[Federal Register Volume 63, Number 182 (Monday, September 21, 1998)]
[Rules and Regulations]
[Pages 50388-50437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21027]



[[Page 50387]]

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Part III





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 136 and 439



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

  Federal Register / Vol. 63, No. 182 / Monday, September 21, 1998 / 
Rules and Regulations  

[[Page 50388]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 136 and 439

[FRL-6135-7]
RIN 2040-AA13


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

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: This final regulation limits the discharge of pollutants into 
navigable waters of the United States and into publicly owned treatment 
works (POTWs) by existing and new pharmaceutical manufacturing 
facilities. This regulation revises limitations and standards for four 
subcategories of the pharmaceutical manufacturing Point Source 
Category: Subcategory A (Fermentation), Subcategory B (Extraction), 
Subcategory C (Chemical Synthesis): and Subcategory D (Mixing, 
Compounding, and Formulating); and reformats and clarifies language 
without revision to certain specified provisions of these four 
subcategories and a fifth subcategory: Subcategory E (Research). This 
regulation establishes effluent limitations guidelines and standards 
under the Clean Water Act including ``best conventional pollutant 
control technology (BCT) and ``best available technology economically 
achievable (BAT)'' for existing direct dischargers, ``new source 
performance standards (NSPS)'' for new direct dischargers and 
pretreatment standards for existing and new indirect dischargers (PSES 
and PSNS). This regulation also amends and clarifies some of the 
limitations based on ``best practicable control technology (BPT)'' for 
pharmaceutical manufacturing facilities and establishes analytical 
methods for certain organic pollutants contained in this regulation. 
EPA is today also publishing final Maximum Available Control Technology 
(MACT) standards under the Clean Air Act (CAA) for the pharmaceutical 
manufacturing industry elsewhere in today's Federal Register. The MACT 
standards final rule will control emissions of hazardous air pollutants 
(HAPs) from pharmaceutical manufacturing emission sources including 
wastewater collection and treatment systems. The Offices of Water and 
Air and Radiation have coordinated the development of these regulations 
and have used a common technology basis in developing limitations and 
standards for the volatile organic compounds (VOCs).
    The final MACT standards and effluent limitations guidelines and 
standards rules will benefit the environment by removing a total of 
85.4 million pounds per year of conventional, nonconventional and toxic 
(priority) pollutants from water discharges. The effluent limitations 
guidelines and standards portion of those removals is 13.9 million 
pounds per year of nonconventional and 16.0 million pounds per year of 
organic pollutants including VOCs.

DATES: This regulation shall become effective November 20, 1998. The 
incorportion by reference of certain publications listed in Part 136 is 
approved by the Director of the Federal Register as of November 20, 
1998.

ADDRESSES: For additional technical information write to Dr. Frank H. 
Hund, Engineering and Analysis Division (4303), U.S. EPA, East Tower, 
401 M Street SW, Washington, D.C. 20460 or send E-mail to: 
[email protected] or call at (202) 260-7182. For additional 
economic information contact Mr. William Anderson at the address above 
or by calling (202) 260-5131 or send E-mail to: 
[email protected].
    The complete record (excluding confidential business information) 
for this Clean Water Act rulemaking is available for review at EPA's 
Water Docket, Room EB57; 401 M Street, SW, Washington, DC 20460. For 
access to Docket materials, call (202) 260-3027 between 9 a.m. and 3:30 
p.m. for an appointment. The EPA public information regulation (40 CFR 
part 2) provides that a reasonable fee may be charged for copying.
    The Technical Development Document and Economic Impact Analysis 
supporting today's final water rule may be obtained by writing to the 
EPA Office of Water Resource Center (RC-4100), 401 M Street SW., 
Washington, DC 20460, or calling (202) 260-7786.

FOR FURTHER INFORMATION CONTACT: For additional technical information 
call Dr. Frank H. Hund at (202) 260-7182. For additional information on 
the economic impact analyses contact Mr. William Anderson at (202) 260-
5131.
SUPPLEMENTARY INFORMATION: 

Judicial Review

    In accordance with 40 CFR 23.2, the rule will be considered 
promulgated for purposes of judicial review at 1:00 p.m. Eastern time 
on October 5, 1998. Under section 509(b)(1) of the Act, judicial review 
of this regulation can be obtained only by filing a petition for review 
in the United States Court of Appeals within 120 days after the 
regulation is considered promulgated for purposes of judicial review. 
Under section 509 (b)(2) of the Act, the requirements in this 
regulation may not be challenged later in civil or criminal proceedings 
brought by EPA to enforce these requirements.

Regulated Entities

    Entities potentially regulated by this action include:

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             Category                  Examples of regulated entities   
------------------------------------------------------------------------
Industry..........................  Facilities that generate process    
                                     wastewater from the manufacture of 
                                     pharmaceutical products and/or     
                                     pharmaceutical intermediates by    
                                     fermentation, extraction, chemical 
                                     synthesis and/or mixing,           
                                     compounding and formulating.       
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be regulated by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be regulated by this action. Other types of entities 
not listed in the table could also be regulated. To determine whether 
your facility is regulated by this action, you should carefully examine 
the applicability criteria in Secs. 439.1, 439.10, 439.20, 439.30, 
439.40 and 439.50 of this final rule. If you have questions regarding 
the applicability of this action to a particular entity, consult the 
technical information person listed in the preceding FOR FURTHER 
INFORMATION CONTACT section.

Compliance Dates

    The compliance date for PSES is as soon as possible, but no later 
than September 21, 2001. The compliance dates for NSPS and PSNS are the 
dates the new source commences discharging.

[[Page 50389]]

Deadlines for compliance with BPT, BCT, and BAT are established in the 
National Pollutant Discharge Elimination System (NPDES) permits.

Organization of This Document

I. Legal Authority
II. Background
    A. Clean Water Act
    1. Best Practicable Control Technology Currently Available (BPT)
    2. Best Available Technology Economically Achievable (BAT) 
(Section 304(b)(2) of the Act)
    3. Best Conventional Pollutant Control Technology (BCT) (Section 
304(b)(4) of the Act)
    4. New Source Performance Standards (NSPS) (Section 306 of the 
Act)
    5. Pretreatment Standards for Existing Sources (PSES) (Section 
307(b) of the Act)
    6. Pretreatment Standards for New Sources (PSNS) (Section 307(b) 
of the Act)
    B. Section 304(m) Requirements and the Pollution Prevention Act
    C. Updated Profile of the Industry
    D. Existing and Proposed Rules
    1. Clean Water Act Proposal
    2. Clean Air Act Proposal
    3. Clean Water Act Federal Register Notice of Availability
    E. Discussion of Final Clean Air Act Rule Published Elsewhere in 
Today's Federal Register
    F. Relationship Between the MACT and CWA Rules
    G. Final Clean Water Act Effluent Limitations Guidelines and 
Standards Rule
III. Summary of Most Significant Changes to Water Rules From 
Proposal
    A. Limitations and Standards for Volatile Organic Compounds
    B. Change in BAT Technology Basis for Organic Pollutants
    C. BPT and BAT/BCT Limitation Changes
    D. Pollutant Selection
IV. The Final Clean Water Act Regulation
    A. Applicability and Scope of the Final Rule
    B. Options Selection
    C. Best Practicable Control Technology Currently Available (BPT)
    D. Best Available Technology Economically Achievable
    E. Pretreatment Standards for Existing Sources (PSES)
    F. New Source Performance Standards (NSPS)
    G. Pretreatment Standards for New Sources (PSNS)
    H. Best Conventional Pollutant Control Technology (BCT)
V. Assessment of Costs and Impacts for the Final Pharmaceutical 
Regulations
    A. Introduction
    B. Summary of Economic Analysis Methodology and Data
    C. Changes to the Economic Analysis Since Proposal
    D. Estimated Economic Impacts
    1. Costs of Compliance
    2. Economic Impacts on Facilities
    3. Economic Impacts on Firms
    4. Impacts on Output and Employment
    5. Other Secondary Impacts
    6. Impacts on New Sources
    E. Regulatory Flexibility Analysis
    F. Cost-Benefit Analysis
    G Cost-Effectiveness Analysis
VI. Environmental Benefits
VII. Non-Water Quality Environmental Impacts
    A. Air Pollution
    B. Solid Waste
    C. Energy Requirements
VIII. Regulatory Implementation
    A. Implementation of the Limitations and Standards
    B. Upset and Bypass Provisions
    C. Variances and Modifications
    1. Fundamentally Different Factors Variances
    2. Removal Credits
    D. Analytical Methods
IX. Regulatory Assessment Requirements
    A. Executive Order 12866
    B. Regulatory Flexibility Act and the Small Business Regulatory 
Enforcement Fairness Act of 1996 (SBREFA)
    C. Submission to Congress and the General Accounting Office
    D. Paperwork Reduction Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 12875 Enhancing Intergovernmental Partnership
    G. National Technology Transfer and Advancement Act
    H. Executive Order 13045 and Protecting Children's Health
X. Summary of Public Participation
    A. Summary of Proposal Comments and Responses
    B. Summary of Notice of Availability Comments and Responses
Appendix A to the Preamble--List of Abbreviations, Acronyms, 
Definitions and Other Terms Used in This Document

I. Legal Authority

    This final regulation establishes effluent limitations guidelines 
and standards of performance and analytical methods for the 
pharmaceutical manufacturing point source category under the 
authorities of sections 301, 304, 306, 307, 308, 402 and 501 of the 
Clean Water Act (``the Act''), 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 
1342 and 1361.

II. Background

A. Clean Water Act

    The Federal Water Pollution Control Act Amendments of 1972 
established a comprehensive program to ``restore and maintain the 
chemical, physical, and biological integrity of the Nation's waters,'' 
(section 101(a)). To implement the Act, EPA is to issue effluent 
limitations guidelines, pretreatment standards and new source 
performance standards for industrial dischargers.
    These guidelines and standards are summarized briefly below:
1. Best Practicable Control Technology Currently Available (BPT) 
(Section 304(b)(1) of the Act)
    BPT effluent limitations apply to all discharges from existing 
direct dischargers. BPT effluent limitations guidelines are generally 
based on the average of the best existing performance by plants of 
various sizes, ages, and unit processes within the category or 
subcategory for control of pollutants.
    In establishing BPT effluent limitations guidelines, EPA considers 
the total cost of achieving effluent reductions in relation to the 
effluent reduction benefits, the age of equipment and facilities 
involved, the processes employed, process changes required, engineering 
aspects of the control technologies, non-water quality environmental 
impacts (including energy requirements) and other factors as the EPA 
Administrator deems appropriate (Section 304(b)(1)(B) of the Act). The 
Agency considers the category or subcategory-wide cost of applying the 
technology in relation to the effluent reduction benefits. Where 
existing performance is uniformly inadequate within a category or 
subcategory, BPT may be transferred from a different subcategory or 
category.
2. Best Available Technology Economically Achievable (BAT) (Section 
304(b)(2) of the Act)
    In general, BAT effluent limitations represent the best existing 
economically achievable performance of plants in the industrial 
subcategory or category, based upon available technology. The Act 
establishes BAT as the principal national means of controlling the 
direct discharge of toxic and nonconventional pollutants to navigable 
waters. 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) (Section 304(b)(2)(B)). 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 subcategory or category. BAT may include process 
changes or internal controls, even when these technologies are not 
common industry practice.

[[Page 50390]]

3. Best Conventional Pollutant Control Technology (BCT) (Section 
304(b)(4) of the Act)
    The 1977 Amendments to the Act established BCT for discharges of 
conventional pollutants from existing industrial point sources. Section 
304(a)(4) designated the following as conventional pollutants: 
Biochemical oxygen demanding pollutants (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).
    BCT is not an additional limitation, but replaces BAT for the 
control of conventional pollutants. In addition to other factors 
specified in Section 304(b)(4)(B), the Act requires that BCT 
limitations be established in light of a two part ``cost-
reasonableness'' test. American Paper Institute v. EPA, 660 F.2d 954 
(4th Cir. 1981). EPA's current methodology for the general development 
of BCT limitations was issued in 1986 (51 FR 24974; July 9, 1986).
4. New Source Performance Standards (NSPS) (Section 306 of the Act)
    NSPS are based on the best available demonstrated control 
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 
numerical values attainable through the application of the best 
available control technology for all pollutants (e.g., conventional, 
nonconventional, and toxic pollutants). In establishing NSPS, EPA is 
directed to take into consideration the cost of achieving the effluent 
reduction and any non-water quality environmental impacts and energy 
requirements.
5. Pretreatment Standards for Existing Sources (PSES) (Section 307(b) 
of the Act)
    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 Act authorizes 
EPA to establish pretreatment standards for pollutants that pass 
through POTWs or interfere with POTWs' treatment processes or sludge 
disposal methods. The legislative history of the 1977 Act indicates 
that pretreatment standards are to be technology-based and analogous to 
the BAT effluent limitations guidelines for removal of toxic 
pollutants. For the purpose of determining whether to promulgate 
national category-wide pretreatment standards, EPA generally determines 
that there is pass through of a pollutant and thus a need for 
categorical standards if the nation-wide average percent removal of a 
pollutant removed by well-operated POTWs achieving secondary treatment 
is less than the percent removed by the BAT model treatment system.
    The General Pretreatment Regulations, which set forth the framework 
for the implementation of categorical pretreatment standards, are found 
at 40 CFR Part 403. (Those regulations contain a definition of pass 
through that addresses localized rather than national instances of pass 
through and does not use the percent removal comparison test described 
above. See 52 FR 1586, January 14, 1987.)
6. Pretreatment Standards for New Sources (PSNS) (Section 307(b) of the 
Act)
    Like PSES, PSNS are designed to prevent the discharges of 
pollutants that pass through, interfere with, or are otherwise 
incompatible with the operation of POTWs. PSNS are to be issued at the 
same time as NSPS. New indirect dischargers, like new direct 
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.

B. Section 304(m) Requirements and the Pollution Prevention Act

    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 (``effluent guidelines''), 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). The plaintiffs charged that EPA's plan did not meet the 
requirements of sec. 304(m). A Consent Decree in this litigation was 
entered by the Court on January 31, 1992. The terms of the Consent 
Decree are reflected in the Effluent Guidelines Plan published on 
September 8, 1992 (57 FR 41000). This plan, as modified, required, 
among other things, that EPA propose effluent guidelines for the 
pharmaceutical manufacturing category by February, 1995 and take final 
action on these effluent guidelines by April, 1998. Recently EPA filed 
an unopposed motion requesting an extension of time until July 30, 1998 
for the Administrator to sign the final rule.
    The Pollution Prevention Act of 1990 (PPA) (42 U.S.C. 13101 et 
seq., Pub. L. 101-508, November 5, 1990) ``declares it to be the 
national policy of the United States that pollution should be prevented 
or reduced whenever feasible; pollution that cannot be prevented should 
be recycled in an 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 release 
into the environment should be employed only as a last resort...'' 
(Sec. 6602; 42 U.S.C. 13101(b). In short, preventing pollution before 
it is created is preferable to trying to manage, treat or dispose of it 
after it is created. This effluent guideline was reviewed for its 
incorporation of pollution prevention as part of this Agency effort.
    According to the PPA, source reduction reduces the generation and 
release of hazardous substances, pollutants, wastes, contaminants or 
residuals at the source, usually within a process. The term source 
reduction ``include[s] equipment or technology modifications, process 
or procedure modifications, reformulation or redesign of products, 
substitution of raw materials, and improvements in housekeeping, 
maintenance, training, or inventory control.'' The term ``source 
reduction'' does not include any practice which alters the physical, 
chemical, or biological characteristics or the volume of a hazardous 
substance, pollutant, or contaminant through a process or activity 
which itself is not integral to or necessary for the production of a 
product or the providing of a service.'' 42 U.S.C. 13102(5) In effect, 
source reduction means reducing the amount of a pollutant that enters a 
waste stream or that is otherwise released into the environment prior 
to out-of-process recycling, treatment, or disposal.
    The PPA directs the Agency to, among other things, ``review 
regulations of the Agency prior and subsequent to their proposal to 
determine their effect on

[[Page 50391]]

source reduction'' (Sec. 6604; 42 U.S.C. 13103(b)(2). This directive 
led the Agency to implement a pilot project called the Source Reduction 
Review Project that would facilitate the integration of source 
reduction in the Agency's regulations, including the technology-based 
effluent guidelines and standards.
    In the preamble to the proposed regulations, EPA discussed the 
possible pollution prevention alternatives available in pharmaceutical 
manufacturing. At that time, EPA indicated that pollution prevention 
opportunities were limited in the active ingredient manufacturing 
subcategories (namely, fermentation, natural extraction and chemical 
synthesis) but the use of water-based coatings in the formulation 
subcategory operations was a viable pollution prevention approach which 
eliminates the need for solvents in tablet coating operations. This 
approach may only be applicable to some and not most tablet coating 
operations, however. Since the proposal, EPA has received two 
suggestions for incorporating pollution prevention into the final 
regulations which were discussed in the August 8, 1997 Notice of 
Availability at 62 FR 42720. One suggestion presented to the Agency was 
that Subcategories B and D dischargers that incorporate best management 
practices (BMPs), which reduce their discharge of any of the regulated 
pollutants should not have to monitor for the specific regulated 
pollutants, and possibly only monitor for the conventional pollutants 
and COD. This pollution prevention approach is similar to the one 
adopted in the Pesticide Formulators, Packagers and Repackagers (PFPR) 
final regulation which was published in the Federal Register on 
November 6, 1996 at 61 FR 57518. (It should be noted that PFPR 
facilities that use the promulgated pollution prevention option have to 
assess their wastewater and may be required to treat wastewater prior 
to discharge.) EPA evaluated this suggestion and decided that since EPA 
is not promulgating BAT limitations for specific organic pollutants, 
this pollution prevention suggestion was not relevant to compliance by 
subcategory B and D direct dischargers with final BAT limitations. For 
PSES, EPA believes the suggestion may be workable for indirect 
dischargers, since standards for specific organic pollutants are 
contained in the final rule; however, no information was submitted to 
identify the pollution prevention practices that would be incorporated 
into the rule, and EPA has been unable to identify any.
    Another pollution prevention approach suggested to EPA was that 
Subcategories A and C facilities that can demonstrate a reduction in 
the use of a regulated pollutant and resultant lowered air emissions or 
water discharges should receive a higher effluent discharge limitation. 
As suggested, the higher effluent discharge limitation would be 
directly proportional to the amount of reduction achieved in the use of 
the regulated pollutant. Along with this suggestion, the commenters 
provided examples of how this pollution prevention suggestion could 
work in individual instances.
    In evaluating this suggestion including the examples provided, EPA 
was concerned about the amount and type of process information that 
would have to be obtained from facilities and the methodology for 
estimating the pollutant reductions as the result of any pollution 
prevention practices. Another concern of the Agency had to do with the 
determination of when, in the new product development phase of work, 
the practice represents a pollution prevention activity or is just part 
of normal process development work in bringing a new product process to 
full scale production. EPA was also concerned that pollutant discharge 
or emission reductions achieved in the bench scale or pilot scale 
product development activities may not be realized during full scale 
production operations. In the period following publication of the NOA, 
the Agency did not receive sufficient information relative to these 
concerns to enable it to develop a viable pollution prevention 
alternative based on this suggestion.

C. Updated Profile of the Industry

    The pharmaceutical manufacturing industry covered by this 
rulemaking is made up of 566 facilities located in 39 states, Puerto 
Rico and the Virgin Islands. EPA estimates that 304 of these facilities 
could be affected by today's final rule. The major concentrations of 
manufacturing facilities are located in the Northeast, the Midwest and 
Puerto Rico.
    The pharmaceutical manufacturing industry is defined by four types 
of manufacturing operations or processes. These activities result in 
subcategorization for purposes of this rulemaking. The four 
subcategories are referred to as:
     Subcategory A: Fermentation
     Subcategory B: Natural Extraction
     Subcategory C: Chemical Synthesis
     Subcategory D: Formulating, Mixing and Compounding
    A complete discussion of each subcategory's manufacturing 
operations and wastewater characteristics may be found in Sections 3 
and 5 of the final Technical Development Document (TDD), ``Development 
Document for Final Effluent Limitations Guidelines and Standards for 
the Pharmaceutical Manufacturing Point Source Category'' (EPA 821-R-98-
005).
    A fifth subcategory, Subcategory E: Research, was excluded from 
regulation beyond the existing BPT regulation promulgated on October 
27, 1983 at 48 FR 49808. The Research subcategory is defined by bench-
scale activities or operations related to the research on and 
development of pharmaceutical products. BAT/BCT limitations for this 
subcategory are determined on a case by case best professional judgment 
(BPJ) basis. For indirect dischargers, the general prohibition in 40 
CFR part 403 apply; in addition POTWs will establish local pretreatment 
limits on a case by case basis as necessary.

D. Existing and Proposed Rules

    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 through E). The five 
subcategories of the pharmaceutical manufacturing industry (40 CFR part 
439) were defined at that time as:
     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 biochemical 
oxygen demand (BOD5) and chemical oxygen demand (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 concentration-based limitations for total 
suspended solids (TSS) 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.

[[Page 50392]]

    On October 27, 1983, at 48 FR 49808, EPA revised the subcategory 
names to those currently applicable and promulgated revised BPT, BAT, 
PSES and PSNS for Subparts A thru D to cover the toxic pollutant 
cyanide, 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, D and E. The revisions for TSS consisted 
of deriving the limitations by the use of a multiplication factor of 
1.7 times each plant's BOD5 discharge. EPA also promulgated 
BPT, BAT, PSES and PSNS for pH (6.0-9.0) and BAT concentration-based 
limitations controlling the discharge of cyanide for subcategory A 
through D. The Agency also proposed NSPS for BOD5, TSS and 
pH in the October 1983 notice, but did not publish final NSPS for these 
parameters.
    On December 16, 1986, at 51 FR 45094, EPA promulgated BCT effluent 
limitations guidelines for BOD5, TSS and pH for 
subcategories A thru D. That final rule set BCT effluent limitations 
equal to the existing BPT effluent limitations guidelines for 
BOD5, TSS, and pH.
1. Clean Water Act Proposal
    On May 2, 1995 at 60 FR 21592, EPA proposed revised BPT 
concentration based limitations for BO5, COD and TSS based 
on advanced biological treatment for all subcategories and cyanide 
limitations based on hydrogen peroxide oxidation technology for the A 
(Fermentation) and C (Chemical Synthesis) subcategories. For BAT, EPA 
proposed end-of-pipe limitations for 53 organic pollutants plus 
ammonia, cyanide and COD for subcategories A and C. For subcategories B 
(Natural Extraction) and D (Formulating, Mixing and Compounding), EPA 
proposed BAT limitations for 53 organic pollutants and COD. The 
technology basis for the volatile organic compounds (VOCs) limitations 
was steam stripping plus advanced biological treatment for 
subcategories A and C and advanced biological treatment for 
subcategories B and D. The technology basis for the non-volatile 
organics was advanced biological treatment only, and the proposed 
ammonia limitations were based on nitrification. The proposed BAT 
cyanide limitations were equivalent to the BPT limitations, and the BCT 
limitations were also proposed equal to BPT for all manufacturing 
subcategories.
    For NSPS, EPA proposed end-of-pipe standards for 53 organic 
pollutants plus ammonia, BO5, TSS, cyanide and COD for 
subcategories A and C and end-of-pipe standards for 53 organic 
pollutants plus BO5, TSS, and COD for subcategories B and D. 
The BO5, COD, and TSS standards were based on two sets of 
performance data from the best performing plants in each of the A or C 
and B or D subcategories. The end-of-pipe VOC limitations were based on 
steam stripping with distillation and advanced biological treatment.
    For PSES EPA detailed two coproposals (A and B) to control VOCs in 
all subcategories. Coproposal A had pretreatment standards for 12 
highly volatile organic compounds and 33 less volatile organic 
compounds. To show compliance with the pretreatment standards, 
monitoring for the 12 highly volatile compounds would have been 
required in-plant. Coproposal B had only the pretreatment standards for 
the 12 highly volatile compounds. In addition, EPA proposed cyanide 
(identical to BPT) and ammonia standards (based on steam stripping) for 
subcategories A and C. The proposed PSNS differed from PSES in that the 
standards for all volatile organic compounds were based on steam 
stripping plus distillation technologies.
    Finally, EPA proposed that pilot plant wastewater would not be 
regulated by Subcategory E (Research) limitations but under appropriate 
manufacturing subcategory limitations.
2. Clean Air Act Proposal
    On April 2, 1997 at 62 FR 15753, EPA proposed National Emission 
Standards for Hazardous Air Pollutants (NESHAPs) for the 
Pharmaceuticals Production Source Category. In that proposed rule, the 
Agency proposed Maximum Available Control Technology (MACT) standards 
for controlling emissions of hazardous air pollutants (HAPs) from 
process vents, storage tanks, equipment leaks, wastewater collection 
and treatment systems and heat exchange systems at pharmaceutical 
manufacturing facilities that are determined to be major sources of 
HAPs.
    The proposed MACT standards for wastewater emission sources 
contained two alternative formats for achieving compliance, a percent 
removal and a reference control technology. Applicability 
determination, definitions, and control requirements were similar to 
the Hazardous Organic NESHAPs (HON) MACT standards for wastewater. The 
proposed standard required facilities to control wastewater streams 
that exceed the concentration cutoff where the process wastewater 
stream exits the pharmaceutical process equipment identified as the 
point of determination (POD). The proposed concentration cutoffs were 
1,300 parts per million by weight (ppmw) for partially soluble HAPs and 
5,200 ppmw for total HAPs at processes or PODs with annual HAP loads of 
1 megagram per year or metric ton per year (Mg/yr).
    Also, the proposed standard required all streams having a HAP 
concentration of 10,000 ppmw to be controlled at facilities with annual 
HAP loads of 1 Mg/yr or greater.
    The proposed standards required that the control of wastewater 
emissions be accomplished in one of the following manners: (1) Using a 
design biotreatment system for soluble HAPs; (2) Demonstrating removals 
achieving 99 percent by weight of partially soluble HAPs and 90 percent 
by weight of soluble HAPs from treatment systems; or (3) Demonstrating 
a removal of 95 percent by weight of total organic HAP from the 
treatment system. The MACT standard proposal also discussed options for 
CWA controls in light of the CAA MACT standard proposal for controlling 
emissions from wastewater streams at pharmaceutical facilities being 
covered by the proposed effluent limitations guidelines and standards. 
EPA's intent was that the effluent limitations guidelines and standards 
build on the MACT standards, and the discussion suggested several 
options to accomplish this.
3. Clean Water Act Federal Register Notice of Availability
    EPA published a Notice of Availability (NOA) in the Federal 
Register on August 8, 1997 at 62 FR 42720. EPA published this Notice in 
order to: allow public comment on the data received since the May 2, 
1995 CWA proposal, further develop and revise options for the control 
of the VOCs that were presented in the April 2, 1997 CAA MACT proposal, 
and suggest responses to some comments on the 1995 CWA proposal.
    In section II of the NOA, EPA provided the results of an EPA 
sampling study designed to provide information concerning the pass 
through analysis for water soluble organic pollutants such as methanol 
and discussed the pass through analysis that EPA would be performing 
with respect to these and other pollutants.
    In section III, EPA presented revisions of the pretreatment options 
which were earlier described in the MACT proposal, and presented 
options for reducing the discharge loadings of VOCs not controlled by 
the proposed MACT

[[Page 50393]]

standards. One option was compliance with the proposed MACT standards 
together with additional PSES requirements for all VOCs except alcohols 
and related compounds based on the performance database used in the 
1995 proposal. A second option included coverage of additional 
pollutants including alcohols and related compounds. EPA also presented 
costs and loadings for two scenarios involving these two options. One 
scenario would exclude facilities that discharged less than 10,000 
pounds per year of pollutants of concern, while the other scenario 
would not exclude them.
    In section IV, EPA presented the results of analyses with respect 
to the proposed data base for NSPS requirements for the conventional 
pollutants, COD and ammonia, pollutant exclusions, use of surrogate 
pollutants for compliance monitoring, small facility exclusion and 
changes to engineering costs and loadings removal estimates. In 
addition, EPA presented data editing criteria and methodologies for 
deriving BPT and BAT effluent limitations and PSES. On pages 42722-
42724 of the NOA, EPA presented BPT, BAT limitations and PSES being 
considered.

E. Discussion of Final Clean Air Act Rule Published Elsewhere in 
Today's Federal Register

    EPA received a number of comments on the proposed MACT standards 
for wastewater streams. While certain changes were made (see the final 
MACT rule published elsewhere in today's Federal Register) the controls 
required by the proposed MACT standards have not changed. As proposed, 
the final MACT incorporates the HON wastewater standards, thereby 
clarifying the MACT requirements for off-site treatment of wastewater. 
Under specified conditions, a source can transfer affected wastewater 
streams containing soluble HAPs and less than 50 ppmw partially soluble 
HAPs off-site for treatment. In addition, if the off-site treatment 
facility is a POTW with uncovered headworks (grit chamber, primary 
settling tanks, etc.) a demonstration that less than five percent of 
the total soluble HAPs are emitted is required. For POTWs with 
completely covered headworks, the final rule does not require a 
demonstration that less than five percent of the total soluble HAPs are 
emitted.

F. Relationship Between the MACT and CWA Rules

    As noted above, the CAA MACT rule being promulgated today sets 
emission standards for HAPs from wastewater collection and treatment 
systems at major source pharmaceutical manufacturing facilities. The 
CWA final effluent limitations guidelines and standards control the 
discharge of toxic, conventional and nonconventional pollutants in 
wastewater discharges from pharmaceutical manufacturing facilities. 
Some of the water pollutants being controlled by today's effluent 
guidelines and standards are also HAPs and thus these pollutants are 
being controlled by both the MACT and CWA final rules. The extent of 
the coverage of waterborne HAPs by the air and water rules will be 
discussed in subsequent sections, as will the joint economic analysis 
and environmental benefits assessment that were conducted for the two 
rules.

G. Final Clean Water Act Effluent Guidelines Limitations and Standards 
Rule

    Today EPA is promulgating revised BPT limitations only for COD 
based on advanced biological treatment for all four subcategories.
    For subcategories A and C, EPA is promulgating BAT limitations for 
COD equal to the revised BPT limitations and for 30 organic pollutants, 
including 28 VOCs (of which 13 are HAPS) based on advanced biological 
treatment identified as a basis for the revised COD limitations. In 
addition, for subcategories A and C, EPA is promulgating BAT ammonia 
limitations based on nitrification technology, and is modifying the BAT 
compliance monitoring requirements for the existing cyanide 
limitations.
    For subcategories B and D, EPA is adding BAT limitations for COD 
equal to the revised BPT requirements, and is withdrawing the existing 
BPT and BAT cyanide limitations since the facilities in these 
subcategories do not generate cyanide in their wastewaters.
    The Agency is promulgating PSES for 23 VOCs (10 of which are HAPs) 
plus ammonia for subcategories A and C, and is also clarifying the 
compliance requirements for the existing cyanide pretreatment 
standards. For subcategories B and D, EPA is promulgating PSES for the 
5 VOCs (1 of which is a HAP) and, for the same reason given above, is 
withdrawing the existing cyanide standards. Subcategories A and C 
facilities must continue to comply with the cyanide standards, and 
achieve compliance with the standards for ammonia and the 23 organic 
pollutants within three years. Subcategories B and D facilities must 
achieve compliance with the 5 organic pollutant standards within three 
years. The compliance times of up to three years is being given because 
of the design and installation of technologies used as a basis for the 
standards, such as steam stripping and nitrification require sufficient 
lead times for implementation.
    EPA is promulgating NSPS for subcategories A and C equal to the BAT 
limitations for COD, ammonia and the organic pollutants, including the 
VOCs, and revised limitations for BOD5 and TSS based on 
advanced biological treatment. EPA is also promulgating NSPS for 
subcategories B and D equal to BAT for COD and revised limitations for 
BOD5 and TSS based on advanced biological treatment, and is 
withdrawing the existing cyanide NSPS for these two subcategories.
    For PSNS EPA is promulgating standards equal to PSES for all 
pollutants and subcategories and is withdrawing the existing cyanide 
PSNS for subcategories B and D. Finally, EPA is promulgating BCT 
limitations equal to the existing BPT limitations for BOD5, 
TSS and pH.
    In today's rule, EPA has republished many parts of the existing 
guideline in Part 439 to make the changes made today easier to 
understand, and also reformated the guideline to make it more clear and 
easier to use. The republication or reformatting of existing 
requirements is not intended to introduce substantive changes to these 
regulatory provisions. For that reason, EPA believes prior notice and 
comment on these provisions is unnecessary.

