[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7184-7186]
[FR Doc No: 2022-02604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1051]

Clinical Pharmacology Considerations for Antibody-Drug
Conjugates; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Clinical
Pharmacology Considerations for Antibody-Drug Conjugates,'' which
provides recommendations for the development of antibody-drug
conjugates (ADCs). Specifically, this guidance addresses the FDA's
current thinking regarding clinical pharmacology considerations and
recommendations for ADC development programs, including bioanalytical
methods, dose selection and adjustment, dose- and exposure-response
analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-
drug interactions (DDIs). Currently, there are

no FDA guidances outlining the clinical pharmacology considerations for
antibody-drug conjugates. This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by May 9, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2021-D-1051 for ``Clinical Pharmacology Considerations for
Antibody-Drug Conjugates.'' Received comments 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on 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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kimberly Maxfield, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 209903,<PHONE_NUMBER>,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Pharmacology Considerations for Antibody-Drug
Conjugates.'' An ADC is a type of therapeutic biologic product that is
composed of a small-molecule moiety and an antibody moiety conjugated
together by a chemical linker. An antibody or antibody fragment carrier
is selected or engineered against a specific antigen of interest
present on the target, which is ideally unique to the disease state
being treated (e.g., a tumor-specific antigen). In general, when the
antibody or antibody fragment binds to its target antigen, the ADC is
internalized through physiological mechanisms (e.g., endocytosis), at
which point the small-molecule drug or payload moiety is released
either upon exposure to the low pH of the lysosome or by degradation of
the antibody/linker by lysosomal enzymes. The released small-molecule
drug then exerts its effect in the targeted cell (e.g., the cells
expressing the specific antigen of interest) while, ideally, minimizing
the effect on healthy cells (e.g., cells that do not express the
specific antigen of interest).
    ADCs combine the selectivity of an antibody or antibody fragment
with the potency of a small molecule. Therefore, development of ADCs
requires careful consideration of the differences between the clinical
pharmacology of the antibody or antibody fragment and the small
molecule. This draft guidance addresses FDA's current thinking
regarding clinical pharmacology considerations and recommendations for
ADC development programs, including bioanalytical methods, dose
selection and adjustment, dose- and exposure-response analysis,
intrinsic factors, QTc assessments, immunogenicity, and DDIs. Although

this draft guidance is primarily based on FDA's experience with ADCs
for oncology indications, the principles discussed in this guidance are
also generally applicable to the development of ADCs for other
indications.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Clinical
Pharmacology Considerations for Antibody-Drug Conjugates.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for submissions of investigational new drug
applications, new drug applications, and biologic license applications
in 21 CFR parts 312, 314, and 601 have been approved under OMB control
numbers 0910-0014, 0910-0001, and 0910-0338, respectively. In addition,
the submission of prescription drug labeling under 21 CFR 201.56 and
201.57 has been approved under OMB control number 0910-0572. The
collections of information in 21 CFR part 211 have been approved under
OMB control number 0910-0139; and the collections of information
regarding good laboratory practice in 21 CFR part 58 have been approved
under OMB control number 0910-0119.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02604 Filed 2-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46976-46977]
[FR Doc No: 2013-18633]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 10, 2013, from
8 a.m. to 4:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Stephanie Begansky, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On September 10, 2013, the committee will discuss the new
molecular entity new drug application (NDA) 203975, for umeclidinium
and vilanterol powder for inhalation (proposed trade name Anoro
Ellipta), sponsored by Glaxo Group (d/b/a/GSK) for the long-term, once-
daily, maintenance treatment of airflow obstruction in patients with
chronic obstructive pulmonary disease, including chronic bronchitis and
emphysema.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 26, 2013. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before August 16, 2013. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by August 19, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Stephanie Begansky
at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 29, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-18633 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Rules and Regulations]
[Page 16543-16547]
[DOCID:fr28mr08-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2007-0647; FRL-8546-3]

Approval and Promulgation of State Implementation Plans; State of
Utah; Interstate Transport of Pollution and Other Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action approving State
Implementation Plan (SIP) revisions submitted by the State of Utah on
March 22 and September 17, 2007. The revisions address Interstate
Transport Pollution requirements of Section 110(a)(2)(D)(i) of the
Clean Air Act and a typographical error in Rule R307-130-4,
``Options.'' The March 22, 2007 submittal adds ``Section XXIII,
Interstate Transport'' to the Utah SIP, and Rule R307-110-36 to the
Utah Administrative Code (UAC). The new Rule R307-110-36 incorporates
by reference the Interstate Transport declaration into the State rules.
The September 17, 2007 submittal amends UAC Rule R307-130-4,
``Options,'' by removing from the text the word ``not'' which had been
accidentally placed in this rule. This action is being taken under
section 110 of the Clean Air Act.

DATES: This rule is effective on May 27, 2008 without further notice,
unless EPA receives adverse comment by April 28, 2008. If adverse
comment is received, EPA will publish a timely withdrawal of the direct
final rule in the Federal Register informing the public that the rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2007-0647, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>and
<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Callie Videtich, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129.
     Hand Delivery: Callie Videtich, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129. Such deliveries are only accepted
Monday through Friday, 8 a.m. to 4:55 p.m., excluding Federal holidays.
Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2007-0647. 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 e-mail.
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 e-
mail comment directly to EPA, without going through www.regulations.gov
your e-mail 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
instructions on submitting comments, go to Section I. General
Information of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute.

Certain other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly-available docket materials are
available either electronically in www.regulations.gov or in hard copy
at the Air Program, Environmental Protection Agency (EPA), Region 8,
Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129. EPA requests
that if at all possible, you contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section to view the hard copy of the
docket. You may view the hard copy of the docket Monday through Friday,
8 a.m. to 4 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Domenico Mastrangelo, Air Program,
U.S. Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.
    (iv) The words State or Utah mean the State of Utah, unless the
context indicates otherwise.

