[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Proposed Rules]
[Pages 2865-2871]
[FR Doc No: 2015-00640]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0701; FRL-9921-70-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
District of Columbia; Infrastructure Requirements for the 2008 Ozone,
2010 Nitrogen Dioxide, and 2010 Sulfur Dioxide National Ambient Air
Quality Standards; Approval of Air Pollution Emergency Episode Plan

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve portions of three State Implementation Plan (SIP) revision
submittals from the District of Columbia (hereafter ``the District'')
pursuant to the Clean Air Act (CAA). Whenever new or revised national
ambient air quality standards (NAAQS) are promulgated, the CAA requires
states to submit a plan for the implementation, maintenance, and
enforcement of such NAAQS. The plan is required to address basic
program elements, including, but not limited to, regulatory structure,
monitoring, modeling, legal authority, and adequate resources necessary
to assure attainment and maintenance of the standards. These elements
are referred to as infrastructure requirements. The District has made
three separate submittals addressing the infrastructure requirements
for the 2008 ozone NAAQS, the 2010 nitrogen dioxide (NO2)
NAAQS, and the 2010 sulfur dioxide (SO2) NAAQS. One of the
infrastructure submittals also includes the ``Revised Air Quality
Emergency Plan for the District of Columbia'' for

satisfying EPA's requirements for air quality emergency episodes. In
this rulemaking action, EPA is proposing to approve, in accordance with
the requirements of the CAA: The three infrastructure SIP submissions
with the exception of the portions of the submittals addressing
transport of pollution and the portions of the submittals addressing
the Prevention of Significant Deterioration (PSD) permitting
requirements; and the District's Air Quality Emergency Plan which also
meets EPA's requirements for air pollution prevention contingency
plans.

DATES: Written comments must be received on or before February 20,
2015.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2014-0701 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2014-0701, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2014-0701. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the District of Columbia Department of the
Environment, Air Quality Division, 1200 1st Street NE., 5th floor,
Washington, DC 20002.

FOR FURTHER INFORMATION CONTACT: Emlyn V[eacute]lez-Rosa, (215) 814-
2038, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 27, 2008 (73 FR 16436), EPA promulgated a revised NAAQS
for ozone based on 8-hour average concentrations. EPA revised the level
of the 8-hour ozone NAAQS from 0.08 parts per million (ppm) to 0.075
ppm. On February 9, 2010 (75 FR 6474), EPA established a new 1-hour
primary NAAQS for NO2 at a level of 100 parts per billion
(ppb), based on a 3-year average of the 98th percentile of the yearly
distribution of 1-hour daily maximum concentrations. On June 22, 2010
(75 FR 35520), EPA promulgated a revised NAAQS for the 1-hour primary
SO2 at a level of 75 parts per billion (ppb), based on a 3-
year average of the annual 99th percentile of 1-hour daily maximum
concentrations.
    Pursuant to section 110(a)(1) of the CAA, states are required to
submit SIPs meeting the applicable requirements of section 110(a)(2)
within three years after promulgation of a new or revised NAAQS or
within such shorter period as EPA may prescribe. Section 110(a)(2)
requires states to address basic SIP elements such as requirements for
monitoring, basic program requirements, and legal authority that are
designed to assure attainment and maintenance of the NAAQS. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affects the content of the
submission. The content of such SIP submission may also vary depending
upon what provisions the state's existing SIP already contains.
    More specifically, section 110(a)(1) provides the procedural and
timing requirements for SIPs. Section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS. As mentioned earlier, these
requirements include basic SIP elements such as requirements for
monitoring, basic program requirements, and legal authority that are
designed to assure attainment and maintenance of the NAAQS.

II. Summary of State Submittals

    The District through the District Department of the Environment
(DDOE) submitted three separate revisions to its SIP to satisfy the
requirements of section 110(a)(2) of the CAA for the different NAAQS.
On June 6, 2014, DDOE submitted a SIP revision addressing the
infrastructure requirements for the 2010 NO2 NAAQS. On June
13, 2014, DDOE submitted an infrastructure SIP revision for the 2008
ozone NAAQS. On July 17, 2014, DDOE submitted an infrastructure SIP
revision for the 2010 SO2 NAAQS. Each of the infrastructure
SIP revisions addressed the following infrastructure elements for the
applicable NAAQS: Section 110(a)(2)(A), (B), (C), (D)(i)(I),
(D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) of the
CAA. The three infrastructure SIP submittals do not address section
110(a)(2)(I) which pertains to the nonattainment requirements of part
D, Title I of the CAA, because this element is not required to be
submitted by the 3-year submission deadline of CAA section 110(a)(1)
and will be addressed in a separate process, if necessary.
    In addition, the June 13, 2014 SIP submittal includes the ``Revised
Air Quality Emergency Plan for the District of Columbia,'' which the
District is requesting EPA to approve into the SIP to address EPA's
requirements for preventing air pollution emergency episodes which are
located in 40 CFR

part 51, subpart H and section 110(a)(2)(G) of the CAA. Section
110(a)(2)(G), among other things, requires state SIPs to provide
adequate contingency plans to implement a state's authority similar to
section 303 of the CAA regarding imminent and substantial endangerment
authority. The entire District is part of the National Capital
Interstate air quality control region, which is classified as a
Priority I region for particulate matter, sulfur oxides
(SOX), carbon monoxide (CO), and ozone and as a Priority III
region for NO2. See 40 CFR 52.471. Therefore, in accordance
with 40 CFR part 51, subpart H, the District submitted its Air Quality
Emergency Plan with contingency measures for all pollutants, including
particulate matter, SOX, CO, and ozone.

