[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13668-13671]
[FR Doc No: 2018-06381]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2017-0266; FRL-9975-79--Region 1]

Air Plan Approval; New Hampshire; Approval of Recordkeeping and
Reporting Requirements and Single Source Order

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) revisions submitted by the State of New
Hampshire. The revisions establish recordkeeping and reporting
obligations for sources of air pollution. Additionally, we are
approving an order limiting emissions of volatile organic compounds
from a facility in the State. This action is being taken in accordance
with the Clean Air Act.

DATES: This rule is effective on April 30, 2018.

ADDRESSES: EPA has established a docket for this action under Docket

Identification No. EPA-R01-OAR-2017-0266. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available at www.regulations.gov or at the U.S. Environmental
Protection Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office Square--Suite 100,
Boston, MA. EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Environmental Engineer,
Air Quality Planning Unit, Air Programs Branch (Mail Code OEP05-02),
U.S. Environmental Protection Agency, Region 1, 5 Post Office Square,
Suite 100, Boston, Massachusetts, 02109-3912;<PHONE_NUMBER>;
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On November 14, 2017 (82 FR 52683), EPA published a Notice of
Proposed Rulemaking (NPRM) for the State of New Hampshire. The NPRM
proposed approval of a revised single source order limiting emissions
of volatile organic compounds (VOCs) from Sturm Ruger & Company, and a
revised state regulation identified as Env-A 900, Owner or Operator
Recordkeeping and Reporting Obligations. During the public comment
period we received four comment letters. Two of the comment letters did
not contain information that was specific or germane to our proposed
actions for New Hampshire. One comment letter noted that approving New
Hampshire's SIP revisions was ``a bad idea,'' but did not explain why
or how New Hampshire's SIP revisions should be changed. One letter did
contain relevant adverse comments and those comments are responded to
below. In light of these relevant adverse comments, on January 11, 2018
(83 FR 1302) we published a withdrawal of the direct final rule we
published in conjunction with our November 14, 2017 NPRM (82 FR 52664).

II. Response to Comments

Comment

    A comment was received indicating that EPA should not approve the
``reasonably available control technology'' (RACT) order for Sturm
Ruger & Company for the following reasons. First, the commenter notes
that Table 1 of the order illustrates that the company is able to meet
a more stringent emission limit for topcoats than the order requires,
and therefore the order should not be approved because this emission
limit does not represent the lowest emission limit the source can meet
for that coating. Additionally, the commenter notes that EPA should not
approve sections of the order that involve SIP-approved rules because
doing so is redundant, and may create conflicting requirements if the
state changes the SIP-approved rule at some point in the future.

Response

    With regard to the commenter's first point, we note that the RACT
order that we are approving into the New Hampshire SIP, Order ARD-03-
001 issued to Sturm Ruger & Company, is divided into four parts as
follows: Section A, Introduction; Section B, Parties; Section C,
Statement of Fact and Law; and Section D, Order. Section D, Order,
contains the RACT requirements New Hampshire has tailored to the
facility. Table 1, which the commenter alludes to as being indicative
that the order contains insufficient requirements for RACT because the
emission limit contained within it does not represent the lowest
emission limit the source can meet for that coating, is found within
Section C, Statement of Fact and Law, and the volatile organic compound
(VOC) limits cited within it are from a state regulation previously
approved into the New Hampshire State Implementation Plan (SIP).\1\
Section C is provided as informative background as to what air
pollution control regulations the source is subject to. Table 1 of
Section C indicates that the source at issue in this SIP action uses
coatings with VOC contents that are lower than allowed by the State's
regulation, which illustrates that the source is in compliance with
those existing state requirements. New Hampshire adopted the regulation
in question, Env-A 1213, Wood Furniture, Burial Caskets, and Gunstock
Coatings, to meet, in part, its obligation to ensure that RACT is
required at major, and some non-major, sources of VOC emissions. EPA
approved the State's regulation as meeting RACT on March 10, 1998 (63
FR 11600). EPA is not taking any action on those previously-approved
SIP provisions in this action. The fact that the source has found
coatings with VOC content limits that are lower than required by the
State's regulation does not dictate that New Hampshire revise its
regulation to make it more stringent; rather, as noted previously, it
indicates that the source is in compliance with the State's RACT
requirements for such facilities. The commenter's assertion that the
levels shown in Table 1 can't be RACT because it is not the lowest
emission limit the source can meet appear to confuse RACT, which
requires ``reasonably available control technology,'' with the
requirements of a more rigorous regulatory tool of ``lowest achievable
emission rate'' (LAER). LAER, as defined at 40 CFR 51.165(a)(1)(xiii),
could in some instances require a more stringent level of control than
RACT.
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    \1\ Table 1 of the order contains an outdated citation; it cites
``Env-A-1204.27 and 1204.28(a)(3), which are currently part of the
``definitions'' section of New Hampshire's VOC regulations. The
current citations are as follows: For topcoats, Env-A 1213.03(a);
for sealers, Env-A 1213.03(b); for strippable booth coatings, Env-A
1213.04(a)(3).
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    In response to the commenter's second point regarding the Sturm
Ruger & Company order, we do agree that some portions of Section D of
the order are currently part of the New Hampshire SIP, and are
therefore duplicative and not needed within the order. We have included
in the Docket for this action a version of the State's order that
excludes the portions of Section D of the order that are duplicative of
existing, SIP-approved requirements, and are incorporating that version
into the NH SIP. A copy of the version of RACT Order ARD-03-001, as
amended February 2, 2017, that we are approving into the New Hampshire
SIP has been placed into the Docket for this rulemaking.

