FR Doc 03-5716

[Federal Register: March 13, 2003 (Volume 68, Number 49)]
[Rules and Regulations]
[Page 12265-12275]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr03-16]

[[Page 12265]]

-----------------------------------------------------------------------

Part III

Environmental Protection Agency

-----------------------------------------------------------------------

40 CFR 439

Effluent Limitations Guidelines, Pretreatment Standards, and New Source
Performance Standards for the Pharmaceutical Manufacturing Point Source
Category; Direct Final Rule and Proposed Rule

[[Page 12266]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439

[FRL-7462-8]

Effluent Limitations Guidelines, Pretreatment Standards, and New
Source Performance Standards for the Pharmaceutical Manufacturing Point
Source Category

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to amend certain provisions of the effluent guidelines for
the Pharmaceutical Manufacturing Point Source Category, which were
published on September 21, 1998 (63 FR 50424). First, EPA is clarifying
the date on which a discharger subject to the New Source Performance
Standards (NSPS) and the Pretreatment Standards for New Sources (PSNS)
would be subject to effluent limitations and pretreatment standards
established in the 1998 regulation. Second, this rule re-establishes a
minimum concentration for the maximum monthly average BOD5
limitation that EPA inadvertently omitted from the Best Practicable
Control Technology (BPT) requirements in two subcategories of the 1998
regulation. Next, the amendments correct an error in EPA's pass-through
analysis prepared in support of the 1998 rule and, as a result, deletes
methyl Cellosolve (2-methoxyethanol) from the pretreatment standards in
two subcategories and from Appendix A, Table 2, ``Surrogate Parameters
for Indirect Dischargers.'' Finally, the Agency is making other non-
substantive editorial and format changes such as removing redundancies,
and adding definitions.

DATES: This rule is effective on June 11, 2003 without further notice,
unless EPA receives adverse comment by May 12, 2003. If we receive such
comment, we will publish a timely withdrawal in the Federal Register
informing the public that this rule will not take effect.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Please mail comments to the Water
Docket, Environmental Protection Agency, Mailcode: 4101T, 1200
Pennsylvania Avenue, NW., Washington, DC, 20460 or submit them
electronically to http://www.epa.gov/edocket. Send either to the

electronically to http://www.epa.gov/edocket. Send either to the

Attention of Docket ID No. OW-2003-0007. See section I.C., of the
SUPPLEMENTARY INFORMATION section for more information on submitting
comments.

FOR FURTHER INFORMATION CONTACT: Dr. Frank Hund, EPA Office of Water by
phone at (202)566-1027 or by e-mail at hund.frank@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Regulated Entities

Entities potentially regulated by this action include facilities of
the following types that discharge pollutants directly or indirectly to
U.S. waters.

----------------------------------------------------------------------------------------------------------------
Category Examples of regulated entities SIC (NAICS) code
----------------------------------------------------------------------------------------------------------------
Industry........................ Facilities that generate process 2833, R834, 2836 (2834-04, 2834-98).
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 definitions and applicability criteria in Sec. Sec. 439.1, 439.10,
439.20, 439.30, 439.40 and 439.50 of title 40 of the Code of Federal
Regulations. If you have questions regarding the applicability of this
action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under Docket ID No. OW-2003-0007. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
The official public docket is the collection of materials that is
available for public viewing at the Water Docket in the EPA Docket
Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Water Docket is (202) 566-
2426. For access to docket materials, please call ahead to schedule an
appointment. Every user is entitled to copy 100 pages before incurring
a charge. The Docket may charge 15 cents a page for each page over the
100-page limit.
2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

An electronic version of the public docket is available through

EPA's electronic public docket and comment system, ``EPA Dockets.'' You
may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view

may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view

public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, select
``search,'' then key in the appropriate docket identification number.

II. Legal Authority

The U.S. Environmental Protection Agency is promulgating these
regulations under the authority of 33 U.S.C. 1311, 1314, 1316, 1317,
1318, 1342 and 1361.

III. Overview of Effluent Limitations Guidelines and Standards

Congress adopted the Clean Water Act (CWA) to ``restore and
maintain the chemical, physical, and biological integrity of the
Nation's waters'' (section 101(a), 33 U.S.C. 1251(a)). To achieve this
goal, the CWA prohibits the discharge of pollutants into navigable
waters except in compliance with the statute. The Clean Water Act
confronts the problem of water pollution on a number of different
fronts. Its primary reliance, however, is on establishing restrictions
on the types and amounts of pollutants discharged from various
industrial, commercial, and public sources of wastewater.