III. EPA's Approach To Review Infrastructure SIPs

    EPA is acting upon the District's SIP submissions that addresses
the infrastructure requirements of section 110(a)(1) and (2) of the CAA
for the 2008 ozone NAAQS, the 2010 NO2 NAAQS, and the 2010
SO2 NAAQS. The requirement for states to make a SIP
submission of this type arises out of section 110(a)(1). Pursuant to
section 110(a)(1), states must make SIP submissions ``within 3 years
(or such shorter period as the Administrator may prescribe) after the
promulgation of a national primary ambient air quality standard (or any
revision thereof),'' and these SIP submissions are to provide for the
``implementation, maintenance, and enforcement'' of such NAAQS. The
statute directly imposes on states the duty to make these SIP
submissions, and the requirement to make the submissions is not
conditioned upon EPA's taking any action other than promulgating a new
or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address.
    EPA has historically referred to these SIP submissions made for the
purpose of satisfying the requirements of section 110(a)(1) and (2) as
``infrastructure SIP'' submissions. Although the term ``infrastructure
SIP'' does not appear in the CAA, EPA uses the term to distinguish this
particular type of SIP submission from submissions that are intended to
satisfy other SIP requirements under the CAA, such as ``nonattainment
SIP'' or ``attainment plan SIP'' submissions to address the
nonattainment planning requirements of part D of Title I of the CAA,
``regional haze SIP'' submissions required by EPA rule to address the
visibility protection requirements of section 169A of the CAA, and
nonattainment new source review permit program submissions to address
the permit requirements of CAA, Title I, part D.
    Section 110(a)(1) addresses the timing and general requirements for
infrastructure SIP submissions and section 110(a)(2) provides more
details concerning the required contents of these submissions. The list
of required elements provided in section 110(a)(2) contains a wide
variety of disparate provisions, some of which pertain to required
legal authority, some of which pertain to required substantive program
provisions, and some of which pertain to requirements for both
authority and substantive program provisions.\1\ EPA therefore believes
that while the timing requirement in section 110(a)(1) is unambiguous,
some of the other statutory provisions are ambiguous. In particular,
EPA believes that the list of required elements for infrastructure SIP
submissions provided in section 110(a)(2) contains ambiguities
concerning what is required for inclusion in an infrastructure SIP
submission.
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    \1\ For example: Section 110(a)(2)(E)(i) provides that states
must provide assurances that they have adequate legal authority
under state and local law to carry out the SIP; Section 110(a)(2)(C)
provides that states must have a SIP-approved program to address
certain sources as required by part C of Title I of the CAA; and
section 110(a)(2)(G) provides that states must have legal authority
to address emergencies as well as contingency plans that are
triggered in the event of such emergencies.
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    The following examples of ambiguities illustrate the need for EPA
to interpret some section 110(a)(1) and section 110(a)(2) requirements
with respect to infrastructure SIP submissions for a given new or
revised NAAQS. One example of ambiguity is that section 110(a)(2)
requires that ``each'' SIP submission must meet the list of
requirements therein, while EPA has long noted that this literal
reading of the statute is internally inconsistent and would create a
conflict with the nonattainment provisions in part D of Title I of the
CAA, which specifically address nonattainment SIP requirements.\2\
Section 110(a)(2)(I) pertains to nonattainment SIP requirements and
part D addresses when attainment plan SIP submissions to address
nonattainment area requirements are due. For example, section 172(b)
requires EPA to establish a schedule for submission of such plans for
certain pollutants when the Administrator promulgates the designation
of an area as nonattainment, and section 107(d)(1)(B) allows up to two
years or in some cases three years, for such designations to be
promulgated.\3\ This ambiguity illustrates that rather than apply all
the stated requirements of section 110(a)(2) in a strict literal sense,
EPA must determine which provisions of section 110(a)(2) are applicable
for a particular infrastructure SIP submission.
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    \2\ See, e.g., ``Rule To Reduce Interstate Transport of Fine
Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions
to Acid Rain Program; Revisions to the NOX SIP Call;
Final Rule,'' 70 FR 25162, at 25163-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \3\ EPA notes that this ambiguity within section 110(a)(2) is
heightened by the fact that various subparts of part D set specific
dates for submission of certain types of SIP submissions in
designated nonattainment areas for various pollutants. Note, e.g.,
that section 182(a)(1) provides specific dates for submission of
emissions inventories for the ozone NAAQS. Some of these specific
dates are necessarily later than three years after promulgation of
the new or revised NAAQS.
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    Another example of ambiguity within section 110(a)(1) and (2) with
respect to infrastructure SIPs pertains to whether states must meet all
of the infrastructure SIP requirements in a single SIP submission, and
whether EPA must act upon such SIP submission in a single action.
Although section 110(a)(1) directs states to submit ``a plan'' to meet
these requirements, EPA interprets the CAA to allow states to make
multiple SIP submissions separately addressing infrastructure SIP
elements for the same NAAQS. If states elect to make such multiple SIP
submissions to meet the infrastructure SIP requirements, EPA can elect
to act on such submissions either individually or in a larger combined
action.\4\ Similarly, EPA interprets the CAA to allow it to take action
on the individual parts of one larger, comprehensive infrastructure SIP
submission for a given NAAQS without concurrent action on the entire
submission. For example, EPA has sometimes elected to act at different
times on various elements and sub-elements of the same infrastructure
SIP submission.\5\
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    \4\ See, e.g., ``Approval and Promulgation of Implementation
Plans; New Mexico; Revisions to the New Source Review (NSR) State
Implementation Plan (SIP); Prevention of Significant Deterioration
(PSD) and Nonattainment New Source Review (NNSR) Permitting,'' 78 FR
4339 (January 22, 2013) (EPA's final action approving the structural
PSD elements of the New Mexico SIP submitted by the State separately
to meet the requirements of EPA's 2008 PM2.5 NSR rule),
and ``Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Infrastructure and Interstate Transport Requirements for
the 2006 PM2.5 NAAQS,'' 78 FR 4337 (January 22, 2013)
(EPA's final action on the infrastructure SIP for the 2006
PM2.5 NAAQS).
    \5\ On December 14, 2007, the State of Tennessee, through the
Tennessee Department of Environment and Conservation, made a SIP
revision to EPA demonstrating that the State meets the requirements
of sections 110(a)(1) and (2). EPA proposed action for
infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR
3213) and took final action on March 14, 2012 (77 FR 14976). On
April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA
took separate proposed and final actions on all other section
110(a)(2) infrastructure SIP elements of Tennessee's December 14,
2007 submittal.

