Fenpropathrin Interim Registration Review Decision Case Number 7601 September 2020


Docket Number EPA-HQ-OPP-2010-0422
www.regulations.gov



Fenpropathrin

Interim Registration Review Decision
Case Number 7601

September 2020

Approved by:



Elissa Reaves, Ph.D.

Acting Director

Pesticide Re-evaluation Division

Date: 09/30/2020

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Table of Contents

I.	INTRODUCTION	3

A.	Updates since the Proposed Interim Decision was Issued	5

B.	Summary of Fenpropathrin Registration Review	5

C.	Summary of Public Comments on the Proposed Interim Decision and Agency
Responses	8

II.	USE AND USAGE	9

III.	SCIENTIFIC ASSESSMENTS	10

A.	Human Health Risks	10

1.	Pyrethroids FQPA Safety Factor Determination	10

2.	Risk Summary and Characterization	11

3.	Tolerances	11

4.	Human Health Data Needs	12

B.	Ecological Risks	13

1. Ecological and Environmental Fate Data Needs	15

C.	Benefits Assessment	15

IV.	INTERIM REGISTRATION REVIEW DECISION	16

A.	Required Risk Mitigation and Regulatory Rationale	16

1.	Mitigation Measures for Outdoor Urban Uses	16

2.	Mitigation Measures for Agricultural Use Products	18

3.	Pollinator Risk Mitigation	24

4.	Insecticide Resistance Management	27

B.	Tolerance Actions	28

C.	Interim Registration Review Decision	28

D.	Data Requirements	28

V.	NEXT STEPS AND TIMELINE	28

A.	Interim Registration Review Decision	28

B.	Implementation of Mitigation Measures	29

Appendix A: Summary of Required Actions for Fenpropathrin	30

Appendix B: Required Labeling Changes for Fenpropathrin Products	31

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I. INTRODUCTION

This document is the Environmental Protection Agency's (EPA or the Agency) Interim
Registration Review Decision (ID) for fenpropathrin (PC Code 127901, case 7601), and is being
issued pursuant to 40 CFR §§ 155.56 and 155.58. A registration review decision is the Agency's
determination whether a pesticide continues to meet, or does not meet, the standard for
registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency
may issue, when it determines it to be appropriate, an interim registration review decision before
completing a registration review. Among other things, the interim registration review decision
may require new risk mitigation measures, impose interim risk mitigation measures, identify data
or information required to complete the review, and include schedules for submitting the
required data, conducting the new risk assessment and completing the registration review.
Additional information on fenpropathrin can be found in EPA's public docket (EPA-HQ-OPP-
2010-0422) at www.regulations.gov.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the
continuous review of existing pesticides. All pesticides distributed or sold in the United States
must be registered by EPA based on scientific data showing that they will not cause
unreasonable risks to human health or to the environment when used as directed on product
labeling. The registration review program is intended to make sure that, as the ability to assess
and reduce risk evolves and as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects. Changes in science, public
policy, and pesticide use practices will occur over time. Through the registration review
program, the Agency periodically re-evaluates pesticides to make sure that as these changes
occur, products in the marketplace can continue to be used safely. Information on this program is
provided at http://www.epa.eov/pesticide-reevaluation. In 2006, the Agency implemented the
registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide
every 15 years to determine whether it continues to meet the FIFRA standard for registration.

EPA is issuing an ID for fenpropathrin so that it can (1) move forward with aspects of the
registration review that are complete and (2) implement interim risk mitigation (see Appendices
A and B). The Agency is currently working with the U.S. Fish and Wildlife Service and the
National Marine Fisheries Service (collectively referred to as, "the Services") to improve the
consultation process for threatened and endangered (listed) species for pesticides in accordance
with the Endangered Species Act (ESA) § 7. Therefore, although EPA has not yet fully evaluated
risks to federally listed species, the Agency will complete its listed species assessment and any
necessary consultation with the Services for fenpropathrin prior to completing the fenpropathrin
registration review. Likewise, the Agency will complete endocrine screening for fenpropathrin,
pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) § 408(p), before completing
registration review.

Fenpropathrin is a restricted use pesticide in the class of insecticides known as pyrethroids.
Products containing fenpropathrin are registered for use on ornamentals and agricultural crops,
including apples, barley, cantaloupes, grapefruit, grapes, oranges, pears, peppers, strawberries
and tomatoes. There are no products containing fenpropathrin registered for residential use.
Fenpropathrin is formulated as an emulsifiable concentrate as well as a ready-to-use total-release

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fogger. The first product containing fenpropathrin was registered in 1989. Thus, it was not
subject to the reregi strati on requirements of FIFRA. In 1997, EPA reassessed fenpropathrin
tolerances consistent with FQPA (62 Fed. Reg. 63,029, November 26, 1997).

Fenpropathrin is a member of the pyrethroids and pyrethrins class of insecticides, which share
the same mode of action. These insecticides work by altering nerve function, causing paralysis in
target insect pests (also called 'knockdown'), and eventually resulting in death. The Agency has
determined that the pyrethroids and pyrethrins belong to a common mechanism group
("http ://www. regulations.gov; EPA-HQ-OPP-2008-0489-0006), and the Insecticide Resistance
Action Committee (IRAC), composed of industry and university scientists, categorizes them
together in Mode of Action Group 3 A since they all have the same site of action in affected
insects. A screening-level cumulative risk assessment to assess human health risks from this
group of pesticides was completed in 2011. This analysis did not identify cumulative risks of
concern for children and adults. For further information, please see Section III.A.2. of this
document and the cumulative risk assessment for the pyrethroids and pyrethrins, published on
November 9, 2011 (available at http://www.regulations.gov; EP A-HQ-OPP-2011-0746).

In addition to this fenpropathrin ID, which describes the risk management approach for
fenpropathrin determined to be necessary by the Agency, EPA previously published and opened
a 60-day public comment periods on the following documents: Fenpropathrin Proposed Interim
Registration Review Decision, which summarizes the risk assessment and proposes mitigation
for fenpropathrin, Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23
Chemicals, which summarizes the ecological risk assessment approach and outlines EPA's
proposed mitigation to address potential ecological risks for pyrethroids as a whole, and IJSEPA
Office of Pesticide Programs' Re-Evaluation of the FQPA Safety Factor for Pyrethroids:
Updated Literature and CAPHRA Program Data Review, which discusses the data and rationale
underlying the Agency's decision to remove the 10X FQPA safety factor for the pyrethroids,
including fenpropathrin. Those documents, as well as additional supporting documents, are
located in the fenpropathrin docket and in the Special Docket for Pyrethroids, Pyrethrins, and
Synergists located at http://www.regiilations.gov (Docket #: EP A-HQ-OPP-2010-0422 and EPA-
HQ-OPP-2008-0331, respectively).

Having considered stakeholder comments on the fenpropathrin Proposed Interim Decision (PID),
the Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals, and
USEPA Office of Pesticide Programs' Re-Evaluation of the FQPA Safety Factor for Pyrethroids:
Updated Literature and CAPHRA Program Data Review, EPA has consolidated the necessary
human health and ecological risk management and mitigation measures in this interim decision
document for fenpropathrin.

This document describes changes or updates since the fenpropathrin PID and is organized in five
sections: the Introduction, which includes this summary and a summary of public comments and
EPA's responses; Use and Usage, which describes how and why fenpropathrin is used and
summarizes data on its use; Scientific Assessments, which summarizes EPA's risk and benefits
assessments, updates or revisions to previous risk assessments, and provides broader context
with a discussion of risk characterization; the Interim Registration Review Decision, which
describes the mitigation measures necessary to address risks of concern and the regulatory

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rationale for EPA's ID; and, lastly, the Next Steps and Timeline for completion of this
registration review.

A. Updates since the Proposed Interim Decision was Issued

In May 2020, EPA published the PID for fenpropathrin. In this ID, there are several updates to
what was proposed in the PID. The updates include changes made to the ecological risk
mitigation as proposed in the Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal
for 23 Chemicals. Label language has been revised for outdoor and agricultural uses to improve
clarity and consistency. The vegetative filter strip (VFS) requirement for the agricultural uses of
pyrethroids has been revised to add flexibility for users. For Western irrigated agriculture, EPA
is allowing use of a sediment control basin in lieu of constructing and maintaining a VFS, and
the Agency is adding an allowance for treatment areas of 10 acres or less to retain a 15-foot VFS.
The Agency considers the use of sediment control basins for Western irrigated agriculture as
effective as a VFS in retaining sediment and minimizing runoff, without the burden of
constructing and maintaining a VFS. The allowance for treatment areas of 10-acres or less to
retain a smaller VFS will alleviate some of the impact on small scale operations, which may be
disproportionately impacted by the expanded VFS requirements. See the Pyrethroids and
Pyrethrins Revised Ecological Risk Mitigation and Response to Comments on the Ecological
Risk Mitigation Proposal For 23 Chemicals, for a detailed discussion of the changes made to the
proposed mitigation.

There are no updates to the human health mitigation from what was proposed in the PID, nor any
additional updates to the draft risk assessment (DRA). This ID thus finalizes the Agency's draft
supporting documents: Fenpropathrin. Draft Human Health Risk Assessment for Registration
Review, Fenpropathrin: Updated Human Health Draft Risk Assessment in Support of
Registration Review, Preliminary Comparative Environmental Fate and Ecological Risk
Assessment for Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins, and the
Ecological Risk Management Rationale for Pyrethroids in Registration Review, which are
available in the fenpropathrin public docket.

B. Summary of Fenpropathrin Registration Review

Pursuant to 40 CFR § 155.50, EPA formally initiated registration review for fenpropathrin with
the opening of the registration review docket for the case. The following summary highlights the
docket opening and other significant milestones that have occurred thus far during the
registration review of fenpropathrin.

• June 2010 - The Fenpropathrin. Human Health Assessment Scoping Document in
Support of Registration Review; Fenpropathrin-ADDENDUM to D371484 Human
Health Assessment Scoping Document in Support of Registration Review; the
Registration Review Problem Formulation for Fenpropathrin; and the Fenpropathrin
Summary Document Registration Review (this includes the Fenpropathrin Preliminary
Work Plan (PWP) and a factsheet), were posted to the docket for a 60-day public
comment period.

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•	January 2011 - The Final Work Plan (FWP) for fenpropathrin was issued. Several
comments were received on the PWP; however, the comments did not change the
schedule, risk assessment needs, or anticipated data requirements in the FWP.

•	October 2011 - A Generic Data Call-in Notice (GDCI-127901-1037) was issued for
guideline 875.1700 product use information. GDCI-127901-1037 was issued to
registrants who formed the Residential Exposure Joint Venture (REJV) and is
satisfied. EPA has received and accepted data from companies who represent the REJV.

