[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Proposed Rules]
[Pages 43788-43793]
[FR Doc No: 2020-14425]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0177; FRL-10011-68-Region 4]

Air Plan Approval; FL; GA; KY; MS; NC; SC: Definition of Chemical
Process Plants Under State Prevention of Significant Deterioration
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the State Implementation Plans (SIP) for Florida,
Georgia, the Jefferson County portion of Kentucky, Mississippi, North
Carolina, and South Carolina. The SIP revisions incorporate changes to
the definition of chemical process plants under the States' Prevention
of Significant Deterioration (PSD) regulations. Consistent with an EPA
regulation completed in 2007, EPA is proposing to approve the rules for
Florida, Georgia, the Jefferson County portion of Kentucky,
Mississippi, North Carolina, and South Carolina that modify the
definition of chemical process plant to exclude ethanol manufacturing
facilities that produce ethanol by natural fermentation processes. This
will clarify that the PSD major source applicability threshold in the
SIPs for these ethanol plants is 250 tons per year (tpy) (rather than
100 tpy) and removes the requirement to include fugitive emissions when
determining if the source is major for PSD. EPA is proposing to find
that the changes to the state and local rules described herein are
approvable because the Agency believes that they are consistent with
EPA regulations governing state PSD programs and will not interfere
with any applicable requirement concerning attainment and reasonable
further progress (as defined in section 171 of the Clean Air Act (CAA
or Act)), or any other applicable requirement of the CAA.

DATES: Comments must be received on or before August 19, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2020-0177 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: D. Brad Akers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Akers can be
reached via electronic mail at<EMAIL_ADDRESS>or via telephone at
(404) 562-9089.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is being addressed in this notice?
II. Background
    A. PSD Permitting Thresholds for Chemical Processing Plants
    B. Ethanol Rule
    C. Petitions for Review and Reconsideration of the 2007 Ethanol
Rule
III. What SIP revisions are being proposed by EPA?
IV. Have the requirements for approval of a SIP revision been met?
V. What action is EPA proposing to take?
VI. Incorporation by Reference
VII. Statutory and Executive Order Reviews

I. What is being addressed in this notice?

    EPA is proposing to approve the following revisions to SIPs
received by EPA from Florida, Georgia, Kentucky, Mississippi, North
Carolina, and South Carolina: (1) A portion of a SIP revision provided
to EPA through the Florida Department of Environmental Protection (FL
DEP) via letter dated December 12, 2011; (2) a SIP revision provided to
EPA through the Georgia Environmental Protection Division (GA EPD) via
letter dated September 15, 2008; \1\ (3) a SIP revision to the
Jefferson County portion of the Kentucky SIP that was provided to EPA
through the Kentucky Division for Air Quality (KDAQ) via a letter dated
July 1, 2009; \2\ (4) a SIP revision provided to EPA through the
Mississippi Department of Environmental Quality (MDEQ) via letter dated
November 28, 2007; (5) a SIP revision provided to EPA through the North
Carolina Department of Environmental Quality (NC DEQ) \3\ via letter
dated June 20, 2008; \4\ and (6) a portion of a SIP revision provided
to EPA through the South Carolina Department of Health and
Environmental Control (SC DHEC) via letter dated April 14, 2009, as
updated in a portion of SIP revision provided to EPA via letter dated
April 10, 2014. These revisions conform the State rules to changes to
EPA regulations reflected in EPA's final rule entitled ``Prevention of
Significant Deterioration, Nonattainment New Source Review, and Title
V: Treatment of Certain Ethanol Production Facilities Under the ``Major
Emitting Facility'' Definition'' (hereinafter referred to as the ``2007
Ethanol Rule'') as published in the Federal Register on May 1, 2007.
See 72 FR 24060.
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    \1\ EPA received the submittal on September 29, 2008.
    \2\ In 2003, the City of Louisville and Jefferson County
governments merged and the ``Jefferson County Air Pollution Control
District'' was renamed the ``Louisville Metro Air Pollution Control
District.'' See The History of Air Pollution Control in Louisville,
available at https://louisvilleky.gov/government/air-pollution-control-district/history-air-pollution-control-louisville. However,
each of the regulations in the Jefferson County portion of the
Kentucky SIP still has the subheading ``Air Pollution Control
District of Jefferson County.'' Thus, to be consistent with the
terminology used in the SIP, EPA refers throughout this notice to
regulations contained in the Jefferson County portion of the
Kentucky SIP as the ``Jefferson County'' regulations.
    \3\ At the time of the 2008 submittal, the NC DEQ was the North
Carolina Department of Environment and Natural Resources. Throughout
this proposed rulemaking, EPA will refer to the State Agency as NC
DEQ.
    \4\ EPA received the submission on June 25, 2008.
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    The 2007 Ethanol Rule amends the PSD definition of ``major
stationary source'' to exclude certain ethanol facilities from the
``chemical process plant'' source category and clarifies that the PSD
major source applicability threshold for certain ethanol plants is 250
tpy (rather than 100 tpy). The 2007 Ethanol Rule also removed the
requirement to include fugitive emissions when determining if the
source is major for PSD and Title V permitting. On October 21, 2019,
EPA responded to a petition for reconsideration of the 2007 Ethanol
Rule, and EPA denied the petition with respect to the revisions of the
PSD Regulations reflected in that rule (as described in more detail
below). EPA is now proposing to approve these SIP revisions that are
based on a part of the 2007 Ethanol Rule.

II. Background

A. PSD Permitting Thresholds for Chemical Processing Plants

    Under the CAA, there are two potential thresholds for determining
whether a source is a major emitting facility that is potentially
subject to the construction permitting requirements under the PSD
program; one threshold is 100 tpy per pollutant, and the other is 250
tpy per pollutant. Section 169(1) of the CAA lists twenty-eight source
categories that qualify as major emitting facilities if their emissions
exceed the 100 tpy threshold. If the source does not fall within one of
twenty-eight source categories listed in section 169, then the 250 tpy
threshold is applicable.
    One of the source categories in the list of twenty-eight source
categories to which the 100 tpy threshold applies is chemical process
plants. Since the Standard Industrial Classification (SIC) code for
chemical process plants includes facilities primarily engaged in
manufacturing ethanol fuel, EPA and States had previously considered
such facilities to be subject to the 100 tpy thresholds.
    As a result of this classification, pursuant to EPA regulations
interpreting CAA section 302(j), chemical process plants were also
required to include fugitive emissions for determining the potential
emissions of such sources. Thus, prior to promulgation of the 2007
Ethanol Rule, the classification of fuel and industrial ethanol
facilities as chemical process plants had the effect of requiring these
plants to include fugitive emissions of criteria pollutants when
determining whether their emissions exceed the applicability thresholds
for the PSD and nonattainment new source review (NA NSR) permit
programs.

B. Ethanol Rule

    On May 1, 2007, EPA published in the Federal Register the 2007
Ethanol Rule (72 FR 24060). This final rule amended EPA's PSD and NA
NSR regulations to exclude ethanol manufacturing facilities that
produce ethanol by natural fermentation processes from the ``chemical
process plants'' category under the regulatory definition of ``major
stationary source.''
    This change to EPA's NSR regulations affected the threshold used to
determine PSD applicability for these ethanol production facilities,
clarifying that such facilities were subject to the 250 tpy major
source threshold. The 2007 Ethanol Rule also included changes to other
provisions which established that ethanol facilities need not count
fugitive emissions when determining whether such a source is ``major''
under the Federal PSD, NA NSR, and Title V permitting programs.

