[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81317-81318]
[FR Doc No: 2015-32751]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0774, FRL-9940-25]

 Alpha-Chlorohydrin, Registration Review Proposed Interim
Decision; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
interim registration review decision for alpha-chlorohydrin and opens a
public comment period on this proposed interim decision. Registration
review is EPA's periodic review of pesticide registrations to ensure
that each pesticide continues to satisfy the statutory standard for
registration, that is, that the pesticide can perform its intended
function without unreasonable adverse effects on human health or the
environment. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before February 29, 2016.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the Table 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: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in the Table.
    For general information on the registration review program,
contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-8015; 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, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may 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 Chemical Review Manager for the pesticide of interest
identified in the Table.

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 of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a

copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public docket. Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed interim registration review decision for the
pesticide shown in the following table, and opens a 60-day public
comment period on this proposed interim decision.

          Table--Registration Review Proposed Interim Decisions
------------------------------------------------------------------------
                                                        Chemical review
  Registration review case name    Pesticide docket   manager, telephone
             and No.                    ID No.           number, email
                                                            address
------------------------------------------------------------------------
Alpha-chlorohydrin (Case 4120)..  EPA-HQ-OPP-2015-07  Matthew Manupella,
                                   26<EMAIL_ADDRESS>(703)
                                                       347-0411.
------------------------------------------------------------------------

    Alpha-chlorohydrin (Proposed Interim Decision). The registration
review docket for alpha-chlorohydrin (EPA-HQ-OPP-2015-0726) is opening
in December 2015. The only registered use for alpha-chlorohydrin is as
a tamper-proof bait station/bait application delivery system for
elimination of Norway rats. Alpha-chlorohydrin is approved for use in
and around the indoors of commercial/industrial facilities and sanitary
sewers. The label states not to use the product in any facility where
children may be present, and there are no outdoor uses permitted. EPA
is also publishing a draft human health risk assessment and a draft
ecological problem formulation at the time of the docket opening for a
60-day public comment period. In this alpha-chlorohydrin proposed
interim decision, the Agency has determined that no additional data are
required and no changes to the affected registration or its labeling
are currently required. At this time, EPA is making no human health or
environmental safety findings associated with the Endocrine Disruptor
Screening Program (EDSP) screening of alpha-chlorohydrin, nor is it
making an endangered species finding. EPA's registration review
decision for alpha-chlorohydrin will depend upon the result of an EDSP
Federal Food, Drug and Cosmetic Act (FFDCA) section 408(p)
determination, and Endangered Species Assessment (ESA) determination.
    The registration review docket for a pesticide generally includes
earlier documents related to the registration review of the case. In
the case of alpha-chlorohydrin the Agency expedited the registration
review and is opening the docket with the proposed interim decision and
supporting documents.
    The registration review program is being conducted under
congressionally mandated time frames, and EPA recognizes the need both
to make timely decision and to involve the public. Section 3(g) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.
136a(g)) required EPA to establish by regulation procedures for
reviewing pesticide registrations, originally with a goal of reviewing
each pesticide's registration every 15 years to ensure that a pesticide
continues to meet the FIFRA standard for registration. The Agency's
final rule to implement this program was issued in August 2006 and
became effective in October 2006, and appears at 40 CFR part 155,
subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA)
was amended and extended in September 2007. FIFRA, as amended by PRIA
in 2007, requires EPA to complete registration review decisions by
October 1, 2022, for all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed interim
registration review decisions. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the proposed interim decisions. All
comments should be submitted using the methods in ADDRESSES, and must
be received by EPA on or before the closing date. These comments will
become part of the docket for the pesticide included in the Table.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The interim registration review decision will explain the
effect that any comments had on the interim decision and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
http://www2.epa.gov/pesticide-reevaluation.

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

    Dated: December 16, 2015.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2015-32751 Filed 12-28-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 146 (Tuesday, August 1, 2017)]
[Rules and Regulations]
[Pages 35655-35657]
[FR Doc No: 2017-16165]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-1088]
RIN 1625-AA00

Safety Zone; Pleasure Beach Piers, Bridgeport, CT

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of Pleasure Beach, Bridgeport, CT for the Pleasure
Beach Piers. This temporary final rule is necessary to provide for the
safety of life on navigable waters. Entry into, transit through,
mooring, or anchoring within the safety zone is prohibited unless
authorized by Captain of the Port (COTP) Long Island Sound.

DATES: This rule is effective without actual notice from August 1, 2017
until June 30, 2018. For the purposes of enforcement, actual notice
will be used from July 1, 2017 until August 1, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2015-1088 and USCG-2015-1123 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
contact Petty Officer Katherine Linnick,

Prevention Department, U.S. Coast Guard Sector Long Island Sound,
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
LIS Long Island Sound
NPRM Notice of Proposed Rulemaking
NAD83 North American Datum 1983

II. Background Information and Regulatory History

    This rulemaking establishes a safety zone for the waters around the
Pleasure Beach Piers, Bridgeport, CT. Corresponding regulatory history
is discussed below.
    The Coast Guard was made aware on December 9, 2015, of damage to
Pleasure Beach Bridge, the result of which created a hazard to
navigation. On December 22, 2015, the Coast Guard published a temporary
final rule entitled, ``Safety Zone; Pleasure Beach Bridge, Bridgeport,
CT'' in the Federal Register (80 FR 79480). On June 23, 2016, the Coast
Guard published a second temporary final rule entitled, ``Safety Zone;
Pleasure Beach Bridge, Bridgeport, CT'' in the Federal Register (81 FR
40814). On July 25, 2016, the Coast Guard published a third temporary
final rule entitled, ``Safety Zone; Pleasure Beach Bridge, Bridgeport,
CT'' in the Federal Register (81 FR 48329). On January 19, 2017, the
Coast Guard published a fourth temporary final rule entitled, ``Safety
Zone; Pleasure Beach Bridge, Bridgeport, CT'' in the Federal Register
(82 FR 6250).
    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM with respect to this rule
because doing so would be impracticable and contrary to the public
interest. A solution to remedy the safety hazards associated with this
structure was initially projected to be completed prior to the
expiration of the current safety zone, but has been delayed. It would
be impracticable and contrary to the public interest to delay
promulgating this rule, as it is necessary to protect the safety of
waterway users.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), and for the
same reasons stated in the preceding paragraph, the Coast Guard finds
that good cause exists for making this rule effective less than 30 days
after publication in the Federal Register.