Comment

    A comment was received requesting that EPA not approve New
Hampshire's recordkeeping and reporting rule, Env-A 900, until the
state clarifies the applicability section of the rule. The commenter
asserted that, as currently structured, the rule would apply to many
small sources, including individual users of consumer products, and is
therefore far too burdensome. The

commenter cites Env-A 902.01 and 903.01 as examples of the asserted
broad reach of the rule's authority.

Response

    The applicability criteria of New Hampshire's Env-A 900 differ by
section of the regulation, and are structured such that they would not
apply to the small entities noted by the commenter. The provisions at
Env-A 902.01 are not applicability provisions; rather, they provide the
record retention and record availability requirements for sources that
are subject to the rule. Env-A 903.01 does contain applicability
criteria. For example, Env-A 903.01(a) provides applicability criteria
as follows: ``Except as provided in (b),\2\ below, this part shall
apply to any stationary source, area source, or device that is subject
to Env-A 600'' (underlined emphasis added). Env-A 600 is applicable to
sources required to obtain a permit from the New Hampshire Department
of Environmental Services (NH DES), and there are various, specific
applicability criteria within that regulation identifying who needs to
do so. For example, Env-A 607, Temporary Permits, applies to the
sources identified within Env-A 607.01, including those noted in
paragraph (a) of that section: external combustion devices with a heat
input of greater than or equal to 10 million British Thermal Units
(BTUs) per hour burning gas, liquid propane, distillate fuel, or any
combination of these fuels. Env-A 607.01 continues with specific
applicability criteria for other types of equipment, and in no case
would apply to the small entities noted by the commenter. In addition,
Env-A 900, section 904.01 provides applicability criteria for equipment
that has ``. . . actual VOC emissions greater than or equal to 10 tons
in any calendar year or that is subject to Env-A 1200 `VOC RACT'. . .
.'' Here, as within Env-A 600, the specific applicability criteria of
New Hampshire's regulations preclude their application to the small
entities contemplated by the commenter, and no part of the regulation
we are approving, Env-A 900, provides the state with such authority.
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    \2\ Paragraph (b) of Env-A 903.01 lists several specific source
types that are exempt from the section's requirements.
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III. Final Action

    EPA is approving portions of New Hampshire's revised regulation
Env-A 900, Owner or Operator Recordkeeping and Reporting Obligations,
and certain parts of the RACT Order ARD-03-001 issued to Sturm Ruger &
Company, as revisions to the New Hampshire SIP. This rule, which
responds to the adverse comments received, finalizes our proposed
approval of these SIP revisions.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of portions
of Env-A 900, Owner or Operator Recordkeeping and Reporting
Obligations, and portions of Order ARD-03-001, as amended February 2,
2017, as described in the amendments to 40 CFR part 52 set forth below.
The EPA has made, and will continue to make, these documents generally
available through www.regulations.gov, and at the EPA Region 1 Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 29, 2018. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. 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, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: March 20, 2018.
Alexandra Dapolito Dunn,
Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart EE--New Hampshire

0
2. Amend Sec.  52.1520 by:
0
a. In paragraph (c), amend the table by revising the entry ``Env-A
900''; and
0
b. In paragraph (d), amend the table by:
0
i. Removing the two entries entitled ``Sturm, Ruger & Company''; and
0
ii. Adding a new entry entitled ``Sturm Ruger & Company'' at the end of
the table.
    The revisions and additions read as follows:

Sec.  52.1520  Identification of plan.