III. Summary of Most Significant Changes to Water Rules From 
Proposal

    This section describes the most significant changes to the rule 
since proposal. Many of these changes have resulted from the comments 
that are discussed below (see section X). This section will discuss the 
major changes in the rule concerning revisions to the limitations and 
standards for VOCs, changes in the BAT technology basis and changes in 
the BPT and BAT limitations for pollutants other than the VOCs. More 
detailed explanations for changes may be found in the comment response 
document in the record of the final rule.

A. Limitations and Standards for Volatile Compounds

    In today's final rule, EPA is not requiring that the limitations 
for VOCs be measured in-plant as proposed. For all four subcategories, 
BAT, NSPS, PSES, and PSNS limitations and standards, except for cyanide 
limitations and standards in subcategories A and C, this rule does not 
alter the generally applicable rule

[[Page 50394]]

(122.45(h) or 403.6(e)) that limitations generally are measured at the 
end-of-pipe discharge point. This rule provides clarification of the 
existing in-plant monitoring for cyanide as discussed in the 
Implementation Section of this preamble (see section VIII A).
    At proposal, EPA proposed PSES for 13 alcohols and related 
pollutants (compounds) under coproposal B. These pollutants were 
methanol, ethanol, n-propanol, isopropanol, n-butyl alcohol, tert-butyl 
alcohol, amyl alcohol, formamide, N,N-dimethylaniline, pyridine, 1,4-
dioxane, aniline, and petroleum naphtha. No PSES/PSNS are being 
promulgated for these pollutants today because EPA determined these 
pollutants do not pass through POTWs or interfere with the treatment 
works. (See section IV.E for a discussion of the passthrough analysis 
for these pollutants).

B. Change in BAT Technology Basis for Organic Pollutants

    In the August 8, 1997 NOA, EPA discussed changing the technology 
basis for BAT organic pollutant limitations for subcategories A and C 
facilities from in-plant steam stripping and advanced biological 
treatment to advanced biological treatment only. EPA received comments 
supporting this change in technology basis. The final MACT standards 
being promulgated today will control most emissions of VOCs from 
wastewaters at subcategories A and C direct discharging facilities 
based on the use of steam stripping technology. Accordingly, EPA 
believes that it is not necessary or appropriate to include this 
technology in the BAT technology basis; the CWA limitations and 
standards are calculated from a data base representing advanced 
biological treatment only. Thus, EPA is promulgating BAT limitations 
for all of the 30 organic pollutants for subcategories A and C 
facilities based on advanced biological treatment only. EPA notes that 
one facility not covered by the MACT standards would need to install 
steam stripping technology in order to achieve the effluent limitations 
following the biological treatment system.

C. BPT and BAT/BCT Limitation Changes

    Based on the receipt of new data from commenters, proposed 
limitations were revised for the nonconventional pollutants COD and 
ammonia and a number of the organic pollutants. In addition, commenters 
on the proposed limitations for the conventional pollutants BOD5 and 
TSS, as well as COD, indicated that EPA should eliminate all non-
process wastewater in the calculation of limitations for these 
parameters. In developing limitations for the proposal, EPA did not 
back out the estimated non-process wastewater from the total wastewater 
flow and adjust the concentration accordingly because the non-process 
flow data provided by facilities in the data sets were only gross 
estimates and were not based on daily measurements of non-process flow. 
Despite requesting more precise information (such as daily non-process 
flow data) from facilities that generated the data sets used to 
calculate the proposed limitations for BOD5, TSS and COD, EPA did not 
obtain this information. However, in the NOA, EPA presented revised 
proposed limitations for BOD5 and TSS and COD that were calculated from 
the existing plant data sets using the gross estimates of non-process 
flow, as described below, to adjust the concentrations in addition to 
several new data sets from plants other than those used for the 
proposal.
    In a previous EPA effluent limitations guidelines and standards 
rulemaking for the Organic Chemicals, Plastics and Synthetic Fibers 
(OCPSF) industry (52 FR 42522), only plant data sets that contained 
less than 25 percent non-process wastewater through treatment were used 
in calculating limitations. Thus, the 25 percent level of non-process 
wastewater dilution was determined as a benchmark in order to evaluate 
biological treatment performance. For the purposes of the NOA, in cases 
where the non-process flow was estimated to be more than 25 percent of 
the total flow, the non-process wastewater was backed out of the total 
flow volume and the parameters corrected for the absence of this non-
process wastewater. However, for the final rule, limitations for COD 
are developed from data sets in which the reported flow volume contains 
less than 25 percent non-process wastewater and the limitations are 
calculated without correcting the data sets for the non-process flow 
dilution. This change is discussed further in section IV.D below. As 
further discussed below, limitations for BOD5 and some of the remaining 
TSS are not being revised at this time since the revised COD limits 
requiring advanced biological treatment will incidentally remove a 
large portion of the remaining BOD5 and TSS.
    Another change to the proposal involved the limitations and 
standards proposed for cyanide. EPA proposed BPT, BAT, NSPS, PSES and 
PSNS limitations and standards for cyanide based on the performance of 
hydrogen peroxide oxidation technology. Following the proposal, EPA 
received comments indicating that the use of the hydrogen peroxide 
technology to destroy cyanide could possibly result in equipment 
explosions with certain types of wastewater. Other commenters indicated 
that hydrogen peroxide technology may not be an appropriate cyanide 
destruction technology for all treatment situations. Along with these 
comments, EPA received additional data on the performance of alkaline 
chlorination technology in destroying cyanide. Based on these comments 
and the new performance data, EPA indicated in the NOA that it was 
considering promulgating two sets of cyanide limitations, one based on 
the performance of hydrogen peroxide technology and the other based on 
the performance of alkaline chlorination technology. In the NOA, EPA 
indicated that only those facilities that could demonstrate that a 
potential safety hazard could result from their use of hydrogen 
peroxide technology would be subject to the alkaline chlorination 
limitations and standards. EPA also solicited information and comments 
regarding wastestreams with high organic content as evidenced by high 
COD or total organic carbon (TOC) levels, and at what levels these 
pollutants would indicate that the wastestream(s) high organic content 
would present a safety concern and would more appropriately be 
controlled by limitations based on alkaline chlorination. After 
consideration of the information provided in response to the 
solicitation in the NOA, particularly new performance data representing 
current (post 1990 base year) loadings, EPA has decided not to revise 
the existing limitations and standards for cyanide based on the small 
amount of cyanide discharge loadings that would be removed. However, 
the final rule continues to require compliance with the cyanide 
limitations be established in-plant, prior to commingling the cyanide 
bearing wastestreams with non-cyanide wastestreams for those facilities 
where the cyanide levels would be below the level of detection at the 
end-of-pipe monitoring location.
    Along with comments on its proposed numerical limitations and 
standards for ammonia and organic pollutants, EPA received data 
concerning the performance of steam strippers, advanced biological 
treatment and nitrification in connection with these proposed 
limitations. EPA evaluated these data, and provided revised numerical 
limitations and standards in the NOA for ammonia, several organic 
pollutants controlled by BAT technology (advanced biological treatment) 
and several VOCs controlled

[[Page 50395]]

by steam stripping technology for PSES. As the result of the data 
received and evaluated, along with comments on the NOA, EPA has changed 
the numerical BAT limitations for ammonia. In response to comments in 
the NOA indicating that indirect dischargers should be able to achieve 
the PSES ammonia limitations using either two-step nitrification 
technology or steam stripping, EPA has decided to set the PSES ammonia 
limitations equal to the BAT ammonia limitations, and to provide that 
indirect discharging subcategories A and C facilities discharging to 
POTWs with nitrification capability need not comply with the 
categorical limit for ammonia. EPA has also changed the numerical BAT 
limitations and PSES for several organic pollutants based on its 
analysis of data received in response to the proposal.

D. Pollutant Selection

    EPA received several comments concerning the reasoning behind the 
regulation of certain pollutants as well as the overall rationale for 
selecting pollutants for regulation. In the NOA, EPA indicated that it 
had reviewed the loadings bases of all the pollutants selected for 
regulation and had determined that in the case of eight pollutants, 
insufficient amounts of the pollutants are being discharged to justify 
national regulation. These pollutants are diethyl ether, cyclohexane, 
chloromethane, dimethylamine, methylamine, furfural, 2-methylpyridine 
and trichlorofluoromethane. Since the NOA, EPA has reevaluated its 
final loadings database and has determined that the exclusion of these 
pollutants along with an additional 15 pollutants is appropriate. The 
additional 15 pollutants are excluded from the BAT regulation based on 
the lack of removals from current discharge or the control of 
discharges of the pollutant by other regulated pollutant parameters. 
These pollutants are butanone, formaldehyde, n-butanol, tertiary 
butanol, n-propanol, ethylene glycol, polyethylene glycol 600, aniline, 
petroleum naphtha, 1,4-dioxane, formamide and dimethyl formamide, 
dimethylaniline, dimethylacetamide and pyridine.
    EPA proposed PSES for 45 organic pollutants, 37 of which are VOCs, 
under co-proposal A with compliance for the standards for 12 of the 
VOCs to be monitored in-plant, and compliance for the standards for the 
remaining 33 organics to be monitored at the end-of-pipe. In the NOA, 
EPA presented two revised PSES options, under which EPA would 
promulgate pretreatment standards for VOCs with end-of-pipe monitoring. 
The pollutants not regulated under one of these PSES options include 
water soluble alcohols such as methanol and related compounds. After 
consideration of comments and evaluating the results of the 
Barcelonetta POTW study and its implications on the final pass through 
analysis (see further discussion of pass through analysis in section IV 
E below) and further evaluation of incidental removals and the amount 
of or discharge removals for the pollutants, EPA is promulgating PSES 
and PSNS for 23 VOCs for subcategories A and C and 5 VOCs for 
subcategories B and D. The PSES and PSNS do not include the alcohols 
and related compounds, and are based on monitoring at the end-of-pipe 
unless the POTW determines it to be impractical per 40 CFR 403.6(e).

IV. The Final Clean Water Act Regulation

    This section discusses the applicability of the final rule, 
regulatory options considered and the rationale for the selected 
options for BPT, BCT, BAT, PSES, PSNS and NSPS.

A. Applicability and Scope of the Final Rule

    Today's final effluent limitations guidelines and standards are 
intended to cover pollutants in process wastewater discharges from 
existing and new pharmaceutical manufacturing facilities. Based on 
comments, EPA has revised the proposed scope of the rule. This final 
rule contains revisions to the effluent limitations guidelines and 
standards in four subcategories (A thru D) of the pharmaceutical 
manufacturing point source category, EPA is not revising the scope of 
the applicability for the fifth subcategory (Subcategory E-Research).
    With regard to subcategory E facilities, EPA proposed to revise the 
description of the research subcategory in the applicability section of 
the existing subcategory E regulations to exclude pilot or full-scale 
operations that generate wastewater using fermentation, extraction, 
chemical synthesis or mixing, compounding and formulating from the 
scope of subpart E, and these operations were proposed to be covered by 
the appropriate subcategory A through D. After considering the comments 
received concerning the regulation of wastewaters from pilot-scale 
operations, EPA has decided not to change the existing description of 
the research subcategory in the applicability section. EPA believes 
that it does not have sufficient information concerning subcategory E 
generated wastewaters to change the existing description. Subpart E 
facilities remain subject to the BPT limitations in the existing 
guidelines. If pilot scale operations occur at either stand alone 
research facilities or during operations at manufacturing facilities, 
then BAT and BCT limits for these wastewaters can be determined by 
permit writers on a best professional judgment (BPJ) basis, or 
similarly, such wastewater generated at indirect discharging facilities 
may be addressed by the regulations found at 40 CFR 403.5 and by local 
limits on a case-by-case basis.
    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 
the manufacturing subcategories in this final regulation include, but 
are not limited to:
    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 or 
other categorical limitations and standards if they are manufactured by 
a pharmaceutical manufacturer by processes that generate wastewaters 
that in turn closely correspond to those of pharmaceutical products. 
(An example of such a product is citric acid.)
    g. Cosmetic preparations covered by SIC Code No. 2844 that contain 
pharmaceutically active ingredients or

[[Page 50396]]

ingredients intended for treatment of some skin condition. (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, shaving preparations and non-medicated shampoos 
that do not function primarily as a skin treatment.)
    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 
pharmaceutical manufacturing category are contained in the 
applicability provision of the final rule and in sections 2 and 3 of 
the final TDD.
    In the NOA, EPA indicated that it was considering excluding from 
the scope of the regulation organic chemical manufacturers covered by 
the OCPSF regulation (40 CFR, Part 414) that manufacture pharmaceutical 
intermediates and active ingredients provided that the pharmaceutical 
portion of the process wastewater is less than 50 percent of the total 
process wastewater. EPA received no adverse comments concerning this, 
and has decided to promulgate this exclusion as described in the NOA. 
Thus facilities will be covered by the existing OCPSF regulation for 
both their OCPSF and pharmaceutical manufacturing process wastewaters 
provided that the pharmaceutical portion of the process wastewater at 
the facility is less than 50 percent of the total.

B. Options Selection

    EPA evaluated final technology options for BPT, BAT, BCT, NSPS, 
PSES and PSNS limitations and standards for all four subcategories A 
thru D. The options considered for each level of control are discussed 
below in sections IV.C thru H.

C. Best Practicable Control Technology Currently Available (BPT)

    EPA proposed to revise BPT for the conventional pollutants 
BOD5 and TSS, the nonconventional pollutant COD, and the 
toxic pollutant cyanide for subcategories A and C, and for 
subcategories B and D, proposed to revise BPT limitations for 
BOD5, TSS, and COD and to withdraw the cyanide limitations. 
In response to this proposal, EPA received comments claiming that EPA 
lacks the legal authority to revise BPT for the conventional pollutants 
since the proposed revised BPT limitations did not pass the BCT cost-
reasonableness test. EPA also received comments claiming that COD and 
cyanide should not be regulated at BPT but only at the BAT level.
    In today's rulemaking, EPA is revising BPT limitations only as to 
COD. The current BPT limitations for BOD5, TSS and cyanide 
will continue to apply (except for subcategories B and D where EPA is 
withdrawing the BPT limitations for cyanide). Accordingly, issues 
raised by commenters regarding EPA's legal authority to revise BPT for 
BOD5, TSS, or cyanide do not need to be addressed in this 
rulemaking. Nonetheless, EPA continues to believe that it has the legal 
authority to revise BPT limitations as appropriate. EPA further 
believes it can do so for conventional pollutants without having to 
apply the BCT cost-reasonableness test. Because EPA's authority to 
revise BPT limitations for conventional pollutants or cyanide is no 
longer an issue in this rulemaking, EPA is providing only a general 
statement of its statutory authority to revise BPT. For example, 
section 304(b) of the CWA directs EPA to revise all effluent limitation 
guidelines, including those based on BPT, at least annually if 
appropriate. Similarly, section 304(m) directs EPA to establish a 
schedule ``for the annual review and revision of promulgated effluent 
guidelines, in accordance with subsection (b) of this section.'' EPA 
does not believe that the addition of the BCT provisions to the CWA 
supplanted the BPT provisions. When enacting the more recent BCT 
provisions, Congress did not strip EPA of its explicit authority to 
revise or update BPT as necessary and appropriate. Moreover, the 
different purposes of BPT and BCT limitations would support an EPA 
decision to promulgate best ``practicable'' control technology for 
conventional pollutant control (represented by BPT), rather than the 
higher ``best available'' standard (represented by BCT).
    Similarly, it is the Agency's position that it is not required to 
regulate COD or cyanide only at the BAT level. As noted above, section 
304(b) of the CWA as well as section 304(m) directs EPA to revise all 
effluent limitations guidelines, including those based on BPT, at least 
annually if necessary and appropriate. It is EPA's view that the 
addition of BAT provisions to the CWA did not supplant the BPT 
provisions. When enacting the more recent BAT provisions, Congress did 
not strip EPA of its authority to revise or update BPT as necessary and 
appropriate. Further, the different purposes of BPT and BAT limitations 
would support an EPA decision to promulgate revised effluent limitation 
guidelines for nonconventional or toxic pollutants that reflect simply 
the next generation of best ``practicable'' control technology 
(represented by BPT), rather than the higher ``best available'' 
standard (represented by BAT).
    Since EPA is not revising BPT limitations for cyanide (but rather 
is modifying the compliance monitoring requirements for cyanide for 
subcategories A and C, and withdrawing the limitations as to 
subcategories B and D), the issue need not be addressed further in this 
rulemaking.
    EPA believes that the decision of whether or not to revise BPT for 
nonconventional pollutants should be made based upon consideration of a 
number of factors, including, but not necessarily limited to, cost, the 
technology being considered and the relative performance being achieved 
(best ``practicable'' versus best ``available''), the anticipated 
pollutant reductions, and implementation burden on permit writers.
    In this case, EPA has made a determination that the costs and 
removals associated with the implementation of advanced biological 
treatment at a best ``practicable'' level warrant revision of COD at 
BPT. This is in part due to the relatively high concentrations of COD 
in the effluent that are allowed under the existing percent removal BPT 
limitations which are unique to this industry. In other cases, the 
Agency has decided not to revise BPT (see, for example, Effluent 
Limitation Guidelines for the Pulp, Paper, and Paperboard Category, 
subparts B and E, 63 FR 18534, April 15, 1998).
    As noted above, EPA proposed to revise BPT for the conventional 
pollutants BOD5 and TSS, the nonconventional pollutant COD, 
and the toxic pollutant cyanide for subcategories A and D, and for 
subcategories B and D, to revise BPT limitations for BOD5, 
TSS, and COD and to withdraw the existing cyanide limitations. The 
technology basis of the proposed BPT limitations was advanced 
biological treatment. EPA also determined that the level of performance 
necessary for a plant to be considered as a best performer at the best 
``practicable'' level was full compliance with the existing BPT 
limitations. Of the plants considered as best performers at proposal, 
EPA selected five A and C subcategory plants and two B and D 
subcategory plants. The Agency then calculated long-term average 
performance concentrations for regulated pollutants from the best 
performing A and C and B and D plants.
    In developing the final BPT limitations, EPA has essentially

[[Page 50397]]

followed the proposal methodology except that EPA used only data sets 
representing less than 25 percent non-process wastewater through 
treatment and included the additional data sets received since proposal 
in its final limitations determinations. Except for one facility which 
adds non-process wastewater after treatment but before the end-of-pipe 
sample point, the BPT data sets were not corrected for non-process 
wastewater and the final limitations were calculated using the plant 
flow that included some non-process wastewater.
    EPA did not back out the estimated non-process wastewater in 
developing the proposed BPT concentration based limitations because 
non-process flow data available at that time were only gross estimates 
not identified in sufficient detail and were not based on daily 
measurements of non-process flow. Regarding the proposed BPT 
limitations, commenters indicated that EPA should eliminate all non-
process wastewater from the calculation of BPT limitations. EPA did not 
have information such as daily non-process flow data from facilities 
that generated the data sets used in the calculation of BPT and BAT 
limitations for BOD5, TSS and COD to allow adjustment. In 
the recent NOA, EPA presented BPT limitations for BOD5 and 
TSS and BAT COD limitations that were calculated from plant data sets 
which included the additional data submissions obtained since proposal 
from which the non-process wastewater had been backed out. In cases 
where the non-process flow was estimated by EPA to be more than 25 
percent of the total flow using the available data, the fraction of the 
non-process to process flow volume was used to calculate a correction 
factor and the long-term average concentration values for each of the 
BPT parameters were adjusted to reflect the parameters absence of this 
non-process wastewater. No corrections were made to data sets where the 
non-process flow was estimated to be less than 25 percent of the total 
flow.
    EPA received no adverse comments regarding these adjusted 
limitations. However, based on further analysis, EPA believes that it 
is more appropriate to follow the methodology used in developing the 
final Organic Chemicals, Plastics, and Synthetic Fibers (OCPSF) 
regulation (52 FR 52522) final BPT limitations. In that rule, only 
plant data sets that contained less than 25 percent non-process 
wastewater through treatment were used in the calculation of BPT 
limits, and the effluent data were not adjusted to take into account 
plant data sets that contained more than 25 percent non-process 
wastewater through treatment. EPA selected this approach in calculating 
the final BPT limitations in this rule for the same two reasons used 
during development of the OCPSF rule. (See 52 FR 42522). First, using 
data sets with greater than 25 percent non-process wastewater through 
treatment introduces considerable uncertainty into the limitation 
calculations because the flow data that would be used are only in part 
based on daily flow measurements whereas the concentration-based 
limitations are calculated from the long term average of daily 
measurements over long periods of time (12-24 months). Second, the 
final limitations should represent as much as possible the performance 
of treatment technology on process wastewater. In determining permit 
mass limits, permit writers and, where applicable, pretreatment control 
authorities should identify the amount of non-process wastewater being 
treated. The flow volume representing 25 percent or less of the total 
flow should be included in the volume used to calculate allowable mass 
discharges. Any additional volume would have to be evaluated on a case-
by-case basis to determine what, if any, mass allowances are 
appropriate.
    EPA considered four options for the final BPT limitations. Under 
the first option, EPA would not revise the existing BPT limitations for 
BOD5, TSS, COD and cyanide. No costs or removals are 
associated with this option. Under the second option, EPA would revise 
the BPT limitations based on advanced biological treatment only for 
COD, and revise the monitoring requirements for the existing cyanide 
limitations. Under option three, EPA would revise BPT limitations for 
BOD5 and TSS based on advanced biological treatment and 
revise the monitoring requirements for the existing cyanide 
limitations. Under the fourth option, EPA would revise BPT limitations 
for BOD5, TSS, and COD based on advanced biological 
treatment, and revise the monitoring requirements for the existing 
cyanide limitations. The options for all subcategories are the same, 
except as to cyanide where the option for subcategories B and D 
contains the option to withdraw the cyanide limitations rather than 
just modify the monitoring requirements.
    The pretax total annualized costs, pollutant removals, and costs 
per pound removed associated with the options, except the ``no action'' 
option, are shown below in Table IV.C.1.

              Table IV.C.1.--BPT Pretax Option Costs, Pollutant Removals and Cost per Pound Removed             
----------------------------------------------------------------------------------------------------------------
                                                                       Total                                    
                                                                    annualized       Pollutant    Cost per pound
                        Treatment option                             cost  ($        removals        ($1996/lb) 
                                                                   million 1997)       (lbs)                    
----------------------------------------------------------------------------------------------------------------
                                                 A/C Subcategory                                                
----------------------------------------------------------------------------------------------------------------
Clarify cyanide monitoring, revise COD only.....................           $2.48      14,352,000           $0.17
Clarify cyanide monitoring, revise BOD5 & TSS...................            2.61       4,692,000            0.56
Clarify cyanide monitoring, revise BOD5, TSS, & COD.............            3.10      15,731,000            0.20
----------------------------------------------------------------------------------------------------------------
                                                 B/D Subcategory                                                
----------------------------------------------------------------------------------------------------------------
Withdraw cyanide, revise COD only...............................           $1.38         539,000           $2.56
Withdraw cyanide, revise BOD5 & TSS.............................            1.89         588,000            3.21
Withdraw cyanide, revise BOD5, TSS, & COD.......................            2.16         598,000            3.62
----------------------------------------------------------------------------------------------------------------

    In selecting these treatment options, EPA considered the total cost 
in relation to the effluent reduction benefits, the age of equipment 
and facilities involved, the processes employed, process changes 
required, engineering aspects of the control technologies, non-water 
quality environmental impacts (including energy requirements) and

[[Page 50398]]

other factors in accordance with section 304(b)(1)(B) of the CWA.
    EPA has determined to revise BPT effluent limitations only for COD. 
EPA is also clarifying the compliance monitoring requirements for the 
existing BPT limitations for cyanide for subcategories A and C, and 
withdrawing the existing cyanide limitations for subcategories B and D. 
As discussed above, EPA believes that it has the statutory authority to 
revise BPT and that it has the discretion to determine whether to 
revise BPT effluent limitations guidelines in particular circumstances. 
The CWA requires EPA, when setting BPT, to examine the total cost of 
treatment technologies in relation to the effluent reduction benefits 
achieved. In addition, in determining whether to set BCT limitations, 
the Agency needs to consider the reasonableness of the cost of reducing 
conventional pollutants and compare the cost of removing those 
pollutants by regulated plants and by POTWs. Accordingly, EPA examined 
the use of advanced biological treatment as a basis for both BPT and 
BCT limitations for BOD5 and TSS. The Agency found that the 
reductions in these conventional contaminants achieved by this 
technology were not commensurate with the costs, largely because of the 
large operational costs associated with the removal of TSS. While it is 
EPA's view that it can revise BPT limitations for conventional 
pollutants without passing the BCT cost test (where the BPT effluent 
reduction ratio is favorable), the Agency is not generally inclined to 
do so unless the removals achieved by the existing BPT limitations are 
significantly fewer than would be achieved through revision of BPT. 
That was not the case here. Revising BPT (and BAT) for COD plants will 
not only remove large amounts of COD, but also achieve significant 
incidental removals of BOD5 and TSS. For this reason, EPA 
has determined that it is not necessary to separately revise the BPT 
limits for BOD5 and TSS in this case.
    EPA has determined to revise BPT for COD because the biological 
treatment technology used as a basis for the limitations really 
represents BPT technology and is widely used in the industry.
    The bulk parameter and nonconventional pollutant COD is an 
indicator of organic matter in the wastestream that is susceptible to 
strong oxidation, and as such would also measure organic material 
susceptible to biochemical oxidation, as well as some that is more 
difficult to oxidize biochemically. In addition, limited studies and 
discharge monitoring data have identified toxicity associated with the 
COD levels contained in effluents from pharmaceutical manufacturing 
facilities. Further discussion of the toxicity levels measured in the 
effluents from pharmaceutical manufacturing facilities is contained in 
Section 6 of the TDD. The revised COD limitations are estimated to 
remove approximately 14.9 million pounds annually, including incidental 
removal of 2.7 million pounds of BOD at an annualized cost of $2.48 
million ($1997).
    The revised COD provisions require the use of either the new 
effluent concentration limitations or the existing 74 percent reduction 
requirement, depending upon which method determines the more stringent 
plant permit limitation. This is being done in order to avoid back-
sliding issues for existing plants that because of low influent 
concentration already meet lower effluent limits for COD.
    With regard to cyanide, EPA is retaining the existing BPT 
limitations for the A and C subcategories. Further revision of the BPT 
cyanide limitations was not selected since the removals were estimated 
to be less than 42 pounds per year, thus, determined not to be 
beneficial in relation to the annualized costs of over $200,000 
($1997).
    However, EPA is modifying the requirements for compliance 
monitoring (for subcategories A and C). The current limitations require 
compliance monitoring after cyanide treatment and before dilution with 
other wastestreams, or in the alternative, monitoring after mixing with 
other wastestreams based on a standard dilution factor. Today's rule 
does not change the prohibition on dilution to meet the effluent 
limitations for cyanide. The rule continues to require monitoring for 
compliance with the existing limitations in-plant, prior to the 
commingling of cyanide-bearing wastestreams with non-cyanide bearing 
wastestreams for those facilities where the cyanide levels would be 
below the level of detection at the end-of-pipe monitoring location. 
The only change in the monitoring requirements is to eliminate the 
current dilution standard that applied industry-wide, and to allow 
individual facilities to demonstrate that end-of-pipe monitoring for 
cyanide is feasible (i.e., cyanide is detectable); those facilities may 
continue to monitor at the end of pipe.
    The ability of EPA to require in-plant monitoring has recently been 
questioned in connection with the Great Lakes water quality guidance 
program. American Iron and Steel Institute (AISI) v. EPA, 115 F.3d 979 
(D.C. Cir. 1997). The Court held that although EPA has the authority to 
require monitoring of internal wastestreams, see AISI, 115 F.3d at 995, 
the CWA does not authorize EPA to require compliance with water quality 
based effluent limitations at a point inside the facility and thereby 
deprive a permittee of the ability to choose its own control system to 
meet the limitations, see id. at 966. EPA does not believe that 
decision controls here. The AISI court did not consider the question 
whether EPA has authority to regulate internal wastestreams in the 
context of technology-based controls such as BPT/BAT, PSES and NSPS/
PSNS. Unlike water quality-based effluent limitations, which are 
calculated to ensure that water quality standards for the receiving 
water are attained, technology-based limitations and standards are 
derived to measure the performance of specific model technologies that 
EPA is required by statute to identify. In identifying these 
technologies, EPA is directed to consider precisely the type of 
internal controls that are irrelevant to the development of water 
quality-based effluent limitations, such as the processes employed, 
process changes, and the engineering aspects of various types of 
control techniques. EPA's technology-based effluent limitations are 
intended to reflect, for each industrial category or subcategory, the 
``base level'' of technology (including process changes) and to ensure 
that ``in no case * * * should any plant be allowed to discharge more 
pollutants per unit of production than is defined by that base level.'' 
E.I. du Pont de Nemours & Co. v. Train, 430 U.S. at 129 (1973).
    EPA believes that it can require in-plant monitoring to demonstrate 
compliance with technology-based effluent limitations in accordance 
with the CWA and its regulations at 40 CFR 122.44(i), 122.45(h), 
125.3(e) and 403.6(e). In today's rule, EPA is continuing to require 
in-plant monitoring for cyanide except where cyanide can be detected in 
the final effluent. Were EPA to require compliance monitoring of the 
final effluent without adjustment for the amount of dilution in 
cyanide-bearing waste streams, there would be no way to determine 
whether the facility had adequately controlled for cyanide or whether 
the effluent has simply been diluted below the analytical detection 
level. Diluting pollutants in this manner rather than preventing their 
discharge is inconsistent with achieving the removals represented by 
the technology-based levels of control and hence with

[[Page 50399]]

the purposes of the limitations. It is also inconsistent with the goals 
of the CWA in general.

