 430,000

n-Butyl Acetate ......................................................................................................................................................... 23,900 8,050

n-Butyl Alcohol ......................................................................................................................................................... 10,900,000 3,690,000

tert-Butyl Alcohol ...................................................................................................................................................... 607,000 205,000

o-Dichlorobenzene ................................................................................................................................................... 23,900 8,050

1,2–Dichloroethane .................................................................................................................................................. 23,900 8,050

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 23,900 8,050

Dimethylamine ......................................................................................................................................................... 607,000 205,000

N,N-Dimethylaniline ................................................................................................................................................. 607,000 205,000

1,4-Dioxane .............................................................................................................................................................. 10,900,000 3,690,000

Ethanol ..................................................................................................................................................................... 2,200,000 784,000

Ethyl Acetate ............................................................................................................................................................ 23,900 8,050

Formamide ............................................................................................................................................................... 607,000 205,000

Furfural ..................................................................................................................................................................... 607,000 205,000

Isobutyraldehyde ...................................................................................................................................................... 23,900 8,050

Isopropanol .............................................................................................................................................................. 597,000 198,000

Isopropyl Acetate ..................................................................................................................................................... 23,900 8,050

Isopropyl Ether ......................................................................................................................................................... 23,900 8,050

Methanol .................................................................................................................................................................. 11,700,000 3,800,000

Methylamine ............................................................................................................................................................. 607,000 205,000

Methyl Formate ........................................................................................................................................................ 23,900 8,050

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ 23,900 8,050

2-Methylpyridine ....................................................................................................................................................... 607,000 205,000

Petroleum Naphtha .................................................................................................................................................. 10,900,000 3,690,000

n-Propanol ................................................................................................................................................................ 2,790,000 941,000

Pyridine .................................................................................................................................................................... 1,000 1,000
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21667

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Tetrahydrofuran ........................................................................................................................................................ 9,210 3,360

Triethylamine ............................................................................................................................................................ ND ND

(b) [Reserved]

11. Section 439.27 is amended by

revising paragraph (a) introductory text

and paragraph (b) to read as follows:

§ 439.27 Pretreatment standards for new

sources (PSNS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following pretreatment standards for

new sources until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the standards specified in

§ 439.26.

* * * * *

(b) Except as provided in 40 CFR

403.7 and paragraph (a) of this section,

any new source subject to this subpart

that introduces pollutants into a

publicly owned treatment works must

comply with 40 CFR part 403 and

achieve the following pretreatment

standards for new sources.

(1) Subpart B (For In-Plant Monitoring

Points).

[Note: With respect to pollutants in this

table, EPA does not propose pretreatment

standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone* ................................................................................................................................................................... 1,190 600

Amyl Alcohol* ........................................................................................................................................................... 8,690 3,220

Benzene ................................................................................................................................................................... 573 212

n-Butyl Alcohol* ........................................................................................................................................................ 8,690 3,220

tert-Butyl Alcohol* .................................................................................................................................................... 8,690 3,220

Chlorobenzene ......................................................................................................................................................... 573 212

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 573 212

Cyclohexane ............................................................................................................................................................ 573 212

Diethylamine* ........................................................................................................................................................... ND ND

Diethyl Ether* ........................................................................................................................................................... 2,230 826

Dimethylamine* ........................................................................................................................................................ ND ND

Ethanol* .................................................................................................................................................................... 8,690 3,220

Formamide* .............................................................................................................................................................. ND ND

n-Heptane ................................................................................................................................................................ 573 212

n-Hexane .................................................................................................................................................................. 573 212

Isopropanol* ............................................................................................................................................................. 8,690 3,220

Methanol* ................................................................................................................................................................. 8,320 ND

Methylamine* ........................................................................................................................................................... ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Methyl Formate* ....................................................................................................................................................... 2,230 826

n-Propanol* .............................................................................................................................................................. 8,690 3,220

Toluene .................................................................................................................................................................... 184 135

Trichlorofluoromethane ............................................................................................................................................ 573 212

Triethylamine* .......................................................................................................................................................... ND ND

Xylenes .................................................................................................................................................................... 573 212

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

[Note: With respect to pollutants in this table, EPA does not propose pretreatment standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

n-Amyl Acetate* ....................................................................................................................................................... 2,230 826

Aniline* ..................................................................................................................................................................... 8,690 3,220

2-Butanone (MEK)* .................................................................................................................................................. 161,000 57,900

n-Butyl Acetate* ....................................................................................................................................................... 2,230 826

o-Dichlorobenzene* .................................................................................................................................................. 2,230 826

1,2-Dichloroethane* ................................................................................................................................................. 2,230 826
21668 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

N,N-Dimethylaniline* ................................................................................................................................................ 8,690 3,220

1,4-Dioxane* ............................................................................................................................................................ 8,690 3,220

Ethyl Acetate* .......................................................................................................................................................... 2,230 826

Furfural* ................................................................................................................................................................... 8,690 3,220

Isobutyraldehyde* .................................................................................................................................................... 2,230 826

Isopropyl Acetate* .................................................................................................................................................... 2,230 826

Isopropyl Ether* ....................................................................................................................................................... 2,230 826

Methyl Isobutyl Ketone (MIBK)* ............................................................................................................................... 2,230 826

2-Methylpyridine* ..................................................................................................................................................... 8,690 3,220

Petroleum Naphtha* ................................................................................................................................................. 8,690 3,220

Pyridine* ................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran* ...................................................................................................................................................... 9,210 3,360

§ 439.28 [Reserved]

Subpart C—Chemical Synthesis

Subcategory

12. Sections 439.30 through 439.34

are revised to read as follows:

§ 439.30 Applicability; description of the

chemical synthesis subcategory;

prohibition.