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    Ambiguities within section 110(a)(1) and (2) may also arise with
respect to infrastructure SIP submission requirements for different
NAAQS. Thus, EPA notes that not every element of section 110(a)(2)
would be relevant, or as relevant, or relevant in the same way, for
each new or revised NAAQS. The states' attendant infrastructure SIP
submissions for each NAAQS therefore could be different. For example,
the monitoring requirements that a state might need to meet in its
infrastructure SIP submission for purposes of section 110(a)(2)(B)
could be very different for different pollutants, because the content
and scope of a state's infrastructure SIP submission to meet this
element might be very different for an entirely new NAAQS than for a
minor revision to an existing NAAQS.\6\
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    \6\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
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    EPA notes that interpretation of section 110(a)(2) is also
necessary when EPA reviews other types of SIP submissions required
under the CAA. Therefore, as with infrastructure SIP submissions, EPA
also has to identify and interpret the relevant elements of section
110(a)(2) that logically apply to these other types of SIP submissions.
For example, section 172(c)(7) requires attainment plan SIP submissions
required by part D to meet the ``applicable requirements'' of section
110(a)(2); thus, attainment plan SIP submissions must meet the
requirements of section 110(a)(2)(A) regarding enforceable emission
limits and control measures and section 110(a)(2)(E)(i) regarding air
agency resources and authority. By contrast, it is clear that
attainment plan SIP submissions required by part D would not need to
meet the portion of section 110(a)(2)(C) that pertains to the PSD
program required in part C of Title I of the CAA, because PSD does not
apply to a pollutant for which an area is designated nonattainment and
thus subject to part D planning requirements. As this example
illustrates, each type of SIP submission may implicate some elements of
section 110(a)(2) but not others.
    Given the potential for ambiguity in some of the statutory language
of section 110(a)(1) and section 110(a)(2), EPA believes that it is
appropriate to interpret the ambiguous portions of section 110(a)(1)
and section 110(a)(2) in the context of acting on a particular SIP
submission. In other words, EPA assumes that Congress could not have
intended that each and every SIP submission, regardless of the NAAQS in
question or the history of SIP development for the relevant pollutant,
would meet each of the requirements, or meet each of them in the same
way. Therefore, EPA has adopted an approach under which it reviews
infrastructure SIP submissions against the list of elements in section
110(a)(2), but only to the extent each element applies for that
particular NAAQS.
    Historically, EPA has elected to use guidance documents to make
recommendations to states for infrastructure SIPs, in some cases
conveying needed interpretations on newly arising issues and in some
cases conveying interpretations that have already been developed and
applied to individual SIP submissions for particular elements.\7\ EPA
most recently issued guidance for infrastructure SIPs on September 13,
2013 (2013 Guidance).\8\ EPA developed this document to provide states
with up-to-date guidance for infrastructure SIPs for any new or revised
NAAQS. Within this guidance, EPA describes the duty of states to make
infrastructure SIP submissions to meet basic structural SIP
requirements within three years of promulgation of a new or revised
NAAQS. EPA also made recommendations about many specific subsections of
section 110(a)(2) that are relevant in the context of infrastructure
SIP submissions.\9\ The guidance also discusses the substantively
important issues that are germane to certain subsections of section
110(a)(2). EPA interprets section 110(a)(1) and (2) such that
infrastructure SIP submissions need to address certain issues and need
not address others. Accordingly, EPA reviews each infrastructure SIP
submission for compliance with the applicable statutory provisions of
section 110(a)(2), as appropriate.
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    \7\ EPA notes, however, that nothing in the CAA requires EPA to
provide guidance or to promulgate regulations for infrastructure SIP
submissions. The CAA directly applies to states and requires the
submission of infrastructure SIP submissions, regardless of whether
or not EPA provides guidance or regulations pertaining to such
submissions. EPA elects to issue such guidance in order to assist
states, as appropriate.
    \8\ ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),''
Memorandum from Stephen D. Page, September 13, 2013.
    \9\ EPA's September 13, 2013, guidance did not make
recommendations with respect to infrastructure SIP submissions to
address Section 110(a)(2)(D)(i)(I). EPA issued the guidance shortly
after the U.S. Supreme Court agreed to review the D.C. Circuit
decision in EME Homer City, 696 F.3d 7 (D.C. Cir. 2012) which had
interpreted the requirements of section 110(a)(2)(D)(i)(I). In light
of the uncertainty created by ongoing litigation, EPA elected not to
provide additional guidance on the requirements of section
110(a)(2)(D)(i)(I) at that time. As the guidance is neither binding
nor required by statute, whether EPA elects to provide guidance on a
particular section has no impact on a state's CAA obligations.
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    As an example, section 110(a)(2)(E)(ii) is a required element of
section 110(a)(2) for infrastructure SIP submissions. Under this
element, a state must meet the substantive requirements of section 128,
which pertain to state boards that approve permits or enforcement
orders and heads of executive agencies with similar powers. Thus, EPA
reviews infrastructure SIP submissions to ensure that the state's SIP
appropriately addresses the requirements of section 110(a)(2)(E)(ii)
and section 128. The 2013 Guidance explains EPA's interpretation that
there may be a variety of ways by which states can appropriately
address these substantive statutory requirements, depending on the
structure of an individual state's permitting or enforcement program
(e.g., whether permits and enforcement orders are approved by a multi-
member board or by a head of an executive agency). However they are
addressed by the state, the substantive requirements of Section 128 are
necessarily included in EPA's evaluation of infrastructure SIP
submissions because section 110(a)(2)(E)(ii) explicitly requires that
the state satisfy the provisions of section 128.
    As another example, EPA's review of infrastructure SIP submissions
with respect to the PSD program requirements in section 110(a)(2)(C),
(D)(i)(II), and (J) focuses upon the structural PSD program
requirements contained in part C and EPA's PSD regulations. Structural
PSD program requirements include provisions necessary for the PSD
program to address all regulated sources and NSR pollutants, including
Green House Gases (GHGs). By contrast, structural PSD program
requirements do not include provisions that are not required under
EPA's regulations at 40 CFR 51.166 but are merely available as an
option for the state, such as the option to provide grandfathering of
complete permit applications with respect to the 2013 PM2.5
NAAQS. Accordingly, the latter optional provisions are types of
provisions EPA considers irrelevant in the context of an infrastructure
SIP action.
    For other section 110(a)(2) elements, however, EPA's review of a
state's infrastructure SIP submission focuses