•	November 2016 - The Agency announced the availability of the Fenpropathrin. Draft
Human Health Risk Assessment for Registration Review and Preliminary Comparative
Environmental Fate and Ecological Risk Assessment for the Registration Review of Eight
Synthetic Pyrethroids and the Pyrethrins (also referred to as the "Ecological Risk
Assessment") and the Ecological Risk Management Rationale for Pyrethroids in
Registration Review (also referred to as the "Rationale Document"), to the fenpropathrin
docket for a 60-day public comment period. The same FR Notice (81 FR 85952) also
announced the availability of the risk assessments for several other pyrethroids, and the
Ecological Risk Assessment and Rationale Document, in the individual chemical dockets.
The comment period was extended from January until July 2017.

o During the public comment period, the EPA received over 1,400 public

comments across all the dockets of the pyrethroids.
o Forty-nine comments were received in the fenpropathrin docket. Of these
comments, forty-eight addressed pyrethroids in general and sixteen within
these mention fenpropathrin. These comments and the Agency's responses
can be found in the Joint Response from OPP 's Environmental Fate and
Effects Division and Preliminary Risk Assessments for the Pyrethroids and
Pyrethrins Insecticides, which can be found in at http://www.regulations. gov
(EPA-HQ-OPP-2008-0331). One comment was specific to fenpropathrin; it
did not change the risk assessment or registration review timeline for
fenpropathrin.

•	August 2019 - The Agency announced the availability of USEPA Office of Pesticide
Programs' Re-Evaluation of the FQPA Safety Factor for Pyrethroids: Updated
Literature and CAPHRA Program Data Review on the webpage

https://www.epa.eov/sites/prodiiction/files/2019-08/dociiments/2019-PYrethroid-fqpa-
caphra.pdf. which discusses the data and rationale underlying the Agency's decision
to remove the 10X FQPA safety factor for the pyrethroids, including fenpropathrin.

•	November 2019 - The Agency opened a 60-day public comment period for USEPA
Office of Pesticide Programs' Re-Evaluation of the FQPA Safety Factor for
Pyrethroids: Updated Literature and CAPHRA Program Data Review. This
document is located in the Special Docket for Pyrethroids, Pyrethrins, and Synergists
http://www.reeulations.eov (EPA-HQ-OPP-2008-0331). The following supporting
documents are also available in this docket:

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¦	Pyrethroids: Documentation of Systematic Literature Review
Conducted in Support of Registration Review

¦	cis-Permethrin: Statistical Analysis of PBPK Simulated Data for
DDEF

¦	Pyrethroids: Tier II Epidemiology Report

•	November 2019 - The Agency opened a 60-day public comment period for the
Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals in
the Special Docket for Pyrethroids, Pyrethrins, and Synergists located at
http://www.reeulations.eov (EPA-HQ-OPP-2008-0331). The comment period was
extended an additional 30 days, due to multiple requests for an extension. The
following supporting documents are also available in this docket:

¦	Joint Response from OPP 's Environmental Fate and Effects Division
and Pesticide Re-evaluation Division to Comments on the Preliminary
Risk Assessments for Pyrethroids and Pyrethrins Insecticides

¦	Updated Ecological Incidents Search for the Pyrethroids and
Pyrethrins

¦	Usage Characterization and Qualitative Overview of Agricultural
Importance for Pyrethroids Insecticides for Selected Crops and
Impacts of Potential Mitigation for Ecological Risks

¦	Review of USD A 's Assessment of the Benefits of Pyrethroids

¦	Review of Estimated Benefits of Pyrethroids in U.S. Agriculture from
"The Value of Pyrethroids in U.S. Agriculture and Urban Settings"
Prepared by Aglnfomatics, LLC for the Pyrethroid Working Group

¦	Biological and Economic Analysis Division (BEAD) Summary of
Public Comments Related to Benefits of Pyrethroids Submitted in
Response to the Preliminary Comparative Environmental Fate and
Ecological Risk Assessment for the Registration Review of Eight
Synthetic Pyrethroids and the Pyrethrins

¦	Review of "Economic Benefits of Pyrethroids Insecticides for Select
California Crops, " Report Prepared by ERA Economics for the
Pyrethroids Working Group

¦	Alternatives Assessment for Synthetic Pyrethroid/Pyrethrin Insecticides
as Wide Area Mosquito Adulticides in Support of Registration Review

¦	Readers Guide - Instructions for Commenting on the Registration
Review Documents in the Pyrethroids Group (also posted in the
fenpropathrin registration review docket (EPA-HQ-OPP-2010-0422)

•	May 2020 - The Agency announced the availability of the fenpropathrin PID in the
fenpropathrin registration review docket (EPA-HQ-OPP-2010-0422), for a 60-day
public comment period.

The following documents are also available in the fenpropathrin registration
review docket:

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¦	Fenpropathrin: Response to Public Comments on the Draft Risk
Assessment for Registration Review

¦	Fenpropathrin: Revised Draft Human Health Risk Assessment for
Registration Review

• September 2020 - The Agency has completed the fenpropathrin ID and will post it in
the fenpropathrin registration review docket (EPA-HQ-OPP-2010-0422).
o Along with the fenpropathrin ID, the following documents will also be
available in the fenpropathrin registration review docket (EPA-HQ-OPP-
2010-0422):

¦	Pyrethroids: Health Effects Division Response to Public Comments
Submitted to the Special Docket for Pyrethroids, Pyrethrins, and
Synergists [EPA-HQ-OPP-2008-0331], September 2020

¦	Pyrethroids and Pyrethrins Revised Ecological Risk Mitigation and
Response to Comments on the Ecological Risk Mitigation Proposal
For 23 Chemicals, September 2020

C. Summary of Public Comments on the Proposed Interim Decision and Agency
Responses

During the 60-day public comment period for the Fenpropathrin Proposed Interim Registration
Review Decision, which opened on May 5, 2020 and closed on July 6, 2020, the Agency received
65 substantive comments from various stakeholders on the pyrethroids as a group and one
comment addressing several pyrethroids, including fenpropathrin. Valent (technical registrant)
submitted some procedural suggestions regarding the timing of label implementation. The
Northwest Horticultural Council (NHC) supported the label changes and mitigation proposed in
the PID. The United States Department of Agriculture (USD A) supported the overall proposed
label language and mitigation with additional concerns that are addressed in detail below. Bay
Area Clean Water Agencies (BACWA), San Francisco Bay Regional Water Quality Control
Board (SFBRWQCB), and National Association of Clean Water Agencies (NACWA) submitted
comments relating to pyrethroids in general that were not specific to fenpropathrin.

Public comments pertaining to overarching pyrethroid ecological concerns and the Agency's
responses are addressed in the Pyrethroids and Pyrethrins Revised Ecological Risk Mitigation
and Response to Comments on the Ecological Risk Mitigation Proposal For 23 Chemicals.

Public comments pertaining to overarching pyrethroid human health and pet health concerns and
the Agency's responses are addressed in detail in the documents titled Pyrethroids: Health
Effects Division Response to Public Comments Submitted to the Special Docket for Pyrethroids,
Pyrethrins, and Synergists (EPA-HQ-OPP-2008-0331). Both of these documents are available in
the Special Docket for Pyrethroids, Pyrethrins, and Synergists (EPA-HQ-OPP-2008-0331) and
the fenpropathrin docket (EPA-HQ-OPP-2010-0422).

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Comments Submitted by USDA (Docket ID: EPA-HO-QPP-2010-0422-0105)

Comment: The USDA encourages EPA to evaluate the potential for Codex MRL harmonization
to the greatest extent possible or provide detailed, risk-based explanations for not harmonizing
when U.S. tolerances are lower than the Codex MRLs. In addition, USDA encourages EPA to
consider a more comprehensive approach to MRL harmonization by evaluating not only existing
U.S. tolerances, but also cases where Codex has established an MRL and EPA has no
corresponding tolerance.

EPA Response: EPA thanks the USDA for its comments and will take them into
consideration. Regarding the potential for additional harmonization with Codex MRLs, EPA
attempts to harmonize existing US tolerances with Codex MRLs where feasible. However,
harmonization is not possible in some cases due to a difference in tolerance expression (e.g., a
difference in metabolites covered), a difference in commodity definition (e.g., livestock meat
versus livestock fat), or a difference in use pattern (e.g., in season versus post-
harvest). Additionally, the Agency does not establish new tolerances in the registration review
process other than those that might result from crop group updates. Any petition to establish a
new tolerance should be sent to the Registration Division Product Manager for fenpropathrin.

Comments Submitted by Pyrethrin Joint Venture and Various Registrants

Comment: Pyrethrin Joint Venture (PJV) (posting in the pyrethroids special docket, EPA-HQ-
OPP-2008-0331), Bayer CropScience LP (posting in the deltamethrin docket, EPA-HQ-OPP-
2009-0637), and Valent (posting in the esfenvalerate docket, EPA-HQ-OPP-2009-0301)
submitted comments requesting additional time for label submission (following the Interim
Decision) and/or additional time to complete implementation of updated labels on containers.
Bayer and Valent request an additional 60 days for a total of 120 days for registrants to submit
revised labels following the issuance of the Interim Decisions. In addition, the PJV and Valent
requested 18-24 months following EPA's approval of these amended labels for registrants to
begin selling and distributing product containers reflecting these new amended labels. PJV
believes the 18-month implementation timeline to be in accordance with 40 CFR 152.130(c).

Agency Response: EPA thanks the submitters for their comments and has determined that an
extension to the 60-day timeframe is acceptable based on the number of pyrethroid labels that
will be revised and submitted to the Agency. EPA agrees to extend the label submission deadline
to 120 days following the issuance of the IDs. The Office of Pesticide Programs is currently
looking into the timing concerns raised related to label implementation ( i.e. 40 CFR 152.130(c))
as an overall issue for the program and will consider the comments received before issuing a
response.

II. USE AND USAGE

Products containing fenpropathrin are registered for use on ornamentals and agricultural crops
and may also be used for commercial nonfood applications to ornamental plants in both indoor
(e.g., greenhouses, interiorscapes) and outdoor (e.g., landscaping, nursery) settings.

Fenpropathrin is not registered for use in residential or public recreational areas. It is an ingestion

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and contact pesticide used to control a variety of arthropods including aphids, worms, moths,
beetles, mites, spiders, thrips, flies and other pests. Fenpropathrin is formulated as an
emulsifiable concentrate as well as a ready to use total-release fogger. It can be applied by
aircraft, airblast ground sprayer, broadcast ground sprayer, overhead chemigation, and aerosol
can.

On average from 2013-2017, approximately 130,000 pounds of fenpropathrin per year were
applied to about 440,000 acres, with an average application rate of 0.3 pounds active ingredient
per acre (lbs ai/A). Agricultural uses are responsible for most of fenpropathrin usage and include
applications to peanuts, avocados, citrus fruit, pome and stone fruit, tree nuts, cotton, berries,
Brassicaceae and cucurbits. There are no registered uses of fenpropathrin that are expected to
result in residential exposure. Citrus crops account for nearly 310,000 acres and about 70 percent
of the pounds applied; usage in lemons has increased substantially over the most recent five
years of data. Stone and pome fruit account for another 49,000 acres treated with fenpropathrin.
In terms of the percent crop treated (PCT), about 38% of oranges, 28% of grapefruit, 24% of
cherries and 14% of strawberries are treated with fenpropathrin (Market Research Data, 2013-
2017).