D. Best Available Technology Economically Achievable

    EPA proposed adding new end-of-pipe BAT limitations for 53 organic 
pollutants plus ammonia, revising the existing cyanide limitations and 
adding the BPT revised COD limitations for subcategories A and C. For 
subcategories B and D, EPA proposed adding new end-of-pipe BAT 
limitations for 53 organics, BPT revised COD limitations and 
withdrawing the existing cyanide limitations. The technology basis for 
the limitations for VOCs was steam stripping plus advanced biological 
treatment for subcategories A and C and advanced biological treatment 
for subcategories B and D. The technology basis for the ammonia 
limitations was nitrification. The revised cyanide limitations for the 
A and C subcategories were the same as the revised BPT proposed 
limitations. For subcategories B and D cyanide limitations were 
proposed to be withdrawn since facilities in these subcategories do not 
use or generate cyanide in their wastewaters.
    EPA received a number of comments indicating that steam stripping 
technology was not appropriate for the treatment of VOCs and that 
emissions of these pollutants from wastewater should be controlled by 
CAA regulations. In the preamble to the proposed MACT standards, EPA 
indicated that, in view of the MACT proposed wastewater standards, that 
it was considering changing the BAT technology basis for subcategory A 
and C VOCs limitations to end-of-pipe advanced biological treatment. In 
the NOA, EPA reiterated this option and provided cost information which 
compared the original proposal technology basis (steam stripping and 
advanced biological treatment) to the advanced biological treatment 
technology basis.
    EPA also received comments on its proposed ammonia limitations. 
Commenters indicated that the ammonia limitations were inadequately 
supported by nitrification data. In the NOA, EPA indicated that after 
reevaluating its nitrification data base, it intended to base the BAT 
ammonia limitations on both one or two stage nitrification technology, 
presented compliance costs estimates based on two stage nitrification 
technology and revised limitations based on incorporating additional 
data, including data representing two stage nitrification, into the 
data base. In comments on the NOA, commenters indicated that some 
plants employing the proposed technology basis did not believe that 
they could achieve consistent compliance with the revised limitations.
    In order to respond to these commenters, EPA evaluated additional 
nitrification data received from facilities after the August 8, 1997 
publication of the NOA. As a result of this evaluation, EPA has 
recalculated the ammonia limitations that were presented in the NOA. In 
doing so, EPA used only data that showed evidence that nitrification 
was occurring and compared separate sets of limitations developed using 
single-stage and two-stage nitrification data sets, respectively. The 
results of this comparison gave final limitations less stringent than 
those calculated for the NOA, but reflective of systems that nitrify 
continuously whether they are one or two stage systems.
    EPA considered three regulatory options as the basis for BAT 
limitations for subcategory A and C facilities. All three options 
modify the existing BAT regulations to parallel the BPT regulations and 
to clarify the compliance monitoring point for the existing cyanide 
limitations. The first option is a no cost revision which incorporates 
the BPT clarification for cyanide and revised BPT limitations for COD. 
The second option adds limitations for 30 organic pollutants based on 
advanced biological treatment and revised limitations for COD equal to 
the final BPT limitations and clarifies the compliance monitoring point 
for cyanide. The third option adds limitations for 30 organic 
pollutants based on advanced biological treatment, ammonia limitations 
based on one or two stage biological nitrification technology, 
incorporates the revised COD limitations and clarifies the compliance 
monitoring point for cyanide. The pretax total annualized compliance 
costs and pollutant removals associated with the second and third 
options (only options incurring costs) are shown below in Table IV.D.1 
for subcategories A and C:

   Table IV.D.1--BAT Pretax Options Costs, and Pollutant Removals for   
                 Subcategory A and C Direct Dischargers                 
------------------------------------------------------------------------
                                               Total         Pollutant  
                                            annualized       removals   
            Regulatory option                 cost ($      (million lbs 
                                           million 1997)      per yr)   
------------------------------------------------------------------------
Add Organics and COD and clarify cyanide            $2.3             1.4
Add Organics, Ammonia and COD and                                       
 clarify cyanide........................             3.6             2.2
------------------------------------------------------------------------

    EPA evaluated the costs and economic impacts associated with each 
option and determined that all the options were economically 
achievable. After considering the pollutant load removals, the costs, 
as well as the non-water quality environmental impacts associated with 
the options, EPA selected the third option which adds effluent 
limitations for 30 organic pollutants, ammonia and COD and modifies the 
cyanide monitoring requirements. EPA believes that this option is 
economically achievable and there are no significant adverse non-water 
quality impacts associated with it. In addition, EPA believes the 
discharge loadings of ammonia, COD and the organic pollutants are 
significant from subcategory A and C facilities, and that limitations 
on these discharges are appropriate. EPA has also evaluated the 
technology bases of the final BAT limitations in the context of the BAT 
statutory factors, i.e., the age of equipment and facilities involved, 
the process(s) employed, potential process changes and non-water 
quality impacts such as energy requirements. EPA believes the final BAT 
limitations are appropriate based on its assessment of these factors in 
relation to A and C subcategory facilities.
    For facilities with subcategories B and D operations, EPA has 
identified only the pollutant COD for control by BAT limitations based 
on advanced biological treatment (the technology selected as the basis 
for the BPT limitations). As discussed under BPT, cyanide is not a 
pollutant of concern for subcategories B and D operations and EPA is 
withdrawing the current BAT cyanide limitations for facilities with 
subcategories B and D operations. EPA

[[Page 50400]]

also has determined that ammonia is not a pollutant of concern for 
these subcategories since ammonia is not found in significant amounts 
in wastewaters from these operations.
    Thus, for subcategories B and D, EPA considered two final BAT 
regulatory options. The first option is a no cost option consisting of 
the withdrawal of the existing cyanide limitations, the same as the 
final BPT withdrawal of cyanide control and the addition of the BPT 
revised COD limitations. The second option includes the withdrawal of 
the existing cyanide limitations and the addition of the BPT revised 
COD limitations and limitations based only on advanced biological 
treatment for 30 of the same organic pollutants selected for regulation 
at the subcategories A and C facilities.
    The total annualized cost and annual pollutant removal associated 
with the second option are $0.410 million ($1997) and 22,300 pounds per 
year.
    EPA has evaluated the discharge loadings of organic pollutants from 
subcategories B and D facilities and has determined that 95 percent of 
the discharge of organic pollutants is from two facilities. Most direct 
discharging subcategories B and D facilities do not discharge any 
organic pollutants. EPA believes these organic pollutant discharges are 
not sufficient to justify national regulations for these subcategories. 
If permit writers determine the need to further control the organic 
pollutants from the two facilities, the appropriate limits contained in 
the subcategories A and C BAT regulations may be used. For this final 
rule, EPA has selected the first option, which is to only add the BPT 
revised COD limitations to BAT for subcategories B and D facilities, 
and to withdraw the existing cyanide limitations.

E. Pretreatment Standards for Existing Sources (PSES)

    EPA proposed pretreatment standards for 45 organic pollutants 
(including 37 VOCs), with in-plant monitoring for 12 VOCs and end-of-
pipe monitoring for the remaining 33 organics (25 of which are VOCs) 
under coproposal A; and in-plant monitoring only for the 12 VOCs under 
coproposal B. EPA received considerable comment on its proposal pass 
through analysis which indicated that the 45 organic pollutants passed 
through POTW treatment works. Thirty-seven of the organic pollutants, 
including 13 alcohols and related compounds had Henry's Law Constants 
greater than 10 -6 atm m3/gmole, which was the 
physical property used to consider a pollutant to be too volatile to be 
treated properly at POTWs. The other eight organic pollutants were 
determined to pass through based on the BAT technology percent removal 
exceeding that of well operated activated sludge treatment represented 
by EPA's 50 POTW data base.
    Many commenters objected to the assumption that pollutants with 
Henry's Law constants greater than 10-6 atm m3/
gmole would be considered to pass through based on their volatility. 
The pollutants commenters identified as being insufficiently volatile 
and highly biodegradable included: methanol, ethanol and other 
pollutants with Henry's Law constants lower than 1 x 10-5 
atm m3/gmole. Commenters indicated that many of the alcohols 
and related compounds were easily biodegraded by POTWs and did not pass 
through.
    EPA also received a number of comments concerning the proposed in-
plant monitoring point for the 12 VOCs. Commenters indicated that CAA 
MACT standards not CWA pretreatment standards should control in-plant 
emissions of these pollutants from internal wastestreams.
    In order to address these and other comments related to controlling 
the alcohols and related compounds, EPA conducted a sampling study in 
August 1996 at a POTW in Barceloneta, Puerto Rico. This POTW treats 
pharmaceutical industry wastewaters containing measurable amounts of 
the predominant alcohols and related compounds, such as methanol, 
ethanol and isopropanol. The purpose of the sampling study was to 
determine the extent to which methanol and other compounds with similar 
Henry's Law Constants volatilize in the primary treatment works 
(aerated grit chambers and primary clarifiers) prior to the 
biodegradation unit process. Amounts volatilized prior to the 
biodegradation unit are not considered to be treated.
    In the NOA, EPA published the preliminary results of the study 
along with those of a separate bench-scale study of anaerobic 
degradation in the Barceloneta primary clarifiers conducted by 
industry. EPA indicated in the NOA that it was considering a finding of 
no pass through for 13 of the organic pollutants (methanol and other 
alcohols and related compounds) based on the belief that the 
volatization of these pollutants in the primary works of POTWs is 
roughly equivalent to that observed in the primary works of direct 
discharging BAT level facilities. Thus, the treatment of these 
pollutants by a well operated POTW is roughly equivalent to that 
achieved by industrial facilities meeting BAT. As noted earlier in 
section III.D. EPA proposed PSES for 45 organic pollutants, and 
subsequently removed eight pollutants based on no pass through at the 
POTWs, thus making a total of 21 (with the alcohols and related 
compounds) not passing through POTWs.
    In addition to discussing results of its pass through analyses in 
the NOA, EPA presented two revised pretreatment options for all four 
subcategories, with end-of-pipe monitoring for all VOCs including the 
12 volatile pollutants for which in-plant monitoring for PSES/PSNS had 
been proposed. In the NOA, EPA indicated that PSES for these 12 
pollutants were unnecessary because they would be controlled by the 
MACT wastewater standards which require an in-plant compliance 
demonstration for 10 of the 12 VOCs which are HAPs. The remaining 12 
VOCs, in addition to the two non-HAPs that are part of the 12 VOCs 
discussed above, are controlled by end-of-pipe limits based on steam 
stripping, with removals incidental to controlling HAPs either directly 
by the MACT standards or separately from the MACT standards at smaller 
facilities not covered by the MACT rule but controlled by this CWA 
final rule.
    In finalizing the methodology for the pass through analysis 
discussed above, EPA relied on three criteria that had to be met before 
a pollutant was deemed to pass through. These criteria included 
volatility, solubility in water, and the BAT and POTW technologies 
percent removal comparison. With regard to volatility, EPA raised its 
Henry's Law Constant threshold for volatility from 1 x 10-
\6\ atm/gmole/m \3\ to 1 x 10-
\5\ atm/gmole/m\3\ based on comments that the Henry's 
Law Constant used at proposal was not consistent with what was used for 
the OCPSF final rule. Pollutants with Henry Law Constants greater than 
1 x 10-\5\ atm/gmole/m \3\ were believed to 
volatilize significantly before reaching treatment at a POTW. In 
connection with volatility, in order to be consistent with the MACT 
standards approved for controlling water soluble HAPs, EPA also 
considered whether a pollutant was water soluble because water soluble 
compounds are less likely to volatilize than compounds that are 
partially soluble. Finally, EPA considered differences in removal 
percentages for organic pollutants obtained by comparing the BAT model 
treatment system percentage removal to the average pollutant removal 
percentage achieved by well-operated POTWs achieving secondary 
treatment performance standards.
    In developing BAT pollutant removal percentages, EPA only used 
pollutant data pairs where the influent

[[Page 50401]]

concentrations were greater than ten times the pollutant method 
detection limits which was the approach used in developing the 
supporting information for the NOA. In developing the final POTW 
pollutant removal percentages, EPA utilized the acclimated data from 
the same sources used to develop these percentages for the NOA. These 
removal percentages are the POTW removal percentages used in the final 
comparison. Thus, in order for a pollutant to be deemed to pass 
through, it had to have a Henry's Law Constant greater than 
1 x 10-\5\ atm/gmole/m \3\, be less than totally 
soluble in water, and have a BAT removal percentage greater than its 
POTW removal percentage. Based on this analysis, EPA has determined 
that 23 organic pollutants in subcategories A and C and 5 organic 
pollutants in subcategories B and D, that pass through POTWs are 
regulated by pretreatment standards in today's rule. A more detailed 
description of this analysis may be found in section 17 of the final 
TDD.
    In addition to pretreatment standards for VOCs, EPA proposed 
ammonia standards based on either steam stripping or two-stage 
nitrification. In May 1995 EPA proposed ammonia pretreatment standards 
based only on steam stripping technology. The Agency received a number 
of comments concerning the proposed ammonia pretreatment standards. 
Some commenters indicated that steam stripping may not be a reliable 
treatment technology. Others questioned the need for national ammonia 
standards because many POTWs have imposed local limits for ammonia and 
others have nitrification capability. EPA discussed both of these 
concerns in the NOA. EPA suggested in the NOA that ammonia does not 
pass through POTWs with nitrification, and requested comments on the 
preliminary discussion not to set pretreatment standards for industrial 
users which discharge to POTWs with this technology. Comments from POTW 
control authorities and industry supported this approach to developing 
PSES ammonia standards. The final rule contains ammonia pretreatment 
standards only for subcategories A and C, based on the BAT technology 
of nitrification and is applicable to those facilities discharging to 
POTWs without nitrification capability.
    EPA determined that cyanide passes through POTWs based on the 
percent removal comparison with the hydrogen peroxide (BAT) technology. 
Thus, EPA proposed revised cyanide pretreatment standards based on 
hydrogen peroxide technology but maintaining that the standards based 
on in-plant monitoring for the requirements. EPA received comments 
raising safety concerns using this technology for high organic strength 
wastes. Based on these comments and additional data submitted by 
facilities, in the NOA, EPA proposed establishing two sets of cyanide 
standards. One standard would be identical to the proposed standards 
based on hydrogen peroxide technology, while the other standard would 
be based on alkaline chlorination technology and applicable only to 
those facilities that could demonstrate, due to safety concerns, that 
hydrogen peroxide technology was not an appropriate technology to use 
with their wastewater. EPA estimated compliance costs and loadings 
removals to be the same for both sets of standards because it was 
assumed that the vast majority of facilities would meet these standards 
based on the use of the more expensive and efficient hydrogen peroxide 
technology.
    In developing the final PSES for subcategories A and C, EPA 
considered three options. The first option was not to develop 
pretreatment standards for ammonia or any of the VOC pollutants, and to 
modify the monitoring requirements for the existing cyanide standards. 
The second option would build on compliance with the MACT standard with 
additional pretreatment standards for 23 VOCS based on steam stripping 
technology and ammonia based on steam stripping or nitrification and 
modify the cyanide monitoring requirements. The third option would be 
the same as the second option, with the addition of revised 
pretreatment standards for cyanide.
    The annualized compliance costs (1997 dollars) and pollutant 
removals for the second and third options (the only ones incurring 
costs) are shown below in Table IV.E.1. EPA did not consider additional 
options involving small facility exclusions because results of the 
economic analyses for the small facilities using the costs for both 
options described above showed that both options are economically 
achievable (see section V of this preamble for more discussion).

   Table IV.E.1--PSES Pretax Options Costs and Pollutant Removals for   
               Subcategories A and C Indirect Dischargers               
------------------------------------------------------------------------
                                               Total                    
                                            annualized       Pollutant  
            Treatment option                  cost ($        removals   
                                           million 1996)   (million lbs)
------------------------------------------------------------------------
Add organics and ammonia and modify                                     
 cyanide monitoring requirements........           $44.5          10.653
Add organics and ammonia and revise                                     
 cyanide limits.........................            44.8          10.654
------------------------------------------------------------------------

    Due to the low pollutant removals achievable by the revised cyanide 
standards (approximately 1000 lbs per year with 97 percent of the 
removals coming from one facility) in relation to the compliance costs, 
EPA has decided not to revise the existing cyanide standards, and has 
selected the option to add organics and ammonia only and modify the 
current cyanide monitoring requirements. The selected option adds 
standards for ammonia and the 23 organic pollutants determined to pass 
through (see previous discussion in this section), and modifies the 
monitoring point for the current cyanide pretreatment standards for 
subcategories A and C.
    EPA is setting pretreatment standards for ammonia for subcategories 
A and C because of the high loads of ammonia currently being discharged 
by a number of pharmaceutical facilities to POTWs that do not have 
nitrification capability and receive wastewaters from subcategories A 
and C facilities. However, EPA is aware that some POTWs treating 
pharmaceutical wastewaters from these subcategories have nitrification 
capability, and EPA has made a determination of no passthrough for 
ammonia at these POTWS. Thus, PSES ammonia limitations will not apply 
to subcategory A and C facilities discharging to POTWs with 
nitrification capability. POTWs with nitrification capability oxidize 
ammonium salts to nitrites (via Nitrosomonas bacteria) and the further 
oxidize nitrites to nitrates via Nitrobacter bacteria and achieve 
greater removals of ammonia than POTWs

[[Page 50402]]

without nitrification. Nitrification can be accomplished in either a 
single or two-stage activated sludge system. In addition, POTWs that 
have wetlands which are developed and maintained for the expressed 
purpose of removing ammonia with a marsh/pond configuration are also 
examples of having nitrification capability. Indicators of 
nitrification capability are: (1) biological monitoring for ammonia 
oxidizing bacteria (AOB) and nitrite oxidizing bacteria (NOB) to 
determine if nitrification is occurring, and (2) analysis of the 
nitrogen balance to determine if nitrifying bacteria reduce the amount 
of ammonia and increase the amount of nitrite and nitrate.
    For subcategories B and D, EPA considered two options. The first 
option was not to add regulated pollutants to the existing PSES and, 
since cyanide is not present in wastewaters for these subcategories 
facilities, to withdraw the existing cyanide standards. Thus, 
compliance with the MACT standard would be the only requirement for 
controlling VOC pollutants. The second option was to add pretreatment 
standards for 5 VOCs (not including the alcohols and related compounds 
and 19 pollutants determined not to be present in subcategory B and D 
wastewaters) based on steam stripping in addition to withdrawing the 
existing cyanide standards. No ammonia standards were considered since 
facilities in these subcategories do not generate significant levels of 
ammonia in their wastewaters. The pretax annualized compliance cost for 
this second option is $8.8 million ($1997) and annual pollutant 
removals are 3.35 million pounds.
    For PSES for subcategories B and D, EPA has selected the second 
option. EPA is basing this selection on the fact that the 5 pollutants 
(VOCs) have been determined to passthrough, and the pollutant removals 
are relatively high with respect to the compliance costs. The costs are 
economically achievable and the nonwater quality environmental impacts 
are acceptable.

F. New Source Performance Standards (NSPS)

    EPA proposed NSPS for 53 organic pollutants, BOD5, TSS 
and COD based on steam stripping or distillation and advanced 
biological treatment for subcategories A and C. EPA also proposed NSPS 
for ammonia and cyanide based on nitrification and hydrogen peroxide 
oxidation technologies, respectively for these two subcategories. EPA 
received comments indicating that distillation technology was not a 
demonstrated technology for removing soluble VOCs (such as methanol), 
and therefore, should not be part of the technology basis of NSPS. EPA 
has reevaluated its steam stripping and distillation database and has 
concluded that distillation technology is sufficiently demonstrated to 
be considered BADT (Best Available Demonstrated Technology). However, 
after taking into account the high removal of these pollutants 
achievable by steam stripping and advanced biological treatment, the 
addition of distillation technology is unnecessary. Consequently EPA 
did not consider distillation technology as part of final NSPS model 
technology.
    EPA evaluated technology options capable of achieving greater 
pollutant removal of conventional pollutants (BOD5 and TSS), 
COD, Organics, Cyanide and Ammonia than those selected as the basis for 
existing source limitations (BPT, BCT and BAT). The only option 
potentially capable of achieving additional removals involves the use 
of granular activated carbon (GAC) adsorption technology. This 
technology is capable of reducing the COD from some direct discharging 
A and C subcategory facilities. However, there is only limited GAC 
performance data available, from one pilot study.
    For subcategories B and D, EPA proposed NSPS for 53 organic 
pollutants, BOD5, TSS and COD based on in-plant steam 
stripping with distillation and end-of-pipe advanced biological 
treatment. As was the case with the proposed NSPS for subcategories A 
and C, EPA received comments stating that use of distillation 
technology as BADT for new sources is inappropriate because its ability 
to remove methanol and other water soluble organic pollutants has not 
been demonstrated with respect to representative wastestreams.
    For subcategories A and C, EPA is promulgating NSPS equal to the 
final BAT effluent limitations for 30 organic pollutants, cyanide and 
ammonia. For subcategories B and D, EPA is promulgating NSPS equal to 
BAT (including withdrawal of the existing cyanide standards). EPA is 
also promulgating revised NSPS for BOD5, COD and TSS for all 
four subcategories at a level equal to the discharge characteristics of 
the best performing BPT plants which for COD is also the BAT/BPT level 
of control. These final standards are based on the best available 
demonstrated control technologies, which include advanced biological 
treatment, cyanide destruct and nitrification. In developing these 
final standards, the Agency considered factors including the cost of 
achieving effluent reductions, non-water quality environmental impacts, 
and energy requirements. EPA finds that the final standards represent 
the best available demonstrated control technologies, are economically 
achievable and do not present a barrier to entry and have acceptable 
non-water quality environmental impacts.

G. Pretreatment Standards for New Sources (PSNS)

    EPA proposed PSNS for 45 organic pollutants, cyanide and ammonia 
for subcategories A and C, and the same 45 organic pollutants only, for 
subcategories B and D. The technology basis for the proposed organic 
pollutant standards was steam stripping with distillation, and the 
technology bases for the proposed cyanide and ammonia standards were 
hydrogen peroxide oxidation and steam stripping technologies, 
respectively.
    The proposed pretreatment standards for new sources were more 
stringent than the proposed PSES. However, for the final rule, EPA was 
unable to identify a technology that would achieve greater removal of 
the pollutants to be controlled by the PSES being promulgated today and 
is therefore promulgating PSNS equal to PSES for all four 
subcategories.

H. Best Conventional Pollutant Control Technology (BCT)

    EPA proposed BCT equal to BPT for the conventional pollutants 
BOD5 and TSS for all four subcategories. The Agency 
indicated that it had not identified technologies that achieve greater 
removals of conventional pollutants other than those associated with 
the proposed revision of BPT limits, and that these technologies did 
not pass the two-part BCT cost reasonable test. EPA has not received 
any comments concerning its proposal BCT cost test analysis. The Agency 
has repeated the cost test with the postproposal data, with the same 
results. Based on the failure to identify any incremental conventional 
pollutant removal technology options that pass the BCT cost reasonable 
test, EPA is promulgating BCT limitations equal to the existing BPT 
limitations for BOD5 and TSS for all subcategories.

V. Assessment of Costs and Impacts for the Final Pharmaceutical 
Regulations

A. Introduction

    The economic analysis for the final pharmaceutical effluent 
limitations guidelines and standards assesses the costs and impacts of 
these guidelines. The results of this analysis are contained in the 
record for this final

[[Page 50403]]

rule and are summarized in a document entitled Economic Analysis for 
Final Effluent Guidelines and Standards for the Pharmaceutical Industry 
(EPA-821-B-98-009). Included in the Economic Analysis (EA) and 
summarized below are (1) the annualized costs of the rule by 
subcategory, separately and together with the costs of the MACT 
standards rule discussed previously; (2) the impacts of the rule both 
separately and together with the MACT standards on pharmaceutical 
facilities, both existing and new sources; (3) the impacts of these 
rules on pharmaceutical firms; (4) the impacts of these rules on 
employment and communities; and (5) other secondary impacts on trade, 
inflation, POTWs, environmental justice, and distributional equity. 
Also included in the EA are a Final Regulatory Flexibility Analysis as 
required under the Regulatory Flexibility Act and a Cost-Benefit 
Analysis, as required under the Unfunded Mandates Reform Act (UMRA) and 
Executive Order 12866, which are summarized in Sections V.E and V.F of 
this preamble. An additional document, Cost Effectiveness Analysis for 
Effluent Limitations Guidelines and Standards for the Pharmaceutical 
Industry (EPA-821-B-98-010), assesses the cost-effectiveness of the 
rule. The results of this analysis are summarized below in Section V.G.

B. Summary of the Economic Analysis Methodology and Data

    EPA determined the annualized costs of compliance in exactly the 
same way as was done for proposal, with the exception of the choice of 
discount rate (discussed in V.C). Costs are annualized at seven percent 
over 16 years (a 1-year installation period a 15-year project life is 
assumed). The cost annualization also accounts for tax shields on both 
O&M and depreciation (calculated using the modified accelerated cost 
recovery system allowed by IRS rules) to develop a posttax estimate of 
annual costs (see Section 4 of the Economic Analysis for a detailed 
discussion). For analytical consistency, MACT standards costs are also 
annualized in the same way, both pretax and posttax. This is slightly 
different from the way EPA annualized the MACT standards costs in the 
preamble to the MACT standards rule, where costs are annualized at 
seven percent over ten years (with no delay for installation) to create 
a pretax annual cost (i.e., without accounting for tax shields). 
Additionally, the MACT standards costs presented in the preamble to the 
MACT standards rule include costs for new sources, which are not 
included in this preamble. Despite the differences in annualization 
method, the current cost annualization approach in no way conflicts 
with the alternative analysis.
    To assess impacts on firms and facilities, EPA has set up three 
baselines in the analysis. Baseline 1 is the usual baseline analyzed in 
all effluent guidelines. It is a scenario that reflects a baseline 
condition without additional regulation, that is, no additional 
effluent limitations guidelines and standards or MACT standards costs 
are considered. This baseline is taken from the current (i.e., 1990 
Survey) financial data. Baseline 2 incorporates certain MACT standards 
costs pertaining only to wastewater emission controls, and does not 
include costs for controlling emissions from process vents, equipment 
leaks and storage tanks. This baseline is presented in the EA, but 
results of this baseline (which are not appreciably different from 
those for Baseline 1) are not discussed at length in this preamble. 
Baseline 3 incorporates costs for all components associated with the 
MACT standards rule. EPA estimated the capital and operating costs for 
MACT standards cost components for emission controls on wastewater 
streams (on which Baseline 2 is based), as well as the capital and 
operating costs for all MACT components (on which Baseline 3 is based) 
as a part of the Agency's MACT standards rulemaking process.
    To model Baseline 2, EPA used the capital and operating costs 
associated with the wastewater emission controls for all facilities in 
the MACT analysis for which costs were developed and matched them to 
the facilities that are also in the effluent guidelines analysis. 
However, a number of facilities in the effluent guidelines analysis are 
not covered by the MACT standards and were not assigned MACT costs.
    EPA annualized the costs at seven percent over 16 years in the cost 
annualization model and also developed a present value of posttax 
compliance costs over this same time frame. EPA subtracted the present 
value posttax compliance costs from the Baseline 1 present value 
posttax facility earnings (derived from the Survey data) to determine 
Baseline 2 posttax earnings for each facility in the effluent 
guidelines analysis. EPA used this same approach to derive Baseline 3 
posttax earnings (for those facilities without MACT standards costs, 
earnings are the same in all three baselines).
    A facility whose posttax earnings are zero or negative in Baseline 
1 is counted as a Baseline 1 closure; a facility whose posttax earnings 
are zero or negative in Baseline 2 is counted as a Baseline 2 closure; 
and a facility whose posttax earnings are zero or negative in Baseline 
3 is counted as a Baseline 3 closure.
    EPA then incorporated the present value posttax costs of the 
effluent guidelines into each of the baselines in the same way as MACT 
standards costs were incorporated to calculate postcompliance, posttax 
earnings. EPA then tallied the closure results (in terms of whether 
postcompliance, posttax earnings are zero or negative) by counting 
postcompliance closures incrementally from each baseline. In other 
words, EPA considered any closures that occurred additional to those 
occurring in each of the baselines as postcompliance closures under the 
three baseline scenarios. Any facilities that certified that the 
effluent guidelines would have no impact on them were assumed not to 
close under any baseline or in postcompliance. Note that as in the 
proposal Economic Impact Analysis (EIA), impacts on single-facility 
firms were assessed at the firm level.
    MACT standards costs were also incorporated into firm-level data 
under the same three baseline scenarios. In the firm-level analysis, 
however, the key data that could change were assets, liabilities, and 
earnings before interest and taxes, which were used in an equation 
called Altman's Z, a multi-discriminant ratio analysis approach to 
identifying relative firm health. This equation is composed of several 
common financial ratios that are weighted according to their relative 
ability to predict bankruptcy based on empirical industry data. The 
result of this equation is called the Altman's Z-score. Scores below a 
certain value are considered indicative of poor financial health and a 
high likelihood of bankruptcy.
    For Baseline 1, EPA used the current survey data in the Altman's Z 
model to determine a Baseline 1 Altman's Z-score. For Baseline 2, EPA 
took the MACT standards capital costs aggregated at the firm level 
(since firms often own more than one facility) and adjusted both assets 
and liabilities to reflect the acquisition of capital equipment through 
an increase in debt. EPA then adjusted earnings before interest and 
taxes by subtracting the annualized amount of operating costs plus 
depreciation computed by the cost annualization model, given the 
Baseline 2 MACT standards capital and operating costs (also aggregated 
at the firm level) and then computed a Baseline 2 Altman's Z-score.
    EPA used the same approach using the Baseline 3 MACT standards 
operating and capital costs to create the Baseline 3 Altman's Z-score. 
If any of

[[Page 50404]]

these three baseline scores were below the cutoff point considered a 
sign of poor financial health, EPA considered the firm a baseline 
failure.
    Compliance costs for the effluent guidelines were then used in the 
same manner to further adjust the financial data used in the Altman's Z 
model in each of the baselines. Where the Altman's Z-score changed from 
one reflecting a healthy firm or one in indeterminate status in any of 
the baselines to one of poor financial health, EPA considered the firm 
to be a postcompliance firm failure relative to the baseline under 
consideration.
    EPA's methodology for computing output and employment effects is 
discussed in detail in Section V.C. These effects are presented as net 
effects in Section V.D.4. To compute net effects, EPA calculated both 
losses and gains in output and employment and subtracted losses from 
gains (or vice versa). Thus EPA calculated net national-level output 
effects, net national-level employment effects, and net direct 
employment effects (employment losses in the pharmaceutical industry 
driven by output losses in the industry). EPA also estimated the 
employment losses estimated to occur as a result of closures and 
failures. These types of losses were used to determine whether any 
community-level impacts are likely.
    Trade impacts were assessed in the same way as in the EIA for the 
proposal, except that a profit margin analysis has been added, as 
described below in Section V.C. Impacts on inflation were assessed by 
comparing the cost of the regulation to gross domestic product (GDP). 
The potential for distributional impacts was assessed by identifying 
facilities where compliance costs were greater than 10 percent of 
operating costs and determining what types of products might be most 
affected if costs are passed through to consumers. The users of these 
products were then qualitatively identified to determine if these 
potential users might be disproportionately represented by economically 
disadvantaged groups. Impacts on environmental justice were also 
qualitatively addressed.