on assuring that the state's SIP meets basic structural requirements.
For example, section 110(a)(2)(C) includes, inter alia, the requirement
that states have a program to regulate minor new sources. Thus, EPA
evaluates whether the state has an EPA-approved minor new source review
program and whether the program addresses the pollutants relevant to
that NAAQS. In the context of acting on an infrastructure SIP
submission, however, EPA does not think it is necessary to conduct a
review of each and every provision of a state's existing minor source
program (i.e., already in the existing SIP) for compliance with the
requirements of the CAA and EPA's regulations that pertain to such
programs.
    With respect to certain other issues, EPA does not believe that an
action on a state's infrastructure SIP submission is necessarily the
appropriate type of action in which to address possible deficiencies in
a state's existing SIP. These issues include: (i) Existing provisions
related to excess emissions from sources during periods of startup,
shutdown, or malfunction that may be contrary to the CAA and EPA's
policies addressing such excess emissions (SSM); (ii) existing
provisions related to ``director's variance'' or ``director's
discretion'' that may be contrary to the CAA because they purport to
allow revisions to SIP-approved emissions limits while limiting public
process or not requiring further approval by EPA; and (iii) existing
provisions for PSD programs that may be inconsistent with current
requirements of EPA's ``Final NSR Improvement Rule,'' 67 FR 80186
(December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (NSR
Reform). Thus, EPA believes it may approve an infrastructure SIP
submission without scrutinizing the totality of the existing SIP for
such potentially deficient provisions and may approve the submission
even if it is aware of such existing provisions.\10\ It is important to
note that EPA's approval of a state's infrastructure SIP submission
should not be construed as explicit or implicit re-approval of any
existing potentially deficient provisions that relate to the three
specific issues just described.
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    \10\ By contrast, EPA notes that if a state were to include a
new provision in an infrastructure SIP submission that contained a
legal deficiency, such as a new exemption for excess emissions
during SSM events, then EPA would need to evaluate that provision
for compliance against the rubric of applicable CAA requirements in
the context of the action on the infrastructure SIP.
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    EPA's approach to review of infrastructure SIP submissions is to
identify the CAA requirements that are logically applicable to that
submission. EPA believes that this approach to the review of a
particular infrastructure SIP submission is appropriate, because it
would not be reasonable to read the general requirements of section
110(a)(1) and the list of elements in section 110(a)(2) as requiring
review of each and every provision of a state's existing SIP against
all requirements in the CAA and EPA regulations merely for purposes of
assuring that the state in question has the basic structural elements
for a functioning SIP for a new or revised NAAQS. Because SIPs have
grown by accretion over the decades as statutory and regulatory
requirements under the CAA have evolved, they may include some outmoded
provisions and historical artifacts. These provisions, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP
submission. EPA believes that a better approach is for states and EPA
to focus attention on those elements of section 110(a)(2) of the CAA
most likely to warrant a specific SIP revision due to the promulgation
of a new or revised NAAQS or other factors.
    For example, EPA's 2013 Guidance gives simpler recommendations with
respect to carbon monoxide than other NAAQS pollutants to meet the
visibility requirements of section 110(a)(2)(D)(i)(II), because carbon
monoxide does not affect visibility. As a result, an infrastructure SIP
submission for any future new or revised NAAQS for carbon monoxide need
only state this fact in order to address the visibility prong of
section 110(a)(2)(D)(i)(II).
    Finally, EPA believes that its approach with respect to
infrastructure SIP requirements is based on a reasonable reading of
section 110(a)(1) and (2) because the CAA provides other avenues and
mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow EPA to take appropriately
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or to otherwise comply with the CAA.\11\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\12\ Significantly, EPA's
determination that an action on a state's infrastructure SIP submission
is not the appropriate time and place to address all potential existing
SIP deficiencies does not preclude EPA's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action to
correct those deficiencies at a later time. For example, although it
may not be appropriate to require a state to eliminate all existing
inappropriate director's discretion provisions in the course of acting
on an infrastructure SIP submission, EPA believes that section
110(a)(2)(A) may be among the statutory bases that EPA relies upon in
the course of addressing such deficiency in a subsequent action.\13\
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    \11\ For example, EPA issued a SIP call to Utah to address
specific existing SIP deficiencies related to the treatment of
excess emissions during SSM events. See ``Finding of Substantial
Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revisions,'' 74 FR 21639 (April 18, 2011).
    \12\ EPA has used this authority to correct errors in past
actions on SIP submissions related to PSD programs. See ``Limitation
of Approval of Prevention of Significant Deterioration Provisions
Concerning Greenhouse Gas Emitting-Sources in State Implementation
Plans; Final Rule,'' 75 FR 82536 (December 30, 2010). EPA has
previously used its authority under section 110(k)(6) of the CAA to
remove numerous other SIP provisions that the Agency determined it
had approved in error. See, e.g., 61 FR 38664 (July 25, 1996) and 62
FR 34641 (June 27, 1997) (corrections to American Samoa, Arizona,
California, Hawaii, and Nevada SIPs); 69 FR 67062, November 16, 2004
(corrections to California SIP); and 74 FR 57051 (November 3, 2009)
(corrections to Arizona and Nevada SIPs).
    \13\ See, e.g., EPA's disapproval of a SIP submission from
Colorado on the grounds that it would have included a director's
discretion provision inconsistent with CAA requirements, including
section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 (July 21,
2010) (proposed disapproval of director's discretion provisions); 76
FR 4540 (January 26, 2011) (final disapproval of such provisions).
---------------------------------------------------------------------------

