2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) final work plan (FWP) for the registration review of pyraflufen-ethyl. This work plan addresses public comments received on the preliminary work plan (PWP), which was posted in th e pyraflufen-ethyl registration review docket (EPA-HQ-OPP-2014-0415). Pyraflufen-eth yl is a contact type herbicide registered

for use as a defoliant in cotton a nd as a desiccant in potatoes to facilitate harvesting. Pyraflufenethyl is also registered for use as a pre-plant burn-down, on plants before crop emergence, and as a post-emergence treatment depending on the crop and stage of crop growth.

The Agency is implementing the registration revi ew program 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 th e FIFRA standard for registration. Changes in scienc e, public policy, and pesticide us e practices occur over time. The registration review program is intended to make su re that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard. The public phase of registration review begins wh en the initial docket is opened for each case. Information on this program is provided on the Agency’s website. 1

The FWP begins with any updates since the PWP wa s issued. Next is a summary of substantive comments received during the public comment peri od 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 responses to those comme nts. This section is followed by registration review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline for pyraflufen-ethyl. Lastly, there is a disc ussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

At the May 5, 2014 focus meeting for pyraflufen-eh tyl, Nichino America, the sole technical registrant, committed to clarify label language, where appropriate, and to provide additional information to inform the Agency’s assessment of this active ingredient. Nichino has recently submitted multiple fate and ecotoxicity studies for the E-2 and E-3 degradates of pyraflufenethyl, which the Agency is in the process of reviewing. Additional detail on the Focus Meeting can be found in the pyraflufen-et hyl registration review docket, Pyraflufen-ethyl: Focus Meeting

with Nichino America Notes.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the pyraflufen-ethyl PWP, which opened on June 25, 2014, and closed on August 25, 2014, the Agency received two public comments. Comments were submitted by the FIFRA Endangered Species Task Force and the Center for Biological Diversity. The comments do not addre ss the timeline described in the PWP, but they do address the planned ecological an d human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the sp ecific topics of environmental justice, water

1 http://www.epa.gov/oppsrrd1/registration_review/3 quality concerns, and trade irri tants, but no comments or info rmation were received on those

issues.

Summarized below are public comments that resu lted in changes to the anticipated registration review data needs, risk assessmen ts, or timeline, or are of a br oader regulatory nature. Public comments and EPA responses in their entirety are located in the docket, EPA-HQ-OPP-2014-

0415.

Comments submitted by the Center for Biol ogical Diversity (CBD), in EPA-HQ-OPP-2014-

0415-0011.

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 Natio nal Marine Fisheries Service (the Services) on the registration review of pyraflufen-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 assessments, 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 determina tions regarding the effects of pyraflufen-ethyl on endangered and threatened (listed) species and their designat ed critical habitat fo r the pyraflufen-ethyl registration review.

Response: EPA has reviewed the comments fr om CBD on the registration review docket opening for pyraflufen-ethyl and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risk s of pesticides to list ed species based on the recommendations of the April 2013 National Acad emy of Sciences (NAS) report. EPA will address concerns specific to pyraflufen-ethyl in connection with the development of its final registration review deci sion for this pesticide.

In November 2013, EPA, along with the Services and USDA, released a summary of their joint interim approaches for assessing risks to endangered and threatened (listed) species from pesticides. The interim approach es were developed jointly by th e agencies in response to the NAS recommendations and reflect a common ap proach to risk assessment shared by the agencies as a way of 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 connection 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 presen ted the joint interim approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agenci es also held stakeholder workshops in April and October 2014, allowing additional opportunities for stakeholders to comment on the interim approaches. Add itional workshops are planned to enhance stakeholder involvement. As part of a phase d, iterative process for developing the interim

2 http://www.nap.edu/catalog.php?record_id=183444 approaches, the agencies will also consider public comments on the interim approaches in connection with the development of upcoming regi stration review decisions. The details of the joint interim approaches are contained in the white paper, Interim Approaches for National-Level Pesticide Endangered Sp ecies Act Assessments Based on the Recommendations of the National Acade my of Sciences April 2013 Report 3 , dated November 1, 2013.

Given that the agencies are continuing to de velop and work toward implementation of the interim approaches to assess the potential risk s of pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this FWP for pyraflufen-ethyl does not describe the specific ESA analysis, incl uding effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem formulati on document for pyraflufen-ethyl, EPA described the screening-level risk assessment to determin e the potential effects of pyraflufen-ethyl on all taxa of non-target wildlife and plants, whic h will assume that listed species and their designated critical habitats may be present in the vicinity of the a pplication of pyraflufenethyl. This screening-level assessment will allo w EPA to focus its future evaluations on the types of species where the potential for eff ects exists once the scie ntific methods being developed by the agencies have been fully vett ed. While the agencies continue to develop a common method for ESA analysis, the planned screening-level risk assessment for the registration review of pyraflufen-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 desi gnated critical habitats, these methods will be applied to subsequent analyses for pyraflufen-ethyl as part of completing this registration

review.