(a) The provisions of this subpart are

applicable to discharges resulting from

the manufacture of pharmaceutical

products by chemical synthesis

operations. Chemical synthesis is

defined as the process(es) of using a

chemical reaction or series of chemical

reactions to produce a specified

product. Chemical synthesis operations

include pilot-scale research operations

not covered by the provisions of subpart

E, Research Subcategory.

(b) The discharge of non-process

wastewater and materials excluded from

the definition of process wastewater at

§ 439.1 is not covered by this subpart.

Discharge of such non-process

wastewater and excluded materials into

publicly owned treatment works or

waters of the United States by a source

subject to this subpart without an

NPDES permit or individual control

mechanism authorizing such discharge

is prohibited.

§ 439.31 Specialized definitions.

For the purpose of this subpart:

(a) Except as provided in paragraph

(b) of this section, the general

definitions, abbreviations, and methods

of analysis set forth in 40 CFR part 401

and § 439.1 shall apply to this subpart.

(b) The term ‘‘product’’ shall mean

any pharmaceutical product derived

from chemical synthesis processes.

§ 439.32 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best practicable

control technology currently available

(BPT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best practicable

control technology currently available.

(1) Subpart C (For In-Plant Monitoring

Points).

Pollutant or pollutant

property

BPT effluent limitations micrograms per

liter (μg/L)

Maximum

for any

one day

Monthly

average

Cyanide (Total) ......... 766 406

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

Effluent).

Pollutant or pollutant

property

BPT effluent limitations micrograms per

liter (mg/L)

Maximum

for any

one day

Monthly

average

BOD5 ......................... 137 58

TSS ........................... 318 110

COD .......................... 1100 628

3) The pH shall be within the range

of 6.0–9.0 standard units.

(b) Permittees not using or generating

cyanide are deemed to comply with the

monitoring requirements specified in

paragraph (a) of this section for cyanide

if they certify to the permit issuing

authority that they are not using or

generating this pollutant.

§ 439.33 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best conventional

pollutant control technology (BCT).

Except as provided in 40 CFR 125.30

through 125.32, any existing point

source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best conventional

pollutant control technology: The

limitations shall be the same as those

specified for conventional pollutants

BOD5 and TSS in § 439.32 for the best

practicable control technology currently

available.

§ 439.34 Effluent limitations representing

the degree of effluent reduction attainable

by the application of best available

technology economically achievable (BAT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best available

technology economically achievable.

(1) Subpart C (For In-Plant Monitoring

Points)

Pollutant or pollutant

property

BAT effluent limitations micrograms per

liter (μg/L)

Maximum

for any

one day

Monthly

average

Cyanide (Total) ......... 766 406

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

Effluent). The limitations in the

following table do not apply for any

pollutant(s) for which the permit writer

finds it necessary to specify in-plant

monitoring requirements pursuant to 40

CFR 122.44(i) and 122.45(h).

Limitations for those pollutant(s) would

be established on a best professional
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21669

judgment basis pursuant to 40 CFR

125.3.

Pollutant or pollutant property

BAT effluent limitations

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... ND ND

Acetonitrile ............................................................................................................................................................... ND ND

Ammonia .................................................................................................................................................................. 4,850 3,230

n-Amyl Acetate ......................................................................................................................................................... 105 45

Amyl Alcohol ............................................................................................................................................................ 668 ND

Aniline ...................................................................................................................................................................... 10 10

Benzene ................................................................................................................................................................... ND ND

2-Butanone (MEK) ................................................................................................................................................... 202 86

n-Butyl Acetate ......................................................................................................................................................... 87 37

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... 668 284

Chemical Oxygen Demand (COD) .......................................................................................................................... 1,100,000 628,000

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... ND ND

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 100 35

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 574 244

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 50

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. 220 94

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 105 45

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 2,670 1,140

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 1,370 581

Isopropanol .............................................................................................................................................................. ND ND

Isopropyl Acetate ..................................................................................................................................................... 87 37

Isopropyl Ether ......................................................................................................................................................... 574 244

Methanol .................................................................................................................................................................. ND ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methyl Formate ........................................................................................................................................................ 105 ND

Methylene Chloride .................................................................................................................................................. ND ND

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ ND ND

2-Methylpyridine ....................................................................................................................................................... 50 50

Petroleum Naphtha .................................................................................................................................................. ND ND

Phenol ...................................................................................................................................................................... 25 14

Polyethylene glycol 600 ........................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ ND ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 910 264

Toluene .................................................................................................................................................................... ND ND

Trichlorofluoromethane ............................................................................................................................................ ND ND

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND

(b) Permittees not using or generating

cyanide are deemed to comply with the

monitoring requirements specified in

paragraph (a) of this section for cyanide

if they certify to the permit issuing

authority that they are not using or

generating this pollutant.