* * * * *
    (c) * * *

                                     EPA-Approved New Hampshire Regulations
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                                                        State
       State citation             Title/subject       effective     EPA approval date 1        Explanations
                                                         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Env-A 900..................  Owner or Operator         7/18/2015  3/30/2018, [Insert      Approved sections Env-
                              Obligations.                         Federal Register        A 901 through 911,
                                                                   citation].              except for the
                                                                                following sections
                                                                                withdrawn by the
                                                                                State and which are
                                                                                not part of the
                                                                                approved SIP: Env-A
                                                                                907.01(d) and (e);
                                                                                907.02(a)(1), (d)(1)
                                                                                a. and c., (d)(2),
                                                                                and (e); 907.03;
                                                                                911.04(b) and (c);
                                                                                911.05.

                                                  * * * * * * *
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1 In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

    (d) * * *

                             EPA-Approved New Hampshire Source Specific Requirements
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                                                                                Additional
         Name of source                Permit No.            State       EPA approval date    explanations/Sec.
                                                        effective date           2            52.1535  citation
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                                                  * * * * * * *
Sturm Ruger & Company..........  ARD-03-001...........        2/2/2017  3/30/2018, [Insert  VOC RACT Order, as
                                                                         Federal Register    amended February 2,
                                                                         citation].          2017, except
                                                                                sections D.1, and
                                                                                introductory
                                                                                clauses to sections
                                                                                D.2, D.3.b, D.5.a.i
                                                                                and b.i.
----------------------------------------------------------------------------------------------------------------
2 In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *
[FR Doc. 2018-06381 Filed 3-29-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17145-17146]
[FR Doc No: 2021-06719]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1061-103]

Pacific Gas and Electric Company; Notice Soliciting Scoping
Comments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 1061-103.
    c. Date Filed: August 24, 2020.
    d. Applicant: Pacific Gas and Electric Company.
    e. Name of Project: Phoenix Hydroelectric Project.
    f. Location: The existing project is located on the South Fork
Stanislaus River and in the Tuolumne River Basin, in Tuolumne County,
California. The project occupies 26.99 acres of federal land
administered by the U.S. Forest Service and 0.59 acres administered by
the Bureau of Land Management.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Jan Nimick, Vice President, Power Generation,
Pacific Gas and Electric Company, 245 Market Street, San Francisco, CA
94105,<PHONE_NUMBER>.
    i. FERC Contact: Jim Hastreiter,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing scoping comments: April 26, 2021.
    The Commission strongly encourages electronic filing. Please file
scoping comments using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For

assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. All filings must clearly identify the project name and
docket number on the first page: Phoenix Hydroelectric Project (P-1061-
103).
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. The application is not ready for environmental analysis at this
time.
    l. The Phoenix Hydroelectric Project consists of the following
existing facilities: (1) A 535-foot-long and 132-foot-high concrete
arch dam on the South Fork Stanislaus River, (2) a 172.3 acre
reservoir, (3) a 133.1-foot-long and 20-foot-high concrete arch cushion
dam, (4) a 15.38-mile-long Main Tuolumne Canal, (5) a Header Box
(forebay), a 5,611-foot-long penstock, and a powerhouse with an impulse
turbine rated at 1.6 megawatts. The project is estimated to generate an
average of 9,956 megawatt-hours annually.
    m. 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 via the internet through
the Commission's Home Page (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. 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 FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    n. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

o. Scoping Process

    Commission staff will prepare either an environmental assessment
(EA) or an Environmental Impact Statement (EIS) that describes and
evaluates the probable effects, if any, of the licensee's proposed
action and alternatives. The EA or EIS will consider environmental
impacts and reasonable alternatives to the proposed action. The
Commission's scoping process will help determine the required level of
analysis and satisfy the NEPA scoping requirements, irrespective of
whether the Commission prepares an EA or an EIS. Due to restrictions on
mass gatherings related to COVID-19, we do not intend to conduct a
public scoping meeting and site visit in this case. Instead, we are
soliciting written comments and suggestions on the preliminary list of
issues and alternatives to be addressed in the NEPA document, as
described in scoping document 1 (SD1), issued March 26, 2021.
    Copies of the SD1 outlining the subject areas to be addressed in
the NEPA document were distributed to the parties on the Commission's
mailing list and the applicant's distribution list. Copies of SD1 may
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, call 1-866-
208-3676 or for TTY,<PHONE_NUMBER>.