C. Changes to the Economic Analysis Since Proposal

    The most significant change in the EA since proposal is associated 
with the change in costs. The costs of the effluent limitations 
guidelines and standards for the pharmaceutical industry point source 
category are now substantially lower than those estimated at proposal 
because the costs of controlling air emissions are now a part of EPA's 
MACT standards. Impacts from the final rule do not change measurably 
from proposal, however, mostly because impacts both now and at proposal 
were estimated to be very small.
    Costs for control of air pollutants, previously assigned to the 
effluent guidelines at proposal, are now assigned to the MACT standards 
requirements. The economic analyses show the impacts of the effluent 
guidelines against three separate regulatory baselines: no MACT 
standards requirements in place, wastewater emissions control and 
treatment system requirements in place, and all MACT standards 
requirements in place (see Section II.E. of this preamble for a 
description of MACT standards requirements). In this way, EPA can 
present impacts from the effluent guidelines alone and in combination 
with impacts from the MACT standards requirements. The methods EPA used 
to assess the impact of MACT standards on the baselines against which 
the effluent guidelines are measured were discussed in Section V.B.
    EPA is now using a seven percent discount rate in all of its 
analyses. Previously, the Agency used the seven percent rate only in 
determining the pretax cost of the regulation. EPA has chosen to use a 
seven percent social discount rate (in real terms) in this analysis, 
rather than the 11.4 percent discount rate used in the proposal, for 
two reasons. First, the seven percent discount rate is strongly 
recommended by the Office of Management and Budget for use in economic 
analyses (see the EA for more details). Second, the cost of capital has 
generally declined since 1990. This change in discount rate, however, 
has little effect on the analysis. A comparison of estimated impacts in 
the proposal to impacts as estimated here show that the analyses are 
not sensitive to assumptions about discount rates in the ranges used.
    In terms of content, the economic analyses are now presented as a 
more comprehensive report, in which the EIA and Regulatory Impact 
Analysis (RIA) have been combined into one report (the EA). The cost-
benefit portion of the RIA is now contained in Section 10 of the EA 
report.
    EPA has also made a few methodological changes in its firm and 
facility analyses. In the EIA for the proposal, EPA included salvage 
value in the calculations for the facility closure analysis for 
projection of baseline closures (i.e., before compliance costs are 
considered) and postcompliance closures. EPA recognized some potential 
difficulties with the salvage value calculations and, in the proposal 
EIA, investigated the effects of assuming salvage value does not play a 
role in determining facility viability. EPA found that the facility 
closure projections were not sensitive to the alternate salvage value 
assumption. Furthermore, industry also commented that using salvage 
value overstated baseline closures. Thus EPA believes that its current 
analysis, which does not consider salvage value but rather uses 
negative posttax earnings as the indicator of closure, is the best 
methodology to use, given the uncertainty of salvage value data.
    An additional difference in the closure analysis addresses the 
issue of non-self-supporting facilities (baseline facility closures). 
In the current analysis, EPA investigates all baseline closures at the 
firm level to determine if a multi-facility firm could install and 
operate pollution control equipment at all of its affected facilities, 
including those estimated as baseline closures. If the firms can 
continue to support a baseline closure facility without risk of 
failure, EPA determines that impacts to the firm and its affected 
facilities are minimal. EPA performed this analysis under the 
assumption that if the facility was not expected to support itself in 
the baseline, the firm level is the appropriate level at which to 
assess impacts.
    EPA also modified the methodology for determining impacts on firms. 
In response to comments that baseline firm failures were overstated 
because the Agency used benchmarks that identified lowest quartile 
firms as baseline failures, EPA reassessed the methodology and turned 
to a more sophisticated method for determining firm financial health. 
EPA used a multi-discriminant analysis approach for evaluating the 
financial health of firms. This analysis, developed by Edward Altman, 
is known as Altman's Z-score analysis. This approach allows the 
simultaneous analysis of several common financial ratios and answers 
the question of how to determine financial health when some ratios 
appear strong and some appear weak. The equation developed by Altman 
assigns relative weights to the various ratios on the basis of how well 
they predict bankruptcy (determined using actual firm data and 
information on whether the firms did in fact go bankrupt). This 
approach reduced the proportion of firms considered baseline failures 
from 28 percent in the EIA for the proposal to about 10 percent (see 
Section V.D.3), thus allowing for substantially more firms to be 
evaluated at the firm level in the postcompliance

[[Page 50405]]

analysis. The Altman's Z analysis is also described in Section V.B 
above and is fully described in Section 6 of the EA Report.
    The Agency has added an analysis of national-level output and 
employment effects to the EA for the final rule. Output is measured in 
terms of revenues, and under the assumption that industry cannot pass 
through compliance costs to consumers, the worst-case output loss to 
the pharmaceutical industry is equal to the pretax costs of compliance. 
The output losses occurring in the pharmaceutical industry (direct 
effects) affect input industries, which are industries that provide 
inputs (e.g., raw chemicals) to the pharmaceutical industry. These 
effects are known as indirect effects. The direct output losses also 
affect consumption, as workers lose jobs or work fewer hours and their 
households reduce purchases of goods and services. These effects are 
called induced effects. Thus a dollar of output lost in the 
pharmaceutical industry can also result in additional dollars lost in 
the U.S. economy as a whole through indirect and induced effects. EPA 
calculates these additional losses at the national level using input-
output analysis. The relevant multipliers used in the analysis were 
developed by the U.S. Department of Commerce's Bureau of Economic 
Analysis (BEA).
    In addition to output losses, EPA calculates national-level output 
gains based on output gains in pollution control industries. These 
industries receive revenues from the pharmaceutical industry for 
pollution control equipment and operations. Using BEA multipliers, the 
Agency calculates the subsequent effect of these gains on the pollution 
control industries' input industries and consumption (i.e., indirect 
and induced effects). By comparing national-level output losses and 
gains, EPA develops a net national-level output loss or gain.
    In the EA, EPA no longer relies exclusively on employment losses 
from closures and failures to calculate employment losses in the 
pharmaceutical industry or national-level employment losses. Because 
output effects and employment are linked in input-output analysis, EPA 
calculates employment losses based on output effects using BEA's final 
demand and direct effect multipliers. EPA uses final demand employment 
multipliers to compute the total number of jobs lost (including direct, 
indirect, and induced job losses) given the total loss of output in 
millions of dollars in the pharmaceutical industry and uses direct 
effect multipliers to compute the total number of job losses occurring 
just in the pharmaceutical industry (direct losses), given the total 
jobs lost nationwide (which include direct, indirect, and induced 
losses).
    Output-based employment losses can be thought of as longer-term 
losses associated with longer-term market equilibrium, whereas losses 
associated with closures and failures can be considered the more 
immediate impact of the rule before market equilibrium is achieved. 
Thus output-based employment losses may be greater than or less than 
the losses estimated on the basis of closures and failures, which means 
that nonclosing facilities might gain or lose production and employment 
depending on how many facilities close. If no facilities close, 
nonclosing facilities might lose some production and employment. If 
many facilities close, nonclosing facilities might actually gain 
production and employment if closure losses ``overshoot'' the expected 
losses at market equilibrium. Note, however, that both the output-based 
employment effects and the closure/failure employment effects derived 
here are worst-case impacts within the pharmaceutical industry since 
EPA assumes the industry cannot pass through the costs of compliance to 
consumers.
    EPA also computes employment gains on the basis of output gains in 
pollution control industries in much the same way as was done for the 
EIA for the proposal. The approach has been changed slightly to 
accommodate labor costs estimated as a part of the engineering cost 
analysis rather than relying on assumed labor shares. EPA compares the 
employment losses and gains to estimate a net gain or loss in 
employment both at the national level and in the pharmaceutical 
industry alone (some gains will occur in the pharmaceutical industry 
since labor to operate pollution control equipment is required).
    EPA now performs an assessment of impacts on profit margins to 
address commenter concerns that pharmaceutical firms will locate (or 
relocate) facilities outside of the U.S. because of environmental 
regulatory requirements. EPA assumes that those firms most likely to 
consider relocating facilities are those with measurable differences in 
profitability with sufficient means to effect a relocation. EPA also 
addresses comments that reductions in loadings to POTWs will result in 
substantial impacts on POTWs.
    All other methodologies used and analyses undertaken in the EA 
remain substantively the same as those in the EIA for the proposal.

D. Estimated Economic Impacts

1. Costs of Compliance
    Table V.D.1 presents a summary of compliance costs for the effluent 
limitations guidelines and standards and for the MACT standards. EPA 
estimated annualized compliance costs on both a pre-tax and post-tax 
basis; both sets of costs are shown in Table V.D.1. Post-tax costs 
reflect tax savings accruing to the industry from the installation and 
operation of pollution control equipment; the post-tax costs are used 
in the economic analysis to assess impacts to facilities and firms in 
the industry. Pre-tax costs are a component of the total social cost of 
the regulatory action (see Section V.F).
    EPA describes the cost annualization procedure in Section V.B and 
in the EA. The annualized costs in Table V.D.1 for both the effluent 
limitations guidelines and standards and the MACT standards rule 
incorporate the same annualization period assumptions. The annualized 
costs reported in the preamble to the MACT standards rule are based on 
another annualization period and thus, do not correspond exactly to 
Table V.D.1. As noted in Section V.B, costs are annualized over 16 
years (with an 1-year installation period and a 15-year project life), 
while in the preamble to the MACT standards rule, costs are annualized 
over 10 years (with no delay for installation). As an illustration, 
Table V.D.1 reports pre-tax annualized costs for the MACT standards 
rule for all facilities (referred to as ``existing sources'' in the 
MACT standards rule) at $58.4 million. In the preamble to the MACT 
standards rule, the corresponding annualized costs are reported at 
$64.8 million.
    The annualized post-tax compliance costs for effluent guidelines 
for the selected options are $39.4 million. The annualized post-tax 
compliance costs of the MACT standards for the subset of facilities 
also subject to effluent guidelines are $32.4 million. The total 
annualized costs for facilities covered by both the effluent guidelines 
and MACT standards are $71.8 million, and the total annualized costs 
for all facilities (i.e., including those facilities covered by MACT 
standards only) are $77.5 million.

[[Page 50406]]



            Table V.D.1--Annualized Costs of Compliance for Effluent Guidelines and MACT Requirements           
----------------------------------------------------------------------------------------------------------------
                                                                                      Posttax         Pretax    
                                                                                    annualized      annualized  
                                                                                      cost of         cost of   
                  Subcategory                                Option                 compliance      compliance  
                                                                                     (million        (million   
                                                                                      1997$)          1997$)    
----------------------------------------------------------------------------------------------------------------
A/C Direct....................................  BPT=Revise COD and modify                   $1.6            $2.5
                                                 cyanide.                                                       
                                                BAT=Add organics, ammonia and                2.3             3.6
                                                 COD and modify cyanide.                                        
B/D Direct....................................  Revise BPT COD and withdraw                  0.9             1.4
                                                 cyanide.                                                       
A/C Indirect..................................  PSES=Add organics and ammonia               28.8            44.5
                                                 and modify cyanide.                                            
B/D Indirect..................................  PSES=Add organics and withdraw               5.8             8.8
                                                 cyanide.                                                       
                                                                                 -------------------------------
    Total Annualized Cost of Effluent           ................................            39.4            60.8
     Guidelines for all Selected Options.                                                                       
Cost of MACT Standards........................  Effluent Guidelines Facilities..            32.4            49.6
                                                All Facilities..................            38.1            58.4
                                                                                 -------------------------------
    Total Annualized Cost of Effluent           ................................            71.8           110.4
     Guidelines and MACT Standards for                                                                          
     Effluent Guidelines Facilities.                                                                            
                                                                                 ===============================
    Total Annualized Costs of Effluent          ................................            77.5           119.2
     Guidelines and MACT Standards for All                                                                      
     Facilities.                                                                                                
----------------------------------------------------------------------------------------------------------------

2. Economic Impacts on Facilities
    EPA determined on the basis of zero or negative posttax earnings 
that 18 facilities, or 9 percent of all facilities in the analysis, 
would be likely to close even without the effect of the effluent 
guidelines or MACT standards requirements. The impacts to the firms of 
installing and operating pollution control equipment at these 
facilities are, however, assessed at the firm level to determine if the 
firms can continue to support these facilities postcompliance (see 
below under results of the firm analysis). When all MACT standards 
costs are incorporated into the initial baseline financial conditions 
(Baseline 3), no additional facilities close.
    When the costs of compliance for this final effluent guidelines 
rule are incorporated into the financial conditions of facilities in 
the analysis (the postcompliance analysis), only one additional 
facility closes (an A/C indirect). Even though this facility does not 
close when faced with costs of meeting this effluent guidelines rule 
alone, EPA conservatively attributes this closure to the effluent 
guidelines. In general, however, neither MACT standards costs nor 
effluent guidelines costs singly or together have major impacts on 
pharmaceutical facilities operated by multifacility firms.
3. Economic Impacts on Firms
    EPA projected that 18 firms would be likely to fail even without 
the effect of the effluent guidelines or MACT standards requirements 
(Baseline 1). Two additional firms are projected to fail before 
effluent guidelines costs are considered when all MACT standards costs 
are included in the initial baseline financial conditions (Baseline 3).
    In the postcompliance analysis, EPA estimated that four firms would 
fail under the Baseline 1 scenario and two firms would fail under the 
Baseline 3 scenario. (There are two fewer postcompliance firm failures 
under the Baseline 3 scenario because these failures were estimated to 
be precompliance failures when all MACT standards costs were included.) 
Thus at most, regardless of baseline, four firms fail postcompliance. 
To be conservative in the EA, EPA attributes these failures to the 
Pharmaceutical Effluent Guidelines alone. Out of the four firm failures 
projected to occur, EPA estimates only one will result in both a firm 
failure and a facility closure (because earnings become negative at the 
only facility owned by the firm). The other three firms will incur 
substantial impacts, up to and including firm failure, but own 
financially viable facilities. Because the facilities are self-
supporting, they are likely to be attractive for acquisition by 
financially stronger firms. Therefore, the three failing firms with 
viable facilities might not fail, but instead might be forced to sell 
their facilities.
    As discussed in Section V.D.2, EPA evaluated all facilities 
projected to close in the baseline analysis at the firm level, under 
the assumption that perhaps these facilities are not expected to be 
self-supporting and thus might not close in the baseline. If this is 
so, the appropriate level of analysis is the firm. EPA determined that 
all facilities projected to close in the baseline facility closure 
analysis can continue to be supported by their firms postcompliance 
without significant impact on these firms.

                             Table V.D.3 Firm Failure Analysis Results (Baseline 1)                             
----------------------------------------------------------------------------------------------------------------
                                                                          Failures only                         
                                               -----------------------------------------------------------------
              Type of discharger                    Number       Percentage of                    Percentage of 
                                                 Failures with   total firms in      Number       total firms in
                                                   closures       subcategory                      subcategory  
----------------------------------------------------------------------------------------------------------------
A/C Direct....................................               0              0                 0              0  
B/D Direct....................................               0              0                 0              0  
A/C Indirect..................................               2              3.2               1              1.6
B/D Indirect..................................               1              1.2               0              0  

[[Page 50407]]

                                                                                                                
    Total All Firms...........................               3              1.8               1              0.6
----------------------------------------------------------------------------------------------------------------

4. Impacts on Output and Employment
    EPA estimates that at the national level, output gains will exceed 
output losses. EPA determines a net output gain of about $21.7 million 
(1996$) as a result of the effluent guidelines. Net output gains for 
the combined rulemakings (including MACT standards for facilities in 
the effluent guidelines analysis only) will total $40.1 million 
(1996$). EPA also determines that employment gains will exceed 
employment losses at the national level. The net gain in national-level 
employment as a result of the effluent guidelines alone will total 218 
full-time equivalents (a full-time equivalent, or FTE, equals 2,080 
hours per year of labor), and net employment gains for the combined 
rulemakings (including MACT standards for facilities in the effluent 
guidelines analysis only) will total 407 FTEs.
    Despite net employment gains at the national level, EPA calculates 
that losses will exceed gains in the pharmaceutical industry. Direct 
losses in the pharmaceutical industry are composed of two types of 
losses--output-based losses and closure/failure type losses. As noted 
in Section V.C., closure/failure employment losses might be less than 
the output-based employment losses that are driven by the contraction 
in the pharmaceutical industry as it responds to the compliance costs 
and a new market equilibrium is achieved. Closure/failure employment 
losses can also be greater than these output-based losses if they 
``overshoot'' the expected market equilibrium result. In this case, the 
direct losses computed on the basis of output losses (and net of gains 
in employment in the industry due to the need to operate the pollution 
control equipment) are slightly greater than the closure/failure losses 
(which are estimated to total 139 FTEs). Output-based losses total 138 
FTEs, or 0.1 percent of pharmaceutical employment in the analysis. With 
MACT standards costs for facilities included in the effluent guidelines 
analysis, net direct employment losses will total 254 FTEs, or 0.1 
percent of employment.
    Because output-based employment losses are greater than closure/
failure employment losses, nonclosing facilities might experience some 
small reductions in labor hours and production over time that are 
additional to the losses of labor hours and production associated with 
facilities that close or fail (assuming a worst-case scenario where no 
costs can be passed through to consumers).
    The losses in employment due to closures/failures will have a 
negligible impact on individual communities. No community is expected 
to experience a change in its unemployment rate exceeding 0.4 percent.
5. Other Secondary Impacts
    No trade losses or major changes in the balance of payments are 
associated with closures/failures of firms or facilities, as these 
firms and facilities indicate no foreign shipments. Thus EPA finds that 
neither rule, together or separately, will have a substantial impact on 
trade or the balance of payments.
    An analysis of profit margin shows only a few firms will experience 
impacts on profit margin as a result of the effluent guidelines. A 
total of 8 firms (6 percent of the firms analyzed) have a greater than 
10 percent change (e.g., go from a 5 percent profit margin to a 4.5 
percent profit margin) in their profit margin. Most of these firms are 
considered the least likely to relocate their facilities to foreign 
countries. These firms tend to be small, and generally, they are 
unlikely to have experience in international locations. The transaction 
costs of learning how to operate in foreign countries, along with the 
expense of relocating, are likely to be prohibitively expensive for 
these firms. With the MACT standards costs included for the facilities 
analyzed as part of this effluent guidelines final rule, one additional 
firm shows a greater than 10 percent change in profit margin. Thus EPA 
has determined that even under the combined effect of the two rules, 
firms are unlikely to relocate to foreign countries to escape the 
impacts on profitability induced by the two rules.
    The rules, together or separately, will have no major impact on 
inflation, as the costs of the two rules are at most only 0.001 percent 
of gross domestic product (GDP).
    Although the Agency received comments on the proposal arguing 
otherwise, EPA expects that impacts on POTWS will be minimal. EPA is 
promulgating pretreatment standards for 24 VOCs for all four 
subcategories and ammonia for subcategories A and C. The Agency expects 
that the reduction in the BOD discharged to POTWs as the result of 
compliance with PSES for these pollutants will be minimal. As a result, 
EPA believes that any reduction in revenue to POTWs that charge 
industrial users subject to the PSES will be insignificant. Since many 
of these pollutants are highly volatile and are volatilized in the 
POTWs primary units before they can be biodegraded, EPA believes that 
the final PSES should not have any substantial effect on the variable 
operating costs of POTWs as well. In summary, EPA believes that 
compliance with the final PSES by pharmaceutical facilities should not 
have any significant effect on the POTW revenues. Furthermore, EPA 
believes that the benefits associated with reduced discharges of VOCs 
and ammonia to POTWs by pharmaceutical industrial users will outweigh 
any revenue losses.
    Based on the analysis in the proposal EIA and further investigation 
in the EA for this final rule, the MACT standards and effluent 
guidelines, together or separately, will have no major distributional 
impacts. Compliance costs are generally a very small percentage of 
baseline operating costs, thus any cost increases are likely to be very 
small and are not likely to have any major effect on any one group of 
consumers.
    Impacts on environmental justice also should be minimal. As noted 
above, any price increases on drugs will be very small and impacts on 
disadvantaged groups such as the poor and certain minority groups will 
be minimal. Furthermore, many of these groups will benefit from the 
effluent guidelines final rule. A large portion of the affected 
facilities are located in urban areas where poor or minority 
populations tend to be high. Although everyone benefits, it is these 
populations that will

[[Page 50408]]

likely benefit the most from the cleaner water resulting from both 
rules.
6. Impacts on New Sources
    The selected options for new sources are equivalent to the selected 
options for existing sources. Because the costs for designing in 
pollution control technologies are generally no more expensive than and 
are usually less expensive than retrofitting pollution control 
technologies, costs for new facilities will be no more expensive than 
costs for existing facilities. Because EPA has shown that the 
requirements for existing sources are economically achievable, they 
should be economically achievable for new sources. Furthermore, since 
the requirements for new sources will not be more expensive than those 
for existing sources, the rule will not pose a barrier to entry for new 
sources. In response to proposal comments, EPA also investigated 
whether impacts from the effluent guidelines rule (with and without 
MACT standards) might contribute to firms locating new facilities in 
foreign countries. EPA found the median percentage of capital costs of 
compliance to total costs to build a new facility to be negligible 
(0.21 percent, on average including MACT standards costs among surveyed 
newer facilities). Thus compliance costs are unlikely to be a major 
impetus to locating new facilities outside the U.S.

E. Regulatory Flexibility Analysis

    There are no major changes to EPA's Regulatory Flexibility Analysis 
(RFA), except that the Agency has undertaken a revenue test in addition 
to the closure analysis to better assess the potential impact on small 
firms. The revenue test measures impact on the basis of annual 
compliance costs as a percentage of annual revenues. The analysis 
indicates that out of 145 firms considered small (i.e., firms with 
fewer than 750 employees), only four firms will experience annual 
compliance costs that are greater than one percent of annual revenues 
(six with MACT costs included). No firms will experience annual 
compliance costs exceeding 3 percent. When MACT standards costs are 
included only one small firm will experience annual compliance costs 
that exceed three percent of annual revenues, but this firm is not 
estimated to incur any effluent guideline costs.
    The RFA further also considered impacts to small firms in terms of 
firm failures or facility closures. Five small firms are significantly 
affected by the rule. The regulatory action is found to be economically 
achievable for all dischargers, including small entities as detailed in 
Section V.D. Further, the analysis indicates no disproportionate effect 
on small entities, compared to large entities. Based on these findings, 
EPA certifies that this final rule does not have a significant impact 
on a substantial number of small entities.

F. Cost-Benefit Analysis

    Because the combined costs of the rules are at the level that 
defines a major rule both under Executive Order 12866 and UMRA 
(although neither rule considered separately would be near this level), 
EPA has undertaken a cost-benefit analysis. As in the proposal, pretax 
costs for all facilities are used as a proxy for social cost. The major 
portion of the social cost of the effluent guidelines is the total 
pretax annual cost, which is $60.8 million (1997$). Adding in the cost 
of administering the rule and providing administrative services to the 
unemployed (the only other significant cost categories), the total 
social cost of the rule is $61.0 million (1997$). Combined with the 
costs of the MACT standards rule for facilities in the effluent 
guidelines analysis, the two rules together have annual social cost of 
$110.7 million (1997$). (Costs of both rules including MACT standards 
costs to facilities that will not be affected by the effluent 
guidelines are $119.5 million (1997$)).
    Benefits include the benefits of water removals and benefits of air 
removals. Types of benefits analyzed include human health risk, 
recreational use benefits, benefits to POTWs, and benefits of 
reductions in VOCs (other than human health). The benefits to POTWs, 
however, could not be monetized (see Section VI.E. of this preamble for 
more details). Total monetizable benefits of the effluent guidelines 
alone total $0.93 to $14.0 million (1997$), while the combined benefits 
of the two rules total $4.06 to $81.1 million (1997$).

                               Table V.F.1                              
------------------------------------------------------------------------
                                                                        
------------------------------------------------------------------------
                           Costs ($ millions)                           
------------------------------------------------------------------------
Total Social Cost of Effluent Guidelines.  $61.0                        
Total Social Cost of MACT (ELG facilities  49.7                         
 only).                                                                 
Total Social Cost of MACT (all             58.4                         
 facilities).                                                           
Social Cost of Combined Rules (ELG         110.7                        
 facilities only).                                                      
Social Cost of Combined Rules (all         119.5                        
 facilities).                                                           
------------------------------------------------------------------------
                          Benefits ($ millions)                         
------------------------------------------------------------------------
Effluent Guidelines......................  0.9 to 14.0                  
MACT Standards...........................  3.9 to 67.2                  
                                          ------------------------------
    Total................................  4.8 to 81.1                  
------------------------------------------------------------------------

G. Cost-Effectiveness Analysis

    Cost-effectiveness evaluates the relative efficiency of options in 
removing toxic pollutants. Costs evaluated include direct compliance 
costs, such as capital expenditures and operation and maintenance 
costs.
    Cost-effectiveness results are expressed in terms of the 
incremental and average costs per pound-equivalent removed. A pound 
equivalent is a measure that addresses differences in the toxicity of 
pollutants removed. Total pound-equivalents are derived by taking the 
number of pounds of a pollutant removed and multiplying this number by 
a toxic weighting factor. EPA calculates the toxic weighting factor 
using ambient water quality criteria and toxicity values. The toxic 
weighting factors are then standardized by relating them to a 
particular pollutant, in this case copper. EPA's standard procedure is 
to rank the options considered for each subcategory in order of 
increasing pounds-equivalent (PE) removed. The Agency calculates 
incremental cost-effectiveness as the ratio of the incremental annual 
costs to the incremental pounds-equivalent removed under each option, 
compared to the previous (less effective) option. Average cost-
effectiveness is calculated for each option as a ratio of total costs 
to total pounds-equivalent removed. EPA reports annual costs for all 
cost-effectiveness analyses in 1981 dollars to enable limited 
comparisons of the cost-effectiveness among regulated industries.
    Table V.G.1 presents the results of the cost-effectiveness analysis 
for all subcategories. As the table shows, the average and incremental 
cost-effectiveness of the selected BAT option for subcategories A and C 
is $224/lb. eq., the average and incremental cost-effectiveness of the 
selected PSES option for subcategories A and C is $96/lb. eq. and the 
average and incremental cost-effectiveness of the selected PSES option 
for subcategories B and D is $66/lb. eq. The selected BAT option for 
the subcategories B and D directs is the no additional action 
alternative, so no cost-effectiveness results are calculated.
    The cost-effectiveness determined for this rule does not represent 
an estimate of the removal of the toxic pounds resulting from the 
removal of COD. As discussed previously in section IV.C., discharges 
from pharmaceutical manufacturing facilities exhibit toxicity as 
measured by the whole effluent

[[Page 50409]]

toxicity test and reported as part of the routine NPDES discharge 
monitoring reports (DMRs). One study conducted by EPA at a 
pharmaceutical manufacturing facility showed a significant decrease in 
toxicity with a corresponding decrease in COD level for the tested 
effluent sample from the facility and a sample effluent of a pilot 
scale biological treatment plant study. Because of the limited amount 
of data, and the inability to identify the different mix of specific 
organic compounds represented by the COD measurement, the total amount 
of toxic pound-equivalent represented by the nonconventional pollutant 
parameter of COD could not be determined.
    Based on the lack of pound-equivalents associated with COD removals 
the cost-effectiveness analysis results understates the true cost-
effectiveness of this rule. EPA therefore considers these options to be 
cost-effective.

                                                    Table V.G.1--Cost/Effectiveness Analysis Results                                                    
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Total Annual                     Incremental                                         
                                                         ----------------------------------------------------------------   Average C-E   Incremental C-
                         Option                               Lb. eq.                         Lb. eq.                       ($/lb.eq.)    E  ($/lb. eq.)
                                                              removed      Cost  (1981$)      removed      Cost  (1981$)                                
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       A/C Direct                                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
MACT Only...............................................               0              $0               0              $0              NA              NA
Advanced Bio............................................           9,780       2,186,106           9,780       2,186,106            $224            $224
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      A/C Indirect                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
MACT Only...............................................               0               0               0               0              NA              NA
Steam Stripping no alcohols.............................         282,614      26,990,998         282,614      26,990,998              96              96
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      B/D Indirect                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
MACT Only...............................................               0               0               0               0              NA              NA
Steam Stripping no alcohols.............................          80,807       5,353,790          80,807       5,353,790              66              66
--------------------------------------------------------------------------------------------------------------------------------------------------------

VI. Environmental Benefits

    In addition to costs and impacts, EPA also estimated the 
environmental and human health benefits of implementing CWA 
requirements. Benefits identified as a result of this final rule are 
associated with improvements in both water quality and air quality, 
since many of the regulated and incidentally controlled pollutants are 
prone to volatilization from the effluent waste streams. Section IV of 
this preamble and Section IX of the TDD describe the estimated 
reductions in effluent discharges, and those reductions and the 
estimates of incremental environmental improvements noted in Section IV 
are derived compared to a baseline consisting of current discharges. 
Because current discharges are a function of current technology, this 
is the same baseline that is used to establish the costs of complying 
with this rule.
    EPA is confident that its estimation of compliance costs is a full 
and accurate account of such costs; however, EPA is less confident that 
the estimation of benefits is similarly complete. EPA is not currently 
able to quantitatively evaluate all human health and ecosystem benefits 
associated with air and water quality improvements. EPA is even more 
limited in its ability to assign monetary values to these benefits. A 
comparison of costs to only the limited monetized subset compromises 
the validity of the cost-benefit analysis. The economic benefit values 
described below and in Section 10.4 of the EA should be considered a 
limited subset of the total benefits of this rule and should be 
evaluated along with descriptive assessments of benefits and the 
acknowledgment that even these may fall short of the real-world 
benefits that may result from this rule. For example, the analyses 
consider the impacts of toxic pollutants, but do not evaluate the 
impacts of other pollutants (such as BOD5, COD, and TSS) 
which can produce significant adverse environmental impacts.
    Within these limitations, EPA analyzes the effects of current air 
and water emissions and assesses the benefits of reductions in these 
emissions resulting from this final regulation. EPA expects a variety 
of human health, environmental, and economic benefits to result from 
these reductions in effluent loadings and air emissions (See 
Environmental Assessment of the Final Effluent Guidelines for the 
Pharmaceutical Manufacturing Industry, (July 1998, EPA-821-B-98-008). 
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 hazard 
(systemic); ecological and recreational benefits due to improved water 
quality with respect to toxic pollutants, including intrinsic benefits; 
and benefits to publicly owned treatment works (POTWs) from reductions 
in interference, pass through, and sludge contamination problems, 
improvements in worker health and safety, and elimination of some of 
the efforts associated with establishing local pretreatment limits. EPA 
monetizes the estimated benefits for reductions in air emissions of 
ozone precursors, cancer risk reductions, improvements in recreational 
fishing opportunities, and improvements in intrinsic value, but is 
unable to quantify the dollar magnitude of benefits from the other 
benefit categories. Air benefits due to reductions in emissions of 
ozone precursors, are estimated using the methods and data summarized 
in the November 5, 1997 OAQPS memorandum titled ``Benefits-Transfer 
Analysis for Pulp and Paper''. This methodology is based on the 
recently published benefits analyses provided in the Regulatory Impact 
Analyses for the Particulate Matter and Ozone National Ambient Air 
Quality Standards and Proposed Regional Haze Rule. The methodology and 
data used in the estimate of all benefits are described in detail in 
the Environmental Assessment.