III. Legal Authority and Need for Rule

    The legal basis for this temporary rule is 33 U.S.C. 1231.
    On December 9, 2015, the Coast Guard was made aware of damage
sustained to Pleasure Beach Bridge, Bridgeport, CT that has created a
hazard to navigation. After further analysis of the bridge structure,
the Coast Guard concluded that the overall condition of the structure
restricts, endangers, and interferes with navigation. The COTP LIS has
determined that the safety zone established by this temporary final
rule is necessary to provide for the safety of life on navigable
waterways.

IV. Discussion of the Rule

    The safety zone established by this rule will cover all navigable
waters of the entrance channel to Johnsons Creek in the vicinity of the
Pleasure Beach Piers, Bridgeport, CT. This safety zone will be bound
inside an area that starts at a point on land at position 41-10.2 N.,
073-10.7 W. and then east along the shoreline to a point on land at
position 41-9.57 N., 073-9.54 W. and then south across the channel to a
point on land at position 41-9.52 N., 073-9.58 W. and then west along
the shoreline to a point on land at position 41-9.52 N., 073-10.5 W.
and then north across the channel back to the point of origin.
    This rule prohibits vessels from entering, transiting, mooring, or
anchoring within the area specifically designated as a safety zone
unless authorized by the COTP or designated representative.
    The Coast Guard will notify the public and local mariners of this
safety zone through appropriate means, which may include, but are not
limited to, publication in the Federal Register, the Local Notice to
Mariners and Broadcast Notice to Mariners.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    The Coast Guard determined that this rulemaking is not a
significant regulatory action for the following reasons: (1) Persons or
vessels desiring to enter the safety zone may do so with permission
from the COTP LIS or a designated representative; and (2) the Coast
Guard will notify the public of this rule via appropriate means, such
as via Local Notice to Mariners and Broadcast Notice to Mariners to
increase public awareness of this safety zone.

B. Impact on Small Entities

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

the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard
will not retaliate against small entities that question or complain
about this proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

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

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T01-1088 to read as follows:

Sec.  165.T01-1088  Safety Zone; Pleasure Beach Piers, Bridgeport, CT.

    (a) Location. The following area is a safety zone: All navigable
waters of the entrance channel to Johnsons Creek in the vicinity of the
Pleasure Beach Piers, Bridgeport, CT bound inside an area that starts
at a point on land at position 41[deg]10'02.964'' N.,
073[deg]10'08.148'' W. and then east along the shoreline to a point on
land at position 41[deg]09'57.996'' N., 073[deg]09'54.324'' W. and then
south across the channel to a point on land at position
41[deg]09'52.524'' N., 073[deg]09'58.861'' W. and then west along the
shoreline to a point on land at position 41[deg]09'52.776'' N.,
073[deg]10'04.944'' W. and then north across the channel back to the
point of origin.
    (b) Enforcement period. This rule will be enforced from 12 a.m. on
July 1, 2017 to 12 a.m. June 30, 2018.
    (c) Definitions. The following definitions apply to this section: A
``designated representative'' is any commissioned, warrant, or petty
officer of the U.S. Coast Guard who has been designated by the Captain
of the Port (COTP) Long Island Sound, to act on his or her behalf. The
designated representative may be on an official patrol vessel or may be
on shore and will communicate with vessels via VHF-FM radio or
loudhailer. ``Official patrol vessels'' may consist of any Coast Guard,
Coast Guard Auxiliary, state, or local law enforcement vessels assigned
or approved by the COTP Long Island Sound. In addition, members of the
Coast Guard Auxiliary may be present to inform vessel operators of this
regulation.
    (d) Regulations. (1) The general regulations contained in 33 CFR
165.23 apply.
    (2) In accordance with the general regulations in 33 CFR 165.23,
entry into or movement within this zone is prohibited unless authorized
by the COTP Long Island Sound.
    (3) Operators desiring to enter or operate within the safety zone
should contact the COTP Long Island Sound at<PHONE_NUMBER> (Coast Guard
Sector Long Island Sound Command Center) or the designated
representative via VHF channel 16 to obtain permission to do so.
    (4) Any vessel given permission to enter or operate in the safety
zone must comply with all directions given to them by the COTP Long
Island Sound, or the designated on-scene representative.
    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel shall proceed
as directed.

    Dated: June 30, 2017.
K.B. Reed,
Commander, U.S. Coast Guard, Acting Captain of the Port Long Island
Sound.
[FR Doc. 2017-16165 Filed 7-31-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26766-26768]
[FR Doc No: 2022-09628]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Retailer Training Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions
associated with ``Tobacco Retailer Training Programs.''

DATES: Submit either electronic or written comments on the collection
of information by July 5, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 5, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-D-0350 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tobacco Retailer Training
Programs.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<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>.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Tobacco Retailer Training Programs