13. Section 439.35 is amended by

revising paragraph (a) introductory text

and paragraph (b) and by adding

paragraph (c) to read as follows:

§ 439.35 New source performance

standards (NSPS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following new source performance

standards until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the effluent limitations
21670 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

specified in §§ 439.32, 439.33, and

439.34.

* * * * *

(b) Except as provided in paragraph

(a) of this section, any new source

subject to this subpart must achieve the

following new source performance

standards.

(1) Subpart C (For In-Plant Monitoring

Points).

Pollutant or pollutant

property

New source performance standards

micrograms per liter

(μg/L)

Maximum

for any

one day

Monthly

average

Cyanide (Total) ......... 766 406

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

Effluent). The standards in the following

table do not apply for any pollutant(s)

for which the permit writer finds it

necessary to specify in-plant monitoring

requirements pursuant to 40 CFR

122.44(i) and 122.45(h). Standards for

those pollutant(s) would be established

on a best professional judgment basis

pursuant to 40 CFR 125.3.

Pollutant or pollutant property

New source performance

standards micrograms per liter

(μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... ND ND

Acetonitrile ............................................................................................................................................................... ND ND

Ammonia .................................................................................................................................................................. 4,850 3,230

n-Amyl Acetate ......................................................................................................................................................... 14 6

Amyl Alcohol ............................................................................................................................................................ ND ND

Aniline ...................................................................................................................................................................... 10 4

Benzene ................................................................................................................................................................... ND ND

2-Butanone (MEK) ................................................................................................................................................... 144 61

n-Butyl Acetate ......................................................................................................................................................... 11 ND

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... ND ND

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... ND ND

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 13 ND

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 74 ND

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 45

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. ND ND

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 14 ND

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 53 ND

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 304 129

Isopropanol .............................................................................................................................................................. ND ND

Isopropyl Acetate ..................................................................................................................................................... 11 ND

Isopropyl Ether ......................................................................................................................................................... 74 32

Methanol .................................................................................................................................................................. ND ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methyl Formate ........................................................................................................................................................ ND ND

Methylene Chloride .................................................................................................................................................. ND ND

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ ND ND

2-Methylpyridine ....................................................................................................................................................... 50 45

Petroleum Naphtha .................................................................................................................................................. ND ND

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Glycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ ND ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 910 264

Toluene .................................................................................................................................................................... ND ND

Trichlorofluoromethane ............................................................................................................................................ ND ND

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21671

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

Effluent).

Pollutant or pollutant

property

New source performance standards

milligrams per liter

(mg/L)

Maximum

for any

one day

Monthly

average

BOD5 ......................... 62 29

COD .......................... 781 538

TSS ........................... 87 43

pH ............................. (a) (a)

(a) Within the range of 6.0 to 9.0 standard

units.

(c) Permittees not using or generating

cyanide are deemed to comply with the

monitoring requirements specified in

paragraph (a) of this section for cyanide

if they certify to the permit issuing

authority that they are not using or

generating this pollutant.

14. Section 439.36 is revised to read

as follows:

§ 439.36 Pretreatment standards for

existing sources (PSES).

(a) Except as provided in 40 CFR

403.7 and 403.13, any existing source

subject to this subpart that introduces

pollutants into a publicly owned

treatment works must comply with 40

CFR part 403 and by [date 3 years from

the promulgation date of the final rule]

achieve the following pretreatment

standards for existing sources.

(1) Subpart C (For In-Plant Monitoring Points).

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Benzene ................................................................................................................................................................... 796 268

Chlorobenzene ......................................................................................................................................................... 796 268

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 796 268

Cyanide .................................................................................................................................................................... 766 406

Cyclohexane ............................................................................................................................................................ 796 268

n-Heptane ................................................................................................................................................................ 796 268

n-Hexane .................................................................................................................................................................. 796 268

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Toluene .................................................................................................................................................................... 198 148

Trichlorofluoromethane ............................................................................................................................................ 796 268

Xylenes .................................................................................................................................................................... 796 268

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

[Note: With respect to the pollutants in this table, EPA proposes pretreatment standards for existing sources only for ammonia

under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... 31,400 9,690

Ammonia .................................................................................................................................................................. 12,900 10,900

n-Amyl Acetate ......................................................................................................................................................... 23,900 8,050

Amyl Alcohol ............................................................................................................................................................ 607,000 205,000

Aniline ...................................................................................................................................................................... 10,900,000 3,690,000

2-Butanone (MEK) ................................................................................................................................................... 1,440,000 430,000

n-Butyl Acetate ......................................................................................................................................................... 23,900 8,050

n-Butyl Alcohol ......................................................................................................................................................... 10,900,000 3,690,000

tert-Butyl Alcohol ...................................................................................................................................................... 607,000 205,000

o-Dichlorobenzene ................................................................................................................................................... 23,900 8,050

1,2-Dichloroethane ................................................................................................................................................... 23,900 8,050

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 23,900 8,050

Dimethylamine ......................................................................................................................................................... 607,000 205,000

N,N-Dimethylaniline ................................................................................................................................................. 607,000 205,000

1,4-Dioxane .............................................................................................................................................................. 10,900,000 3,690,000

Ethanol ..................................................................................................................................................................... 2,200,000 784,000

Ethyl Acetate ............................................................................................................................................................ 23,900 8,050

