[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which provisions are being withdrawn.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Register is withdrawn, all comments pertaining to those provisions will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
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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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