OMB Control Number 0910-0745--Extension

    Tobacco products are governed by chapter IX of the Federal Food,
Drug, and Cosmetic Act (sections 900 through 920) (21 U.S.C. 387
through 21 U.S.C. 387u). The FDA intends to issue regulations
establishing standards for approved tobacco retailer training programs
under section 906(d) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 387f(d)). In the interim, FDA published a guidance document
which can be downloaded at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs. The
guidance is intended to assist tobacco retailers to voluntarily
implement effective training programs for employees.
    The guidance discusses recommended elements that should be covered
in a training program, such as: (1) Federal laws restricting the access
to, and the advertising and promotion of, cigarettes, smokeless, and
covered tobacco products; (2) the health and economic effects of
tobacco use, especially when the tobacco use begins at a young age; (3)
written company policies against sales to youth and other restrictions
on the access to, and the advertising and promotion of, tobacco
products; (4) identification of the tobacco products sold in the retail
establishment that are subject to the Federal laws and regulations
prohibiting their sale to underage persons; (5) age verification
methods; (6) practical guidelines for refusing sales; and (7) testing
to ensure that employees have the required knowledge. The guidance
recommends that retailers require current and new employees to take a
written test prior to selling tobacco products and that refresher
training be provided at least annually and more frequently as needed.
The guidance recommends that retailers maintain certain written records
documenting that all individual employees have been trained and that
retailers retain these records for 4 years in order to be able to
provide evidence of a training program during the 48-month time period
covered by the civil money penalty schedules outlined in the law.
    The guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The guidance suggests that applicants and current
employees be notified both verbally and in writing of the importance of
complying with laws prohibiting the sales of tobacco products to
underage persons. In addition, FDA recommends that retailers implement
an internal compliance check program and document the procedures and
corrective actions for the program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
  Activity; guidance section IV      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Develop training program........          79,700               1          79,700              16       1,275,200
Develop written policy against            79,700               1          79,700               1          79,700
 sales to youth and employee
 acknowledgement................
Develop internal compliance               79,700               1          79,700               8         637,600
 check program..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,992,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
       Activity; guidance section IV           Number of      records per    Total annual          Average burden per recordkeeper          Total hours
                                             recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training program..........................          79,700               4         318,800  0.25 (15 minutes)...........................          79,700
Written policy against sales to youth and           79,700               4         318,800  0.10 (6 minutes)............................          31,880
 employee acknowledgement.
Internal compliance check program.........          79,700               2         159,400  0.5 (30 minutes)............................          79,700
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................         191,280
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the number of respondents in tables 1 and 2 is
based on data from the deeming rule Final Regulatory Impact
Analysis,\1\ which showed there are an estimated 362,273 retail
establishments that currently sell tobacco products. The Agency
reviewed these numbers again for this notice, and believe they are an
accurate estimation. We assume that 75 percent of tobacco retailers
already have some sort of age and identification verification training
program in place. We expect that some of those retailer training
programs already meet the elements in the guidance, some retailers
would update their training program to meet the elements in the
guidance, and other retailers would develop a training program for the
first time. Thus, we estimate that two-thirds of tobacco retailers
would develop a training program that meets the elements in the
guidance (66 percent of 362,273 = 239,100; then annualized to 79,700).
---------------------------------------------------------------------------

    \1\ Deeming Tobacco Products to be Subject to the Food, Drug,
and Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act: Final Regulatory Impact Analysis, 2016 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf.
---------------------------------------------------------------------------

    We have adjusted our burden estimate and the number of respondents,
which has resulted in a decrease to the currently approved burden and
respondent count. This adjustment is based on available data estimating
the number of retail establishments that sell tobacco products in the
United States. Additionally, the burden chart was updated to reflect a
change from an estimation over the course of 3 years to annualized
burden.

    Dated: April 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09628 Filed 5-4-22; 8:45 am]
BILLING CODE 4164-01-P


                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         -  -  - WASHINGTON D.C., 20460 -  -

                                                      OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION

MEMORANDUM
SUBJECT:	Response to Comments on "Draft Guidance: Pesticides; Pesticide Registrants on Herbicide Resistance Management Labeling, Education, Training, and Stewardship (PRN 2017-2)"; EPA-HQ-OPP-2016-0226 and Other Dockets

FROM:	Bill Chism, Ph.D., Senior Biologist
            Jonathan Becker, Ph.D., Senior Science Advisor
            Biological Analysis Branch
            Biological and Economic Analysis Division (7503P)

THRU:	Monisha Kaul, Chief
		Biological Analysis Branch
            Biological and Economic Analysis Division (7503P)

            Anita Pease, Acting Deputy Director
            Wynne Miller, Director
            Biological and Economic Analysis Division (7503P)

TO:	EPA Docket:  EPA-HQ-OPP-2016-0226

Product Review Panel Review:   May 24, 2017

Background
This document responds to the public comments received on the draft Pesticide Registration Notice (PRN) entitled, "PR Notice 2016-XX. Draft Guidance. EPA's Guidance for Herbicide-Resistance Management, Labeling, Education, Training, and Stewardship." The draft has been revised based on the comments received and the final PRN, 2017-2: Guidance for Herbicide-Resistance Management, Labeling, Education, Training, and Stewardship, may be found at https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year.

In June 2016, the United States Environmental Protection Agency (EPA or the Agency) issued and sought public comments on a draft PRN entitled, "PR Notice 2016-XX. Draft Guidance. EPA's Guidance for Herbicide-Resistance Management, Labeling, Education, Training, and Stewardship." At the same time, the Agency released the draft PRN 2016-X, Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which revised and updated PRN 2001-5. Since then, the EPA has incorporated Herbicide Resistance Management language/requirements into the Proposed Interim Decisions of several herbicides and sought comment related to specific chemicals.
During the 90-day public comment period, a number of entities including academia, commodity groups, federal government, non-governmental organizations, pesticide registrants, industry representatives, resistance action committees, and scientific societies submitted comments to the docket for this PRN (EPA-HQ-OPP-2016-0226) or other dockets listed in Appendix 1.  This document first responds to several general comments, followed by comments specific to individual sections or elements listed in the draft of PRN 2017-2.  Specific comments on the language and text have been incorporated into the final PRN (i.e., PRN-2017-2) but will not be discussed in this document.  Based on the public comments, PRN 2017-2 has been updated as follows:

  (a) the individual resistance management elements have been reorganized into three topic groups rather than individually-numbered elements (i.e., the three topic groups include elements for placement on the label, elements and terms of registration for the registrant, and elements for education, training, and stewardship);
  (b) all herbicides have been placed into a single category (instead of three separate categories of concern);
  (c) OPP eliminated the recommendation that registrants provide a list of weeds resistant to each herbicide product and instead provides a general recommendation that users look to see if there are weeds resistant to the herbicides they are applying in their state or region; and
  (d) OPP clarified the types of pesticides covered by the PRN.

Commenters

The Agency appreciates the many thoughtful comments that were made to the dockets on the management of herbicide resistance. Herbicide resistance management is a complex problem that can only be addressed through cooperation between the many stakeholders  -  federal agencies, herbicide registrants, academic and extension specialists, crop consultants and advisors, and most importantly, the herbicide user.

Public comments on the Agency's draft guidance on resistance management were submitted to docket (EPA-HQ-OPP-2016-0226, and to the other dockets listed in Appendix 1).  For ease of reference, the Agency has organized the commenters into the following groups.  The number in brackets are the document number in docket EPA-HQ-OPP-2016-0226.

      Academic / Extension:  Bronson, Academic / Extension, University of Tennessee (-0016), Jay McCurdy, Mississippi State University, and Jim Brosnan, University of Tennessee (-0034).

      Commodity Groups: California Specialty Crops Council (-0017); National Cotton Council (-0029).