Formamide ............................................................................................................................................................... 607,000 205,000

Furfural ..................................................................................................................................................................... 607,000 205,000

Isobutyraldehyde ...................................................................................................................................................... 23,900 8,050

Isopropanol .............................................................................................................................................................. 597,000 198,000

Isopropyl Acetate ..................................................................................................................................................... 23,900 8,050
21672 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Isopropyl Ether ......................................................................................................................................................... 23,900 8,050

Methanol .................................................................................................................................................................. 11,700,000 3,800,000

Methylamine ............................................................................................................................................................. 607,000 205,000

Methyl Formate ........................................................................................................................................................ 23,900 8,050

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ 23,900 8,050

2-Methylpyridine ....................................................................................................................................................... 607,000 205,000

Petroleum Naphtha .................................................................................................................................................. 10,900,000 3,690,000

n-Propanol ................................................................................................................................................................ 2,790,000 941,000

Pyridine .................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran ........................................................................................................................................................ 9,210 3,360

Triethylamine ............................................................................................................................................................ ND ND

(b) Indirect dischargers not using or

generating cyanide are deemed to

comply with the monitoring

requirements specified in paragraph (a)

of this section for cyanide if they certify

to the control authority that they are not

using or generating this pollutant.

15. Section 439.37 is amended by

revising paragraph (a) introductory text

and paragraph (b) and by adding

paragraph (c) to read as follows:

§ 439.37 Pretreatment standards for new

sources (PSNS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following pretreatment standards for

new sources until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the standards specified in

§ 439.36.

* * * * *

(b) Except as provided in 40 CFR

403.7 and paragraph (a) of this section,

any new source subject to this subpart

that introduces pollutants into a

publicly owned treatment works must

comply with 40 CFR part 403 and

achieve the following pretreatment

standards for new sources.

(1) Subpart C (For In-Plant Monitoring Points).

[Note: With respect to pollutants in this table, EPA does not propose pretreatment standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone* ................................................................................................................................................................... 1,190 600

Amyl Alcohol* ........................................................................................................................................................... 8,690 3,220

Benzene ................................................................................................................................................................... 573 212

n-Butyl Alcohol* ........................................................................................................................................................ 8,690 3,220

tert-Butyl Alcohol* .................................................................................................................................................... 8,690 3,220

Chlorobenzene ......................................................................................................................................................... 573 212

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 573 212

Cyanide .................................................................................................................................................................... 766 406

Cyclohexane ............................................................................................................................................................ 573 212

Diethylamine* ........................................................................................................................................................... ND ND

Diethyl Ether* ........................................................................................................................................................... 2,230 826

Dimethylamine* ........................................................................................................................................................ ND ND

Ethanol* .................................................................................................................................................................... 8,690 3,220

Formamide* .............................................................................................................................................................. ND ND

n-Heptane ................................................................................................................................................................ 573 212

n-Hexane .................................................................................................................................................................. 573 212

Isopropanol* ............................................................................................................................................................. 8,690 3,220

Methanol* ................................................................................................................................................................. 8,320 ND

Methylamine* ........................................................................................................................................................... ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Methyl Formate* ....................................................................................................................................................... 2,230 826

n-Propanol* .............................................................................................................................................................. 8,690 3,220

Toluene .................................................................................................................................................................... 184 135

Trichlorofluoromethane ............................................................................................................................................ 573 212

Triethylamine* .......................................................................................................................................................... ND ND

Xylenes .................................................................................................................................................................... 573 212

(2) Subpart C (For End-of-Pipe Monitoring Points).
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21673

[Note: With respect to pollutants in this table, EPA does not propose pretreatment standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

Ammonia .................................................................................................................................................................. 12,900 10,900

n-Amyl Acetate* ....................................................................................................................................................... 2,230 826

Aniline* ..................................................................................................................................................................... 8,690 3,220

2-Butanone (MEK)* .................................................................................................................................................. 161,000 57,900

n-Butyl Acetate* ....................................................................................................................................................... 2,230 826

o-Dichlorobenzene* .................................................................................................................................................. 2,230 826

1,2-Dichloroethane* ................................................................................................................................................. 2,230 826

N,N-Dimethylaniline* ................................................................................................................................................ 8,690 3,220

1,4-Dioxane* ............................................................................................................................................................ 8,690 3,220

Ethyl Acetate* .......................................................................................................................................................... 2,230 826

Furfural* ................................................................................................................................................................... 8,690 3,220

Isobutyraldehyde* .................................................................................................................................................... 2,230 826

Isopropyl Acetate* .................................................................................................................................................... 2,230 826

Isopropyl Ether* ....................................................................................................................................................... 2,230 826

Methyl Isobutyl Ketone (MIBK)* ............................................................................................................................... 2,230 826

2-Methylpyridine* ..................................................................................................................................................... 8,690 3,220

Petroleum Naphtha* ................................................................................................................................................. 8,690 3,220

Pyridine* ................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran* ...................................................................................................................................................... 9,210 3,360

(c) Indirect dischargers not using or

generating cyanide are deemed to

comply with the monitoring

requirements specified in paragraph (a)

of this section for cyanide if they certify

to the control authority that they are not

using or generating this pollutant.