III. SCIENTIFIC ASSESSMENTS

A. Human Health Risks

A summary of the Agency's human health risk assessment is presented below. The Agency used
the most current science policies and risk assessment methodologies to prepare a risk assessment
in support of the registration review of fenpropathrin. For additional details on the human health
assessment for fenpropathrin, see the Fenpropathrin: Draft Human Health Risk Assessment in
Support of Registration Review and Fenpropathrin: Revised Draft Human Health Risk
Assessment for Registration Review, which are available in the fenpropathrin registration review
docket (EPA-HQ-OPP-2010-0422).

1. Pyrethroids FQPA Safety Factor Determination

The Food Quality Protection Act (1996) requires EPA to apply a ten-fold margin of safety (10X
FQPA safety factor) for infants, children, and women of child-bearing age to account for
potential juvenile sensitivity to pesticides, unless there are reliable data to reduce this safety
factor. The Agency considers the FQPA safety factor as having two components: 3X assigned to
pharmacokinetic (PK) differences and 3X to pharmacodynamic (PD) differences. In conjunction
with registration review for the synthetic pyrethroid active ingredients, EPA previously used a
3X safety factor based on concerns for pharmacokinetic differences between adults and children.
In 2019, EPA re-evaluated the need for an FQPA Safety Factor for human health risk
assessments for pyrethroid pesticides. The previous conclusion that the PD contribution to the
FQPA factor is IX remains the same. Based on a review of the available guideline and literature
studies as well as data from the Council for the Advancement of Pyrethroid Human Risk
Assessment (CAPHRA) program, EPA concluded that the PK contribution to the FQPA factor is
also IX for adults, including women of child-bearing age, and children. Therefore, the Agency

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concluded the total FQPA safety factor for pyrethroids can be reduced to IX for all
populations. This conclusion was supported by two documents posted to the Agency's website
and the Special Docket for_Pyrethroids, Pyrethrins and Synergists (EPA-HQ-OPP-2008-0331):
1) "Re-Evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA
Program Data Review," December 12, 2019; and 2) "Pyrethroids: Current Use and Potential
Applications of a Generic Physiologically-Based Pharmacokinetic (PBPK) Model", December
17, 2019.

2. Risk Summary and Characterization

The Agency has not identified any human health risks of concern for fenpropathrin.

Dietary (Food + Water), Residential Handler and Post-Application, Bystander, Aggregate and
Occupational Handler and Post-Application Risks

The EPA conducted a refined acute dietary assessment (food + drinking water) in addition to
aggregate, bystander, and occupational handler assessments for registered fenpropathrin uses and
did not identify any risks exceeding the Agency's levels of concern. A chronic dietary
assessment was not conducted as use of the acute endpoint and dose is protective for repeated
dose exposure for fenpropathrin. A residential assessment was not conducted as there are no
residential uses of fenpropathrin. An occupational post-application dermal assessment was not
conducted as there was no dermal hazard identified for fenpropathrin. While a quantitative
occupational post-application inhalation exposure assessment was not conducted, it is expected
that handler inhalation exposure estimates would be protective of most occupational post-
application inhalation exposure scenarios.

Cumulative Risks

The Agency has determined that the pyrethroids and pyrethrins share a
common mechanism group (http://www.reeiilations.eov: EPA-HQ-OPP-2008-0489-0006) with
respect to human health. A 2011 cumulative risk assessment for the pyrethroids and pyrethrins
did not identify cumulative risks of concern. After all chemical-specific interim decisions have
been completed for all pyrethroids and pyrethrins, an update of the cumulative risk assessment
may be performed in association with registration review.

For more information on the human health risk conclusions for fenpropathrin, refer to
Fenpropathrin. Draft Human Health Risk Assessment for Registration Review and
Fenpropathrin: Revised Draft Human Health Risk Assessment for Registration Review, which
are available in the fenpropathrin public docket (EPA-HQ-OPP-2010-0422).

3. Tolerances

Tolerances for residues of fenpropathrin are established in 40 CFR §180.466. Tolerance updates
are required in accordance with the standard practice and policies. Tolerances are currently
established for Crop Group 12 and for Crop Group 14. In the crop group regulation, these crop
groups have been updated to Crop Groups 12-12 and 14-12, respectively. There are numerous

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Codex Maximum Residue Levels (MRLs) for fenpropathnn. In some of the cases where there
are botli U.S. tolerances and Codex MRLs, the tolerances and MRLs are harmonized. However,
the U.S. tolerances for livestock commodities are all higher than the corresponding Codex
MRLs. Ill these cases, harmonization might not be feasible because the tolerances are based on
the livestock feeds registered in the U.S. In other cases, the U.S. tolerances are lower than the
Codex MRLs. In most of these cases, there are opportunities for harmonization. See the table
below for the tolerances EPA intends to update as part of registration review. The Agency will
use its FFDCA rulemaking authority to make any needed changes to the tolerances.

Table 1: Summary of Required Tolerance Actions

|l t iijuopaliu in 40 < I K ^ INO.-tfifij: Mimmnt\<)t KcnnmiH udt d 1 olcraitic Adjoin

Commodity

Established

Recommended

Comments

Tolerance (ppill)

Tolerance ippm)

Fruit. >tone. crop group

12, except cherry

1 ."t

Cancel. Replace with crop -ubaroup tolerances
fui Peach, ^ubs^ioiip and I luuu ^nhgiot.ip

12-12C.

Cherry, sweet

5.0

Cancel. Expand to Cheny. subgroup 12-12A.

Cherrv, tan

5.0

Cancel, Expand to Cheny. subgroup 12-12A.

Cheny, subgroup 12-12A

Expand cheny. sweet and cheny. tart to cherry
subgroup.

Peach, subgroup 12-12B

—

1.4

Establish in conjunction with replacement of
stone fruit group with subgroups

Plum, subgroup 12-12C

—

Establish in conjunction with replacement of
stone fruit group with subgroups. Harmonize
with Codex MRL for the same subgroup.

Prune

Establish in conjunction with replacement of

stone fruit group with subgroups. Harmonize
with Codex MRL.

Update commodity definition:

Nut. tree, crop group 14

0.1

0.15

Nut, tree, group 14-12,
Increase to harmonize with Codex

Almond, hulls

4.5

Increase tolerance to harmonize with Codex

Citrus, oil

100

Increase tolerance to harmonize with Codex

ppiii=paits per million; rug/

4. Human Health Data Needs

II te Agency does not anticipate any further human health data needs for fenpropathnn

registration review at this time.

The GDCI 127901-1101 (for guideline 875.1700 product use information) was issued to
registrants who formed the Residential Exposure Joint Venture (Rfc'JY) and is satisfied. EPA has
received and accepted data from companies who represent the REJV.

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B. Ecological Risks

The Agency used the most current science policies and risk assessment methodologies to prepare
a risk assessment in support of the registration review of the pyrethroids and pyrethrins. EPA's
2016 Preliminary Comparative Environmental Fate and Ecological Risk Assessment for
Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins is a quantitative
ecological assessment of nine cases: bifenthrin, cyfluthrin (6eta-cyfluthrin), cyhalothrins
{lambda-cyhalothrin and gamma-cy\\d\ othrin), cypermethrin {alpha-cypermethrin and zeta-
cypermethrin), deltamethrin, esfenvalerate, fenpropathrin, permethrin, and pyrethrins. The 2016
risk assessment was divided into five sections: risks from indoor "down the drain" uses;1 risks
from outdoor residential, commercial, turf, and nursery uses; risks from agricultural uses; risks
from mosquito adulticide uses; and, an assessment of risk to bees from agricultural uses of
pyrethroids and pyrethrins.

The Agency primarily focused on potential effects to aquatic organisms (for all uses) as well as
terrestrial invertebrates (for agricultural uses). A quantitative assessment was conducted for these
nine pesticides, for which the Agency had a relatively large amount of data. A companion piece,
titled the Ecological Risk Management Rationale for Pyrethroids in Registration Review or the
Rationale Document, summarized potential risk concerns for the remaining pyrethroids and was
published at the same time. The pesticides covered in the Rationale Document are: cyphenothrin,
d-phenothrin, etofenprox, flumethrin, imiprothrin, momfluorothrin, prallethrin, taw-fluvalinate,
esfenvalerate, and tetramethrin. The Rationale Document describes EPA's approach in using the
quantitative assessment of the nine cases to serve as a basis for making risk management and
regulatory decisions for all 23 affected pesticides currently undergoing registration review.
Potential risks that were identified for the eight pyrethroids and pyrethrins assessed in 2016 were
determined to be representative of the risks for the other pyrethroids also undergoing registration
review. For additional details on the ecological assessment for the pyrethroids, see the
Preliminary Comparative Environmental Fate and Ecological Risk Assessment for Registration
Review of Eight Synthetic Pyrethroids and the Pyrethrins and the Ecological Risk Management
Rationale for Pyrethroids in Registration Review, which are available in the public docket.

For registration review, the Agency issued a single ecological risk mitigation proposal to address
the potential ecological risks of concern for the 23 pyrethroids and pyrethrins, based on their
common insecticidal mode of action and similar potential ecological risks of concern {i.e., risk to
aquatic invertebrates). This ecological risk mitigation proposal {Pyrethroids and Pyrethrins
Ecological Risk Mitigation Proposal for 23 Chemicals found in EPA-HQ-OPP-2008-0331)
ensured a consistent approach to mitigating potential ecological risk and provided equity to
stakeholders when implementing regulatory changes for pesticides in this group.

For fenpropathrin, risks of concern were identified for aquatic invertebrates, fish, aquatic-phase
amphibians, birds, reptiles, terrestrial-phase amphibians, mammals, and bees based on
fenpropathrin's outdoor and agricultural use.

1 "Down the drain" uses refer to indoor uses of pesticides that may be discharged as residues in domestic wastewater
from indoor drains and then enter into publicly-owned treatment works, potentially resulting in releases to water
bodies.

13

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Terrestrial Invertebrates (honeybees)

lists to bees were assessed for the agricultural uses of certain pesticides in the Agency's
Preliminary Comparative Environmental Fate and Ecological Risk Assessment for the
Registration Review of Eight Synthetic Pyrethroids and the Pyrethiins: bifentluin, cylluthrins,
cyhalothrins. cypermetlinns. dehainethrui. esfenvalerate. lenpropathrin. pennetlirin. and
pyrethrins. The Agency's pollinator risk assessment was limited by the scarcity of bee toxicity
data available across the pyrethroids pyrethrins. Only honeybee (Apis me 11 if era) adult acute
contact and acute oral toxicity studies are available for a select number of pyrethroids pyrethrins.
Based on the available data, risk quotients indicate a potential for adverse effects on bee-- from
acute exposure from particular uses of pyrethroids pyrethrins. Reported bee mortahn incidents
from spray drift support these risks of concern.

