[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[Notices]
[Page 11106]
[DOCID:fr29fe08-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-41-000]

Bicent (California) Malburg LLC; Notice of Filing

February 25, 2008.
    Take notice that on February 15, 2008, pursuant to Rule 207 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.207 (2007),
Bicent (California) Malburg LLC filed a Petition of Declaratory Order
Disclaiming Jurisdiction.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 7, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-3883 Filed 2-28-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31547-31549]
[FR Doc No: 2022-11166]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-161-000]

Gulf South Pipeline Company, LLC; Notice of Scoping Period
Requesting Comments on Environmental Issues for the Proposed Index 130
MS River Replacement Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental document, that will discuss
the environmental impacts of the Index 130 MS River Replacement Project
(Project), involving the replacement of its existing pipelines under
the Mississippi River by Gulf South Pipeline Company, LLC (Gulf South)
in Ascension Parish, Louisiana. The purpose of the Project is to
accommodate the Mississippi River Ship Channel Deepening Project
planned by the U.S. Army Corps of Engineers, in partnership with the
Louisiana Department of Transportation and Development. The Commission
will use this environmental document in its decision-making process to
determine whether the project is in the public convenience and
necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies regarding the project. As part of the National Environmental
Policy Act (NEPA) review process, the Commission takes into account
concerns the public may have about proposals and the environmental
impacts that could result from its action whenever it considers the
issuance of a Certificate of Public Convenience and Necessity. This
gathering of public input is referred to

as ``scoping.'' The main goal of the scoping process is to focus the
analysis in the environmental document on the important environmental
issues. Additional information about the Commission's NEPA process is
described below in the NEPA Process and Environmental Document section
of this notice.
    By this notice, the Commission requests public comments on the
scope of issues to address in the environmental document. To ensure
that your comments are timely and properly recorded, please submit your
comments so that the Commission receives them in Washington, DC on or
before 5:00 p.m. Eastern Time on June 17, 2022. Comments may be
submitted in written form. Further details on how to submit comments
are provided in the Public Participation section of this notice.
    Your comments should focus on the potential environmental effects,
reasonable alternatives, and measures to avoid or lessen environmental
impacts. Your input will help the Commission staff determine what
issues they need to evaluate in the environmental document. Commission
staff will consider all written comments during the preparation of the
environmental document.
    If you submitted comments on this project to the Commission before
the opening of this docket on April 8, 2022, you will need to file
those comments in Docket No. CP22-161-000 to ensure they are considered
as part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the project, the Natural Gas Act conveys the right of eminent
domain to the company. Therefore, if you and the company do not reach
an easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law. The Commission does
not subsequently grant, exercise, or oversee the exercise of that
eminent domain authority. The courts have exclusive authority to handle
eminent domain cases; the Commission has no jurisdiction over these
matters.
    Gulf South provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' which addresses typically asked questions, including
the use of eminent domain and how to participate in the Commission's
proceedings. This fact sheet along with other landowner topics of
interest are available for viewing on the FERC website (www.ferc.gov)
under the Natural Gas Questions or Landowner Topics link.

Public Participation

    There are three methods you can use to submit your comments to the
Commission. Please carefully follow these instructions so that your
comments are properly recorded. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or [email protected].
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. Using eComment is an easy method for
submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is also on the Commission's website (www.ferc.gov) under
the link to FERC Online. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; a comment on a particular project is considered a ``Comment on
a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP22-
162-000) on your letter. 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.
    Additionally, the Commission offers a free service called
eSubscription which makes it easy to stay informed of all issuances and
submittals regarding the dockets/projects to which you subscribe. These
instant email notifications are the fastest way to receive notification
and provide a link to the document files which can reduce the amount of
time you spend researching proceedings. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.