§ 439.38 [Reserved]

Subpart D—Mixing, Compounding and

Formulating Subcategory

16. Sections 439.40 through 439.44

are revised to read as follows:

§ 439.40 Applicability; description of the

mixing, compounding and formulating

subcategory; prohibition.

(a) The provisions of this subpart are

applicable to discharges resulting from

the mixing, compounding and

formulating operations of

pharmaceutical products. Mixing,

compounding, and formulating

operations are defined as processes

through which pharmaceutical products

are put in dosage forms. Mixing,

compounding, and formulating

operations include pilot-scale research

operations not covered by the

provisions of subpart E, Research

Subcategory.

(b) The discharge of non-process

wastewaters and materials excluded

from the definition of process

wastewater at § 439.1 is not covered by

this subpart. Discharge of such nonprocess wastewater and excluded

materials into publicly owned treatment

works or waters of the United States, by

a source subject to this subpart, without

an NPDES permit or individual control

mechanism authorizing such discharge

is prohibited.

§ 439.41 Specialized definitions.

For the purpose of this subpart:

(a) Except as provided below, the

general definitions, abbreviations, and

methods of analysis set forth in 40 CFR

part 401 and § 439.1 shall apply to this

subpart.

(b) The term ‘‘product’’ shall mean

products from plants that blend, mix,

compound, and formulate

pharmaceutical ingredients.

Pharmaceutical preparations for human

and veterinary use such as ampules,

tablets, capsules, vials, ointments,

medicinal powders, solutions, and

suspensions are included.

§ 439.42 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best practicable

control technology currently available

(BPT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best practicable

control technology currently available.

(1) Subpart D (For End-of-Pipe

Effluent).

Pollutant or pollutant

parameter

BPT effluent limitations milligrams per

liter (mg/L)

Maximum

for any

one day

Monthly

average

BOD5 ......................... 37 11

TSS ........................... 80 27

COD .......................... 145 60

(2) The pH shall be within the range

of 6.0–9.0 standard units.

(b) [Reserved]

§ 439.43 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best conventional

pollutant control technology (BCT).

Except as provided in 40 CFR 125.30

through 125.32, any existing point

source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best conventional

pollutant control technology. The

limitations shall be the same as those

specified for conventional pollutants

BOD5 and TSS in § 439.42 for the best

practicable control technology currently

available.

§ 439.44 Effluent limitations representing

the degree of effluent reduction attainable

by the application of best available

technology economically achievable (BAT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of
21674 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

effluent reduction attainable by the application of the best available

technology economically achievable.

(1) Subpart D (For End-of-Pipe

Effluent).

Pollutant or pollutant property

BAT effluent limitations

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... 413 178

Acetonitrile ............................................................................................................................................................... ND ND

n-Amyl Acetate ......................................................................................................................................................... 3,000 1,280

Amyl Alcohol ............................................................................................................................................................ 3,980 1,690

Aniline ...................................................................................................................................................................... 10 10

Benzene ................................................................................................................................................................... 40 17

2-Butanone (MEK) ................................................................................................................................................... 202 86

n-Butyl Acetate ......................................................................................................................................................... 500 500

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... 3,980 1,690

Chemical Oxygen Demand (COD) .......................................................................................................................... 145,000 59,900

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... 22 13

Chloromethane ......................................................................................................................................................... 206 87

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 438 152

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 4,870 2,070

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 50

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. 220 94

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 3,000 1,280

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 3,000 1,280

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 1,370 581

Isopropanol .............................................................................................................................................................. 1,120 476

Isopropyl Acetate ..................................................................................................................................................... 500 500

Isopropyl Ether ......................................................................................................................................................... 4,870 2,070

Methanol .................................................................................................................................................................. 6,660 ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 1,420 357

Methyl Formate ........................................................................................................................................................ 3,000 1,280

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ 119 51

2-Methylpyridine ....................................................................................................................................................... 50 50

Petroleum Naphtha .................................................................................................................................................. 40 17

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Glycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ 3,980 ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 15,000 4,350

Toluene .................................................................................................................................................................... 40 17

Trichlorofluoromethane ............................................................................................................................................ 599 322

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND

(2) [Reserved]

(b) [Reserved]

17. Section 439.45 is amended by

revising paragraph (a) introductory text

and paragraph (b) to read as follows:

§ 439.45 New source performance

standards (NSPS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following new source performance

standards until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the effluent limitations

specified in §§ 439.42, 439.43, and

439.44.

* * * * *

(b) Except as provided in paragraph

(a) of this section, any new source

subject to this subpart must achieve the

following new source performance

standards.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21675

(1) Subpart D (For End-of-Pipe

Monitoring Points). The standards in the

following table do not apply for any

pollutant(s) for which the permit writer

finds it necessary to specify in-plant

monitoring requirements pursuant to 40

CFR 122.44(i) and 122.45(h). Standards

for those pollutant(s) would be

established on a best professional

judgment basis pursuant to 40 CFR

125.3.