Table of Contents

I. General Information
II. What is the purpose of this action?
III. What is the State process to submit these materials to EPA?
IV. EPA's Evaluation of the State of Utah March 22, 2007 Submittal
V. EPA's Evaluation of the State of Utah September 17, 2007
Submittal
VI. Final Action
VII. Statutory and Executive Order Reviews

I. General Information

A. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. What is the purpose of this action?

    EPA is approving the addition of ``Section XXIII, Interstate
Transport'' to the Utah SIP, and of Rule R307-110-36 (incorporating by
reference Section XXIII) to the Utah Administrative Code (UAC). The
Interstate Transport SIP and Rule R307-110-36 were adopted by the Utah
Air Quality Board (UAQB) on February 7, 2007, and were submitted by the
Governor to EPA on March 22, 2007. Section XXIII of the Utah SIP,
Interstate Transport, addresses the requirements of the ``good
neighbor'' provisions of the CAA Section 110(a)(2)(D)(i). This section
requires that each state's SIP include adequate provisions prohibiting
emissions that adversely affect another state's air quality through
interstate transport of air pollutants.
    EPA is also approving an amendment removing the word ``not,'' a
typographical error, from the provisions of Rule R307-130-4,
``Options.'' The amendment to this rule was adopted by the UAQB on June
21, 2007, effective July 13, 2007, and submitted by the Governor to EPA
on September 17, 2007.

III. What is the State process to submit these materials to EPA?

    Section 110(k) of the CAA addresses EPA actions on submissions of
revisions to a SIP. The CAA requires States to observe certain
procedural requirements in developing SIP revisions for submittal to
EPA. Section 110(a)(2) of the CAA requires that each SIP revision be
adopted after reasonable notice and public hearing. This must occur
prior to the revision being submitted by a state to EPA.
    The UAQB held a public hearing on December 21, 2006 for the
addition of Section XXIII, Interstate Transport to the Utah SIP, and
Rule R307-110-36 to the Utah Administrative Code (UAC). The new Rule
R307-110-36 incorporates by reference the Interstate Transport
declaration into the State rules. These additions to the State SIP were
adopted by the Board on February 7, 2007, and were submitted by the
Governor to EPA on March 22, 2007. Rule R307-110-36 became effective
February 9, 2007.
    The UAQB held a public hearing on April 18, 2007 for a revision to
UAC Rule R307-130-4, Options, correcting a typographical error. This
revision was adopted by the Board on June 21, 2007, effective July 13,
2007, and submitted by the Governor to EPA on September 17, 2007.
    We have evaluated the Governor's submittals of these SIP revisions
and have determined that the State met the requirements for reasonable
notice and public hearing under Section 110(a)(2) of the CAA.

IV. EPA's Evaluation of the State of Utah March 22, 2007 Submittal

    EPA has reviewed the State of Utah Interstate Transport SIP
submitted on March 22, 2007, and believes that approval is warranted.
The ``good neighbor'' provisions of the CAA, Section 110 (a)(2)(D)(i),
require that the Utah SIP contain adequate provisions prohibiting air
pollutant emissions from sources or activities in the State from
adversely affecting another state. A state SIP must include provisions
that prohibit sources from emitting pollutants in amounts which will:
(1) Contribute significantly to nonattainment of the NAAQS in another
state; (2) interfere with maintenance of the NAAQS by another state;
(3) interfere with another state's measures to prevent significant
deterioration of its air quality; and (4) interfere with the efforts of
another state to protect visibility. EPA issued guidance on August 15,
2006 relating to SIP submissions that meet the requirements of Section
110 (a)(2)(D)(i) for the 1997

PM2.5 and 8-hour ozone standards. Section XXIII of the SIP, Interstate
Transport, submitted by the State of Utah is consistent with the
guidance.
    To support the first two of the four elements noted above, the
State of Utah relies on EPA assessments and modeling analysis results
published in Federal Register notices as part of the Clean Air
Interstate Rule (CAIR) rulemaking process.\1\ In addition, EPA has
examined factors specific to Utah and to a number of downwind or
potentially downwind states that have the potential to be significantly
affected by any transport of PM2.5 and ozone or ozone precursors from
Utah. Utah's neighboring states considered here as downwind or
potentially downwind include Colorado, Idaho, Montana, North and South
Dakota, and Wyoming.
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    \1\ Unless otherwise noted, in this action the expression CAIR
rulemaking process or CAIR rule refers to materials (data, analyses,
assessments) developed during the rulemaking process that resulted
in the May 12, 2005 Federal Register notice ``Rule to Reduce
Interstate Transport of Fine Particulate Matter and Ozone (Clean Air
Interstate Rule); Revisions to Acid Rain Program; Revisions to
NOX SIP Call; Final Rule,'' (70 FR 25162).
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    The Utah Interstate Transport SIP addresses the question of
potential PM2.5 and ozone transport to other states by quoting from the
explanation given by EPA in support of the exclusion of seven western
states (including Utah) from the analysis that underlies the CAIR
notice of proposed rulemaking:

    In analyzing significant contribution to nonattainment, we
determined it was reasonable to exclude the Western U.S., including
the States of Washington, Idaho, Oregon, California, Nevada, Utah
and Arizona from further analysis due to geography, meteorology, and
topography. Based on these factors, we concluded that the PM2.5 and
8-hour ozone nonattainment problems are not likely to be affected
significantly by pollution transported across these States'
boundaries. Therefore, for the purpose of assessing State's
contributions to nonattainment in other States, we have only
analyzed the nonattainment counties located in the rest of the
US.\2\
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    \2\ ``Rule to Reduce Interstate Transport of Fine Particulate
Matter and Ozone (Interstate Air Quality Rule); Proposed Rule,''
January 30, 2004 (69 FR 4566). Alaska and Hawaii complete the list
of states not included in EPA's modeling analysis.