    Dated: March 26, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-06719 Filed 3-31-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Pages 20392-20395]
[FR Doc No: 2012-8085]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0230; FRL-9343-7]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review Problem Formulation for the Reassessment of
Ecological Risks from the Use of Atrazine.

DATES: The meeting will be held on June 12-14, 2012, from 9 a.m. to
approximately 5:30 p.m. and on June 15, 2012, from 9 a.m. to
approximately 12:30 p.m.
    Comments. The Agency encourages that written comments be submitted
by May 29, 2012, and requests for oral comments be submitted by June 5,
2012. However, written comments and requests to make oral comments may
be submitted until the date of the meeting, but anyone submitting
written comments after May 29, 2012, should contact the Designated
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
For additional instructions, see Unit I.C. of the SUPPLEMENTARY
INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before April 18,
2012.
    Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, http://www.epa.gov/scipoly/sap for information on how
to access the webcast. Please note that the webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0230, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2012-0230. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instructions before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://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
regulations.gov or email. The regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through regulations.gov, your email address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Sharlene R. Matten, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-0130; fax number: (202) 564-

8382; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    2. 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.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

 C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2012-0230 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than May 29,
2012, to provide FIFRA SAP the time necessary to consider and review
the written comments. Written comments are accepted until the date of
the meeting, but anyone submitting written comments after May 29, 2012,
should contact the DFO listed under FOR FURTHER INFORMATION CONTACT.
Anyone submitting written comments at the meeting should bring 30
copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than June 5, 2012, in order to be included on the meeting agenda.
Requests to present oral comments will be accepted until the date of
the meeting and, to the extent that time permits, the Chair of FIFRA
SAP may permit the presentation of oral comments at the meeting by
interested persons who have not previously requested time. The request
should identify the name of the individual making the presentation, the
organization (if any) the individual will represent, and any
requirements for audiovisual equipment (e.g., overhead projector, 35 mm
projector, chalkboard). Oral comments before FIFRA SAP are limited to
approximately 5 minutes unless prior arrangements have been made. In
addition, each speaker should bring 30 copies of his or her comments
and presentation slides for distribution to the FIFRA SAP at the
meeting.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP
for this meeting. As part of a broader process for developing a pool of
candidates for each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals nominated
for this meeting should have expertise in one or more of the following
areas: Aquatic community ecology, surface water monitoring, water
quality, environmental fate and transport, aquatic toxicity, plant
toxicity, and statistics. Nominees should be scientists who have
sufficient professional qualifications, including training and
experience, to be capable of providing expert comments on the
scientific issues for this meeting. Nominees should be identified by
name, occupation, position, address, and telephone number. Nominations
should be provided to the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before April 18, 2012. The Agency will consider all
nominations of prospective candidates for this meeting that are
received on or before this date. However, final selection of ad hoc
members for this meeting is a discretionary function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the
function of the panel and the expertise needed to address the Agency's
charge to the panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a Federal department or agency or their employment by a Federal
department or agency except the EPA. Other factors considered during
the selection process include availability of the potential panel
member to fully participate in the panel's reviews, absence of any
conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of lack
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on FIFRA SAP. Numerous qualified
candidates are identified for each panel. Therefore, selection
decisions involve carefully weighing a number of factors including the
candidates' areas of expertise and professional qualifications and
achieving an overall balance of different scientific perspectives on
the panel. In order to have the collective breadth of experience needed
to address the Agency's charge for this meeting, the Agency anticipates
selecting approximately 10-12 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by the EPA in 5
CFR part 6401. In anticipation of this requirement, prospective
candidates for service on the FIFRA SAP will be asked to submit
confidential financial information which shall fully disclose, among
other financial interests, the candidate's employment, stocks and
bonds, and where applicable, sources of research support. The EPA will
evaluate the candidates financial disclosure form to assess whether
there are financial conflicts of interest, appearance of a lack of
impartiality or any prior involvement with the development of the
documents under consideration (including previous scientific peer

review) before the candidate is considered further for service on FIFRA
SAP. Those who are selected from the pool of prospective candidates
will be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP Web site at http://www.epa.gov/scipoly/sap or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

II. Background

 A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is
structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. FIFRA SAP is composed of a permanent
panel consisting of seven members who are appointed by the EPA
Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.