[[Page 50410]]

a. Reduced Emissions of Ozone Precursors

    These final effluent guidelines are expected to result in 
reductions in ambient ozone concentrations due to reductions in VOC 
emissions. Controlling VOC emissions is beneficial because some VOCs 
are precursors to ozone, which negatively affects human health and 
plant life.
    EPA estimates that the annual monetized benefits resulting from 
reductions in VOC emissions due to this final rule range from $755,000 
to $9.8 million ($1997). The benefits are monetized using a benefits-
transfer-based approach. Specifically, the estimated reductions in VOC 
emissions in nonattainment areas alone, and in both nonattainment and 
attainment areas (1,254 Mg to 3,608 Mg, respectively) are multiplied by 
an existing estimate of the range of the value of a unit reduction in 
VOC emissions ($602/Mg to $2,723/Mg, $1997). This range is based on the 
ozone National Ambient Air Quality Standard (NAAQS) benefits analysis, 
which used new scientific studies to quantify the association between 
ozone exposure and premature mortality. The $602/Mg estimate does not 
include mortality effects associated with ozone exposure, while the 
$2,723/Mg estimate includes mortality effects.
    The overall benefit estimate for ozone precursor reduction also 
includes an estimate of the potential adverse effects which may result 
from increased emissions of particulate matter (PM) and sulfur dioxide 
(SO2) related to steam stripping of the VOCs. Emissions of 
PM and SO2 arise from the use of fossil fuels as an energy 
source for the steam stripping technology basis. The quantity of these 
emissions is based on the type of fossil fuel (natural gas or fuel oil) 
used.
    Particulate matter is associated with adverse human health and 
welfare effects. EPA estimates that the annual monetized adverse 
environmental impact resulting from increases in PM emissions due to 
this final rule is $266,000 ($1997). This value was obtained by using 
an estimated increase in PM emissions of 20 Mg multiplied by an 
estimate of the value of a unit reduction in PM emissions of $13,325 
per Mg ($1997). This value is based on the PM NAAQS benefits analysis.
    Sulfur dioxide is associated with the adverse human health effects 
and environmental impacts, including ``acid rain.'' EPA estimates that 
the annual monetized adverse environmental impact resulting from 
increases in SO2 emissions range from $311,000 to $688,000 
($1997). This value was obtained using an estimated increase in 
SO2 emissions of 52.1 Mg (51.8 Mg eastern U.S. and 0.3 Mg 
western U.S.) multiplied by an estimate of the value of a unit 
reduction in SO2 emissions of $5,984 to $13,251 per Mg 
($1997) for the eastern U.S. and $4,329 to $5,164 per Mg ($1997) for 
the western U.S. These ranges are based on the PM NAAQS benefits 
analysis and assumes emission reductions of SO2 are 
proportional to emission reductions of PM. The lower values include a 
measure of premature mortality due to short-term exposure, and the 
higher values use a measure of premature mortality due to long-term 
exposure.
    The benefits transfer method is utilized to value the pollutants 
discussed above (VOCs, PM, and SO2). This method relies on 
previous benefit studies that have been conducted for the same 
pollutants that are identified in this rulemaking. These studies 
provide useful data that can be transferred across contexts in order to 
approximate the benefits of the pharmaceuticals industry's emission 
reductions.
    The impacts and benefits associated with the different emission 
components are aggregated by adding the lower values separately from 
the higher values to give a maximum total range. Using this method of 
analysis, the total monetized air benefits from reduction of ozone 
precursors, including associated PM and SO2 increases, range 
from an adverse environmental impact of $0.20 million ($1997) to a 
benefit of $9.2 million ($1997).

b. Reduced Human Health Cancer Risk

    The benefits from the final rule include human health benefits from 
reductions in excess cancer risk. EPA expects the final 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 fugitive air emissions, EPA estimates that the 
final guidelines will result in 0.15 excess cancer cases avoided per 
year nationwide due to reduced exposure to four identified pollutants 
(benzene, chloroform, 1,2-dichloroethane, and methylene chloride). The 
estimated monetized value of the human health benefits from these 
cancer risk reductions ranges from $350,000 to $1.9 million ($1997) 
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 $2.3 million to 12.6 million 
($1997). This estimated range is based on EPA's Office of Policy, 
Planning and Evaluation (OPPE) review of willingness-to-pay studies for 
valuing an avoided event of premature mortality or a statistical life 
saved.

c. Reduced Noncarcinogenic Human Health Hazard

    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. This 
final rule is expected to generate human health benefits by reducing 
exposure to these substances, thus reducing the hazards of these 
associated effects.
    As in the case of the cancer risk assessment, systemic hazards from 
exposure to fugitive air emissions and consumption of contaminated fish 
tissue and drinking water are evaluated. Based on this analysis, 
reductions in fugitive air emissions are expected to result in reduced 
systemic hazard to 32,300 individuals due to reduced exposure to four 
identified toxic pollutants (ammonia, chlorobenzene, methyl cellosolve, 
and triethylamine). No systemic hazards 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. Improved Ecological Conditions and Recreational Activity

    EPA expects this final rule 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., preservation of habitat), and passive use (intrinsic) values 
(e.g., aesthetics). 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 and value of recreational experiences of users, such 
as anglers fishing in the affected streams. EPA considers the value of 
the recreational fishing benefits and intrinsic benefits resulting from 
this final rule, but does not evaluate the

[[Page 50411]]

other types of ecological and environmental benefits (e.g., increased 
assimilative capacity of the receiving stream, protection of 
terrestrial wildlife and birds that consume aquatic organisms, and 
improvements to other recreational activities, such as swimming, 
boating, water skiing, and wildlife observation) due to data 
limitations.
    To estimate some of the benefits from the improvements in water 
quality expected to result from this rule, instream concentration 
estimates are modeled and then compared to both aquatic life and human 
health ambient water quality criteria (AWQC) or toxic effect levels to 
evaluate whether these discharges pose risk to aquatic organisms or to 
human health. The projected reductions in toxic loadings to surface 
waters and POTWs are significant. Modeled end-of-pipe pollutant 
loadings are estimated to decline by 71 percent, from 11.2 million 
pounds per year under current conditions to 3.3 million pounds per year 
under this final rule.1 The analysis comparing instream 
concentration levels to AWQC estimates that current discharge loadings 
result in excursions of AWQC at five locations. The analysis also 
indicates that no excursions are expected to occur at these five sites 
under this final rule.
---------------------------------------------------------------------------

    \1 2 3\ These benefits are a result of the CAA MACT Rule and/or 
the CWA Rule. Monetized benefits of $290,000 to $1.0 million ($1997) 
of the total recreational benefit to anglers can be solely 
attributed to the CWA Rule. Monetized benefits of $140,000 to 
$510,000 ($1997) of the total intrinsic benefit can be solely 
attributed to the CWA Rule.
---------------------------------------------------------------------------

    EPA estimates that the annual monetized recreational benefits to 
anglers associated with the expected changes in water quality range 
from $520,000 to $1.8 million ($1997).2 EPA evaluates these 
recreational benefits, applying a model that considers the increase in 
value of a ``contaminant-free fishery'' to recreational anglers 
resulting from the elimination of pollutant concentrations in excess of 
AWQC at these five sites. The monetized value of impaired recreational 
fishing opportunity is estimated by first calculating the baseline 
value of the receiving stream using a value per person day of 
recreational fishing, and the number of person-days fished on the 
receiving stream. The value of improving water quality in this fishery, 
based on the increase in value to anglers of achieving contaminant-free 
fishing, is then calculated.
    In addition, EPA estimates that the annual monetized intrinsic 
benefits to the general public, as a result of the same improvements in 
water quality, range from at least $260,000 to $920,000 
($1997).3 These intrinsic benefits are estimated as half of 
the recreational benefits and may be significantly underestimated.

e. Improved POTW Operations/Conditions

    EPA considers three potential sources of benefits to POTWs from 
this final regulation: (1) reductions in the likelihood of 
interference, pass through, and sewage sludge contamination problems; 
(2) reductions in health and safety risks to POTW workers; and (3) 
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 reducing these 
effects at POTWs might be substantial, the EPA does not quantify all of 
these benefits due to data limitations.
    First, regarding potential interference, pass through and sewage 
sludge contamination problems, this final 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 sampling 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 three POTWs for five pollutants 
(acetonitrile, diethylamine, N,N-dimethylacetamide, N,N-
dimethylformamide, and triethylamine) under current conditions. 
Inhibition problems are projected to remain at the same three POTWs for 
three of these pollutants (acetonitrile, N,N-dimethylacetamide, and 
N,N-dimethylformamide) after this final rule.4 While this 
rule is not expected to completely eliminate inhibition problems, the 
reduction in pollutant loadings is expected to reduce the severity of 
the impact. Sufficient data are not available to further quantify this 
benefit category.
---------------------------------------------------------------------------

    \4\ This benefit is a result of the CAA MACT Rule and/or the CWA 
Rule.
---------------------------------------------------------------------------

    Furthermore, toxic substances, particularly the VOCs, in effluent 
discharges to POTWs pose health risks to POTW workers. This final 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 the toxic pollutants (primarily acetonitrile, benzene, 
chloroform, diethylamine, n-heptane, n-hexane, methylene chloride, 
toluene, and triethylamine), this final rule is estimated to reduce 
occupational risk at nine POTWs.5 Data are not available to 
monetize this benefit category.
---------------------------------------------------------------------------

    \5\ This benefit is a result of the CAA MACT Rule and/or the CWA 
Rule. Reduction of occupational risk at five POTWs can be solely 
attributed to the CWA Rule.
---------------------------------------------------------------------------

    Finally, reducing the pollutant load to local POTWs may eliminate 
some of the efforts associated with establishing local pollutant 
limits. Local limits are sometimes required to protect against pass-
through and interference, and to protect worker health and safety. 
Establishing local limits involves labor and analytical costs to 
determine the relative contribution of each industrial discharger and 
to set limits which will be protective of the treatment works, the 
workers, and the receiving environment. Several POTWs contacted in 
EPA's survey indicated that establishment of more effective national 
pretreatment standards would help them avoid these significant costs. 
In addition, they indicated that where local limits are still required, 
stricter national pretreatment standards will bolster the validity of 
the limits they set.
    Furthermore, reducing the discharge of toxic pollutants reduces the 
likelihood that the POTW effluents will exhibit excessive toxicity. 
When POTW effluent exhibits excessive toxicity, the POTW must enact a 
rigorous, costly analytical program to identify and reduce the source 
of toxicity.

f. Other Unquantified Benefits

    The above benefit analyses focus mainly on identified compounds 
with quantifiable toxic or carcinogenic effects. This leads to a 
potentially large underestimation of benefits, since some significant 
pollutant characterizations are not considered. For example, the 
analyses do not include the benefits associated with reducing the 
particulate load (measured as TSS), or the oxygen demand (measured as 
BOD and COD) of the effluents. TSS loads can degrade ecological habitat 
by reducing light penetration and primary productivity, and from 
accumulation of solid particles that alter benthic spawning grounds and 
feeding habitats. BOD and COD loads can deplete oxygen levels, which 
can produce mortality or other adverse effects in fish, as well as 
reduce biological diversity.
    The benefits of COD reduction extend beyond reducing oxygen 
depletion, since COD also represents the presence of organic chemicals 
in a waste stream. Due to a lack of analytical methods, not all of the 
compounds represented by COD are identified. In this benefits

[[Page 50412]]

assessment, specifically identified compounds represent only 2.2 
million pounds of the 11.5 million pounds of COD projected to be 
removed. This limits the estimate of benefits, since the analysis 
relies on comparing instream concentrations to established criteria, 
and there are obviously no established criteria for unidentified 
compounds. However, there is inherent value in reducing pollutant 
loads, despite (or perhaps due to) the lack of quantifiable effects.
    The benefits analyses are further limited because they concentrate 
on projected excursions from established minimum standards, and do not 
account for protection of higher quality conditions. Likewise, they do 
not account for prevention of future impacts which could occur due to 
increased effluent loadings.

g. Summary of Benefits from Effluent Limitations Guideline Final Rule

    EPA estimates that the annual monetized benefits resulting from 
this final effluent guidelines rule will range from $0.93 million to 
$14 million ($1997). This range includes $0.34 to $1.2 million that 
cannot be differentiated between the effluent guidelines rule and the 
wastewater portion of the MACT standard. Table XI.B.9.g summarizes 
these benefits, by category. The range reflects the uncertainty in 
evaluating the effects of this final rule and in placing a dollar value 
on these effects. As indicated in the table, these monetized benefits 
ranges do not reflect many of the benefit categories expected to result 
under this final rule, including reduced noncarcinogenic human health 
hazards; improved ecological conditions from improvements in water 
quality; improved POTW operations; and improved worker health and 
safety at POTWs. Therefore the reported benefit estimate understates 
the total benefits of this final rule.

h. Benefits of the MACT Rule

    The CAA MACT Rule will regulate an estimated 101 facilities. The 
Rule is expected to produce environmental and human health benefits due 
to reductions in fugitive air emissions from four planks: wastewater, 
process vents, storage tanks, and equipment leaks. EPA conducted 
analyses on the 23 facilities covered under the wastewater plank, based 
on site-specific raw loadings data from the 1990 Pharmaceuticals 
Section 308 Questionnaire. These analyses were conducted using the same 
methodologies, within the same limitations, as those conducted to 
evaluate the CWA Rule as discussed in the previous Sections. Data on 
emission reductions from the other planks were obtained by OAQPS, 
however, a detailed benefit analysis of these planks was not conducted 
due to data limitations (specifically, the lack of site-specific data).
    Within these limitations, the estimated benefits are as follows:
Reduced Emissions of Ozone Precursors
    EPA estimates that the final MACT Rule will produce benefits due to 
reductions in fugitive VOC emissions from wastewater, process vents, 
storage tanks, and equipment leaks at pharmaceutical manufacturing 
facilities. Considering the wastewater plank only, EPA estimates that 
the annual monetized benefits range from $1.2 million to $45 million 
($1997). These benefits are based on estimated emission reductions in 
VOC emissions in nonattainment areas alone, and in both nonattainment 
and attainment areas (2,057 Mg to 16,619 Mg, respectively).
    The annual monetized adverse environmental impacts for these 23 
facilities due to increases in PM emissions is estimated by EPA at 
$56,000 ($1997). This value is based on an estimated increase in PM 
emissions of 4.2 Mg. EPA also estimates that the annual monetized 
adverse environmental impacts for these 23 facilities due to increases 
in SO2 emissions due to the final MACT Rule range from 
$65,000 to $143,000 based on an estimated increase in SO2 
emissions of 11.0 Mg (10.6 Mg eastern U.S., and 0.4 Mg western U.S.).
    The total monetized air benefits from reductions of ozone 
precursors from wastewater, after correction for PM and SO2 
increases, range from $1.0 million to $45 million ($1997).
    In addition, based on the analysis of the 101 pharmaceutical 
manufacturing facilities covered by the MACT rule, EPA estimates that 
the reductions in fugitive VOC emissions from process vents, storage 
tanks, and equipment leaks would result in a range of annual monetized 
air benefits of $0.77 million to $11 million ($1997). These benefits 
are based on estimated reductions in VOC emissions in nonattainment 
areas alone, and in both nonattainment and attainment areas (1,278 Mg 
to 4,027 Mg, respectively). Adverse impacts due to increased energy 
consumption from control of these planks are not quantified due to data 
limitations. The total monetized benefits from reductions in VOC 
emissions from all four planks are estimated to be $1.8 million to $56 
million ($1997).
Reduced Human Health Cancer Risk
    The estimated monetized value of the human health benefits from 
cancer risk reductions due to reductions in fugitive air emissions from 
wastewater ranges from $2.1 million to $11 million ($1997) annually. 
This is based on EPA estimates that the MACT Rule will result in 0.88 
cancer cases avoided per year nationwide, considering an inhalation 
exposure route. EPA also 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 tissues.
    EPA estimates that cancer risk will be further reduced due to 
reductions in fugitive air emissions from process vents, storage tanks, 
and equipment leaks. However, these reductions were not quantified due 
to lack of site-specific data.
Reduced Noncarcinogenic Human Health Hazard
    EPA estimates that reductions in fugitive air emissions from 
wastewater are expected to result in reduced systemic hazard to 370,000 
individuals due to reduced exposure to four identified toxic 
pollutants. EPA also expects that reductions in fugitive air emissions 
from process vents, storage tanks, and equipment leaks will result in 
reduced systemic hazard. However, EPA does not quantify these benefits 
due to data limitations. No systemic hazard reductions are expected to 
result from reduced exposure to contaminated fish tissue or drinking 
water.
Improved Ecological Conditions and Recreational Activity
    EPA estimates that the annual monetized recreational benefits to 
anglers associated with the expected changes in water quality at two 
locations range from $230,000 to $820,000 ($1997). The annual monetized 
intrinsic benefits to the general public range from at least $115,000 
to $410,000 ($1997). These benefits are a result of the CAA MACT Rule 
and/or the CWA Rule. These monetized benefits cannot be solely 
attributed to the MACT Rule.
Improved POTW Operations
    Inhibition problems are projected by EPA to occur at three POTWs 
for five pollutants under current conditions. Inhibition problems are 
projected to remain at the same three POTWs for three of these 
pollutants. The benefits cannot be solely attributed to the MACT Rule.

[[Page 50413]]

    Additionally, the MACT Rule is expected to reduce health risks to 
POTW workers. This rule is estimated to reduce occupational risks at 
four POTWs. However, these benefits cannot be solely attributed to the 
MACT Rule.
Summary of Benefits From MACT Final Rule
    EPA estimates that the annual monetized benefits resulting from the 
MACT final rule will range from at least $3.9 million to $67 million 
($1997). Additional annual monetized benefits that cannot be solely 
attributed to the CAA portion of this final rule will range from $0.34 
million to $1.2 million ($1997). Table VI.B.9.h summarizes these 
benefits, by category. As explained previously in Section g, the 
expected benefit estimate understates the total benefits of the MACT 
rule. The estimate is further constrained by data limitations.

    Table VI.B.9.g.--Potential Economic Benefits From Final Effluent    
         Limitations Guidelines for the Pharmaceutical Industry         
------------------------------------------------------------------------
                                                Millions of 1997 dollars
               Benefit category                         per year        
------------------------------------------------------------------------
Reduced Emissions of Ozone Precursors........  -$0.20 to $9.2.          
Reduced Cancer Risk..........................  $0.35 to $1.9.           
Reduced Noncarcinogenic Hazard...............  Unquantified.            
Improved Ecological Conditions...............  Unquantified.            
Improved Recreational Activity...............  $0.52 to $1.8.           
Improved Intrinsic Value.....................  $0.26 to $0.92.          
Improved POTW Operations (Inhibition and       Unquantified.            
 Sludge Contamination).                                                 
Improved Occupational Conditions at POTWs....  Unquantified.            
                                              --------------------------
    Total Monetized Benefits.................  $0.93 to $14.0.          
------------------------------------------------------------------------
Note: These benefits include a portion of recreational and intrinsic    
  monetized benefits attributed to the CAA Rule. Specifically, two      
  facilities included in the modeling were required to have MACT        
  strippers and were also costed for additional strippers to meet the   
  CWA effluent guidelines. Overall removals due to these strippers      
  cannot be differentiated between MACT and CWA requirements. These two 
  facilities represent a total of $0.34 to $1.2 million based on        
  improved recreational activity and improved intrinsic value.          


         Table VI.B.9.h.--Potential Economic Benefits From CAA MACT Rule for the Pharmaceutical Industry        
----------------------------------------------------------------------------------------------------------------
                                                        Millions of 1997 dollars per year                       
       Benefit category        ---------------------------------------------------------------------------------
                                         Wastewater           Other fugitive emissions\1\      Total benefits   
----------------------------------------------------------------------------------------------------------------
Reduced Emissions of Ozone      $1.0 to $45.................  $0.77 to $11$..............  $1.8 to $56.         
 Precursors.                                                                                                    
Reduced Cancer Risk...........  $2.1 to $11.................  Unquantified...............  $2.1 to $11.         
Reduced Noncarcinogenic Hazard  Unquantified................  Unquantified...............  Unquantified.        
Improved Ecological Conditions  Unquantified................  Unquantified...............  Unquantified.        
Improved POTW Operations        Unquantified................  Unquantified...............  Unquantified.        
 (Inhibition and Sludge                                                                                         
 Contamination).                                                                                                
Improved Occupational           Unquantified................  Unquantified...............  Unquantified.        
 Conditions at POTWs.                                                                                           
    Total Monetized Benefits..  $3.1 to $56.................  $0.77 to $11...............  $3.9 to $67.         
                               ---------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
\1\ Includes process vents, storage tanks, and equipment leaks.                                                 
Notes: These benefits exclude a portion of the recreational and intrinsic monetized benefits attributed to the  
  CAA Rule. Specifically, two facilities included in the modeling were required to have MACT strippers and were 
  also costed for additional strippers to meet the CWA effluent guidelines. Overall removals due to these       
  strippers cannot be differentiated between MACT and CWA requirements. These two facilities represent a total  
  of $0.34 to $1.2 million dollars, based on improved recreational activity and improved intrinsic value.       
The benefits analysis for the MACT Rule is particularly limited due to data constraints.                        

VII. Non-Water Quality Environmental Impacts

    The elimination or reduction of one form of pollution may create or 
aggravate other environmental problems. Therefore, Sections 304(b) and 
306 of the Act call for EPA to consider the non-water quality 
environmental impacts of effluent limitations guidelines and standards. 
Accordingly, EPA has considered the effect of these regulations on air 
pollution, solid waste generation, and energy consumption.

A. Air Pollution

    EPA estimated the impacts of the selected technology options for 
the existing source BAT and PSES regulations and the technology basis 
for the MACT standard on air emissions. EPA considered emissions of 
HAPs and non-HAPs as well as criteria air pollutants (CO, 
NoX, SO2 and particulate matter) in its analysis. 
EPA estimates that the MACT standards steam strippers will reduce air 
emissions of HAPs and non-HAPs at direct and indirect subcategory A and 
C facilities by 14.1 and 41.4 million lbs. per year, respectively. No 
emission reductions have been estimated for B and D subcategory direct 
and indirect dischargers as the result of the MACT standard because 
these facilities are not ``major sources'' of hazardous air pollutants 
(HAPs) (defined as facilities with total annual emissions of HAPs 
greater than 25,000 metric tons). EPA has estimated the reduction in 
air emissions of HAPs and non-HAPs as the result of steam strippers 
that may be installed to comply with PSES for VOC pollutants for A and 
C and B and D subcategory facilities to be 10.7 and 3.3 million lbs. 
per year, respectively. With

[[Page 50414]]

respect to criteria pollutants, EPA estimates that as a result of steam 
generation requirements for PSES steam strippers, emissions of criteria 
pollutants will increase by 616,000 pounds per year.

B. Solid Waste

    EPA has estimated the increases in solid waste generation as from 
the use of advanced biological treatment (the basis for BPT/BCT 
limitations), and steam stripping technology (the basis for PSES). EPA 
also estimated an increase in waste hydrogen chloride due to scrubber 
liquor generated by facilities with wastewater containing ammonia.
    EPA estimates that compliance with the BPT/BCT limitations will 
increase the mass of wastewater treatment sludge by subcategories A and 
C and B and D direct dischargers by 343 and 194 tons per year, 
respectively. Compliance with BAT ammonia and organic limitations by A 
and C subcategory plants is expected to increase wastewater sludge 
generation by 308 tons per year. No increase in sludge generation is 
expected as the result of the subcategories B and D BAT COD limitations 
because these limitations are equivalent to the BPT COD limitations and 
there are no BAT organic compound limitations for these subcategories. 
EPA does expect that indirect discharging A and C facilities will 
generate an increase in waste aqueous hydrogen chloride resulting from 
the use of wet hydrogen chloride scrubbers to control air emissions 
from steam strippers used to remove ammonia from wastewater. EPA 
estimates that waste aqueous hydrogen chloride generation will increase 
by 283 tons per year.
    Compliance with PSES subcategory A and C and subcategory B and D 
facilities is expected to increase the amount of waste solvents 
generated. This increase in waste solvent generation is due to the 
waste solvents recovered from the in-plant steam stripping operations 
at these facilities. EPA anticipates that 10,600 and 3,310 tons/yr of 
waste solvents will be generated at subcategory A and C and B and D 
facilities, respectively.
    Ten of the pollutants being regulated by BAT limitations and 
pretreatment standards are solvents listed as hazardous waste 
constituents (F0002, F0003, and F0005) under 40 CFR 261.31. These 
pollutants are acetone, 4-methyl-2-pentanone (MIBK), ethyl acetate, 
methanol, benzene, toluene, xylenes, methylene chloride, chlorobenzene, 
and o-dichlorobenzene. EPA is promulgating PSES for nine of these 
pollutants and has included costs for disposal of all overheads from 
steam stripping as hazardous wastes in its steam stripping cost 
estimates. As noted above, EPA has estimated increased sludge 
generation as a result of compliance with BAT limitations for 29 
pollutants including the 10 pollutants listed above. EPA has assumed 
that this sludge will be incinerated in developing its final BAT cost 
estimates, but does not believe that the increased sludge generated 
will be considered as hazardous.

C. Energy Requirements

    EPA has estimated the energy impacts on the pharmaceutical 
manufacturing industry associated with compliance with the final BPT, 
BAT and PSES regulations. The Agency estimates that electrical usage 
would increase for subcategory A and C and subcategory B and D 
facilities by 5.9  x  106 and 1.07  x  106 
kilowatt hours (kWh) as the result of the final BPT and BAT 
regulations. This increase is equivalent to a 0.1 percent increase 
above current electrical usage by the industry. EPA also estimated the 
increase in electrical usage as the result of increased steam 
generation. The increased steam generation is required to operate the 
steam strippers that EPA anticipates will be installed to comply with 
the pretreatment standards for VOCs. (The impacts of the BPT and BAT 
regulations on electrical usage for steam generation are negligible). 
EPA estimates that electrical usage for steam generation will increase 
for subcategories A and C and subcategories B and D indirect 
dischargers by 454  x  106 and 58.8  x  106 kWh, 
respectively. The total of these two increases in electrical usage is 
equivalent to an eight percent overall increase in electrical usage 
above current levels.

VIII. Regulatory Implementation

    The purpose of this section is to provide assistance and direction 
to permit writers and control authorities to aid in their 
implementation of this regulation and its unique compliance 
alternative. This section also discusses the relationship of upset and 
bypass provisions, variances and modifications, and analytical methods 
to the final limitations and standards.

A. Implementation of the Limitations and Standards

    Upon the promulgation of these regulations, the effluent 
limitations for the appropriate subcategory must be applied in all 
Federal and State NPDES permits issued to direct dischargers in the 
pharmaceutical manufacturing industry. In addition, the pretreatment 
standards are directly applicable to indirect dischargers.
    Permit writers and pretreatment authorities need to be aware of 
special circumstances involving compliance with the cyanide limitations 
and standards, ammonia pretreatment standards, pH monitoring and the 
portion of nonprocess wastewater in the final effluent. In the case of 
the cyanide limitations and standards, EPA determined that the 
monitoring point for purposes of compliance with the cyanide will 
generally be in-plant at a point before the cyanide-bearing wastewaters 
are commingled with noncyanide-bearing waste streams in accordance EPA 
permit and pretreatment program regulations at 40 CFR 122.44(i)(1)(iii) 
for direct dischargers and Sec. 403.6(e) for indirect dischargers. 
These regulations allow permit writers and pretreatment control 
authorities to establish in-plant monitoring points for regulated 
pollutants in cases where it is impractical or infeasible to monitor at 
the normal end-of-pipe monitoring point e.g., because the regulated 
pollutant is not detectable at the end-of-pipe. This, in turn, is the 
result of the wastewater stream bearing the regulated pollutant being 
commingled with significantly higher volume streams not bearing the 
regulated pollutant. EPA's analysis of waste stream flow data, from 
subcategories A and C facilities containing cyanide in their 
wastewaters, indicate that the volume of cyanide-bearing wastewaters 
is, on average, less than 2.1 percent of the total process wastewater 
flow and that all but two of the facilities required to monitor for 
cyanide do so at an in-plant monitoring point. Facilities that can 
demonstrate that it is not impractical or infeasible to monitor for 
cyanide at the normal end-of-pipe point, i.e., cyanide can be detected 
at the end-of-pipe point, may do so.
    In connection with the ammonia pretreatment standards being 
promulgated for subcategories A and C, EPA has determined that the 
pollutant ammonia does not passthrough POTWs that possess nitrification 
capability. As a result, ammonia pretreatment standards would not apply 
to subcategories A and C industrial users that discharge to these 
POTWs. In order to provide guidance to pretreatment authorities, EPA 
describes the treatment system requirements under which nitrification 
is considered to occur in section 17 of the final TDD and defines the 
basis for considering a POTW to have acceptable nitrification 
capability in Sec. 439.1 of the final rule. POTWs that nitrify should 
impose local limits for

[[Page 50415]]

ammonia if they believe that the ammonia load from the pharmaceutical 
industrial user(s) will nevertheless pass through their facilities (see 
40 CFR 403.5).
    During the post-proposal period, EPA has received comments from 
industry commenters that complying with the pH requirements 100 percent 
of the time when using continuous monitoring is not practical for many 
facilities. Direct discharging pharmaceutical facilities are required 
by today's final regulation to maintain effluent pH in the 6.0-9.0 
range. The general pretreatment regulations specifically in 40 CFR 
403.5(b)(2), set a pH minimum of 5.0, except in certain design 
conditions, but do not set an upper boundary. EPA has addressed the 
problem of random excursions at 40 CFR 401.17 for direct discharging 
facilities. This regulation recognizes that random excursions from the 
pH range (6.0-9.0) may occur in the process of continuous monitoring 
and these random excursions should not be treated as violations. EPA is 
developing a proposal for a similar provision for indirect dischargers 
and expects to propose this provision by the end of this year.
    In implementing the final limitations and standards, permit writers 
need to account for the facility's nonprocess wastewater contained in 
the effluent being discharged in developing either mass or 
concentration based permit limits. As discussed previously, in section 
IV of this preamble, the final limitations and standards are developed 
from data sets from plants which had less than 25 percent nonprocess 
wastewater in the total plant discharge. The flow basis of the final 
limitations and standards is discussed in section 13 of the TDD. In 
addition, examples of BPT and BAT permit limit calculations involving 
different plant flow configurations are provided in Appendix A to the 
TDD. In addition, permitting authorities have requested clarification 
on whether certain operations performed at pharmaceutical facilities 
would cause those facilities to be regulated under additional effluent 
guidelines. Specifically, guidance has been requested in cases where 
pharmaceutical facilities, during routine maintenance and cleaning 
periods, use acid containing solutions on or in stainless steel 
processing equipment. Some permitting authorities have inquired whether 
these operations are considered passivation operations which would 
place the wastewater generated during such cleaning operations under 
the limitations set forth by 40 CFR Part 433, the Metal Finishing Point 
Source Category. The Food and Drug Administration requires that 
pharmaceutical products must be of high purity and cannot be 
contaminated with dirt, biological organisms, or corrosion products. 
The pharmaceutical production equipment includes many interconnected 
pipes, storage vessels, and reactors. Most of the piping system and 
tanks are fabricated from austenitic stainless steel similar to AISI 
304. The Agency is aware of several pharmaceutical facilities which 
clean production equipment with a mild alkaline ``soap'' followed by a 
flush with an acid containing solution. Some of these acid solutions 
contain nitric acid. The alkaline cleaner/acid-rinse operation is 
usually performed during plant shut-downs or routine preventative 
maintenance. Because much of the plant piping is fabricated from 
austenitic stainless steel, and such stainless steels are known to be 
``passivated'' using nitric acid solutions, it has been asked if the 
nitric-acid-based process used by the pharmaceutical facilities would 
be considered ``passivation'' or ``cleaning'' for the purpose of 
regulation under the 40 CFR Part 433 Metal Finishing regulation.
    The ``Development Document for Effluent Limitations Guidelines, New 
Source Performance Standards for the Metal Finishing Point Source 
Category'' describes the ``coating'' unit operation, which includes 
``passivation'', as one of the six key ``trigger'' processes, while the 
``cleaning'' operation description includes a discussion of acid 
cleaning as an operation that is not one of the six ``trigger'' 
processes. For a process wastestream to be regulated under 40 CFR Part 
433, a facility must perform one of the six ``trigger'' operations. To 
determine the status of the alkaline ``soap''/acid-based operations 
performed at pharmaceutical facilities, key provisions of the 
``passivation'' and ``cleaning'' definitions were reviewed. From the 
definitions provided in the Development Document ``passivation'' is a 
process in which iron particles are removed from a surface, while a 
protective coating is formed. ``Cleaning'' is a process in which acid 
can be used in combination with detergent to remove soil from metal 
surfaces. Based on these definitions from the Metal Finishing 
Development Document, the process conducted at pharmaceutical 
facilities should be considered cleaning for the following three 
reasons:
    1. The processes in question use both acid and detergent.
    2. The processes in question are not used to remove imbedded iron 
particles.
    3. The processes in question are not used to form a coating on 
stainless steel piping. (This conclusion can be reached based on the 
inherent vulnerability of non-passivated stainless to corrosion. If the 
pipes in this system were not already passivated, they would corrode 
during the production operations and contaminate the pharmaceutical 
products.)
    For the reasons listed above, the pharmaceutical production 
operations performed at these facilities should be considered ``acid 
cleaning'' and non ``passivation'' with respect to 40 CFR Part 433 
Metal Finishing. Because the facilities only perform ``acid cleaning'' 
and not ``passivation'' there is no metal finishing ``trigger'' process 
performed at the facility and therefore the facility would not be 
regulated using 40 CFR Part 433.