[[Page 12267]]

Congress recognized that regulating only those sources that
discharge effluent directly into the nation's waters would not be
sufficient to achieve the CWA's goals. Consequently, the CWA requires
EPA to promulgate nationally applicable pretreatment standards that
restrict pollutant discharges for those who discharge wastewater
indirectly through sewers flowing to publicly-owned treatment works
(POTWs) (section 307(b) and (c), 33 U.S.C. 1317(b) and (c)). National
pretreatment standards are established for those pollutants in
wastewater from indirect dischargers which may pass through or
interfere with POTW operations. Generally, pretreatment standards are
designed to ensure that wastewater from direct and indirect industrial
dischargers are subject to similar levels of treatment. In addition,
POTWs are required to implement local pretreatment limits applicable to
their industrial indirect dischargers to satisfy any local requirements
(40 CFR 403.5).
Direct dischargers must comply with effluent limitations in
National Pollutant Discharge Elimination System (NPDES) permits;
indirect dischargers must comply with pretreatment standards. These
limitations and standards are established by regulation for categories
of industrial dischargers and are based on the degree of control that
can be achieved using various levels of pollution control technology.
On November 17, 1976, (41 FR 50676) EPA promulgated ``best
practicable control technology currently available'' (BPT) effluent
limitations guidelines for the Pharmaceutical Manufacturing Point
Source Category. On October 27, 1983, (48 FR 49808) the Agency revised
the BPT limitations and promulgated additional limitations covering the
``best available technology economically achievable'' (BAT) and
pretreatment and new source standards for this point source category.
On September 21, 1998, (63 FR 50388) EPA again revised the effluent
limitations guidelines and standards for the Pharmaceutical
Manufacturing Point Source Category. We subsequently received comments
from the regulated community and after our own analysis and review, we
determined that several minor amendments which are discussed below were
warranted.

IV. Amendment to New Source Effective Dates

Section 306 of the Clean Water Act requires EPA to establish, and
from time to time, revise standards of performance for categories of
new sources which may discharge pollutants. Under the Act, point
sources constructed to meet these NSPS may not be subject to more
stringent standards during a statutorily prescribed period following
construction of such source, generally 10 years. EPA first promulgated
NSPS for the Pharmaceutical Manufacturing Point Source Category in 1983
when the Agency established effluent limitations guidelines and
pretreatment standards for this category. When EPA promulgated revised
limitations and standards, including NSPS, for the Pharmaceuticals
Manufacturing Point Source Category in 1998, 40 CFR 439.15(c),
439.25(c), 439.35(c), and 439.45(c) provided for this protection period
from more stringent standards. For example, paragraph (c) of Sec.
439.15 states:

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. Sec. 439.13
and 439.14. (Emphasis supplied)

In order to remove any ambiguity about which regulations applied to
dischargers constructing new facilities and commencing discharge after
the 1983 regulation but before the effective date of the 1998
regulations, EPA is amending the regulation. EPA is amending paragraph
(c) of each of the four sections cited above to state clearly that any
new source that commenced discharging after November 21, 1988, and
before November 20, 1998, must continue to achieve the standards
specified for 40 CFR part 439 in the October 27, 1983, Federal Register
(48 FR 49808) (which are contained in the 1988 edition of the CFR)
until the expiration of the applicable time period specified in 40 CFR
122.29(d)(1). Thereafter, the source must comply with the applicable
effluent limitations specified in the September 21, 1998, regulation
(63 FR 50388). The amendments substitute for the phrase ``earlier
version'' a specific reference to the 1988 edition of 40 CFR part 439.
This will remove any uncertainty about the standards with which a point
source discharger must comply.
Section 307(c) of the CWA also requires EPA to promulgate
pretreatment standards for new sources simultaneously with the
promulgation of NSPS for a category of sources. When EPA promulgated
the PSNS for the Pharmaceutical Manufacturing Point Source Category in
1998, PSNS in Sec. Sec. 439.17, 439.27, 439.37, and 439.47 failed to
specify when a source constructed before the date on which the new PSNS
became effective would be subject to the more stringent standards. To
correct this oversight, EPA is revising each of these four sections to
read as follows:

Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharging after November 21, 1988, and
prior to November 20, 1998, must continue to achieve the
pretreatment standards specified for this section in the 1988
edition of 40 CFR part 439 during a ten-year period beginning on the
date the source commenced discharge, or during the period of
depreciation or amortization of the facility, which ever comes
first, after which the source must achieve the same standards as
specified in [insert the appropriate PSES section for the subpart].