C. Petitions for Review and Reconsideration of the 2007 Ethanol Rule

    On July 2, 2007, the National Resources Defense Council (NRDC)
petitioned the United States Court of Appeals for the District of
Columbia Circuit (D.C. Circuit) to review the 2007 Ethanol Rule. On
that same day, EPA received a petition for administrative
reconsideration and request for stay of the 2007 Ethanol Rule from
NRDC. On March 27, 2008, EPA denied NRDC's 2007 administrative petition
for reconsideration.
    On March 2, 2009, EPA received a second petition for
reconsideration and request for stay from NRDC. In 2009, NRDC also
filed a petition for judicial review challenging EPA's March 27, 2008,
denial of NRDC's 2007 administrative petition in the D.C. Circuit. This
challenge was consolidated with NRDC's challenge to the 2007 Ethanol
Rule. In August of 2009, the D.C. Circuit granted a joint motion to
hold the case in abeyance, and the case has remained in abeyance.
    On October 21, 2019, EPA partially granted and partially denied
NRDC's 2009 administrative petition for reconsideration. Specifically,
EPA granted the request for reconsideration with regard to NRDC's claim
that the 2007 Ethanol Rule did not appropriately address the CAA
section 193 anti-backsliding requirements for nonattainment areas. EPA
denied the remainder of the requests for reconsideration on the grounds
that NRDC failed to establish that reconsideration was warranted under
CAA section 307(d)(7)(B).

III. What SIP revisions are being proposed by EPA?

    As mentioned above, EPA is proposing to approve revisions to SIPs
dated: Florida on December 12, 2011; Georgia on September 15, 2008;
Kentucky, corresponding to the Jefferson County portion of the Kentucky
SIP, on July 1, 2009; Mississippi on November 28, 2007; North Carolina
on June 20, 2008; and South Carolina on April 14, 2009, and April 10,
2014. These revisions adopt language that is the same or consistent
with that contained in EPA's 2007 Ethanol Rule. EPA is not acting on
any changes with respect to NA NSR. The State regulations that EPA is
proposing to approve exclude ethanol production facilities that produce
ethanol by natural fermentation from the ``chemical process plants''
category. The revisions thus clarify that an ethanol facility is
subject to a PSD major source threshold of 250 tpy and that such
sources need not count fugitive emissions to determine potential
emissions that are compared to this threshold. The revisions proposed
for approval in this action do not affect NA NSR. More detail on the
SIP revisions that EPA is proposing to approve is provided below. Each
subsection below begins by identifying the rules as modified by each
state or local government to include the ethanol exemption in its PSD
program.

A. Florida

    Florida rule 62-210.200, Definitions, Florida Administrative Code
(F.A.C.) at 62-210.200(189) ``Major Stationary Source'': ``Any of the
following stationary sources of air pollutants which emits, or has the
potential to emit, 100 tons per year or more of any regulated NSR
pollutant: Chemical process plants (the term ``chemical process
plants'' shall not include ethanol production facilities that produce
ethanol by natural fermentation included in North American Industry
Classification System (NAICS) codes 325193 or 312140) . . .'' Florida
rule 62-210.200(214) ``North American Industry Classification System''
or ``NAICS'': ``A federal system of classifying business establishments
according to similarity in the process used to produce goods or
services, as described in the 2007 NAICS definition file (available
free of cost at http://www.census.gov/eos/www/naics/ or available in CD
ROM or book from at a cost from the US Department of Commerce at 1-800-
553-6847), hereby adopted and incorporated by reference (https://www.flrules.org/Gateway/reference.asp?No=Ref-00705).'' Additionally,
Chapter 62-212.400, Prevention of Significant Deterioration, at (3)(b):
``The requirements of subsections 62-212.400(4) through (12), F.A.C.,
shall not apply to a major stationary source or major modification if
the source of modification would be a major stationary source or major
modification only if fugitive emissions, to the extent quantifiable,
are considered in calculating the potential to emit of the stationary
source or modification and the source does not belong to one of the
following categories . . . 20. Chemical process plants (the term
``chemical process plants'' shall not include ethanol production
facilities that produce ethanol by natural fermentation included in
North American Industry Classification

System (NAICS) codes 325193 or 312140) . . .''
    Chapter 62-210 of the F.A.C., which contains Florida's definitions
regulation, generally applies to stationary sources in Florida. These
definitions are referenced throughout Florida's rules, including in
Chapter 62-212, which governs preconstruction review, including PSD.
Chapter 62-212 of the F.A.C., which contains Florida's PSD regulation,
applies to new or modified ``major stationary sources,'' as that term
is defined in 62-210.200. As identified above, Florida revised 62-
210.200 to exclude ethanol production facilities from the ``chemical
process plants'' major stationary source category such that ethanol
facilities emitting less than 250 tpy of a regulated air pollutant are
not subject to PSD.\5\ Additionally, Florida incorporated a definition
for NAICS as part of this rulemaking. Furthermore, Florida's PSD
regulation at 62-212.400(3)(b)20. says that emissions from these same
facilities are not considered in determining whether the facility is
subject to PSD. The state effective date of Florida's revision to the
definition of ``chemical process plants'' in Rule 62-210.200 and the
change to applicability procedures in Rule 62-212.400 is December 12,
2011.
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    \5\ Florida's definition of ``major stationary source'' at 62-
210.200 is also cross-referenced in the portion of its SIP-approved
NA NSR regulation, 62-212.500, Preconstruction Review in
Nonattainment Areas, that sets the fugitive emissions exclusion for
determining rule applicability. See Rule 62-212.500(2)(b). If the
definition of ``chemical process plants'' within the term of ``major
stationary source'' were updated to exclude these ethanol producing
facilities for the purposes of NA NSR, then fugitive emissions would
not need to be considered in determining whether the source is
major. All sources in nonattainment areas are major at 100 tpy, and
certain classifications of nonattainment areas for ozone and
PM2.5 establish lower thresholds for major source
applicability. See 40 CFR 51.165(b)(iv)(A). However, Florida's
December 12, 2011, submittal did not seek to revise, nor ask EPA to
revise, the State's SIP-approved NA NSR program. Therefore, EPA is
not approving the revision to the definition of ``chemical process
plant'' within the term ``major stationary source'' to apply to the
NA NSR program. Accordingly, if EPA finalizes this action, the
ethanol production facility exclusion within the definition of
``major stationary source'' at 62-210.200 will not apply in the SIP
for the purposes of determining applicability in Rule 62-212.500,
and EPA will note this in the list of SIP-approved Florida
regulations at 40 CFR 52.520(c). There are currently no
nonattainment areas in Florida.
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B. Georgia

    Official Compilation of Rules and Regulations of the State of
Georgia (Ga. Comp. R. & Regs.) 391-3-1-.02(7), Prevention of
Significant Deterioration of Air Quality, (a)2.(iii): ``The definition
of major stationary source contained in 40 CFR part 52.21(b)(1) is
hereby incorporated by reference except as follows . . .''
Additionally, (b)6.: ``Review of major stationary sources and major
modifications--source applicability and general exemptions: 40 CFR part
52.21 (i), as amended, is hereby incorporated and adopted by reference
with the following exception . . .''
    This regulation incorporates by reference portions of 40 CFR 52.21,
including most portions of the federal definition of ``major stationary
source'' and most portions of EPA's applicability procedures as revised
and amended on July 1, 2007, which include the 2007 Ethanol Rule
provisions. This revision aligns paragraph (a)2.(iii) with the
incorporation by reference of provisions in 40 CFR 52.21 at paragraph
(a)1.
    The term ``major stationary source'' is defined in 40 CFR
52.21(b)(1)(i)(a) as ``[a]ny of the following stationary sources of air
pollutants which emits, or has the potential to emit, 100 tons per year
or more of any regulated NSR pollutant: . . . Chemical process plants
(which does not include ethanol production facilities that produce
ethanol by natural fermentation included in NAICS codes 325193 or
312140).'' Additionally, 40 CFR 52.21(b)(1)(iii) excludes fugitive
emissions from ethanol production facilities from the ``chemical
process plants'' category such that fugitive emissions are not
considered in determining whether the facility is subject to PSD.
    Because Georgia's incorporation by reference of 40 CFR 52.21
includes the ethanol exclusion, ethanol facilities emitting less than
250 tpy of a regulated air pollutant are not subject to PSD, and
fugitive emissions from ethanol facilities are not considered in
determining whether the facility is subject to PSD.