Summary of the Proposed Project

    To accommodate the Mississippi River Ship Channel Deepening
Project, Gulf South proposes to replace via horizontal directional
drill its MS River Crossing consisting of three 20-inch-diameter
pipelines with approximately 5,750 feet of two 30-inch-diameter
pipelines under the Mississippi River and install auxiliary and
appurtenant equipment. Gulf South requests authorization to abandon
three segments of the 20-inch-diameter MS River Crossing pipeline by
removal (combined total of approx. 9,455 feet) and the remaining
pipeline in place (combined total of approx. 7,380 feet). Gulf South
also proposes to reconfigure its existing mainline valve yards on the
west and east banks of the Mississippi River--the Modeste Valve Site
and Sugar Bowl Pig Trap/Valve Site, respectively. Where Index 804
connects to the Index 130 and Index 130L, the reconfiguration will
require expanding Index 804 by approximately 730 feet of 6-inch-
diameter pipeline to the new tie-in location, and the existing Sugar
Bowl Pig Trap/Valve site will be removed.
    The general location of the project facilities is shown in appendix
1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary''. For instructions on
connecting to eLibrary, refer to the last page of this notice. 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 protected] or call toll free,<PHONE_NUMBER>
or TTY<PHONE_NUMBER>.
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Land Requirements for Construction

    Construction of the Project will require the use of 185.52 acres of
land, resulting in both temporary and permanent impacts. Operational
impacts (11.55 acres) will be associated with the new permanent
easement, two new mainline valve sites, and new permanent access roads.
No areas within the new permanent right-of-way would require routine
vegetation mowing by Gulf South during operation; therefore, following
completion of construction, a total of 180.50 acres will

be restored to pre-construction conditions.

NEPA Process and the Environmental Document

    Any environmental document issued by the Commission will discuss
impacts that could occur as a result of the construction and operation
of the proposed project under the relevant general resource areas:

     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     land use;
     air quality and noise;
     reliability and safety;
     socioeconomics
     environmental justice

    Commission staff will also evaluate reasonable alternatives to the
proposed project or portions of the project and make recommendations on
how to lessen or avoid impacts on the various resource areas. Your
comments will help Commission staff identify and focus on the issues
that might have an effect on the human environment and potentially
eliminate others from further study and discussion in the environmental
document.
    Following this scoping period, Commission staff will determine
whether to prepare an Environmental Assessment (EA) or an Environmental
Impact Statement (EIS). The EA or the EIS will present Commission
staff's independent analysis of the issues. If Commission staff
prepares an EA, a Notice of Schedule for the Preparation of an
Environmental Assessment will be issued. The EA may be issued for an
allotted public comment period. The Commission would consider timely
comments on the EA before making its decision regarding the proposed
project. If Commission staff prepares an EIS, a Notice of Intent to
Prepare an EIS/Notice of Schedule will be issued, which will open up an
additional comment period. Staff will then prepare a draft EIS which
will be issued for public comment. Commission staff will consider all
timely comments received during the comment period on the draft EIS and
revise the document, as necessary, before issuing a final EIS. Any EA
or draft and final EIS will be available in electronic format in the
public record through eLibrary \2\ and the Commission's natural gas
environmental documents web page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If eSubscribed, you
will receive instant email notification when the environmental document
is issued.
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    \2\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
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    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this project to formally cooperate in the
preparation of the environmental document.\3\ Agencies that would like
to request cooperating agency status should follow the instructions for
filing comments provided under the Public Participation section of this
notice.
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Section 1501.8.
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Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the applicable State Historic Preservation Office(s),
and to solicit their views and those of other government agencies,
interested Indian tribes, and the public on the project's potential
effects on historic properties.\4\ The environmental document for this
project will document findings on the impacts on historic properties
and summarize the status of consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project and includes a mailing address with their
comments. Commission staff will update the environmental mailing list
as the analysis proceeds to ensure that Commission notices related to
this environmental review are sent to all individuals, organizations,
and government entities interested in and/or potentially affected by
the proposed project.
    If you need to make changes to your name/address, or if you would
like to remove your name from the mailing list, please complete one of
the following steps:
    (1) Send an email to [email protected] stating your
request. You must include the docket number CP22-161-000 in your
request. If you are requesting a change to your address, please be sure
to include your name and the correct address. If you are requesting to
delete your address from the mailing list, please include your name and
address as it appeared on this notice. This email address is unable to
accept comments.

OR

    (2) Return the attached ``Mailing List Update Form'' (appendix 2).