The Agency did not have sufficient information to assess clu oinc risk to bees or effects on
honeybee colonies. EPA concludes that additional pollinator data are necessary to fully evaluate
risks to bees from use of the pyrethroids pyrethrins. The Agency has determined the MI suite of
pollinator studies for the pyrethroids/pyrethiins that may impact pollinators is necessary, where

such data are not currently available. EPA will issue a Data Call-in (DCI) for the pollinator
studies listed in Table 1.

l itblc 1: Pollinator Ihita Rerjiiiieimnis

<.nidi-line = | Slud\

frv y 'V * /,!- * f a

850.3020

Acute contact toxicity study with adult
honeybees

850.3030

Honeybee toxicity of residues on foliage

Non-Guideline (OECD
213)

Honeybee adult acute oral toxicity

Non-( mideline (OECD

237)

Honeybee larvae acute oral toxicity

Non-Guideline

Honevbee adult chronic oral toxicity

Non-Guideline

Honevbee larvae chronic oral toxicity

... ' i

Non-Guideline

Field trial of residues in pollen and nectar

Non-Guideline (OECD 75)

Semi-field testms for pollinators

r J' ~* //4>' , ////, '/ , "//,/'J' *> jsr // 4

- sii ;,i j11

l ull-Field testing for pollinators

T The need for higher tier tests for pollinators will be determined based upon the results of lower tiered tests and/or
other lines of evidence and the need for a refined pollinator risk assessment,

EPA will consider proposals from registrants to bridge pollinator datasets across pyrethroids.
When available EPA will share any additional guidance on the underlying principles to consider
when designing a bridging proposal in the Special Docket for Pyrethroids, Pyrethrins, and
Synergists located at i > ¦ i 1 (Docket EPA-HQ-OPP-2008-0331).

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Once adequate pollinator data are received and reviewed, the Agency will reassess risk to
pollinators and consider any additional mitigation changes for fenpropathrin.

1. Ecological and Environmental Fate Data Needs

As noted previously, additional pollinator data are necessary to fully evaluate risks to bees from
use of fenpropathrin. EPA will issue a DCI for the necessary pollinator studies.

C. Benefits Assessment

Fenpropathrin, a synthetic pyrethroid, is a Restricted Use Product (RUP) registered for use on
agricultural crops including multiple vegetables, fruits, and nuts, as well as cotton and for use in
nursery operations.

Fenpropathrin may be used for the control of a wide variety of insect pests and mites in several
agricultural and ornamental crops. Fenpropathrin provides high value and benefits for growers of
fruit, vegetable and orchard crops especially in citrus (orange, grapefruit, and lemon) and cherry
production. In terms of primary target pests of fenpropathrin in citrus, 100% of treated acres in
grapefruit and more than 90% of treated acres in oranges targeted the Asian citrus psyllid (ACP;
Diaphorina citri Kuwayama). Other pests targeted along with the ACP in citrus include mites,
katydids, thrips, caterpillars, weevils, and leafminers. In cherries, fenpropathrin is used to control
the spotted wing drosophila (SWD; Drosophila suzuki Matsumura), other fruit flies (Rhagoletis
cingulata Loew, R. indifferens Curran, R. fausta Osten Sacken), and, to a lesser extent
leafrollers, leafhoppers, mites, and aphids.

Fenpropathrin is an efficacious and cost-effective foliar spray option for growers. Based on
extension recommendations and market research data, the most likely insecticide alternatives to
fenpropathrin for targeting ACP in citrus include other pyrethroids, avermectins, neonicotinoids,
and organophosphates.

In terms of the total acres treated and particularly in the variety of crops that depend on them,
pyrethroids have largely surpassed the organophosphate and carbamate classes as the preferred
options by growers for cost-effective and broad-spectrum insect control.

For more information on the usage of fenpropathrin, refer to the Fenpropathrin. Screening Level
Usage Analysis (SLUA) and Usage Characterization and Qualitative Overview of Agricultural
Importance for Pyrethroids Insecticides for Selected Crops and Impacts of Potential Mitigation
for Ecological Risks, which are available in the public docket (EP A-HQ-OPP-2010-0422). For
additional information on the benefits of pyrethroids, in general, refer to the Pyrethroids and
Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals, also available in the public
docket (EPA-HQ-OPP-2008-0331).

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IV. INTERIM REGISTRATION REVIEW DECISION
A. Required Risk Mitigation and Regulatory Rationale

The Agency has determined that there are no human health risks of concern from registered
fenpropathrin uses. The Agency identified potential risks for various taxa (birds, freshwater and
terrestrial invertebrates, mammals, and fish), with the major potential risks of concern focusing
on aquatic invertebrates and terrestrial invertebrates from agricultural uses of fenpropathrin.
Mitigation to address risks to aquatic and terrestrial invertebrates will benefit the other taxa to
the extent that there is any risk.

Based on the use pattern for fenpropathrin, there is little concern for aquatic invertebrates and
fish as a result of urban runoff, spray drift or improper disposal of pyrethroid products unlike
other pyrethroid outdoor urban use patterns. Therefore, no mitigation measures to reduce the
urban footprint are needed for fenpropathrin.

Agricultural uses of the pyrethroids are expected to result in potential risks of concern to aquatic
invertebrates and fish, primarily from runoff and spray drift. However, the benefits of
pyrethroids in agricultural crop production outweigh the risks, and the necessary mitigation is
expected to allow continued use of pyrethroids in agricultural settings while putting reasonable
measures in place to reduce risk to non-target organisms from runoff and spray drift. The VFS
requirement has been expanded in some cases but the Agency has added flexibility for Western
irrigated agriculture and areas where soil conservation practices are being used. The Agency has
also identified potential risks of concern to terrestrial invertebrates from the foliar applications of
pyrethroids in agricultural areas. The Agency has determined that mitigation to address potential
terrestrial invertebrate risks is necessary and has revised the terrestrial invertebrate
Environmental Hazard Statement, adding information on stewardship and best management
practices, promoting State Managed Pollinator Protection Plans (MP3s), and adding information
on Pollinator Incident Reporting.

For a detailed discussion of the mitigation to address risks to aquatic and terrestrial invertebrates,
refer to the Pyrethroids and Pyrethrins Revised Ecological Risk Mitigation and Response to
Comments on the Ecological Risk Mitigation Proposal For 23 Chemicals (EPA-HQ-OPP-2008-
0331). In keeping with the Agency's current approach for insecticides and to address generic
labeling requirements, EPA has determined that the addition of insect resistance management
language to fenpropathrin labels is necessary, where applicable.

1. Mitigation Measures for Outdoor Urban Uses

EPA has determined that mitigation measures for outdoor urban uses of pyrethroids in residential
and commercial settings (i.e., structural, turf, ornamental, nursery) are appropriate. To mitigate
potential risks to aquatic organisms, it is the goal of the Agency to reduce runoff into water
bodies from treated urban environments. By reducing the total amount of chemical applied to an
area, there is less potential that could result in runoff into water bodies. However, because the
only outdoor, non-agricultural use for fenpropathrin is a total-release fogger, aquatic risks are not
anticipated and these mitigation measures do not apply.

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Based on the use pattern for fenpropathrin, there is less concern for aquatic invertebrates and fish
as a result of urban runoff, spray drift or improper disposal of pyrethroid products unlike other
pyrethroid outdoor urban use patterns. Therefore, based on fenpropathrin's limited outdoor
urban use pattern the following label changes described below are necessary.

A.	Statements for Outdoor Label Consistency and Clean-up

The Agency has determined that several label changes for consistency with other products and
current policy (e.g., EPA's January 10, 2013 letter Revisions to Environmental Hazard and
General Labeling for Pyrethroid Non-Agricultural Outdoor Products) are necessary. Labels
must explicitly say whether particular products are to be applied outdoors only, or both indoors
and outdoors (as described in the previous section).

The Agency also has determined that several specific mitigation measures to reduce the amount
of runoff entering waterbodies and drainage systems are necessary. These include:

B.	Buffer from Water Statement

•	"For soil or foliar applications, do not apply by ground within 25 feet of lakes,
reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries and
commercial fish farm ponds."

C.	Water Protection Statements

•	"Do not spray the product into fish pools, ponds, streams, or lakes. Do not apply
directly to sewers or storm drains, or to any area like a drain or gutter where drainage
to sewers, storm drains, water bodies, or aquatic habitat can occur."

•	"Do not allow the product to enter any drain during or after application."

D.	Rain-Related Statements

•	"Do not make applications during rain. Avoid making applications when rainfall is
expected before the product has sufficient time to dry (minimum 4 hours)."

•	"Rainfall within 24 hours after application may cause unintended runoff of pesticide
application."

The Agency has determined that mitigation measures for specific industry sectors to reduce off-
site drift to waterbodies, increase distances between the area treated and waterbodies, as well as
to reduce the potential for over spraying are necessary. These include:

E.	Statements for Outdoor Applications at Commercial Nurseries

•	"Do not apply when the wind speed is greater than 15 mph."

•	"Applicators are required to select the nozzle and pressure that deliver a medium or
coarser droplet size (ASABE S572)."

•	"For soil or foliar applications, do not apply by ground equipment within 25 feet of
lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries and
commercial fish farm ponds."

17

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The Agency has not assessed the impact the application wind speed restriction of no greater than
15 mph for these industry sectors; however, it is likely to decrease the number of days available
for applications. However, high wind speeds interfere with proper dispersion of the pesticide, so
relatively few applications may be affected by the prohibition.

The Agency does not know how efficacy may be impacted when droplet sizes are determined to
be necessary for various insecticides in commercial nurseries. Pyrethroids are contact
insecticides which require thorough coverage of the treated surface for effective pest control.
University extension recommendations for contact insecticides such as pyrethroids are for
ASABE droplet sizes of fine to medium (Wolf and Bretthauer, 20092). For foliar applications,
insect control would likely be negatively impacted given the requirement for a medium or larger
droplet size. Growers may be driven to use higher rates, mix with another insecticide, make
additional applications per season, or increase application volume with larger droplet sizes to
achieve the same efficacy they were able to with finer droplet sizes. However, many pyrethroid
products are already subject to droplet size restrictions and buffers to water bodies, so impacts
may be limited.

