[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14660-14662]
[FR Doc No: 2019-07168]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1388]

Responsible Innovation in Dietary Supplements; Public Meeting;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Responsible
Innovation in Dietary Supplements.'' The purpose of the public meeting
is to give interested parties an opportunity to present ideas for
facilitating responsible innovation in the dietary supplement industry
while preserving and strengthening FDA's ability to efficiently and
effectively protect the public from unsafe and unlawful products.

DATES: The public meeting will be held on May 16, 2019, from 8:30 a.m.
to 4 p.m. Eastern Time. Submit either electronic or written comments on
this public meeting by July 15, 2019. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public meeting will be held at Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Wiley
Auditorium, 5001 Campus Dr., College Park, MD 20740.
    FDA is establishing a docket for public comment on this meeting.
You may submit comments as follows. Please note that late, untimely
filed comments may not be considered. Electronic comments must be
submitted on or before July 15, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of July 15, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1388 for ``Responsible Innovation in Dietary Supplements;
Public Meeting; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-009),
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On February 11, 2019, FDA announced new efforts to strengthen the
regulation of dietary supplements by modernizing and reforming FDA's
oversight (see Statement from FDA Commissioner Scott Gottlieb, M.D., on
the Agency's new efforts to strengthen regulation of dietary
supplements by modernizing and reforming FDA's oversight, available at
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm). FDA's announcement acknowledged the need to ensure that
our regulatory framework is flexible enough to adequately evaluate
product safety without unnecessarily restricting innovation. We invite
public input about whether and how we should adjust our current dietary
supplement regulatory approach to better allow for innovation and
growth in the dietary supplement marketplace while maintaining and
strengthening our ability to efficiently and effectively evaluate
product safety and protect the public health.
    The Dietary Supplement Health and Education Act of 1994 (DSHEA)
(Pub. L. 103-417) amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and defined ``dietary supplement,'' in part, as a product
(other than tobacco) intended to supplement the diet that bears or
contains one or more of the following dietary ingredients:
    (A) A vitamin;
    (B) a mineral;
    (C) an herb or other botanical;
    (D) an amino acid;
    (E) a dietary substance for use by man to supplement the diet by
increasing the total dietary intake; or
    (F) a concentrate, metabolite, constituent, extract, or combination
of any ingredient described in clause (A), (B), (C), (D), or (E).
    Section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)).
    DSHEA clarified that dietary supplements are generally subject to
regulation as foods under the FD&C Act but also included dietary
supplement-specific adulteration and misbranding provisions. Among
other things, DSHEA provided authority for FDA to establish current
good manufacturing practice requirements for dietary supplements and
clarified the statements of nutritional support that can be made in
product labeling. Dietary supplement manufacturers and distributors are
responsible for selling products that comply with these requirements.
FDA is responsible for regulating dietary supplements and has authority
to take enforcement action when dietary supplements are adulterated or
misbranded.
    DSHEA also added section 413 of the FD&C Act (21 U.S.C. 350b),
which defines the term ``new dietary ingredient'' (NDI) and describes
requirements for NDIs. Among other things, section 413 of the FD&C Act
requires the manufacturer or distributor of an NDI, or of a dietary
supplement containing an NDI, to submit a premarket notification to FDA
at least 75 days before introducing the NDI or dietary supplement into
interstate commerce, unless the NDI and any other dietary ingredients
in the dietary supplement have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered (21 U.S.C. 350b(a)(1)).
    DSHEA contemplated a dynamic dietary supplement market with a role
for innovation. In the 25 years since DSHEA was enacted, the dietary
supplement market has grown significantly. What was once a $4 billion
industry comprising about 4,000 products is now an industry worth more
than $40 billion with more than 50,000--and possibly as many as 80,000
or even more--products available to consumers. Innovative new products
involving novel technologies related to ingredients, manufacturing
processes, and delivery systems represent a substantial portion of this
growth.
    A robust NDI notification process is an integral part of the DSHEA
framework and represents FDA's only opportunity to evaluate the safety
of NDIs in dietary supplements before they become available to
consumers. Despite the expanded marketplace, however, we have only
received about 1,200 NDI notifications since DSHEA's enactment. FDA
recognizes that not every new

dietary supplement product is subject to the notification requirement,
so we continue to provide clarifications on when premarket
notifications are required.\1\ A transparent, common understanding of
the requirements surrounding dietary ingredient status and
notification, with predictable expectations regarding compliance and
consequences for non-compliance, will help our regulatory processes
operate effectively. Public discussion of these issues will further our
efforts to strengthen regulation of dietary supplements through
modernization and reform and help us better protect the public health.
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    \1\ See, e.g., Draft Guidance for Industry: Dietary Supplements:
New Dietary Ingredient Notifications and Related Issues (August
2016), available at https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm. This draft guidance, when finalized, will represent
FDA's current thinking on this topic.
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II. Topics for Discussion at the Public Meeting

    FDA will host a one-day public meeting to provide interested
parties an opportunity to discuss various issues related to responsible
innovation in dietary supplements, including the following topics:
    (1) The scope of the phrase ``dietary substance for use by man to
supplement the diet by increasing the total dietary intake,'' as used
in DSHEA (section 201(ff)(1)(E) of the FD&C Act);
    (2) Understanding exceptions to the requirement for premarket
notification, and evaluating whether and how growth in the marketplace
since 1994 has altered the impact of those provisions;
    (3) Potential commercial or marketing advantages to incentivize
responsible innovation; and
    (4) Promoting overall compliance with the premarket notification
requirement through enforcement.
    The issues discussed at the public meeting, including the above
topics, and any comments submitted to the docket by July 15, 2019, will
help us evaluate how to proceed with our efforts to modernize and
reform FDA's oversight of dietary supplements.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability. Persons
interested in attending this public meeting should register by May 6,
2019, 11:59 p.m. Eastern Time. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 8 a.m. We will let registrants know if registration closes
before the day of the public meeting. Please visit the website at
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm for this information as well as the final meeting agenda.
    If you need special accommodations due to a disability, please
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later
than May 1, 2019.
    Requests for Oral Comments: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We are seeking a broad
representation of ideas and issues presented at the meeting. We will do
our best to accommodate requests to make public comments. Individuals
and organizations with common interests are urged to consolidate or
coordinate their remarks and to request time for a joint comment. After
registration closes, we will determine the amount of time allotted to
each participant and the approximate time each oral comment is to begin
and will select and notify participants by May 10, 2019. All requests
to make oral comments must be received by the close of registration on
May 1, 2019. No commercial or promotional material will be permitted to
be presented or distributed at the public meeting.
    Those without internet or email access can register and/or request
to participate by contacting Juanita Yates by the above dates (see FOR
FURTHER INFORMATION CONTACT).
    Streaming Webcast of the public meeting: This public meeting will
also be webcast. Please visit the following website to register:
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It also may be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the transcript will also be available
on the internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm632939.htm.