 B. Public Meeting

    In 2006, EPA initiated a program called Registration Review to re-
evaluate all pesticides on a regular cycle as part of the requirements
of the FQPA. The program reviews each pesticide active ingredient every
15 years to make sure that as the ability to assess risks to human
health and the environment evolves and as policies and practices
change, all pesticide products in the marketplace can still be used
safely. EPA will soon be reviewing atrazine as part of Registration
Review.
    An important step in the development of a risk assessment is the
problem formulation. In a problem formulation, available information,
including stressor sources and characteristics, exposure, ecological
effects on plants and animals (e.g., amphibians, fish, invertebrates,
birds, and mammals), and characteristics of the ecosystem(s), is used
to define assessment endpoints and to develop a preliminary
understanding of potential risks (i.e., develop a risk hypothesis and
conceptual model) associated with the use of a pesticide. The problem
formulation also serves as an opportunity to identify missing
information/uncertainties that may limit the assessment and any
assumptions that may be made in the absence of such data. This SAP
meeting will focus on the proposed use of the Plant Assemblage Toxicity
Index (PATI)-model, amphibians, and monitoring data all which are
components of the problem formulation.
    For the June 2012 SAP meeting, EPA will provide an overview of the
current state of information on atrazine use, environmental fate
(exposure), and ecological effects (toxicity) for assessing the
potential ecological risk from the use of atrazine. Emphasis of the SAP
meeting will be directed at re-evaluation of micro/mesocosm studies and
their impact on a PATI-derived level of concern (LOC) for aquatic plant
communities and a strategy for using the PATI-derived LOC for
identification of watersheds at risk. The strategy will employ
adjustments to control for bias in atrazine concentrations from
monitoring data according to sampling frequency. EPA will also include
a review of atrazine studies with amphibians published in the open
literature since the 2007 SAP on amphibians. This review will explore
whether additional effects have been associated with exposure to
atrazine and whether there is a relationship between effects reported
across various studies and common study design elements. The SAP will
be asked to comment on whether the review is thorough and whether
uncertainties have been sufficiently characterized.
    The Interim Reregistration Eligibility Decision (IRED) presented
the results of the atrazine ecological risk assessment that identified
the potential for community and population risk to sensitive aquatic
species. Information in the revised IRED was based in part on the
review and recommendations of the SAP which met in June 2003 to discuss
the potential developmental effects of atrazine on amphibians. At that
meeting, the Panel concurred with EPA's analysis that there was
sufficient evidence to formulate a hypothesis that atrazine exposure
may impact gonadal development in amphibians, but there were
insufficient data at that time to confirm or refute the hypothesis.
This led EPA to seek additional data through a data call-in (DCI) to
reduce uncertainties regarding potential risk to amphibians.
    In October 2007, EPA convened a second SAP meeting to evaluate
available data on atrazine effects on gonadal development in
amphibians. The SAP reviewed the document entitled ``White Paper on the
Potential for Atrazine to Affect Amphibian Gonadal Development'' and
concurred with EPA that atrazine does not consistently affect amphibian
gonadal development. Although the 2003 SAP indicated that African
clawed frog (Xenopus laevis) was an appropriate test species given the
extent to which the animal is used in amphibian developmental studies,
the 2007 Panel concluded that a major uncertainty in the registrant
data was the use of X. laevis as the test organism and the Panel
recommended that additional studies were warranted on North American
frog species. The SAP acknowledged though that there was uncertainty
whether study methods for North American species were sufficiently
developed or vetted to yield consistent results. Following the October
2007 SAP meeting, EPA determined that it was reasonable to reject the
hypothesis that atrazine exposure can affect gonadal development.
Consistent with the recommendations from the 2003 SAP, the Agency also
determined, that given the absence of consistent effects and inability
to reproduce effects used to support the hypothesis that atrazine
affects amphibian development, there was no compelling reason to pursue
additional testing with regard to the potential effects of atrazine on
amphibian gonadal development. However, the Agency acknowledged that it
would continue to monitor research on this subject as it becomes
available.
    Also as a condition of the 2003 reregistration, the atrazine
registrants were required to develop a monitoring program to determine
the extent to which atrazine concentrations associated with corn,
sorghum, and sugarcane production may be exceeding levels that could
cause effects to aquatic plant communities. Forty watersheds
representing high atrazine use locations vulnerable to atrazine runoff
were selected for monitoring using a