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field. Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at [email protected] or<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of all formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: May 18, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-11166 Filed 5-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Pages 55791-55792]
[FR Doc No: 2014-22027]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0567; FRL-9915-58]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Pesticide Program Public Sector Collections (FIFRA
Sections 18 and 24(c))'' and identified by EPA ICR No. 2311.02 and OMB
Control No. 2070-0182, represents the renewal of an existing ICR that
is scheduled to expire on May 31, 2015. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection that is summarized in
this document. The ICR and accompanying material are available in the
docket for public review and comment.

DATES: Comments must be received on or before November 17, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0567, 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 commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Rame Cromwell, Field External and
Affairs Division (7506P), 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. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Pesticide Program Public Sector Collections (FIFRA) Sections
18 and 24(c).
    ICR number: EPA ICR No. 2311.02.
    OMB control number: OMB Control No. 2070-0182.
    ICR status: This ICR is currently scheduled to expire on May 31,
2015. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR covers the paperwork burden under the PRA
associated with two types of pesticide registration requests made by
states, U.S. Territories, or Federal agencies. Specifically, this ICR
covers emergency exemption requests, which allow for an unregistered
use of a pesticide, and requests by states to register a pesticide use
to meet a special local need (SLN). Section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the EPA
to grant emergency exemptions to states, U.S. Territories, and Federal
agencies to allow an unregistered use of a pesticide for a limited time
if EPA determines that emergency conditions exist. Section 18 requests
include unregistered pesticide use exemptions for specific
agricultural, public health, and quarantine purposes. Section 24(c) of
FIFRA authorizes the EPA to grant permission to a particular state to
register additional uses of a federally registered pesticide for
distribution and use within that state to meet a SLN.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average
18,315 hours annually for state government ``applicants'' for FIFRA
section 18 program, and for applicants under the FIFRA 24(c) program an
annual estimate of 15,860 hours, for a combined total of 34,175 burden
hours annually. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by
this ICR are pesticide registrants, which may be identified by
pesticide and other agricultural chemical manufacturing (North American
Industrial Classification System (NAICS) code 325320) and governments
that administer environmental quality programs (NAICS code 9241).
    Estimated total number of potential respondents: 980.
    Frequency of response: On occasion.

    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 34,175 hours.
    Estimated total annual costs: $2,332,954. This includes an
estimated cost of $1,086,403 for the Section 18 program and an
estimated cost of $1,236,551 for the Section 24(c) program. This ICR
does not involve any capital investment or maintenance and operational
costs.

III. Are there changes in the estimates from the last approval?

    There is no change in the estimated respondent burden hours per SLN
application for this ICR from the currently-approved ICR for Section
24(c) applications, for either registrants or states. The total annual
respondent burden estimate (registrants + states) has decreased
slightly from 16,900 to 15,860 hours due to a small decrease in the
average number of petitions received annually, from about 325 to 305.
Although EPA does not require Section 24(c)'s and cannot estimate
precisely how many submissions will be received in the future, the
Agency expects to receive approximately 305 Section 24(c) applications
annually over the next 3 years. As a result of the decrease in the
number of applications and updating the wage rates, the estimated
respondent cost increased slightly from $1.235 million to $1.237
million.
    The estimated unit burden for a given FIFRA section 18 application
is unchanged. EPA estimates an increase in the number of section 18
application submissions and estimated annual burden relative to the
existing, approved collection. EPA estimates that the total annual
respondent burden has increased from 12,672 hours to about 18,315
hours. The increase corresponds with an increase in the average number
of Section 18s requested per year, from 128 to 185. Although EPA does
not require Section 18s and cannot estimate precisely how many
submissions will be received in the future, the Agency expects to
receive approximately 185 Section 18 applications annually over the
next 3 years. As a result of the increase in the number of applications
and updating the wage rates, the estimated respondent cost increased
from $739 thousand to $1.086 million.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: September 5, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2014-22027 Filed 9-16-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 190 (Wednesday, September 30, 2020)]
[Notices]
[Pages 61753-61755]
[FR Doc No: 2020-21624]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1791]

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential--Questions and
Answers; International Council for Harmonisation; 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 ``E14 and
S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation
and Proarrhythmic Potential--Questions and Answers.'' The draft
guidance was prepared under the auspices of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH), formerly the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human
Use. The draft guidance contains revised questions and answers (Q&As)
for the ICH guidance for industry ``E14 Clinical Evaluation of the QT/
QTc Interval Prolongation and Proarrhythmic Potential for Non-
Antiarrhythmic Drugs'' and new Q&As for the ICH guidance for industry
``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals''
that provide recommendations on considerations for an integrated risk
assessment combining nonclinical and clinical data--in particular, at
later stages of drug development when clinical data are available. The
draft guidance is intended to provide a harmonized approach to
integrate nonclinical and clinical information for proarrhythmia risk
assessment to streamline drug development and provide clarity on
regulatory decision making.

