I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of flufenpyr

- ethyl . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the flufenpyr

- ethyl registration review docket (EPA

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- ethyl is a contact herbicide currently registered for the p ost

- emergence control of broadleaf weed species, and is a light

dependent peroxidizing herbicide (LDPH). This class of herbicides is known to have a photo

toxic mode of action in plants and possibly in animals. LDPHs may be more toxic to plants and aquatic animals when exposed to natural sunlight, such as exposure conditions in the field. Flufenpyr

- ethyl is formulated as a water dispersible granular. Application equipment and methods for flufenpyr

- ethyl include ground application, soil band treatment, soil broadcast, direct spray, and aerial application. Flufenpyr

- ethyl is registered for use on field corn, soybeans, and sugarcane. There are no registered residential uses for any flufenpyr

- ethyl product.

The Agency is implementing the registration review pro gram pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science, p ublic policy, and pesticide use practices occur over time. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory s tandard. The public phase of registration review begins when the initial docket is opened for each case. Informatio n on this program is provided on the Agency’s website

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The FWP begins with any updates since the PWP was issued. Next is a summary of subs tantive
comments received during the public comment period for the PWP concerning anticipated data needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for flufenpyr

- ethyl

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

After the PWP was issued, the Agency received a formal request from Valent U.S.A. Corporation , the sole registrant, requesting voluntary cancellation of all existing registrations for products containing the active ingredient flufenpyr

- ethyl. In the near future, the Agency intends to announce receipt of this request in a Federal Register Notice and take comment for a 30

- day period. If the Agency does not receive any substantive comments during this period, EPA will grant the request for voluntary cancella tion in a subsequent cancellation order.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Flufenpyr

- ethyl Preliminary Work Plan , which opened on December 19, 2014 and closed on February 17, 2015 , the Agency receive d two public
comments. Comments were submitted by the FIFRA Endangered Species Task Force and the

1 http://www.epa.gov/oppsrrd1/registration_review/

2Center for Biological Diversity. The comments do not address the timeline described in the PWP, but they do address the planned ecological risk assessments. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns, and trade irritants, but no comments or information were received on those issues.

Summarized below are public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public comments and EPA responses in their entirety are located in the docket , EPA

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. Comments submitted by th e Center for Biological Diversity (CBD), in EPA

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1. Comment: The Center for Biological Diversity’s (CBD) comments focus on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of flufenpyr

- ethyl in accordance with the Endangered Species Act (ESA). CBD mentions various aspects of the risk assessment process, including use of the best available data to develop endangered species risk

asses sments, and evaluation of effects on endangered and threatened species and their designated critical habitat. CBD also expressed concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of flufenpyr

- ethyl on endangered and threatened (listed) species and their designated critical habitat for the flufenpyr

- ethyl registration review.

Response: EPA has reviewed the comments from CBD on the registration review docket opening for flufenpyr

- ethyl and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address c oncerns specific to flufenpyr

- ethyl in connection with the development of its final registration review decision for this pesticide.

In November 2013, EPA, along with the Services and USDA, released a summary of their joint interim approaches for assessi ng risks to endangered and threatened (listed) species from pesticides. The interim approaches were developed jointly by the agencies in response to the NAS recommendations and reflect a common approach to risk assessment shared by the agencies as a way o f addressing scientific differences between the EPA and the Services. The NAS report 2 outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in

c onnection with their obligations under the ESA and FIFRA.

The joint interim approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint interim approaches at the December 2013 Pesticide Pr ogram Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group ( SFIREG) meetings. The agencies also held stakeholder workshops in April and October 2014, allowing additional opportunities for stakeholders to

2 http://www.nap.edu/catalog.php?record_id=18344

3comment on the interim app roaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing the interim approaches, the agencies will also consider public comments on the interim approaches in connection with the d evelopment of upcoming registration review decisions. The details of the joint interim approaches are contained in the white paper, Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the Nati onal Academy of Sciences April 2013 Report 3 , dated November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the interim approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting th is FWP for flufenpyr

- ethyl does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem formulation document for flufenpyr

- ethyl , EPA described the screening

- level risk assessment to determine the potential effects of flufenpyr

- ethyl on all taxa of non

- target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity of the application of flufenpyr

- ethyl

. This screening

- level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

- level risk assessment for the registration review of flufenpyr

- ethyl will describe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for flufenpyr

- ethyl as part of completing this registration review.

Comments submitted by FIFRA Endangered Species Task Force (FESTF), in EPA

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1. Comment: The technical registrant for flufenp yr

- ethyl , as identified on the fact sheet included in the PWP, is Valent U.S.A. Corporation , which is a FESTF member and is entitled to rely on FESTF data.

Response: EPA appreciates FESTF’s comments and will consider this information during the registrat ion review of flufenpyr

- ethyl

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3 http://www.epa.gov/espp/2013/nas.html

4PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for flufenpyr

- ethyl based on the Registration Review

– Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments for Flufenpyr

- ethyl and Flufenpyr

- ethyl. Human Health Assessment Scoping Document and Preliminary Human Health Risk Assessment in Support of Registration Review

. The planned data needs have not changed from what was included in the PWP

.