C. Jefferson County Portion of the Kentucky SIP

    Jefferson County Regulation 2.05, Prevention of Significant
Deterioration of Air Quality. This regulation incorporates by reference
40 CFR 52.21, as revised and amended on July 1, 2008, with exceptions.
    The term ``major stationary source'' is defined in 40 CFR
52.21(b)(1)(i)(a) as ``[a]ny of the following stationary sources of air
pollutants which emits, or has the potential to emit, 100 tons per year
or more of any regulated NSR pollutant: . . . Chemical process plants
(which does not include ethanol production facilities that produce
ethanol by natural fermentation included in NAICS codes 325193 or
312140).'' Additionally, 40 CFR 52.21(b)(1)(iii) excludes fugitive
emissions from ethanol production facilities from the ``chemical
process plants'' category such that fugitive emissions are not
considered in determining whether the facility is subject to PSD.
    Because Jefferson County's incorporation by reference of 40 CFR
52.21 includes the ethanol exclusion, ethanol facilities emitting less
than 250 tpy of a regulated air pollutant are not subject to PSD, and
fugitive emissions from ethanol facilities are not considered in
determining whether the facility is subject to PSD.

D. Mississippi

    11 Mississippi Administrative Code (MAC) Part 2, Chapter 5,
Regulations for the Prevention of Significant Deterioration of Air
Quality. This regulation incorporates by reference 40 CFR 52.21, as
revised and amended on June 15, 2007, with exceptions.
    The term ``major stationary source'' is defined in 40 CFR
52.21(b)(1)(i)(a) as ``[a]ny of the following stationary sources of air
pollutants which emits, or has the potential to emit, 100 tons per year
or more of any regulated NSR pollutant: . . . Chemical process plants
(which does not include ethanol production facilities that produce
ethanol by natural fermentation included in NAICS codes 325193 or
312140).'' Additionally, 40 CFR 52.21(b)(1)(iii) excludes fugitive
emissions from ethanol production facilities from the ``chemical
process plants'' category such that fugitive emissions are not
considered in determining whether the facility is subject to PSD.
    Because Mississippi's incorporation by reference of 40 CFR 52.21
includes the ethanol exclusion, ethanol facilities emitting less than
250 tpy of a regulated air pollutant are not subject to PSD, and
fugitive emissions from ethanol facilities are not considered in
determining whether the facility is subject to PSD.

E. North Carolina

    15 North Carolina Administrative Code (NCAC) 02D .0530, Prevention
of Significant Deterioration. This regulation incorporates by reference
40 CFR 52.21, as revised and amended on June 13, 2007, with exceptions.
    The term ``major stationary source'' is defined in 40 CFR
52.21(b)(1)(i)(a) as ``[a]ny of the following stationary sources of air
pollutants which emits, or has the potential to emit, 100 tons per year
or more of any regulated NSR pollutant: . . . Chemical process plants
(which does not include ethanol production facilities that produce

ethanol by natural fermentation included in NAICS codes 325193 or
312140).'' Additionally, 40 CFR 52.21(b)(1)(iii) excludes fugitive
emissions from ethanol production facilities from the ``chemical
process plants'' category such that fugitive emissions are not
considered in determining whether the facility is subject to PSD.
    Because North Carolina's incorporation by reference of 40 CFR 52.21
includes the ethanol exclusion, ethanol facilities emitting less than
250 tpy of a regulated air pollutant are not subject to PSD, and
fugitive emissions from ethanol facilities are not considered in
determining whether the facility is subject to PSD.

F. South Carolina

    South Carolina Code of Regulations Annotated (S.C. Code Ann.
Regs.), Rule 61-62.5, Standard No. 7, Prevention of Significant
Deterioration, at 61-62.5, Standard No. 7(b)(32) ``Major stationary
source'' at (i)(a): ``Any of the following stationary sources of air
pollutants which emits, or has the potential to emit, 100 tons per year
or more of any regulated NSR pollutant: . . . chemical process plants
(which does not include ethanol production facilities that produce
ethanol by natural fermentation included in North American Industrial
Classification System (NAICS) codes 325193 or 312140) . . .''
Additionally, another part of the definition at Standard No.
7(b)(32)(iii): ``The fugitive emissions of a stationary source shall
not be included in determining for any of the purposes of this
regulation whether it is a major stationary source, unless the source
belongs to one of the following categories of stationary sources: . . .
(t) Chemical process plants--The term chemical processing plant shall
not include ethanol production facilities that produce ethanol by
natural fermentation included in North American Industrial
Classification System (NAICS) codes 325193 or 312140 . . .''
    SC DHEC's Rule 61-62.5, Standard No. 7, applies to new or modified
``major stationary sources.'' As identified above, Standard No. 7 was
revised to exclude ethanol production facilities from the ``chemical
process plants'' major stationary source category such that ethanol
facilities emitting less than 250 tpy of a regulated air pollutant are
not subject to PSD. Furthermore, South Carolina's PSD regulation at 61-
62.5, Standard No. 7(b)(32)(iii) was revised to say that fugitive
emissions at these same facilities are not considered in determining
whether the facility is subject to PSD. The state effective date of SC
DHEC's revision to the definition of ``major stationary source'' at 61-
62.5, Standard No. 7(b)(32)(i) and (iii) was initially April 24, 2009,
as transmitted in the April 14, 2009, SIP revision.
    Subsequently, South Carolina made additional changes to Standard
No. 7 regarding these provisions. Specifically, South Carolina made a
minor change to spell out the term ``North American Industrial
Classification System'' the first time it appears in Regulation No. 7
at Regulation No. 7(b)(32)(i)(a). The State published its proposed
changes in the South Carolina State Register on August 23, 2013, and
held a public hearing on December 12, 2013. South Carolina adopted the
amended rule on December 27, 2013, at which point it became state
effective. On April 10, 2014, South Carolina submitted a request to EPA
Region 4 to revise the South Carolina SIP with these additional changes
made to South Carolina's PSD program.

IV. Have the requirements for approval of a SIP revision been met?

    All of the aforementioned regulations are consistent with EPA's PSD
program requirements in 40 CFR 51.166, as amended in the 2007 Ethanol
Rule. Further, all submissions have met the public notice requirements
for SIP submissions in accordance with 40 CFR 51.102.
    FL DEP published a Notice of Proposed Rule on September 16, 2011,
in the Florida Administrative Weekly, with a public hearing offered on
October 13, 2011, if requested within 21 days of the published Notice.
FL DEP received no request for a public hearing and therefore did not
hold an official hearing. FL DEP received no comments from on its
proposed revisions and therefore did not change the rules based on
public input.
    GA EPD issued a Notice of Public Hearing and Proposed Revisions on
May 4, 2008. A public hearing was then held on June 3, 2008. No
comments were received on the proposed revision, and GA EPD therefore
did not make changes to the rule based on public input.
    Louisville Metro Air Pollution Control District (LMAPCD) noticed
proposed changes in newspapers published on February 20, 2009, and held
a public hearing on May 20, 2009. Two sets of comments were received on
the draft revisions, and LMAPCD responded to the comments received and
noted that it made no substantive changes in response to the comments.
    MDEQ published its notice of public hearing and proposed changes
via newspapers on June 15, 2007, June 22, 2007, and June 29, 2007, and
held a public hearing on July 17, 2007. MDEQ did not receive any
comments on its proposed changes and therefore did not make any changes
to its rules based on public input.
    NC DEQ published a notice of proposed amendments in newspapers by
October 7, 2007, and in the North Carolina Register on October 15,
2007, and a public hearing was held on November 7, 2007. NC DEQ
received one set of public comments on the proposed rule and made
changes to the rule based on those comments. No substantive comments
were received on the adoption of regulations consistent with the 2007
Ethanol Rule.
    SC DHEC issued a notice of proposed rulemaking in the State
Register on January 23, 2009, for the April 14, 2009, submittal, and
held a public hearing on April 9, 2009. In addition, for the April 10,
2014, submittal, SC DHEC issued a notice of proposed rulemaking on
August 23, 2013, in the State Register and held a public hearing on
December 12, 2013. SC DHEC received no comments on either of its
proposed revisions, and therefore made no changes based on public
input.
    The SIP submissions also satisfy the completeness criteria of 40
CFR part 51, appendix V. In addition, these revisions meet the
substantive SIP requirements of the CAA, including section 110 and
implementing regulations. A Technical Support Document (TSD) for each
state or local revision, available as part of the docket to this
proposed rulemaking, contains an analysis of the potential impact of
the SIP revisions on air quality and whether approval of the SIP
revisions will interfere with attainment or maintenance of the national
ambient air quality standards (or standards) or any other CAA
requirement. Existing ethanol plants, where a state has any, are listed
with information from their permits, including applicable requirements,
current PSD status, and applicable federal rules that control emissions
in lieu of PSD. The existing ethanol plants, where a state has any, are
mapped along with the ambient air monitors to demonstrate the
relationship between ethanol production and air quality.
    Emissions from ethanol plants are compared to other emissions data
categories for four major pollutants revealing that for the major
pollutants associated with ethanol production, ethanol plants make up
less than 1 percent of the total anthropogenic emissions of that
pollutant in all six states. EPA graphed air quality trends in each
state, since the date of promulgation of the 2007 Ethanol Rule, for all
criteria pollutants associated with