      Federal Government:  Office of Pest Management Policy, United States Department of Agriculture (-0013); Western Integrated Pest Management Center (-0007).

      Non-Governmental Organizations (NGO):  Beyond Pesticides (-0006); Center for Food Safety (-0008, -0014).

      Pesticide Registrants:  Nufarm Americas, Inc. (-0015); DuPont Crop Protection (-0031); Bayer CropScience LP (-0028); FMC Corporation (-0033); Summit Agro USA, LLC (-0027); E. I. DuPont de Nemours and Company (-0012); Syngenta Crop Protection, LLC (-0032); Frank Wong of Bayer Crop Science (-0034); BASF Corporation Crop Protection (-0025); Valent U.S.A. Corporation (-0020); Dow AgroSciences, LLC (-0023).

      Pesticide Registrant Organizations:  CropLife America (-0010, -0030); RISE, Responsible Industry for a Sound Environment (-0026); Biotechnology Innovation Organization (-0024); Industry Task Force II on 2, 4-D Research Data (-0018).

      Resistance Action Committees (Registrant Organizations):  North America Fungicide Resistance Action Committee (-0021); US Herbicide Resistance Action Committee (-0005); Insecticide Resistance Action Committee (-0019).

      Scientific Societies:  American Phytopathological Society (-0022); Weed Science Society of America, Aquatic Plant Management Society, North Central Weed Science Society, Northeastern Weed Science Society, Southern Weed Science Society, and Western Society of Weed Science (-0011; -0035).

Comments Received and Agency Response
General Comments and Clarifications

How to Amend Labels:  Some herbicide registrants expressed concern about the level of effort needed to amend labels with herbicide resistance management language.

Response:  EPA encourages registrants to add the appropriate resistance-management statements through any of the Agency's regulatory mechanisms.  In particular, the addition of these statements will be permitted on existing products by (1) notification, (2) amendment or (3) as part of an application for a new product.

Use Sites Covered by this PRN:  Several registrants asked about which of the following use sites are covered by this PRN: turfgrass, residential lawns, home gardens, aquatic vegetation, industrial vegetation, forestry, and ornamentals.  Registrants also sought clarification if technical and manufacturing products were included.
Response: The Agency used data from Heap (2016) to identify the number of confirmed resistant weed species by use site and ensure that use sites where herbicide-resistant weeds are known to occur are addressed.  As is seen in Table 1, most of the use sites identified by the commenters for exclusion have multiple confirmed cases of herbicide resistance.  For example, in the United States (U.S.), there are 10 herbicide-resistant weeds found in turfgrass, 8 species in nurseries, 5 species in golf courses, and 2 species in industrial sites.
Table 1.  Number of Herbicide-Resistant Weeds in the United States (U.S.) by Crop or Site (Heap, 2016).

                                 Crop or Site
          Number of Confirmed Herbicide-Resistant Species in the U.S.
Corn (maize)
                                      51
Soybean
                                      50
Rice
                                      26
Wheat
                                      24
Cotton
                                      18
Roadsides
                                      15
Turfgrass
                                      10
Sorghum
                                       9
Nurseries
                                       8
Orchards
                                       8
Canola
                                       6
Lentils
                                       6
Peas
                                       6
Winter wheat
                                       6
Asparagus
                                       5
Blueberries
                                       5
Chickpea
                                       5
Golf courses
                                       5
Grapes
                                       5
Mint
                                       5
Railways
                                       5
Spring Barley
                                       5
Alfalfa
                                       4
Almonds
                                       4
Carrots
                                       4
Grass seed
                                       4
Onions
                                       4
Sugar beets
                                       4
Tomatoes
                                       4
Seed corn
                                       3
Sugarcane for sugar
                                       3
Vegetables
                                       3
Aquatic
                                       2
Fallow
                                       2
Fence lines
                                       2
Horseradish
                                       2
Industrial sites
                                       2
Pastures
                                       2
Peanut (groundnut)
                                       2
Potatoes
                                       2
Cabbages
                                       1
Kentucky bluegrass
                                       1
Lettuce
                                       1
Pecan
                                       1
Sunflower
                                       1
Sweet corn
                                       1

This PRN communicates the Agency's approach to address herbicide-resistant weeds. It is germane to end-use herbicide products used in agriculture, including commercial turf and sod farms, ornamental production in the open.  It also applies to non-agricultural use sites such as golf courses, aquatic vegetation, rights-of-way and vegetation management along roadways.  This PRN does not apply to herbicide products labeled for use by the general consumer, such as residential use pesticides.  Technical and manufacturing use products are expressly excluded.

 Applicability of this PRN to Aquatic Use Sites:  The Aquatic Plant Management Society (APMS) provided a link to a white paper (APMS 2014)  that highlighted the differences between herbicide resistance management in terrestrial versus aquatic use sites.  For example, there are very few cases of herbicide-resistant aquatic weeds, they occur in limited areas, rotation to herbicides with a different MOA is difficult for aquatic managers because there are only a few aquatic herbicides available, and there are a limited number of non-chemical control strategies (e.g., controlling water level or mechanical control).
Response:  The Agency agrees that the chemical control of aquatic weeds and the selective pressures for the evolution of herbicide resistance are significantly different from those in terrestrial settings.  Current recommendations for aquatic weed control include some measures that both increase and decrease the likelihood of herbicide resistance developing in aquatic weeds.  Aquatic ecosystems are a unique and varied use site, and a one-size-fits-all approach to control and resistance management is not feasible.  The Agency will continue to work with APMS and aquatic weed specialists to maintain flexibility in regards to herbicide use in aquatic plant control programs and to identify appropriate herbicide resistance best management practices.

Communication, Implementation and Measurement of Success:  The weed science societies commented that the Agency should communicate to the agricultural community the expectations for the resistance management plan, how much it will cost to implement, and how the success or failure of this approach will be measured.  The United States Department of Agriculture (USDA) Office of Pest Management Policy commented that maintaining local level flexibility and engagement is important and that the herbicide resistance management program undergo periodic review and revision.  The Weed Science Society of America (WSSA) and USDA commented that the Agency should explain the expectations of the plan and how the implementation will be measured.
Response:  The Agency agrees that communication, rational implementation, and periodic review and revision are critical to the continued success of a resistance management strategy.  The Agency intends to work with scientific societies, consultants, registrants, the USDA and other federal agencies, and resistance action committees to communicate the goals and expectations of the herbicide resistance management plan and to determine if revisions are needed.  Further, the Agency plans to consult with these entities on whether realistic, implementable, and precise methods/tools are available to measure the success of these measures.  The EPA's Office of Inspector General (EPA 2017) has recently reviewed the oversight of herbicide resistance and recommended the Agency work to develop way to measure success.