Pollutant or pollutant property

New source performance

standards micrograms per liter

(μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... ND ND

Acetonitrile ............................................................................................................................................................... ND ND

Ammonia .................................................................................................................................................................. 4,850 3,230

n-Amyl Acetate ......................................................................................................................................................... 14 6

Amyl Alcohol ............................................................................................................................................................ ND ND

Aniline ...................................................................................................................................................................... 10 4

Benzene ................................................................................................................................................................... ND ND

2-Butanone (MEK) ................................................................................................................................................... 144 61

n-Butyl Acetate ......................................................................................................................................................... 11 ND

n-Butyl Alcohol ......................................................................................................................................................... ND ND

tert-Butyl Alcohol ...................................................................................................................................................... ND ND

Chlorobenzene ......................................................................................................................................................... ND ND

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... ND ND

Cyclohexane ............................................................................................................................................................ ND ND

o-Dichlorobenzene ................................................................................................................................................... ND ND

1,2-Dichloroethane ................................................................................................................................................... 13 ND

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 74 ND

Dimethylamine ......................................................................................................................................................... ND ND

N,N-Dimethylacetamide ........................................................................................................................................... ND ND

N,N-Dimethylaniline ................................................................................................................................................. 50 45

N,N-Dimethylformamide ........................................................................................................................................... 45 19

Dimethyl Sulfoxide ................................................................................................................................................... ND ND

1,4-Dioxane .............................................................................................................................................................. ND ND

Ethanol ..................................................................................................................................................................... ND ND

Ethyl Acetate ............................................................................................................................................................ 14 ND

Ethylene Glycol ........................................................................................................................................................ ND ND

Formaldehyde .......................................................................................................................................................... 1,480 623

Formamide ............................................................................................................................................................... ND ND

Furfural ..................................................................................................................................................................... 53 ND

n-Heptane ................................................................................................................................................................ ND ND

n-Hexane .................................................................................................................................................................. ND ND

Isobutyraldehyde ...................................................................................................................................................... 304 129

Isopropanol .............................................................................................................................................................. ND ND

Isopropyl Acetate ..................................................................................................................................................... 11 ND

Isopropyl Ether ......................................................................................................................................................... 74 32

Methanol .................................................................................................................................................................. ND ND

Methylamine ............................................................................................................................................................. ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methyl Formate ........................................................................................................................................................ ND ND

Methylene Chloride .................................................................................................................................................. ND ND

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ ND ND

2-Methylpyridine ....................................................................................................................................................... 50 45

Petroleum Naphtha .................................................................................................................................................. ND ND

Phenol ...................................................................................................................................................................... 25 14

Polyethylene Glycol 600 .......................................................................................................................................... 4,870 2,070

n-Propanol ................................................................................................................................................................ ND ND

Pyridine .................................................................................................................................................................... 10 10

Tetrahydrofuran ........................................................................................................................................................ 910 264

Toluene .................................................................................................................................................................... ND ND

Trichlorofluoromethane ............................................................................................................................................ ND ND

Triethylamine ............................................................................................................................................................ ND ND

Xylenes .................................................................................................................................................................... ND ND

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

Pollutant or pollutant property

New source performance

standards milligrams per liter

(mg/L)

Maximum for

any one day

Monthly

average

BOD5 ........................................................................................................................................................................ 34 10
21676 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant or pollutant property

New source performance

standards milligrams per liter

(mg/L)

Maximum for

any one day

Monthly

average

COD ......................................................................................................................................................................... 60 24

TSS .......................................................................................................................................................................... 40 12

pH ............................................................................................................................................................................. (a) (a)

(a) Within the range of 6.0–9.0 standard units.

18. Section 439.46 is revised to read as follows:

§ 439.46 Pretreatment standards for existing sources (PSES).

(a) Except as provided in 40 CFR 403.7 and 403.13, any existing source subject to this subpart that introduces

pollutants into a publicly owned treatment works must comply with 40 CFR part 403 and by [date 3 years from

the promulgation date of the final rule] achieve the following pretreatment standards for existing sources.

(1) Subpart D (For In-Plant Monitoring Points).

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Benzene ................................................................................................................................................................... 796 268

Chlorobenzene ......................................................................................................................................................... 796 268

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 796 268

Cyclohexane ............................................................................................................................................................ 796 268

n-Heptane ................................................................................................................................................................ 796 268

n-Hexane .................................................................................................................................................................. 796 268

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Toluene .................................................................................................................................................................... 198 148

Trichlorofluoromethane ............................................................................................................................................ 796 268

Xylenes .................................................................................................................................................................... 796 268

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

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

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone .................................................................................................................................................................... 31,400 9,690

n-Amyl Acetate ......................................................................................................................................................... 23,900 8,050

Amyl Alcohol ............................................................................................................................................................ 607,000 205,000

Aniline ...................................................................................................................................................................... 10,900,000 3,690,000

2-Butanone (MEK) ................................................................................................................................................... 1,440,000 430,000

n-Butyl Acetate ......................................................................................................................................................... 23,900 8,050

n-Butyl Alcohol ......................................................................................................................................................... 10,900,000 3,690,000

tert-Butyl Alcohol ...................................................................................................................................................... 607,000 205,000

o-Dichlorobenzene ................................................................................................................................................... 23,900 8,050

1,2-Dichloroethane ................................................................................................................................................... 23,900 8,050

Diethylamine ............................................................................................................................................................ ND ND

Diethyl Ether ............................................................................................................................................................ 23,900 8,050

Dimethylamine ......................................................................................................................................................... 607,000 205,000

N,N-Dimethylaniline ................................................................................................................................................. 607,000 205,000

