[Federal Register Volume 68, Number 49 (Thursday, March 13, 2003)]
[Proposed Rules]
[Pages 12276-12278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5715]



  Federal Register / Vol. 68, No. 49 / Thursday, March 13, 2003 / 
Proposed Rules  

[[Page 12276]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439

[FRL-7462-7]


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

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing 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, 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: Comments must be received by May 12, 2003. Comments postmarked 
after this date may not be considered.

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 
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, U.S. EPA Office of 
Water by phone at (202) 566-1027 or by e-mail at [email protected].

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.

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               Category                         Examples of regulated entities               SIC (NAICS) code
----------------------------------------------------------------------------------------------------------------
Industry.............................  Facilities that generate process wastewater from  2833, R834, 2836 (2834-
                                        the manufacture of pharmaceutical products and/   04, 2834-98).
                                        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.  439.10, 
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 
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.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as confidential business information (CBI) and 
other information whose disclosure is restricted by statute, which is 
not included in the official public docket, will not be available for 
public viewing in EPA's electronic public docket. EPA's policy is that 
copyrighted material will not be placed in EPA's electronic public 
docket but will be available only in printed, paper form in the 
official public docket. To the extent feasible, publicly available 
docket materials will be made available in EPA's electronic public 
docket. When a document is selected from the index list in EPA Dockets, 
the system will identify whether the document is available for viewing 
in EPA's electronic public docket. Although not all docket materials 
may be available electronically, you may still access any of the 
publicly available docket materials through the docket facility 
identified in section I.B.1. EPA intends to work towards providing 
electronic access to all of the publicly available docket materials 
through EPA's electronic public docket.

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    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the Docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.
    For additional information about EPA's electronic public docket 
visit EPA Dockets online or see 67 FR 38102, May 31, 2002.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. Please submit with your comments any references cited 
in your comments. To ensure proper receipt by EPA, identify the 
appropriate docket identification number in the subject line on the 
first page of your comment. Please ensure that your comments are 
submitted within the specified comment period. Comments received after 
the close of the comment period will be marked ``late.'' EPA is not 
required to consider these late comments; however, late comments may be 
considered if time permits. If you wish to submit CBI or information 
that is otherwise protected by statute, please follow the instructions 
in section I.D. Do not use EPA Dockets or e-mail to submit CBI or 
information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed below, EPA recommends that you include your name, mailing 
address, and an e-mail address or other contact information in the body 
of your comment. Also include this contact information on the outside 
of any disk or CD-ROM you submit, and in any cover letter accompanying 
the disk or CD-ROM. This ensures that you can be identified as the 
submitter of the comment and allows EPA to contact you in case EPA 
cannot read your comment due to technical difficulties or needs further 
information on the substance of your comment. EPA's policy is that EPA 
will not edit your comment, and any identifying or contact information 
provided in the body of a comment will be included as part of the 
comment that is placed in the official public docket, and made 
available in EPA's electronic public docket. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. To 
access EPA's electronic public docket from the EPA Internet Home Page, 
select ``Information Sources,'' ``Dockets,'' and ``EPA Dockets.'' Once 
in the system, select ``search,'' and then key in Docket ID No. OW-
2003-0007. The system is an ``anonymous access'' system, which means 
EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by electronic mail (e-mail) to [email protected], Attention Docket ID No. OW-2003-0007. In contrast to 
EPA's electronic public docket, EPA's e-mail system is not an 
``anonymous access'' system. If you send an e-mail comment directly to 
the Docket without going through EPA's electronic public docket, EPA's 
e-mail system automatically captures your e-mail address. E-mail 
addresses that are automatically captured by EPA's e-mail system are 
included as part of the comment that is placed in the official public 
docket, and made available in EPA's electronic public docket.
    iii. Disk or CD-ROM. You may submit comments on a disk or CD-ROM 
that you mail to the mailing address identified in section 1.C.2. These 
electronic submissions will be accepted in Word Perfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By Mail. Send an original and three (3) copies of your comments 
to the Water Docket, Environmental Protection Agency, Mail Code 4101T, 
1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID 
No. OW-2003-0007.
    3. By Hand Delivery or Courier. Deliver your comments to: Water 
Docket, EPA Docket Center, EPA West, Room B102, 1301 Constitution Ave., 
NW., Washington, DC, Attention Docket ID No. OW-2003-0007. Such 
deliveries are only accepted during the Docket's normal hours of 
operation as identified in section I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. 
Send information identified as CBI by mail only to the following 
address: Office of Science and Technology, Mail Code 4303T, U.S. 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460, Attention: Frank Hund, Docket ID No. OW-2003-
0007.
    You may claim information that you submit to EPA as CBI by marking 
any part or all of that information as CBI (if you submit CBI on disk 
or CD-ROM, mark the outside of the disk or CD-ROM as CBI and then 
identify electronically within the disk or CD-ROM the specific 
information that is CBI). Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD-ROM, mark the outside 
of the disk or CD-ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person identified in the FOR FURTHER INFORMATION CONTACT section.

II. Discussion of Direct Final Rulemaking

    In the ``Rules and Regulations'' section of today's Federal 
Register, EPA is promulgating these revisions as a direct final rule 
without prior proposal because we view them as noncontroversial 
revisions and anticipate no adverse comment. We have explained our 
reasons for these revisions in the preamble to the direct final rule. 
If we receive no adverse comment, we will not take further

[[Page 12278]]

action on this proposed rule. If we receive adverse comment, we will 
withdraw the direct final rule or portions thereof, and the direct 
final rule or portions thereof will not take effect. We will address 
all public comments in a subsequent final rule based on this action. We 
will not institute a second comment period on this action. Any parties 
interested in commenting must do so at this time.

III. Related Acts of Congress, Executive Orders, and Agency Initiatives

    For the various statutes and Executive Orders that require findings 
for rulemaking, EPA incorporates the findings from the direct final 
rule into this companion proposal for the purpose of providing public 
notice and opportunity for comment.

List of Subjects in 40 CFR Part 439

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

    Dated: February 28, 2003.
Christine Todd Whitman,
Administrator.
[FR Doc. 03-5715 Filed 3-12-03; 8:45 am]
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