    Dated: April 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07168 Filed 4-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Proposed Rules]
[Pages 47573-47580]
[FR Doc No: 2012-19565]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0402; FRL-9714-8]

Approval and Promulgation of Implementation Plans; Mississippi;
110(a)(2)(E)(ii) Infrastructure Requirements for the 1997 and 2006 Fine
Particulate Matter National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve in part, and disapprove in part, a
draft revision to the Mississippi State Implementation Plan (SIP),
submitted by the Mississippi Department of Environmental Quality
(MDEQ), on July 13, 2012, for parallel processing. This proposal
pertains to certain Clean Air Act (CAA) section 128 and section
110(a)(2)(E)(ii) requirements for the 1997 annual and 2006 24-hour fine
particulate matter (PM2.5) National Ambient Air Quality
Standards (NAAQS) infrastructure SIP. Section 110(a) of the CAA
requires that each state adopt and submit a SIP for the implementation,
maintenance, and enforcement of each NAAQS promulgated by EPA, which is
commonly referred to as an ``infrastructure'' SIP. The requirements of
section 128 of the CAA are incorporated into the State's infrastructure
SIP pursuant to section 110(a)(2)(E)(ii). EPA is proposing to approve
the section 110(a)(2)(E)(ii) submission as it relates to the public
interest requirements of section 128(a)(1) and the conflict of interest
disclosure provisions of section 128(a)(2). EPA is proposing to
disapprove Mississippi's section 110(a)(2)(E)(ii) submission as it
pertains to compliance with the significant portion of income
requirements of section 128(a)(1). The subject of this notice is
limited to the July 13, 2012, infrastructure section 110(a)(2)(E)(ii)
and substantive section 128 SIP revisions submitted by Mississippi. All
other applicable Mississippi infrastructure elements are being
addressed in a separate rulemaking.

DATES: Written comments must be received on or before September 10,
2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2012-0402, by one of the following methods:

    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2012-0402,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2012-0402. 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 through www.regulations.gov or
email information that you consider to be CBI or otherwise protected.
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. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    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 at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960. EPA requests, that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
Table of Contents

I. What is parallel processing?
II. Background
III. What elements are required under Sections 110(a)(1) and (2)?
IV. Scope of Infrastructure SIPs
V. What are the requirements of Section 128?
VI. What is EPA's analysis of the Mississippi draft Section 128
revision?
VII. What is the Section 110(a)(2)(E)(ii) Infrastructure
requirement?
VIII. What is EPA's analysis of how Mississippi addressed the
Section 110(a)(2)(E)(ii) Infrastructure requirement?
IX. Proposed Action
X. Statutory and Executive Order Reviews

I. What is parallel processing?

    Consistent with EPA regulations found at 40 CFR Part 51, appendix
V, section 2.3.1, for purposes of expediting review of a SIP submittal,
parallel processing allows a state to submit a plan to EPA prior to
actual adoption by the state. Generally, the state submits a copy of
the proposed regulation or other revisions to EPA before conducting its
public hearing. EPA reviews this proposed state action and prepares a
notice of proposed rulemaking. EPA's notice of proposed rulemaking is
published in the Federal Register during the same time frame that the
state is holding its public process. The state and EPA then provide for
concurrent public comment periods on both the state action and federal
action.
    If the revision that is finally adopted and submitted by the state
is changed in aspects other than those identified in the proposed
rulemaking on the parallel process submission, EPA will evaluate those
changes and if necessary and appropriate, issue another notice of
proposed rulemaking. The final rulemaking action by EPA will occur only
after the SIP revision has been adopted by the state and submitted
formally to EPA for incorporation into the SIP.
    On July 13, 2012, the State of Mississippi, through MDEQ, submitted
a request for parallel processing of a draft SIP revision that the
State is taking through public comment. MDEQ requested parallel
processing so that EPA could begin to take action on its draft SIP
revision in advance of the State's submission of the final SIP
revision.

II. Background

    On July 18, 1997 (62 FR 38652), EPA established an annual
PM2.5 NAAQS at 15.0 micrograms per cubic meter ([mu]g/m\3\)
based on a 3-year average of annual mean PM2.5
concentrations. At that time, EPA also established a 24-hour NAAQS of
65 [mu]g/m\3\. See 40 CFR 50.7. On October 17, 2006 (71 FR 61144), EPA
retained the 1997 annual PM2.5 NAAQS at 15.0 [mu]g/m\3\
based on a 3-year average of annual mean PM2.5
concentrations, and promulgated a new 24-hour NAAQS of 35 [mu]g/m\3\
based on a 3-year average of the 98th percentile of 24-hour
concentrations. By statute, SIPs meeting the requirements of sections
110(a)(1) and (2) are to be submitted by states within three years
after promulgation of a new or revised NAAQS. Sections 110(a)(1) and
(2) require states to address basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the NAAQS. States were required to submit such SIPs
to EPA no later than July 2000 for the 1997 annual PM2.5
NAAQS and no later than October 2009 for the 2006 24-hour
PM2.5 NAAQS.
    On March 4, 2004, Earthjustice submitted a notice of intent to sue
related to EPA's failure to issue findings of failure to submit related
to the ``infrastructure'' requirements for the