1,4-Dioxane .............................................................................................................................................................. 10,900,000 3,690,000

Ethanol ..................................................................................................................................................................... 2,200,000 784,000

Ethyl Acetate ............................................................................................................................................................ 23,900 8,050

Formamide ............................................................................................................................................................... 607,000 205,000

Furfural ..................................................................................................................................................................... 607,000 205,000

Isobutyraldehyde ...................................................................................................................................................... 23,900 8,050

Isopropanol .............................................................................................................................................................. 597,000 198,000

Isopropyl Acetate ..................................................................................................................................................... 23,900 8,050

Isopropyl Ether ......................................................................................................................................................... 23,900 8,050

Methanol .................................................................................................................................................................. 11,700,000 3,800,000

Methylamine ............................................................................................................................................................. 607,000 205,000

Methyl Formate ........................................................................................................................................................ 23,900 8,050
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21677

Pollutant or pollutant property

Pretreatment standards for

existing sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Methyl Isobutyl Ketone (MIBK) ................................................................................................................................ 23,900 8,050

2-Methylpyridine ....................................................................................................................................................... 607,000 205,000

Petroleum Naphtha .................................................................................................................................................. 10,900,000 3,690,000

n-Propanol ................................................................................................................................................................ 2,790,000 941,000

Pyridine .................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran ........................................................................................................................................................ 9,210 3,360

Triethylamine ............................................................................................................................................................ ND ND

(b) [Reserved]

19. Section 439.47 is amended by

revising paragraph (a) introductory text

and paragraph (b) to read as follows:

§ 439.47 Pretreatment standards for new

sources (PSNS).

(a) Any new source subject to this

subpart that was a ‘‘new source’’ under

40 CFR 122.29 prior to [promulgation

date of the final rule] must achieve the

following pretreatment standards for

new sources until the expiration of the

applicable time period specified in 40

CFR 122.29(d)(1), after which the source

must achieve the standards specified in

§ 439.46.

* * * * *

(b) Except as provided in 40 CFR

403.7 and paragraph (a) of this section,

any new source subject to this subpart

that introduces pollutants into a

publicly owned treatment works must

comply with 40 CFR part 403 and

achieve the following pretreatment

standards for new sources.

(1) Subpart D (For In-Plant Monitoring

Points).

[Note: With respect to pollutants in this

table, EPA does not propose pretreatment

standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources

micrograms per liter (μg/L)

Maximum for

any one day

Monthly

average

Acetone* ................................................................................................................................................................... 1,190 600

Amyl Alcohol* ........................................................................................................................................................... 8,690 3,220

Benzene ................................................................................................................................................................... 573 212

n-Butyl Alcohol* ........................................................................................................................................................ 8,690 3,220

tert-Butyl Alcohol* .................................................................................................................................................... 8,690 3,220

Chlorobenzene ......................................................................................................................................................... 573 212

Chloroform ............................................................................................................................................................... ND ND

Chloromethane ......................................................................................................................................................... 573 212

Cyclohexane ............................................................................................................................................................ 573 212

Diethylamine* ........................................................................................................................................................... ND ND

Diethyl Ether* ........................................................................................................................................................... 2,230 826

Dimethylamine* ........................................................................................................................................................ ND ND

Ethanol* .................................................................................................................................................................... 8,690 3,220

Formamide* .............................................................................................................................................................. ND ND

n-Heptane ................................................................................................................................................................ 573 212

n-Hexane .................................................................................................................................................................. 573 212

Isopropanol* ............................................................................................................................................................. 8,690 3,220

Methanol* ................................................................................................................................................................. 8,320 ND

Methylamine* ........................................................................................................................................................... ND ND

Methyl Cellosolve ..................................................................................................................................................... ND ND

Methylene Chloride .................................................................................................................................................. 809 279

Methyl Formate* ....................................................................................................................................................... 2,230 826

n-Propanol* .............................................................................................................................................................. 8,690 3,220

Toluene .................................................................................................................................................................... 184 135

Trichlorofluoromethane ............................................................................................................................................ 573 212

Triethylamine* .......................................................................................................................................................... ND ND

Xylenes .................................................................................................................................................................... 573 212

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

[Note: With respect to pollutants in this table, EPA does not propose pretreatment standards for new sources for pollutants with

an asterisk (*) under co-proposal (2).]

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

n-Amyl Acetate* ....................................................................................................................................................... 2,230 826
21678 Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules

Pollutant or pollutant property

Pretreatment standards for

new sources micrograms per

liter (μg/L)

Maximum for

any one day

Monthly

average

Aniline* ..................................................................................................................................................................... 8,690 3,220

2-Butanone (MEK)* .................................................................................................................................................. 161,000 57,900

n-Butyl Acetate* ....................................................................................................................................................... 2,230 826

o-Dichlorobenzene* .................................................................................................................................................. 2,230 826

1,2—Dichloroethane* ............................................................................................................................................... 2,230 826

N,N-Dimethylaniline* ................................................................................................................................................ 8,690 3,220

1,4-Dioxane* ............................................................................................................................................................ 8,690 3,220

Ethyl Acetate* .......................................................................................................................................................... 2,230 826

Furfural* ................................................................................................................................................................... 8,690 3,220

Isobutyraldehyde* .................................................................................................................................................... 2,230 826

Isopropyl Acetate* .................................................................................................................................................... 2,230 826

Isopropyl Ether* ....................................................................................................................................................... 2,230 826

Methyl Isobutyl Ketone (MIBK)* ............................................................................................................................... 2,230 826

2-Methylpyridine* ..................................................................................................................................................... 8,690 3,220

Petroleum Naphtha* ................................................................................................................................................. 8,690 3,220

Pyridine* ................................................................................................................................................................... 1,000 1,000

Tetrahydrofuran* ...................................................................................................................................................... 9,210 3,360

§ 439.48 [Reserved]

Subpart E—Research Subcategory

20. Sections 439.50 through 439.52

are revised to read as follows:

§ 439.50 Applicability; description of the

research subcategory; prohibition.