2. Mitigation Measures for Agricultural Use Products
Vegetative Filter Strip (VFS) Language

To reduce the amount of pyrethroids that enter waterbodies from runoff, EPA has determined
that an increase to the existing vegetative filter strip (VFS) for agricultural products to 25 feet is
necessary. EPA is concerned that sediment from agricultural land, with which pyrethroids bind,
erodes into aquatic habitats exposing aquatic organisms susceptible to these pesticides.
Pyrethroid monitoring data have been collected in water and sediment across the United States,
with pyrethroid detections widespread that are directly related to agricultural uses. Data
supported by the PWG and USDA have shown that VFS can be an effective method of reducing
sediment transport into aquatic systems when designed with field specific factors and are well
maintained. EPA concludes that the expansion of the VFS size will reduce risk to aquatic
organisms. Based on public comments, EPA is now providing greater flexibility for Western
irrigated agriculture and for areas where soil erosion control practices are already present. This
flexibility will still reduce risk to aquatic organisms while better preserving the agricultural
benefits pyrethroids provide.

Currently, all pyrethroid products, except etofenprox and pyrethrins, already have a 10-foot VFS
requirement on the labels. VFS are somewhat expensive to implement and maintain, and they
must be maintained or they will lose efficacy and cause channelized flow across the VFS after a
few years. VFS are most effective at removing non-source point pollutants (e.g., pesticides) from
runoff water sources. However, the effectiveness of a VFS is influenced by various land
management practices (e.g., flood and furrow irrigated fields) which may impact their utility.3

2 Wolf, R., and S. Bretthauer. 2009. Droplet Size Calibration: A New Approach to Effective Spraying. Kansas State
University Agricultural Experiment Station and Cooperative Extension Service. MF 2869.

https://www.bae ksu.edu/facultv/wolf/PDF/MF2869%20Droplet%20Calibration.pdf

3 https://www regulations.gov/doeiiment?D=EPA~HQ~QPP~2008~033.1.-0.1.75

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The Agency has considered several additional sources of research which contextualize the
benefits of VFS and has determined that increasing the use of VFS is appropriate mitigation to
reduce pyrethroid residues in aquatic habitats.

Product labels are required to include a minimum 25-foot VFS. However, the 25-foot VFS
requirement may be reduced to 15 feet if other soil conservation practices are used. Areas that
qualify for a reduced 15-feet VFS are: areas considered prime farmland, areas where
conservation tillage is implemented, areas with a functional terrace system, areas where water
and sediment control basins are present and maintained, and areas that are less than or equal to
10 acres. Prime farmland, as defined in 7 CFR § 657.5, is not excessively erodible and
pyrethroids binding to soil particles are less likely to enter adjacent waterways. Conservation
tillage also works to reduce soil erosion, because remaining crop residues remain on the field.
Terrace farming and the presence of water and sediment control basins also reduce soil erosion.
Additionally, based on public comments on the Ecological Risk Mitigation Proposal, the VFS
requirement is reduced to 15 feet, if the area of application is less than or equal to 10 acres—this
reduces the impact on small-scale operations that are not primary contributors to runoff. These
added criteria for a reduced VFS are intended to allow more flexibility for stakeholders.

Further, the Agency has determined that the burden on the arid parts of the country that rely on
irrigation to grow agricultural crops (Western irrigated agriculture), to develop and maintain a
VFS, would be too impractical and therefore has determined that an increase of the existing 10
foot VFS in those areas is not necessary. A larger VFS would be more expensive to maintain,
and runoff is less likely in these drier, more arid parts of the country. These areas would likely
need irrigation to maintain a VFS, and on fields where water is managed carefully there is less
likely to be runoff and erosion into a waterbody, so the existing 10-foot wide VFS is appropriate.
These Western states, referred to as "Western irrigated agriculture" include WA, OR, CA, ID,
NV, UT, AZ, MT, WY, CO, NM, and TX (west of 1-35).

Since sediment control basins may be installed in Western irrigated agriculture to collect runoff
and improve drainage, and may fulfill similar functions as a VFS, the Agency revised the VFS
requirement for Western irrigated agriculture: if a functioning sediment control basin is already
present, the Agency has determined that creating or maintaining a 10 foot VFS will no longer be
necessary. In many situations a sediment control basin is as effective at controlling runoff and
erosion for this type of agriculture. EPA decided to promote the use of sediment control basins
for Western irrigated agriculture by allowing growers in these areas to use sediment control
basins in lieu of creating and maintaining a VFS when pyrethroids are used. This exception will
also reduce the amount of water Western growers will be required to use to maintain a VFS.

The following mitigation measures apply to all pyrethroids with agricultural uses (except
pyrethrins). They are determined to be necessary and are separate from the spray drift buffer
zones described later in this ID; spray drift buffer zones are still necessary if a vegetated filter
strip is present. The vegetative filter strip requirement reads as follows:

"Construct and maintain a vegetative filter strip, according to the width specified below, of

grass or other permanent vegetation between the field edge and nearby down gradient aquatic

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habitat (such as, but not limited to, lakes; reservoirs; rivers; streams; marshes or natural
ponds; estuaries; and commercial fish farm ponds).

Only apply products containing fenpropathrin onto fields where a maintained vegetative filter
strip of at least 25 feet exists between the field edge and where a down gradient aquatic
habitat exists. This minimum required width of 25 feet may be reduced or removed under the
following conditions:

• For Western irrigated agriculture, a maintained vegetative filter strip of at least 10 feet wide
is required. Western irrigated agriculture is defined as irrigated farmland in the following
states: WA, OR, CA, ID, NV, UT, AZ, MT, WY, CO, NM, and TX (west of 1-35).

o For Western irrigated agriculture, if a sediment control basin is present, a vegetative
filter strip is not required.

• In all other areas, a vegetative filter strip with a minimum width of 25 feet is required, unless
the following conditions are met. The required vegetative filter strip may be reduced from 25
feet to 15 feet if at least one of the following applies:

o The area of application is considered prime farmland (as defined in 7 CFR § 657.5).
o Conservation tillage is being implemented on the area of application. Conservation
tillage is defined as any system that leaves at least 30% of the soil surface covered by
residue after planting. Conservation tillage practices can include mulch-till, no-till, or
strip-till.

o A functional terrace system is maintained on the area of application,
o Water and sediment control basins for the area of application are present, functional,

and maintained,
o The area of application is less than or equal to 10 acres.

For further guidance on vegetated filter strips, refer to the following publication for information
on constructing and maintaining effective buffers: Conservation Buffers to Reduce Pesticide
Losses. Natural Resources Conservation Services.

https://www.reeutations.gov/documem * < IPA.-H.Q-OPP-20Q\ 0 '< '<1 01 ¦>"

Potential VFS Mitigation Impacts

The impact of the VFS mitigation can be highly localized and depends critically on the size and
shape of a field. When growing areas are adjacent to water bodies, vegetative filter strips may
require growers to remove land from production thus decreasing revenue while imposing costs to
maintain the filter strips. These impacts will disproportionally affect growers producing crops
from small acreage fields. As a result of a comments on the proposed mitigation, the Agency will
allow application on areas of 10 acres or less to maintain a VFS of 15 feet instead of 25 feet. The
reduction in VFS size for areas of application 10 acres or less is intended to lessen the burden on
small scale agricultural practices which will likely be using less pyrethroids than larger farms
and agricultural operations.

Estimates of losses from increasing the size of the VFS for the 10th percentile and the median
field size by crop are available in EPA document "Usage Characterization and Qualitative
Overview of Agricultural Importance for Pyrethroid Insecticides for Selected Crops and Impacts
of Potential Mitigation for Ecological Risks." These impact estimates vary widely by crop. As an
example for a smaller crop on a smaller field, the 25 foot VFS loss estimate for the 10th

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percentile cabbage field is almost $1,800 per acre, although the 10th percentile field size is only
0.2 acres. The highest losses estimated were for strawberries and peppers with losses of almost
$3,500 per acre on the median strawberry field, and over $1,300 per acre for the median pepper
field from an increase in the VFS to 25 feet, and much higher losses for smaller fields. In
general, increasing the VFS will have higher losses per acre for relatively high value crops, like
strawberries, peppers, pears, celery and apples. For high acreage crops, the impacts of increasing
the VFS is smaller on a per acre basis, because the per acre value of the crop is lower and fields
tend to be larger. These losses are only estimates and would not apply to fields where an
increase in the width of the VFS is not needed.

In addition to any reduced crop production, growers would need to manage the space taken out
of production and put into a VFS. Costs would differ across states and regions, and also vary
according to the size and shape of the field. In addition to the cost of establishing the VFS, the
cost of annual maintenance must also be considered. Yearly maintenance costs are estimated to
be $40 to $240 per acre (for four mowing or weed control applications). Maintenance costs could
be higher if additional operations are required such as additional mowing or weed control
expenses, reseeding of disturbed areas, or regrading of the filter strip with reseeding if sediment
deposition were to jeopardize its function.4

These additional costs could lead growers to substitute an alternative insecticide to replace
pyrethroids. If the necessary mitigation prevent growers from using pyrethroids, they will most
likely replace pyrethroid applications with other insecticides, such as organophosphates and
carbamates, which could lead to declining yields and/or increased production costs for growers if
the alternatives are less effective, more expensive or not available.

Spray Drift Reduction Measures

Most pyrethroids and pyrethrins labels currently have spray drift language to reduce the potential
for the pesticides to drift off-target. EPA has determined that label clarifications to bring all
labels up to date with the latest existing spray drift language, to reduce off-target spray drift and
establish a baseline level of protection that is consistent across all affected products for this
interim decision are necessary. Reducing spray drift will reduce the extent of environmental
exposure and risk to non-target plants and animals. Although the Agency is not making an
endangered species finding at this time, these label changes are expected to reduce the extent of
exposure and may reduce risk to listed species whose range and/or critical habitat co-occur with
the use areas of the pyrethroids.

The Agency has determined that the following spray drift mitigation language to be included on
all product labels for the pesticide addressed in this interim decision is necessary. The required
spray drift language is mandatory, enforceable statements and supersede any existing language
already on product labels (either advisory or mandatory) covering the same topics. In addition,
the Agency is providing language that will allow the registrants to standardize all advisory spray
drift language on the product labels (see Appendix B for required advisory language).

Registrants must ensure that any existing advisory language left on labels does not contradict or
modify the mandatory spray drift statements required in this interim decision once effective.

4 Lynch and Tjaden, 2003 and Solano and Yolo Co. Resource Conservation. Dist., 2006

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Required Statements for Aerial Applications

• "Do not release spray at a height greater than 10 feet above the vegetative canopy,
unless a greater application height is necessary for pilot safety.

• Applicators are required to select nozzle and pressure that deliver medium or coarser
droplets (ASABE S641).

• Do not apply when wind speeds exceed 15 mph at the application site. If the wind
speed is greater than 10 mph, the boom length must be 65% or less of the wingspan
for fixed wing aircraft and 75% or less of the rotor diameter for helicopters.
Otherwise, the boom length must be 75% or less of the wingspan for fixed-wing
aircraft and 90% or less of the rotor diameter for helicopters.

