[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Rules and Regulations]
[Pages 75692-75693]
[FR Doc No: 2016-26315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2011-N-0920]

What You Need To Know About the Food and Drug Administration
Regulation: Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Human Food; Small Entity Compliance
Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled ``What
You Need To Know About the FDA Regulation: Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human
Food''--Small Entity Compliance Guide. The small entity compliance
guide (SECG) is intended to help small entities comply with the final
rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Human Food.''

DATES: Submit either electronic or written comments on FDA guidances at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0920 for ``What You Need To Know About the FDA Regulation:
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food (21 CFR part 117).'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover

sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the SECG to the Office
of Food Safety, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two
self-addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the SECG.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 17, 2015 (80 FR 55908), we
issued a final rule titled ``Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Human Food''
(the final rule) in which we modernized the longstanding current good
manufacturing practice requirements in 21 CFR part 110 and added the
requirements for facilities subject to registration to establish and
implement hazard analysis and risk-based preventive controls for human
food. The final rule, which is codified at part 117 (21 CFR part 117),
became effective November 16, 2015 (except for the amendment to part
110 in instruction 13, which is effective September 17, 2018, and
paragraph (2) of the definition of ``qualified auditor'' in Sec.
117.3, and Sec. Sec.  117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c),
117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and
117.475(c)(13)) but has compliance dates staggered over several years
after publication of the final rule.
    We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule will have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
explain the actions that a small entity must take to comply with the
rule.
    We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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 21 CFR part 117 have been approved under
OMB control number 0910-0751.

III. Electronic Access

    Persons with access to the Internet may obtain the SECG at either
http://www.fda.gov/FoodGuidances, 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: October 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26315 Filed 10-31-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Rules and Regulations]
[Pages 38400-38403]
[FR Doc No: 2015-16396]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0075; FRL-9929-73-Region 5]

Approval of Air Quality Implementation Plans; Sheboygan County,
Wisconsin 8-Hour Ozone Nonattainment Area; Reasonable Further Progress
Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving an
Early Progress Plan and motor vehicle emissions budgets (MVEBs) for
volatile organic compounds (VOCs) and oxides of nitrogen
(NOX) for Sheboygan County, Wisconsin. Wisconsin submitted
an Early Progress Plan for Sheboygan County on January 16, 2015. This
submittal was developed to establish MVEBs for the Sheboygan 8-hour
ozone nonattainment area. This approval of the Early Progress Plan for
the Sheboygan 8-hour ozone area is based on EPA's determination that
Wisconsin has demonstrated that the State Implementation Plan (SIP)
revision containing these MVEBs, when considered with the emissions
from all sources, shows some progress toward attainment from the 2011
base year through a 2015 target year.

DATES: This direct final rule will be effective September 4, 2015,
unless EPA receives adverse comments by August 5, 2015. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0075, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2015-0075. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, 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 www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, 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 email comment
directly to EPA without going through www.regulations.gov your email
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.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Michael Leslie, Environmental Engineer,
at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Michael Leslie, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this action?
II. What are the criteria for Early Progress Plans?
III. What is EPA's analysis of the request?
IV. What are the MVEBs for the Sheboygan County 8-hour ozone area?
V. What action is EPA taking?
VI. Statutory and Executive Order Reviews

I. What is the background for this action?

    EPA's final rule designating nonattainment areas and associated
classifications for the 2008 ozone National Ambient Air Quality
Standards (NAAQS) was published in the Federal Register on May 21, 2012
(77 FR 30088). Sheboygan County was designated as marginal
nonattainment. The Sheboygan County 8-hour ozone area had been
previously designated nonattainment for the 1-hour ozone standard and
had 1-hour MVEBs for NOX and VOC established in the
Wisconsin 1-hour maintenance plan SIP. The 1-hour MVEBs are the only
approved MVEBs for Sheboygan County and were based on EPA's MOBILE6.2
emissions model. Consequently, the transportation partners in the
Sheboygan area have to use the 1-hour MVEB test to demonstrate
transportation conformity for the 8-hour ozone standard until new MVEBs
are approved or found adequate, as required by the transportation
conformity rule at 40 CFR 93.109(c)(2)(i). Wisconsin submitted this
plan to establish new MVEBs developed with EPA's current MOVES2014
model.