DATES: Submit either electronic or written comments on the draft
guidance by November 30, 2020 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-2020-D-1791 for ``E14 and S7B Clinical and Nonclinical Evaluation
of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions
and Answers'' 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,<PHONE_NUMBER>.
     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 this 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 the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: David Strauss,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 64, Rm. 2072, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; 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,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential--Questions and
Answers.'' The draft guidance was prepared under the auspices of ICH.
ICH has the mission of achieving greater regulatory harmonization
worldwide to ensure that safe, effective, high-quality medicines are
developed, registered, and maintained in the most resource-efficient
manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In July 2020, the ICH Assembly endorsed the draft guideline
entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential--Questions and
Answers'' and agreed that the guideline should be made available for
public comment. The draft guideline is the product of the E14 and S7B
Implementation Working Group of the ICH. Comments about this draft will
be considered by FDA and the ICH E14 and S7B Implementation Working
Group.
    The draft guidance contains revised Q&As about the ICH guidance for
industry ``E14 Clinical Evaluation of the QT/QTc Interval Prolongation
and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and new Q&As
about the ICH guidance for industry ``S7B Nonclinical Evaluation of the
Potential for Delayed Ventricular Repolarization (QT Interval
Prolongation) by Human Pharmaceuticals'' that provide recommendations
on considerations for an integrated risk assessment combining
nonclinical and clinical data--in particular, at later stages of drug
development when clinical data are available. For ICH E14, revised Q&As
provide recommendations for how an integrated nonclinical and clinical
risk assessment can be particularly valuable under scenarios when a
sufficiently high multiple of maximum therapeutic exposure cannot be
achieved (ICH E14 Q&A 5.1); and under scenarios where a placebo-
controlled comparison is not possible, safety considerations preclude
administering supratherapeutic doses to obtain high clinical exposures
and/or safety or tolerability prohibit the use of the product in
healthy participants (ICH E14 Q&A 6.1). For ICH S7B, new Q&As provide
recommendations on an integrated risk assessment and how it can inform
the design of clinical investigations and the interpretation of their
results (ICH S7B Q&As 1.1 and 1.2); best-practice considerations for in
vitro (ICH S7B Q&As 2.1 to 2.5) and in vivo (ICH S7B Q&As 3.1 to 3.5)
studies; and principles for proarrhythmia models, including in silico
(ICH S7B Q&As 4.1 to 4.3). The draft guidance is intended to provide a
harmonized approach to integrate nonclinical and clinical information
for proarrhythmia risk assessment to streamline drug development and
provide clarity on regulatory decision making. FDA seeks public comment
on all aspects of these draft Q&As of note, ICH E14 Q&A 6.1 encourages
public comment on how to define the lack of clinically relevant QT
prolongation in the context of this Q&A.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``E14 and S7B Clinical and Nonclinical
Evaluation of QT/QTc Interval Prolongation and Proarrhythmic
Potential--Questions and Answers.'' 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