Enforceability and Voluntary Nature of the PRN: Comments were received concerning the enforceability and voluntary nature of the PRN from multiple registrants, registrant organizations, NGOs, and academic researchers.  Further, clarification was sought from the American Phytopathology Society on the specificity of several terms and whether these are enforceable when placed of pesticide labels.
Response:  PRNs are issued by the Office of Pesticide Programs to inform pesticide registrants and other interested parties about important policies, procedures and regulatory decisions. As such, PRNs do not create new legally binding requirements.

The Agency plans to use the herbicide resistance management PRN as the basis to evaluate and implement appropriate actions for individual herbicides as new active ingredients are registered, as old active ingredients are reevaluated in registration review, and when new uses are added to existing registrations.

Pesticide labels contain both enforceable and advisory language.  For example, enforceable language would be the maximum application rate for a crop (e.g., Do not apply more than 1 lb a.i. per acre per year).  Advisory language could include recommendations, not requirements, for scouting (e.g., Fields should be scouted before application to ensure herbicides and application rates will be appropriate for the crop and weed species present).
The herbicide resistance management label language is advisory and is intentionally generic because of the diversity of production practices in the United States and to allow the grower flexibility to accommodate local conditions.

Categories of Concern and Categorization of Herbicides:  EPA proposed three categories of concern for herbicide resistance development, with the number of management elements increasing with the increasing risk of development of herbicide resistance.  The Agency received comments on this proposal from pesticide registrants, registrant organizations, commodity groups, NGOs, USDA, and scientific societies.

There was little support from the commenters for the proposed three categories of concern.  Some commenters thought that multiple categories would introduce unnecessary complexity, which could result in user confusion, registrant disputes, and potentially be misleading for co-formulated products containing multiple active ingredients with different Mechanism of Actions (MOA).  The USDA and other commenters maintained that measures should be applied to all herbicides to reduce the likelihood for resistance evolving regardless of their resistance potential and that all users of herbicides should be provided with the same educational and training materials regardless of the herbicides being used.

Two alternatives were proposed by commenters. The first alternative does away with the categorization all together and treats all herbicides the same in terms of resistant management.  The second alternative is similar, except that in some cases additional resistance management measures may be required for a given herbicide.

Response:  The Agency has found the comments against three categories of concern to be compelling and will treat all the herbicides the same, and therefore have a single category.  However, in some cases, the Agency may determine that it is necessary to require additional resistant management measures.  This single category approach has numerous advantages including the following:

 Provides a consistent approach across all herbicides in order to slow and control the evolution of herbicides resistance regardless of the potential of an individual herbicide to develop herbicide resistance and the current number of herbicide-resistant weeds.
 Provides all herbicides users with educational and training materials, resistance management plans, and other mitigation measures.
 Simplifies the approach and minimizes the number of label changes needed as conditions change.
 Simplifies label language for premix products containing multiple active ingredients with different MOAs.
 Allows for additional resistant management measures to be selectively added when the Agency determines it is necessary.

Applicability to Weeds with Confirmed Resistance:  Commenters requested that EPA indicate how it intends to use the proposed 11 elements for herbicides or herbicide groups for which there are already significant numbers or acreage of herbicide-resistant weeds.
Response:  As described above, the Agency will treat all herbicides the same in terms of resistant management measures, regardless of whether there are significant numbers of confirmed herbicide-resistant weeds in the U.S.

Categorization of Herbicide Resistance Crops:  Several registrants and registrant organizations commented that the herbicide partners of herbicide-resistant crops should not be considered to be of high concern because these active ingredients do not have a higher risk of selecting herbicide-resistant weeds than those active ingredients used on other crops.

Response:  The Agency agrees that a given herbicide / weed combination has the same inherent potential for the selection of herbicide-resistant individuals, whether it is an Herbicide Resistant (HR) traited crop or a non-HR crop.  The difference lies with the agronomic practices associated with the use of an herbicide partner on an HR traited crop.  As has been shown with glyphosate, when several crops, all possessing the same HR trait, are grown in rotation, the diversity of weed control chemicals and practices can be limited resulting in continual selection pressure for herbicide-resistant biotypes. A further concern is that some herbicide-resistant crops (e.g., canola, rice, and sorghum) can outcross with weedy relatives and confer herbicide resistance to populations of those weed species.  Since the final PRN will treat all herbicides the same in terms of resistant management, the Agency considers that this is no longer an issue.

Comments on Individual Resistance Management Elements
Draft Element 1.  List Mechanism of Action (MOA) Group Number on label.
Comments:  The Agency received comments from multiple registrants, resistance action committees, commodity groups, and scientific societies.   All commenters, including the USDA, supported the placement of the MOA on the label.  Some commenters questioned which classification system should be used.  One system, used by the Herbicide Resistance Action Committee (HRAC) uses an alphabetic system to group herbicide active ingredients.  The Weed Science Society of America (WSSA) uses a numeric system for MOA groups.  The website, http://hrac.tsstaging.com/tools/classification-lookup, may be used to translate between the two systems.  Some commenters asked for clarification about reporting the MOA on the label when the product contains multiple herbicides in more than one MOA group.

Response:  The Agency will retain this element in the PRN.  There was strong support across all stakeholder groups for including the MOA Group Number on the herbicide label.  Herbicide labels in the U.S. currently displaying the MOA group use the WSSA numeric groups.  The Agency prefers the continued use of WSSA numeric groups to denote the MOA.

Clarification about listing the MOA on the label if the product contains multiple active ingredients are addressed in PRN 2017-1, Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling.

Final PRN:  Place the MOA, using the WSSA Groupings (as described in PRN 2017-1), on the label.

Draft Element 2.  List seasonal and annual maximum number of applications and amounts.

Comments:  The Agency received comments from multiple registrants, resistance action committees, and commodity groups supportive of the requirement to list the seasonal and annual maximum number of applications and amounts of active ingredient on the label.  Some groups were concerned that this was an attempt by the Agency to reduce application rates.