1997 annual PM2.5 NAAQS. On March 10, 2005, EPA entered into
a consent decree with Earthjustice which required EPA, among other
things, to complete a Federal Register notice announcing EPA's
determinations pursuant to section 110(k)(1)(B) as to whether each
state had made complete submissions to meet the requirements of section
110(a)(2) for the 1997 PM2.5 NAAQS by October 5, 2008. In
accordance with the consent decree, EPA made completeness findings for
each state based upon what the Agency received from each state for the
1997 PM2.5 NAAQS as of October 3, 2008.
    On October 22, 2008, EPA published a final rulemaking entitled
``Completeness Findings for Section 110(a) State Implementation Plans
Pertaining to the Fine Particulate Matter (PM2.5) NAAQS''
making a finding that each state had submitted or failed to submit a
complete SIP that provided the basic program elements of section
110(a)(2) necessary to implement the 1997 PM2.5 NAAQS. See
73 FR 62902. For those states that did receive findings, the findings
of failure to submit for all or a portion of a state's implementation
plan established a 24-month deadline for EPA to promulgate a Federal
Implementation Plan (FIP) to address the outstanding SIP elements
unless, prior to that time, the affected states submitted, and EPA
approved, the required SIPs.
    The findings that all or portions of a state's submission are
complete established a 12-month deadline for EPA to take action upon
the complete SIP elements in accordance with section 110(k).
Mississippi's infrastructure submissions were received by EPA on
December 7, 2007, for the 1997 annual PM2.5 NAAQS and on
October 6, 2009, for the 2006 24-hour PM2.5 NAAQS. The
submissions were determined to be complete on June 7, 2008, and April
6, 2010, respectively. Mississippi was among other states that did not
receive findings of failure to submit because it had provided a
complete submission to EPA to address the infrastructure elements for
the 1997 PM2.5 NAAQS by October 3, 2008.
    On July 6, 2011, WildEarth Guardians and Sierra Club filed an
amended complaint related to EPA's failure to take action on the SIP
submittal related to the ``infrastructure'' requirements for the 2006
24-hour PM2.5 NAAQS. On October 20, 2011, EPA entered into a
consent decree with WildEarth Guardians and Sierra Club which required
EPA, among other things, to complete a Federal Register notice of the
Agency's final action either approving, disapproving, or approving in
part and disapproving in part the Mississippi 2006 24-hour
PM2.5 NAAQS Infrastructure SIP submittal addressing the
applicable requirements of sections 110(a)(2)(A)-(H), (J)-(M), except
for section 110(a)(2)(C) the nonattainment area requirements and
section 110(a)(2)(D)(i) interstate transport requirements, by September
30, 2012.
    Today's action is proposing to approve in part and disapprove in
part Mississippi's July 13, 2012, infrastructure submission for the
1997 annual and 2006 24-hour PM2.5 NAAQS addressing CAA
section 110(a)(2)(E)(ii) requirements. EPA is taking action on
Mississippi's infrastructure submissions for the 1997 and 2006
PM2.5 NAAQS for sections 110(a)(2)(A)-(D), E(i) and E(iii),
(F)-(H), (J)-(M), except for section 110(a)(2)(C) the nonattainment
area requirements and section 110(a)(2)(D)(i) interstate transport
requirements in a separate actions.
    As part of today's proposed approval actions, EPA is proposing to
approve the substantive SIP revisions related to section 128 of the CAA
submitted for parallel processing by Mississippi on July 13, 2012.

III. What elements are required under Sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide
for the implementation, maintenance, and enforcement of a new or
revised NAAQS within three years following the promulgation of such
NAAQS, or within such shorter period as EPA may prescribe. 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 contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains. In the case of the 1997 and 2006 PM2.5 NAAQS,
states typically have met the basic program elements required in
section 110(a)(2) through earlier SIP submissions in connection with
previous PM NAAQS.
    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 above, these
requirements include SIP infrastructure elements such as modeling,
monitoring, and emissions inventories that are designed to assure
attainment and maintenance of the NAAQS. The requirements that are the
subject of the infrastructure rulemaking process are listed below \1\
and in EPA's October 2, 2007, memorandum entitled ``Guidance on SIP
Elements Required Under Section 110(a)(1) and (2) for the 1997 8-Hour
Ozone and PM2.5 National Ambient Air Quality Standards,''
and EPA's September 25, 2009, memorandum entitled ``Guidance on SIP
Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-Hour
Fine Particle (PM2.5) National Ambient Air Quality Standards
(NAAQS) .''
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    \1\ Two elements identified in section 110(a)(2) are not
governed by the three-year submission deadline of section 110(a)(1)
because SIPs incorporating necessary local nonattainment area
controls are not due within three years after promulgation of a new
or revised NAAQS, but rather due at the time the nonattainment area
plan requirements are due pursuant to section 172. These
requirements are: (1) Submissions required by section 110(a)(2)(C)
to the extent that subsection refers to a permit program as required
in part D Title I of the CAA; and (2) submissions required by
section 110(a)(2)(I) which pertain to the nonattainment planning
requirements of part D, Title I of the CAA. Today's proposed
rulemaking does not address infrastructure elements related to
section 110(a)(2)(I) or the nonattainment planning requirements of
110(a)(2)(C).
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     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C): Program for enforcement of control
measures.\2\
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    \2\ This element is only addressed in the PM2.5
context as it relates to attainment areas.
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     110(a)(2)(D): Interstate transport.\3\
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    \3\ Today's proposed rule does not address element
110(a)(2)(D)(i) (Interstate Transport) for the 1997 and 2006
PM2.5 NAAQS. Interstate transport requirements were
formerly addressed by Mississippi consistent with the Clean Air
Interstate Rule (CAIR). On December 23, 2008, CAIR was remanded by
the DC Circuit Court of Appeals, without vacatur, back to EPA. See
North Carolina v. EPA, 531 F.3d 896 (DC Cir. 2008). Prior to this
remand, EPA took final action to approve Mississippi SIP revision,
which was submitted to comply with CAIR. See 72 FR 56268 (October 3,
2007). In so doing, Mississippi CAIR SIP revision addressed the
interstate transport provisions in section 110(a)(2)(D)(i) for the
1997 and 2006 PM2.5 NAAQS. In response to the remand of
CAIR, EPA has recently finalized a new rule to address the
interstate transport of nitrogen oxides and sulfur oxides in the
eastern United States. See 76 FR 48208 (August 8, 2011) (Transport
Rule). That rule was recently stayed by the DC Circuit Court of
Appeals. EPA's action on element 110(a)(2)(D)(i) will be addressed
in a separate action.
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     110(a)(2)(E): Adequate resources.
     110(a)(2)(F): Stationary source monitoring system.
     110(a)(2)(G): Emergency power.
     110(a)(2)(H): Future SIP revisions.

     110(a)(2)(I): Areas designated nonattainment and meet the
applicable requirements of part D.\4\
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    \4\ This requirement was inadvertently omitted from EPA's
October 2, 2007, memorandum entitled ``Guidance on SIP Elements
Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards,'' but
as mentioned above is not relevant to today's proposed rulemaking.
---------------------------------------------------------------------------

     110(a)(2)(J): Consultation with government officials;
public notification; and PSD and visibility protection.
     110(a)(2)(K): Air quality modeling/data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.
    In today's action, EPA is only addressing section 110(a)(2)
requirements related to element 110(a)(2)(E)(ii) for both the 1997 and
2006 PM2.5 NAAQS. EPA is addressing the other 1997 and 2006
PM2.5 NAAQS infrastructure requirements in a separate
rulemaking.