IV. Summary of EPA's Rationale for Proposing Approval

    In accordance with 40 CFR part 51, appendix V, EPA found that each
of the infrastructure SIP submittals is technically incomplete for the
portions of the infrastructure elements in section 110(a)(2)(C),
(D)(i)(II), (D)(ii), and (J) relating to the permitting program for
PSD, because the District has not adequately addressed the requirements
of part C of Title I of the CAA for having a SIP-approved PSD program.
EPA found the remainder of the SIP submittals to be administratively
and technically complete. EPA sent letters to DDOE in July 21, 2014 and
November 4, 2014 notifying the District of these determinations for
each of the applicable NAAQS.\14\ As a result of

these incompleteness findings, EPA is not taking rulemaking action on
the PSD-related portions of section 110(a)(2)(C), (D)(i)(II), (D)(ii),
and (J) for the District's infrastructure SIP submittals for the 2010
NO2 NAAQS, the 2008 ozone NAAQS, and the 2010 SO2
NAAQS, until the District through DDOE submits a SIP to address the PSD
permit program requirements of part C of Title I of the CAA.
---------------------------------------------------------------------------

    \14\ Letters regarding EPA's completeness determinations are
included in the docket for this rulemaking action.
---------------------------------------------------------------------------

    EPA recognizes, however, that the District of Columbia is already
subject to a Federal Implementation Plan (FIP) containing the Federal
PSD program \15\ to correct the SIP deficiency and that DDOE would not
have to take further action for the FIP-based permitting process to
continue operating. Thus, EPA anticipates that there will be no adverse
consequences to DDOE from these incompleteness findings for the PSD-
related portions of section 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J)
for the 2008 ozone NAAQS and 2010 NO2 and SO2
NAAQS. Mandatory sanctions would not apply to the District under CAA
section 179 because the failure to submit a PSD SIP is neither (1) with
respect to a submission that is required under CAA Title I part D, or
(2) in response to a SIP call under CAA section 110(k)(5). In addition,
EPA is not subject to any further FIP duties from our finding of
incompleteness for these SIP submittals because there is already the
FIP implementing the Federal PSD program for DDOE which addresses the
SIP deficiency.
---------------------------------------------------------------------------