Response:  The Agency will retain this element in the PRN.  Most commenters agreed that both the seasonal and annual maximum number of applications should appear on the label.  This label information will allow growers and crop consultants to design an herbicide resistance management plan that takes into account the maximum amount of an herbicide allowed to be applied in a season or year.  The intent of this element is to provide clarity and information for planning purposes and not to reduce application rates as some comments suggested.  Maximum rates and number of applications of a pesticide forms the basis for the Agency risk assessments for human health and the environmental effects, but has not always been completely and clearly described on the label.

Final PRN:  Clearly express all currently required application parameters and product information on the label, including: maximum dose per application, maximum dose per crop cycle or per year, maximum number of applications per crop cycle or per year.  Example label statement are provided in the PRN.

Draft Element 3.  Provide Resistance Management language from PR Notice 2016-X, and/or Best Management Practices (BMP) language from Weed Science Society of America (WSSA) & Herbicide Resistance Action Committee (HRAC), and/or HRAC proposed guidelines for herbicide labels.  Note that BMPs should be appropriate to crop and production system.

Comments:  EPA received comments from several groups both for and against this element.  The groups supporting this information, including the USDA, thought it could be a valuable tool for users and crop consultants and many registrants already place this type of information on their labels.  Other groups felt that labels were already too long, that the information would be confusing, or might not be locally relevant.  Some commenters said that labels are not the best place for this information and that adding resistance management language would not be effective.  Some commenters said that a website might be more effective place for the information while other comments said that users would not look at a website.  Some comments said that there could be substantial work in amending their labels to include this information.

Response:  The Agency will retain and modify this element so that information on BMPs is available in a condensed form on the label.  The Agency considers this to be the most expedient and direct method of providing the information to herbicide users.  The Agency has determined that adding this general language to the label will not be an excessive burden on the registrants because it could occur during normal label changes and would not require regular updating.

Final PRN:  Label statements describing best management practices for resistance management based on PRN 2017-1.  Best Management Practices from WSSA, and the HRAC proposed guidance. Example label statements are provided in the PRN.

Draft Element 4.  Instruction to users to scout before and after application.

Comments:  The Agency received comments from several groups, including the USDA, that were supportive of this element.  However, some groups did not support the idea for specific use sites because they said the users did not have the resources to properly scout the sites (e.g., turf, ornamentals, vegetation management, forestry, or aquatic systems).  Two groups recommended that historic information on pest pressure could be used in conjunction with scouting to help inform decisions (e.g., historic information could be used to recommend a pre-emergence herbicide application).  Several groups requested that the Agency clarify that scouting is a recommendation and not a requirement.

Response:  The Agency will retain this element in the PRN.  This label language will remind users and crop consultants to scout before and after an herbicide is applied.  The suggested language is not a requirement but rather a reminder to users and crop consultants that scouting is an important tool for control of herbicide-resistant weed species.

Final PRN:  Recommendations (not requirement) that the field should be scouted both before and after a pesticide application (as described in PRN 2017-1).  Example label statement is provided in the PRN.

Draft Element 5.  Provide definition of Likely Resistance on label.

Comments:  EPA received comments both for and against defining resistance on herbicide labels.  Commenters, including the USDA, recommended that the Agency use the term "suspected" resistance as originally described by the WSSA instead of "likely" resistance.  Some commenters thought the definition should be provided on a website instead of the label.  Some comments said that providing the definition could lead to the reporting of likely resistance in weed species in error.

Response:  The Agency will retain this element in the PRN, but will use the term "suspected" resistance instead of "likely" resistance.  The Agency recommends placing the definition of suspected resistance on the labels to increase awareness among users and their representatives to help identify suspected herbicide-resistant weeds and proactively take action before they become widespread in their fields.  The Agency recommends that the definitions be placed on labels because this is the most expedient and direct method of providing the information to herbicide users.  The Agency thinks there will be very few cases of inaccurate reporting because the definition of suspected resistance from the WSSA (listed below) easily rules out equipment and application problems and registrants, their representatives, or possibly extension agents will likely be contacted to review the situation before it is reported to anyone else.

Final PRN:  A statement defining suspected resistance should be placed on the label, as follows:

Suspected herbicide-resistant weeds may be identified by these indicators (Norsworthy et al. 2012, 0.39).
 Failure to control a weed species normally controlled by the herbicide at the dose applied, especially if control is achieved on adjacent weeds;
 A spreading patch of non-controlled plants of a particular weed species; and
 Surviving plants mixed with controlled individuals of the same species.

Draft Element 6.  Instruction to user to report lack of performance to registrant or their representative.

Comments:  The Agency received many comments in support of this element, including the USDA, and the potential to help find and identify "suspected" resistant weeds before that biotype can become established in a field.  Commenters recommended that these reports be available to crop advisors, weed scientists, and others in the industry to help develop an effective early warning system.  Some commenters have stated that this element should apply to all registrants including those whose business models do not include performance guarantees or field staff.  Some comments from registrants did not support this element because they do not have the technical expertise or resources to address each occurrence of lack of performance.

Response:  The Agency will retain this element in the PRN.  The Agency recommends that users report lack of performance to the registrant of that herbicide.  For many users and consultants reporting lack of performance is already a normal practice and considered an intrinsic part of their business process.  Reporting lack of performance will allow the registrant or its representative to identify suspected herbicide-resistant weeds and suggest methods to proactively take action before these biotypes become widespread in their fields.

Final PRN:  Label statement that the grower should report lack of performance to the registrant or their representative and proactively take action before escaped weeds become widespread in their fields. Example label statements are provided in the PRN.

Draft Element 7.   List confirmed resistant weeds in a separate table and list recommended rates for these weeds with the table.

Comments:  The Agency received many comments on this proposed element.  In general, commenters agreed that information about the confirmed resistant weed species and the methods of control would be useful to the growers.  However, there was little support for placement of this information on the product label.  Major objections included: the burden associated with multiple label updates as new resistant species evolved, more complicated labels, and that listing multiple rates on a label for different weed species could be confusing to users.  Commenters suggested that this information may be better suited for a website, with a link on the label.

Response:  The Agency will modify this element in the PRN.  EPA acknowledges that creating this type of table would require a great deal of effort, could list numerous weed species, and could require multiple updates over time.  The Agency will recommend that an advisory statement (as provided in the PRN) be placed with the list of target pests rather than a separate table listing herbicide-resistant weeds.