ethanol production. The air quality trends reveal that while ethanol
production increased in certain areas, air quality improved for
generally every pollutant monitored in each of the states.
    EPA also describes requirements for each state or local
government's minor source NSR program because the facilities that would
be below the 250 tpy PSD major source threshold under this rulemaking
will still need to obtain minor source construction permits.\6\ EPA
further analyzes the impact of increasing the threshold to 250 tpy on
ozone and particulate matter (PM) precursors in each state. The
analysis for ozone and secondary PM demonstrates that sources of this
size will not cause any interference with attainment or maintenance of
the standard in these states.
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    \6\ With the exception of facilities with a potential to emit
between 100-250 tpy in several counties adjacent to the Atlanta,
Georgia ozone nonattainment area for the 2015 8-hour ozone NAAQS,
which are subject to Georgia's NA NSR program. See the TSD for
Georgia in the docket for this proposed rulemaking for more
information.
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    Based on EPA's analysis in each TSD, EPA proposes to conclude that
approval of this action will not interfere with any applicable
requirement concerning attainment and reasonable further progress (as
defined in section 171 of the CAA), or any other applicable requirement
of the CAA as required under CAA section 110(l).

V. What action is EPA proposing to take?

    EPA is proposing to approve revisions to the Florida SIP, Georgia
SIP, Jefferson County portion of the Kentucky SIP, Mississippi SIP,
North Carolina SIP, and South Carolina SIP. EPA plans to take final
action after consideration of any comments received on this proposed
rulemaking.
    The revisions to state rules that EPA is proposing to approve
change the definition of ``major stationary source'' under each state
or local PSD regulations. These proposed changes make clear that the
PSD applicability threshold for certain ethanol plants is 250 tpy and
remove the requirement to include fugitive emissions when determining
if an ethanol plant is major for PSD. EPA proposes to determine that
these revisions are consistent with EPA's PSD regulations and that
approval of these revisions is consistent with the requirements of CAA
section 110(l) and will not adversely impact air quality. EPA's
analysis is available in the individual State TSDs that are part of the
docket for this proposed rulemaking. This proposed action will ensure
consistency between the State and federally approved rules and ensure
Federal enforceability of the State's revised air program rules.

VI. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference the following regulations: Florida Rule 62-210.200, F.A.C.,
``Definitions,'' state effective March 28, 2012; 7 8 Florida
Rule 62-212.400, ``Prevention of Significant Deterioration,'' state
effective March 28, 2012; \9\ Georgia Rule 391-3-1-.02(7), ``Prevention
of Significant Deterioration of Air Quality (PSD),'' state effective
July 20, 2017; \10\ Jefferson County Regulation 2.05, ``Prevention of
Significant Deterioration of Air Quality,'' version 13, state effective
January 17, 2018 \11\ for the Jefferson County portion of the Kentucky
SIP; Mississippi Rule 11 MAC Part 2, Rule 5.2, ``Adoption of Federal
Rules by Reference,'' state effective May 28, 2016; \12\ North Carolina
Rule 02D .0530, ``Prevention of Significant Deterioration,'' state
effective September 1, 2017; \13\ and South Carolina Rule 61-62.5,
Standard No. 7, ``Prevention of Significant Deterioration,'' state
effective August 25, 2017.\14\ EPA has made, and will continue to make,
these materials generally available through www.regulations.gov and at
the EPA Region 4 office (please contact the person identified in the
FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).
---------------------------------------------------------------------------

    \7\ Except for the purposes of determining applicability in Rule
62-212.500, ``Preconstruction Review for Nonattainment Areas.'' See
footnote 5 for additional information.
    \8\ The effective date of the change to Florida Rule 62-210.200
made in Florida's December 12, 2011, SIP revision is December 4,
2011. However, for purposes of the state effective date included at
40 CFR 52.520(c), that change to Florida's rule is captured and
superseded by Florida's update in a February 27, 2013, SIP revision,
state effective on March 28, 2012, which EPA previously approved on
October 6, 2017. See 82 FR 46682.
    \9\ The effective date of the change to Florida Rule 62-212.400
made in Florida's December 12, 2011, SIP revision is December 4,
2011. However, for purposes of the state effective date included at
40 CFR 52.520(c), that change to Florida's rule is captured and
superseded by Florida's update in a February 27, 2013, SIP revision,
state effective on March 28, 2012, which EPA previously approved on
September 19, 2012. See 77 FR 58027.
    \10\ The effective date of the change to Georgia Rule 391-3-
1-.02(7) made in Georgia's September 15, 2008, SIP revision is
September 11, 2008. However, for purposes of the state effective
date included at 40 CFR 52.570(c), that change to Georgia's rule is
captured and superseded by Georgia's update in a November 29, 2017,
SIP revision, state effective on July 20, 2017, which EPA previously
approved on December 4, 2018. See 83 FR 62466.
    \11\ The effective date of the change to Jefferson County
Regulation 2.05 made in Kentucky's July 1, 2009, SIP revision is
June 20, 2009. However, for purposes of the state effective date
included at 40 CFR 52.920(c), that change to Jefferson County's rule
is captured and superseded by Kentucky's update in a March 15, 2018,
SIP revision, state effective on January 17, 2018, which EPA
previously approved on April 10, 2019. See 84 FR 14268.
    \12\ The effective date of the change to Mississippi Rule APC-S-
5, ``Regulations for the Prevention of Significant Deterioration of
Air Quality'' made in Mississippi's November 28, 2007, SIP revision
is August 23, 2007. However, for purposes of the state effective
date included at 40 CFR 52.1270(c), that change to Mississippi's
rule is captured and superseded by Mississippi's update in a June 7,
2016, SIP revision, state effective on May 28, 2016, which EPA
previously approved on August 8, 2017. See 82 FR 37015. Furthermore,
Mississippi has recodified previous Rule APC-S-5 as 11 MAC Part 2,
Rule 5, with the relevant part from the November 28, 2007, SIP
revision now included in Rule 5.2.
    \13\ The effective date of the change to North Carolina Rule 02D
.0530 made in North Carolina's June 20, 2008, SIP revision is May 1,
2008. However, for purposes of the state effective date included at
40 CFR 52.1770(c), that change to North Carolina's rule is captured
and superseded by North Carolina's update in a October 17, 2017, SIP
revision, state effective on September 1, 2017, which EPA previously
approved on September 11, 2018. See 82 FR 45827.
    \14\ The effective date of the change to South Carolina Rule 61-
62.1, Standard No. 7 made in South Caorlina's April 10, 2014, SIP
revision is December 27, 2013. However, for purposes of the state
effective date included at 40 CFR 52.2120(c), that change to South
Carolina's rule is captured and superseded by South Carolina's
update in a September 5, 2017, SIP revision, state effective on
August 25, 2017, which EPA previously approved on February 13, 2019.
See 84 FR 3705.
---------------------------------------------------------------------------

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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 CAA. These proposed actions
merely propose to approve state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, these proposed actions:
     Are not significant regulatory actions 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);
     Are not Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory actions because SIP approvals are exempted under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

     Are 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.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are 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
     Do 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).
    For Florida, Georgia, the Jefferson County portion of Kentucky,
Mississippi, and North Carolina, the SIPs are 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 proposed rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor
will it impose substantial direct costs on tribal governments or
preempt tribal law.
    For South Carolina, because this proposed action merely proposes to
approve state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law, this action
for the State of South Carolina does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Therefore, this proposed action will not impose substantial direct
costs on Tribal governments or preempt Tribal law. The Catawba Indian
Nation Reservation is located within the boundary of York County, South
Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C.
Code Ann. 27-16-120 (Settlement Act), ``all state and local
environmental laws and regulations apply to the Catawba Indian Nation
and Reservation and are fully enforceable by all relevant state and
local agencies and authorities.'' The Catawba Indian Nation also
retains authority to impose regulations applying higher environmental
standards to the Reservation than those imposed by state law or local
governing bodies, in accordance with the Settlement Act.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and Recordkeeping requirements, Volatile
organic compounds.

