[Federal Register Volume 70, Number 92 (Friday, May 13, 2005)]
[Proposed Rules]
[Pages 25671-25673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9476]



  Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Proposed 
Rules  

[[Page 25671]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[OAR-2004-0023; FRL-7911-4]
RIN 2060-AM52


National Emission Standards for Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; amendments.

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SUMMARY: On September 21, 1998, EPA promulgated national emission 
standards for pharmaceuticals production (40 CFR part 63, subpart GGG). 
This action proposes to amend the national emission standards for 
pharmaceuticals production to include provisions for planned routine 
maintenance of wastewater tanks and alternative monitoring for 
condensers and scrubbers. The proposed amendments also reference 
general standards for containers.
    In the Rules and Regulations section of this Federal Register, we 
are taking direct final action on the proposed amendments because we 
view the amendments as noncontroversial and anticipate no adverse 
comments. We have explained our reasons for the amendments in the 
preamble to the direct final rule. If we receive no adverse comments, 
we will take no further action on the proposed amendments. If we 
receive adverse comments, we will withdraw those provisions on which we 
received adverse comments. We will publish a timely withdrawal in the 
Federal Register indicating which provisions will become effective and 
which provisions are being withdrawn. If part or all of the direct 
final rule in the Rules and Regulations section of today's Federal 
Register is withdrawn, all comments pertaining to those provisions will 
be addressed in a subsequent final rule based on the proposed 
amendments. We will not institute a second comment period on the 
subsequent final action. Any parties interested in commenting must do 
so at this time.

DATES: Comments. Written comments must be received on or before June 
13, 2005, unless a hearing is requested by May 23, 2005. If a hearing 
is requested, written comments must be received on or before June 27, 
2005.
    Public Hearing. If anyone contacts the EPA requesting to speak at a 
public hearing, a public hearing will be held on May 27, 2005.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2004-
0023, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Web site: http://www.epa.gov/edocket. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     E-mail: [email protected].
     Fax: (202) 566-1741.
     Mail: EPA Docket Center, Environmental Protection Agency, 
Mailcode: 6102T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 
Please include a duplicate copy, if possible.
     Hand Delivery: Air and Radiation Docket, Environmental 
Protection Agency, 1301 Constitution Avenue, NW, Room B-108, 
Washington, DC 20460. Such deliveries are only accepted during the 
Docket's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information.
    We request that a separate copy also be sent to the contact person 
listed below (see FOR FURTHER INFORMATION CONTACT).
    Instructions: Direct your comments to Docket ID No. OAR-2004-0023. 
EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov Web sites are 
``anonymous access'' systems, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. 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. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102).
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Air and Radiation Docket, EPA/DC, EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC. The 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 Air Docket is (202) 566-
1742.
    Public Hearing. If a public hearing is held, it will be held at 10 
a.m. at the EPA's Environmental Research Center Auditorium, Research 
Triangle Park, North Carolina or at an alternate site nearby.

FOR FURTHER INFORMATION CONTACT: Mr. Randy McDonald, Organic Chemicals 
Group, Emission Standards Division (C504-04), Office of Air Planning 
and Standards, U.S. EPA, Research Triangle Park, North Carolina 27711, 
telephone number (919) 541-5402, electronic mail address 
[email protected].

SUPPLEMENTARY INFORMATION: Regulated Entities. The regulated category 
and entities affected by this action include:

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                                                                                        Examples of regulated
              Category                     NAICS codes              SIC codes                  entities
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Industry...........................  325411 and 325412.....  2833 and 2834.........   Producers of
                                                                                      finished dosage forms of
                                                                                      drugs (e.g., tablets,
                                                                                      capsules, and solutions),
                                                                                      active ingredients, or
                                                                                      precursors.