Final PRN:  Label statements on local resistant weeds. Example label statements are provided in the PRN.

Draft Element 8.  Registrant report new cases of suspected and confirmed resistance to EPA and users yearly.  This is in addition to any adverse effects reporting currently required under FIFRA Section 6 (a)(2).

Comments:  The Agency received comments both for and against this element to report suspected and confirmed resistant weed species to the Office of Pesticide Programs.  Some commenters thought that this would help provide users with early warning of herbicide-resistant weed species.  The USDA said the Agency, in partnership with registrants, should determine the limits on reporting.  The criteria for deciding when sufficient cases of suspected resistance have been reported and further reports are no longer needed.  Some commenters oppose reporting new cases because the current 6(a)(2) reporting system is effective and additional reporting is viewed as overly burdensome.  Others oppose additional reporting because they believe that once an herbicide-resistant weed is reported anywhere in the U.S. further reporting is not needed.  Also, some commenters stated that this reporting element should apply to all registrants, including those who do not have field staff, to ensure that all registrants participate equally in this type of reporting.  Commenters requested clarification as to whether reporting of suspected resistance would require resistance testing and noted that resistance testing could be costly.  Some commenters incorrectly thought that reporting of suspected and confirmed resistance would be a label requirement.

Response:  The Agency will retain this element in the PRN.  Registrants should report suspected and confirmed resistance to the Agency and should make it publicly available in order to raise awareness of developing problems and to enable crop consultants and users to proactively take action before herbicide-resistant biotypes become widespread in their fields.  The Agency plans to work with the USDA and registrants to clarify the limits on reporting of confirmed herbicide-resistant weeds.  The EPA's Office of Pesticide Programs, Information Technology and Resources Management Division (OPP/ITRMD) receives and tracks reports of adverse environmental impacts and herbicide-resistant weeds in the 6(a)(2) adverse incident database (and in the a 6(a)(2) Letters and Studies database) from August 5, 1988 to the present.  Because registrants are already required to report adverse environmental impacts and herbicide-resistant weeds, the Agency does not anticipate there will significant additional costs involved in implementing this element.

The Agency is also aware that there is low compliance with the reporting requirements under FIFRA Section 6 (a)(2).  The Agency compared the number of reports of unique cases of herbicide-resistant weeds submitted under 6(a)(2) adverse effects reporting requirement to the number of unique cases reported in the International Survey of Herbicide Resistant Weeds (Heap, 2016), and found that only 10 percent of the cases had been reported.

Final PRN:  Registrant(s) to report new cases of suspected and confirmed resistance to EPA and users.

Draft Element 9.  Provide growers with (a) Resistance Management Plan, (b) Remedial Action Plan (to control resistant weeds this season or next season) and (c) Educational materials on resistance management. Plans should be locally developed and easily modified.  EPA recommends that registrants work with Extension, Consultants, Crop Groups, HRAC, & USDA.

Comments:  The Agency received many comments supportive of this recommended goal.  Some comments suggested that the Agency should work with commodity, industry and state university extension groups to improve resistance management plans and that these plans would be a logical extension of existing IPM (Integrated Pest Management), stewardship and training programs already in use for many crops.  The WSSA requested further clarification of the plan (e.g., definitions for what is included in a plan, what entities are responsible for implementing the plan, what "locally" means).  Also, the WSSA recommended 10 items for inclusion in a resistance management plan and made several recommendations for items to include in a remedial plan.  Some commenters recommended that this information be made available on a website.  The USDA agreed with this element and stressed that the plans should address local conditions.

Some commenters oppose this element saying it is too broad, would be a large resource drain, and needs further clarification on some of the terms (e.g., "locally produced" and specifying the elements of a resistance plan).  Some commenters mistakenly thought that this would be information on a label.

Response:  The Agency will retain this element in the PRN.  The Agency has discussed these plans and educational materials with the HRAC, USDA, and WSSA and will continue to work with commodity, industry, and state university extension groups to discuss way to provide resistance management plans, remedial action plans, and educational materials to users.  These plans would be a logical extension to the existing IPM, stewardship, and training plans already in place for many crops.  The Agency has included, as an appendix to the PRN, the items that the WSSA recommended be part of a resistance management plan.

Final PRN:  Provide educational and training materials for growers and users.  These should include a resistance management plan, a remedial action plan (to control resistant weeds this season or next season), and educational materials on resistance management. Plans should be locally developed and easily modified.  EPA recommends that registrants work with Extension, Consultants, Crop Groups, HRAC, and the USDA.

Draft Element 10.  For combination products with multiple MOAs, list which herbicide is controlling which weed (a 3-way mixture may only have one effective MOA for some problem weeds).  List minimum recommended rate if resistance is suspected.

Comments:  There were a number of comments for and against this element.  In general, commenters agreed that information about the confirmed resistant weed species and the information on the number of effective MOAs for each weed species would be useful to the growers.  However, there was little support for placing this information on the product label.  Some commenters objected because of the difficulty in collecting the information, the complexity of the table required to show the information, the differences in regional sensitivity of weeds, and the work involved in keeping the information current.

Response:  There are over 33 different weed species in the United States with confirmed resistance to more than one MOA as of November, 2016 (Heap, 2016), which demonstrates how difficult it can be for an individual user to determine if a given mixture will be effective on their use site.  However, the Agency does acknowledge that creating and maintaining a table with this information would require a great deal of effort and the information necessary to fill out the table is not always readily available. The Agency will modify this element in the PRN and will provide advisory label statements in place of this element.

In addition to advisory language, the Agency will work with the WSSA and HRAC to explore other approaches for making this type of information available to users and crop consultants.

Final PRN:  Label statements on local resistant weeds.  Example label statements are provided in the PRN.

Draft Element 11.  Any additional specific requirements (e.g. mandatory crop rotation, unique agronomic aspects, additional training, time limited registration, etc.).

Comments:  There were a number of comments for and against this element.  Several commenters support this element and agree there may be other measures that could be effective in reducing the selective pressure for the evolution of resistance.  Other commenters requested that any specific requirements should apply equally to all registrants and that the Agency should consider standardizing those requirements across all registrations of similar products.  Some commenters oppose this element saying it is not needed or it could create uncertainty for registrants because it is open-ended.  The USDA recommended that the Agency consider the impact on growers of any additional requirements.