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

    Dated: June 26, 2020.
Mary Walker,
Regional Administrator, Region 4.

[FR Doc. 2020-14425 Filed 7-17-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Page 44103]
[FR Doc No: 2015-18204]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9022-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements
Filed 07/13/2015 Through 07/17/2015
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20150198, Draft, USAF, OR, Proposed Establishment and
Modification of Oregon Military Training Airspace, comment period ends:
09/08/2015, Contact: Kevin Marek<PHONE_NUMBER>.
EIS No. 20150199, Draft, OSM, Other, Stream Protection Rule, comment
period ends: 09/15/2015, Contact: Robin Ferguson<PHONE_NUMBER>.
EIS No. 20150200, Draft, USFWS, CA, South Bay Salt Pond Restoration
Project Phase 2, comment period ends: 09/22/2015, Contact: Anne Morkill
510-792-0222.
EIS No. 20150201, Draft, FERC, LA, Magnolia Liquefied Natural Gas (LNG)
and Lake Charles Expansion Projects, comment period ends: 09/08/2015,
Contact: Janine Cefalu<PHONE_NUMBER>.
EIS No. 20150202, Final, FHWA, LA, ADOPTION--I-12 to Bush, Louisiana
Proposed Highway, review period ends: 08/24/2015, Contact: Carl
Highsmith<PHONE_NUMBER>.

    The U.S. Department of Transportation's Federal Highway
Administration (FHWA) and Louisiana Department of Transportation has
adopted the U.S. Army Corps of Engineers' final EIS #20120055, filed
02/29/2012 with EPA. The FHWA was not a cooperating agency for the
above EIS. Therefore recirculation of the EIS is necessary under the
CEQ Regulations Section 1506.3.

    Dated: July 21, 2015.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2015-18204 Filed 7-23-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Proposed Rules]
[Pages 68296-68297]
[FR Doc No: 2010-28002]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2009-0559; FRL-9222-4]
RIN 2060-AP90

Standards of Performance for New Stationary Sources and Emission
Guidelines for Existing Sources: Sewage Sludge Incineration Units;
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; technical correction.

-----------------------------------------------------------------------

SUMMARY: This action clarifies certain text of the proposed rules
titled ``Standards of Performance for New Stationary Sources and
Emission Guidelines for Existing Sources: Sewage Sludge Incineration
Units.'' The proposed rules were published in the Federal Register on
October 14, 2010. The action proposes how EPA will address Clean Air
Act requirements to establish new source performance standards for new
units and emission guidelines for existing units for specific
categories of solid waste incineration units.

DATES: Comments must be received on or before November 29, 2010.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2009-0559 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
<EMAIL_ADDRESS>     Facsimile: Fax your comments to<PHONE_NUMBER>, Attention
Docket ID Number EPA-HQ-OAR-2009-0559.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (EPA/DC), Air and Radiation Docket Information Center, 1200
Pennsylvania Avenue, NW.; Mail Code: 6102T, Washington, DC 20460.
Please include a total of two copies. We request that a separate copy
also be sent to the contact person identified in the FOR FURTHER
INFORMATION CONTACT section below.
     Hand Delivery: To send comments or documents through a
courier service, the address to use is: EPA Docket Center, Public
Hearing Room, EPA West, Room 334, 1301 Constitution Avenue, NW.,
Washington, DC 20004. Such deliveries are accepted only during the
Docket's normal hours of operation--8:30 a.m. to 4:30 p.m., Monday
through Friday. Special arrangements should be made for deliveries of
boxed information. Please include a total of two copies.

FOR FURTHER INFORMATION CONTACT: Ms. Amy Hambrick, Natural Resource and
Commerce Group, Sector Policies and Programs Division (E143-03),
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; facsimile number: (919) 541-
3470; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Organization of This Document. The following outline is provided to
aid in locating information in this notice.

I. What is the background for the correction?
II. What are the corrections to the proposed rules (75 FR 63260)?
III. Statutory and Executive Order Reviews

I. What is the background for the correction?

    On October 14, 2010 (75 FR 63260), EPA proposed rules that would
address in part Clean Air Act requirements to establish new source
performance standards (NSPS) for new units and emission guidelines (EG)
for existing units for specific categories of solid waste incineration
units. In that action, EPA proposed NSPS and EG for sewage sludge
incineration (SSI) units. EPA subsequently determined that one sentence
in the proposed regulatory text could have been interpreted in a manner
inconsistent with what EPA intended to propose. This notice clarifies
that language.
    This action does not affect the substance of the proposed rules,
nor does it change the rights or obligations of any party. Rather, this
notice merely clarifies certain regulatory text in the proposed rules.
This action is minor,

noncontroversial, and does not substantively change the proposed rule.

II. What are the corrections to the proposed rules (75 FR 63260)?

    In this notice, we are clarifying the scope of the proposed
affirmative defense for exceedance of an emission limit or standard
during a malfunction. See proposed regulatory text at 75 FR 63260.
Specifically, we are clarifying the regulatory text to reflect that the
affirmative defense is available only against claims for civil
penalties. The preamble to the October 14, 2010 (75 FR 63283), notice
stated this position, as did other portions of the proposed regulatory
text. See 75 FR 63299 proposed Sec.  60.4861(b) and 75 FR 63323
proposed Sec.  60.5181(b). However, one sentence in the regulatory text
created a potential ambiguity that may not have reflected the Agency's
intent. Therefore, we are clarifying this in the proposed regulatory
text to explain that a facility may assert an affirmative defense to a
claim for civil penalties for exceedances of the standards that are
caused by a malfunction, as defined in 40 CFR 60.2, but may not assert
such a defense to a claim for injunctive relief.
    EPA is soliciting public comment on the proposed SSI rule published
on October 14, 2010, until November 15, 2010, unless a public hearing
is held. If a public hearing is held, then comments on the proposed SSI
rule published on October 14, 2010, must be received by November 29,
2010. Members of the public may also comment on this technical
correction during that time, and should submit any such comments to the
docket for that proposed rule. Submit your comments, identified by
Docket ID Number EPA-HQ-OAR-2009-0559, by one of the following methods
identified in 75 FR 63260.

III. Statutory and Executive Order Reviews

    EPA's compliance with relevant statutes and Executive Orders for
the proposed SSI rule is discussed in the October 14, 2010, Federal
Register notice titled ``Standards of Performance for New Stationary
Sources and Emission Guidelines for Existing Sources: Sewage Sludge
Incineration Units.'' (75 FR 63260). This technical correction does not
affect the analyses contained in the October 14, 2010, notice.

List of Subjects in 40 CFR Part 60

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

    Dated: October 29, 2010.
Gina A. McCarthy,
Assistant Administrator.

    For the reasons stated in the preamble, FR Doc. No. 2010-25122,
published in the Federal Register on October 14, 2010, at 75 FR 63260
is corrected as follows:
    1. Beginning on page 63298, in the third column, remove the second
sentence in Sec.  60.4861 introductory text and add the following two
sentences in its place: ``Appropriate penalties may be assessed,
however, if the respondent fails to meet its burden of proving all of
the requirements in the affirmative defense. The affirmative defense
shall not be available for claims for injunctive relief.''
    2. On page 63323, in the center column, remove the second sentence
in Sec.  60.5181 introductory text and add the following two sentences
in its place: ``Appropriate penalties may be assessed, however, if the
respondent fails to meet its burden of proving all of the requirements
in the affirmative defense. The affirmative defense shall not be
available for claims for injunctive relief.''