    Next, the Utah Interstate Transport SIP quotes a paragraph from an
EPA April 2005 response to public comments to the CAIR notice of
proposed rule. EPA's response extrapolates from the results of the
modeling analysis conducted for the January 30, 2004 proposed rule to
validate the previous decision to exclude Utah and other six western
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states from the CAIR analysis:

    Regarding modeling of all states, in the PM2.5 modeling for the
NPRM, we modeled 41 states, and found that the westernmost of these
states made very small contributions to nonattainment in any other
state. For the revised modeling for the final rule, we reduced the
set of states modeled for reasons of efficiency. The results again
showed that the westernmost states modeled did not make
contributions above the significance threshold, indicating that had
other even more western States been modeled they also would not have
done so.\3\
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    \3\ ``Corrected Response to Significant Public Comments on the
Proposed Clean Air Interstate Rule Received in response to: Rule to
Reduce Interstate Transport of Fine Particulate Matter and Ozone
(Interstate Air Quality Rule); Proposed Rule (69 FR 4566; January
30, 2004) Supplemental Proposal for the Rule to Reduce Interstate
Transport of Fine Particulate Matter and Ozone (Clean Air Interstate
Rule); Proposal Rule (69 FR 32684; June 10, 2004) Docket Number OAR-
2003-0053,'' April 2005.

    These assessments are substantiated by data and consideration of
additional factors EPA examined. Findings from the modeling analysis
conducted by EPA for the CAIR proposed rule include the maximum annual
average PM2.5 contribution by 41 states to the downwind counties
identified in nonattainment for the base years 2010 and 2015. For the
states included in the study, the maximum PM2.5 annual average
contribution to nonattainment by the westernmost states amounted to:
0.04 [mu]g/m\3\ for Colorado, 0.03 for Montana, 0.08 for Nebraska, 0.12
for North Dakota, 0.04 for South Dakota, and 0.05 for Wyoming (69 FR
4608). These amounts are well below the ``significant contribution''
threshold of 0.20 [mu]g/m\3\ set by EPA.
    A review of the attainment/nonattainment areas for the 1997 PM2.5
standard in these states and in Utah yields similar conclusions. Utah's
closest, potentially downwind, PM2.5 nonattainment area is centered in
Libby, Lincoln County, Montana, which is about 500 miles north of the
northern Utah border. EPA's findings based on a nine-factor analysis of
Lincoln County, and reported in the Agency's technical support document
for the December 17, 2004 designations, stressed the local origins of
PM2.5 nonattainment in Libby.\4\ These findings, in combination with
other factors such as the absence of PM2.5 nonattainment areas in Utah,
the distance between Utah and Libby, and the absence of PM2.5
nonattainment areas along the 500 miles between the Utah northern
border and Libby lead to the conclusion that it is unlikely that Utah
is making a significant contribution to the PM2.5 nonattainment status
of Lincoln County or interfering with maintenance of the NAAQS in
Montana. Similarly, the absence of PM2.5 nonattainment areas in Utah
and in the other neighboring downwind states makes it unlikely that
Utah interferes with the maintenance of the 1997 PM2.5 NAAQS standard
in Colorado, Idaho, North Dakota, South Dakota, or Wyoming.
---------------------------------------------------------------------------

    \4\ ``Technical Support for State and Tribal Air Quality Fine
Particle (PM2.5) Designations,'' December 2004; Chapter 6, pages
347-352.
---------------------------------------------------------------------------

    For the 1997 8-hour ozone standard, our review of the attainment/
nonattainment status in Utah and its downwind states confirms the EPA
positions incorporated by the State of Utah into its Interstate
Transport SIP. Utah does not have any ozone nonattainment areas, and
the same is true for all of its closest downwind states, except
Colorado. On this basis it is plausible to conclude that Utah does not
contribute significantly to ozone nonattainment, or interfere with
ozone maintenance, in the states of Idaho, Montana, Nebraska, North
Dakota, South Dakota, and Wyoming.
    Several factors need to be considered about potential ozone
transport between Utah and the Denver-Fort Collins metropolitan area,
in Colorado, which is designated nonattainment for the 1997 8-hour
ozone standard. Certain geographical, topographical, and meteorological
factors indicate that it is unlikely that Utah contributes
significantly to the 8-hour ozone nonattainment of the Denver-Fort
Collins metropolitan area. The 400 miles distance between Salt Lake
City and Denver, in combination with high natural barriers such as the
Wasatch Range in Utah and several ranges of the Rocky Mountains in
Colorado, constitute a sizeable physical barrier to potential eastward
transport of ozone or ozone precursors from Utah to Colorado. Also,
observed days of high ozone levels in the Salt Lake City metropolitan
area are usually associated with a `bowl effect' resulting from an
inversion that has a stagnant air pollution mass surrounded by the
Oquirrh Mountains to the west, the Great Salt Lake to the north, and
the Wasatch Range on the east. In contrast, high ozone levels in the
Denver metropolitan area are often associated with light up-slope
(easterly) winds occurring at the surface level, that keep ozone and
its precursors stagnating against the Front Range on the west side of
metropolitan Denver and Fort Collins. In light of these considerations,
it is unlikely that Utah makes a significant contribution of ozone and/
or ozone precursors to ozone nonattainment in the Denver-Fort Collins
metropolitan area.
    The third element of the Section 110(a)(2)(D)(i) provisions
requires states to prohibit emissions that interfere with any other
state's measures to prevent

significant deterioration (PSD) of air quality. The State of Utah's SIP
provisions include EPA-approved PSD and Nonattainment New Source Review
(NNSR) programs that have been successfully implemented in past years.
For PM2.5, the State PSD and NNSR programs are being
implemented in accordance with EPA's interim guidance calling for the
use of PM10 as a surrogate for PM2.5 in the PSD
program. In addition, Utah has committed to transitioning from use of
the interim PM2.5 guidance to the final PM2.5
implementation guidance after this guidance is finalized. EPA published
proposed regulations to establish this guidance on September 21, 2007
(72 FR 54112).
    The fourth element of the ``good neighbor'' provisions concerns the
requirement that a state SIP prohibit sources from emitting pollutants
that interfere with the efforts of another state to protect visibility.
Consistent with EPA's August 15, 2007 guidance, the Utah Interstate
Transport SIP declares that, under the 1980 regulations addressing
Reasonably Attributable Visibility Impairment (RAVI), in Utah there are
no sources that interfere with implementation of RAVI in other states.
The Interstate Transport SIP refers also to the Utah Regional Haze SIP
submitted to EPA in 2003 as an indication of the State's commitment to
reduce impacts on Class I areas on the Colorado Plateau. Consistent
with the EPA guidance cited above, Utah will fully address in the
State's regional haze SIP the requirements for SIP measures protecting
visibility in downwind states.
    Based on EPA's review and analysis of how the State of Utah
addresses the four elements identified in the ``good neighbor''
provisions, we are approving the State's Section XXIII of its SIP,
Interstate Transport, as meeting the requirements of the CAA Section
110(a)(2)(D)(i). We are also approving the Utah Administrative Code
(UAC) Rule R307-110-36 which incorporates Section XXIII of the SIP into
the State rules.