    \15\ On August 7, 1980 (45 FR 52676, at 52741), EPA disapproved
a number of states SIPs for PSD purposes, including the District and
incorporated by reference portions of the Federal PSD provisions in
40 CFR 52.21 into the implementation plans for those states. This
FIP was subsequently amended to reflect amendments to the Federal
PSD rule on March 10, 2003 (68 FR 11316, at 11322) and December 24,
2003 (68 FR 74483, at 74488). At present, the PSD FIP, incorporated
by reference in the District SIP in 40 CFR 52.499, specifically
contains the provisions of 40 CFR 52.21, with the exception of
paragraph (a)(1).
---------------------------------------------------------------------------

    In addition, EPA is also not taking rulemaking action at this time
on the portion of the infrastructure SIP submittals which address
section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS and the 2010
NO2 and SO2 NAAQS. EPA will take later rulemaking
action on these submittals regarding section 110(a)(2)(D)(i)(I). In
this rulemaking action, EPA is proposing approval of the remainder of
the submittals to address infrastructure requirements for the 2010
NO2 NAAQS, the 2008 ozone NAAQS, and the 2010 SO2
NAAQS. A detailed summary of EPA's review and rationale for proposing
to approve these portions of the District's infrastructure SIP
submittals may be found in the Technical Support Document (TSD) for
this proposed rulemaking action which is available on line at
www.regulations.gov, Docket ID Number EPA-R03-OAR-2014-0701.
    As mentioned previously, on June 13, 2014, the District also
submitted a SIP revision addressing EPA's contingency plan requirements
in 40 CFR part 51, subpart H (40 CFR 51.150 through 51.153) and in CAA
section 110(2)(G). Section 110(a)(2)(G), among other things, requires
state SIPs to provide adequate contingency plans to implement the
state's authority similar to section 303 of the CAA, regarding imminent
and substantial endangerment authority. Pursuant to 40 CFR part 51,
subpart H, the District is required to have a contingency plan for
particulate matter, SOX, CO, and ozone. EPA notes that there
are no applicable requirements under 40 CFR part 51, subpart H for
NO2, and consequently no applicable contingency plan
requirements under CAA section 110(a)(2)(G) for NO2 for the
District, as Priority III regions are not required to have emergency
episode plans.
    EPA finds that the District's Emergency Plan satisfies the
requirements of 40 CFR part 51, subpart H with respect to contingency
plans for all applicable pollutants. In this rulemaking action, EPA is
proposing to approve into the SIP the ``Revised Air Quality Emergency
Plan for the District of Columbia,'' pursuant to section 110 of the
CAA, and is also proposing that the three infrastructure SIP submittals
for the applicable NAAQS meet the applicable contingency plan
requirements in CAA section 110(a)(2)(G) for the 2008 ozone NAAQS, 2010
NO2 NAAQS, and 2010 SO2 NAAQS. A detailed summary
of EPA's review and rationale for approving the ``Revised Air Quality
Emergency Plan for the District of Columbia'' into the District's SIP
because it meets requirements in CAA section 110 and 40 CFR part 51,
subpart H is provided in our TSD accompanying this proposed rulemaking
action. EPA is soliciting public comments on the issues discussed in
this document. These comments will be considered before taking final
action.

V. Proposed Action

    EPA is proposing to approve the District's infrastructure
submittals dated June 6, 2014, June 13, 2014, and July 17, 2014 for the
2010 NO2 NAAQS, the 2008 ozone NAAQS, and the 2010
SO2 NAAQS, respectively, as meeting the requirements of
section 110(a)(2) of the CAA, including specifically section
110(a)(2)(A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J),
(K), (L), and (M) for the three NAAQS with the exception of the
requirements related to the PSD permitting program of part C, Title I
of the CAA in section 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J), and
with the exception of the transport requirement of section
110(a)(2)(D)(i)(I). EPA is not taking action on the portions of the
three infrastructure submittals intended to address section
110(a)(2)(D)(i)(I) for transport or on the portions of the three
infrastructure SIP submittals addressing the PSD related requirements
in section 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J). EPA will take
later separate action on section 110(a)(2)(D)(i)(I) of the CAA for
transport for the three NAAQS.
    EPA is also proposing to approve as a SIP revision the ``Revised
Air Quality Emergency Plan for the District of Columbia,'' submitted on
June 13, 2014, as it satisfies the requirements of 40 CFR part 51,
subpart H for all applicable pollutants and section 110 of the CAA,
including specifically section 110(a)(2)(G) for the 2008 ozone NAAQS,
the 2010 NO2 NAAQS, and the 2010 SO2 NAAQS.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive

Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking action, pertaining to the
District of Columbia's section 110(a)(2) infrastructure requirements
for the 2008 ozone, the 2010 NO2, and the 2010
SO2 NAAQS and to the District of Columbia's contingency plan
for the prevention of air pollution episodes, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: December 18, 2014.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2015-00640 Filed 1-20-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Notices]
[Page 19461-19462]
[DOCID:fr14ap10-124]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0045]

Receipt of Petition for Decision That Nonconforming 2006 and 2007
Mercedes Benz G-Class Long-Wheelbase MPVs Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of petition.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA) has
received a petition to decide that 2006 and 2007 Mercedes Benz G-Class
(463 chassis) LWB multipurpose passenger vehicles (MPVs) that were not
originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS) are eligible for importation into the
United States because: (1) They are substantially similar to vehicles
that were originally manufactured for sale in the United States and
that were certified by their manufacturer as complying with the safety
standards (the U.S.-certified 2006 and 2007 Mercedes Benz G-Class (463
chassis) LWB MPV), and (2) they are capable of being readily altered to
conform to the standards.