(a) The provisions of this subpart are

applicable to discharges resulting from

bench-scale pharmaceutical research

operations and product development

activities. This subpart does not apply

to pilot- or full-scale operations that

generate wastewaters using

fermentation, extraction, chemical

synthesis, or mixing, compounding and

formulating. Such operations are

covered under subparts A, B, C, and D,

respectively.

(b) The discharge of non-process

wastewaters and materials excluded

from the definition of process

wastewater at § 439.1 is not covered by

this subpart. Discharges of such nonprocess wastewater and excluded

materials into publicly owned treatment

works or waters of the United States, by

a source subject to this subpart without

an NPDES permit or individual control

mechanism authorizing such discharge

is prohibited.

§ 439.51 Specialized definitions.

For the purpose of this subpart:

(a) Except as provided below, the

general definitions, abbreviations, and

methods of analysis set forth in 40 CFR

part 401 and § 439.1 shall apply to this

subpart.

(b) The term ‘‘product’’ shall mean

any product or service resulting from

pharmaceutical research, which

includes microbiological, biological,

and chemical operations.

§ 439.52 Effluent limitations representing

the degree of effluent reduction attainable

by the application of the best practicable

control technology currently available

(BPT).

(a) Except as provided in 40 CFR

125.30 through 125.32, any existing

point source subject to this subpart must

achieve the following effluent

limitations representing the degree of

effluent reduction attainable by the

application of the best practicable

control technology currently available.

(1) The allowable discharge for the

pollutant parameters BOD5 and COD

shall be expressed in mass per unit time

and shall represent the specified

wastewater treatment efficiency in terms

of a residual discharge associated with

an influent to the waste treatment plant

corresponding to the maximum

production period for a given

pharmaceutical plant as defined in

paragraph (a)(4) of this section.

(2) The allowable effluent discharge

limitation for the daily average mass of

BOD5 in any calendar month shall

specifically not reflect not less than 90

percent reduction in the long term daily

average raw waste content of BOD5

multiplied by a variability factor of 3.0.

However, a plant shall not be required

to attain a 30-day average BOD5 effluent

limitation of less than the equivalent of

45 mg/L.

(3) The allowable effluent discharge

limitation for the daily average mass of

COD in any calendar month shall

specifically not reflect not less than 74

percent reduction in the long term daily

average raw waste content of COD

multiplied by a variability factor of 2.2.

However, a plant shall not be required

to attain a 30-day average COD effluent

limitation of less than the equivalent of

220 mg/L.

(4) The long term daily average raw

waste load for the pollutant parameters

BOD5 and COD is defined as the average

daily mass of each pollutant influent to

the wastewater treatment system over a

12 consecutive month period within the

most recent 36 months, which shall

include the greatest production effort.

(5) To assure equity in regulation of

discharges from sources covered by this

subpart of the point source category,

calculation of raw waste loads of BOD5

and COD for the purpose of determining

NPDES permit limitations (i.e., the base

numbers to which the percent

reductions are applied) shall exclude

any waste load associated with solvents

in those raw waste loads, except the

residual amounts of solvents remaining

after the practice of solvent recovery

and/or separate disposal or reuse. These

practices of removal, disposal, or reuse

include recovery of solvents from waste

streams and incineration of

concentrated solvent waste streams

(including tar still bottoms). This

subpart does not prohibit inclusion of

such wastes in the raw waste loads in

fact, nor does it mandate any specific

practice, but rather describes the

rationale for determining permit

conditions. These limits may be

achieved by any one of several programs

and practices or a combination thereof.

(6) The allowable effluent discharge

limitation for the daily average mass of

TSS in any calendar month shall be 1.7

times the BOD5 limitation determined in

paragraph (a)(2) of this section.

(7) The pH shall be within the range

of 6.0–9.0 standard units.
Federal Register / Vol. 60, No. 84 / Tuesday, May 2, 1995 / Proposed Rules 21679

(b) [Reserved]

439.53 Effluent limitations representing

the degree of effluent reduction attainable

by the best conventional pollutant control

technology (BCT). [Reserved]

439.54 Effluent limitations representing

the degree of effluent reduction attainable

by the application of best available

technology economically achievable (BAT).

[Reserved]

439.55 New source performance

standards (NSPS). [Reserved]

439.56 Pretreatment standards for existing

sources (PSES). [Reserved]

439.57 Pretreatment standards for new

sources (PSNS). [Reserved]

439.58 [Reserved]

[FR Doc. 95–5663 Filed 5–1–95; 8:45 am]

BILLING CODE 6560–50–P