V. EPA's Evaluation of the State of Utah September 17, 2007 Submittal

    In its September 17, 2007 submittal to EPA, Utah corrected a
typographical error in UAC Rule R307-130-4 by eliminating the term
``not'' from its language. This change is approvable as it does not
modify, and makes clearer, the meaning of the rule. During the required
five year review of State rules, the Utah Division of Air Quality,
Department of Environmental Quality, discovered that the term ``not''
was a typographical error. Rule R307-130-4, ``Options,'' under the
General Penalty Policy Provisions of the UAC, reads: ``Consideration
may be given to suspension of monetary penalties in trade-off for
expenditures resulting in additional controls and/or emissions
reductions beyond those not [italics ours] required to meet existing
requirements. Consideration may be given to an increased amount of
suspended penalty as deterrent to future violations where
appropriate.'' It is clear that Utah intended for the rule to indicate
that monetary penalties assessed for violations may be suspended by the
State in exchange for a violator's investment in additional pollution
control measure and/or emissions reductions ``beyond those required to
meet existing requirements,'' thus, the change is appropriate.

VI. Final Action

    EPA is approving, through direct final rulemaking, the addition of
Section XXIII, Interstate Transport, to the Utah SIP, and of Rule R307-
110-36 (which incorporates Section XXIII) to the Utah Administrative
Code (UAC), to reflect that the State has adequately addressed the
required elements of Section 110(a)(2)(D)(i) of the Clean Air Act.
These revisions were adopted on February 7, 2007, and were submitted to
EPA on March 22, 2007. Rule R307-110-36 became effective February 9,
2007.
    EPA is also approving the removal of the word ``not,'' a
typographical error, from the provisions of Rule R307-130-4,
``Options.'' The amended text was adopted by the UAQB on June 21, 2007,
effective July 13, 2007, and submitted by the Governor to EPA on
September 17, 2007.
    EPA is publishing this rule without prior proposal because the
Agency views this as a noncontroversial amendment and anticipates no
adverse comments. This rule will be effective May 27, 2008 without
further notice unless the Agency receives adverse comments by April 28,
2008. If the EPA receives adverse comments, EPA will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect. EPA will address all public comments in a
subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. Please note that if
EPA receives adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, EPA may adopt as final those provisions of the rule that are
not the subject of an adverse comment.

VII. Statutory and Executive Order Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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).
    This rule also does not have tribal implications because it will
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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the

absence of a prior existing requirement for the State to use voluntary
consensus standards (VCS), EPA has no authority to disapprove a SIP
submission for failure to use VCS. It would thus be inconsistent with
applicable law for EPA, when it reviews a SIP submission, to use VCS in
place of a SIP submission that otherwise satisfies the provisions of
the Clean Air Act. Thus, the requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) do not apply. This rule does not impose an information collection
burden under the provisions of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 27, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: March 12, 2008.
Carol Rushin,
Acting Regional Administrator, Region 8.

0
40 CFR part 52 is amended to read as follows:

PART 52--[AMENDED]

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

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

Subpart TT--Utah

0
2. Section 52.2320 is amended by adding paragraph (c)(65) to read as
follows:

Sec.  52.2320  Identification of plan.

* * * * *
    (c) * * *
    (65) On March 22, 2007 the Governor of Utah submitted the addition
to the Utah Administrative Code (UAC) of Rule R307-110-36. This rule
incorporates by reference Section XXIII, Interstate Transport, of the
Utah State Implementation Plan (SIP). The Interstate Transport
declaration satisfies the requirements of Section 110(a)(2)(D)(i) of
the Clean Air Act (CAA). On September 17, 2007, the Governor of Utah
also submitted an amendment to the UAC Rule R307-130-4, ``Options,''
that removes from the text a typographical error. It removes the word
``not'' which had been accidentally placed in this rule.
    (i) Incorporation by reference.
    (A) Addition to the UAC of rule R307-110-36 that incorporates by
reference Section XXIII, ``Interstate Transport,'' of the Utah SIP.
Rule R307-110-36 was adopted by the UAQB on February 7, 2007, effective
February 9, 2007, and it was submitted by the Governor to EPA on March
22, 2007.
    (B) Revision to UAC Rule R307-130-4, ``Options.'' This revision
removes from the text the word ``not.'' The amended text was adopted by
the UAQB on June 21, 2007, effective July 13, 2007, and it was
submitted by the Utah Governor to EPA on September 17, 2007.
    (ii) Additional material.
    (A) Replacement page for UAC Rule R307-110-36 attached to the March
22, 2007 submittal letter by the Utah Governor to EPA. The new page
correctly refers to Section XXIII of the Utah SIP instead of the
incorrect reference to Section XXII included in the corresponding page
submitted with the Administrative Documentation for Rule R307-110-36.

0
3. Section 52.2354 is added to read as follows:

Sec.  52.2354  Interstate Transport.