[FR Doc. 2010-28002 Filed 11-4-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18649-18651]
[FR Doc No: 2018-08504]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0056]

Request for Information: Improving Prehospital Trauma Care

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: NHTSA, on behalf of the Federal Interagency Committee on
Emergency Medical Services (FICEMS), is seeking comments from all
sources (public, private, governmental, academic, professional, public
interest groups, and other interested parties) on improving prehospital
trauma care.
    The purpose of this notice is to solicit comments on improving
prehospital trauma care, and to request responses to specific questions
provided below. This is neither a request for proposals nor an
invitation for bids.

DATES: It is requested that comments on this announcement be submitted
by July 26, 2018.

ADDRESSES: You may submit comments [identified by Docket No. NHTSA-
2018-0056] through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Gamunu Wijetunge, Office of Emergency
Medical Services,<PHONE_NUMBER>, [email protected], located at
the United States Department of Transportation; 1200 New Jersey Avenue
SE, NPD-400, Room W44-232, Washington, DC 20590. Office hours are from
9 a.m. to 5 p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    FICEMS was created (42 U.S.C. 300d-4) by the Secretaries of
Transportation, Health and Human Services and Homeland Security to, in
part, ensure coordination among the Federal agencies involved with
State, local, tribal or regional emergency medical services and 9-1-1
systems. FICEMS has statutory authority to identify State and local
Emergency Medical Services (EMS) and 9-1-1 needs, to recommend new or
expanded programs and to identify the ways in which Federal agencies
can streamline their processes for support of EMS. FICEMS includes
representatives from the Department of Defense (DoD) Office of the
Assistant Secretary of Defense Health Affairs, the Department of Health
and Human Services (HHS) Office of the Assistant Secretary for
Preparedness and Response (ASPR), HHS Indian Health Service (IHS), HHS
Centers for Disease Control and Prevention (CDC), HHS Health Resources
and Services Administration (HRSA), HHS Centers for Medicare and
Medicaid Services (CMS), the Department of Homeland Security (DHS)
Office of Health Affairs (OHA), DHS U.S. Fire Administration (USFA),
NHTSA, the Federal Communications Commission (FCC) and a State EMS
Director appointed by the Secretary of Transportation.
    In 2016 the National Academies of Sciences, Engineering, and
Medicine (NASEM) published a report, A National Trauma Care System:
Integrating Military and Civilian Trauma Systems to Achieve Zero
Preventable Deaths After Injury (2016 NASEM Trauma Report), that
estimated as many as 20 percent of the nearly of 200,000 annual trauma
deaths in the United States could be prevented.
    On December 2, 2016 the National Emergency Medical Services
Advisory Council (NEMSAC) issued recommendations to FICEMS in response
to the NASEM report (https://www.ems.gov/pdf/nemsac/NEMSAC_Advisory_MTSPE_Alignment_Trauma_Care_Report.pdf). NEMSAC
recommended that FICEMS develop an integrated Federal strategy to
address both the recommendations of the NASEM report and the need to
update the Model Trauma Systems Planning and Evaluation (MTPSE)
document which includes a Benchmarks, Indicators and Scoring (BIS)
tool.
    On December 6, 2017, FICEMS and the Council on Emergency Medical
Care (CEMC) co-hosted a listening session to hear from stakeholders
about the challenges facing prehospital trauma care, especially in
rural settings, and how to better integrate military and civilian EMS
systems. An integrated national trauma care system would allow lessons
learned from the battlefield to be translated to civilian EMS and
provide opportunities for improved patient care.
    A national trauma care system, that integrates military and
civilian capabilities, is a crucial part of our Nation's infrastructure
and is vital to preserve the health and productivity of the American
people.
    The 2016 NASEM report estimates that as many as 20% of the nearly
200,000 annual trauma deaths in the United States could be prevented.
In its report, the NASEM defined preventable deaths after injury as
those casualties whose lives could have been saved by appropriate and
timely medical care, irrespective of tactical, logistical, or
environmental issues.

Questions on Improving Prehospital Trauma Care

    Responses to the following questions are requested. Please provide
references as appropriate.
    1. What are the current impediments, and possible solutions, to
achieving zero preventable deaths in the following settings:
    a. Wilderness;
    b. Rural;
    c. Suburban; and
    d. Urban.
    2. What should be the national aim for preventable prehospital
trauma deaths?
    3. What should be the interim national goals to achieve zero
preventable deaths in the prehospital setting?
    4. What are the most promising or innovative opportunities to
improve prehospital trauma care in the following settings:
    a. Military;
    b. Wilderness;
    c. Rural;
    d. Suburban; and
    e. Urban.
    5. How could the Learning Health System model (as described in the
2016 NASEM Trauma Report) be applied to civilian EMS?
    6. Are there actions that could be taken today in the prehospital
setting (such as promising clinical interventions) that could
dramatically improve outcomes for patients who are:
    a. Suffering from traumatic pain;
    b. Severely injured in a rural roadway crash;
    c. Suffering from penetrating trauma;
    d. Subjected to a compromised airway;
    e. Suffering from a major hemorrhage;
    f. Suffering from a pneumothorax;
    g. Suffering from blunt force trauma;
    h. Suffering from traumatic brain injury;
    i. Other clinical conditions (please explain).
    7. What EMS evidence based guidelines could be developed to improve
trauma patient outcomes?
    8. As an EMS stakeholder what do you see is the potential role of
the National EMS Information System (NEMSIS) and the EMS Compass
performance measures in improving prehospital trauma care?
    9. How might active duty, National Guard, and reserve component
military resources be used to improve civilian trauma care outcomes in
the following settings:
    a. Use of military rotary wing assets to support civilian EMS;
    b. Placement of military medics in the field to support and cross
train with civilian EMS.

    10. What actions can be taken to improve public awareness of
traumatic injury as a public health issue?
    11. What actions could be taken to improve the rapid extrication of
motor vehicle crash patients?
    12. What actions could be taken to improve the rapid transport of
trauma patients?
    13. What actions could be taken to improve prehospital care for
pediatric trauma patients?
    14. What actions could be taken to improve tribal prehospital
trauma care?
    15. What research is needed to improve prehospital trauma care
during a mass casualty incident?
    16. What is the potential role of 9-1-1 in improving prehospital
trauma care outcomes?
    17. What is the potential role of bystander care, such as Stop the
Bleed, in improving prehospital trauma care outcomes?
    18. What is the potential role of vehicle telematics in improving
prehospital trauma care outcomes?
    19. What is the potential role of telemedicine in improving
prehospital trauma care outcomes?
    20. What is the potential role of community paramedicine, mobile
integrated healthcare, and other emerging EMS subspecialties in
improving prehospital trauma care outcomes?
    21. How could data-driven and evidence-based improvements in EMS
systems improve prehospital trauma care?
    22. How could enhanced collaboration among EMS systems, health care
providers, hospitals, public safety answering points, public health,
insurers, and others improve prehospital trauma care?
    23. What are some opportunities to improve exchange of evidence
based prehospital trauma care practices between military and civilian
medicine?
    24. Do you have any additional comments regarding prehospital
trauma care?

    Authority: 44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC, on April 19, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-08504 Filed 4-26-18; 8:45 am]
 BILLING CODE 4910-59-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on May 4, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 2000-8438

________________________________________________________________________
________________________________________________________

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).

Applicant:  AEROTRANSPORTE de CARGA UNION, S.A. de C.V.
            Date Filed:  March 29, 2004

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct all-cargo charter operations between
Mexico and the United States, and other all-cargo charters in accordance
with 14 CFR Part 212

If renewal, date and citation of last action:  April 22 2003, in this
Docket.