DATES: The closing date for comments on the petition is May 14, 2010.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://
www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for sale in the United States, certified under
49 U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register

of each petition that it receives, and affords interested persons an
opportunity to comment on the petition. At the close of the comment
period, NHTSA decides, on the basis of the petition and any comments
that it has received, whether the vehicle is eligible for importation.
The agency then publishes this decision in the Federal Register.
    J.K. Technologies, LLC, of Baltimore, Maryland (J.K.) (Registered
Importer 90-006) has petitioned NHTSA to decide whether nonconforming
2006 and 2007 Mercedes Benz G-Class (463 chassis) LWB MPVs are eligible
for importation into the United States. The vehicles which J.K.
believes are substantially similar are 2006 and 2007 Mercedes Benz G-
Class (463 chassis) LWB MPVs that were manufactured for sale in the
United States and certified by their manufacturer as conforming to all
applicable FMVSS.
    The petitioner claims that it carefully compared non-U.S. certified
2006 and 2007 Mercedes Benz G-Class (463 chassis) LWB MPVs, to their
U.S.-certified counterparts, and found the vehicles to be substantially
similar with respect to compliance with most FMVSS.
    J.K. submitted information with its petition intended to
demonstrate that non-U.S. certified 2006 and 2007 Mercedes Benz G-Class
(463 chassis) LWB MPVs, as originally manufactured, conform to many
FMVSS in the same manner as their U.S. certified counterparts, or are
capable of being readily altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 2006
and 2007 Mercedes Benz G-Class (463 chassis) LWB MPVs, are identical to
their U.S.-certified counterparts with respect to compliance with
Standard Nos. 102 Transmission Shift Lever Sequence, Starter Interlock,
and Transmission Braking Effect, 103 Windshield Defrosting and
Defogging Systems, 104 Windshield Wiping and Washing Systems, 106 Brake
Hoses, 113 Hood Latch System, 116 Motor Vehicle Brake Fluids, 124
Accelerator Control Systems, 135 Light Vehicle Brake Systems, 139 New
Pneumatic Radial Tires for Light Vehicles, 201 Occupant Protection in
Interior Impact, 202 Head Restraints, 204 Steering Control Rearward
Displacement, 205 Glazing Materials, 206 Door Locks and Door Retention
Components, 207 Seating Systems, 210 Seat Belt Assembly Anchorages, 212
Windshield Mounting, 214 Side Impact Protection, 216 Roof Crush
Resistance, 219 Windshield Zone Intrusion, 301 Fuel System Integrity,
and 302 Flammability of Interior Materials.
    Petitioner also contends that the vehicle is capable of being
readily altered to meet the following standards, in the manner
indicated:
    Standard No. 101 Controls and Displays:
    (a) Replacement of the instrument cluster with a U.S.-model
component; (b) installation or activation of the U.S.-version control
and display software; and (c) installation of a U.S.-model cruise
control lever.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: Installation of the following U.S.-model components on
vehicles that are not already so equipped: (a) Front sidemarker lamps;
(b) headlamps; and (c) tail lamps with integral rear side marker lamps.
    Standard No. 110 Tire Selection and Rims and Motor Home/
Recreational Vehicle Trailer Load Carrying Capacity Information for
Motor Vehicles with a GVWR of 4,536 Kilograms (10,000 pounds) or Less:
Installation of a tire information placard.
    Standard No. 111 Rearview Mirrors: Installation of a U.S.-model
passenger side rearview mirror, or inscription of the required warning
statement on the face of that mirror on all vehicles not already so
equipped.
    Standard No. 114 Theft Protection: Installation of U.S.-version
software on all vehicles not already so equipped.
    Standard No. 118 Power-Operated Window, Partition, and Roof Panel
Systems: Installation or activation of U.S.-version software in the
vehicle's computer system to meet the requirements of this standard on
vehicles that do not already have this software installed or activated.
    Standard No. 138 Tire Pressure Monitoring Systems: Inspection of
all vehicles and installation of a conforming tire monitoring system on
vehicles not already so equipped.
    Standard No. 208 Occupant Crash Protection: Installation or
activation of U.S.-version software to ensure that the seat belt
warning system meets the requirements of this standard.
    The petitioner states that the occupant crash protection systems
used in these vehicles are identical to the U.S.-version with the
exception of the front and rear passenger seat belt assemblies. All
seat belt assemblies with the exception of the driver's seat belt
assembly must be replaced with ones that meet the requirements of FMVSS
No. 208 and FMVSS No. 209.
    Standard No. 209 Seat Belt Assemblies: All seat belt assemblies
with the exception of the driver's seat belt assembly must be replaced
with ones that meet the requirements of FMVSS No. 208 and FMVSS No.
209.
    Standard No. 225 Child Restraint Anchorage Systems: Installation of
U.S.-model child restraint anchorage system components that meet the
requirements of FMVSS No. 225.
    The petitioner additionally states that a vehicle identification
plate must be affixed to the vehicles near the left windshield post to
meet the requirements of 49 CFR part 565.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority: 49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: April 8, 2010.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-8483 Filed 4-13-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Pages 12582-12583]
[FR Doc No: 2018-05797]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-N-1027; FDA-2017-N-1064; FDA-2014-D-0329; FDA-
2013-N-1429; FDA-2009-N-0505; and FDA-2014-N-0192]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB Control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Infant Formula Recall Regulations.......       0910-0188      12/31/2020
State Petitions for Exemptions from            0910-0277      12/31/2020
 Preemption.............................
Guidance for Industry: Fees for Human          0910-0776      12/31/2020
 Drug Compounding Outsourcing Facilities
 Under Sections 503B and 744K of the
 Federal Food, Drug, and Cosmetic Act...
Guidance for Industry: Registration of         0910-0777      12/31/2020
 Human Drug Compounding Outsourcing
 Facilities Under Section 503B of the
 Federal Food, Drug, and Cosmetic Act...
Reporting and Recordkeeping Requirements       0910-0623       1/31/2021
 for Human Food and Cosmetics
 Manufactured from, Processed With, or
 Otherwise Containing, Material from
 Cattle.................................
Establishing and Maintaining a List of         0910-0839       1/31/2021
 U.S. Milk and Milk Product, Seafood,
 Infant Formula, and Formula for Young
 Children Manufactured/Processors with
 Interest in Exporting to China.........
------------------------------------------------------------------------