II. What are the criteria for Early Progress Plans?

    EPA allows for the establishment of MVEBs for the 8-hour ozone
standard prior to a state submitting its first required 8-hour ozone
SIP that would include new MVEBs. Although voluntary, these ``early''
MVEBs must be established through a plan that meets all the
requirements of a SIP submittal. This plan is known as the ``Early
Progress Plan.'' Specifically and in reference to Early Progress Plans,
the preamble of the July 1, 2004, final transportation conformity rule
(see, 69 FR 40019) reads as follows:
    ``The first 8-hour ozone SIP could be a control strategy SIP
required by the Clean Air Act (e.g., rate-of-progress SIP or attainment
demonstration) or a maintenance plan. However, 8-hour ozone
nonattainment areas `are free to establish, through the SIP process, a
motor vehicle emissions budget or budgets that addresses the new NAAQS
in advance of a complete SIP attainment demonstration. That is, a state
could submit a motor vehicle emission budget that does not demonstrate
attainment but is consistent with projections and commitments to
control measures and achieves some progress toward attainment' (August
15, 1997, 62 FR 43799). A SIP submitted earlier than otherwise required
can demonstrate a significant level of emissions reductions from
current level of emissions, instead of a specific percentage required
by the Clean Air Act for moderate and above ozone areas.''
    The Early Progress Plan must demonstrate that the SIP revision
containing the MVEBs, when considered with emissions from all sources,
and when projected from the base year to a future year, shows some
progress toward attainment. EPA has previously indicated that a 5
percent to 10 percent reduction in emissions from all sources could
represent a significant level of emissions reductions from current
levels (69 FR 40019). This allowance is provided so that areas have an
opportunity to use the budget test to demonstrate conformity as opposed
to the interim conformity tests (i.e., 2002 baseline test and/or action
versus baseline test). The budget test with an adequate or approved SIP
budget is generally more protective of air quality and provides a more
relevant basis for conformity determinations than the interim emissions
test. (69 FR 40026).
    It should also be noted that the Early Progress Plan is not a
required plan and does not substitute for required submissions such as
an attainment demonstration or rate-of-progress plan, if such plans
become required for the Sheboygan 8-hour ozone area.

III. What is EPA's analysis of the request?

    On January 16, 2015, the State submitted to EPA an Early Progress
Plan for the sole purpose of establishing MVEBs for the Sheboygan 8-
hour ozone area. The submittal utilizes a base year of 2011, and a
projected year 2015 to establish NOX and VOC MVEBs. The
planning assumptions used to develop the MVEBs were discussed and
agreed to by the Sheboygan interagency consultation group, which
consists of the transportation and air quality partners in the
Sheboygan 8-hour ozone nonattainment area. Tables 1 and 2 below show
the differences by source categories between the 2011 base year and
2015 forecast year. The NOX and VOC emissions in tons per
day (tpd) within the Sheboygan nonattainment area are expected to
decrease significantly, 28.6 percent and 8.7 percent, respectively,
between 2011 and 2015. These emission trends demonstrate that progress
will be made towards attainment of the 2008 8-hour ozone NAAQS.

                 Table 1--Sheboygan County NOX Emissions
------------------------------------------------------------------------
                                                          2011     2015
                        Source                            NOX      NOX
                                                         (tpd)    (tpd)
------------------------------------------------------------------------
Point.................................................    10.22     6.15
Area..................................................     1.32     1.33
On-road Mobile........................................     5.41     4.44
                                                       -----------------
Non-Road Mobile.......................................     3.61     2.76
                                                       -----------------
    Total.............................................    20.56    14.68
                                                       -----------------
Total Percent Reduction...............................        28.6%
------------------------------------------------------------------------

                 Table 2--Sheboygan County VOC Emissions
------------------------------------------------------------------------
                                                           2011    2015
                       VOC Source                           VOC     VOC
                                                           (tpd)   (tpd)
------------------------------------------------------------------------
Point...................................................    2.63    2.63
Area....................................................    6.43    6.34
On-road Mobile..........................................    2.44    1.97
                                                         ---------------
Non-Road Mobile.........................................    3.03    2.76
                                                         ---------------
    Total...............................................   14.53   13.27
                                                         ---------------
Total Percent Reduction.................................       8.7%
------------------------------------------------------------------------

    EPA found these MVEBs adequate for transportation conformity
purposes in an earlier action (80 FR 17428). As of April 16, 2015, the
effective date of EPA's adequacy finding for these MVEBs, conformity
determinations in Sheboygan County must meet the budget test using
these 8-hour MVEBs, instead of the 1-hour ozone MVEBs. Please note that
this adequacy finding does not relate to the merits of the SIP
submittal, nor does it indicate whether the submittal meets the
requirements for approval. This EPA rulemaking action takes formal
action on the Early Progress Plan SIP revision.