V. Amendment to BOD Minimum Limitation

When EPA issued regulations for the Pharmaceutical Manufacturing
Point Source Category on October 27, 1983 (49 FR 49808), the best
practicable control technology (BPT) regulation in Sec. Sec. 439.22
and 439.42 provided for a minimum monthly average limitation for
BOD5, which was qualified by the following sentence:
``However, a plant shall not be required to attain a maximum 30-day
average BOD5 effluent limitation of less than the equivalent
of 45 mg/l.'' EPA included this provision because dischargers with
BOD5 levels up to 100 mg/L in their raw wastewater could not
achieve the required 90% reduction of BOD5 using biological
treatment, the technological basis for the limitation. Since biological
treatment could not achieve the required reduction for such
dischargers, EPA established a qualified provision for a minimum
BOD5 concentration in the 1983 regulation.
EPA inadvertently omitted this qualified provision of the
BOD5 limitations from the final rule published in 1998, and
this language consequently has not been included in subsequent editions
of 40 CFR part 439. Today EPA is correcting this omission by adding to
Sec. Sec. 439.22(a) and 439.42(a) the phrase: `` * * *, except that no
facility shall be required to attain a monthly average limitation for
BOD5 that is less than the equivalent of 45 mg/L.''

VI. Amendment To Delete Methyl Cellosolve From Pretreatment Standards

EPA is amending 40 CFR part 439 by deleting the pretreatment
standards for methyl Cellosolve from Sec. Sec. 439.16, 439.17, 439.36
and 439.37, and from Table 2 of Appendix A. In the 1998 regulation, EPA
established pretreatment standards for methyl

[[Page 12268]]

Cellosolve and other pollutants which EPA's pass-through analysis
concluded would pass through POTW treatment rather than be removed by
POTW treatment. EPA based its determination on a chemical and
engineering evaluation of which pollutants would not be susceptible to
treatment in POTW biological treatment systems. EPA's pass-through
analysis depended on a number of calculations, relying in part on a
comparison of a parameter's Henry's Law Constant (HL) with a
threshold HL value.
In a letter to EPA dated November 28, 2000, the Pharmaceutical
Research and Manufacturers of America (PhRMA) indicated that EPA had
used an incorrect HL value for methyl Cellosolve in the
pass-through analysis by assuming an HL value of 2.9 x
10^-3 atm/gmole/m³. This was the same
HL value that had been used for methyl Cellosolve by EPA's
Office of Air Quality Planning and Standards (OAQPS) in establishing
the Maximum Air Control Technology (MACT) standards for pharmaceutical
manufacturers that were promulgated in 1998, and that had been
developed concomitantly with revised pretreatment standards for 40 CFR
part 439. The OAQPS, however, subsequently revised its HL
value for methyl Cellosolve from 2.9 x 10^-3 to 3.3 x
10^-7 atm/gmole/m³, based on a value reported by
Johanson G. and Dynesius B. in ``Liquid/air partition coefficients of
six commonly used glycol ethers,'' British Journal of Industrial
Medicine, 1988, 45:561-564.
The determination of an incorrect HL constant was
reinforced when EPA also considered the analytical technique required
to measure low concentrations of methyl Cellosolve in wastewater.
Analytical methods to measure volatile organic analytes (VOAs) utilize
an inert gas purging technique to recover VOAs from a wastewater
sample. But methyl Cellosolve does not purge efficiently and so must be
analyzed using a direct injection technique. This fact offered
additional evidence that EPA had used an inappropriate HL
value for methyl Cellosolve in the earlier pass-through analysis of the
pretreatment standards.
The revised HL for methyl Cellosolve (3.3 x
10^-7 atm/gmole/m³) is well below the threshold
HL value (1 x 10^-5 atm/gmole/m³) that
EPA used to classify a compound as a volatile organic compound (VOC)
for purposes of the Agency's pass-through analysis. Thus, EPA relied on
an inappropriate HL value for methyl Cellosolve in the pass-
through analysis for the 1998 rule. This caused this compound to be
identified as a VOC, which the Agency's pass-through analysis
determined would pass through a POTW's treatment. When EPA used the
corrected lower HL value and found that methyl Cellosolve
was not a VOC, the Agency's pass-through analysis determined that this
compound would not pass through a POTW's treatment.

VII. Additional Edits to 40 CFR Part 439

Today's rule also includes non-substantive edits and format changes
to the rule promulgated in 1998 in order to shorten and clarify 40 CFR
part 439. The ``Authority'' citation was shortened to conform with
current guidance from the Federal Register Office. The text from Sec.
439.4 was merged into Sec. 439.2 and the heading of Sec. 439.2 was
revised to read: ``General monitoring requirements.'' Section 439.4 was
re-designated under a new heading ``General limitation or standard for
pH'' and the term ``Subcategory'' was removed from the heading of all
subparts. EPA has also added definitions of ``Maximum daily'' and
``Maximum monthly average'' to Sec. 439.1. These definitions are
similar to those used in other effluent limitations guidelines and
pretreatment standards regulations and reflect the definitions used to
promulgate the limits in the existing 40 CFR part 439. Finally, the
initial phrase, ``The term * * * '' was removed from all definitions,
column headings and titles of all tables. Corresponding text
referencing these headings and titles was also revised.