Table 1: Planned D ata Needs for the Flufenpyr

- ethyl Registration Review

Guideline Number 4 Study Title 2 Test Material Estimated Timeframe (Months from receipt of DCI)

Non

Guideline Honey bee adult acute oral toxicity TGAI 12

Non

Guideline Honey bee adult chronic oral toxicity TGAI 12

Non

Guideline Honey bee larval acute oral toxicity TGAI 12

Non

Guideline Honey bee larval chronic oral toxicity TGAI 12

Non

Guideline Semi

- field testing for pollinators TEP or TGAI 24

Non

Guideline Field trial of residues in pollen and nectar TEP 24

850.3040 Field testing for pollinators TEP 24 TGAI = technical grade active ingredient; TEP = typical end

- use product ;

4 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850

– Ecological Effects Tests

– including renumbering and other designations or chang es for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!docume ntDetail;D=EPA

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5RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent ecological and environmental fate risk assessment was completed in 2003 when flufenpyr

- ethyl was registered as a new chemical with EPA . A comprehensive human health risk assessment for flufenpyr

- ethyl was completed on November 26, 2014, prior to which the most recent human health risk assessment was completed in 2003 for flufenpyr

- ethyl’s initial registration. Findings and conclusions from these risk assessments are summarized in the Registration Review

– Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments for Flufe npyr

- ethyl and Flufenpyr

- ethyl. Human Health Assessment Scoping Document and Preliminary Human Health Risk Assessment in Support of Registration Review

. During registration review, the Agency will conduct a revised aquatic animal risk assessment, a risk a ssessment for pollinators, and an endangered species assessment for all uses of flufenpyr

ethyl. If toxicological endpoints or points of departure are revised based on the data that are planned to be required for registration review, they will be consider ed in the new assessment, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

Table 2 below summarizes the recently completed draft human health risk assessment and the planned ecological and environmental fate ris k assessment for registration review

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6Table 2: Planned Ecological and Environmental Fate Risk Assessments and Summary of Draft Human Health Risk Assessment for the Flufenpyr

- ethyl Registration Review Type of Risk Assessment Conduct ? Notes
Eco logical and Environmental Fate Ecological risk assessment for aquatic organisms, pollinators, and an endangered species biological evaluation Y

Incidents Will check for updates There are no reported ecological incidents for flufenpyr

- ethyl. Human Health Dietary Food Y An updated chronic dietary (food and drinking water) exposure and risk assessment was conducted. The chronic dietary exposure estimates were below the Agency’s level of concern (LOC) for the general U.S. population and all population subgroups. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y An updated occupational exposure assessment for flufenpyr

- ethyl was conducted for mixers/loaders, applicators, and flaggers for aerial and groundboom applications. Inhalation risk estimates were not of concern. EPA assessed only inhalation exposures since a dermal hazard was not identified. Post

- application N The Agency did not assess post

- application dermal exposures since a dermal hazard was not identified. P ost

- application inhalation exposure s were not assessed either as the handler inhalation exposure estimates are expected to be protective of most occupational post

- application inhalation exposure scenarios. Residential Handlers N There are no proposed or registered products containing flufenpyr

- ethyl that would result in residential handler exposure as there are no registered residential uses. Therefore, a conventional residential exposure assessment was not performed. However, a quantitative spray drift assessment was conducted and risk estimates from ground boom and aerial applications are not of concern. Post

- application Y

7Other Aggregate Y As there are no registered residential uses, the aggregate risk assessment is equivalent to the chronic dietary assessment. The chronic aggregate (food + drinking water) exposure and risk estimates did not exceed the Agency’s LOC. Cumulative N EPA has not made a common mechanism of toxicity finding as to flufenpyr

- ethyl and any oth er substances and flufenpyr

- ethyl does not appear to produce a toxic metabolite produced by other substances. Therefore, EPA has assumed that flufenpyr

- ethyl does not have a common mechanism of toxicity with other substances. Tolerances Y The tolerance ex pression for flufenpyr

- ethyl was reviewed and recommendations for updates were made on page 7 of Flufenpyr

- ethyl. Human Health Assessment Scoping Document and Preliminary Human Health Risk Assessment in Support of Registration Review. Incidents Will check for updates There were no incidents involving flufenpyr

- ethyl reported to either OPP Incident Data System (IDS) or Sentinel Event Notification System for Occupational Risk (SENSOR)

- Pesticides for the time period from 1998 to 2010.

TIMELINE

EPA has crea ted the following estimated timeline for the completion of the flufenpyr

- ethyl registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Projected Flufenpyr

- ethyl Registration Review Timeline
Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period December 2014

– Completed Close Public Comment February 2015

– Completed Case Development Final Work Plan May 2015

– Completed Issue DCI 2015 July

– Sept. Data Submission 2017 July

– Sept. 60

- day Public Comment Period for Draft Risk Assessments 5 2019 Jan.

- March

5 The regulations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pest icides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.

8Table 3: Projected Flufenpyr

- ethyl Registration Review Timeline
Activities Estimated Date Registration Review Decision 60

- day Public Comment Period for Proposed Registration Review D ecision 2019 Oct.

– Dec.

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2020 Total ( years ) 6

NEXT STEPS

As noted previously, EPA intends to issu e in the Federal Register a notice of receipt of request to voluntar il y cancel all existing registrations for products containing the active ingredient flufenpyr

- ethyl. T he Agency will take comment on this request for a 30

- day period. If the Agency does not receive any substantive comments during this period, EPA will gran t the request for voluntary cancellation in a subsequent cancellation order. Should the request not be granted

, the Agency plans to continue with the registration review of flufenpyr

- ethyl and require several ecological effects studies through a D ata C all

- I n Notice , expected to be issued in 2015

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