    CAA Section 110(a)(2)(D)(i) requirements for the 1997 8-hour ozone
and PM2.5 standards. Section XXIII, Interstate Transport, of
the Utah SIP submitted by the Utah Governor on March 22, 2007,
satisfies the requirements of the Clean Air Act Section 110(a)(2)(D)(i)
for the 8-hour ozone and PM2.5 NAAQS promulgated by EPA in
July 1997. Section XXIII, Interstate Transport, was adopted by the UAQB
on February 9, 2007. The March 22, 2007 Governor's letter included as
an attachment a set of replacement pages for the Interstate Transport
text. The new pages reflect correctly that the Interstate Transport
declaration is under Section XXIII of the Utah SIP and not under
Section XXII as incorrectly indicated in the pages submitted with the
Administrative Documentation for the adoption of this SIP section.

 [FR Doc. E8-6275 Filed 3-27-08; 8:45 am]

BILLING CODE 6560-50-P


            Pesticide Reregistration Performance Measures and Goals;
                            Annual Progress Report;
                               Fiscal Year 2018

I.  Introduction
      The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a et seq.) requires EPA to publish information about EPA's annual achievements in meeting its performance measures and goals for pesticide reregistration.  This report addresses EPA's achievements in this area during fiscal year 2018.  This report discusses the integration of tolerance reassessment with the reregistration process and describes the status of various regulatory activities associated with reregistration and tolerance reassessment.  The report also presents total numbers of products reregistered and products registered under the "fast-track" provisions of FIFRA.
II.  Background
      EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, under section 4(l) of FIFRA, 7 U.S.C. 136a-1(l).  Specifically, such measures and goals are to include:
 The status of reregistration.
 The number of products reregistered, canceled, or amended.
 The number and type of data requests of Data Call-In (DCI) notices under FIFRA section 3(c)(2)(B) issued to support product reregistration by active ingredient.
 Progress in reducing the number of unreviewed, required reregistration studies.
 The aggregate status of tolerances reassessed.
 The number of applications for registration submitted under FIFRA section 4(k)(3) (which provides for expedited processing and review of certain applications) that were approved or disapproved.
 The future schedule for reregistrations in the current and succeeding fiscal year.
 The projected year of completion of the reregistrations under FIFRA section 4.
	FIFRA required EPA to conduct a comprehensive pesticide reregistration program -- a complete review of the human health and environmental effects of older pesticides originally registered before November 1, 1984.  Pesticides meeting today's scientific and regulatory standards could be declared "eligible" for reregistration.  To be eligible, an older pesticide must have a substantially complete data base and must not cause unreasonable adverse effects to human health or the environment when used according to Agency approved label directions and precautions.
	In addition, all pesticides with food uses must meet the safety standard of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.  Under FFDCA, EPA must make a determination that pesticide residues remaining in or on food are "safe;" that is, "that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue" from dietary and other sources.  In determining allowable levels of pesticide residues in food, EPA must, among other requirements, perform a comprehensive assessment of each pesticide's risks, considering:
 Aggregate exposure (from food, drinking water, and residential uses).
 Cumulative effects from all pesticides sharing a common mechanism of toxicity.
 Possible increased susceptibility of infants and children.
 Possible endocrine or estrogenic effects.
	The 1996 FFDCA amendments also required the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they met the safety standard of the law.  EPA was directed to give priority to the review of those pesticides that appeared to pose the greatest risk to public health.  The Agency completed the last of 9,721 required tolerance reassessment decisions in September 2007, ensuring that all pesticides used on food in the United States meet the law's safety standard.  EPA's approach to tolerance reassessment under FFDCA was described fully in the Agency's document, "Raw and Processed Food Schedule for Pesticide Tolerance Reassessment" (62 FR 42020, August 4, 1997) (FRL-5734-6).
	The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004 (Pub. Law 108-199, Div. G, Title V, Sec. 501, 118 Stat. 419).  Among other things, PRIA amended FIFRA section 4(g)(2) to require EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use REDs by October 3, 2008.  The Agency completed REDs for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadline.  REDs are available on the Agency's Pesticide Chemical Search web page at https://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.
III.  Program Accountability
	Through this summary of performance measures and goals for pesticide reregistration and expedited registration, EPA describes progress made during 2018 in each of the program areas specified in FIFRA section 4(l).
A.  Status of Reregistration
	The last reregistration eligibility decisions for 613 reregistration cases (representing pesticide active ingredients or groups of pesticide active ingredients) were completed in FY 2008.  Product reregistration was not complete in FY 2018; the Agency's progress towards completion is discussed in detail below.  During FY 2018, as in the intervening years, the Agency focused on implementing the REDs as applicable to individual pesticide products.
B.  Product Reregistration; Numbers of Products Reregistered, Canceled, and Amended
	At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered.  This concluding part of the reregistration process is called "product reregistration."
	In issuing a completed RED document, EPA sends registrants a DCI notice requesting any product-specific data and specific revised labeling needed to complete reregistration for each of the individual pesticide products covered by the RED.  Based on the results of EPA's review of these data and labeling, products found to meet FIFRA and FFDCA standards may be reregistered.
	A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process.  Ideally, in response to the DCI, the pesticide producer, or registrant, will submit the required product-specific data and revised labeling, which EPA will review and find acceptable.  At that point, the Agency may reregister the pesticide product.  However, some products contain multiple active ingredients and receive multiple DCIs issued at different times.  Products containing multiple active ingredients may require more than one round of label revisions depending on the timing of the REDs and DCIs.  A product with multiple active ingredients cannot be fully reregistered until the last active ingredient in its formulation is determined to be eligible for reregistration and all requirements of the applicable REDs satisfied (e.g., label changes, data requirements).  In other situations, the Agency may temporarily suspend a product's registration if the registrant has not submitted required product-specific studies within the time frame specified.  The Agency may cancel a product's registration because the registrant did not pay the required registration maintenance fee.  Alternatively, the registrant may request a voluntary cancellation of their end-use product registration.
	1.  Product reregistration actions in FY 2018.  EPA counts each of the post-RED product outcomes described above as a product reregistration action.  A single pesticide product may be the subject of several product reregistration actions within the same year.  For example, a product's registration initially may be amended, then the product may be reregistered, or the product may first be suspended and later it may be voluntarily canceled.  During FY 2018, with a goal of 400 total product reregistration actions, the EPA completed the product reregistration actions detailed in Table 1.