stratified, random statistical survey design. Sampling within these
watersheds began in 2004 and is ongoing in selected watersheds. There
are an additional 25 sites where monitoring began in 2010 to refine the
approach for identifying vulnerable watersheds. EPA is evaluating the
results of the atrazine monitoring program, also in part, to identify
the characteristics of those watersheds that resulted in atrazine
exposures exceeding the Agency's LOC and to extrapolate those results
to other non-monitored locations to determine where atrazine
concentrations may exceed the LOC.
    In December 2007, EPA presented to the SAP the use of the
Comprehensive Aquatic Systems Model (CASM) as a tool to determine an
LOC that relates time variable monitoring data to effects identified in
a series of microcosm and mesocosm studies. The SAP recommended that
EPA:
    1. Work with the CASM-Atrazine model to make the population time
series more realistic;
    2. Provide a better validation of this model, and
    3. Conduct a more comprehensive sensitivity analysis.
    In May 2009, EPA presented a simpler alternative to the CASM-based
approach to relate surface water monitoring data to the microcosm and
mesocosm data, called the PATI. Other issues presented at this meeting
included a revised assessment of the microcosm and mesocosm exposure
profiles, an update on the ecological monitoring program results,
interpretation of the monitoring results with PATI, identification of
the watershed factors driving atrazine runoff, and extrapolation of
those results to the entire atrazine use area to identify other areas
where atrazine exposures may exceed the LOC. The 2009 Panel suggested
that both the CASM-Atrazine model (presented by Syngenta) and PATI were
suitable assessment tools for atrazine. The PATI model was recommended
by the SAP as a generic assessment tool for developing an LOC, while
CASM was recommended by the SAP as a site-specific assessment tool
because of the need for extensive site-specific data. The Panel noted
that a limitation in the CASM model is the lack of understanding of the
sensitivity of model predictions with correlations among model
parameters. The SAP recommended that EPA re-evaluate the meso/microcosm
data set for study quality and concentration-specific effects, and
provided additional citations for meso/microcosm studies to consider
including in the assessment. They also recommended using a
probabilistic approach to determine the LOC. The SAP concurred with
EPA's incorporation of depth to impervious layer and slope to identify
vulnerable watersheds for atrazine runoff as part of the atrazine
vulnerability index. They also cautioned EPA that several watershed
factors such as atrazine use intensity and rainfall are temporally
dependent and, therefore, should not be considered minimum criteria in
the vulnerability index.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc
members for this meeting), and the meeting agenda will be available at
least 15 days prior to the meeting. In addition, the Agency may provide
additional background documents as the materials become available. You
may obtain electronic copies of these documents, and certain other
related documents that might be available electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.
    FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP Web site or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 27, 2012.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2012-8085 Filed 4-3-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47287-47288]
[FR Doc No: 2019-19324]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0433; FRL 9998-18]

Pesticides; Interim Process for Evaluating Potential Synergistic
Effects of Pesticides During the Registration Process; Notice of
Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of and soliciting public
comment on an interim process it developed to address risk estimate
uncertainties associated with U.S. patent assertions of greater than
additive effects (GTA effects) in mixtures of pesticide active
ingredients for controlling pests (often referred to as ``synergy'').
EPA developed a process to document, review and, if necessary, revise
ecological risk estimates; and invites public comment on this process
to obtain and analyze GTA effects data identified in patent assertions.

DATES: Comments must be received on or before October 24, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number, EPA-HQ-OPP-2017-0433, 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 Confidential Business
Information (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.html.
    Additional instructions on comments or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Edward Odenkirchen, Environmental Fate
and Ecological Effects Division (7507P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. 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?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, farm
worker, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides and/or the potential impacts of pesticide use on
listed species and designated critical habitat. Given the broad
interest, the Agency has not attempted to identify or describe all the
specific entities that may be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all 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 preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    EPA regulates pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., which governs the
production, use, distribution, and sale of pesticides. Under FIFRA,
pesticides distributed or sold in the United States must first be
registered with EPA unless they qualify for an exemption. A cornerstone
of the pesticide registration process is the data requirements that
applicants must fulfill regarding the pesticide's effects on human
health, the environment, and in some cases, its efficacy in controlling
pests.
    The burden of demonstrating that a product meets the standards for
registration rests on the registrant or applicant for registration. To
obtain registration, applicants are responsible for citing or
generating all data necessary to meet data requirements specified by
EPA's regulations at 40 CFR part 158. An ecological risk assessment is
one key assessment EPA performs to determine what risks are posed by a
pesticide and whether changes to the use or proposed use are necessary
to protect the environment. To inform such assessments, EPA requires a
range of data in specific categories including: Product chemistry,
environmental and mammalian toxicity, environmental fate, residue
chemistry, reentry exposure, and spray drift.
    EPA's historical process for evaluating pesticide ecological risks
has relied on toxicity information from studies conducted with single
active ingredients based on the lack of information on pesticide
interactions and the expectation that they are rare. In 2013, the
National Research Council (NRC) (Ref. 1) stated that toxicological
interactions between pesticide active ingredients that produce GTA
effects are rare and suggested that the Agency consider pesticide
active ingredient interactions when the best available scientific
evidence supports the evaluation.
    However, in a lawsuit challenging EPA's 2014 decision to register a
new pesticide product containing two herbicide active ingredients
(Enlist Duo Herbicide) (Ref. 2), the plaintiffs presented evidence--
previously unknown to EPA--that the U.S. Patent and Trademark Office
(USPTO) had granted a patent for claims that Enlist Duo produced GTA
effects towards pest species. EPA subsequently discovered that a number
of other registrants were making similar claims of GTA effects towards
pest species before the USPTO, but were not disclosing these GTA claims
to EPA. Based on the new information regarding the potential
synergistic effects on non-target organisms when the two pesticide
active ingredients of Enlist Duo Herbicide are applied together, EPA
asked the court to remand the Enlist Duo Herbicide registration
decision to EPA for consideration of its potential for synergistic
effects (Ref. 3). Subsequently, in 2016, and 2017, EPA received
petitions asking it to require registrants to provide information on
potential synergy for consideration in EPA's ecological risk
assessments. In addition, subsequent public comments submitted
regarding pesticide regulatory