B. Upset and Bypass Provisions

    A recurring issue is whether industry limitations and standards 
should include provisions authorizing noncompliance with effluent 
limitations during periods of ``upset'' or ``bypass''. An upset, 
sometimes called an ``excursion,'' is an unintentional and temporary 
noncompliance with technology based effluent limitations occurring for 
reasons beyond the reasonable control of the permittee. EPA believes 
that upset provisions are necessary to recognize an affirmative defense 
for an exceptional incident. Because technology-based limitations can 
require only what properly designed, maintained and operated technology 
can achieve, it is claimed that liability for such situations is 
improper.
    While an upset is an unintentional episode during which effluent 
limitations are exceeded, a bypass is an act of intentional 
noncompliance during which wastewater treatment facilities are 
circumvented in emergency situations.
    EPA has both upset and bypass provisions in NPDES permits, and has 
promulgated NPDES and pretreatment regulations which include upset and 
bypass provisions. (40 CFR 122.41(m), 122.41(n) and 40 CFR 403.16 and 
403.17.) The upset provision establishes an upset as an affirmative 
defense to prosecution for violation of technology-based effluent 
limitations. The bypass provision provides that EPA may enforce against 
facilities that bypass except where necessary to prevent loss of life, 
personal injury, or severe property damage; there were no feasible 
alternatives; or permittee submitted notices as required under 
122.41(n)(3).

C. Variances and Modifications

    Upon the promulgation of these regulations, the effluent 
limitations for

[[Page 50416]]

the appropriate subcategory must be applied in all Federal and State 
NPDES permits issued to direct dischargers in the pharmaceutical 
manufacturing industry. In addition, the pretreatment standards are 
directly applicable to indirect dischargers.

1. Fundamentally Different Factors Variances

    For the BPT effluent limitations, the only exception to the binding 
limitations is EPA's ``fundamentally different factors'' (``FDF'') 
variance (40 CFR Part 125 Subpart D). This variance recognizes factors 
concerning a particular discharger which are fundamentally different 
from the factors considered in this rulemaking. Although this variance 
clause was set forth in EPA's 1973-1976 effluent guidelines, it is now 
included in the NPDES regulations and not the specific industry 
regulations. (See 44 FR 32854, 32893 [June 7, 1979] for an explanation 
of the ``fundamentally different factors'' variance). The procedures 
for application for a BPT FDF variance are set forth at 40 CFR 
122.21(m)(1)(I)(A).
    Dischargers subject to the BAT limitations and PSES in these final 
regulations may also apply for an FDF variance, under the provisions of 
sec. 301(n) of the Act, which regulates BAT, BCT, and PSES for existing 
sources pretreatment FDFs. (See 40 CFR 122.21 and 40 CFR 403.13, 
respectively) In addition, BAT limitations for nonconventional 
pollutants may be modified under sec. 301(c) (for economic reasons) and 
301(g) (for water quality reasons) of the Act. Under sec. 301(l) of the 
Act, these latter two statutory modifications are not applicable to 
``toxic'' or conventional pollutants.
2. Removal Credits
    Congress, in enacting Section 307(b) of the CWA, recognized that, 
in certain instances, POTWs could provide some or all of the treatment 
of an industrial user's wastestream 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 amount of pollutants to 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 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 (3rd 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 which 
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 which 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 February 19, 1993, EPA published the 
Round One sewage sludge regulations establishing standards, including 
numerical pollutant limits, for the use and disposal of sewage sludge. 
58 FR 9248. EPA established pollutant limits for ten metals when sewage 
sludge is applied to land, for three metals when it is disposed of at 
surface disposal sites and for seven metals and total hydrocarbons, a 
surrogate for organic pollutant emissions, when sewage sludge is 
incinerated. These requirements are codified at 40 CFR Part 503.
    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 at 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 sewage sludge. 
See 40 CFR 403.7(a)(3)(iv)(C).
    Thus, given compliance with the requirements of EPA's removal 
credit regulations, following promulgation of the pretreatment 
standards in today's rule, 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. Currently there are two pretreatment programs 
authorized to issue removal credits. EPA is not promulgating 
pretreatment standards for metals, thus removal credits for metals are 
not applicable. Given compliance with Sec. 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, chloroform, 1,2-dichloroethane, methylene chloride and 
toluene.

D. Analytical Methods

    Section 304(h) of the Act directs EPA to promulgate guidelines 
establishing test methods for the analysis of pollutants. These methods 
are used to determine the presence and concentration of pollutants in 
wastewater, and are used for compliance monitoring and for filing 
applications for the NPDES program

[[Page 50417]]

under 40 CFR 122.21, 122.41, 122.44 and 123.25, and for the 
implementation of the pretreatment standards under 40 CFR 403.10 and 
403.12. To date, EPA has promulgated methods for conventional 
pollutants, toxic pollutants, and for some nonconventional pollutants. 
The five conventional pollutants are defined at 40 CFR 401.16. Table I-
B at 40 CFR Part 136 lists the analytical methods approved for these 
pollutants. The 65 toxic metals and organic pollutants and classes of 
pollutants are defined at 40 CFR 401.15. From the list of 65 classes of 
toxic pollutants EPA identified a list of 126 ``Priority Pollutants.'' 
This list of Priority Pollutants is shown, for example, at 40 CFR Part 
423, Appendix A. The list includes non-pesticide organic pollutants, 
metal pollutants, cyanide, asbestos, and pesticide pollutants. 
Currently approved methods for metals and cyanide are included in the 
table of approved inorganic test procedures at 40 CFR 136.3, Table I-B. 
Table I-C at 40 CFR 136.3 lists approved methods for measurement of 
non-pesticide organic pollutants, and Table I-D lists approved methods 
for the toxic pesticide pollutants and for other pesticide pollutants. 
Dischargers must use the test methods promulgated at 40 CFR 136.3 or 
incorporated by reference in the tables, when available, to monitor 
pollutant discharges from the pharmaceutical manufacturing industry, 
unless specified otherwise by the permitting authority.
    As a part of today's final rule, EPA is promulgating additional 
test methods for the additional pollutants to be regulated under Part 
439 by adding a new Table IF at 40 CFR 136.3 listing test methods for 
the pharmaceutical pollutants. To support the Part 439 regulations at 
the time of proposal, EPA published test methods developed specifically 
for the pharmaceutical industry in a compendium entitled, ``Analytical 
Methods for the Determination of Pollutants in Pharmaceutical 
Manufacturing Industry Wastewater,'' EPA-821-B-94-001. These proposed 
test methods were discussed in the proposed rule. The proposed test 
methods have been revised in response to public comment and the revised 
test methods are available for monitoring some pollutants covered by 
today's final rule. The revised test methods have been published in a 
revised compendium (the ``Pharmaceutical Methods Compendium, Revision 
A''; EPA-821-B-98-016 [A, July 1998] with the same title as the 
proposed compendium. EPA does not anticipate that any dischargers from 
industrial categories other than the pharmaceutical manufacturing 
industry will ever need to monitor for the additional pollutants (with 
methods listed in Table 1F).
    In addition, EPA is allowing use of applicable drinking water 
methods that have been promulgated at 40 CFR part 141 and use of ASTM 
Methods D3371, D3695, and D4763, for monitoring of the pollutants 
included in this rulemaking. The final rule allows for use of these 
additional test methods for several reasons: (1) it allows greater 
flexibility in monitoring as requested by some commenters; (2) it 
conforms use of methods in EPA's drinking water and wastewater 
programs, (3) it moves toward a performance-based measurement system, 
and (4) it allows use of technical standards as contemplated by the 
National Technology Transfer and Advancement Act of 1995 (NTTAA; see 
Section IX.G.).
    For pollutants to be monitored under today's final rule, EPA has 
included a new table of methods in Sec. 136.3(a). The methods in this 
table are in addition to other methods approved at 40 CFR 136.3. The 
listed methods are incorporated by reference into this rule.
    With the allowed use the methods included in the new Table IF at 40 
CFR 136.3, in addition to those already approved in other Tables at 40 
CFR 136.3, EPA believes that dischargers in the pharmaceutical 
manufacturing point source category will have great flexibility in 
selection of a method for monitoring the pollutants being regulated in 
today's final rule.
    On October 6, 1997, EPA published a Notice of the Agency's intent 
to implement a Performance Based Measurement System (PBMS) in all of 
its programs to the extent feasible (62 FR 52098). The Agency is 
currently determining the specifics steps necessary to implement PBMS 
in its programs and preparing an implementation plan. Final decisions 
have not yet been made concerning the implementation of PBMS in water 
programs. However, EPA is currently evaluating what relevant 
performance characteristics should be specified for monitoring methods 
used in the water programs under a PBMS approach to ensure adequate 
data quality. EPA would then specify performance requirements in its 
regulations to ensure that any method used for determination of a 
regulated analyte is at least equivalent to the performance achieved by 
other currently approved methods. EPA expects to publish its PBMS 
implementation strategy for water programs in the Federal Register by 
the end of calendar year 1998.
    Once EPA has made its final determinations regarding implementation 
of PBMS in programs under the Clean Water Act, EPA would incorporate 
specific provisions of PBMS into its regulations, which may include 
specification of the performance characteristics for measurement of the 
regulated pollutants in today's final rule.

IX. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to Office of Management and Budget (OMB) review 
and the requirements of this Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may: (1) have an annual effect of the economy of $100 million 
or more or adversely affect in a material way the economy, a sector of 
the economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in this Executive 
Order.
    Pursuant to the terms of the Executive Order, it has been 
determined that this rule is a ``significant regulatory action'' As 
such, this action was submitted to OMB for review. Changes made in 
response to suggestions or recommendations are documented in the public 
record.

B. Regulatory Flexibility Act and the Small Business Regulatory 
Enforcement Fairness Act of 1996 (SBREFA)

    Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
as amended by SBREFA, EPA generally is required to conduct a regulatory 
flexibility analysis describing the impact of the regulatory action on 
small entities as part of the rulemaking. However, under section 605 
(b) of the RFA, EPA is not required to prepare the regulatory 
flexibility analysis if EPA certifies that the rule will not have a 
significant economic impact on a substantial number of small entities.

[[Page 50418]]

    Pursuant to section 605(b) of the RFA, the Administrator certifies 
that this rule will not have a significant impact on a substantial 
number of small entities. Nevertheless, the Agency prepared a small 
business analysis, which is presented in the Economic Analysis for 
Final Effluent Guidelines and Standards for the Pharmaceutical Industry 
and summarized in Section V.E. of this document. Briefly, EPA estimates 
that 145 small businesses will incur costs to comply with this rule 
(based on a small business definition of 750 or fewer employees as 
recommended by the U.S. Small Business Administration). EPA evaluated 
the compliance costs of the regulatory action relative to the company's 
annual revenue. When considering the effluent limitations guidelines 
and standards costs only, four small firms are estimated to incur 
annualized compliance costs exceeding one percent of revenue and no 
firms are estimated to incur annualized compliance costs exceeding 
three percent of revenue. When considering the aggregate costs of the 
effluent limitations guidelines and standards and the MACT standards, 
six small firms are estimated to incur annualized compliance costs 
exceeding one percent of revenue and one firm is estimated to incur 
annualized compliance costs exceeding three percent of revenue. No 
firms are expected to incur annualized compliance costs in excess of 
four percent of revenue.
    Further, EPA's economic achievability analysis considers the 
potential for facility closure and corporate bankruptcy. The analysis 
indicates no disproportionate effects for small businesses compared to 
large businesses. The regulatory action is found to be economically 
achievable for all dischargers, including small businesses.

C. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives and the Comptroller General of the 
General Accounting Office prior to publication of the rule in today's 
Federal Register. This rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

D. Paperwork Reduction Act

    This rule contains no new information collection activities 
requiring an information collection request, and therefore, no 
information collection request was submitted to OMB for review under 
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. 
OMB has approved information collection requirements for existing 
regulations (40 CFR Part 439) and assigned OMB Control No. 2040-0110 in 
connection with NPDES related information collection requirements and 
No. 2040-0009 in connection with pretreatment information collection 
requirements. The information collection requirements resulting from 
the regulations being promulgated today are covered by these OMB 
control numbers.

E. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), P.L. 
104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and Tribal 
governments, and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and Tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    EPA has determined that this CWA rule does not contain a Federal 
mandate that may result in expenditures of $100 million or more for 
State, local or tribal governments, in the aggregate, or the private 
sector in any one year. EPA estimates that the annual compliance costs 
to the private sector are $61.0 million ($1996). Thus, this rule is not 
subject to the requirements of sections 202 and 205 of UMRA. EPA has 
also determined that this rule contains no regulatory requirements that 
might significantly or uniquely affect small governments and thus, this 
rule is not subject to the requirements of section 203 of UMRA. 
Nevertheless, EPA has consulted with state and local governments 
pertaining to implementation issues. EPA's evaluation of their comments 
is reflected in the final rules.

F. Executive Order 12875 Enhancing Intergovernmental Partnership

    To reduce the burden of Federal regulations on States and small 
governments, the President issued Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership, on October 28, 1993 (58 FR 
58093). Under Executive Order 12875, EPA may not issue a regulation 
that is not required by statute and that creates a mandate upon a 
State, local or Tribal government unless the Federal government 
provides the necessary funds to pay the direct costs incurred by the 
State, local or Tribal government or EPA provides to the Office of 
Management and Budget a description of the extent of the Agency's prior 
consultation and written communications with elected officials and 
other representatives of affected State, local and Tribal governments, 
the nature of their concerns, and an Agency statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local and Tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.'' As 
discussed above in paragraph IX.E, this regulation would not result in 
expenditures to state, local and tribal governments of $100 million or 
more in any one year. The discussion of the Unfunded Mandates Reform 
Act of 1995 that precedes this paragraph applies to Executive Order 
12875 as well and is incorporated here by reference. Since this rule 
does not impose a significant unfunded mandate on governments subject 
to this Executive Order, the provisions of the Order do not apply. 
Nonetheless, EPA did consult with State and local

[[Page 50419]]

governments during development of this rule. In particular, EPA has had 
numerous discussions with representatives of the North Shore Sanitary 
District regarding PSES for pharmaceutical plants. In addition, EPA 
also consulted with the Puerto Rico Aqueducts and Sewer Authority 
(PRASA) regarding discharges of VOCs by pharmaceutical industrial 
users. In addition, prior to the proposal, EPA sent a questionnaire 
concerning pharmaceutical discharges to a number of POTWs receiving 
significant amounts of these discharges. The meeting summaries and 
questionnaire responses may be found in the record of this rule.

G. National Technology Transfer and Advancement Act

    Under Section 12(d) of the National Technology Transfer and 
Advancement Act (NTTAA), the Agency is required to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. Where available and potentially applicable voluntary consensus 
standards are not used by EPA, the Act requires the Agency to provide 
Congress, through the Office of Management and Budget (OMB), an 
explanation of the reasons for not using such standards.
    EPA performed a search of the technical literature to identify any 
applicable analytical test methods from industry, academia, voluntary 
consensus standard bodies, and other parties that could measure the 
analytes in this rule. EPA's search revealed that there are consensus 
standards for many of the analytes specified in the tables at 40 CFR 
136.3. Even prior to enactment of the NTTAA, EPA has traditionally 
included any applicable consensus test methods in its regulations. 
Consistent with the requirements of the CWA, those applicable consensus 
test methods are incorporated by reference in the tables at 40 CFR 
136.3. The consensus test methods in these tables include American 
Society for Testing Materials (ASTM) and Standard Methods.
    Today's rule requires dischargers to monitor for 31 organic 
pollutants, ammonia nitrogen and COD. Examples of pollutants with 
consensus methods promulgated by reference in today's rule include 
various volatile organics such as benzene, chlorobenzene, chloroform, 
chloromethane, methylene chloride, and toluene. In addition, EPA 
developed several test methods for certain nonconventional pollutants 
not included in the tables at 40 CFR 136.3 in support of the 
pharmaceutical rule and these methods were discussed in the proposal. 
Examples of the pollutants for which methods were developed are 
acetone, cyclohexane, diethylamine, ethanol and methylamine. The test 
methods being promulgated for those pollutants without test methods 
listed at 40 CFR 136.3 are EPA Methods 1665, 1666, 1667, 1671 and 1673 
which are found in a Methods Compendium, and EPA Method 8015. EPA notes 
that no applicable consensus methods were found for those pollutants.

H. Executive Order 13045 and Protecting Children's Health

    The Executive Order ``Protection of Children From Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies 
to any rule that EPA determines (1) ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health or 
safety effects of the planned rule on children; and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    EPA interprets the E.O. 13045 as encompassing only those regulatory 
actions that are risk based or health based, such that the analysis 
required under section 5-501 of the E.O. has the potential to influence 
the regulation. This rule is not subject to E.O. 13045 because it does 
not involve decisions regarding environmental health or safety risks.

X. Summary of Public Participation

    The following section describes the major comments on the proposed 
rule and the NOA, and EPA's responses. The full comment summary and 
response document can be found in the public record for this 
rulemaking.

A. Summary of Proposal Comments and Response Summary

    Sixty six different commenters provided detailed comments on all 
aspects of the May 2, 1995 proposal. In all, the comments dealt with 27 
separate aspects of the proposal. In this comment and response summary, 
only major comments and responses will be summarized. Responses to all 
comments are contained in the Comment Response Document in the record 
for this final rule. In selecting comments and responses for summary in 
this section, the Agency has selected those major and controversial 
issues that received considerable numbers and types of comments. 
Alternatively, comments and responses on other less controversial 
issues and issues where EPA essentially agrees with the commenters are 
not included in the comment and response summaries below.
    Comment: EPA's decision to set in-plant limits is primarily based 
on controlling air emissions. The appropriate statutory authority for 
regulating air emissions from wastewater is under the MACT rule, 
therefore, in-plant wastewater limits should not be used for the 
purpose of controlling air emissions. The intention of the Clean Water 
Act is to set limits at the end-of-pipe to protect surface water 
quality and POTW's from pass through and interference. Application of 
end-of-pipe standards and limitations will fulfill this intent.
    Response: EPA agrees that the intention of the Clean Water Act is 
to set limits to protect surface water quality and POTWs from pass 
through and interference. EPA is promulgating effluent limitations 
guidelines and standards for which compliance will generally be 
monitored end-of-pipe, except for cyanide. EPA has the authority to 
control any pollutants found in wastewater. Although in-plant air 
emissions will be regulated under the MACT standards rule, organic 
pollutants in wastewater will be controlled by this effluent guidelines 
rule using limits monitored at end-of-pipe except in cases where end-
of-pipe monitoring is impractical as authorized in Sec. 122.45 or 
Sec. 403.6(e).
    Comment: Oxygenated organic solvents such as methanol, ethanol, 
acetone, and isopropanol should not be regulated by pretreatment 
standards because they do not volatilize in appreciable amounts and do 
not typically pass through the POTW or interfere with POTW operations.
    Response: EPA agrees that oxygenated organic solvents such as 
methanol, ethanol, acetone and isopropanol with Henry's Law Constants 
less than 1.0 x 10-5atm/gmole/m3 will not 
volatilize in appreciable amounts in POTWs and sewers, and will 
biodegrade in POTW biological treatment units to a large extent. EPA 
has made this determination based on information submitted by PhRMA 
which estimated sewer losses of VOCs and EPA and PhRMA empirical 
sampling and modeling data from the Barceloneta POTW sampling episode. 
Based on an evaluation of this data, EPA agrees that

[[Page 50420]]

the oxygenated (alcohols and related) compounds under normal conditions 
will not pass through or interfere with POTW operations. Therefore, EPA 
is not promulgating categorical pretreatment standards for these 
pollutants for the pharmaceutical industry. However, local control 
authorities can set local limits for these compounds to take care of 
any site specific pass through or interference problems that may occur 
(Sec. 403.5.b.2).
    Comment: Steam stripping with distillation is not a demonstrated 
treatment technology for the pharmaceutical industry since the Agency 
has not demonstrated the performance of this technology for any 
pollutant other than methanol and the data set used for proposing 
limits and standards was generated during treatment of a clean process 
wastewater which is not representative of typical industry process 
wastewaters.
    Response: EPA agrees that the distillation data set used at 
proposal for setting limitations and standards based on steam stripping 
with distillation for alcohols were generated during treatment of a 
wastewater for a process which generated mostly methanol in the 
wastewater. EPA has not used these performance data in the calculation 
of final BAT limitations for the alcohols. Since the alcohols are not 
being regulated at PSES or PSNS because they do not pass through or 
interfere with the POTW operation, use of steam stripping with 
distillation technology is not an issue.
    Comment: Solgar is a small business with process wastewater flow of 
approximately 100 gallons per day. They manufacture vitamins of natural 
origin and are not under the jurisdiction of the FDA. The definition of 
Subcategory D includes products and processes covered by SIC No. 2833 
(Medical and Botanical Products). Being a regulated facility creates an 
adverse economic effect because of the operating costs related to 
permitting, sampling, analysis and reporting. EPA should consider 
exempting such facilities from the definition of pharmaceutical 
manufacturing.
    Response: EPA has estimated compliance costs for all of the 
pharmaceutical manufacturing facilities which discharge pollutants for 
which effluent limitations and standards have been developed. If a 
facility does not discharge regulated pollutants, the compliance costs 
connected with sampling and analysis will be minimal. Permitting costs 
were not included in the cost estimates because these costs would be 
incurred by all dischargers regardless of category and are not specific 
to this regulation. EPA does not believe that small facilities such as 
the one described in the comment will incur significant costs in 
complying with the final rule. In a part of the economic analysis for 
this rule, special emphasis was placed on small businesses as required 
by the Regulatory Flexibility Act. Results of this analysis showed that 
there are no significant adverse impacts on small facilities or firms. 
(See the Economic Analysis Report)
    Comment: Facilities should not be required to monitor for 
constituents that they do not use. In lieu of annual testing, 
facilities could submit annual (or on other frequencies) certifications 
regarding the constituent used or expected in the wastewater based on a 
review of all raw materials used and an assessment of all chemical 
processes used, considering resulting products and by-products. This 
would avoid incorrect data created by inflow of contaminated 
groundwater in facility sewers. Most commenters supported the 
certification approach.
    Response: EPA agrees that facilities should not be required to 
monitor for constituents that they do not use. EPA disagrees that in 
lieu of annual testing, facilities could submit annual certifications 
regarding the constituents used or expected in the wastewater based on 
a review of all raw materials used and an assessment of all chemical 
processes used. Facilities will not have permit limits or be required 
to monitor regularly for constituents not used in their pharmaceutical 
processes, and EPA agrees that most commenters support the 
certification approach. In cases where groundwater may be contaminated 
by regulated pollutants which are not used in manufacturing operations 
at a facility, the facility should submit groundwater sampling data 
along with the other certification information to avoid regular 
monitoring for these regulated pollutants.
    Comment: Provisions d and f of the applicability section of the 
Preamble, Section IV.B, would have the effect of extending the 
applicability of the proposed regulations to many diagnostic products 
listed in SIC Code 2835. The processes used in, and the wastewater 
produced from the manufacture of many of these products is 
substantially different from products listed in SIC code no. 2833, 
2834, and 2836. EPA should define applicability by SIC code, without 
the exceptions contained in provisions d and f, and excluding SIC code 
no. 2835. Provisions d and f will be difficult to administer because 
they are based on subjective determinations.
    Response: Defining applicability strictly by SIC code could result 
in considerable amounts of wastewater at some facilities not being 
covered by any categorical limitations and standards and therefore the 
Agency has not adopted this approach in the final regulation. The 
Agency agrees that regulatory decisions based on applicability section 
IV.B.f. may require a subjective judgement by the permit writer or 
pretreatment authority with regard to the nature of the wastewater 
generated by the manufacture of the products in question. In order to 
remove any ambiguity that may be associated with this applicability 
section, EPA has revised the applicability provision of the final rule 
in 439.1.

B. Summary of Notice of Availability Comments and Responses

    EPA received comments on the August 8, 1997 Notice of Availability 
from 25 commenters regarding seven major topics and 35 subtopics. A 
summary of the major comments and EPA responses is provided below. 
Responses to all of the comments are contained in the Comment Response 
Document in the record for this final rule.
    Comment: The commenters support Option 1 for PSES and PSNS that 
provided for compliance with the MACT standards plus some regular 
monitoring. Option 1 will reduce redundant regulation, needless cost, 
confusion, and potentially contradictory rulemakings.
    Response: EPA disagrees with the commenters. EPA is promulgating 
PSES/PSNS limitations based on Option 2 because this option controls 
VOC wastewater discharges from pharmaceutical wastewaters that are not 
controlled by the final MACT standard for the pharmaceutical industry. 
Therefore, EPA does not believe that selecting Option 2 will result in 
a redundant, confusing, and potentially contradictory regulation. EPA 
is directed to control pollutants found in wastewater that pass through 
or interferes with POTWs. EPA has taken into account the effects of the 
MACT rule in estimating the compliance costs for the industry to meet 
the final effluent guidelines and standards.
    Comment: The commenters believe EPA should also exclude benzene and 
o-dichlorobenzene from coverage under this regulation because they are 
each discharged by only one plant. The fact that a pollutant is a 
priority pollutant is not justification for regulating it when it is 
found at a small number of sources within an industrial point source 
category. EPA excluded 20 priority

[[Page 50421]]

pollutants from regulation by the Organic Chemicals, Plastics, and 
Synthetic Fibers (OCPSF) effluent guidelines under the authority of 
Paragraph 8(a)(iii) of the then applicable consent decree (Table VI-3, 
OCPSF Development Document, EPA 440/1-87/009). Another reason for 
excluding benzene is that the one plant that currently discharges this 
chemical has permanently shut down the process generating this 
pollutant.
    Response: Benzene and o-dichlorobenzene were reported in the 1990 
Questionnaire as discharged from one facility; however, EPA sampling 
data found they were present at more than one facility. Using industry 
supplied data, EPA has determined that benzene and o-dichlorobenzene 
were discharged in 1990 at quantities of approximately 120,200 and 
21,500 lbs per year, respectively, well above the 3,000 lbs/year small 
discharge limit and there are estimated removals in excess of 1000 lbs/
year. Both criteria that are used to determine which pollutants are 
excluded from this regulation. In addition, given the variable nature 
of the pharmaceutical industry, EPA has not excluded pollutants from 
regulation that may be present at more that one facility. Benzene is a 
good case in point, since even though only one facility identified it 
as discharged in 1990, it was found to be present in 10 of the samples 
taken by EPA in August 1996 at the Barceloneta Regional Wastewater 
Treatment Plant, which is a POTW that receives predominately 
pharmaceutical wastewaters.
    Comment: Several commenters will be requesting fundamentally 
different factor (FDF) variances for ammonia production because EPA has 
not properly developed nitrification-based BAT ammonia limits. (1) EPA 
did not properly identify facilities that may have to treat ammonia, 
(2) it excluded data from the biological nitrification database for 
plants that had influent ammonia concentrations of greater than 100 mg/
L, (3) it assumed ammonia in process wastewaters are all ammonium 
hydroxide and not ammonium nitrate or ammonium phosphate, (4) and it 
did not consider the effects of high organic nitrogen loading present 
with high ammonia nitrogen loading. Because of the incorrect chemistry 
and engineering assumptions, EPA has overestimated the feasibility to 
meet the proposed BAT limits on ammonia-nitrogen. Therefore, commenters 
would request that EPA handle wastewater discharges of ammonia-nitrogen 
from certain facilities in a fundamentally different manner.
    Response: In response to point one, EPA has identified all 
facilities that may have to treat ammonia from information provided in 
the 1990 questionnaire responses and data submissions provided in 
response to the proposal. With regard to point two, the five plant data 
sets used to develop the final limits included numerous influent 
ammonia concentration points greater than 100 mg/L. With regard to 
point three, EPA has converted all ammonium salt and hydroxide loadings 
to NH3 nitrogen loadings. In response to point four, EPA did consider 
the effect of the presence of high organic ammonia along with high 
ammonia nitrogen with respect to achieving compliance with the final 
ammonia limitations. EPA has concluded that ability of nitrification 
systems to nitrify ammonia is not affected by large loadings of organic 
amines because these compounds are biodegraded to ammonia in the 
advanced biological treatment along with other carbonaceous waste. The 
ammonia thus generated is then nitrified in the nitrification system. 
In certain cases, where organic amine levels are sufficiently high, 
two-stage nitrification will be necessary. The limitations and 
standards for ammonia in the final rule were determined using all of 
the data (one and two stage), after comparing the single stage and two 
stage performance data, and then setting the limits at the levels that 
were reflected by the data bases being examined separately. In 
conclusion, EPA costed compliance with the limits by two-stage 
nitrification, and believes the final BAT limits based on two stage 
nitrification technology are appropriate.