VIII. Rationale for Direct Final Rule

EPA is publishing this rule without prior proposal because we view
this as a noncontroversial amendment and anticipate no adverse comment.
The changes here will facilitate the implementation of part 439 and
will not affect environmental impacts or compliance costs. They merely
clarify applicable dates, correct an inadvertent error and omission,
and make other non-substantive edits. However, in the ``Proposed
Rules'' section of today's Federal Register, we are publishing a
separate document that will serve as the proposal to amend part 439, as
described herein, if adverse comments are filed. This rule will be
effective on June 11, 2003 without further notice, unless we receive
adverse comment by May 12, 2003. If EPA receives adverse comment on one
or more distinct amendments, paragraphs, or sections of this
rulemaking, we will publish a timely withdrawal in the Federal Register
indicating which provisions will become effective and which provisions
are being withdrawn due to adverse comment. Any distinct amendment,
paragraph, or section of today's rulemaking for which we do not receive
adverse comment will become effective on the date set out above,
notwithstanding any adverse comment on any other distinct amendment,
paragraph, or section of today's rule. We will address all adverse
public comments in a subsequent final rule based on the proposed rule.
We will not institute a second comment period on this action. Any
parties interested in commenting must do so at this time.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

Under Executive Order 12866 (58 FR 51735, (October 4, 1993)), the
Agency must determine whether a regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the 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 on 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
the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.

B. Paperwork Reduction Act

This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
It merely clarifies applicable dates, corrects an inadvertent error and
omission, and makes other non-substantive edits.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology

[[Page 12269]]

and systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C.
601 et seq., generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations and small
governmental jurisdictions.
For purposes of assessing the impact of today's final rule on small
entities, a small entity is defined as (1) a small business with gross
revenue under $6 million (based on Small Business Administration size
standards); (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population less than 50,000; and (3) a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field.
After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. It merely
clarifies applicable dates, corrects an inadvertent error and omission,
and makes other non-substantive edits. As explained above, the change
to the PSNS sections of the regulation merely removes any ambiguity
about the applicability of the earlier 1983 pretreatment standards
during the 10-year protection period prior to November 20, 1998, and
makes them consistent with the latest NSPS sections. The PSNS revision
does not establish any new requirements with respect to those subject
to the regulation. The other changes similarly would have either no
effect on the regulated entities, or at most an inconsequential effect.
The deletion of methyl Cellosolve would reduce the economic impacts of
the regulation on those entities, including small entities, subject to
pretreatment standards in the two subparts which currently contain
methyl Cellosolve as a regulated parameter. In addition, as noted
above, the revision to re-establish the minimum concentration for
BOD5 would correct an earlier inadvertent omission and
reflect the requirements of existing discharge permits.

D. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 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 final rule does not contain a Federal
mandate that may result in expenditures of $100 million or more for
State, local and tribal governments, in the aggregate, or the private
sector in any one year. It merely clarifies applicable dates, corrects
an inadvertent error and omission, and makes other non-substantive
edits. Thus, today's rule is not subject to the requirements of
sections 202 and 205 of UMRA.
For the same reason, EPA has determined that this final rule
contains no regulatory requirements that might significantly affect
small governments. The final rule does not uniquely affect small
governments because small and large governments are affected in the
same way. Thus, today's rule is not subject to the requirements of
section 203 of UMRA.

E. Executive Order 13132: Federalism

Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. Today's rule amends effluent
limitations and pretreatment standards which impose requirements that
apply to facilities when they discharge wastewater or introduce
wastewater to a POTW. It merely clarifies applicable dates, corrects an
inadvertent error, and omission, and makes other non-substantive edits.
EPA has determined that there are no pharmaceutical facilities owned
and/or operated by State or local governments that would be subject to
today's rule. Further, the rule would only incidentally affect State
and local governments in their capacity as implementers of CWA NPDES
permitting programs. Thus, Executive Order 13132 does not apply to this
rule.

[[Page 12270]]

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have substantial direct effects on one or more Indian tribes, on
the relationship between Federal government and Indian tribes or on the
distribution of power and responsibilities between the Federal
government and Indian tribes.
This final rule does not have tribal implications. It will not have
substantial direct effects on tribal governments, on the relationship
between this Federal government and Indian tribes or on the
distribution of power and responsibilities between the Federal
government and Indian tribes. It merely clarifies applicable dates,
corrects an inadvertent error and omission, and makes other non-
substantive edits. EPA has not identified any pharmaceutical facilities
covered by today's rule that are owned and/or operated by Indian tribal
governments. No Indian tribes are responsible for implementing the CWA
NPDES permitting program. Thus, Executive Order 13175 does not apply to
this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

Executive Order 13045 ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``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.
This final rule is not subject to Executive Order 13045 because it
is not an economically significant rule as defined under Executive
Order 12866. Further, this rule does not concern an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children.

H. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use

This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355; May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA 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) that are developed or adopted
by voluntary consensus standards bodies. The NTTAA directs EPA to
provide Congress, through the Office of Management and Budget (OMB),
explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.

J. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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 United States prior
to the publication of the rule in Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective June 11, 2003.

List of Subjects in 40 CFR Part 439

Environmental protection, Drugs, Reporting and recordingkeeping
requirements, Waste treatment and disposal, Water pollution control.

Dated: February 28, 2003.
Christine Todd Whitman,
Administrator.
For reasons set out in the preamble, part 439, title 40, chapter I
of the Code of Federal Regulations is amended as follows:

PART 439--PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY

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

Authority: 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and
1361.

2. Section 439.1 is amended by revising paragraphs (b) through (n)
and adding paragraphs (o) and (p) to read as follows:

Sec. 439.1 General definitions.

* * * * *
(b) Bench-scale operation means the laboratory testing of
materials, methods, or processes on a small scale, such as on a
laboratory worktable.
(c) Cyanide (T) means the parameter total cyanide.
(d) 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 en route
to the end-of-pipe.
(e) Maximum daily means the highest allowable discharge of
wastewater pollutants during a calender day or any 24 hour period that
reasonably represents a calender day for purposes of sampling.
(f) Maximum monthly average means the highest allowable average of
daily discharges of wastewater pollutants over a calendar month, and is
calculated as the sum of all daily values measured during a calendar
month divided by the number of daily values measured during that month.
(g) mg/L means milligrams per liter or parts per million (ppm)
(h) Minimum level means the level at which an analytical system
gives recognizable signals and an acceptable calibration point.
(i) 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

[[Page 12271]]

increase in the concentrations of nitrites and nitrates.
(j) Non-detect (ND) means a concentration value below the minimum
level that can be reliably measured by the analytical method.
(k) 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.
(l) POTW means publicly owned treatment works (40 CFR 403.3).
(m) 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.
(n) Non-conventional pollutants means parameters that are neither
conventional pollutants (40 CFR 401.16), nor ``toxic'' pollutants (40
CFR 401.15).
(o) 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 of 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.
(p) Xylenes means a combination of the three isomers: o-xylene, m-
xylene, and p-xylene.

3. Section 439.2 is revised to read as follows:

Sec. 439.2 General monitoring requirements.

(a) Permit compliance monitoring is 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 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
a recommendation of any surrogate must be submitted with permit
applications for approval by the permitting authority, reconfirmed by
an annual chemical analysis of wastewater from each monitoring
location, and measurement of a non-detect value for each regulated
pollutant or its surrogate. Permits must 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.
(b) Unless noted otherwise, self-monitoring will be conducted at
the point where the final effluent is discharged.

4. Section 439.4 is revised to read as follows:

Sec. 439.4 General limitation or standard for pH.

The pH must remain within the range 6.0 to 9.0 in any discharge
subject to BPT, BCT or NSPS limitations or standards in this part.

5. Revise the heading of subpart A to read as follows:

Subpart A--Fermentation Products

6. Section 439.11 is revised to read as follows:

Sec. 439.11 Special definitions.

For the purpose of this subpart:
(a) 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) Product means pharmaceutical products derived from fermentation
processes.

7. Section 439.12 is amended by revising paragraphs (a)
introductory text, and (b) through (e) to read as follows:

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

* * * * *
(a) The maximum monthly average limitation for BOD5,
expressed as mass loading (lbs., kg) 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.
* * * * *
(b) The maximum monthly average limitation for TSS, expressed as
mass loading (lbs., kg) 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
limitations for COD are as follows:

Effluent Limitations (BPT)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
COD............................................... 1675 856
------------------------------------------------------------------------
\1\mg/L (ppm).

(d) If the maximum monthly average COD concentration in paragraph
(c) of this section is higher than a concentration value 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 monthly average limitation for COD
corresponding to the lower concentration value must be applied.
(e) The effluent limitations for cyanide are as follows:

Effluent Limitations (BPT)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
Cyanide (T)....................................... 33.5 9.4
------------------------------------------------------------------------
\1\mg/L (ppm).

* * * * *
8. Section 439.14 is revised to read as follows:

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

(a) Except as provided in 40 CFR 125.30 through 125.32, any
existing point source subject to this subpart must achieve the
following effluent limitations representing the application of BAT:

[[Page 12272]]