• If the windspeed is 10 miles per hour or less, applicators must use V2 swath
displacement upwind at the downwind edge of the field. When the windspeed is
between 11-15 miles per hour, applicators must use 3/4 swath displacement upwind at
the downwind edge of the field.

• Do not apply during temperature inversions."

Required Statements for Airblast Applications

• "Sprays must be directed into the canopy.

• Do not apply when wind speeds exceed 15 mph at the application site.

• User must turn off outward pointing nozzles at row ends and when spraying outer
row.

• Do not apply during temperature inversions."

Ground Boom Applications

• "User must only apply with the nozzle height recommended by the manufacturer, but
no more than 4 feet above the ground or crop canopy.

• Applicators are required to select nozzle and pressure that deliver medium or coarser
droplets (ASABE S641).

• Do not apply when wind speeds are sustained above 15 miles per hour at the
application site.

• Do not apply during temperature inversions."

EPA does not expect the requirements for release height to impact users since they largely
correspond to current practice and recommendations. Due to the varying use sites and target
pests of pyrethroids it is difficult to assess the impacts of a droplet size restriction across all
crops. Components of applications, including droplet size, are complex, but essentially insects
need to come into contact with, or ingest, a lethal dose of insecticide to be effectively controlled
which requires proper coverage throughout the plant. Pyrethroids are contact insecticides and
require a certain amount of coverage for efficacy. For foliar applications, insect control would
likely be negatively impacted by requiring a medium droplet size or larger. Growers may be
driven to use higher rates, mix with another insecticide, make additional applications per season,
or increase gallons applied per acre with larger droplet sizes to achieve the same efficacy they
were able to with finer droplet sizes.

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The application wind speed restriction of no greater than 15 mph for ground applications and the
prohibition on applications during temperature inversions will decrease the number of days
available during the growing season for applications and thus result in additional burdens to the
grower, lack of pest control, and potentially yield loss depending on the crop. Because such
weather conditions are variable, growers may be unable to apply when planned, but may also not
be able to apply alternatives if, for example, tanks are already mixed with pyrethroids.

Moreover, temperature inversions may be highly localized and growers or applicators may not be
aware they exist.

If the mitigation prevents growers from using pyrethroids, they will most likely replace
pyrethroid applications with other insecticides, such as organophosphates and carbamates, which
could lead to declining yields and/or increased production costs for growers if the alternatives are
less effective, more expensive or not available.

Required Updates to Spray Drift Buffers

In addition to the spray drift mitigation measures above, EPA is updating the buffers to water
already on labels. The following revised language reflects current spray drift reduction language
limiting the amount of spray drift that enters waterbodies. These required clarifications will
establish a baseline level of protection for waterbodies against spray drift that is consistent across
all products affected by this interim decision. Reducing the overall amount of spray drift that
reaches waterbodies will reduce the extent of environmental exposure and risk to aquatic
organisms. All pyrethroids labels currently require these buffers to water, except for pyrethrins
and etofenprox products. As mentioned previously, pyrethrins are less persistent than the
synthetic pyrethroids in most environments, and as such they also do not have the monitoring
detects as other chemicals in this group. The Agency is not requiring these spray drift buffers to
water for products containing pyrethrins. However, products containing etofenprox do not
currently contain these spray drift buffers to water and based on the potential risks identified in
the assessment for etofenprox EPA is requiring the addition of these spray drift buffers to those
labels. Required label updates encompass the following statements:

•	"For ground applications, do not apply within 25 feet of aquatic habitats (such as, but not
limited to, lakes, reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial
fish ponds).

•	For non-ultra low volume (ULV) aerial applications, do not apply within 150 feet of
aquatic habitats (such as, but not limited to, lakes, reservoirs, rivers, streams, marshes,
ponds, estuaries, and commercial fish ponds).

•	For ULV aerial applications, do not apply within 450 feet of aquatic habitats (such as, but
not limited to, lakes, reservoirs, rivers, streams, marshes, ponds, estuaries, and
commercial fish ponds)."

Many pyrethroid products are already subject to droplet size restrictions and buffers to water
bodies, so impacts may be limited. As with VFS, impacts could include yield losses in untreated
portions of fields.

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3. Pollinator Risk Mitigation

Although the Agency has identified potential acute risks of concern to bees and other terrestrial
invertebrates from use of the pyrethroids/pyrethrins, risk to invertebrates is expected from use of
insecticides, in general. The potential acute risk to bees is considered along with the benefits of
pyrethroids/pyrethrins in agriculture. Pyrethroids/pyrethrins benefits were assessed in the Usage
Characterization and Qualitative Overview of Agricultural Importance for Pyrethroid
Insecticides for Selected Crops and Impacts of Potential Mitigation for Ecological Risks.

Benefits include the following:

1)	inexpensive, effective, and broad-spectrum pest control,

2)	importance in resistance management programs in rotation with other insecticides,

3)	convenience and ease of use due to short restricted entry intervals,

4)	effective management of key pests in crops such as alfalfa, cotton, corn, wheat, rice,
soybean, sunflower, tree nuts, citrus, blueberries, grapes, and many vegetables.

Alternatives for pyrethroids/pyrethrins, in general, include organophosphates, carbamates and/or
neonicotinoid insecticides. These alternatives have their own risk and resistance issues.

In order to educate pesticide users on the importance of pollinator protection and stewardship,
the Agency has determined that addition of the following labeling elements to
pyrethroids/pyrethrins products formulated for outdoor agricultural use are necessary:

a)	updated pollinator environmental hazards language;

b)	information on pollinator stewardship/best management practices;

c)	information on state managed pollinator protection plans; and

d)	information on pollinator incident reporting.

a. Pollinator Environmental Hazard

EPA has determined that expansion of the existing Pollinator Environmental Hazard language to
include a statement referring the reader to the spray drift management section of the label is
necessary. The revised statement serves to warn users of potential risk to bees and pollinating
insects from outdoor foliar applications to agricultural crops as well as to educate users on the
importance of spray drift management. This language is only required for pyrethroid and
pyrethrins labels with foliar agricultural uses and excludes products formulated for residential
use and Ultra Low Volume (ULV) wide area mosquito control applications, which will be
indicated in the label clarifications column of the label table.

The following sentence is required to be added to the existing Pollinator Environmental Hazard
on the label:

"Protect pollinating insects by following label directions intended to minimize drift and to
reduce risk to these organisms. "

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b. Pollinator Stewardship - Promoting Pollinator Best Management
Practices

In addition to establishing both advisory and compulsory language for product labels, EPA's
registration review process provides an opportunity to inform stakeholders and the general public
about opportunities to minimize potential ecological risks and promote pollinator health more
generally. Beyond the necessary mitigation measures above, voluntary stewardship activities and
use of best management practices (BMPs)5 to protect pollinators can be effective in further
reducing pesticide exposure to non-target organisms. Examples of these activities include:

•	promoting the creation of additional pollinator habitat;

•	improving pesticide users' understanding of and adherence to label directions that advise
users on measures to reduce drift and minimize exposure to pollinators;

•	promoting integrated pest management (IPM) solutions; and

•	increasing awareness of potential impacts of pesticides through education {i.e., training
courses, pamphlets, workshops/conferences, and through television, radio, social media
and other communication platforms).

Habitat loss is a significant issue with negative impacts on the health of bees. With access to a
healthy and diverse diet through a thriving habitat, bees may be better able to tolerate stressors,
such as pests, disease, and exposure to pesticides. As a healthy diet is crucial to maintaining
flourishing pollinator populations, and the protection of pollinator habitat is not something that
can be directly addressed on a pesticide product label, EPA and other federal/state/tribal and
local government agencies and non-government organizations (NGOs) promote pollinator
habitat through active education and outreach programs. Helpful guidance on pollinator
protection can be found on EPA's pollinator protection webpage6.

There are several precautions users can employ to minimize potential exposure to pollinators
while using pyrethroid/pyrethrin products. First, try to avoid applying pyrethroid/pyrethrin
products when bees and other pollinators are actively foraging on pollinator-attractive plants
during bloom. Secondly, consider a pesticide's ability to drift to other non-target areas and be
aware of the presence of bee colonies or highly bee-attractive plants nearby an application site.
Some examples of best management practices (BMPs) to promote pollinator health include:

1.	Applying pesticides in the evening and at night when pollinators are not foraging,

2.	Improved communication between beekeepers and growers,

3.	Identifying and confirming hive locations before spraying,

4.	Maintaining buffers between treated areas and hives or foraging habitat, and

5.	Controlling blooming weeds, such as dandelions, in or near treatment areas.

Other things the public can do to minimize potential exposure of pollinators are listed on EPA's
What You Can Do to Protect Honey Bees and Other Pollinators webpage.7

5	https://www.epa.gov/poHinator-protection/fiiKl-best-management-practices-protect-poHinators

6	https://www.epa.gov/poHinator-protection

7	https://www.epa.gov/poHinator-protection/what-voii-can-do-protect-honev-bees-and-other-poHiiBtors

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The Agency encourages strong pollinator protection stewardship in both the public and private
sector in creating tools and fostering effective communication to help reach applicators and
educate them on practices that can reduce risks to the environment. EPA will continue to work
with its partners at the federal, state, tribal, and local levels, along with non-governmental
organizations to promote pollinator protection, education, and outreach. This includes
coordinating with states and tribes on managed pollinator protection plans (MP3), coordinating
with stakeholders on the implementation of, and education around, existing BMPs, and
continued education and outreach to the public on pollinator protection. This language is only
required for pyrethroid and pyrethrins labels with foliar agricultural uses and excludes products
formulated for residential use and Ultra Low Volume (ULV) wide area mosquito control
applications, which will be indicated in the label clarifications column of the label table.

In order to promote pollinator BMPs, the Agency has determined that adding the following text
to pyrethroid/pyrethrin labels is necessary:

"Following best management practices can help reduce risk to terrestrial pollinators.
Examples of best management practices include applying pesticides in the evening and at
night when pollinators are not foraging and checking to confirm hive locations before
spraying. For additional resources on pollinator best management practices, visit
https://www.epa.gov/pollinator-protection/find-best-management-practices-protect-
pollinators."

c. Promoting State Managed Pollinator Protection Plans (MP3s)

The Agency supports state, tribal, and other local efforts to protect pollinators. EPA has been
working with states and tribes to encourage the development of MP3s. Although MP3s are
voluntary, approximately 80% of states have developed MP3s to promote pollinator protection
efforts. The MP3s are developed through open communication among key stakeholders
(including beekeepers, growers, landowners, pesticide applicators, and pest control operators).
The MP3s vary from state to state according to each state's needs, and represent a more tailored,
localized approach to pollinator protection. EPA engaged with states in the development of
MP3s in order to give states and tribes the flexibility to do the following:

•	adopt a regulatory or voluntary approach;

•	expand protection efforts to address other pesticide-related issues;

•	include other factors impacting pollinator health (such as habitat creation); and

•	expand the scope to address wild bees and other types of pollinators.