        TABLE 1. -- PRODUCT REREGISTRATION ACTIONS COMPLETED IN FY 2018
                          (AS OF SEPTEMBER 30, 2018)

                                    Actions
                                                                        FY 2018
Product reregistration actions
                                                                             19
Product amendment actions
                                                                             33
Product cancellation actions
                                                                            125
Product suspension actions
                                                                              0
Total actions
                                                                            177

	2.  Status of the product reregistration universe for FY 2018.  EPA also keeps track of the status of the universe of products subject to reregistration, that is, the overall number of products reregistered, amended, canceled, and sent for suspension, as well as the number of products with actions pending, as of the end of the fiscal year.  This overall status information is not "cumulative" -- it is not derived from summing up a series of annual actions.  Adding annual actions would result in a larger overall number since each individual product is subject to multiple actions -- it can be amended, reregistered, and/or canceled, over time.  Instead, the "big picture" status information in Table 2 should be considered a snapshot in time.  As registrants and EPA make marketing and regulatory decisions in the future, the status of individual products may change, and numbers in this table are expected to fluctuate.
TABLE 2. -- STATUS OF THE UNIVERSE OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2018 (AS OF SEPTEMBER 30, 2018)

                                    Status
                                                                        FY 2018
Products reregistered
                                                                         5,154
Products amended
                                                                          3,638
Products canceled
                                                                         11,949
Products sent for suspension
                                                                             40
Total products with actions completed
                                                                         20,781
Products with actions pending
                                                                          4,193
Total products in product reregistration universe
                                                                         24,974

      At the end of FY 2018, 4,193 products had product reregistration decisions pending.  Some pending products awaited science reviews, label reviews, or reregistration decisions by EPA.
	The universe of products in product reregistration has increased in some years and decreased in other years.  Generally, an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).

	3.  Product reregistration goal in FY 2019.  EPA's goal for FY2019 was to complete 400 product reregistration actions.  Additional information is available on EPA's Reregistration and Other Review Programs Predating Pesticide Registration Review web page at https://www.epa.gov/pesticide-reevaluation/reregistration-and-other-review-programs-predating-pesticide-registration.
C.  Applications for Registration Requiring Expedited Processing; Numbers Approved and Disapproved

	By law, EPA must expedite its processing of certain types of applications for pesticide product registration, i.e., applications for end-use products that would be identical or substantially similar to a currently registered product (me-too products); amendments to current product registrations that do not require review of scientific data; and products for public health pesticide uses.  During FY 2018, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as "fast track" applications) shown in Table 3.
                       TABLE 3. -- FAST TRACK APPLICATIONS APPROVED IN FY 2018
                               Application Type
                                                                        FY 2018
Me-too product registrations/Fast track
                                                                            352
Amendments/Fast track
                                                                          1,951
Total applications processed by fast track means
                                                                          2,303

	For those applications not approved, the Agency generally notifies the registrant of any deficiencies in the application that need to be corrected or addressed before the application can be approved.  Applications may have been withdrawn after discussions with the Agency, and 5 (Conventional=1, Antimicrobials=4,) were formally "denied" during FY 2018.
	On a financial accounting basis, EPA devoted 22.8 full-time equivalents (FTEs) in FY 2018 to reviewing and processing applications for fast track me-too product registrations and label amendments submitted to the Office of Pesticide Programs.  The Agency spent approximately $3.4 million in FY 2018 in direct costs (i.e., time on task, not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.
D.  Projected Year of Completion of Reregistrations
	EPA completed the last reregistration eligibility decisions in FY 2008.  Due to resource limitations and focus on other reevaluation programs, the Agency plans to complete product reregistration for conventional pesticides and antimicrobial pesticides in FY 2026.
IV. Can I Comment on this Report?
      EPA does not expect these reports to lead to any particular action and, therefore, is not seeking particular public comment.  However, EPA welcomes input from stakeholders and the general public.  Written comments, identified by the docket identification number EPA-HQ-OPP-2014-0125, and received by EPA on or before 60 days after date of publication in the Federal Register, will be taken into consideration in the event that EPA determines that further action in warranted.
      Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2014-0125, by one of the following methods:
      ::  Federal eRulemaking Portal:  http://www.regulations.gov.  Follow the on-line instructions for submitting comments.  Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
      ::  Mail:  Office of Pesticide Programs (OPP) Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
 	:: Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
      Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
V.  For Further Information Contact
      Ramé Cromwell, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>


[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23017-23018]
[FR Doc No: 2020-08732]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-155-000]

Dakota Natural Gas, LLC; Notice of Application

    Take notice that on April 10, 2020, Dakota Natural Gas, LLC (DNG),
1900 Cardinal Lane, Faribault, Minnesota 55021, filed an application in
Docket No. CP20-155-000, pursuant to section 7(f) of the Natural Gas
Act (NGA) and Part 157 the Federal Energy Regulatory Commission's
(Commission) regulations requesting that the Commission grant it, a
service area determination in Traill County, North Dakota within which
DNG may, without further Commission authorization, enlarge or expand
its natural gas distribution facilities and operations, without further
Commission authorization. Specifically, DNG intends to construct
approximately 62.74 miles of new pipeline in Minnesota and North
Dakota, all of which will be located in existing public road right-of-
way. Further, all construction and operations of this pipeline will be
subject to the jurisdiction of the state utility commissions of those
respective states; only customers in North Dakota are intended to be
provided service.
    All relevant information is more fully set forth in the application
which is on file with the Commission and open to public inspection. The
filing may also be viewed on the web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Kristine Anderson, Corporate Attorney, Dakota Natural Gas, LLC, 1900
Cardinal Lane, P.O. Box 798, Faribault, Minnesota 55021, by email at
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made in the proceeding with the Commission
and must provide a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the

Secretary of the Commission, as soon as possible, an original and two
copies of comments in support of or in opposition to this project. The
Commission will consider these comments in determining the appropriate
action to be taken, but the filing of a comment alone will not serve to
make the filer a party to the proceeding. The Commission's rules
require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commentors will not be required to serve
copies of filed documents on all other parties. However, the non-party
commentors will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TTY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on May 11, 2020.