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

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

    Dated: September 25, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21624 Filed 9-29-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91846-91852]
[FR Doc No: 2016-30467]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0658; FRL-9955-45]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
flumioxazin in or on multiple commodities which are identified and
discussed later in this document. The Inter-Regional Research Project
Number 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 19, 2016. Objections and
requests for hearings must be received on or before February 17, 2017,
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-2015-0658, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; Main 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 EPA's
tolerance regulations at 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-2015-0658 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 February 17, 2017. 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-2015-0658, 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.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition
(PP#5E8399) by Interregional Research No. 4 (IR-4), Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201-W,
Princeton, NJ 08540. The Agency inadvertently republished this notice
on March 16, 2016 (81 FR 14030) (FRL-9942-86). The petition requested
that 40 CFR 180.568 be amended by establishing tolerances for residues
of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-
propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, in or on berry, low growing, subgroup 13-07G at 0.07
parts per million (ppm); caneberry, subgroup 13-07A at 0.4 ppm; citrus,
group 10-10 at 0.02 ppm; citrus oil at 0.1 ppm; clover, forage at 0.02
ppm; clover, hay at 0.15 ppm; fruit, pome, group 11-10 at 0.02 ppm;
fruit, small vine climbing, except for fuzzy kiwifruit, subgroup 13-07F
at 0.02 ppm; fruit, stone, group 12-12 at 0.02 ppm; head and stem
brassica, subgroup 5A at 0.02 ppm; nut, tree, group 14-12 at 0.02 ppm;
onion, bulb subgroup 3-07A at 0.02 ppm; and vegetable, fruiting, group
8-10 at 0.02 ppm.
    The petitioner also requested the removal of the following
established tolerances based on the establishment of tolerances for the
commodities established in this action: Cabbage at 0.02 ppm; cabbage,
Chinese, napa at 0.02 ppm; fruit, pome group 11 at 0.02 ppm; fruit,
stone, group 12 at 0.02 ppm; garlic at 0.02 ppm; grape at 0.02 ppm;
nut, tree group 14 at 0.02 ppm; okra at 0.02 ppm; onion, bulb at 0.02
ppm; pistachio at 0.02 ppm; shallot bulb at 0.02 ppm; strawberry at
0.07 ppm; and vegetable, fruiting group 8 at 0.02 ppm. That document
referenced a summary of the petition prepared by Valent USA
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on these notices of
filings. EPA's response to these comments is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flumioxazin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flumioxazin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Toxicity associated with flumioxazin includes anemia and effects on
the cardiovascular system and liver. Specifically, alterations in
hemoglobin parameters were observed in rats, as well as increased renal
toxicity in male rats, and increased absolute and relative liver
weights and increased alkaline phosphate values were seen in dogs. No
evidence of neurotoxicity was seen in male or female rats in the acute
or subchronic neurotoxicity studies. The oral and dermal developmental
rat studies showed evidence of increased quantitative susceptibility of
fetuses, as cardiovascular anomalies (ventral septal defects) were
found. These developmental effects in the offspring were more severe
and seen at doses lower than those that caused parental and systemic
toxicity. The regulatory endpoints for flumioxazin are protective of
this increased susceptibility, however, so there is low concern and no
residual uncertainties for these effects. Flumioxazin was negative for
mutagenicity in most of the available studies, however, there were
aberrations in a chromosomal aberration assay. The lack of
carcinogenicity in mice and rats permits flumioxazin to be classified
as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Flumioxazin: Human Health Risk
Assessment for the New Uses on Clover Grown for Seed; Citrus Group 10-
10; Caneberry Subgroup 13-07A; Head and Stem Brassica Subgroup 5A; and
Crop Group Expansion for Fruiting Vegetable Group 8-10; Low Growing
Berry Subgroup 13-07G; Nut Tree Group 14-12; Onion Bulb Subgroup 3-07A;
Pome