[[Page 25672]]

 
                                     Typically 325199......  Typically 2869........   Producers of
                                                                                      material whose primary use
                                                                                      is as an active ingredient
                                                                                      of precursor.
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    This table is not intended to be exhaustive, but rather provides a 
guide for readers likely to be interested in the revisions to the 
regulation affected by this action. To determine whether your facility, 
company, business, organization, etc., is regulated by this action, you 
should carefully examine all of the applicability criteria in 40 CFR 
63.1250. If you have questions regarding the applicability of the 
amendments to a particular entity, consult the person listed in the 
preceding FOR FURTHER INFORMATION CONTACT section.
    What should I consider as I prepare my comments for EPA? Submitting 
CBI. Do not submit this information to EPA through EDOCKET, 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, 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 claimed as CBI). In addition to one 
complete version of the comment that includes 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. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.
    Public Hearing. Persons interested in presenting oral testimony or 
inquiring as to whether a hearing is to be held should contact Mr. 
Randy McDonald, Organic Chemicals Group, Emission Standards Division 
(Mail Code C504-04), U.S. EPA, Research Triangle Park, North Carolina 
27711, telephone number (919) 541-5402, electronic mail address 
[email protected]., at least 2 days in advance of the potential 
date of the public hearing. Persons interested in attending the public 
hearing must also call Mr. Randy McDonald to verify the time, date, and 
location of the hearing. The public hearing will provide interested 
parties the opportunity to present data, views, or arguments concerning 
these proposed emission standards.
    Worldwide Web (WWW). In addition to being available in the docket, 
an electronic copy of today's proposal will also be available through 
the WWW. Following the Administrator's signature, a copy of this action 
will be posted on EPA's Technology Transfer Network (TTN) policy and 
guidance page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg. The TTN at EPA's Web site provides information 
and technology exchange in various areas of air pollution control. If 
more information regarding the TTN is needed, call the TTN HELP line at 
(919) 541-5384.
    Direct Final Rule. A direct final rule identical to the proposal is 
published in the Rules and Regulations section of today's Federal 
Register. If we receive any adverse comment pertaining to the 
amendments in the proposal, we will publish a timely notice in the 
Federal Register informing the public that the amendments are being 
withdrawn due to adverse comment. We will address all public comments 
concerning the withdrawn amendments in a subsequent final rule. If no 
relevant adverse comments are received, no further action will be taken 
on the proposal, and the direct final rule will become effective as 
provided in that action.
    The regulatory text for the proposal is identical to that for the 
direct final rule published in the Rules and Regulations section of 
today's Federal Register. For further supplementary information, the 
detailed rationale for the proposal and the regulatory revisions, see 
the direct final rule published in a separate part of this Federal 
Register.

Statutory and Executive Order Reviews

    For a complete discussion of all of the administrative requirements 
applicable to this action, see the direct final rule in the Rules and 
Regulations section of today's Federal Register.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) 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 impacts of today's proposed 
amendments on small entities, a small entity is defined as: (1) A small 
business having up to 500 employees; (2) a small governmental 
jurisdiction that is a government of a city, county, town, school 
district or special district with a population of 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 proposed 
amendments on small entities, EPA has certified that this action will 
not have a significant economic impact on a substantial number of small 
entities. In determining whether a proposed rule has a significant 
economic impact on a substantial number of small entities, the impact 
of concern is any significant adverse economic impact, since the 
primary purpose of the regulatory flexibility analysis is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the proposed rule on small entities' (5 U.S.C. 603 
and 604). Thus, any agency may certify that a rule will not have a 
significant economic impact on a substantial number of small entities 
if the rule relieves regulatory burden or otherwise has a positive 
economic effect on all of the small entities subject to the rule. The 
proposed amendments grant greater flexibility to small entities

[[Page 25673]]

subject to the final rule that may result in a more efficient use of 
resources for them and, therefore, impose no additional regulatory 
costs or requirements on owners or operators of affected sources. The 
EPA continues to be interested in the potential impacts of the proposed 
rule on small entities and welcomes comments on issues related to such 
impacts.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Hazardous substances, Intergovernmental 
relations, Reporting and recordkeeping requirements.

    Dated: May 6, 3005.
Stephen L. Johnson,
Administrator.
[FR Doc. 05-9476 Filed 5-12-05; 8:45 am]
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