Appendix A to the Preamble--Lists of Abbreviations, Acronyms, 
Defintions and Other Terms Used in This Document

I. Definitions, Acronyms, and Abbreviations

    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. 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 Part 439, subpart B).
    BMP or BMPs--Best management practices, as described in section 
304(e) of the Clean Water Act.
    BOD5--Five-Day Biochemical Oxygen Demand. A measure 
of biochemical decomposition of organic matter in a water sample. It 
is determined by measuring the dissolved oxygen consumed by 
microorganisms to oxidize the organic contaminants in a water sample 
under standard laboratory conditions of five days and 20 deg.C. 
BOD5 is not related to the oxygen requirements in 
chemical combustion.
    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 Part 439, subpart C).
    Clarifier--A treatment unit designed to remove suspended 
materials from wastewater, typically by sedimentation.
    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.
    Condensate--Any material that has condensed from a gaseous phase 
into a liquid phase.
    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

[[Page 50422]]

Water Act and the regulations thereunder (i.e., biochemical oxygen 
demand (BOD5), total suspended solids (TSS), oil and 
grease, fecal coliform and pH).
    CWA--Clean Water Act. The Federal Water Pollution Control Act 
Amendments of 1972 (33 U.S.C. 1251 et seq.), as amended, inter alia, 
by the Clean Water Act of 1977 (Pub. L. 95-217) and the Water 
Quality Act of 1987 (Pub. L. 100-4).
    Daily discharge--The discharge of a pollutant measured during 
any calendar day or any 24-hour period that reasonably represents a 
calendar day for purposes of sampling. For pollutants with 
limitations expressed in units of mass, the daily discharge is 
calculated as the total mass of the pollutant discharged over the 
day. For pollutants with limitations expressed in other units of 
measurement, the daily discharge is calculated as the average 
measurement of the pollutant over the day.
    Direct discharger--A facility that discharges or may discharge 
treated or untreated process wastewaters, non-contact cooling 
waters, or non-process wastewaters (including stormwater runoff) 
into waters of the United States.
    Effluent--Wastewater discharges.
    Effluent limitation--Any restriction, including schedules of 
compliance, established by a State or the Administrator on 
quantities, rates, and concentrations of chemical, physical, 
biological, and other constituents which are discharged from point 
sources into waters of the United States, the waters of the 
contiguous zone, or the ocean.
    Emission--Passage of air pollutants into the atmosphere via a 
gas stream or other means.
    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 Part 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 document, 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.
    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.
    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 part 439, subpart D).
    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.
    Nitrification--Nitrification is the oxidation of ammonium salts 
to nitrites (via nitrosomonas bacteria) and the further oxidation of 
nitrite to nitrate via nitrobacter bacteria. Nitrification can be 
accomplished in either a single or two-stage activated sludge 
system. Indicators of nitrification capability are (1) biological 
monitoring for ammonia oxidizing bacteria (AOB) and nitrite 
oxidizing bacteria (NOB) to determine if nitrification is occurring, 
and (2) analysis of the nitrogen balance to determine if nitrifying 
bacteria reduce the amount of ammonia and increase the amount of 
nitrite and nitrate.
    Nonconventional pollutants--Pollutants that are neither 
conventional pollutants nor toxic pollutants.
    Non-detect value--A concentration-based measurement reported 
below the minimum level that can reliably be measured by the 
analytical method for the pollutant.
    Non-water quality environmental impact--An environmental impact 
of a control or treatment technology, other than to surface waters.
    NPDES--The National Pollutant Discharge Elimination System 
authorized under section 402 of the CWA. The Clean Water Act 
requires NPDES permits for discharge of pollutants from any point 
source into waters of the United States.
    NRDC--Natural Resources Defense Council.
    NSPS--New Source Performance Standards. As used in this notice, 
this term refers to standards for new sources under section 306 of 
the CWA.
    OMB--Office of Management and Budget.
    Outfall--The mouth of conduit drains and other conduits from 
which a plant discharges effluent into receiving waters.
    Pharmaceutically active ingredient--Any substance considered to 
be an active ingredient by Food and Drug Administration regulations 
(21 CFR 210.3(6)(7)).
    Pilot-scale operation--The trial operation of processing 
equipment, which is the intermediate stage between laboratory 
experimentation and full-scale operation in the development of a new 
process or product.

[[Page 50423]]

    Point of Determination--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 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
    (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 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 part 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).
    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--Any organic pollutant with a Henry's Law Constant greater 
than or equal to 3.97  x  10-7 atm/gmole/m3.
    Waters of the United States--the same meaning set forth in 40 
CFR 122.2.
    Zero discharge (ZD)--No discharge of pollutants to waters of the 
United States or to a POTW.

List of Subjects

40 CFR Part 136

    Environmental protection, Incorporation by reference, Reporting and 
recordkeeping requirements, Water pollution control.

40 CFR Part 439

    Environmental protection, Pharmaceutical manufacturing pollution 
prevention, Waste treatment and disposal, Water pollution control.

    Dated: July 30, 1998.
Carol M. Browner,
Administrator.

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

PART 136--[AMENDED]

    1. The authority citation for part 136 continues to read as 
follows:

    Authority: Secs. 301, 304(h), 307, and 501(a) Pub. L. 95-217, 
Stat. 1566, et seq. (33 U.S.C. 1251, et seq.) (The Federal Water 
Pollution Control Act Amendments of 1972 as amended by the Clean 
Water Act of 1977).

    2. Section 136.3 is amended by revising paragraph (a) introductory 
text and by adding a new Table IF in numerical order to the end of 
paragraph (a) and revising paragraph (b) introductory text and adding 
paragraph (b)(40) to read as follows:


Sec. 136.3  Identification of test procedures.

    (a) Parameters or pollutants, for which methods are approved, are 
listed together with test procedure descriptions and references in 
Tables IA, IB, IC, ID, IE, and IF. The full text of the referenced test 
procedures are incorporated by reference into Tables IA, IB, IC, ID, 
IE, and IF. The references and the sources which are available are 
given in paragraph (b) of this section. These test procedures are 
incorporated as they exist on the day of approval and a notice of any 
change in these test procedures will be published in the Federal 
Register. The discharge parameter values for which reports are required 
must be determined by one of the standard analytical test procedures 
incorporated by reference and described in Tables IA, IB, IC, ID, IE, 
and IF, or by any alternate test procedure which has been approved by 
the Administrator under the provisions of paragraph (d) of this section 
and Secs. 136.4 and 136.5. Under certain circumstances (paragraph (b) 
or (c) of this section or 40 CFR 401.13) other test procedures may be 
used that may be more advantageous when such other test procedures have 
been previously approved by the Regional Administrator of the Region in 
which the discharge occur, and providing the Director of the State in 
which such discharge will occur does

[[Page 50424]]

not object to the use of such alternate test procedure.
* * * * *

                        Table IF.--List of Approved Methods for Pharmaceutical Pollutants                       
----------------------------------------------------------------------------------------------------------------
   Pharmaceuticals pollutants              CAS registry No.                    Analytical method number         
----------------------------------------------------------------------------------------------------------------
acetonitrile...................  75-05-8............................  1666/1671/D3371/D3695.                    
n-amyl acetate.................  628-63-7...........................  1666/D3695.                               
n-amyl alcohol.................  71-41-0............................  1666/D3695                                
benzene........................  71-43-2............................  D4763/D3695/502.2/524.2.                  
n-butyl-acetate................  123-86-4...........................  1666/D3695.                               
tert-butyl alcohol.............  75-65-0............................  1666.                                     
chlorobenzene..................  108-90-7...........................  502.2/524.2.                              
chloroform.....................  67-66-3............................  502.2/524.2/551.                          
o-dichlorobenzene..............  95-50-1............................  1625C/502.2/524.2.                        
1,2-dichloroethane.............  107-06-2...........................  D3695/502.2/524.2.                        
diethylamine...................  109-89-7...........................  1666/1671.                                
dimethyl sulfoxide.............  67-68-5............................  1666/1671.                                
ethanol........................  64-17-5............................  1666/1671/D3695.                          
ethyl acetate..................  141-78-6...........................  1666/D3695.                               
n-heptane......................  142-82-5...........................  1666/D3695.                               
n-hexane.......................  110-54-3...........................  1666/D3695.                               
isobutyraldehyde...............  78-84-2............................  1666/1667.                                
isopropanol....................  67-63-0............................  1666/D3695.                               
isopropyl acetate..............  108-21-4...........................  1666/D3695.                               
isopropyl ether................  108-20-3...........................  1666/D3695.                               
methanol.......................  67-56-1............................  1666/1671/D3695.                          
Methyl Cellosolve....  109-86-4...........................  1666/1671                                 
methylene chloride.............  75-09-2............................  502.2/524.2                               
methyl formate.................  107-31-3...........................  1666.                                     
4-methyl-2-pentanone (MIBK)....  108-10-1...........................  1624C/1666/D3695/D4763/524.2.             
phenol.........................  108-95-2...........................  D4763.                                    
n-propanol.....................  71-23-8............................  1666/1671/D3695.                          
2-propanone (acetone)..........  67-64-1............................  D3695/D4763/524.2.                        
tetrahydrofuran................  109-99-9...........................  1666/524.2.                               
toluene........................  108-88-3...........................  D3695/D4763/502.2/524.2.                  
triethlyamine..................  121-44-8...........................  1666/1671.                                
xylenes........................  (Note 1)...........................  1624C/1666.                               
----------------------------------------------------------------------------------------------------------------
Table 1F note:                                                                                                  
1. 1624C: m-xylene 108-38-3, o,p-xylene E-14095 (Not a CAS number; this is the number provided in the           
  Environmental Monitoring Methods Index (EMMI) database.); 1666: m,p-xylene 136777-61-2, o-xylene 95-47-6.     

* * * * *
    (b) The full texts of the methods from the following references 
which are cited in Tables IA, IB, IC, ID, IE,and IF are incorporated by 
reference into this regulation and may be obtained from the sources 
identified. All costs cited are subject to change and must be verified 
from the indicated sources. The full texts of all the test procedures 
cited are available for inspection at the National Exposure Research 
Laboratory, Office of Research and Development, U.S. Environmental 
Protection Agency, 26 West Martin Luther King Dr., Cincinnati, OH 45268 
and the Office of the Federal Register, 800 North Capitol Street, NW., 
Suite 700, Washington, DC.
* * * * *
    (40) EPA Methods 1666, 1667, and 1671 listed in the table above are 
published in the compendium titled Analytical Methods for the 
Determination of Pollutants in Pharmaceutical Manufacturing Industry 
Wastewaters (EPA 821-B-98-016). EPA Methods 502.2 and 524.2 have been 
incorporated by reference into 40 CFR 141.24 and are in Methods for the 
Determination of Organic Compounds in Drinking Water, EPA-600/4-88-039, 
December 1988, Revised, July 1991, and Methods for the Determination of 
Organic Compounds in Drinking Water-Supplement II, EPA-600/R-92-129, 
August 1992, respectively. These EPA test method compendia are 
available from the National Technical Information Service, NTIS PB91-
231480 and PB92-207703, U.S. Department of Commerce, 5285 Port Royal 
Road, Springfield, Virginia 22161. The toll-free number is 800-553-
6847. ASTM test methods D3371, D3695, and D4763 are available from the 
American Society for Testing and Materials, 100 Barr Harbor Drive, West 
Conshohocken, PA 19428-2959.
* * * * *

PART 439--[AMENDED]

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

    Authority: Secs. 301, 304, 306, 307, 308, 402 and 501 of the 
Clean Water Act, as amended; 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 
1342 and 1361.

    2. Part 439 is amended by revising the undesignated heading 
``GENERAL PROVISIONS'' to read ``General''.
    3. Section 439.0 is revised to read as follows:


Sec. 439.0  Applicability.

    (a) This part applies to process wastewater discharges resulting 
from the research and manufacture of pharmaceutical products, which are 
generally, but not exclusively, reported under SIC 2833, SIC 2834 and 
SIC 2836 (1987 Standard Industrial Classification Manual).
    (b) Although not reported under SIC 2833, SIC 2834 and SIC 2836, 
discharges from the manufacture of other pharmaceutical products to 
which this part applies include (but are not limited to):
    (1) Products manufactured by one or more of the four types of 
manufacturing

[[Page 50425]]

processes described in subcategories A, B, C or D of this part, and 
considered by the Food and Drug Administration to be pharmaceutical 
active ingredients;
    (2) Multiple end-use products (e.g., components of formulations, 
chemical intermediates, or final products) derived from pharmaceutical 
manufacturing operations and intended for use primarily in 
pharmaceutical applications;
    (3) Pharmaceutical products and intermediates not subject to other 
categorical limitations and standards, provided the manufacturing 
processes generate process wastewaters that are similar to those 
derived from the manufacture of pharmaceutical products elsewhere (an 
example of such a product is citric acid);
    (4) Cosmetic preparations that are reported under SIC 2844 and 
contain pharmaceutical active ingredients, or active ingredients that 
are intended for the treatment of a skin condition. (These preparations 
do not include products such as lipsticks or perfumes that serve to 
enhance appearance, or provide a pleasing odor, but do not enhance skin 
care. Also excluded are deodorants, manicure preparations, shaving 
preparations and non-medicated shampoos that do not function primarily 
as a skin treatment.)
    (c) The provisions of this part do not apply to wastewater 
discharges resulting from the manufacture of the following products, or 
as a result of providing one or more of the following services:
    (1) Surgical and medical instruments and apparatus reported under 
SIC 3841;
    (2) Orthopedic, prosthetic, and surgical appliances and supplies 
reported under SIC 3842;
    (3) Dental equipment and supplies reported under SIC 3843;
    (4) Medical laboratory services reported under SIC 8071;
    (5) Dental laboratory services reported under SIC 8072;
    (6) Outpatient care facility services reported under SIC 8081;
    (7) Health and allied services reported under SIC 8091, and not 
classified elsewhere;
    (8) Diagnostic devices other than those reported under SIC 3841;
    (9) Animal feed products that include pharmaceutical active 
ingredients such as vitamins and antibiotics, where the major portion 
of the product is non-pharmaceutical, and the resulting process 
wastewater is not characteristic of process wastewater from the 
manufacture of pharmaceutical products;
    (10) Food and beverage products fortified with vitamins or other 
pharmaceutical active ingredients, where the major portion of the 
product is non-pharmaceutical, and the resulting process wastewater is 
not characteristic of process wastewater from the manufacture of 
pharmaceutical products;
    (11) Pharmaceutical products and intermediates subject to the 
provisions of 40 CFR part 414, provided their manufacture results in 
less than 50 percent of the total flow of process wastewater that is 
regulated by 40 CFR part 414 at the facility.
    4. Section 439.1 is revised to read as follows:


Sec. 439.1  General definitions.

    As used in this part:
    (a) The general definitions, abbreviations and methods of analysis 
in 40 CFR part 401 shall apply.
    (b) The term bench-scale operation means the laboratory testing of 
materials, methods, or processes on a small scale, such as on a 
laboratory worktable.
    (c) The term cyanide (T) means the parameter total cyanide.
    (d) The term in-plant monitoring point means a location within a 
plant, where an individual process effluent can be exclusively 
monitored before it is diluted or mixed with other process wastewaters 
enroute to the end-of-pipe.
    (e) The term minimum level means the level at which an analytical 
system gives recognizable signals and an acceptable calibration point.
    (f) The term nitrification capability means the capability of a 
POTW treatment system to oxidize ammonia or ammonium salts initially to 
nitrites (via Nitrosomonas bacteria) and subsequently to nitrates (via 
Nitrobacter bacteria). Criteria for determining the nitrification 
capability of a POTW treatment system are: bioassays confirming the 
presence of nitrifying bacteria; and analyses of the nitrogen balance 
demonstrating a reduction in the concentration of ammonia or ammonium 
salts and an increase in the concentrations of nitrites and nitrates.
    (g) The term non-detect (ND) means a concentration value below the 
minimum level that can be reliably measured by the analytical method.
    (h) The term pilot-scale operation means processing equipment being 
operated at an intermediate stage between laboratory-scale and full-
scale operation for the purpose of developing a new product or 
manufacturing process.
    (i) The term POTW means publicly owned treatment works (40 CFR 
403.3).
    (j) The term process wastewater, as defined at 40 CFR 122.2 and for 
the purposes of this part, does not include the following:
    (1) Trimethyl silanol, any active anti-microbial materials, process 
wastewater from imperfect fermentation batches, and process area 
spills. Discharges containing such materials are not subject to the 
limitations and standards of this part.
    (2) Non-contact cooling water, utility wastewaters, general site 
surface runoff, groundwater (e.g., contaminated groundwaters from on-
site or off-site groundwater remediation projects), and other non-
process water generated on site. Discharges of such waters and 
wastewaters are not subject to the limitations and standards of this 
part.
    (k) The term non-conventional pollutants means parameters that are 
neither conventional pollutants (40 CFR 401.16), nor ``toxic'' 
pollutants (40 CFR 401.15).
    (l) The term surrogate pollutant means a regulated parameter that, 
for the purpose of compliance monitoring, is allowed to serve as a 
surrogate for a group of specific regulated parameters. Plants would be 
allowed to monitor for a surrogate pollutant(s), when the other 
parameters for which it stands are receiving the same degree of 
treatment as the surrogate pollutant(s) and all of the parameters 
discharged are in the same treatability class(es) as their respective 
surrogate pollutant(s). Treatability classes have been identified in 
Appendix A to this part for both steam stripping and biological 
treatment technologies, which are the respective technology bases for 
PSES/PSNS and BAT/NSPS limitations controlling the discharge of 
regulated organic parameters.
    (m) The term xylenes means a combination of the three isomers: o-
xylene, p-xylene, and m-xylene.
    5. Section 439.3 is added under the undesignated center heading 
``General'' to read as follows:


Sec. 439.3  General pretreatment standards.

    Any source subject to this part that introduces process wastewater 
pollutants into a publicly owned treatment works (POTW) must comply 
with 40 CFR part 403.
    6. Section 439.4 is added under the undesignated center heading 
``General'' to read as follows:


Sec. 439.4  Monitoring requirements.

    Permit limits and compliance monitoring are required for each 
regulated pollutant generated or used at a pharmaceutical manufacturing 
facility, except where the regulated pollutant is monitored as a 
surrogate parameter. Permit limits and compliance monitoring are not 
required for regulated pollutants that are neither

[[Page 50426]]

used nor generated at the facility. Except for cyanide, for which an 
alternate monitoring requirement is established in subparts A and C of 
this part a determination that regulated pollutants are neither used 
nor generated should be based on a review of all raw materials in use, 
and an assessment of the process chemistry, products and by-products 
resulting from each of the manufacturing processes. This determination 
along with recommendation of any surrogate must be submitted with 
permit applications for approval by the permitting authority, and 
reconfirmed by an annual chemical analysis of wastewater from each 
monitoring location, and the measurement of a non-detect value for each 
regulated pollutant or its surrogate. Permits shall specify that such 
determinations will be maintained in the facility's permit records with 
their discharge monitoring reports and will be available to regulatory 
authorities upon request.

Subpart A--[Amended]

    7. Section 439.10 is revised to read as follows:


Sec. 439.10  Applicability.

    This subpart applies to discharges of process wastewater resulting 
from the manufacture of pharmaceutical products by fermentation.
    8. Section 439.11 is revised to read as follows:


Sec. 439.11  Specialized definitions.

    For the purpose of this subpart:
    (a) The term fermentation means 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.
    (b) The term product means pharmaceutical products derived from 
fermentation processes.
    9. Section 439.12 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    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 application of BPT:
    (a) The average monthly effluent limitation for BOD5, 
expressed as mass loading (pounds, kilograms) per day, must reflect not 
less than 90 percent reduction in the long-term average daily 
BOD5 load of the raw (untreated) process wastewater, 
multiplied by a variability factor of 3.0.
    (1) The long-term average daily BOD5 load of the raw 
process wastewater (i.e., the base number to which the percent 
reduction is applied) is defined as the average daily BOD5 
load during any calendar month, over 12 consecutive months within the 
most recent 36 months, and must include one or more periods during 
which production was at a maximum.
    (2) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 load in the influent to 
the wastewater treatment system must exclude any portion of the load 
associated with separable mycelia and solvents, except for residual 
amounts of mycelia and solvents remaining after the practices of 
recovery and/or separate disposal or reuse. These residual amounts may 
be included in the calculation of the average influent BOD5 
loading.
    (3) The practices of recovery, and/or separate disposal or reuse 
include: physical separation and removal of separable mycelia; recovery 
of solvents from waste streams; incineration of concentrated solvent 
wastestreams (including tar still bottoms); and concentration of broth 
for disposal other than to the treatment system. This part does not 
prohibit the inclusion of such wastes in raw waste loads in fact, nor 
does it mandate any specific practice, but rather describes the 
rationale for determining NPDES permit limitations. The effluent 
limitation for BOD5 may be achieved by any of several, or a 
combination, of these practices.
    (b) The average monthly effluent limitation for TSS, expressed as 
mass loading (pounds, kilograms) per day, must be calculated as 1.7 
times the BOD5 limitation determined in paragraph (a) of 
this section.
    (c) Except as provided in paragraph (d) of this section, the 
effluent limitations for COD and pH are as follows:

------------------------------------------------------------------------
                                                 Effluent limitation \1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
COD...........................................         1675          856
pH............................................        (\2\)        (\2\)
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range 6.0 to 9.0.                                        

    (d) If the average monthly COD concentrations in paragraph (c) of 
this section are higher than concentration values reflecting a 
reduction in the long-term average daily COD load in the raw 
(untreated) process wastewater of 74 percent multiplied by a 
variability factor of 2.2, then the average monthly effluent 
limitations for COD corresponding to the lower concentration values 
must be applied.
    (e) The effluent limitations for cyanide are as follows:

------------------------------------------------------------------------
                                                 Effluent limitation \1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (f) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide effluent limitations in paragraph (e) of this section must be 
demonstrated at in-plant monitoring points pursuant to 40 CFR 122.44(i) 
and 122.45(h). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (g) Compliance with the limitation in paragraph (e) or (f) of this 
section may be achieved by certifying to the permit issuing authority 
that the facility's manufacturing processes neither use nor generate 
cyanide.
    10. Section 439.13 is revised to read as follows:


Sec. 439.13  Effluent limitations 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 application of BCT: Limitations 
for BOD5, TSS and pH are the same as the corresponding 
limitations in Sec. 439.12.
    11. Section 439.14 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    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 application of BAT:

[[Page 50427]]



------------------------------------------------------------------------
                                             Effluent limitations \1\   
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
1  Ammonia (as N).......................           84.1            29.4 
2  Acetone..............................            0.5             0.2 
3  4-Methyl-2-pentanone (MIBK)..........            0.5             0.2 
4  Isobutyraldehyde.....................            1.2             0.5 
5  n-Amyl acetate.......................            1.3             0.5 
6  n-Butyl acetate......................            1.3             0.5 
7  Ethyl acetate........................            1.3             0.5 
8  Isopropyl acetate....................            1.3             0.5 
9  Methyl formate.......................            1.3             0.5 
10  Amyl alcohol........................           10.0             4.1 
11  Ethanol.............................           10.0             4.1 
12  Isopropanol.........................            3.9             1.6 
13  Methanol............................           10.0             4.1 
14  Methyl Cellosolve...................          100.0            40.6 
15  Dimethyl Sulfoxide..................           91.5            37.5 
16  Triethyl Amine......................          250.0           102.0 
17  Phenol..............................            0.05            0.02
18  Benzene.............................            0.05            0.02
19  Toluene.............................            0.06            0.02
20  Xylenes.............................            0.03            0.01
21  n-Hexane............................            0.03            0.02
22  n-Heptane...........................            0.05            0.02
23  Methylene chloride..................            0.9             0.3 
24  Chloroform..........................            0.02            0.01
25  1,2-Dichloroethane..................            0.4             0.1 
26  Chlorobenzene.......................            0.15            0.06
27  o-Dichlorobenzene...................            0.15            0.06
28  Tetrahydrofuran.....................            8.4             2.6 
29  Isopropyl ether.....................            8.4             2.6 
30  Diethyl amine.......................          250.0           102.0 
31  Acetonitrile........................           25.0            10.2 
32  pH..................................        (\2\)           (\2\)   
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range of 6.0-9.0.                                        

    (a) The effluent limitations for COD are the same as the 
corresponding limitations in Sec. 439.12(c) and (d).
    (b) The effluent limitations for cyanide are as follows:

------------------------------------------------------------------------
                                                 Effluent limitation \1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (c) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide effluent limitations in paragraph (b) of this section must be 
demonstrated at in-plant monitoring points pursuant to 40 CFR 122.44(i) 
and 122.45(h). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (d) Compliance with the limitation in paragraph (b) or (c) of this 
section may be achieved by certifying to the permit issuing authority 
that a facility's manufacturing processes neither use nor generate 
cyanide.
    12. Section 439.15 is amended by removing the OMB control number 
citation and revising the section to read as follows:


Sec. 439.15  Standards of performance for new (point) sources (NSPS).

    Any new source subject to this subpart must achieve the following 
performance standards:

------------------------------------------------------------------------
                                             Effluent limitations \1\   
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
1  BOD5.................................          267             111   
2  TSS..................................          472             166   
3  COD..................................         1675             856   
4  Ammonia (as N).......................           84.1            29.4 
5  Acetone..............................            0.5             0.2 
6  4-Methyl-2-pentanone (MIBK)..........            0.5             0.2 
7  Isobutyraldehyde.....................            1.2             0.5 
8  n-Amyl acetate.......................            1.3             0.5 

[[Page 50428]]

                                                                        
9  n-Butyl acetate......................            1.3             0.5 
10  Ethyl acetate.......................            1.3             0.5 
11  Isopropyl acetate...................            1.3             0.5 
12  Methyl formate......................            1.3             0.5 
13  Amyl alcohol........................           10.0             4.1 
14  Ethanol.............................           10.0             4.1 
15  Isopropanol.........................            3.9             1.6 
16  Methanol............................           10.0             4.1 
17  Methyl Cellosolve...................           25.0            10.2 
18  Dimethyl Sulfoxide..................           91.5            37.5 
19  Triethyl Amine......................          250.0           102.0 
20  Phenol..............................            0.05            0.02
21  Benzene.............................            0.05            0.02
22  Toluene.............................            0.06            0.02
23  Xylenes.............................            0.03            0.01
24  n-Hexane............................            0.03            0.02
25  n-Heptane...........................            0.05            0.02
26  Methylene chloride..................            0.9             0.3 
27  Chloroform..........................            0.02            0.01
28  1,2-Dichloroethane..................            0.4             0.1 
29  Chlorobenzene.......................            0.15            0.06
30  o-Dichlorobenzene...................            0.15            0.06
31  Tetrahydrofuran.....................            8.4             2.6 
32  Isopropyl ether.....................            8.4             2.6 
33  Diethyl amine.......................          250.0           102.0 
34  Acetonitrile........................           25.0            10.2 
35  pH..................................        (\2\)           (\2\)   
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range of 6.0--9.0.                                       

    (a) The performance standards for cyanide are as follows:

------------------------------------------------------------------------
                                                  Performance standards 
                                               ------------\1\----------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (b) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide performance standards in paragraph (a) of this section must be 
demonstrated at in-plant monitoring points pursuant to 40 CFR 122.44(i) 
and 122.45(h). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (c) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of this section 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 Secs. 439.13 and 439.14.
    (d) Compliance with the standard in paragraph (a) or (b) of this 
section may be achieved by certifying to the permit issuing authority 
that the facility's manufacturing processes neither use nor generate 
cyanide.
    13. Section 439.16 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    Except as provided in 40 CFR 403.7 and 403.13, any existing source 
subject to this subpart must continue to achieve compliance with 
cyanide pretreatment standards and achieve compliance with all the 
other pretreatment standards by September 21, 2001.

------------------------------------------------------------------------
                                             Pretreatment standards\1\  
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
 1  Ammonia (as N) \2\..................            84.1            29.4
 2  Acetone.............................            20.7             8.2
 3  4-Methyl-2-pentanone (MIBK).........            20.7             8.2
 4  Isobutyraldehyde....................            20.7             8.2
 5  n-Amyl acetate......................            20.7             8.2
 6  n-Butyl acetate.....................            20.7             8.2
 7  Ethyl acetate.......................            20.7             8.2
 8  Isopropyl acetate...................            20.7             8.2

[[Page 50429]]

                                                                        
 9  Methyl formate......................            20.7             8.2
10  Methyl Cellosolve...................           275.0             9.7
11  Isopropyl ether.....................            20.7             8.2
12  Tetrahydrofuran.....................             9.2             3.4
13  Benzene.............................             3.0             0.6
14  Toluene.............................             0.3             0.1
15  Xylenes.............................             3.0             0.7
16  n-Hexane............................             3.0             0.7
17  n-Heptane...........................             3.0             0.7
18  Methylene chloride..................             3.0             0.7
19  Chloroform..........................             0.1            0.03
20  1,2-Dichloroethane..................            20.7             8.2
21  Chlorobenzene.......................             3.0             0.7
22  o-Dichlorobenzene...................            20.7             8.2
23  Diethyl amine.......................           255.0           100.0
24  Triethyl amine......................           255.0           100.0
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Not applicable to sources that discharge to a POTW with             
  nitrification capability.                                             

    (a) Sources that discharge to a POTW with nitrification capability 
(defined at Sec. 439.2(f)) are not required to achieve the pretreatment 
standard for ammonia.
    (b) The pretreatment standards for cyanide are as follows:

------------------------------------------------------------------------
                                                      Pretreatment      
                                                      standards\1\      
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (c) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide standards in paragraph (b) of this section must be demonstrated 
at in-plant monitoring points pursuant to 40 CFR 403.6(e)(2) and (4). 
Under the same provisions, the permitting authority may impose 
monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (d) Compliance with the limitation in paragraph (b) or (c) of this 
section may be achieved by certifying to the permit issuing authority 
that the facility's manufacturing processes neither use nor generate 
cyanide.
    14. Section 439.17 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    Except as provided in 40 CFR 403.7, any new source subject to this 
subpart must achieve the following pretreatment standards:

------------------------------------------------------------------------
                                             Pretreatment standards\1\  
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
 1  Ammonia (as N) \2\..................            84.1           29.4 
 2  Acetone.............................            20.7            8.2 
 3  4-Methyl-2-pentanone (MIBK).........            20.7            8.2 
 4  Isobutyraldehyde....................            20.7            8.2 
 5  n-Amyl acetate......................            20.7            8.2 
 6  n-Butyl acetate.....................            20.7            8.2 
 7  Ethyl acetate.......................            20.7            8.2 
 8  Isopropyl acetate...................            20.7            8.2 
 9  Methyl formate......................            20.7            8.2 
10  Methyl Cellosolve...................           275.0           59.7 
11  Isopropyl ether.....................            20.7            8.2 
12  Tetrahydrofuran.....................             9.2            3.4 
13  Benzene.............................             3.0            0.7 
14  Toluene.............................             0.3            0.1 
15  Xylenes.............................             3.0            0.7 
16  n-Hexane............................             3.0            0.7 
17  n-Heptane...........................             3.0            0.7 
18  Methylene chloride..................             3.0            0.7 
19  Chloroform..........................             0.1            0.03
20  1,2-Dichloroethane..................            20.7            8.2 
21  Chlorobenzene.......................             3.0            0.7 
22  o-Dichlorobenzene...................            20.7            8.2 
23  Diethyl amine.......................           255.0          100.0 

[[Page 50430]]

                                                                        
24  Triethyl amine......................           255.0          100.0 
------------------------------------------------------------------------
\1\ Mg/L (ppm)                                                          
\2\ Not applicable to sources that discharge to a POTW with             
  nitrification capability.                                             

    (a) Sources that discharge to a POTW with nitrification capability 
(defined at Sec. 439.2(f))are not required to achieve the pretreatment 
standard for ammonia.
    (b) The pretreatment standards for cyanide are as follows:

------------------------------------------------------------------------
                                                      Pretreatment      
                                                      standards\1\      
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (c) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide standards in Sec. 439.17(b) must be demonstrated at in-plant 
monitoring points pursuant to 40 CFR 403.6(e)(2) and (4). Under the 
same provisions, the permitting authority may impose monitoring 
requirements on internal wastestreams for any other parameter(s) 
regulated by this section.
    (d) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of this section until the expiration of the applicable time 
period specified in 40 CFR 122.29(d)(1), after which the source must 
achieve the standards specified in Sec. 439.16.
    (e) Compliance with the standards in paragraph (b) or (c) of this 
section may be achieved by certifying to the permit issuing authority 
that a facility's manufacturing processes neither use nor generate 
cyanide.
    15. Section 439.20 is revised to read as follows:


Sec. 439.20  Applicability.

    This subpart applies to discharges of process wastewater resulting 
from the manufacture of pharmaceutical products by extraction.
    16. Section 439.21 is revised to read as follows:


Sec. 439.21  Specialized definitions.