IV. What are the MVEBs for the Sheboygan 8-hour ozone area?

    Through this rulemaking, EPA is approving the 2015 regional MVEBs
for NOX and VOC for the Sheboygan 8-hour ozone area. EPA has
determined that the MVEBs contained in the Early Progress Plan SIP
revision are consistent with emission reductions from all sources
within the nonattainment area and are showing progress toward
attainment.
    The 2015 MVEBs in tpd for VOCs and NOX for the Sheboygan
County, Wisconsin area are as follows:

------------------------------------------------------------------------
                                                           2015    2015
                          Area                             NOX     VOCs
                                                          (tpd)    (tpd)
------------------------------------------------------------------------
Sheboygan County.......................................    4.435   1.972
------------------------------------------------------------------------

V. What action is EPA taking?

    EPA is approving Sheboygan's Early Progress Plan, including the
2015 MVEBs for NOX and VOC. The Early Progress Plan
demonstrates progress towards attainment of the 2008 ozone NAAQS for
the Sheboygan nonattainment area. The NOX and VOC emissions
reductions from 2011 to 2015 for Sheboygan County nonattainment areas
were 28.6 percent and 8.7 percent, respectively. These emission
reductions were based on control measures that are permanent and
enforceable and will continue to improve air quality in the region,
thus demonstrating that the MVEBs are showing progress toward
attainment.
    EPA issues this direct final rulemaking in response to Wisconsin's
January 16, 2015 submittal of an Early Progress Plan. This revision is
a voluntary SIP revision for the sole purpose of establishing MVEBs for
the purpose of implementing transportation conformity in the Sheboygan
8-hour ozone area.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the State plan if relevant adverse
written comments are filed. This rule will be effective September 4,
2015 without further notice unless we receive relevant adverse written
comments by August 5, 2015. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective
September 4, 2015.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 Clean Air Act; 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 4, 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. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of this Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Oxides of nitrogen, Ozone,
Volatile organic compounds.

    Dated: June 19, 2015.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

0
2. Section 52.2585 is amended by adding paragraph (cc) to read as
follows:

Sec.  52.2585  Control strategy: Ozone.

* * * * *
    (cc) Approval--On January 16, 2015, the State of Wisconsin
submitted a revision to its State Implementation Plan for Sheboygan
County, Wisconsin. The submittal established new Motor Vehicle
Emissions Budgets (MVEB) for Volatile Organic Compounds (VOC) and
Oxides of Nitrogen (NOX) for the year 2015. The MVEBs for
Sheboygan County are now: 1.972 tons per day of VOC emissions and 4.435
tons per day of NOX emissions for the year 2015.

[FR Doc. 2015-16396 Filed 7-2-15; 8:45 am]
 BILLING CODE 6560-50-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on May 20, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-13855

________________________________________________________________________
___________________This serves as notice to the public of the action
described below, taken by the Department official indicated (no
additional confirming order will be issued in this matter).

Applications of  US AIRWAYS, INC. filed  2/27/04,  and  3/30/04,  to:

XX Amend exemption under 49 U.S.C. 40109 to provide the following
service:

2/27/04:

Scheduled foreign air transportation of persons, property, and mail
between Ft. Lauderdale, Florida, and Cancun, Mexico.

3/30/04:

Scheduled foreign air transportation of persons, property, and mail
between Washington/Baltimore and Cancun, Mexico.

Applicant rep:  Howard Kass<PHONE_NUMBER> DOT Analyst: Sylvia Moore
(202) 366-6519

D I S P O S I T I O N

XX  Granted Ft. Lauderdale-Cancun request (subject to conditions, see
below)

XX  Deferred Washington/Baltimore-Cancun request (see remarks below)

The authority granted was effective when taken:   May 20, 2004, through
 December 4, 2004 (coextensive with US Airways’ existing authority in
this Docket).

Action taken by:	Paul L. Gretch, Director

			Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:	XX Holder’s
certificates of public convenience and necessity

			XX  Standard exemption conditions (attached)

Special Conditions/Remarks:  The U.S.-Mexico exemption authority granted
is subject to the dormancy notice requirements set forth in condition 7
of Appendix A of Order 88-10-2.  Consistent with our standard practice,
the dormancy notice period for Ft. Lauderdale-Cancun will begin July 17,
2004, US Airways’ proposed startup date for this service.

2

Request for Washington/Baltimore-Cancun:  Under the U.S.-Mexico aviation
agreement, only two U.S. carriers may be designated to provide nonstop
transborder services in each city-pair market.  In its application US
Airways states that, because only one U.S. carrier (United Air Lines,
Inc.) currently serves the Washington, DC-Cancun market and only one
U.S. carrier (Brendan Airways, LLC d/b/a USA 3000) currently serves the
Baltimore-Cancun market, US Airways’ requests for new authority to
serve the Washington/Baltimore-Cancun markets are “within the
double-designation-per-city-pair limitation.”  However,
Washington/Baltimore is considered a single U.S. gateway point under the
bilateral agreement.  Since United and USA 3000 are already using the
two possible designations for the Washington/Baltimore-Cancun city-pair
market, no additional designations are available at this time.  Under
these circumstances, we decided to defer action on this portion of US
Airways’ request.

________________________________________________________________________
___________________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted or deferred, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

			05/2004