Applicant representative:  Pierre Murphy,<PHONE_NUMBER>        DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			       			                       Action date:  May
4, 2004

Effective dates of authority granted:  May 4, 2004, through May 4, 2005.

Basis for approval:  United States-Mexico Air Transport Services
Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated: Standard exemption
conditions.

Special conditions/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in it

s regulations, 14 CFR Part 385, we found that (1) our action was
consistent with Department policy; (2) the applicant was qualified to
perform its proposed operations; (3) grant of the authority was
consistent with the public interest; and (4) 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/deferred/dismissed, 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


[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Rules and Regulations]
[Pages 78054-78056]
[FR Doc No: 2016-26766]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-8455]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by

publication in the Federal Register on a subsequent date. Also,
information identifying the current participation status of a community
can be obtained from FEMA's Community Status Book (CSB). The CSB is
available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Patricia Suber, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 400 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6   [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                              Effective date
                                              authorization/
                                 Community   cancellation of    Current effective map     Date certain Federal
      State and location            No.       sale of flood             date              assistance no longer
                                               insurance in                                available in SFHAs
                                                community
----------------------------------------------------------------------------------------------------------------
          Region II

New York:
    Denning, Town of, Ulster         361439  February 13,     November 18, 2016.......  November 18, 2016.
     County.                                  1976, Emerg;
                                              May 25, 1984,
                                              Reg; November
                                              18, 2016, Susp.
    Hardenburgh, Town of,            361578  December 26,     ......do................   Do.
     Ulster County.                           1975, Emerg;
                                              July 20, 1984,
                                              Reg; November
                                              18, 2016, Susp.
    Hurley, Town of, Ulster          360857  June 20, 1975,   ......do................   Do.
     County.                                  Emerg; July 3,
                                              1985, Reg;
                                              November 18,
                                              2016, Susp.
    Marbletown, Town of,             361219  September 26,    ......do................   Do.
     Ulster County.                           1975, Emerg;
                                              October 22,
                                              1982, Reg;
                                              November 18,
                                              2016, Susp.

    Olive, Town of, Ulster           360860  July 7, 1975,    ......do................   Do.
     County.                                  Emerg;
                                              November 1,
                                              1984, Reg;
                                              November 18,
                                              2016, Susp.
    Shandaken, Town of,              360864  December 18,     ......do................   Do.
     Ulster County.                           1974, Emerg;
                                              January 17,
                                              1985, Reg;
                                              November 18,
                                              2016, Susp.
    Wawarsing, Town of,              360867  September 15,    ......do................   Do.
     Ulster County.                           1975, Emerg;
                                              September 15,
                                              1983, Reg;
                                              November 18,
                                              2016, Susp.
    Woodstock, Town of,              360868  May 28, 1975,    ......do................   Do.
     Ulster County.                           Emerg;
                                              September 27,
                                              1991, Reg;
                                              November 18,
                                              2016, Susp.

          Region IV

Tennessee:
    Franklin County,                 470344  June 12, 1991,   ......do................   Do.
     Unincorporated Areas.                    Emerg; January
                                              2, 1992, Reg;
                                              November 18,
                                              2016, Susp.
    Lincoln County,                  470104  June 3, 1991,    ......do................   Do.
     Unincorporated Areas.                    Emerg; October
                                              1, 1992, Reg;
                                              November 18,
                                              2016, Susp.
----------------------------------------------------------------------------------------------------------------
*do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: October 27, 2016.
Michael M. Grimm,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration, Department of Homeland Security, Federal
Emergency Management Agency.
[FR Doc. 2016-26766 Filed 11-4-16; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Rules and Regulations]
[Pages 15627-15630]
[FR Doc No: 2017-06201]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-N-0011]

Requirements To Submit Prior Notice of Imported Food; Technical
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
prior notice of imported food regulations to reflect a change in the
electronic data interchange system and its expanded capabilities, to
correct inaccurate number designations in section headings, and to
reflect a change in an office's name. This action is ministerial or
editorial in nature.

DATES: This rule is effective March 30, 2017.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Section 801(m) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 381(m)) requires that FDA establish regulations
requiring that those persons importing articles of food or offering
articles of food for import into the United States submit certain
information about imported foods before the products' arrival in the
United States. We have established the regulations at title 21, Code of
Federal Regulations (CFR) part 1, subpart I (21 CFR 1.276 to 1.285).
Section 801(m) of the FD&C Act also provides that an article of food
imported or offered for import is subject to refusal of admission into
the United States if adequate prior notice has not been provided to
FDA. Our regulations in 21 CFR part 1, subpart I, include information
on when to submit prior notice, how to submit prior notice, and what
information is required in a prior notice.

II. Description of the Technical Amendments

    We are making technical amendments in our prior notice regulations
in part 1, subpart I (Sec. Sec.  1.276 to 1.285), to:
     Reflect the change in an electronic data interchange
system and its expanded capabilities;
     correct paragraph number designations in certain
introductory text paragraphs; and
     revise the name of an FDA office receiving certain
information.
    The technical amendments are ministerial or editorial in nature and
are not intended to modify any substantive requirements.

A. Revising an Electronic Data Interchange System and Recognizing Its
Expanded Capabilities

    Our current regulations, at Sec. Sec.  1.279, 1.280, 1.281, and
1.282, refer to the ``Automated Broker Interface/Automated Commercial
System (ABI/ACS)'' or ``Automated Broker Interface of the Automated
Commercial System (ABI/ACS).'' We are amending these regulations to
reflect the change of the electronic data interchange system from
``Automated Broker Interface/Automated Commercial System (ABI/ACS)'' or
``Automated Broker Interface of the Automated Commercial System (ABI/
ACS)'' to ``Automated Broker Interface/Automated Commercial
Environment/International Trade Data System (ABI/ACE/ITDS).'' In the
Federal Register of May 16, 2016 (81 FR 30320), the Department of
Homeland Security's U.S. Customs and Border Protection (CBP) issued a
notice

announcing that the Automated Commercial Environment (ACE) will be the
sole electronic data interchange (EDI) system authorized by the
Commissioner of CBP for processing electronic entries and entry
summaries associated with the entry types specified in the notice, for
merchandise that is subject to our import requirements. The notice also
announced that the Automated Commercial System (ACS) will no longer be
a CBP-authorized EDI system for purposes of processing these electronic
filings. Therefore, we are revising our regulations at Sec. Sec.
1.279, 1.280, 1.281, and 1.282 by replacing all references to the
``Automated Broker Interface/Automated Commercial System (ABI/ACS)''
and ``Automated Broker Interface of the Automated Commercial System
(ABI/ACS)'' with ``Automated Broker Interface/Automated Commercial
Environment/International Trade Data System (ABI/ACE/ITDS)'' to
accurately identify the current EDI system. We note, however, that
there is no change in the FDA Prior Notice System Interface (FDA PNSI).
    Additionally, current Sec.  1.280 states that, for purposes of
submitting prior notice, prior notice for articles that have been
refused under section 801(m)(1) of the FD&C Act and our regulations
must be submitted through the FDA PNSI until such time as we and CBP
issue a determination that ACS or its successor system can accommodate
such transactions. In addition, current Sec.  1.281 describes what
information must be provided in the prior notice and states that, until
such time as we and CBP issue a determination that ACS can accommodate
such transactions, the tracking number may not be submitted in lieu of
other certain information if the prior notice is submitted via ABI/ACS.
Furthermore, if an article of food is arriving by express consignment
operator or carrier, our current regulations state that the tracking
number can only be submitted in certain circumstances when neither the
submitter nor transmitter is the express consignment operator or
carrier, and the prior notice is submitted via the FDA PNSI. We are
revising the regulations to remove these limitations because the new
ACE EDI system can accommodate such transactions. These faster,
streamlined, and automated processes allow traders to submit tracking
numbers much more easily. Therefore, we are removing the limitation
that the tracking number may not be submitted in lieu of certain other
information throughout the prior notice regulations.
    Furthermore, with the tracking number, we can learn the information
we need to make entry determinations, such as port, date and time of
arrival, airway bill, bill of lading, and vessel name and voyage or
flight number. Removing the condition that the transmitter or submitter
cannot be the operator or carrier gives submitters more options for
providing the information we require. Accordingly, the technical
amendment provides greater flexibility to industry while also allowing
us to screen imported food articles adequately.
    These changes are deregulatory in nature because they lessen the
burden imposed on traders without impairing our ability to ensure the
safety of imported food. The expanded capabilities of the new ACE EDI
system allow for additional flexibility in submitting certain
information. Because of technical limitations of the former system, in
certain cases the prior notice information could be submitted only via
FDA PNSI because ACS could not accommodate such transactions. For
example, ACS could not accept the tracking number in lieu of other
certain information such as port, date and time of arrival, airway
bill, bill of lading, vessel name, and voyage or flight number.
    The new ACE EDI system can accommodate these transactions, which
results in additional flexibility to industry. Some filers no longer
have to use two systems to file prior notice information for the same
food import line. In addition, FDA staff will be able to more
efficiently process import entry submissions and more quickly make the
initial import entry determination for food imports, in furtherance of
our goal to ensure the safety of imported food.