    Dated: April 20, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-08732 Filed 4-23-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Rules and Regulations]
[Page 44693]
[FR Doc No: 2014-18286]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-1018]

Special Local Regulation; Seattle Seafair Unlimited Hydroplane
Race, Lake Washington, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Seattle Seafair Unlimited
Hydroplane Race Special Local Regulation on Lake Washington, WA from
8:00 a.m. on August 1, 2014 through 11:59 p.m. on August 3, 2014 during
hydroplane race times. This action is necessary to ensure public safety
from the inherent dangers associated with high-speed races while
allowing access for rescue personnel in the event of an emergency.
During the enforcement period, no person or vessel will be allowed to
enter the regulated area without the permission of the Captain of the
Port, on-scene Patrol Commander or Designated Representative.

DATES: The regulations in 33 CFR 100.1301 will be enforced from 8:00
a.m. on August 1, 2014 through 11:59 p.m. on August 3, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email LTJG Johnny Zeng, Sector Puget Sound Waterways Management
Division, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Seattle
Seafair Unlimited Hydroplane Race Special Local Regulation in 33 CFR
100.1301 from 8:00 a.m. on August 1, 2014 through 11:59 p.m. on August
3, 2014.
    Under the provisions of 33 CFR 100.1301, the Coast Guard will
restrict general navigation in the following area: All waters of Lake
Washington bounded by the Interstate 90 (Mercer Island/Lacey V. Murrow)
Bridge, the western shore of Lake Washington, and the east/west line
drawn tangent to Bailey Peninsula and along the shoreline of Mercer
Island.
    The regulated area has been divided into two zones. The zones are
separated by a line perpendicular from the I-90 Bridge to the northwest
corner of the East log boom and a line extending from the southeast
corner of the East log boom to the southeast corner of the hydroplane
race course and then to the northerly tip of Ohlers Island in Andrews
Bay. The western zone is designated Zone I, the eastern zone, Zone II.
(Refer to NOAA Chart 18447).
    The Coast Guard will maintain a patrol consisting of Coast Guard
vessels, assisted by Coast Guard Auxiliary vessels, in Zone II. The
Coast Guard patrol of this area is under the direction of the Coast
Guard Patrol Commander (the ``Patrol Commander''). The Patrol Commander
is empowered to control the movement of vessels on the racecourse and
in the adjoining waters during the periods this regulation is in
effect. The Patrol Commander may be assisted by other federal, state
and local law enforcement agencies.
    Only vessels authorized by the Patrol Commander may be allowed to
enter Zone I during the hours this regulation is in effect. Vessels in
the vicinity of Zone I shall maneuver and anchor as directed by the
Patrol Commander.
    During the times in which the regulation is in effect, the
following rules shall apply:
    (1) Swimming, wading, or otherwise entering the water in Zone I by
any person is prohibited while hydroplane boats are on the racecourse.
At other times in Zone I, any person entering the water from the
shoreline shall remain west of the swim line, denoted by buoys, and any
person entering the water from the log boom shall remain within ten
(10) feet of the log boom.
    (2) Any person swimming or otherwise entering the water in Zone II
shall remain within ten (10) feet of a vessel.
    (3) Rafting to a log boom will be limited to groups of three
vessels.
    (4) Up to six (6) vessels may raft together in Zone II if none of
the vessels are secured to a log boom. Only vessels authorized by the
Patrol Commander, other law enforcement agencies or event sponsors
shall be permitted to tow other watercraft or inflatable devices.
    (5) Vessels proceeding in either Zone I or Zone II during the hours
this regulation is in effect shall do so only at speeds which will
create minimum wake, seven (07) miles per hour or less. This maximum
speed may be reduced at the discretion of the Patrol Commander.
    (6) Upon completion of the daily racing activities, all vessels
leaving either Zone I or Zone II shall proceed at speeds of seven (07)
miles per hour or less. The maximum speed may be reduced at the
discretion of the Patrol Commander.
    (7) A succession of sharp, short signals by whistle or horn from
vessels patrolling the areas under the direction of the Patrol
Commander shall serve as signal to stop. Vessels signaled shall stop
and shall comply with the orders of the patrol vessel; failure to do so
may result in expulsion from the area, citation for failure to comply,
or both.
    The Captain of the Port may be assisted by other federal, state and
local law enforcement agencies in enforcing this regulation.
    This notice is issued under authority of 33 CFR 100.1301 and 5
U.S.C. 552(a). If the Captain of the Port determines that the regulated
area need not be enforced for the full duration stated in this notice,
he or she may use a Broadcast Notice to Mariners to grant general
permission to enter the regulated area.

    Dated: July 21, 2014.
T.A. Griffitts,
Captain, U.S. Coast Guard Acting Captain of the Port, Puget Sound.
[FR Doc. 2014-18286 Filed 7-31-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39783-39784]
[FR Doc No: 2017-17744]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-969-000.
    Applicants: Mercuria Energy America, Inc., Noble Americas Gas &
Power Corp.
    Description: Joint Petition for Temporary Waiver of Commission
Policies, Capacity Release Regulations and Related Tariff Provisions
and Request for Expedited Treatment of Mercuria Energy America, Inc.,
et al.
    Filed Date: 8/10/17.
    Accession Number: 20170810-5143.
    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: RP17-955-001.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Tennessee Gas Pipeline Company, L.L.C. submits tariff
filing per 154.205(b): Volume No. 2--Amended Statoil--Susquehanna West
Project to be effective 9/1/2017.
    Filed Date: 8/11/17.
    Accession Number: 20170811-5000.
    Comments Due: 5 p.m. ET 8/23/17.