Response:  The Agency will retain this element because it may be helpful in reducing the selective pressure for the evolution of herbicide-resistant weeds.  However, this element would be implemented on a limited basis for unique situations.   Such a case might occur where an herbicide-resistant crop has a weedy relative and use of the herbicide could accelerate evolution of resistance in the weedy relative. In this situation it may be appropriate to place other conditions on the registration (e.g., apply only with another MOA, apply every other year, statements about pollen flow for herbicide resistant crops with weedy relatives, or concern about non-target site resistance).

Final PRN:  Unique terms and conditions of registration may be required on a case-by-case basis.

Comments on the PRN 2016-XX Appendices

APPENDIX I.  Herbicide Mechanisms of Action (MOA) and the Agency's Level of Concern for Herbicide Resistance

Comments:  See comment section related to Categories of Concern and Categorization of Herbicides.

Response:  As discussed in Categories of Concern and Categorization of Herbicides section, the Agency will treat all herbicides the same and has removed the appendix.

APPENDIX III.  Best Management Practices for Herbicide-Resistant Weeds

Comments:  The Agency received comments supportive of the inclusion of the Best Management Practices (BMP) on the label.  However, one commenter suggested that the list was too long and could be shortened.

Response:  The Agency has condensed the text of the herbicide resistance BMPs and recommends that the label only include BMPs that are appropriate for the labeled use sites.

REFERENCES

APMS, 2014.  Herbicide Resistance Stewardship in Aquatic Plant Management.  Aquatic Plant Management Society.  Accessed online on July 11, 2017 at: http://www.apms.org/wp/wp-content/uploads/2014/04/Herbicide-Resistance-Stewardship-in-Aquatic-Plant-Management.pdf

Environmental Protection Agency.  2016.  Draft Guidance: Pesticides; Pesticide Registrants on Herbicide Resistance Management Labeling, Education, Training, and Stewardship.  Accessed online on July 11, 2017 at https://www.regulations.gov/document?D=EPA-HQ-OPP-2016-0226-0001

Environmental Protection Agency.  2017.  Report: EPA Can Strengthen Its Oversight of Herbicide Resistance with Better Management Controls.  Accessed online on July 11, 2017 at  https://www.epa.gov/office-inspector-general/report-epa-can-strengthen-its-oversight-herbicide-resistance-better

Heap, I.  2016.  The International Survey of Herbicide Resistant Weeds.  Accessed online on July 11, 2017 at  www.weedscience.org.

Norsworthy, et al., 2012. Reducing the risks of herbicide resistance: Best managment practices and recommendations. Weed Science 60 Special Issue: 31-62.

Vencill, et al., 2012.  Herbicide resistance:  Toward an understanding of resistance development and the impact of herbicide-resistant crops.  Weed Science, 60, Special Issue:  2-30.

APPENDIX 1.  Dockets for Pesticide Registration Notices and Proposed Interim Decisions

Draft Guidance: Pesticides; Pesticide Registrants on Pesticide Resistance Management Labeling (PRN): EPA-HQ-OPP-2016-0242

Registration Review Proposed Interim Decision: Sodium Acifluorfen: EPA-HQ-OPP-2010-0135

Registration Review Proposed Interim Decision: Propoxycarbazone: EPA-HQ-OPP-2015-0095

Registration Review Proposed Interim Decision: Bentazon: EPA-HQ-OPP-2010-0117; Comment also submitted under HRAC, 08-01-2016 (HRAC, 0005)

Proposed Registration of Dicamba on Dicamba-Tolerant Cotton and Soybean: EPA-HQ-OPP 2016-0187; Comment also submitted under HRAC 08-01-2016 (HRAC, 0005)

Proposed Interim Registration Review Decision for Sulfonylurea Herbicides (as a Group): EPA-HQ-OPP-2015-0774

Proposed Interim Registration Review Decision for Bensulfuron-methyl: EPA-HQ-OPP-2011-0663

Proposed Interim Registration Review Decision for Chlorimuron-ethyl: EPA-HQ-OPP-2010-0478

Proposed Interim Registration Review Decision for Chlorsulfuron: EPA-HQ-OPP-2012-0878

Proposed Interim Registration Review Decision for Flazasulfuron: EPA-HQ-OPP-2011-0994

Proposed Interim Registration Review Decision for Foramsulfuron: EPA-HQ-OPP-2012-0387

Proposed Interim Registration Review Decision for Halosulfuron-methyl: EPA-HQ-OPP-2011-0745

Proposed Interim Registration Review Decision for Imazosulfuron: EPA-HQ-OPP-2015-0625

Proposed Interim Registration Review Decision for Iodosulfuron-methyl-sodium: EPA-HQ-OPP-2012-0717

Proposed Interim Registration Review Decision for Mesosulfuron-methyl: EPA-HQ-OPP-2012-0833

Proposed Interim Registration Review Decision for Metsulfuron-methyl: EPA-HQ-OPP-2011-0375

Proposed Interim Registration Review Decision for Nicosulfuron: EPA-HQ-OPP-2012-0372

Proposed Interim Registration Review Decision for Orthosulfamuron: EPA-HQ-OPP-2011-0438

Proposed Interim Registration Review Decision for Primisulfuron-methyl: EPA-HQ-OPP-2011-0844

Proposed Interim Registration Review Decision for Prosulfuron: EPA-HQ-OPP-2011-1010

Proposed Interim Registration Review Decision for Rimsulfuron: EPA-HQ-OPP-2012-0178

Proposed Interim Registration Review Decision for Sulfometuron-methyl: EPA-HQ-OPP-2012-0433

Proposed Interim Registration Review Decision for Sulfosulfuron: EPA-HQ-OPP-2011-0434

Proposed Interim Registration Review Decision for Thifensulfuron-methyl: EPA-HQ-OPP-2011-0171

Proposed Interim Registration Review Decision for Triasulfuron: EPA-HQ-OPP-2012-0115

Proposed Interim Registration Review Decision for Tribenuron-methyl: EPA-HQ-OPP-2010-0626

Proposed Interim Registration Review Decision for Trifloxysulfuron-Sodium: EPA-HQ-OPP-2013-0409

Proposed Interim Registration Review Decision for Triflusulfuron-methyl: EPA-HQ-OPP-2012-0605