decisions continue to include this issue as a concern.

III. Interim Process

    The criteria for use of GTA data for patent applications are
different than for EPA's quantitative analyses of risk. While the USPTO
patent evaluation process uses a standard that the issued assertion
must be novel and ``non-obvious'' (https://www.uspto.gov/web/offices/pac/mpep/mpep-2100.pdf), for EPA's quantitative risk assessments, the
data must meet the same standards for use of other toxicological data.
To address risk estimate uncertainties associated with patent
assertions of GTA effects, EPA has developed an interim process to
obtain, analyze, and document patent claims of GTA effects in mixtures
of pesticide active ingredients. The purpose of the interim process is
to evaluate the utility of collecting and reviewing GTA patent
information for use in conducting risk assessments, and to determine if
such data, where applicable, affect risk assessments. This process is
described in a document titled ``Process for Receiving and Evaluating
Data Supporting Assertions of Greater than Additive (GTA) Effects in
Mixtures of Pesticide Active Ingredients and Associated Guidance for
Registrants'' (Ref. 4) and summarized in this unit. The document is
available on the Agency's website: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/ecological-risk-assessment-pesticides-technical and in the docket.
    Generally, for new chemicals (specifically new conventional
pesticide active ingredients) and other new products or other active
ingredients for which EPA has specific concerns about the potential for
GTA effects, as part of the registration process, EPA will request
registrants to provide GTA effect information on approved patents and
conduct appropriate statistical analysis of that information using the
following steps:
    Step 1: Search for and identify granted U.S. patents with
applications that made any claims of GTA effects;
    Step 2: Conduct a review of patent data for relevance to ecological
risk assessment;
    Steps 3, Report effects testing data from relevant patents; and
    Step 4: Perform a statistical analysis using an EPA-establish
method to evaluate if observations of GTA effects are statistically
significant.
    Step 5 is an Agency review of the submitted information from Steps
1-4.
    Consistent with EPA's review of any scientific data submitted for
inclusion in the regulatory process, EPA will review submitted patent
searches and relevancy reporting in submissions to ensure that the
process is consistent with the Agency interpretation of patent
reporting and relevancy review.
    EPA has generally been applying this interim process since 2016.
EPA's experience with the application of this interim process to date
suggests that patent submissions with relevant information that
demonstrate a sufficiently large, statistically significant GTA
interaction requiring quantitative consideration in ecological risk
assessments will likely be rare. More specifically, for the 24 new
active ingredient registrations that submitted patent data to date,
three contained pertinent information that indicated a need for further
testing and none ultimately led to adjustment in the risk assessment.
EPA plans to re-evaluate this interim process considering public
comment and after it has collected and analyzed more GTA patent
information submitted during registrations. Ultimately, EPA plans to
look at the results of this process to inform its determination as to
whether patent data has utility in EPA's risk assessments. If the
interim process demonstrates it does, then EPA plans to continue to
request or require registrants provide patent data and follow this
process (or an improved process reflecting comments and/or lessons
learned). If the process demonstrates that the patent data does not
have utility in EPA's risk assessments, EPA plans to communicate that
to the public and discontinue this process.