    Docket Numbers: RP17-970-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: 2017 Penalties Assessed Compliance Filing of Colorado
Interstate Gas Company, L.L.C.
    Filed Date: 8/15/17.
    Accession Number: 20170815-5038.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: RP17-971-000.
    Applicants: Southwest Gas Transmission Company, A Li.
    Description: Southwest Gas Transmission Company, A Limited
Partnership submits tariff filing per 154.204: Company Contact Name to
be effective 8/14/2017.
    Filed Date: 8/15/17.
    Accession Number: 20170815-5045.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: RP17-972-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Wyoming Interstate Company, L.L.C. submits tariff
filing per 385.602: Settlement Agreement in Docket No. RP17-302-000.

    Filed Date: 8/15/17.
    Accession Number: 20170815-5131.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: RP17-973-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. submits tariff filing per 154.204:
Update NAESB 3.0 Order No. 587-W Compliance Filing to be effective 9/
15/2017.
    Filed Date: 8/15/17.
    Accession Number: 20170815-5137.
    Comments Due: 5 p.m. ET 8/28/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated August 16, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-17744 Filed 8-21-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Rules and Regulations]
[Pages 15880-15882]
[FR Doc No: 2013-05814]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0360; FRL-9380-9]
RIN 2070-ZA16

Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide
Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation extends the time-limited interim tolerances
for the combined residues of the insecticide tetrachlorvinphos, in or
on multiple commodities which are identified in Unit III. of this
document, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 13, 2013. Objections and
requests for hearings must be received on or before May 13, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0360, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7504P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0360 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 13, 2013. Addresses for mail and hand delivery of objections and

hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-0360, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    A detailed summary of the background related to EPA's extension of
the time-limited interim tolerances for the combined residues of the
insecticide tetrachlorvinphos, including its metabolites, in or on
multiple commodities can be found in the Federal Register notices of
June 8, 2011 (76 FR 33184) (FRL-8874-7); September 16, 2011 (76 FR
57657) (FRL-8887-5); and March 6, 2013 (78 FR 14487) (FRL-9380-8). The
referenced documents are available in the docket established by this
action, which is described under ADDRESSES. Locate and click on the
hyperlink for docket ID number EPA-HQ-OPP-2011-0360. Double-click on
the documents to view the referenced background summary information.
There were no substantive comments received in response to the proposed
rule of March 6, 2013.

III. Conclusion

    For the reasons stated in the proposed rule of March 6, 2013, EPA
is finalizing its proposal to extend to August 18, 2013, the expiration
dates for the following tolerances listed in 40 CFR 180.252 for
tetrachlorvinphos, (Z)-2-chloro-1-(2,4,5-trichlorophenyl) vinyl
dimethyl phosphate, including its metabolites, 1-(2,4,5-
trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol in or
on: Cattle, fat (of which no more than 0.1 part per million (ppm) is
tetrachlorvinphos per se) at 0.2 (ppm); cattle, kidney (of which no
more than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; cattle,
liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) at
0.5 ppm; cattle, meat (of which no more than 2.0 ppm is
tetrachlorvinphos per se) at 2.0 ppm; cattle, meat byproducts, except
kidney and liver at 1.0 ppm; egg (of which no more than 0.05 ppm is
tetrachlorvinphos per se) at 0.2 ppm; hog, fat (of which no more than
0.1 ppm is tetrachlorvinphos per se) at 0.2 ppm; hog, kidney (of which
no more than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; hog,
liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) at
0.5 ppm; hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos
per se) at 2.0 ppm; hog, meat byproducts, except kidney and liver at
1.0 ppm; milk, fat (reflecting negligible residues in whole milk and of
which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.05 ppm;
poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per
se) at 7.0 ppm; poultry, liver (of which no more than 0.05 ppm is
tetrachlorvinphos per se) at 2.0 ppm; poultry, meat (of which no more
than 3.0 ppm is tetrachlorvinphos per se) at 3.0 ppm; and poultry, meat
byproducts, except liver at 2.0 ppm.

IV. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(e)
of FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this final rule has been exempted from review under Executive
Order 12866, this final rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require any special considerations
under Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels, or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions was published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal

Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 26, 2013.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.252 revise the table in paragraph (a) to read as
follows:

Sec.  180.252  Tetrachlorvinphos; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Cattle, fat (of which no more than 0.1              0.2          8/18/13
 ppm is tetrachlorvinphos per se)........
Cattle, kidney (of which no more than               1.0          8/18/13
 0.05 ppm is tetrachlorvinphos per se)...
Cattle, liver (of which no more than 0.05           0.5          8/18/13
 ppm is tetrachlorvinphos per se)........
Cattle, meat (of which no more than 2.0             2.0          8/18/13
 ppm is tetrachlorvinphos per se)........
Cattle, meat byproducts, except kidney              1.0          8/18/13
 and liver...............................
Egg (of which no more than 0.05 ppm is              0.2          8/18/13
 tetrachlorvinphos per se)...............
Hog, fat (of which no more than 0.1 ppm             0.2          8/18/13
 is tetrachlorvinphos per se)............
Hog, kidney (of which no more than 0.05             1.0          8/18/13
 ppm is tetrachlorvinphos per se)........
Hog, liver (of which no more than 0.05              0.5          8/18/13
 ppm is tetrachlorvinphos per se)........
Hog, meat (of which no more than 2.0 ppm            2.0          8/18/13
 is tetrachlorvinphos per se)............
Hog, meat byproducts, except kidney and             1.0          8/18/13
 liver...................................
Milk, fat (reflecting negligible residues           0.05         8/18/13
 in whole milk and of which no more than
 0.05 ppm is tetrachlorvinphos per se)...
Poultry, fat (of which no more than 7.0             7.0          8/18/13
 ppm is tetrachlorvinphos per se)........
Poultry, liver (of which no more than               2.0          8/18/13
 0.05 ppm is tetrachlorvinphos per se)...
Poultry, meat (of which no more than 3.0            3.0          8/18/13
 ppm is tetrachlorvinphos per se)........
Poultry, meat byproducts, except liver...           2.0          8/18/13
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-05814 Filed 3-12-13; 8:45 am]
BILLING CODE 6560-50-P