IV. Scope of Infrastructure SIPs

    EPA is currently acting upon SIPs that address the infrastructure
requirements of CAA section 110(a)(1) and (2) for ozone and
PM2.5 NAAQS for various states across the country.
Commenters on EPA's recent proposals for some states raised concerns
about EPA statements that it was not addressing certain substantive
issues in the context of acting on those infrastructure SIP
submissions.\5\ Those Commenters specifically raised concerns involving
provisions in existing SIPs and with EPA's statements in other
proposals that it would address two issues separately and not as part
of actions on the infrastructure SIP submissions: (i) Existing
provisions related to excess emissions during periods of start-up,
shutdown, or malfunction (SSM) at sources, that may be contrary to the
CAA and EPA's policies addressing such excess emission; and (ii)
existing provisions related to ``director's variance'' or ``director's
discretion'' that purport to permit revisions to SIP approved emissions
limits with limited public process or without requiring further
approval by EPA, that may be contrary to the CAA (director's
discretion). EPA notes that there are two other substantive issues for
which EPA likewise stated in other proposals that it would address
separately: (i) Existing provisions for minor source New Source Review
(NSR) programs that may be inconsistent with the requirements of the
CAA and EPA's regulations that pertain to such programs (minor source
NSR); and (ii) existing provisions for Prevention of Significant
Deterioration (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). In light of the comments, EPA believes that its statements in
various proposed actions on infrastructure SIPs with respect to these
four individual issues should be explained in greater depth. It is
important to emphasize that EPA is taking the same position with
respect to these four substantive issues in this action on the
infrastructure SIPs for the 1997 and 2006 PM2.5 NAAQS from
Mississippi.
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    \5\ See Comments of Midwest Environmental Defense Center, dated
May 31, 2011. Docket No. EPA-R05-OAR-2007-1179 (adverse comments on
proposals for three states in Region 5). EPA notes that these public
comments on another proposal are not relevant to this rulemaking and
do not have to be directly addressed in this rulemaking. EPA will
respond to these comments in the appropriate rulemaking action to
which they apply.
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    EPA intended the statements in the other proposals concerning these
four issues merely to be informational and to provide general notice of
the potential existence of provisions within the existing SIPs of some
states that might require future corrective action. EPA did not want
states, regulated entities, or members of the public to be under the
misconception that the Agency's approval of the infrastructure SIP
submission of a given state should be interpreted as a re-approval of
certain types of provisions that might exist buried in the larger
existing SIP for such state. Thus, for example, EPA explicitly noted
that the Agency believes that some states may have existing SIP
approved SSM provisions that are contrary to the CAA and EPA policy,
but that ``in this rulemaking, EPA is not proposing to approve or
disapprove any existing state provisions with regard to excess
emissions during SSM of operations at facilities.'' EPA further
explained, for informational purposes, that ``EPA plans to address such
State regulations in the future.'' EPA made similar statements, for
similar reasons, with respect to the director's discretion, minor
source NSR, and NSR Reform issues. EPA's objective was to make clear
that approval of an infrastructure SIP for these ozone and
PM2.5 NAAQS should not be construed as explicit or implicit
re-approval of any existing provisions that relate to these four
substantive issues. EPA is reiterating that position in this action on
the infrastructure SIP for Mississippi.
    Unfortunately, the Commenters and others evidently interpreted
these statements to mean that EPA considered action upon the SSM
provisions and the other three substantive issues to be integral parts
of acting on an infrastructure SIP submission, and therefore that EPA
was merely postponing taking final action on the issues in the context
of the infrastructure SIPs. This was not EPA's intention. To the
contrary, EPA only meant to convey its awareness of the potential for
certain types of deficiencies in existing SIPs and to prevent any
misunderstanding that it was reapproving any such existing provisions.
EPA's intention was to convey its position that the statute does not
require that infrastructure SIPs address these specific substantive
issues in existing SIPs and that these issues may be dealt with
separately, outside the context of acting on the infrastructure SIP
submission of a state. To be clear, EPA did not mean to imply that it
was not taking a full final agency action on the infrastructure SIP
submission with respect to any substantive issue that EPA considers to
be a required part of acting on such submissions under section 110(k)
or under section 110(c). Given the confusion evidently resulting from
EPA's statements in those other proposals, however, we want to explain
more fully the Agency's reasons for concluding that these four
potential substantive issues in existing SIPs may be addressed
separately from actions on infrastructure SIP submissions.
    The requirement for the SIP submissions at issue arises out of CAA
section 110(a)(1). That provision requires that states must make a SIP
submission ``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
that these SIPs are to provide for the ``implementation, maintenance,
and enforcement'' of such NAAQS. Section 110(a)(2) includes a list of
specific elements that ``[e]ach such plan'' submission must meet. EPA
has historically referred to these particular submissions that states
must make after the promulgation of a new or revised NAAQS as
``infrastructure SIPs.'' This specific term does not appear in the
statute, but EPA uses the term to distinguish this particular type of
SIP submission designed to address basic structural requirements of a
SIP from other types of SIP submissions designed to address other
different requirements, such as ``nonattainment SIP'' submissions
required to address the nonattainment planning requirements of part D,
``regional haze SIP'' submissions required to address the visibility
protection requirements of CAA section

169A, NSR permitting program submissions required to address the
requirements of part D, and a host of other specific types of SIP
submissions that address other specific matters.
    Although section 110(a)(1) addresses the timing and general
requirements for these infrastructure SIPs, and section 110(a)(2)
provides more details concerning the required contents of these
infrastructure SIPs, EPA believes that many of the specific statutory
provisions are facially ambiguous. In particular, 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 provisions,
and some of which pertain to requirements for both authority and
substantive provisions.\6\ Some of the elements of section 110(a)(2)
are relatively straightforward, but others clearly require
interpretation by EPA through rulemaking, or recommendations through
guidance, in order to give specific meaning for a particular NAAQS.\7\
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    \6\ For example, section 110(a)(2)(E) 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 substantive program to address
certain sources as required by part C of the CAA; section
110(a)(2)(G) provides that states must have both legal authority to
address emergencies and substantive contingency plans in the event
of such an emergency.
    \7\ For example, section 110(a)(2)(D)(i) requires EPA to be sure
that each state's SIP contains adequate provisions to prevent
significant contribution to nonattainment of the NAAQS in other
states. This provision contains numerous terms that require
substantial rulemaking by EPA in order to determine such basic
points as what constitutes significant contribution. See ``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 (May 12,
2005) (defining, among other things, the phrase ``contribute
significantly to nonattainment'').
---------------------------------------------------------------------------