Fruit Group 11-10; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit
Subgroup 13-07F; and Stone Fruit Group 12-12 at pages 15-22 and 42-55
in docket ID number EPA-HQ-OPP-2015-0658.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for flumioxazin used for
human risk assessment is discussed in Unit III, B of the final rule
published in the Federal Register of September 21, 2012 (77 FR 58493)
(FRL-9358-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR
180.568. EPA assessed dietary exposures from flumioxazin in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for flumioxazin for females 13-49. In
estimating acute dietary exposure, EPA used food consumption
information from the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, EPA incorporated tolerance-level residues, 100 percent crop
treated (PCT) for all commodities and DEEM-FCID version 3.16.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID Version 3.16. This software uses
2003-2008 food consumption data from USDA's NHANES/WWEIA. As to residue
levels in food, EPA incorporated tolerance-level residues, 100 PCT for
all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flumioxazin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flumioxazin. Tolerance level residues and/or
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flumioxazin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flumioxazin. The estimated drinking water
concentrations (EDWCs) are based on aquatic rates of the residues of
concern for flumioxazin and its major degradates (482-HA, and APF),
expressed as flumioxazin equivalents. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) model,
the EDWCs in surface water for acute exposures are 400 parts per
billion (ppb) for flumioxazin only and for chronic exposures are
estimated to be 9.4 ppb, 21.6 ppb, and 110.1 ppb for flumioxazin, 482-
HA and APF degradates, respectively, for a total concentration of 141
ppb. Based on the Screening Concentration in Ground Water (SCI-GROW)
model, for both acute and chronic (non-cancer) exposures, the EDWCs of
482-HA and APF are estimated to be 45.27 ppb and 2.66 ppb,
respectively, for ground water. EDWCs of flumioxazin are estimated to
be negligible in ground water for chronic exposures.
    Estimates of drinking water concentrations were directly entered
into the dietary exposure model as follows. The peak day zero of 0.400
ppm for flumioxazin (degradates 482-HA and APF were not detected) was
used to assess the contribution to drinking water for the acute dietary
risk assessment, and the day 30 total of 0.141 ppm for flumioxazin,
482-HA and APF degradates was used to assess the contribution to
drinking water for the chronic dietary risk assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Flumioxazin is
currently registered for the following uses that could result in
residential exposures: Turf, gardens and trees, and aquatic weeds. EPA
assessed residential exposure with the assumption that homeowner
handlers wear shorts, short-sleeved shirts, socks, and shoes, and that
they complete all tasks associated with the use of a pesticide product
including mixing/loading, if needed, as well as the application.
Residential handler exposure scenarios for both dermal and inhalation
are considered to be short-term only, due to the infrequent use
patterns associated with homeowner products.
    EPA uses the term ``post-application'' to describe exposure to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide. Flumioxazin can be used in
many areas that can be frequented by the general population including
residential areas, lakes, and ponds. As a result, individuals can be
exposed by entering these areas if they have been previously treated.
Therefore, short-term and intermediate-term dermal post-application
exposures and risks were assessed for adults and children. In addition,
oral post-application exposures and risks were assessed for children to
be protective of possible hand-to-mouth, object-to-mouth, and soil
ingestion activities that may occur on treated turf areas. Further
information regarding EPA standard assumptions and generic inputs for

residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flumioxazin to share a common mechanism of
toxicity with any other substances, and flumioxazin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flumioxazin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is evidence of
increased quantitative susceptibility of fetuses in the oral and dermal
developmental rat studies, where cardiovascular abnormalities occurred
in the absence of maternal toxicity. The rat reproduction study also
showed evidence of qualitative and quantitative post-natal
susceptibility since reproductive effects in offspring were more severe
and were seen at lower doses than those that caused parental/systemic
toxicity. Even with this observed increased susceptibility, the Agency
has concluded there is a low concern and no residual uncertainties for
pre- and/or postnatal toxicity because the developmental toxicity
NOAELs/LOAELs are well-characterized after oral and dermal exposure,
and the offspring toxicity NOAEL and LOAEL are well characterized in
the reproduction study.
    Furthermore, the doses and endpoints have been selected from the
developmental and reproductive toxicity studies for risk assessment of
the relevant exposed populations (e.g., pregnant females and children),
with the exception of the chronic dietary endpoint, for which a chronic
study was selected. Therefore, regulatory endpoints for flumioxazin are
protective of the increased susceptibility and there are no residual
concerns for these effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for oral and dermal exposures, but retained
at 10X for inhalation exposures due to the lack of an inhalation study.
That decision is based on the following findings:
    i. The toxicity database for flumioxazin is sufficient for
assessing the toxicity and characterizing the hazard of flumioxazin. An
inhalation study is needed to characterize more completely the
potential for adverse effects associated with the inhalation route of
exposure; therefore, in order to account for any uncertainty attending
the use of the dose and endpoint from an oral rat developmental
toxicity study with an estimated 100% default absorption factor, the
Agency is retaining the 10X FQPA safety factor for assessing inhalation
risk.
    ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is evidence that flumioxazin may result in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The Agency concluded that while there is an increased
susceptibility, there is a low concern and no residual uncertainties
for pre-and/or postnatal toxicity because the developmental toxicity
NOAELs/LOAELs are well characterized after oral and dermal exposure;
the offspring toxicity NOAEL and LOAEL are well characterized in the
reproduction study; and the doses and endpoints have been selected from
the developmental and reproductive toxicity studies for the relevant
populations, except for the chronic dietary endpoint, for which a
chronic study was chosen. Therefore, the regulatory endpoints for
flumioxazin are protective of the increased susceptibility seen in the
developmental and reproduction studies, and there are no residual
concerns for these effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to flumioxazin in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by flumioxazin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flumioxazin will occupy 76% of the aPAD for females 13-49 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 44% of the cPAD for all
infants <1 year old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
flumioxazin is not expected.
    3. Short and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account short-term and intermediate
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Flumioxazin is
currently registered for uses that could result in short-term and