    For the purpose of this subpart:
    (a) The term extraction means process operations that derive 
pharmaceutically active ingredients from natural sources such as plant 
roots and leaves, animal glands, and parasitic fungi by chemical and 
physical extraction.
    (b) The term product means any substance manufactured by an 
extraction process, including blood fractions, vaccines, serums, animal 
bile derivatives, endocrine products and medicinal products such as 
alkaloids that are isolated from botanical drugs and herbs.
    17. Section 439.22 is revised to read as follows:


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

    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 application of BPT:
    (a) The average monthly effluent limitation for BOD5, 
expressed as mass loading (pounds, kilograms) per day, must reflect not 
less than 90 percent reduction in the long-term average daily 
BOD5 load of the raw (untreated) process wastewater, 
multiplied by a variability factor of 3.0.
    (1) The long-term average daily BOD5 load of the raw 
process wastewater (i.e., the base number to which the percent 
reduction is applied) is defined as the average daily BOD5 
load during any calendar month, over 12 consecutive months within the 
most recent 36 months, and must include one or more periods during 
which production was at a maximum.
    (2) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 load in the influent to 
the wastewater treatment system must exclude any portion of the load 
associated with separable mycelia and solvents, except for residual 
amounts of mycelia and solvents remaining after the practices of 
recovery and/or separate disposal or reuse. Residual amounts of these 
substances may be included in the calculation of the average influent 
BOD5 loading.
    (3) The practices of recovery, and/or separate disposal or reuse 
include: physical separation and removal of separable mycelia; recovery 
of solvents from wastestreams; incineration of concentrated solvent 
wastestreams (including tar still bottoms); and broth concentration for 
disposal other than to the treatment system. This part does not 
prohibit the inclusion of such wastes in raw waste loads in fact, nor 
does it mandate any specific practice, but rather describes the 
rationale for determining NPDES permit limitations. The effluent 
limitation for BOD5 may be achieved by any of several, or a 
combination, of these practices.
    (b) The average monthly effluent limitation for TSS, expressed as 
mass loading (pounds, kilograms) per day, must be calculated as 1.7 
times the BOD5 limitation determined in paragraph (a) of 
this section.
    (c) Except as provided in paragraph (d) of this section, effluent 
limitations for COD and pH are as follows:

------------------------------------------------------------------------
                                                Effluent limitations \1\
                                               -------------------------
                                                               Average  
             Regulated  parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
COD...........................................          228           86
pH............................................        (\2\)        (\2\)
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range 6.0 to 9.0.                                        

    (d) If the average monthly COD concentrations in paragraph (c) of 
this section are higher than concentration values reflecting a 
reduction in the long-term average daily COD load in the raw 
(untreated) process wastewater of 74 percent multiplied by a 
variability factor of 2.2, then the average monthly effluent 
limitations for COD corresponding to the lower concentration values 
must be applied.
    18. Section 439.23 is revised to read as follows:


Sec. 439.23  Effluent limitations 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

[[Page 50431]]

source subject to this subpart must achieve the following effluent 
limitations representing the application of BCT: Limitations for 
BOD5, TSS and pH are the same as the corresponding 
limitations in Sec. 439.22.
    19. Section 439.24 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    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 application of BAT: Limitations 
for COD are the same as the corresponding limitations in Sec. 439.22(c) 
and (d).
    20. Section 439.25 is revised to read as follows:


Sec. 439.25  Standards of performance for new (point) sources (NSPS).

    Any new source subject to this subpart must achieve the following 
performance standards:

------------------------------------------------------------------------
                                                Performance standards\1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
BOD5 .........................................           35           18
TSS...........................................           58           31
COD...........................................          228           86
pH............................................        (\2\)        (\2\)
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range 6.0 to 9.0.                                        

    (b) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of this section, 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 Secs. 439.23 and 439.24.
    21. Section 439.26 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    Except as provided in 40 CFR 403.7 and 403.13, any existing source 
subject to this subpart must achieve the following pretreatment 
standards by October 22, 2001:

------------------------------------------------------------------------
                                                        Pretreatment    
                                                        standards\1\    
                                                   ---------------------
                                                                Average 
                Regulated parameter                  Maximum    monthly 
                                                      daily    discharge
                                                    discharge   must not
                                                                 exceed 
------------------------------------------------------------------------
1  Acetone........................................       20.7        8.2
2  n-Amyl acetate.................................       20.7        8.2
  Ethyl acetate...................................       20.7        8.2
4  Isopropyl acetate..............................       20.7        8.2
5  Methylene chloride.............................        3.0        0.7
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    22. Section 439.27 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    (a) Except as provided in 40 CFR 403.7, this subpart must achieve 
the following pretreatment standards:

------------------------------------------------------------------------
                                                        Pretreatment    
                                                        standards \1\   
                                                   ---------------------
                                                                Average 
                Regulated parameter                  Maximum    monthly 
                                                      daily    discharge
                                                    discharge   must not
                                                                 exceed 
------------------------------------------------------------------------
1  Acetone........................................       20.7        8.2
2  n-Amyl acetate.................................       20.7        8.2
3  Ethyl acetate..................................       20.7        8.2
4  Isopropyl acetate..............................       20.7        8.2
5  Methylene chloride.............................        3.0        0.7
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (b) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in Sec. 439.27, 
until the expiration of the applicable time period specified in 40 CFR 
122.29(d)(1), after which the source must achieve the standards 
specified in Sec. 439.26.
    23. Section 439.30 is revised to read as follows:


Sec. 439.30  Applicability.

    This subpart applies to discharges of process wastewater resulting 
from the manufacture of pharmaceutical products by chemical synthesis.
    24. Section 439.31 is revised to read as follows:


Sec. 439.31  Specialized definitions.

    For the purpose of this subpart:
    (a) The term chemical synthesis means using one or a series of 
chemical reactions in the manufacturing process of a specified product.
    (b) The term product means any pharmaceutical product manufactured 
by chemical synthesis.
    25. Section 439.32 is amended by removing the OMB control number 
cite and revising the section to read as follows:


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

    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 application of BPT:
    (a) The average monthly effluent limitation for BOD5, 
expressed as mass loading (pounds, kilograms) per day, must reflect not 
less than 90 percent reduction in the long-term average daily 
BOD5 load of the raw (untreated) process wastewater, 
multiplied by a variability factor of 3.0.
    (1) The long-term average daily BOD5 load of the raw 
process wastewater (i.e., the base number to which the percent 
reduction is applied) is defined as the average daily BOD5 
load during any calendar month, over 12 consecutive months within the 
most recent 36 months, and must include one or more periods during 
which production was at a maximum.
    (2) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 load in the influent to 
the wastewater treatment system must exclude any portion of the load 
associated with separable mycelia and solvents, except for residual 
amounts of mycelia and solvents remaining after the practices of 
recovery and/or separate disposal or reuse. Residual amounts of these 
substances may be included in the calculation of the average influent 
BOD5 loading.
    (3) The practices of recovery, and/or separate disposal or reuse 
include: physical separation and removal of separable mycelia; recovery 
of solvents from wastestreams; incineration of concentrated solvent 
wastestreams (including tar still bottoms); and concentration of broth 
for disposal other than to the treatment system. This part does not 
prohibit the inclusion of such wastes in raw waste loads in fact, nor 
does it mandate any specific practice, but rather describes the 
rationale for determining NPDES permit limitations. The effluent 
limitation for BOD5 may be achieved by any of several, or a 
combination, of these practices.

[[Page 50432]]

    (b) The average monthly effluent limitation for TSS, expressed as 
mass loading (pounds, kilograms) per day, must be calculated as 1.7 
times the BOD5 limitation determined in paragraph (a) of 
this section.
    (c) Except as provided in paragraph (d) of this section, the 
effluent limitations for COD and pH are as follows:

------------------------------------------------------------------------
                                                 Effluent limitation \1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
COD...........................................         1675          856
pH............................................        (\2\)        (\2\)
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range 6.0 to 9.0.                                        

    (d) If the average monthly COD concentrations in paragraph (c) of 
this section are higher than concentration values reflecting a 
reduction in the long-term average daily COD load in the raw 
(untreated) process wastewater of 74 percent multiplied by a 
variability factor of 2.2, then the average monthly effluent 
limitations for COD corresponding to the lower concentration values 
must be applied.
    (e) The effluent limitations for cyanide are as follows:

------------------------------------------------------------------------
                                                Effluent limitation \1\ 
                                             ---------------------------
                                                               Average  
             Regulated parameter                 Maximum       monthly  
                                                  daily       discharge 
                                                discharge     must not  
                                                               exceed   
------------------------------------------------------------------------
Cyanide (T).................................         33.5           9.4 
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (f) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide effluent limitations in Sec. 439.32(e) must be demonstrated at 
in-plant monitoring points pursuant to 40 CFR 122.44(i) and 122.45(h). 
Under the same provisions, the permitting authority may impose 
monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (g) Compliance with the limitation in paragraph (e) or (f) of this 
section may be achieved by certifying to the permit issuing authority 
that the facility's manufacturing processes neither use nor generate 
cyanide.
    26. Section 439.33 is revised to read as follows:


Sec. 439.33  Effluent limitations 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 application of BCT: Limitations 
for BOD5, TSS and pH are the same as the corresponding limitations in 
Sec. 439.32.
    27. Section 439.34 is amended by removing the OMB control number 
cite and revising the section to read as follows:


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

    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 application of BAT:

------------------------------------------------------------------------
                                             Effluent limitations \1\   
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
 1  Ammonia (as N)......................           84.1            29.4 
 2  Acetone.............................            0.5             0.2 
 3  4-Methyl-2-pentanone (MIBK).........            0.5             0.2 
 4  Isobutyraldehyde....................            1.2             0.5 
 5  n-Amyl acetate......................            1.3             0.5 
 6  n-Butyl acetate.....................            1.3             0.5 
 7  Ethyl acetate.......................            1.3             0.5 
 8  Isopropyl acetate...................            1.3             0.5 
 9  Methyl formate......................            1.3             0.5 
10  Amyl alcohol........................           10.0             4.1 
11  Ethanol.............................           10.0             4.1 
12  Isopropanol.........................            3.9             1.6 
13  Methanol............................           10.0             4.1 
14  Methyl Cellosolve...................           25.0            10.2 
15  Dimethyl Sulfoxide..................           91.5            37.5 
16  Triethyl amine......................          250.3           101.5 
17  Phenol..............................            0.05            0.02
18  Benzene.............................            0.05            0.02
19  Toluene.............................            0.06            0.02
20  Xylenes.............................            0.03            0.01
21  n-Hexane............................            0.03            0.02
22  n-Heptane...........................            0.05            0.02
23  Methylene chloride..................            0.9             0.3 
24  Chloroform..........................            0.02            0.01
25  1,2-Dichloroethane..................            0.4             0.1 
26  Chlorobenzene.......................            0.15            0.06
27  o-Dichlorobenzene...................            0.15            0.06
28  Tetrahydrofuran.....................            8.4             2.6 
29  Isopropyl ether.....................            8.4             2.6 
30  Diethyl amine.......................          250.0           102.0 
31  Acetonitrile........................           25.0            10.2 
32  pH..................................        (\2\)           (\2\)   
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range of 6.0-9.0.E.                                      


[[Page 50433]]

    (a) Effluent limitations for COD are the same as the corresponding 
limitations in Sec. 439.32(c) and (d).
    (b) The effluent limitations for cyanide are as follows:

------------------------------------------------------------------------
                                                Effluent limitations \1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (c) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide effluent limitations in paragraph (a) of this section must be 
demonstrated at in-plant monitoring points pursuant to 40 CFR 122.44(i) 
and 122.45(h). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (d) Compliance with the limitation in Sec. 439.34(b) or (c) may be 
achieved by certifying to the permit issuing authority that a 
facility's manufacturing processes neither use nor generate cyanide.
    28. Section 439.35 is amended by removing the OMB control number 
cite and revising the section to read as follows:


Sec. 439.35  Standards of performance for new (point) sources (NSPS).

    Any new source subject to this subpart must achieve the following 
performance standards:

------------------------------------------------------------------------
                                             Effluent limitations \1\   
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
 1  BOD 5...............................          267             111   
 2  TSS.................................          472             166   
 3  COD.................................         1675             856   
 4  Ammonia (as N)......................           84.1            29.4 
 5  Acetone.............................            0.5             0.2 
 6  4-Methyl-2-pentanone (MIBK).........            0.5             0.2 
 7  Isobutyraldehyde....................            1.2             0.5 
 8  n-Amyl acetate......................            1.3             0.5 
 9  n-Butyl acetate.....................            1.3             0.5 
10  Ethyl acetate.......................            1.3             0.5 
11  Isopropyl acetate...................            1.3             0.5 
12  Methyl formate......................            1.3             0.5 
13  Amyl alcohol........................           10.0             4.1 
14  Ethanol.............................           10.0             4.1 
15  Isopropanol.........................            3.9             1.6 
16  Methanol............................           10.0             4.1 
17  Methyl Cellosolve...................          100.0            40.6 
18  Methyl Sulfoxide....................           91.5            37.5 
19  Triethyl amine......................          250.0           102.0 
20  Phenol..............................            0.05            0.02
21  Benzene.............................            0.05            0.02
22  Toluene.............................            0.06            0.02
23  Xylenes.............................            0.02            0.01
24  n-Hexane............................            0.03            0.02
25  n-Heptane...........................            0.05            0.02
26  Methylene chloride..................            0.9             0.3 
27  Chloroform..........................            0.02            0.01
28  1,2-Dichloroethane..................            0.4             0.1 
29  Chlorobenzene.......................            0.15            0.05
30  o-Dichlorobenzene...................            0.15            0.06
31  Tetrahydrofuran.....................            8.4             2.6 
32  Isopropyl ether.....................            8.4             2.6 
33  Diethyl amine.......................          250.0           102.0 
34  Acetonitrile........................           25.0            10.2 
35  pH..................................        (\2\)           (\2\)   
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range of 6.0-9.0.                                        

    (a) The performance standards for cyanide are as follows:

------------------------------------------------------------------------
                                                  Performance standards 
                                               ------------\1\----------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
Cyanide (T)...................................         33.5          9.4
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (b) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide standards in paragraph (a) of this section must be demonstrated 
at in-plant monitoring points pursuant to 40 CFR 122.44(i) and 
122.45(h). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (c) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of this section until the expiration of the applicable time 
period specified in 40 CFR 122.29(d)(1), after

[[Page 50434]]

which the source must achieve the standards specified in Secs. 439.33 
and 439.34.
    (d) Compliance with the standards in paragraph (a) or (b) of this 
section may be achieved by certifying to the permit issuing authority 
that a facility's manufacturing processes neither use nor generate 
cyanide.
    29. Section 439.36 is amended by removing the OMB control number 
cite and revising the section to read as follows:


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

    Except as provided in 40 CFR 403.7 and 403.13, any existing source 
subject to this subpart must continue to achieve compliance with 
cyanide pretreatment standards and achieve compliance with all other 
pretreatment standards by September 21, 2001.

------------------------------------------------------------------------
                                            Pretreatment standards \1\  
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
 1  Ammonia (as N) \2\..................           84.1            29.4 
 2  Acetone.............................           20.7             8.2 
 3  4-Methyl-2-pentanone (MIBK).........           20.7             8.2 
 4  Isobutyraldehyde....................           20.7             8.2 
 5  n-Amyl acetate......................           20.7             8.2 
 6  n-Butyl acetate.....................           20.7             8.2 
 7  Ethyl acetate.......................           20.7             8.2 
 8  Isopropyl acetate...................           20.7             8.2 
 9  Methyl formate......................           20.7             8.2 
10  Methyl Cellosolve...................          275.0            54.7 
11  Isopropyl ether.....................           20.7             8.2 
12  Tetrahydrofuran.....................            9.2             3.4 
13  Benzene.............................            3.0             0.7 
14  Toluene.............................            0.3             0.1 
15  Xylenes.............................            3.0             0.7 
16  n-Hexane............................            3.0             0.7 
17  n-Heptane...........................            3.0             0.7 
18  Methylene chloride..................            3.0             0.7 
19  Chloroform..........................            0.1             0.03
20  1,2-Dichloroethane..................           20.7             8.2 
21  Chlorobenzene.......................            3.0             0.7 
22  o-Dichlorobenzene...................           20.7             8.2 
23  Diethyl amine.......................          255.0           100.0 
24  Triethyl amine......................          255.0           100.0 
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Not applicable to sources that discharge to a POTW with             
  nitrification capability.                                             

    (a) Sources that discharge to a POTW with nitrification capability 
(defined at Sec. 439.2(f)) are not required to achieve the pretreatment 
standard for ammonia.
    (b) The pretreatment standards for cyanide are as follows:

------------------------------------------------------------------------
                                              Pretreatment standards \1\
                                             ---------------------------
                                                               Average  
             Regulated parameter                 Maximum       monthly  
                                                  daily       discharge 
                                                discharge     must not  
                                                               exceed   
------------------------------------------------------------------------
Cyanide (T).................................         33.5           9.4 
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (c) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide pretreatment standards in paragraph (b) of this section must be 
demonstrated at in-plant monitoring points pursuant to 40 CFR 403.6(e) 
(2) and (4). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (d) Compliance with the pretreatment standards in paragraph (b) or 
(c) of this section may be achieved by certifying to the permit issuing 
authority that the facility's manufacturing processes neither use nor 
generate cyanide.
    30. Section 439.37 is amended by removing the OMB control number 
cite and revising the section to read as follows:


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

    Except as provided in 40 CFR 403.7, any new source subject to this 
subpart must achieve the following pretreatment standards:

------------------------------------------------------------------------
                                            Pretreatment standards \1\  
                                         -------------------------------
                                                              Average   
           Regulated parameter             Maximum daily      monthly   
                                             discharge    discharge must
                                                            not exceed  
------------------------------------------------------------------------
 1  Ammonia (as N)\2\...................            84.1           29.4 
 2  Acetone.............................            20.7            8.2 
 3  4-Methyl-2-pentanone (MIBK).........            20.7            8.2 
 4  Isobutyraldehyde....................            20.7            8.2 
 5  n-Amyl acetate......................            20.7            8.2 

[[Page 50435]]

                                                                        
 6  n-Butyl acetate.....................            20.7            8.2 
 7  Ethyl acetate.......................            20.7            8.2 
 8  Isopropyl acetate...................            20.7            8.2 
 9  Methyl formate......................            20.7            8.2 
10  Methyl Cellosolve...................           275.0           59.7 
11  Isopropyl ether.....................            20.7            8.2 
12  Tetrahydrofuran.....................             9.2            3.4 
13  Benzene.............................             3.0            0.7 
14  Toluene.............................             0.3            0.1 
15  Xylenes.............................             3.0            0.7 
16  n-Hexane............................             3.0            0.7 
17  n-Heptane...........................             3.0            0.7 
18  Methylene chloride..................             3.0            0.7 
19  Chloroform..........................             0.1            0.03
20  1,2-Dichloroethane..................            20.7            8.2 
21  Chlorobenzene.......................             3.0            0.7 
22  o-Dichlorobenzene...................            20.7            8.2 
23  Diethyl amine.......................           255.0          100.0 
24  Triethyl amine......................           255.0          100.0 
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Not applicable to sources that discharge to a POTW with             
  nitrification capability.                                             

    (a) Sources that discharge to a POTW with nitrification capability 
(defined at Sec. 439.2(f)) are not required to achieve the pretreatment 
standard for ammonia.
    (b) The pretreatment standards for cyanide are as follows:

------------------------------------------------------------------------
                                                Effluent limitation \1\ 
                                             ---------------------------
                                                               Average  
             Regulated parameter                 Maximum       monthly  
                                                  daily       discharge 
                                                discharge     must not  
                                                               exceed   
------------------------------------------------------------------------
Cyanide (T).................................         33.5           9.4 
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (c) When monitoring for cyanide at the end-of-pipe is impractical 
because of dilution by other process wastewaters, compliance with the 
cyanide pretreatment standards in paragraph (b) of this section must be 
demonstrated at in-plant monitoring points pursuant to 40 CFR 403.6(e) 
(2) and (4). Under the same provisions, the permitting authority may 
impose monitoring requirements on internal wastestreams for any other 
parameter(s) regulated by this section.
    (d) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of Sec. 439.37, until the expiration of the applicable time 
period specified in 40 CFR 122.29(d)(1), after which the source must 
achieve the standards specified in Sec. 439.36.
    (e) Compliance with the standard in paragraph (b) or (c) of this 
section may be achieved by certifying to the permit issuing authority 
that a facility's manufacturing processes neither use nor generate 
cyanide.
    31. Section 439.40 is revised to read as follows:


Sec. 439.40  Applicability.

    This subpart applies to discharges of process wastewater resulting 
from the manufacture of pharmaceutical products by mixing, compounding 
and formulating operations.
    32. Section 439.41 is revised to read as follows:


Sec. 439.41  Specialized definitions.

    For the purpose of this subpart:
    (a) The term mixing, compounding, and formulating operations means 
processes that put pharmaceutical products in dosage forms.
    (b) The term product means any pharmaceutical product manufactured 
by blending, mixing, compounding, and formulating pharmaceutical 
ingredients. The term includes pharmaceutical preparations for both 
human and veterinary use, such as ampules, tablets, capsules, vials, 
ointments, medicinal powders, solutions, and suspensions.
    33. Section 439.42 is amended by removing the OMB control number 
and revising the section to read as follows:


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

    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 application of BPT:
    (a) The average monthly effluent limitation for BOD5, 
expressed as mass loading (pounds, kilograms) per day, must reflect not 
less than 90 percent reduction in the long-term average daily 
BOD5 load of the raw (untreated) process wastewater, 
multiplied by a variability factor of 3.0.
    (1) The long-term average daily BOD5 load of the raw 
process wastewater (i.e., the base number to which the percent 
reduction is applied) is defined as the average daily BOD5 
load during any calendar month, over 12 consecutive months within the 
most recent 36 months, and must include one or more periods during 
which production was at a maximum.
    (2) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 load in the influent to 
the wastewater treatment system must exclude any portion of the load 
associated with separable mycelia and solvents, except for residual 
amounts of mycelia and solvents remaining after the practices of 
recovery and/or separate disposal or reuse. Residual amounts of these 
substances may be included in the calculation of the average influent 
BOD5 loading.
    (3) The practices of recovery, and/or separate disposal or reuse 
include: physical separation and removal of separable mycelia; recovery 
of solvents from wastestreams; incineration of

[[Page 50436]]

concentrated solvent wastestreams (including tar still bottoms); and 
broth concentration for disposal other than to the treatment system. 
This part does not prohibit the inclusion of such wastes in raw waste 
loads in fact, nor does it mandate any specific practice, but rather 
describes the rationale for determining NPDES permit limitations. The 
effluent limitation for BOD5 may be achieved by any of 
several, or a combination, of these practices.
    (b) The average monthly effluent limitation for TSS, expressed as 
mass loading (pounds, kilograms) per day, must be calculated as 1.7 
times the BOD5 limitation determined in paragraph (a) of 
this section.
    (c) Except as provided in paragraph (d) of this section, effluent 
limitations for COD and pH are as follows:

------------------------------------------------------------------------
                                                 Effluent limitations\1\
                                               -------------------------
                                                               Average  
              Regulated parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
COD...........................................          228           86
pH............................................        (\2\)        (\2\)
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range 6.0 to 9.0.                                        

    (d) If the average monthly COD concentrations in paragraph (c) of 
this section are higher than concentration values reflecting a 
reduction in the long-term average daily COD load in the raw 
(untreated) process wastewater of 74 percent multiplied by a 
variability factor of 2.2, then the average monthly effluent 
limitations for COD corresponding to the lower concentration values 
must be applied.
    34. Section 439.43 is revised to read as follows:


Sec. 439.43  Effluent limitations 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 application of BCT: Limitations 
for BOD5, TSS and pH are the same as the corresponding 
limitations in Sec. 439.42.
    35. Section 439.44 is amended by removing the OMB control number 
citation and revising the section to read as follows:


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

    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 application of BAT. Limitations 
for COD are the same as the corresponding limitations in Sec. 439.42 
(c) and (d).
    36. Section 439.45 is amended by removing the OMB control number 
citation and revising the section to read as follows:


Sec. 439.45  Standards of performance for new (point) sources (NSPS).

    (a) Any new source subject to this subpart must achieve the 
following performance standards:

------------------------------------------------------------------------
                                                  Performance standards 
                                               ------------\1\----------
                                                               Average  
             Regulated  parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
BOD5..........................................           35           18
TSS...........................................           58           31
COD...........................................          228           86
pH............................................        (\2\)        (\2\)
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         
\2\ Within the range 6.0 to 9.0.                                        

    (b) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of this section until the expiration of the applicable time 
period specified in 40 CFR 122.29(d)(1), after which the source must 
achieve the standards specified in Sec. 439.43 and 439.44.
    37. Section 439.46 is amended by removing the OMB control number 
cite, and revising the section to read as follows:


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

    Except as provided in 40 CFR 403.7 and 403.13, any existing source 
subject to this subpart must achieve the following pretreatment 
standards by September 21, 2001:

------------------------------------------------------------------------
                                                 Pretreatment standards 
                                                           \1\          
                                               -------------------------
                                                               Average  
             Regulated  parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
1 Acetone.....................................         20.7          8.2
2 n-Amyl acetate..............................         20.7          8.2
3 Ethyl acetate...............................         20.7          8.2
4 Isopropyl acetate...........................         20.7          8.2
5 Methylene chloride..........................          3.0          0.7
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    38. Section 439.47 is amended by removing the OMB control number 
cite, and revising the section to read as follows:


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

    (a) Except as provided in 40 CFR 403.7, any new source subject to 
this subpart must achieve the following pretreatment standards:

------------------------------------------------------------------------
                                                 Pretreatment standards 
                                                           \1\          
                                               -------------------------
                                                               Average  
             Regulated  parameter                 Maximum      monthly  
                                                   daily      discharge 
                                                 discharge     must not 
                                                                exceed  
------------------------------------------------------------------------
1 Acetone.....................................         20.7          8.2
2 n-Amyl acetate..............................         20.7          8.2
3 Ethyl acetate...............................         20.7          8.2
4 Isopropyl acetate...........................         20.7          8.2
5 Methylene chloride..........................          3.0          0.7
------------------------------------------------------------------------
\1\ Mg/L (ppm).                                                         

    (b) Any new source subject to the provisions of this section that 
commenced discharging after November 21, 1988 and prior to November 20, 
1998 must continue to achieve the standards specified in the earlier 
version of this section, until the expiration of the applicable time 
period specified in 40 CFR 122.29(d)(1), after which the source must 
achieve the standards specified in Sec. 439.46.
    39. Section 439.50 is revised to read as follows:


Sec. 439.50  Applicability.

    This subpart applies to discharges of process wastewater resulting 
from pharmaceutical research.
    40. Section 439.51 is revised to read as follows:


Sec. 439.51  Specialized definitions.

    For the purpose of this subpart, the term product means products or 
services resulting from research and product development activities.
    41. Section 439.52 is revised to read as follows:


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

    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 application of BPT:
    (a) The average monthly effluent limitation for BOD5, 
expressed as mass loading (pounds, kilograms) per day, must reflect not 
less than 90 percent reduction in the long-term average daily 
BOD5 load of the raw (untreated) process wastewater, 
multiplied by a

[[Page 50437]]

variability factor of 3.0. No facility shall be required to attain a 
limitation for BOD5 that is less than the equivalent of 45 
mg/L.
    (b) The average monthly effluent limitation for COD, expressed as 
mass loading (pounds, kilograms) per day, must reflect not less than 74 
percent reduction in the long-term average daily COD load of the raw 
(untreated) process wastewater, multiplied by a variability factor of 
2.2. No facility shall be required to attain a limitation for COD that 
is less than the equivalent of 220 mg/L.
    (c) The long-term average daily BOD5 or COD mass loading 
of the raw process wastewater (i.e., the base number to which the 
percent reduction is applied) is defined as the average daily 
BOD5 or COD load during any calendar month, over 12 
consecutive months within the most recent 36 months.
    (1) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 or COD load in the 
influent to the wastewater treatment system must exclude any portion of 
the load associated with solvents, except for residual amounts of 
solvents remaining after the practices of recovery and/or separate 
disposal or reuse. Residual amounts of these substances may be included 
in the calculation of the average influent BOD5 or COD 
loading.
    (2) The practices of recovery, and/or separate disposal or reuse 
include: recovery of solvents from wastestreams; and incineration of 
concentrated solvent wastestreams (including tar still bottoms). This 
part does not prohibit the inclusion of such wastes in raw waste loads 
in fact, nor does it mandate any specific practice, but rather 
describes the rationale for determining NPDES permit limitations. The 
effluent limitation for BOD5 or COD may be achieved by any 
of several, or a combination, of these practices.
    (d) The average monthly effluent limitation for TSS, expressed as 
mass loading (pounds, kilograms) per day, must be calculated as 1.7 
times the BOD5 limitation determined in paragraph (a) of 
this section.
    (e) The pH must be within the range 6.0 to 9.0.


Secs. 439.33 through 439.57  [Removed]

    41. Sections 439.53 through 439.57 are removed.

Appendix A to part 439 [Added]

    42. Appendix A is added to part 439 to read as follows:

Appendix A to Part 439--Tables

          Table 1.--Surrogate Parameters for Direct Dischargers         
               [Utilizing biological treatment technology]              
------------------------------------------------------------------------
        Regulated  parameter                  Treatability class        
------------------------------------------------------------------------
Amyl alcohol.......................  Alcohols.                          
Ethanol............................                                     
Isopropanol........................                                     
Methanol...........................                                     
Phenol.............................                                     
Isobutyraldehyde...................  Aldehydes.                         
n-Heptane..........................  Alkanes.                           
n-Hexane...........................                                     
Diethylamine.......................  Amines.                            
Triethylamine......................                                     
Benzene............................  Aromatics.                         
Toluene............................                                     
Xylenes............................                                     
Chlorobenzene......................                                     
o-Dichlorobenzene..................                                     
Chloroform.........................  Chlorinated Alkanes.               
Methylene chloride.................                                     
1,2-Dichloroethane.................                                     
Ethyl acetate......................  Esters.                            
Isopropyl acetate..................                                     
n-Amyl acetate.....................                                     
n-Butyl acetate....................                                     
Methyl formate.....................                                     
Tetrahydrofuran....................  Ethers.                            
Isopropyl ether....................                                     
Acetone............................  Ketones.                           
4-Methyl-2-pentanone (MIBK)........                                     
Ammonia (aqueous)..................  Miscellaneous.                     
Acetonitrile.......................                                     
Methyl Cellosolve..................                                     
Dimethyl Sulfoxide.................                                     
------------------------------------------------------------------------
Notes:                                                                  
1. Parameters in bold may be used as a surrogate to represent other     
  parameters in the same treatability class.                            
2. Surrogates have not been identified for the ``Miscellaneous''        
  treatability class.                                                   


         Table 2.--Surrogate Parameters for Indirect Dischargers        
            [Utilizing steam stripping treatment technology]            
------------------------------------------------------------------------
        Regulated parameters                  Treatability class        
------------------------------------------------------------------------
Benzene............................  High strippability.                
Toluene............................                                     
Xylenes............................                                     
n-Heptane..........................                                     
n-Hexane...........................                                     
Chloroform.........................                                     
Methylene chloride.................                                     
Chlorobenzene......................                                     
Methyl cellosolve..................                                     
Ammonia (aqueous)..................  Medium strippability.              
Diethyl amine......................                                     
Triethyl amine.....................                                     
Acetone 4-Methyl-2-pentanone (MIBK)                                     
n-Amyl acetate.....................                                     
n-Butyl acetate....................                                     
Ethyl acetate......................                                     
Isopropyl acetate..................                                     
Methyl formate.....................                                     
Isopropyl ether....................                                     
Tetrahydrofuran....................                                     
1,2-Dichloroethane.................                                     
o-Dichlorobenzene..................                                     
------------------------------------------------------------------------
Notes:                                                                  
1. Parameters in bold may be used as a surrogate to represent other     
  parameters in the same treatability class.                            

[FR Doc. 98-21027 Filed 9-18-98; 8:45 am]
BILLING CODE 6560-50-P