    Notwithstanding that section 110(a)(2) provides that ``each'' SIP
submission must meet the list of requirements therein, EPA has long
noted that this literal reading of the statute is internally
inconsistent, insofar as section 110(a)(2)(I) pertains to nonattainment
SIP requirements that could not be met on the schedule provided for
these SIP submissions in section 110(a)(1).\8\ This illustrates that
EPA must determine which provisions of section 110(a)(2) may be
applicable for a given infrastructure SIP submission. Similarly, EPA
has previously decided that it could take action on different parts of
the larger, general ``infrastructure SIP'' for a given NAAQS without
concurrent action on all subsections, such as section 110(a)(2)(D)(i),
because the Agency bifurcated the action on these latter ``interstate
transport'' provisions within section 110(a)(2) and worked with states
to address each of the four prongs of section 110(a)(2)(D)(i) with
substantive administrative actions proceeding on different tracks with
different schedules.\9\ This illustrates that EPA may conclude that
subdividing the applicable requirements of section 110(a)(2) into
separate SIP actions may sometimes be appropriate for a given NAAQS
where a specific substantive action is necessitated, beyond a mere
submission addressing basic structural aspects of the state's
implementation plans. Finally, 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 and the attendant
infrastructure SIP submission for that NAAQS. For example, the
monitoring requirements that might be necessary for purposes of section
110(a)(2)(B) for one NAAQS could be very different than what might be
necessary for a different pollutant. Thus, the content of an
infrastructure SIP submission to meet this element from a state might
be very different for an entirely new NAAQS, versus a minor revision to
an existing NAAQS.\10\
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    \8\ See Id., 70 FR 25162, at 63-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \9\ EPA issued separate guidance to states with respect to SIP
submissions to meet section 110(a)(2)(D)(i) for the 1997 ozone and
1997 PM2.5 NAAQS. See ``Guidance for State Implementation
Plan (SIP) Submissions To Meet Current Outstanding Obligations Under
Section 110(a)(2)(D)(i) for the 8-Hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director, Air Quality Policy Division OAQPS, to Regional Air
Division Director, Regions I-X, dated August 15, 2006.
    \10\ 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.
---------------------------------------------------------------------------

    Similarly, EPA notes that other types of SIP submissions required
under the statute also must meet the requirements of section 110(a)(2),
and this also demonstrates the need to identify the applicable elements
for other SIP submissions. For example, nonattainment SIPs required by
part D likewise have to meet the relevant subsections of section
110(a)(2) such as section 110(a)(2)(A) or (E). By contrast, it is clear
that nonattainment SIPs would not need to meet the portion of section
110(a)(2)(C) that pertains to part C, i.e., the PSD requirements
applicable in attainment areas. Nonattainment SIPs required by part D
also would not need to address the requirements of section 110(a)(2)(G)
with respect to emergency episodes, as such requirements would not be
limited to nonattainment areas. As this example illustrates, each type
of SIP submission may implicate some subsections of section 110(a)(2)
and not others.
    Given the potential for ambiguity of the statutory language of
section 110(a)(1) and (2), EPA believes that it is appropriate for EPA
to interpret that language in the context of acting on the
infrastructure SIPs for a given NAAQS. Because of the inherent
ambiguity of the list of requirements in section 110(a)(2), EPA has
adopted an approach in which it reviews infrastructure SIPs against
this list of elements ``as applicable.'' In other words, EPA assumes
that Congress could not have intended that each and every SIP
submission, regardless of the purpose of the submission or the NAAQS in
question, would meet each of the requirements, or meet each of them in
the same way. EPA elected to use guidance to make recommendations for
infrastructure SIPs for these ozone and PM2.5 NAAQS.
    On October 2, 2007, EPA issued guidance making recommendations for
the infrastructure SIP submissions for both the 1997 8-hour ozone NAAQS
and the 1997 PM2.5 NAAQS.\11\ Within this guidance document,
EPA described the duty of states to make these submissions to meet what
the Agency characterized as the ``infrastructure'' elements for SIPs,
which it further described as the ``basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the standards.'' \12\ As further identification of
these basic structural SIP requirements, ``attachment A'' to the
guidance document included a short description of the various elements
of section 110(a)(2) and additional information about the types of
issues that EPA considered germane in the context of such
infrastructure SIPs. EPA emphasized that the description of the basic
requirements listed on attachment A was not intended ``to constitute an
interpretation of'' the requirements, and was merely a ``brief
description of the required elements.'' \13\ EPA also stated its belief
that with one exception, these requirements were ``relatively self
explanatory, and past experience with

SIPs for other NAAQS should enable States to meet these requirements
with assistance from EPA Regions.'' \14\ However, for the one exception
to that general assumption (i.e., how states should proceed with
respect to the requirements of section 110(a)(2)(G) for the 1997
PM2.5 NAAQS), EPA gave much more specific recommendations.
But for other infrastructure SIP submittals, and for certain elements
of the submittals for the 1997 PM2.5 NAAQS, EPA assumed that
each State would work with its corresponding EPA regional office to
refine the scope of a State's submittal based on an assessment of how
the requirements of section 110(a)(2) should reasonably apply to the
basic structure of the State's implementation plans for the NAAQS in
question.
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    \11\ See ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director, Air Quality Policy Division, to Air Division Directors,
Regions I--X, dated October 2, 2007 (the ``2007 Guidance'').
    \12\ Id., at page 2.
    \13\ Id., at attachment A, page 1.
    \14\ Id., at page 4. In retrospect, the concerns raised by
commenters with respect to EPA's approach to some substantive issues
indicates that the statute is not so ``self explanatory,'' and
indeed is sufficiently ambiguous that EPA needs to interpret it in
order to explain why these substantive issues do not need to be
addressed in the context of infrastructure SIPs and may be addressed
at other times and by other means.
---------------------------------------------------------------------------

    On September 25, 2009, EPA issued guidance to make recommendations
to states with respect to the infrastructure SIPs for the 2006
PM2.5 NAAQS.\15\ In the 2009 Guidance, EPA addressed a
number of additional issues that were not germane to the infrastructure
SIPs for the 1997 8-hour ozone and 1997 PM2.5 NAAQS, but
were germane to these SIP submissions for the 2006 PM2.5
NAAQS (e.g., the requirements of section 110(a)(2)(D)(i) that EPA had
bifurcated from the other infrastructure elements for those specific
1997 ozone and PM2.5 NAAQS). Significantly, neither the 2007
Guidance nor the 2009 Guidance explicitly referred to the SSM,
director's discretion, minor source NSR, or NSR Reform issues as among
specific substantive issues EPA expected states to address in the
context of the infrastructure SIPs, nor did EPA give any more specific
recommendations with respect to how states might address such issues
even if they elected to do so. The SSM and director's discretion issues
implicate section 110(a)(2)(A), and the minor source NSR and NSR Reform
issues implicate section 110(a)(2)(C). In the 2007 Guidance and the
2009 Guidance, however, EPA did not indicate to states that it intended
to interpret these provisions as requiring a substantive submission to
address these specific issues in existing SIP provisions in the context
of the infrastructure SIPs for these NAAQS. Instead, EPA's 2007
Guidance merely indicated its belief that the states should make
submissions in which they established that they have the basic SIP
structure necessary to implement, maintain, and enforce the NAAQS. EPA
believes that states can establish that they have the basic SIP
structure, notwithstanding that there may be potential deficiencies
within the existing SIP. Thus, EPA's proposals for other states
mentioned these issues not because the Agency considers them issues
that must be addressed in the context of an infrastructure SIP as
required by section 110(a)(1) and (2), but rather because EPA wanted to
be clear that it considers these potential existing SIP problems as
separate from the pending infrastructure SIP actions. The same holds
true for this action on the infrastructure SIPs for Mississippi.
---------------------------------------------------------------------------