intermediate residential exposures, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term and intermediate-term residential exposures to
flumioxazin. Since the Agency has determined that the short-term and
intermediate-term points of departure are the same the aggregate risks
are the same for both short-term and intermediate-term exposures.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined
short-term and intermediate-term food, water, and residential exposures
result in aggregate MOEs of 110 for adult females 13-49 years and 200
for children less than two years. Because EPA's level of concern for
flumioxazin is a MOE of 100 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flumioxazin is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) using a
nitrogen phosphorous detector (NPD)) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established any MRLs for flumioxazin.

C. Response to Comments

    EPA received five comments to the two published Notice of Filings.
Two comments stated, in part and without any supporting information,
that EPA should deny this petition because it is a harmful and toxic
chemical with no benefits. The Agency recognizes that some individuals
believe that pesticides should be banned on agricultural crops. The
existing legal framework provided by section 408 of the FFDCA, however,
states that tolerances may be set when persons seeking such tolerances
or exemptions have demonstrated that the pesticide meets the safety
stand imposed by that statute. EPA has assessed the effects of this
chemical on human health and determined that aggregate exposure to it
will be safe. These comments provide no information to support an
alternative conclusion.
    Another comment submitted by the Center for Biological Diversity
was primarily concerned about the environmental risks and Agency
compliance with any relevant obligations under the Endangered Species
Act. This comment is not relevant to the Agency's evaluation of safety
of the flumioxazin tolerances; section 408 of the FFDCA focuses on
potential harms to human health and does not permit consideration of
effects on the environment. Additional comments were submitted in
support of this petition by Interregional Research Project Number 4
(IR-4) and Dr. A. Stanley Culpepper from the University of Georgia
Cooperative Extension.

D. Revisions to Petitioned-For Tolerances

    The petitioner proposed a tolerance of flumioxazin on caneberries
at 0.4 ppm. Both the petitioner and the Agency used the Organization
for Economic Cooperation & Development (OECD) spreadsheet calculator;
however, the Agency did not consider the two Oregon trials to be
independent since they were conducted at the same location on the same
variety of raspberries and applications were made within 30 days of
each other. Therefore, the four samples were accounted as two,
resulting in an Agency recommended tolerance of 0.5 ppm. All other
tolerances are recommended to be at the same levels as petitioned.
    The petitioner proposed a tolerance for head and stem brassica,
subgroup 5A at 0.02 ppm; however, the EPA is establishing a tolerance
for Vegetable, brassica, head and stem, group 5-16 at 0.02 ppm. In the
Federal Register of May 3, 2016 (81 FR 26471) (FRL-9944-87)
establishing the Vegetable, brassica, head and stem, group 5-16, EPA
indicated that, for existing petitions for which a Notice of Filing had
been published, the Agency would attempt to conform these petitions to
the rule. Therefore, consistent with this rule, EPA is establishing
tolerances on Vegetable, brassica, head and stem, group 5-16 rather
than head and stem brassica, subgroup 5A. EPA concludes it is
reasonable to revise the petitioned-for tolerance so that they agree
with the recent crop grouping revisions because (1) the new crop group
includes the same commodities as the subgroup except two commodities
are no longer in the group and (2) the representative commodities for
the revised crop groups/subgroups have not changed.
    Finally, the Agency is establishing tolerances for clover, forage
and clover, hay with regional registrations in (c) since residue field
trial data were only submitted to support registration in Idaho,
Washington, and Oregon.