    Dated: March 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05797 Filed 3-21-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Rules and Regulations]
[Page 74193]
[DOCID:fr31de07-9]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 219

[Docket No. 2001-11213, Notice No. 11]
RIN 2130-AA81

Alcohol and Drug Testing: Determination of Minimum Random Testing
Rates for 2008

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Notice of Determination.

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SUMMARY: Using data from Management Information System annual reports,
FRA has determined that the 2006 rail industry random testing positive
rates were 0.60 percent for drugs and 0.13 percent for alcohol. Because
the industry-wide random drug testing positive rate has remained below
1.0 percent for the last two years, the Federal Railroad Administrator
(Administrator) has determined that the minimum annual random drug
testing rate for the period January 1, 2008, through December 31, 2008,
will remain at 25 percent of covered railroad employees. In addition,
because the industry-wide random alcohol testing violation rate has
remained below 0.5 percent for the last two years, the Administrator
has determined that the minimum random alcohol testing rate will remain
at 10 percent of covered railroad employees for the period January 1,
2008, through December 31, 2008.

DATES: This notice is effective upon publication.

FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program
Manager, Office of Safety Enforcement, Mail Stop 25, Federal Railroad
Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590,
(telephone<PHONE_NUMBER>); or Kathy Schnakenberg, FRA Alcohol/Drug
Program Specialist, (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Administrator's Determination of 2008 Minimum Random Drug and Alcohol
Testing Rates

    In a final rule published on December 2, 1994 (59 FR 62218), FRA
announced that it will set future minimum random drug and alcohol
testing rates according to the rail industry's overall positive rate,
which is determined using annual railroad drug and alcohol program data
taken from FRA's Management Information System. Based on this data, the
Administrator publishes a Federal Register notice each year, announcing
the minimum random drug and alcohol testing rates for the following
year. See 49 CFR 219.602, 608.
    Under this performance-based system, FRA may lower the minimum
random drug testing rate to 25 percent of covered railroad employees
whenever the industry-wide random drug positive rate is less than 1.0
percent for two calendar years while testing at a 50 percent minimum
rate. For both drugs and alcohol, FRA reserves the right to consider
other factors, such as the number of positives in its post-accident
testing program, before deciding whether to lower annual minimum random
testing rates. If the industry-wide random drug positive rate is 1.0
percent or higher in any subsequent calendar year, FRA will return the
minimum random drug testing rate to 50 percent of covered railroad
employees.
    If the industry-wide random alcohol violation rate is less than 1.0
percent but greater than 0.5 percent, the minimum random alcohol
testing rate will be 25 percent of covered railroad employees. FRA will
raise the minimum random rate to 50 percent of covered railroad
employees if the industry-wide random alcohol violation rate is 1.0
percent or higher in any subsequent calendar year. FRA may lower the
minimum random alcohol testing rate to 10 percent of covered railroad
employees whenever the industry-wide violation rate is less than 0.5
percent for two calendar years while testing at a higher rate.
    In this notice, FRA announces that the minimum random drug testing
rate will remain at 25 percent of covered railroad employees for the
period January 1, 2008, through December 31, 2008, because the industry
random drug testing positive rate was below 1.0 percent for the last
two years (.060 in 2006 and .073 in 2005). The minimum random alcohol
testing rate will remain at 10 percent of covered railroad employees
for the period January 1, 2008, through December 31, 2008, because the
industry-wide violation rate for alcohol has remained below 0.5 percent
for the last two years (.013 in 2006 and .017 in 2005). Railroads
remain free, as always, to conduct random testing at higher rates.

    Issued in Washington, DC, on December 17, 2007.
Joseph H. Boardman,
Administrator.
[FR Doc. E7-25353 Filed 12-28-07; 8:45 am]

BILLING CODE 4910-06-P