    \15\ See ``Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2006 24-Hour Fine Particle
(PM2.5) National Ambient Air Quality Standards (NAAQS),''
from William T, Harnett, Director, Air Quality Policy Division, to
Regional Air Division Directors, Regions I-X, dated September 25,
2009 (the ``2009 Guidance'').
---------------------------------------------------------------------------

    EPA believes that this approach to the infrastructure SIP
requirement is reasonable because it would not be feasible to read
section 110(a)(1) and (2) to require a top to bottom, stem to stern,
review of each and every provision of an existing SIP 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 that, 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 considers the overall effectiveness of the
SIP. To the contrary, EPA believes that a better approach is for EPA to
determine which specific SIP elements from section 110(a)(2) are
applicable to an infrastructure SIP for a given NAAQS, and to focus
attention on those elements that are most likely to need a specific SIP
revision in light of the new or revised NAAQS. Thus, for example, EPA's
2007 Guidance specifically directed states to focus on the requirements
of section 110(a)(2)(G) for the 1997 PM2.5 NAAQS because of
the absence of underlying EPA regulations for emergency episodes for
this NAAQS and an anticipated absence of relevant provisions in
existing SIPs.
    Finally, EPA believes that its approach is a reasonable reading of
section 110(a)(1) and (2) because the statute provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow the Agency to take appropriate
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 otherwise to comply with the CAA.\16\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\17\ Significantly, EPA's
determination that an action on the infrastructure SIP is not the
appropriate time and place to address all potential existing SIP
problems does not preclude the Agency's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action 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 the infrastructure SIP, EPA
believes that section 110(a)(2)(A) may be among the statutory bases
that the Agency cites in the course of addressing the issue in a
subsequent action.\18\
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    \16\ EPA has recently issued a SIP call to rectify a specific
SIP deficiency related to the SSM issue. See, ``Finding of
Substantial Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revision,'' 76 FR 21639 (April 18, 2011).
    \17\ EPA has recently utilized 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 CAA 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See 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).
    \18\ EPA has recently disapproved 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 75 FR 42342, 42344 (July 21, 2010) (proposed
disapproval of director's discretion provisions); 76 FR 4540
(January 26, 2011) (final disapproval of such provisions).
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V. What are the requirements of Section 128?

    Section 128 of the CAA requires that states include provisions in
their SIP to address conflicts of interest for state boards or bodies
that oversee CAA permits and enforcement orders and disclosure of
conflict of interest requirements. Specifically, CAA section 128(a)(1)
necessitates that each SIP shall require that at least a majority of
any

board or body which approves permits or enforcement orders shall be
subject to the described public interest service and income
restrictions therein. Subsection 128(a)(2) requires that the members of
any board or body, or the head of an executive agency with similar
power to approve permits or enforcement orders under the CAA, shall
also be subject to conflict of interest disclosure requirements.
    Furthermore, section 128 affords the Administrator of EPA the
authority to incorporate conflict of interest provisions that go beyond
those required by the CAA into the SIP when such provisions are
submitted by a state as part of its implementation plan.

VI. What is EPA's analysis of the Mississippi draft Section 128
revision?

    As described above, Section 128 of the CAA requires that states
include provisions in their SIP to address conflicts of interest and
provide for adequate disclosure of such conflicts. In connection with
these requirements, on July 13, 2012, Mississippi submitted a draft SIP
revision for parallel processing (available for review in the Docket
for today's action). This draft revision proposes to incorporate
certain provisions of the Mississippi State Constitution and sections
of the Mississippi Code into the SIP. These provisions are described
below.
    First, Mississippi seeks to incorporate Article 4, Section 109 of
Mississippi Constitution into the SIP. Article 4, Section 109 provides
that ``[n]o public officer or member of the legislature shall be
interested, directly or indirectly, in any contract with the state, or
any district, county, city or town thereof, authorized by any law
passed or order made by any board of which he may be or may have been a
member, during the term for which her shall have been chosen, or within
one year after the expiration of such term.''
    Second, Mississippi intends to incorporate provisions from the
State's ethical charter as set forth in the Mississippi Code.
Specifically, the State seeks to incorporate portions of Mississippi
Code sections 25-4-25, -27, -29, -103, -105, and -109. For more
information about the portions of the Sections Mississippi has sought
to include in the SIP, please see the State's July 13, 2012, SIP
Revision available in the docket for today's proposed action.
    EPA is today proposing to incorporate these revisions, which have
been submitted by Mississippi for parallel processing, into the SIP
consistent with the authority provided by section 128 of the CAA.

VII. What is the Section 110(a)(2)(E)(ii) Infrastructure requirement?

    Section 110(a)(2)(E)(ii) requires that each implementation plan
provide that the state comply with the CAA section 128 requirements
respecting state boards. In today's action, EPA is proposing to approve
in part and disapprove in part Mississippi's SIP as meeting the
requirements of section 110(a)(2)(E)(ii) (which is one of the three
elements required pursuant to section 110(a)(2)(E)).\19\
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    \19\ EPA is taking action on 110(a)(2)(E)(i) and
110(a)(2)(E)(iii) as it relates to Mississippi in certification
submissions dated December 7, 2007, for the 1997 PM2.5
NAAQS, and October 6, 2009, for the 2006 PM2.5 NAAQS, in
a separate rulemaking.
---------------------------------------------------------------------------