V. Conclusion

    Therefore, tolerances are established for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on tolerances for
residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-
(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, in or on, berry, low growing, subgroup 13-07G at 0.07
parts per million (ppm); caneberry, subgroup 13-07A at 0.5 ppm; citrus,
group 10-10 at 0.02 ppm; fruit, pome, group 11 at 0.02 ppm; fruit,
stone, group 12 at 0.02 ppm; nut, tree, group 14-12 at 0.02 ppm; onion,
bulb subgroup 3-07A at 0.02 ppm; small fruit, vine climbing, except for
fuzzy kiwifruit, subgroup 13-07F at 0.02 ppm; vegetable, brassica, head
and stem, group 5-16 at 0.02 ppm; and vegetable, fruiting, group 8-10
at 0.02 ppm.
    Additionally, EPA is establishing tolerances with regional
registrations for clover, forage at 0.02 ppm and clover, hay at 0.15
ppm. Finally, the EPA is removing tolerances for Cabbage at 0.02 ppm;
cabbage, Chinese, napa at 0.02 ppm; fruit, pome group 11 at 0.02 ppm;
fruit, stone, group 12 at 0.02 ppm; garlic at 0.02 ppm; grape at 0.02
ppm; nut, tree

group 14 at 0.02 ppm; okra at 0.02 ppm; onion, bulb at 0.02 ppm;
pistachio at 0.02 ppm; shallot bulb at 0.02 ppm; strawberry at 0.07 ppm
and vegetable, fruiting group 8 at 0.02 ppm since these will be
superseded by this action.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (NTTAA) (15 U.S.C. 272 note).

VII. 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: December 6, 2016.
Daniel J. Rosenblatt,
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. Revise Sec.  180.568 to read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) General. Tolerances are established for residues of
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only flumioxazin.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Alfalfa, forage..............................................        3.0
Alfalfa, hay.................................................        8.0
Almond, hulls................................................       0.70
Artichoke, globe.............................................       0.02
Asparagus....................................................       0.02
Berry, low growing, subgroup 13-07G..........................       0.07
Bushberry subgroup 13-07B....................................       0.02
Caneberry, subgroup 13-07A...................................       0.50
Citrus, group 10-10..........................................       0.02
Citrus, oil..................................................        0.1
Corn, field, forage..........................................       0.02
Corn, field, grain...........................................       0.02
Corn, field, stover..........................................       0.02
Cotton, gin byproducts.......................................       0.60
Cotton, undelinted seed......................................       0.02
Fish, freshwater.............................................        1.5
Fruit, pome, group 11-10.....................................       0.02
Fruit, small vine climbing, except for fuzzy kiwifruit,             0.02
 subgroup 13-07F.............................................
Fruit, stone, group 12-12....................................       0.02
Grain, aspirated fractions...................................        100
Hop, dried cones.............................................       0.05
Leaf petioles subgroup 4B....................................       0.02
Nut, tree, group 14-12.......................................       0.02
Olive........................................................       0.02
Onion, bulb subgroup 3-07A...................................       0.02
Pea and bean, dried shelled, except soybean, subgroup 6C.....       0.07
Peanut.......................................................       0.02
Peppermint, tops.............................................       0.04
Pomegranate..................................................       0.02
Prickly pear, fruit..........................................       0.07
Prickly pear, pads...........................................       0.06
Rapeseed subgroup 20A........................................       0.40
Soybean forage...............................................       0.03
Soybean hay..................................................       0.02
Soybean, seed................................................       0.02
Spearmint, tops..............................................       0.04
Sugarcane, cane..............................................       0.20
Sunflower subgroup 20B.......................................       0.50
Vegetable, brassica, head and stem, group 5-16...............       0.02
Vegetable, cucurbit, group 9.................................       0.03
Vegetable, fruiting, group 8-10..............................       0.02
Vegetable, tuberous and corm, subgroup 1C....................       0.02
Wheat, forage................................................       0.02
Wheat, grain.................................................       0.40
Wheat, hay...................................................       0.02
Wheat, straw.................................................        6.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are
established for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-
4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only flumioxazin.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Clover, forage...............................................       0.02
Clover, hay..................................................       0.15
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2016-30467 Filed 12-16-16; 8:45 am]
 BILLING CODE 6560-50-P