In order to promote awareness of MP3s, EPA has determined that adding a statement to
pyrethroid/pyrethrin labels to educate pesticide users on the existence of MP3s and to encourage
users to follow their state plans is necessary. This language is only required for pyrethroid and
pyrethrins labels with foliar agricultural uses and excludes products formulated for residential
use and Ultra Low Volume (ULV) wide area mosquito control applications, which will be
indicated in the label clarifications column of the label table.

The Agency has determined that the following text to pyrethroid/pyrethrin labels is necessary:

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"Managed pollinator protection plans are developed by states/tribes to promote
communication between growers, landowners, farmers, beekeepers, pesticide users, and other
pest management professionals to reduce exposure of bees to pesticides. If available, visit
state plans for additional information on how to protect pollinators."

d. Pollinator Incident Reporting

EPA considers incident reporting data as a line of evidence to inform pesticide regulatory
decisions. Information from these reports can help the Agency identify patterns of bee kills
associated with specific uses and specific pesticides or classes of pesticides. EPA has determined
that adding incident reporting information to pyrethroid/pyrethrin labels to encourage users to
report bee kill incidents to the Agency is necessary. This language is only required for pyrethroid
and pyrethrins labels with foliar agricultural uses and excludes products formulated for
residential use and Ultra Low Volume (ULV) wide area mosquito control applications, which
will be indicated in the label clarifications column of the label table.

The Agency has determined that adding the following text to pyrethroid/pyrethrin labels is
necessary:

"How to Report Bee Kills - It is recommended that users contact both the state lead
agency and the U.S. Environmental Protection Agency to report bee kills due to
pesticide application. Bee kills can be reported to EPA at beekill@epa.eov. To
contact your state lead agency, see the current listing of state pesticide regulatory
agencies at the National Pesticide Information Center's website:
http://npic.orst.edu/reg/state agencies.html."

4. Insecticide Resistance Management

Pesticide resistance occurs when genetic or behavioral changes enable a portion of a pest
population to tolerate or survive what would otherwise be lethal doses of a given pesticide. The
development of such resistance is influenced by several factors. One important factor is the
repeated use of pesticides with the same mode (or mechanism) of action. This practice kills
sensitive pest individuals but allows less susceptible ones in the targeted population to survive
and reproduce, thus increasing in numbers. These individuals will eventually be unaffected by
the repeated pesticide applications and may become a substantial portion of the pest population.
An alternative approach, recommended by resistance management experts as part of integrated
pest management (IPM) programs, is to use pesticides with different chemical modes (or
mechanisms) of action against the same target pest population. This approach may delay and/or
prevent the development of resistance to a particular mode (or mechanism) of action without
resorting to increased rates and frequency of application, possibly prolonging the useful life of
pesticides.

EPA has determined that resistance-management labeling, as listed in Appendix B, for products
containing fenpropathrin is necessary in order to provide pesticide users with easy access to
important information to help end users delay or even avoid the development of resistance and

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maintain the effectiveness of useful pesticides. Additional information on EPA's guidance for
resistance management can be found at the following website: https://www.epa.gov/pesticide-

registration/prn- idance-pesticide-registrants-pesticide-resistance-management.

B. Tolerance Actions

The Agency is proposing that fenpropathrin tolerances established in 40 CFR §180.466 need to
be updated to reflect appropriate commodity definitions. Also, tolerances for certain
commodities should be harmonized with the corresponding Codex MRLs. Refer to Section
III. A 3 for details. The Agency will use its FFDCA rulemaking authority to make the needed
changes to the tolerances.

C. Interim Registration Review Decision

In accordance with 40 CFR §§ 155.56 and 155.58, the Agency is issuing this ID. Except for the
Endocrine Disruptor Screening Program (EDSP) and the Endangered Species Act (ESA)
components of this case, the Agency has made the following interim decision: (1) additional
pollinator data are required at this time; and (2) changes to the affected registrations and their
labeling are needed at this time, as described in Section IV. A and Appendices A and B of this
document as well as the Pyrethroids and Pyrethrins Revised Ecological Risk Mitigation and
Response to Comments on the Ecological Risk Mitigation Proposal For 23 Chemicals (EPA-HQ-
OPP-2008-0331).

In this ID, the Agency is making no human health or environmental safety findings associated
with the EDSP screening of fenpropathrin, nor is it making a complete endangered species
finding. Although the Agency is not making a complete endangered species finding at this time,
the necessary mitigation described in this document is expected to reduce the extent of
environmental exposure and may reduce risk to listed species whose range and/or critical habitat
co-occur with the use of fenpropathrin. The Agency's final registration review decision for
fenpropathrin will be dependent upon the result of the Agency's ESA assessment and any needed
§ 7 consultation with the Services, and an EDSP FFDCA § 408(p) determination.

D. Data Requirements

EPA has determined that pollinator data listed under Section III.B is necessary and will issue a
DCI for the data.

V. NEXT STEPS AND TIMELINE
A. Interim Registration Review Decision

A Federal Register Notice will announce the availability of this interim decision for
fenpropathrin. A final decision on the fenpropathrin registration review case will occur after: (1)

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an EDSP FFDCA § 408(p) determination and (2) an endangered species determination under the
ESA and any needed § 7 consultation with the Services.

B. Implementation of Mitigation Measures

Once the Interim Registration Review Decision is issued, the fenpropathrin registrants must
submit amended labels that include the label changes described in Appendices A and B. The
revised labels and requests for amendment of registrations must be submitted to the Agency for
review within 120 days following issuance of the Interim Registration Review Decision.

Registrants must submit a cover letter, a completed Application for Registration (EPA form
8570-1) and electronic copies of the amended product labels. Two copies for each label must be
submitted, a clean copy and an annotated copy with changes. In order for the application to be
processed, registrants must include the following statement on the Application for Registration
(EPA form 8570-1):

"I certify that this amendment satisfies the requirements of the Fenpropathrin Interim
Registration Review Decision and EPA regulations at 40 CFR Section 152.44, and no other
changes have been made to the labeling of this product. I understand that it is a violation of 18
U.S.C. Section 1001 to willfully make any false statement to EPA. I further understand that if
this amendment is found not to satisfy the requirements of the Fenpropathrin Interim
Registration Review Decision and 40 CFR Section 152.44, this product may be in violation of
FIFRA and may be subject to regulatory and/or enforcement action and penalties under FIFRA."

Within the required timeframe, registrants must submit the required documents to the Re-
evaluation section of EPA's Pesticide Submission Portal (PSP), which can be accessed through
EPA's Central Data Exchange (CDX) using the following link: https://cdx.epa.gov/. Registrants
may instead send paper copies of their amended product labels, with an application for a fast-
track, Agency-initiated non-PRIA label amendment to Robert Little at one of the following
addresses, so long as the labels and application are submitted within the required timeframe:

VIA US Mail
USEPA Office of Pesticide Programs
Pesticide Re-evaluation Division
Mail Code 7508P
1200 Pennsylvania Ave NW
Washington, DC 20460-0001

VIA Courier
Pesticide Re-evaluation Division
c/o Front End Processing
Room S-4910, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202-4501

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Appendix A: Summary of Required Actions for Fenpropathrin

Affected
Population s)

Source of Exposure

Route of Exposure

Duration of

Exposure

Potential Risk(s) of
Concern

Actions

Aquatic

invertebrates

•	Water (non-dietary)

•	Residues (at/on site
of treatment)

•	Contact

•	Ingestion

•	Acute

•	Sub-chronic

•	Chronic

•	Growth

•	Mortality

•	Label clarity and consistency

•	Advisory storage and disposal statements

•	Reduced perimeter treatments

•	Defined spot treatment size

•	Rain statements

•	Buffers to water bodies

•	Spray drift management language

•	Precautionary statements

•	Increased width of vegetative filter strips

Fish

• Water (non-dietary)

Residues (at/on site
of treatment)

•	Contact

•	Ingestion

•	Acute

•	Sub-chronic

•	Chronic

•	Growth

•	Mortality

•	label clarity and consistency

•	Advisory storage and disposal statements

•	Reduced perimeter treatments

•	Defined spot treatment size

•	Rain statements

•	Buffers to water bodies

•	Spray drift management language

•	Precautionary statements

•	Increased width of vegetative filter strips

Pollinators

• Residues (at on site
of treatment)

•	Contact

•	Ingestion

• Acute

• Mortality

•	Stewardship information

•	Incident reporting information

•	Pollinator data requirements

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Appendix B: Required Labeling Changes for Fenpropathrin Products

lh'MTipliotl

RtM|ith r(l I .:i!>d l«»r lenpropathiin End I se ProthuK

Phitcnu'tU oil I :tbt!



All Fenpropathrin End Use Products (unless specified)



Mode of Action Group
Number

Applies only to products with
agricultural and/or wide-area
mosquito uses

Note to registrant:

•	Include the name of the ACTIVE INGREDIENT in the first column

•	Include the word GROUP" in the second column

•	Include the MODE/MECHANISM/SITE OF ACTION CODE in the third column

(for fungicides this is the FRAC Code, and for insecticides this is the Primary Site of

Action: for Herbicides this is SITE OF ACTION)

Include the type of pesticide (i.e., INSECTICIDE) in the fourth column.

Front Panel, upper right quadrant.

All text should be black, bold face
and all caps ou a white
background, except the mode of
action code, which should be
white, bold face and all caps on a
black background; all text and
columns should be surrounded by
a black rectangle.



Fenpropathrin

GROUP INSECTICIDE









Resistance management
labeling statements for

insecticides

Applies only to products with
agricultural and/or wide-area
mosquito uses

(

iicltide resistance management label language for in.secticides/acaricides from PRN 2017-1
httos://www.eoa.eov/Desticide-reaistration/Desticide-reaistration-notices-vear')



Directions for Use, prior to
directions for specific crops



Additional Required

Labeling Action. Applies to
all products delivered via
liquid spray applications
(except those with mosquito
adulticide use)

Remove information about volumetric mean diameter from all labels delivered via liauid
spra\ application, except from products with mosquito adulticide use, where such

information currently appears.

Directions for Use

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r.nd-uvi' products with outdoor. urh:m. non-iiurii uses

For all products that lave
outdoor uses only

Add the following language;
"For outdoor use only."

Front Label Panel and/or
Directions for Use

Buffer from Wafer
Statement

"For soil or foliar applications, do not apply by ground within 25 feet of lakes, reservoirs, rivers,
permanent streams, marshes or natural ponds, estuaries and commercial fish farm ponds."

Directions for Use

Wafer Protection
Statements

"Do not spray the product into fish pools, ponds, streams, or lakes. Do not apply directly to sewers or
storm drains, or to any area like a drain or gutter where drainage to sewers, storm drains, water
bodies, or aquatic habitat can occur."

"Do not allow the product to enter any drain during or after application."