Effluent Limitations (BAT)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
Ammonia (as N).................................. 84.1 29.4
Acetone......................................... 0.5 0.2
4-methyl-2-pentanone............................ 0.5 0.2
Isobutyraldehyde................................ 1.2 0.5
n-Amyl acetate.................................. 1.3 0.5
n-Butyl acetate................................. 1.3 0.5
Ethyl acetate................................... 1.3 0.5
Isopropyl acetate............................... 1.3 0.5
Methyl formate.................................. 1.3 0.5
Amyl alcohol.................................... 10.0 4.1
Ethanol......................................... 10.0 4.1
Isopropanol..................................... 3.9 1.6
Methanol........................................ 10.0 4.1
Methyl Cellosolve............................... 100.0 40.6
Dimethyl sulfoxide.............................. 91.5 37.5
Triethyl amine.................................. 250.0 102.0
Phenol.......................................... 0.05 0.02
Benzene......................................... 0.05 0.02
Toluene......................................... 0.06 0.02
Xylenes......................................... 0.03 0.01
n-Hexane........................................ 0.03 0.02
n-Heptane....................................... 0.05 0.02
Methylene chloride.............................. 0.9 0.3
Chloroform...................................... 0.02 0.13
1,2-dichloroethane.............................. 0.4 0.1
Chlorobenzene................................... 0.15 0.06
o-Dichlorobenzene............................... 0.15 0.06
Tetrahydrofuran................................. 8.4 2.6
Isopropyl ether................................. 8.4 2.6
Diethyl amine................................... 250.0 102.0
Acetonitrile.................................... 25.0 10.2
------------------------------------------------------------------------
\1\ mg/L (ppm).

(b) The limitations for COD are the same as specified in Sec.
439.12(c) and (d).
(c) The limitations for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).

9. Section 439.15 is revised to read as follows:

Sec. 439.15 New source performance standards (NSPS).

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

Performance Standards (NSPS)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
BOD5............................................ 267 111
TSS............................................. 472 166
COD............................................. 1675 856
Ammonia (as N).................................. 84.1 29.4
Acetone......................................... 0.5 0.2
4-methyl-2-pentanone............................ 0.5 0.2
Isobutyraldehyde................................ 1.2 0.5
n-Amyl acetate.................................. 1.3 0.5
n-Butyl acetate................................. 1.3 0.5
Ethyl acetate................................... 1.3 0.5
Isopropyl acetate............................... 1.3 0.5
Methyl formate.................................. 1.3 0.5
Amyl alcohol.................................... 10.0 4.1
Ethanol......................................... 10.0 4.1
Isopropanol..................................... 3.9 1.6
Methanol........................................ 10.0 4.1
Methyl Cellosolve............................... 100.0 40.6
Dimethyl sulfoxide.............................. 91.5 37.5
Triethyl amine.................................. 250.0 102.0
Phenol.......................................... 0.05 0.02
Benzene......................................... 0.05 0.02
Toluene......................................... 0.06 0.02
Xylenes......................................... 0.03 0.01
n-Hexane........................................ 0.03 0.02
n-Heptane....................................... 0.05 0.02
Methylene chloride.............................. 0.9 0.3
Chloroform...................................... 0.02 0.13
1,2-dichloroethane.............................. 0.4 0.1
Chlorobenzene................................... 0.15 0.06
o-Dichlorobenzene............................... 0.15 0.06
Tetrahydrofuran................................. 8.4 2.6
Isopropyl ether................................. 8.4 2.6
Diethyl amine................................... 250.0 102.0
Acetonitrile.................................... 25.0 10.2
------------------------------------------------------------------------
\1\ mg/L (ppm)

(b) The limitations for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).
(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 for this
section in the 1988 edition of 40 CFR part 439, 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. Sec.
439.13 and 439.14.

10. Section 439.16 is revised to read as follows:

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

(a) Except as provided in 40 CFR 403.7 and 403.13, any existing
source subject to this subpart must continue achieving the standards
for cyanide specified in paragraph (c) of this section and must achieve
the following standards by September 21, 2001:

Pretreatment Standards (PSES)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
Ammonia (as N) \2\............................... 84.1 29.4
Acetone.......................................... 20.7 8.2
4-methyl-2-pentanone............................. 20.7 8.2
Isobutyraldehyde................................. 20.7 8.2
n-Amyl acetate................................... 20.7 8.2
n-Butyl acetate.................................. 20.7 8.2
Ethyl acetate.................................... 20.7 8.2
Isopropyl acetate................................ 20.7 8.2
Methyl formate................................... 20.7 8.2
Isopropyl ether.................................. 20.7 8.2
Tetrahydrofuran.................................. 9.2 3.4
Benzene.......................................... 3.0 0.7
Toluene.......................................... 0.3 0.2
Xylenes.......................................... 3.0 0.7
n-Heptane........................................ 3.0 0.7
n-Hexane......................................... 3.0 0.7
Methylene chloride............................... 3.0 0.7
Chloroform....................................... 0.1 0.03
1,2-dichloroethane............................... 20.7 8.2
Chlorobenzene.................................... 3.0 0.7
o-Dichlorobenzene................................ 20.7 8.2
Diethyl amine.................................... 255.0 100.0
Triethyl amine................................... 255.0 100.0
------------------------------------------------------------------------
\1\ mg/L (ppm)
\2\ Not applicable to sources that discharge to a POTW with
nitrification capability.