IV. Public Comments Sought

    EPA is seeking comment on the interim process for assessing
potential GTA effects of pesticides during the registration process.
Specifically, EPA solicits comments on the following:
     Are there technical aspects of the interim process that
warrant change? If so, what changes are recommended?
     What aspects of the process could be applied to the
evaluation of open literature sources of GTA effects pesticide
interactions?
     Should EPA consider standardizing a more detailed search
and reporting approach, and how should EPA do that?
     Should EPA continue the evaluation process as described in
this document? If so, what performance metrics (e.g., number of
evaluations) should EPA consider before deciding the utility of this
approach?
     What applicant burden is associated with the activities
described in this memorandum, including compiling, analyzing, and
submitting the information? Specifically, does an estimate of 80--240
hours of burden per applicant cover the respondent burden associated
with the interim process?

V. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.

1. National Research Council (NRC) 2013. Assessing Risks to
Endangered and Threatened Species from Pesticides. The National
Academies Press, Washington DC.
2. Case Nos. 14-73353, 14-73359, 15-71207, 15-71213 United States
Court of Appeals for the Ninth Circuit ID: 9731620, DktEntry: 56-1,
Page 1 of 215.
3. Case Nos. 14-73353, 14-73359, 15-71207, 15-71213 United States
Court of Appeals for the Ninth Circuit ID: 9770038, DktEntry: 121-1,
Page 1 of 12.
4. U.S EPA. Process for Receiving and Evaluation Data Supporting
Assertion of Greater than Additive (GTA) Effects in Mixtures of
Pesticide Active Ingredients and Associated Guidance for
Registrants, August 2019. It is available at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/ecological-risk-assessment-pesticides-technical.

    Authority: 7 U.S.C. 136 et seq.

    Dated: September 3, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator.
[FR Doc. 2019-19324 Filed 9-6-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Notices]
[Pages 58793-58794]
[FR Doc No: 2014-23296]

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

Coast Guard

[USCG-2014-0107; OMB Control Number 1625-0011]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-Day Notice Requesting Comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding Information Collection Requests (ICRs),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of a
Reinstatement, with change, of a previously approved collection for
which approval has expired for the following collection of information:
1625-0011, Applications for Private Aids to Navigation and for Class I
Private Aids to Navigation on Artificial Islands and Fixed Structures.
Review and comments by OIRA ensure we only impose paperwork burdens
commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
October 30, 2014.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2014-0107] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) and/or to OIRA. To avoid
duplicate submissions, please use only one of the following means:
    (1) Online: (a) To Coast Guard docket at http://www.regulations.gov. (b) To OIRA by email via<EMAIL_ADDRESS>    (2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. (b) To
OIRA, 725 17th Street NW., Washington, DC 20503, attention Desk Officer
for the Coast Guard.
    (3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
202-366-9329.
    (4) Fax: (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be

available for inspection or copying at room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. You may also find the docket on the Internet at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, US COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE. SE., STOP 7710, WASHINGTON DC
20593-7710.

FOR FURTHER INFORMATION: Contact Anthony Smith, Office of Information
Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for questions
on these documents. Contact Ms. Cheryl Collins, Program Manager, Docket
Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. These comments will help OIRA determine whether to approve
the ICRs referred to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG 2014-0107], and must be received by October 30,
2014. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2014-0107]; indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES, but please
submit them by only one means. To submit your comment online, go to
http://www.regulations.gov, and type ``USCG-2014-0107'' in the
``Search'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Search'' box insert ``USCG-2014-0107'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Numbers: 1625-0011.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (79 FR 33573, June 11, 2014)
required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.

Information Collection Request

    1. Title: Applications for Private Aids to Navigation and for Class
I Private Aids to Navigation on Artificial Islands and Fixed
Structures.
    OMB Control Number: 1625-0011.
    Type of Request: Reinstatement, with change, of a previously
approved collection for which approval has expired.
    Respondents: Owners of private aids to navigation.
    Abstract: Information received from the private aids to navigation
applications is essential for safe navigation. The forms are used to
collect vital safety information such as the geographic position of the
aid, as well as the characteristic of the aid, the light signal, and
other related safety information.
    Forms: CG-2554 and CG-4143.
    Burden Estimate: The estimated burden has decreased from 3,000
hours to 2,000 hours a year due to a decrease in the average annual
number of respondents.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: September 11, 2014.
Thomas P. Michelli,
Acting Chief Information Officer, U.S. Coast Guard.
[FR Doc. 2014-23296 Filed 9-29-14; 8:45 am]
BILLING CODE 9110-04-P