Comments submitted by FIFRA Endangered Species Task Force (FESTF), in EPA-HQOPP-2014-0415-0012.

1. Comment: The technical registrant for pyraflufen-e thyl, as identified on the fact sheet included in the PWP, is Nichino America, Inc., 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

registration review of pyraflufen-ethyl.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for pyraflufen-ethyl based on the EFED Registration Review Problem Formulation for Pyraflufen-ethyl and Pyraflufen-Ethyl. Human Health Assessment Scoping Document in Support of Registration Review . The planned data needs have not changed from wh at was included in the PWP.

3 http://www.epa.gov/espp/2013/nas.html5 Table 1: Planned Data Needs for the Pyraflufen-ethyl Registration Review

Guideline

Number 4 Study Title 2 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Planned Data Needs for the Parent Pyraflufen-ethyl

850.6100 Environmental chemistry methods and associated independent laboratory validations for soil, sediment, and water TGAI 12

860.1650 Submittal of Analytical Reference Standards TGAI Currently

needed 5

860.1300 Nature of the Residue – Orange 6 TGAI 6
Planned Data Needs for the Degradates E-1, E-2, E-3, and E-15

850.6100 Environmental chemistry methods and associated independent laboratory validations for soil, sediment, and water Degradate E-1, E-2, and E-3 12

860.1650 Submittal of Analytical Reference Standards E-15

Metabolite Currently

needed 3

TGAI = technical grade active ingredient

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species a ssessment, for all uses of pyraf lufen-ethyl. For human health, EPA will conduct revised dietary, residential, aggregate, and occupational risk assessments during registration review. If t oxicological endpoints or points of departure are revised based on the data that are required for registration review, they will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions.

Table 2 below summarizes the planned registrati on review risk assessments based on the EFED problem formulation and HED scoping document. The planned assessments have not changed

from what was included in the PWP.

4 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

5 Previous reference standards have expired and new ones are currently needed.

6 Information needs to be submitted on sample storage conditions and durations for samples analyzed in the orange plant metabolism study (MRID 47872706).6 Table 2: Planned Risk Assessm ents for the Pyraflufen-ethyl Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y Chronic estimated drinki ng water concentrations (EDWCs) will be determined by modeling the total toxic residues of parent and the E-1, E-2, and E-3 degradates, noting that exposure will be mainly associated with E-3 as it is the most persistent degradate.

Incidents Will check for updates For a discussion of reporte d ecological incidents for pyraflufen-ethyl, see page 25 of the problem

formulation.

Human Health Dietary Food Y A new dietary exposure and risk assessment will be needed during registration review to incorporate updated EDWCs into the chronic and cancer dietary
exposure assessments. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y Occupational uses are expected to result in both shortand intermediate-term exposures. An updated occupational assessment will be needed to account for changes in occupational a ssessment policies (e.g., unit exposures and transfer coe fficients) and to evaluate the maximum registered si ngle application rate for

each use site. Post-application Y

Residential Handlers Y The agency will be considering volatilization exposure, as well as the potential for exposure from spray drift as part of th e residential assessment. Post-application Y

Other Aggregate Y Evaluates the comb ined risk from dietary and residential exposures. Cumulative N/A Pyraflufen-ethyl is not a member of a cumulative

group. Tolerances Y The Agency anticipat es updating tolerances to include parent and metabolites E-1 and E-9 for livestock

commodities.

Incidents Will check for updates Due to low frequency and severity of incident cases reported for pyraflufen-ethyl, there does not appear to

be a concern at this time . For further discussion of reported human incidents for pyraflufen-ethyl, see page 10 of the Scoping Document and the Revised: Pyraflufen-ethyl: Tier I R eview of Human Incidents

.7 TIMELINE

EPA has created the following estimated timelin e for the completion of the pyraflufen-ethyl registration review in Table 3 below. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Pyrafluf en-ethyl – Projected Registration Review
Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period June 2014 – Completed Close Public Comment Aug. 2014 – Completed Case Development Final Work Plan Nov. 2014 – Completed

Issue DCI Jan. – March 2015

Data Submission Jan. – March 2016 60-day Public Comment Period for Draft Risk Assessments 7 July – Sept. 2017 Registration Review Decision 60-day Public Comment Period fo r Proposed Registration Review

Decision April – June 2018

Registration Review Decision and Begin Post-Decision Follow-up 2019 Total (years) 5

NEXT STEPS

The Agency is requiring additional data for pyraflu fen-ethyl and will issue a data call-in notice in early 2015.

7 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 pesticides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.