B. Correcting Number Designations in Headings and Changing an FDA
Office's Title

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was
signed into law on January 4, 2011. Section 304 of FSMA amended section
801(m)(1) of the FD&C Act to require that a person submitting prior
notice of imported food, in addition to other information already
required, report ``any country to which the article has been refused
entry.'' On May 5, 2011, we issued an interim final rule (2011 IFR) (76
FR 25542) implementing section 304 of FSMA. Specifically, the 2011 IFR
amended Sec.  1.281 by adding a new requirement to paragraphs (a), (b),
and (c) that any person submitting prior notice of imported food report
the name of any country to which the article has been refused entry.
However, the 2011 IFR neglected to make corresponding edits to change
the paragraph number designations in the introductory text for
paragraphs (a), (b), and (c) in Sec.  1.281 to reflect the additional
data element as added by the 2011 IFR and affirmed in a final rule
published on May 30, 2013 (78 FR 32359). The technical amendment
corrects those designations.
    Furthermore, current Sec.  1.285(i)(2) refers to the ``FDA Prior
Notice Center.'' The office is now named the ``FDA Division of Food
Defense Targeting,'' so we are amending Sec.  1.285(i)(2) accordingly.

III. The Administrative Procedure Act

    Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
Under 5 U.S.C. 553(b)(3)(B) of the APA, an Agency may, for good cause,
find (and incorporate the finding and a brief statement of reasons in
the rules issued) that notice and public comment procedure on a rule is
impracticable, unnecessary, or contrary to the public interest. We have
determined that notice and public comment are unnecessary because these
amendments only make technical or non-substantive, ministerial changes
to reflect the change in an electronic data interchange system and its
expanded capabilities, correct number designations in headings as a
result of the FSMA amendments to prior notice, and amend the name of an
FDA office. For these reasons we have determined that publishing a
notice of proposed rulemaking and providing opportunity for public
comment is unnecessary.
    In addition, we find good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendments do not impose any new regulatory requirements on
affected parties. As a result, affected parties do not need time to
prepare before the rule takes effect. Therefore, we find good cause for
this correction to become effective on the date of publication of this
action.

IV. Paperwork Reduction Act of 1995

    This final rule 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 1, subpart I, have been
approved under OMB control number 0910-0520.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. Amend Sec.  1.279 by revising paragraph (b)(1) to read as follows:

Sec.  1.279  When must prior notice be submitted to FDA?

* * * * *
    (b) * * *
    (1) If prior notice is submitted via the Automated Broker
Interface/Automated Commercial Environment/International Trade Data
System (ABI/ACE/ITDS), you may not submit prior notice more than 30-
calendar days before the anticipated date of arrival.
* * * * *

0
3. Amend Sec.  1.280 by revising paragraphs (a)(1) and (2) and (b) to
read as follows:

Sec.  1.280  How must you submit prior notice?

    (a) * * *
    (1) The U.S. Customs and Border Protection (CBP) Automated Broker
Interface/Automated Commercial Environment/International Trade Data
System (ABI/ACE/ITDS); or
    (2) The FDA PNSI at https://www.access.fda.gov/. You must submit
prior notice through the FDA Prior Notice System Interface (FDA PNSI)
for articles of food imported or offered for import by international
mail, and other transaction types that cannot be made through ABI/ACE/
ITDS.
    (b) If a customhouse broker's or self-filer's system is not working
or if the ABI/ACE/ITDS interface is not working, prior notice must be
submitted through the FDA PNSI.
* * * * *

0
4. Amend Sec.  1.281 by revising paragraphs (a) introductory text,
(a)(11)(iv), (a)(17)(i) and (iii), (b) introductory text, (c)
introductory text, (c)(11)(iii), and (c)(17)(i) and (iii) to read as
follows:

Sec.  1.281  What information must be in a prior notice?

    (a) General. For each article of food that is imported or offered
for import into the United States, except by international mail, you
must submit the information for the article that is required in
paragraphs (a)(1) through (18) of this section:
* * * * *
    (11) * * *
    (iv) Notwithstanding paragraphs (a)(11) introductory text and
(a)(11)(i) through (iii) of this section, if the article of food is
arriving by express consignment operator or carrier, the express
consignment operator or carrier tracking number may be submitted in
lieu of the information required in paragraphs (a)(11) introductory
text and (a)(11)(i) through (iii) of this section.
* * * * *
    (17) * * *
    (i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable. This information is not required for an article of food
when carried by or otherwise accompanying an individual when entering
the United States. If the article of food is arriving by express
consignment operator or carrier, the express consignment operator or
carrier tracking number may by submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s), as applicable;
* * * * *
    (iii) For food arriving by air carrier, the flight number. If the
article of food is arriving by express consignment operator or carrier,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number;
* * * * *
    (b) Articles arriving by international mail. For each article of
food that is imported or offered for import into the United States by
international mail, you must submit the information for the article
that is required in paragraphs (b)(1) through (12) of this section:
* * * * *
    (c) Refused articles. If the article of food has been refused under
section 801(m)(1) of the act and under this subpart, you must submit
the information for the article that is required in paragraphs (c)(1)
through (19) of this section. However, if the refusal is based on Sec.
1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to resubmit
any information previously submitted unless it has changed or the
article has been exported and the original prior notice was submitted
through ABI/ACE/ITDS. If the refusal is based on Sec.  1.283(a)(1)(ii),
you should cancel the previous submission per Sec.  1.282(b) and (c).
* * * * *
    (11) * * *
    (iii) Notwithstanding paragraphs (c)(11) introductory text and
(c)(11)(i) and (ii) of this section, if the article of food arrived by
express consignment operator or carrier, the express consignment
operator or carrier tracking number may be submitted in lieu of the
information required in paragraphs (c)(11) introductory text and
(c)(11)(i) and (ii) of this section.
* * * * *
    (17) * * *
    (i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable; however, this information is not required for an article of
food when carried by or otherwise accompanying an individual when
entering the United States. If the article of food arrived by express
consignment operator or carrier, the express consignment operator or
carrier tracking number may be submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s), as applicable;
* * * * *
    (iii) For food that arrived by air carrier, the flight number. If
the article of food arrived by express consignment operator or carrier,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number;
* * * * *

0
5. Amend Sec.  1.282 by revising paragraph (c) to read as follows:

Sec.  1.282  What must you do if information changes after you have
received confirmation of a prior notice from FDA?

* * * * *
    (c) If you submitted the prior notice via ABI/ACE/ITDS, you should
cancel the prior notice via ACE by requesting that CBP cancel the
entry.

0
6. Amend Sec.  1.285 by revising the first sentence in paragraph (i)(2)
to read as follows:

Sec.  1.285  What happens to food that is imported or offered for
import from unregistered facilities that are required to register under
subpart H of this part?

* * * * *
    (i) * * *
    (2) The FDA Division of Food Defense Targeting must be notified of
the applicable registration number in writing.* * *
* * * * *

    Dated: March 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06201 Filed 3-29-17; 8:45 am]
 BILLING CODE 4164-01-P