(b) Sources that discharge to a POTW with nitrification capability
(defined at Sec. 439.1(i)) are not required to achieve the
pretreatment standard for ammonia (as N).
(c) The limitations for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).

11. Section 439.17 is revised to read as follows:

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

(a) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharge on November 20, 1998, or
thereafter must achieve the same standards as specified in Sec.
439.16.
(b) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharging after November 21, 1988, and
prior to November 20, 1998, must continue to achieve the pretreatment
standards specified for this section in the 1988 edition of 40 CFR part
439 during a ten-year period beginning on the date the source commenced
discharge, or during the period of depreciation or amortization of the
facility, whichever comes first, after which the source must achieve
the same standards as specified in Sec. 439.16.

12. Revise the heading of subpart B to read as follows:

Subpart B--Extraction Products

13. Section 439.21 is revised to read as follows:

Sec. 439.21 Special definitions.

For the purpose of this subpart:
(a) Extraction means process operations that derive
pharmaceutically active ingredients from natural sources

[[Page 12273]]

such as plant roots and leaves, animal glands, and parasitic fungi by
chemical and physical extraction.
(b) 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.

14. Section 439.22 is amended by revising paragraphs (a)
introductory text and (b) through (d) to read as follows:

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

* * * * *
(a) The limitation for BOD5 is the same as specified in
Sec. 439.12(a). No facility shall be required to attain a monthly
average limitation for BOD5 that is less than the equivalent
of 45 mg/L.
* * * * *
(b) The limitation for TSS is the same as specified in Sec.
439.12(b).
(c) Except for the provisions in paragraph (d) of this section, the
limitations for COD are as follows:

Effluent Limitations (BPT)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
COD............................................... 228 86
------------------------------------------------------------------------
\1\ mg/L (ppm)

(d) If the maximum monthly average COD concentration in paragraph
(c) of this section is higher than a concentration value 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 a monthly average limitation for COD
corresponding to the lower concentration value must be applied.

15. Section 439.25 is revised to read as follows:

Sec. 439.25 New source performance standards (NSPS).

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

(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 for this
section in the 1988 edition of 40 CFR part 439, 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. Sec.
439.23 and 439.24.
16. Section 439.26 is revised 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 standards by
September 21, 2001:

17. Section 439.27 is revised to read as follows:

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

(a) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharge on November 20, 1998, or
thereafter must achieve the same standards as specified in Sec.
439.26.
(b) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharging after November 21, 1988, and
prior to November 20, 1998, must continue to achieve the pretreatment
standards specified for this section in the 1988 edition of 40 CFR part
439 during a ten-year period beginning on the date the source commenced
discharge, or during the period of depreciation or amortization of the
facility, whichever comes first, after which the source must achieve
the same standards as specified in Sec. 439.26.

18. Revise the heading of Subpart C to read as follows:

Subpart C--Chemical Synthesis Products

19. Section 439.31 is revised, including the section heading, to
read as follows:

Sec. 439.31 Special definitions.

For the purpose of this subpart:
(a) Chemical synthesis means using one or a series of chemical
reactions in the manufacturing process of a specified product.
(b) Product means any pharmaceutical product manufactured by
chemical synthesis.

20. Section 439.32 is amended by revising paragraphs (a) through
(d) and removing paragraphs (e) through (g) to read as follows:

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

* * * * *
(a)The limitation for BOD5 is the same as specified in
Sec. 439.12(a).
(b) The limitation for TSS is the same as specified in Sec.
439.12(b).
(c) The limitations for COD are the same as specified in Sec.
439.12(c) and (d).
(d) The limitations for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).
* * * * *

21. Section 439.34 is revised 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:
(a) The limitations are the same as specified in Sec. 439.14(a).
(b) The limitations for COD are the same as specified in Sec.
439.12(c) and (d).
(c) The limitations for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).

22. Section 439.35 is revised to read as follows:

Sec. 439.35 New source performance standards (NSPS).

(a) Any new source subject to this subpart must achieve the same
standards as specified in Sec. 439.15(a).
(b) The limitations for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).

[[Page 12274]]

(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 for this
section in the 1988 edition of 40 CFR part 439, 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. 439.33
and Sec. 439.34.
23. Section 439.36 is revised 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 achieving the standards for
cyanide specified in paragraph (b) of this section and must achieve the
standards specified in Sec. 439.16(a) by September 21, 2001.
(a) Sources that discharge to a POTW with nitrification capability
(defined at Sec. 439.1(i)) are not required to achieve the standards
for ammonia (as N).
(b) The standards for cyanide are the same as specified in Sec.
439.12(e), (f) and (g).

