[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Proposed Rules]
[Pages 44483-44484]
[FR Doc No: 2013-17750]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 118

[Docket No. FDA-2000-N-0190 (formerly Docket No. 2000N-0504)]

Draft Guidance for Industry: Questions and Answers Regarding the
Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation (Layers With Outdoor Access);
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Questions and Answers Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation (Layers with Outdoor Access)'' (the draft guidance). The
document provides guidance to egg producers on certain provisions
contained in FDA's final rule entitled, ``Prevention of Salmonella
Enteritidis in Shell Eggs During Production, Storage, and
Transportation'' concerning the management of production systems that
provide laying hens with access to the outdoors. Laying hens are
provided outdoor access in some production systems, including certified
organic production systems governed by the U.S. Department of
Agriculture's National Organic Program regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on the
draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by September 23, 2013.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Division of Plant and Dairy Food Safety/Office of Food Safety, Center
for Food Safety and Applied Nutrition (HFS-315), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to<PHONE_NUMBER>. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a
final rule requiring shell egg producers to implement measures to
prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm
and from further growth during storage and transportation, and
requiring these producers to maintain records concerning their
compliance with the final rule and to register with FDA. The final rule
became effective September 8, 2009, with a compliance date of July 9,
2010, for producers with 50,000 or more laying hens. For producers with
fewer than 50,000, but at least 3,000 laying hens, the compliance date
was July 9, 2012. The compliance date for persons who must comply with
only the refrigeration requirements was July 9, 2010. The final rule is
codified at 21 CFR part 118.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on how to interpret the
requirements in the final rule with regard to production systems that
provide laying hens with access to the outdoors, including questions
and answers on coverage; definitions; SE prevention measures; and
environmental sampling for SE. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternate approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. Sec.  118.5, 118.6, 118.10, and
118.11 have been approved under OMB control number 0910-0660.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or
http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

    Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17750 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Rules and Regulations]
[Pages 40922-40923]
[FR Doc No: 2015-16924]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 70

[EPA-R03-OAR-2015-0119; FRL-9930-30-Region 3]

Clean Air Act Title V Operating Permit Program Revision;
Pennsylvania

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a Title
V Operating Permit Program revision submitted by the Commonwealth of
Pennsylvania. The revision amends the Title V fee program that funds
the Pennsylvania Title V Operating Permit Program. EPA is approving
these revisions to increase Pennsylvania's annual emission fees to $85
per ton of emissions for emissions from Title V sources of up to 4,000
tons of each regulated pollutant in accordance with the requirements of
the Clean Air Act (CAA).

DATES: This final rule is effective on August 13, 2015.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2015-0119. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (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 through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Gerallyn Duke<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 18, 2015 (80 FR 14037), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. In the NPR, EPA
proposed approval of the Pennsylvania Title V Operating Program
revision to increase the annual Title V fees paid by the owners or
operators of all Title V facilities throughout Pennsylvania, including
Allegheny and Philadelphia Counties, from $57.50 per ton of regulated
air pollutant to $85 per ton. The formal Title V Program revision was
submitted by Pennsylvania on February 11, 2014.
    Under 40 CFR 70.9(a) and (b), an approved state Title V operating
permits program must require that the owners or operators of part 70
sources pay annual fees, or the equivalent over some other period, that
are sufficient to cover the permit program costs and ensure that any
fee required under 40 CFR 70.9 is used solely for permit program costs.
Under Pennsylvania's Title V permit emission fee rules at 25 PA Code
127.705, the annual emission fee for emissions occurring in calendar
year 2012 was $57.50 per ton of regulated pollutant for emissions of up
to 4,000 tons of each regulated pollutant. The fee structure has not
been revised since 1994. As discussed further in our proposed approval
of Pennsylvania's Title V fee revision on March 18, 2015, Pennsylvania
has determined that Title V annual emission fee revenues collected are
no longer sufficient to cover Title V program costs.

II. Summary of Title V Operating Permit Program Revision

    In the February 11, 2014 program revision, Pennsylvania included
revised 25 PA Code 127.705 which Pennsylvania has amended to increase
Pennsylvania's annual emission fees. Fees are increased to $85 per ton
of emissions for emissions from Title V sources of up to 4,000 tons of
each regulated pollutant. The provisions for increasing the annual
emissions fees in response to increases in the Consumer Price Index at
25 PA Code 127.705(d) remain unchanged. The revised fees are designed
to cover all reasonable costs required to develop and administer the
Title V program as required by 40 CFR 70.9(a) and (b).

III. Final Action

    EPA is approving the Pennsylvania Title V Operating Program
revision submitted on February 11, 2014 to increase the annual Title V
fees paid by the owners or operators of all Title V facilities
throughout Pennsylvania, including Allegheny and Philadelphia Counties,
from $57.50 per ton of regulated air pollutant to $85 per ton. The
revision meets requirements in 40 CFR 70.9.

IV. Statutory and Executive Order Reviews

A. General Requirements

    This action merely approves state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. For that reason, this action:
     is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule related to Pennsylvania Title V fees does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), because the program is not approved to
apply in Indian country located in the state, and EPA notes that it
will not impose substantial direct costs on tribal governments or
preempt tribal law.

B. Submission to Congress and the Comptroller General

    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 action 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 publication of the rule in the 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).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 14, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action related to Pennsylvania Title V fees may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 70

    Administrative practice and procedure, Environmental protection,
Air pollution control, Carbon monoxide, Incorporation by reference,
Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: June 26, 2015.
William C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 70 is amended as follows:

PART 70--STATE OPERATING PERMIT PROGRAMS

0
1. The authority citation for part 70 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

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2. Appendix A to Part 70 is amended by adding paragraph (d) to the
entry for Pennsylvania to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permit Programs

* * * * *

Pennsylvania

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    (d) The Pennsylvania Department of Environmental Protection
submitted a program revision on February 11, 2014; approval
effective on July 14, 2015.
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[FR Doc. 2015-16924 Filed 7-13-15; 8:45 am]
 BILLING CODE 6560-50-P