VIII. What is EPA's analysis of how Mississippi addressed the Section
110(a)(2)(E)(ii) Infrastructure requirement?

    Mississippi's July 13, 2012, draft SIP revision, proposes to
include in the SIP the sections of the Mississippi Code and portions of
the Mississippi Constitution described above to meet the requirements
of section 128. The State asserts that these state laws and
Constitutional provisions satisfy the requirements of CAA section 128
for the Mississippi Commission on Environmental Quality and the
Mississippi Department of Environmental Quality Permit Board, which are
the ``board[s] or bod[ies] which approve[] permits and enforcement
orders'' under the CAA in Mississippi (hereafter, these two bodies will
be collectively referred to as the ``MS Boards'').
    With respect to meeting the section 128(a)(1) majority composition
requirements regarding the public interest and significant portion of
income tests, Mississippi asserts that the cited state laws and
constitution comply with section 128(a)(1) by satisfying the
requirement that any board or body which approves permits or
enforcement orders shall be subject to the described public interest
and income restrictions therein. Mississippi's draft SIP revision would
incorporate laws into the SIP that preclude certain types of financial
relationships between members of the MS Boards and persons subject the
MS Boards' permitting decisions or enforcement orders. For example,
Article 4, Section 9 of the Mississippi Constitution prohibits public
officers from any interest in any contract with state or political
subdivision thereof. Mississippi Code section 25-4-105 precludes public
servants form using their position to obtain or attempt to obtain
pecuniary benefit for him or herself and prevents such individuals from
performing any service for compensation during his or her term or
employment by which he or she attempts to influence a decision of the
governmental entity of which he or she is a member. Mississippi Code
section 25-4-105 also precludes persons from disclosing information
gained by reason of his official position as a public servant in any
way that could result in pecuniary benefit for himself, any relative or
any other person, if that information is not publically available.
    Based upon a review of these laws and provisions, EPA is today
proposing to approve the section 110(a)(2)(E)(ii) submission as it
relates to the public interest requirement of section 128(a)(1) and
proposing to disapprove Mississippi's section 110(a)(2)(E)(ii)
submission as it pertains to compliance with the significant portion of
income requirement of section 128(a)(1). With respect to the public
interest requirement, the provisions included in the draft submission
apply to all members of the MS Boards, and according to the state,
serve to ensure that all members of the board are precluded from
serving in their self interest. EPA is today proposing to approve the
State's section 110(a)(2)(E)(ii) submission, once the SIP revisions
submitted to EPA for parallel processing on July 13, 2012, have been
approved, as meeting the requirement to ensure that the SIP requires at
least a majority of the members of the MS Boards to serve in the public
interest as required by section 128(a)(1) of the CAA,
    With respect to the significant portion of income requirement, the
provisions included in the draft submission do not preclude at least a
majority of the members of the MS Board from receiving a significant
portion of their income from persons subject to permits or enforcement
orders issued by the MS Boards. While the submitted laws and provisions
preclude members of the MS Boards from certain types of income (e.g.,
contracts with State or political subdivisions thereof, or income
obtained through the use of his or her public office or obtained to
influence a decision of the MS Boards), they do not appear to preclude
a majority of members of the MS Boards from deriving any significant
portion of their income from persons subject to permits or enforcement
orders so long as that income is not derived from one of the proscribed
methods described in the laws and provisions submitted by the State.
Because a majority of board members may still derive a significant

portion of income from persons subject to permits or enforcement orders
issued by the MS Boards, the Mississippi SIP on revised, will still not
meet the section 128(a)(1) majority requirements respecting significant
portion of income, and as such, EPA is today proposing to disapprove
the State's 110(a)(2)(E)(ii) submission as it relates only to this
portion of section 128(a)(1). As described herein, EPA is proposing
approval of all other elements of 110(a)(2)(E)(ii).
    Regarding the section 128(a)(2) requirement for the adequate
disclosure of conflicts of interest, EPA is proposing to approve
Mississippi's 110(a)(2)(E)(ii) submission as it relates to this
requirement based upon the laws submitted by the State for parallel
processing into the SIP. Specifically, Mississippi intends to
incorporate Mississippi Code Section 25-4-25 into the SIP which
requires that members of the MS Boards file annual statements of
economic interest with the Mississippi Ethics Commission which are then
made available for public inspection. The State is also seeking to
incorporate Mississippi Code section 25-4-27 into the SIP. This section
provides for the content of the annual statements of economic interest.
EPA is today proposing to approve Mississippi's 110(a)(2)(E)(ii)
submission as it relates to the conflict of interest disclosure
requirements of section 128(a)(2), once the SIP revisions submitted to
EPA for parallel processing on July 13, 2012, have been incorporated
into the SIP.

IX. Proposed Action

    As described above, EPA is proposing to approve in part and
disapprove in part, Mississippi's July 13, 2012, infrastructure
submission for the 1997 annual and 2006 24-hour PM2.5 NAAQS
addressing CAA section 110(a)(2)(E)(ii) requirements. Today's proposed
approval of the above-described portions of the State's section
110(a)(E)(ii) submission is contingent upon the Agency taking final
action to approve the substantive revisions to pertaining to section
128 also submitted by Mississippi for parallel processing on July 13,
2012. Specifically, EPA is today proposing to approve Mississippi's
110(a)(2)(E)(ii) submission as it relates to the public interest
requirements described at section 110(a)(1) of the CAA and the conflict
of interest disclosure provisions described at section 110(a)(2) of the
CAA. EPA is also proposing to disapprove Mississippi's 110(a)(2)(E)(ii)
submission as it relates to the significant portion of income
requirements described at section 110(a)(1) of the CAA.
    The Section 110(a)(2)(E)(ii) provision (specifically the
significant portion of income provision described at section 128(a)(1)
being proposed for disapproval in today's notice) was not submitted to
meet requirements for Part D or a SIP call, and therefore, if EPA takes
final action to disapprove this submittal, no sanctions will be
triggered. However, if this disapproval action is finalized, that final
action will trigger the requirement under section 110(c) that EPA
promulgate a FIP no later than 2 years from the date of the disapproval
unless the State corrects the deficiency, and EPA approves the plan or
plan revision before EPA promulgates such FIP.
    EPA notes that the Agency is addressing the other section 110(a)(2)
requirements for the 1997 annual and 2006 24-hour PM2.5
NAAQS for Mississippi's SIP in a rulemaking separate from today's
proposed rulemaking.
    In addition, to the above proposed actions respecting
110(a)(2)(E)(ii) infrastructure requirements, EPA is today also
proposing to approve the SIP revisions related to section 128 submitted
by Mississippi for parallel processing on July 13, 2012, into the SIP.
EPA is proposing to approve Mississippi's Article 4, Section 109 of
Mississippi Constitution and portions of Mississippi Code sections 25-
4-25, -27, -29, -103, -105, and -109 into the Mississippi SIP. The
specific provisions been proposed for inclusion in the Mississippi SIP
are described more fully in the State's July 13, 2012, draft SIP
revision which is available in the docket for today's action. As
described above, Mississippi's July 13, 2012, submission was submitted
for parallel processing. As such, the final rulemaking for this action
by EPA will occur consistent with the elements of parallel processing
previously described above in Section I.