24. Section 439.37 is revised to read as follows:

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

(a) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharge on November 20, 1998, or
thereafter must achieve the same standards as specified in Sec.
439.36.
(b) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharging after November 21, 1988, and
prior to November 20, 1998, must continue to achieve the pretreatment
standards specified for this section in the 1988 edition of 40 CFR part
439 during a ten-year period beginning on the date the source commenced
discharge, or during the period of depreciation or amortization of the
facility, whichever comes first, after which the source must achieve
the same standards as specified in Sec. 439.36.

25. Revise the heading of Subpart D to read as follows:

Subpart D--Mixing/Compounding and Formulation

26. Section 439.41 is revised to read as follows:

Sec. 439.41 Special definitions.

For the purpose of this subpart:
(a) Mixing, compounding, and formulating operations means processes
that put pharmaceutical products in dosage forms.
(b) 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.

27. Section 439.42 is amended by revising paragraphs (a) through
(c) and removing paragraph (d) to read as follows:

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

* * * * *
(a) The limitation for BOD5 is the same as specified in
Sec. 439.12(a). No facility shall be required to attain a monthly
average limitation for BOD5 that is less than the equivalent
of 45 mg/L.
(b) The limitation for TSS is the same as specified in Sec.
439.12(b).
(c) The limitations for COD are the same as specified in Sec.
439.22(c) and (d).
* * * * *

28. Section 439.44 is revised to read as follows:

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

29. Section 439.45 is revised to read as follows:

Sec. 439.45 New source performance standards (NSPS).

(a) Any new source subject to this subpart must achieve the same
standards as specified in Sec. 439.25(a).
(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 for this
section in the 1988 edition of 40 CFR part 439, 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 Sec. 439.44.

30. Section 439.46 is revised 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 standards by
September 21, 2001:

Pretreatment Standards (PSES)
------------------------------------------------------------------------
Maximum
Regulated parameter Maximum monthly
daily\1\ average\1\
------------------------------------------------------------------------
Acetone.......................................... 20.7 8.2
n-Amyl acetate................................... 20.7 8.2
Ethyl acetate.................................... 20.7 8.2
Isopropyl acetate................................ 20.7 8.2
Methylene chloride............................... 3.0 0.7
------------------------------------------------------------------------
\1\ mg/L (ppm).

31. Section 439.47 is revised 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 that commenced discharge on November 20, 1998, or
thereafter must achieve the same standards as specified in Sec.
439.46.
(b) Except as provided in 40 CFR 403.7, any new source subject to
this subpart that commenced discharging after November 21, 1988, and
prior to November 20, 1998, must continue to achieve the pretreatment
standards specified for this section in the 1988 edition of 40 CFR part
439 during a ten-year period beginning on the date the source commenced
discharge, or during the period of depreciation or amortization of the
facility, whichever comes first, after which the source must achieve
the same standards as specified in Sec. 439.46.

32. Revise the heading of subpart E to read as follows:

Subpart E--Research

33. Section 439.51 is revised to read as follows:

Sec. 439.51 Special definitions.

For the purpose of this subpart, product means products or services
resulting from research and product development activities.

34. Section 439.52 is amended by revising paragraphs (a) through
(d) to read as follows:

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

* * * * *
(a) The limitation for BOD5 is the same as specified in
Sec. 439.12(a). No

[[Page 12275]]

facility shall be required to attain a monthly average limitation for
BOD5 that is less than the equivalent of 45 mg/L.
(b) The limitation for TSS is the same as specified in Sec.
439.12(b).
(c) The maximum monthly average limitation for COD, expressed as
mass loading (lbs, kg) 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.
(d) 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
regulation 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.
* * * * *

35. Table 2 of Appendix A is revised to read as follows:

Appendix A to Part 439--Tables

* * * * *

Table 2.--Surrogate Parameters for Indirect Dischargers (Utilizing Steam
Stripping Treatment Technology)
------------------------------------------------------------------------
Regulated parameters Treatability class
------------------------------------------------------------------------
Benzene ........................................
Toluene \1\ ........................................
Xylenes ........................................
n-Heptane High strippability.
Chloroform \1\ ........................................
Methylene chloride \1\ ........................................
Chlorobenzene ........................................
-------------------------------
Ammonia (aqueous) ........................................
Diethyl amine ........................................
Triethyl amine ........................................
Acetone \1\ ........................................
4-methyl-2-pentanone ........................................
n-Amyl acetate ........................................
n-Butyl acetate ........................................
Ethyl acetate Medium strippability.
Isopropyl acetate ........................................
Methyl formate ........................................
Isopropyl ether ........................................
Tetrahydrofuran \1\ ........................................
1,2-dichloroethane ........................................
o-Dichlorobenzene ........................................
------------------------------------------------------------------------
\1\ These parameters may be used as a surrogate to represent other
parameters in the same treatability class.

[FR Doc. 03-5716 Filed 3-12-03; 8:45 am]

BILLING CODE 6560-50-P