Directions for Use

Rain Related Statements
(except for products that
require watering in)

"Do not make applications during rain. Avoid making applications when rainfall is expected before
the product lias sufficient time to dry (minimum 4 hours)."

"Rainfall within 24 hours after application may cause unintended runoff of pesticide application."

Directions for Use

Spray drift management
for commercial nurseries

For outdoor applications to commercial nurseries:

•	"Do not apply when the wind speed is greater than 15 rnph."

•	"Applicators are required to select the nozzle and pressure that deliver a medium or coarser
droplet size {ASABE S572)."

•	"For soil or foliar applications, do not apply by ground equipment within 25 feet of lakes,
reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries and commercial fish
farm ponds "

Directions for Use

Ind-use products with :t;jhcultur:i! uses

Enforceable Spray Drift
Management Language

O 5S

for products that allow

aerial applications

Aerial Applications:

•	Do not release spray at a height greater than 10 feet above the vegetative canopy, unless a
greater application height is necessary for pilot safety.

•	Applicators are required to select the nozzle and pressure that deliver a medium or coarser
droplet size (ASABE S641).

Directions for Use, in a box titled

"Mandatory Spray Drift
Management" under the heading

"Aerial Applications"
Placement for these statements
should be in general directions

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• Do not apply when wind speeds exceed 15 mph at the application site. If the wind speed is
greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed wing
aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom length
must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of the rotor
diameter for helicopters.

• If the windspeed is 10 miles per hour or less, applicators must use 'A swath displacement
upwind at the downwind edge of the field. When the windspeed is between 11-15 miles per
hour, applicators must use % swath displacement upwind at the downwind edge of the field.

• Do not apply during temperature inversions.

for use, before the use-specific
directions for use.

Enforceable Spray Drift
Management Language

Airblast Applications:

• Sprays must be directed into the canopy.

• Do not apply when wind speeds exceed 15 mph at the application site.

• User must turn off outward pointing nozzles at row ends and when spraying outer row.

• Do not apply during temperature inversions.

Directions for Use, in a box titled
"Mandatory Spray Drift
Management" under the heading
"Airblast Applications"

Enforceable Spray Drift
Management Language

for products that allow
ground boom applications

Ground Boom Applications:

User must only apply with the nozzle height recommended by the manufacturer, but no more
than 4 feet above the ground or crop canopy.

Applicators are required to select the nozzle and pressure that deliver a medium or coarser
droplet size (ASABE S572).

Do not apply when wind speeds exceed 15 mph at the application site.

Do not apply during temperature inversions.

Directions for Use, in a box titled
"Mandatory Spray Drift
Management" under the heading
"Ground Boom Applications"

Advisory Spray Drift
Management Language

for all products that allow
aerial and ground boom
uses

THE APPLICATOR IS RESPONSIBLE FOR AVOIDING OFF-SITE SPRAY DRIFT.
BE AWARE OF NEARBY NON-TARGET SITES AND ENVIRONMENTAL CONDITIONS.

IMPORTANCE OF DROPLET SIZE

An effective way to reduce spray drift is to apply large droplets. Use the largest droplets that
provide target pest control. While applying larger droplets will reduce spray drift, the potential
for drift will be greater if applications are made improperly or under unfavorable environmental
conditions.

Controlling Droplet Size - Ground Boom

Volume - Increasing the spray volume so that larger droplets are produced will reduce spray
drift. Use the highest practical spray volume for the application. If a greater spray volume is
needed, consider using a nozzle with a higher flow rate.

Directions for Use, just below the
Spray Drift box, under the
heading "Spray Drift Advisories"

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Pressure - Use the lowest spray pressure recommended for the nozzle to produce the target
spray volume and droplet size.

Spray Nozzle - Use a spray nozzle that is designed for the intended application. Consider
using nozzles designed to reduce drift.

Controlling Droplet Size - Aircraft

Adjust Nozzles - Follow nozzle manufacturers recommendations for setting up nozzles.
Generally, to reduce fine droplets, nozzles should be oriented parallel with the airflow in
flight.

BOOM HEIGHT - Ground Boom

For ground equipment, the boom should remain level with the crop and have minimal
bounce.

RELEASE HEIGHT - Aircraft

• Higher release heights increase the potential for spray drift.

SHIELDED SPRAYERS

Shielding the boom or individual nozzles can reduce spray drift. Consider using shielded
sprayers. Verify that the shields are not interfering with the uniform deposition of the spray
on the target area.

TEMPERATURE AND HUMIDITY

When making applications in hot and dry conditions, use larger droplets to reduce effects of
evaporation.

TEMPERATURE INVERSIONS

Drift potential is high during a temperature inversion. Temperature inversions are
characterized by increasing temperature with altitude and are common on nights with limited
cloud cover and light to no wind. The presence of an inversion can be indicated by ground
fog or by the movement of smoke from a ground source or an aircraft smoke generator.
Smoke that layers and moves laterally in a concentrated cloud (under low wind conditions)
indicates an inversion, while smoke that moves upward and rapidly dissipates indicates good
vertical air mixing. Avoid applications during temperature inversions.

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WIND

Drift potential generally increases with wind speed. AVOID APPLICATIONS DURING
GUSTY WIND CONDITIONS.

Applicators need to be familiar with local wind patterns and terrain that could affect spray
drift.

NON-TARGET ORGANISM ADVISORY STATEMENT (Environmental Hazards):

This product is highly toxic to bees and other pollinating insects exposed to direct treatment
or to residues in/on blooming crops or weeds. Protect pollinating insects by following label
directions intended to minimize drift and reduce pesticide risk to these organisms.

Advisory Spray Drift
Management Language for

all products that allow liquid
applications with handheld
technologies

"SPRAY DRIFT ADVISORIES
Handheld Technology ADDlications:

• Take precautions to minimize spray drift."

Directions for Use, just below the
Spray Drift box, under the
heading "Spray Drift Advisories"

Vegetative Filter Strips
Note: This requirement is
separate and in addition to
buffer zones to aquatic
areas, which are still
required if a vegetated filter
strip is present.

"VEGETATIVE FILTER STRIPS

Construct and maintain a vegetative filter strip, according to the width specified below, of grass or
other permanent vegetation between the field edge and nearby down gradient aquatic habitat (such
as, but not limited to, lakes; reservoirs; rivers; streams; marshes or natural ponds; estuaries; and
commercial fish farm ponds).

Only apply products containing fenpropathrin onto fields where a maintained vegetative filter strip of
at least 25 feet exists between the field edge and where a down gradient aquatic habitat exists. This
minimum required width of 25 feet may be reduced or removed under the following conditions:

• For Western irrigated agriculture, a maintained vegetative filter strip of at least 10 feet wide is
required. Western irrigated agriculture is defined as irrigated farmland in the following states:
WA, OR, CA, ID, NV, UT, AZ, MT, WY, CO, NM, and TX (west of 1-35).

o For Western irrigated agriculture, if a sediment control basin is present, a vegetative
filter strip is not required.

• In all other areas, a vegetative filter strip with a minimum width of 25 feet is required, unless the
following conditions are met. The vegetative filter strip requirement may be reduced from 25
feet to 15 feet if at least one of the following applies:

o The area of application is considered prime farmland (as defined in 7 CFR § 657.5).

Directions for Use

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Docket Number EPA-HQ-OPP-2010-0422
www.regulations.gov



o Conservation tillage is being implemented on the area of application. Conservation
tillage is defined as any system that leaves at least 30% of the soil surface covered by
residue after planting. Conservation tillage practices can include mulch-till, no-till, or
strip-till.

o A functional terrace system is maintained on the area of application,
o Water and sediment control basins for the area of application are functional and
maintained.

o The area of application is less than or equal to 10 acres.

For further guidance on vegetated filter strips, refer to the following publication for information on
constructing and maintaining effective buffers: Conservation Buffers to Reduce Pesticide Losses.
Natural Resources Conservation Services. httDs://www.regulations.gov/docurnent?D=EPA-HO-OPP-



2008-03

Buffer Zones to Water
Bodies

Ground Application

"Do not apply within 25 feet of aquatic habitats (such as, but not limited to, lakes, reservoirs,
rivers, streams, marshes, ponds, estuaries, and commercial fish ponds). "

Ultra Low Volume (ULV) Aerial Application

"Do not apply within 450 feet of aquatic habitats (such as, but not limited to, lakes,
reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial fish ponds).
Applications made by mosquito control districts and other public health officials are exempt
from this requirement."

Non-ULV Aerial Application

"Do not apply within 150 feet of aquatic habitats (such as, but not limited to, lakes,
reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial fish ponds)."

Directions for Use

New text to include under
Environmental Hazard
statements:

(For liquid products
formulated for outdoor foliar
applications to agricultural
row crops.)

Update the Environmental Hazard with the bolded statement:

"This product is highly toxic to bees exposed to direct treatment or residues on blooming crops or
weeds. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting
the treatment area. Protect pollinating insects by following label directions intended to minimize
drift and to reduce risk to these organisms."

Environmental Hazard

36

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Docket Number EPA-HQ-OPP-2010-0422
www.regulations.gov

Excludes products formulated
for residential use and Ultra
Low Volume (IJLV) wide area
mosquito control applications





Link to pollinator best
management practices (For
liquid products formulated for
outdoor foliar applications to
agricultural row crops.)

Excludes products formulated
for residential use and Ultra
Low Volume (ULV) wide area
mosquito control applications

"Following best management practices can help reduce risk to terrestrial pollinators. Examples of
best management practices include applying pesticides in the evening and at night when pollinators
are not foraging and checking to confirm hive locations before spraying. For additional resources on
pollinator best management practices, visit httDs://www.eDa.gov/Dollinator-Drotection/find-best-

manaeement-Dractices-Drotect-Dollinators."

Directions for Use, prior to
crop specific directions

Information on state
managed pollinator
protection plans (For liquid
products formulated for
outdoor foliar applications to
agricultural row crops.)

Excludes products formulated
for residential use and Ultra
Low Volume (ULV) wide area
mosquito control applications

"Managed pollinator protection plans are developed by states/tribes to promote communication
between growers, landowners, farmers, beekeepers, pesticide users, and other pest management
professionals to reduce exposure of bees to pesticides. If available, visit state plans for additional
information on how to protect pollinators."

Directions for Use, prior to
crop specific directions

Information on how to
report bee incidents (For
liquid products formulated for
outdoor foliar applications to
agricultural row crops.)

Excludes products formulated
for residential use and Ultra
Low Volume (ULV) wide area
mosquito control applications

"How to Report Bee Kills

It is recommended that users contact both the state lead agency and the U.S. Environmental
Protection Agency to report bee kills due to pesticide application. Bee kills can be reported to EPA
at beekill®.eoa.eov. To contact vour state lead aaencv. see the current listing of state pesticide
regulatory agencies at the National Pesticide Information Center's website:
htto://nDic.orst.edu/ree/state agencies.html."

Directions for Use, prior to
crop specific directions

37

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