X. 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. Accordingly, this
proposed action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this 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 rule 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, Intergovernmental
relations, Nitrogen dioxide, Particulate Matter, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

    Dated: August 1, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-19565 Filed 8-8-12; 8:45 am]
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[Federal Register Volume 82, Number 41 (Friday, March 3, 2017)]
[Rules and Regulations]
[Pages 12416-12418]
[FR Doc No: 2017-04196]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0118]
RIN 1625-AA00

Safety Zone; Columbia River, Sand Island, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule; request for comments.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Columbia River within a 500-yard radius of the small boat ``Nessy''
while in the area of Sand Island, near Chinook, WA, during Double-
Crested Cormorant removal operations being conducted by the U.S. Army
Corps of Engineers and U.S. Department of Agriculture Wildlife
Services. This rule prohibits all persons and vessels from being in the
safety zone unless authorized by the Captain of the Port Sector
Columbia River (COTP), or a designated representative. We invite your
comments on this rulemaking.

DATES: This rule is effective from April 3, 2017, through May 25, 2017.
Comments and related material must be received by the Coast Guard on or
before March 24, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-0118 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments. To view documents mentioned in
this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0118 in the ``SEARCH'' box and
click ``SEARCH.'' Click on Open Docket Folder on the line associated
with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Laura Springer, Waterways Management Division,
Marine Safety Unit Portland, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port Sector Columbia River

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Double-Crested Cormorant removal
operations are scheduled to begin on April 3, 2017 and there is not
sufficient time to publish an NPRM and take comments prior to the
safety zone being needed to help ensure the safety of waterways users.
The Coast Guard received the specific dates that the removal operations
will take place on February 27, 2017.
    The Coast Guard is soliciting public comments on this temporary
interim rule. Although we need to make this interim rule effective
starting April 3, 2017, we will consider public comments and may issue
a temporary final rule that will supersede this interim rule based on
your comment.

III. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include

any personal information you have provided. For more about privacy and
the docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this temporary interim rule as being
available in the docket, and all public comments, will be in our online
docket at http://www.regulations.gov and can be viewed by following
that Web site's instructions. Additionally, if you go to the online
docket and sign up for email alerts, you will be notified when comments
are posted or a final rule is published.

IV. Legal Authority and Need for Rule

    The U.S. Army Corps of Engineers and U.S. Department of Agriculture
Wildlife Services notified the Coast Guard that they intend to conduct
removal operations of Double-Crested Cormorant in the area of Sand
Island on the Columbia River, near Chinook, WA, on the following dates
from 7 a.m. to 3 p.m. each day: April 3-6, April 10-13, April 17-20,
April 24-27, May 1-4, May 8-11, May 15-18, and May 22-25, 2017. These
operations will involve the use of firearms and live ammunition from
the small boat ``Nessy.'' The COTP has determined that the operations
pose a potential safety hazard for anyone within a 500-yard radius of
``Nessy'' due to the live gunfire, unpredictable animal behavior, and
the highly dynamic marine environment in that area, which is
characterized by strong tides, river currents, and wind. As such, the
safety zone is needed to help ensure the safety of all waterways users
in the area. The safety zone is proposed under the authority in 33
U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Department of Homeland Security Delegation No. 0170.1.

V. Discussion of the Rule

    The COTP establishes a 500-yard safety zone around the small boat
``Nessy'' on April 3-6, April 10-13, April 17-20, April 24-27, May 1-4,
May 8-11, May 15-18, and May 22-25, 2017 from 7 a.m. to 3 p.m. while it
is operating in the area encompassed by these points: 46[deg]5'5'' N.,
123[deg]59'39'' W.; 46[deg]15'24'' N., 123[deg]59'42'' W.;
46[deg]13'32'' N., 123[deg]57'18'' W.; 46[deg]15'9'' N.,
123[deg]55'24'' W.; and 46[deg]15'54'' N., 123[deg]58'6'' W. Additional
and/or changes to the dates (within the effective period of this rule)
and times that the safety zone will be enforced may be necessary due to
weather conditions and/or other variables and will be communicated to
the public via Broadcast Notice to Mariners and on-scene notification.
The safety zone is intended to protect persons and vessels from the
potential safety hazards associated with Double-Breasted Cormorant
removal operations being conducted by the U.S. Army Corps of Engineers
and U.S. Department of Agriculture Wildlife Services from ``Nessy'' and
will do so by prohibiting all persons and vessels from entering the
safety zone without permission from the COTP or a designated
representative. ``Nessy'' is described as a 20-foot black and gray
aluminum work skiff with an overhead light arch.

VI. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    This regulatory action determination is based on the limited size,
location, duration, and time-of-day that the safety zone will be in
effect and the fact that vessel traffic would be able to safely transit
around the safety zone. In addition, mariners may request permission
from the COTP to enter the zone if necessary.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
VI.A above this rule would not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR

FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves the establishment of a temporary safety zone. It is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T13-0118 to read as follows:

Sec.  165.T13-0118   Safety Zone; Columbia River, Sand Island, WA.

    (a) Location. The following area is a safety zone: all waters of
the Columbia River within 500 yards of the small boat ``Nessy'' while
in the area encompassing these points: 46[deg]15'45'' N.,
123[deg]59'39'' W.; 46[deg]15'24'' N., 123[deg]59'42'' W.;
46[deg]13'32'' N., 123[deg]57'18'' W.; 46[deg]15'9'' N.,
123[deg]55'24'' W.; and 46[deg]15'54'' N., 123[deg]58'6'' W. ``Nessy''
is a 20-foot black and gray aluminum work skiff with an overhead light
arch.
    (b) Regulations. In accordance with the general regulations in
subpart C of this part, no person may enter or remain in the safety
zone created in this section or bring, cause to be brought, or allow to
remain in the safety zone created in this section any vehicle, vessel,
or object unless authorized by the Captain of the Port or his
designated representative.
    (c) Enforcement. Any Coast Guard commissioned, warrant, or petty
officer may enforce the rules in this section. Where immediate action
is required and representatives of the Coast Guard are not present or
are not present in sufficient force to provide effective enforcement of
this section, any Oregon Law Enforcement Officer or Washington Law
Enforcement Officer may enforce the rules contained in this section
pursuant to 46 U.S.C. 70118. In addition, the Captain of the Port may
be assisted by members of the U. S. Army Corps of Engineers and U.S.
Department of Agriculture Wildlife Services and other federal, state,
or local agencies in enforcing this section.
    (d) Enforcement periods. This section is effective from April 3,
2017 through May 25, 2017. It will be enforced from 7 a.m. to 3 p.m.
each day on the follow dates: April 3 through 6, April 10 through 13,
April 17 through 20, April 24 through 27, May 1 through 4, May 8
through 11, May 15 through 18, and May 22 through 25, 2017. The Coast
Guard will inform mariners of any additions and/or changes to the dates
and times this section is enforced during its effective period via
Broadcast Notice to Mariners and on-scene notification.

D.F. Berliner,
Captain, U.S. Coast Guard, Acting Captain of the Port, Sector Columbia
River.
[FR Doc. 2017-04196 Filed 3-2-17; 8:45 am]
BILLING CODE 9110-04-P