2 I NTRODUCTION

This is the Environm ental Protection a gency’s (EPA or the a gency ) Final Work Plan (FWP) for the registration review of sethoxydim . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the sethoxydim registration review docket (EPA

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- 0088 ). Sethoxydim is a post

- emergent annual and perennial

herbicide registered fo r use against grass weeds in broadleaf crops. Sethoxydim is registered for use in or on agricultural crops (including various grains, fruits, tree nuts, vegetables, and herbs), ornamentals, rights

- of

- ways, recreational areas, buildings and non

- agricultura l sites

The EPA is implementing the registration review 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 the FIFRA stand ard for registration. Changes in science, public 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 standard. 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 a gency’s website

. 1

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive

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

summ ary of the a gency’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 sethoxydim

. Lastly, there is a discussion o f next steps.

UPDATES SINCE THE PWP WAS ISSUED

Since the issuance of the PWP, the EPA completed new use action s for certain sethoxydim registrations (7969

- 56 and 7969

- 58). On June 15, 2015 a final rule was posted to the F ederal

R egister (FRL

- 9928

- 20) which established new and amended certain existing tolerances for sethoxydim. Additional information pertaining to this action can be found at

www. regulations.gov in docket number EPA

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- 0005.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

Duri ng the 60

- day public comment period on the sethoxydim PWP , which opened on March 30,

2015 and closed on May 29, 2015 , the EPA received three public comments. Comments were submitted by BASF Corporation, Center for Biological Diversity (CBD), and the FIFRA

Endan gered Species Task Force (FESTF), none of the comments received affected the anticipated registration review data needs, risk assessments, or timeline. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water qua lity concerns , and trade irritants, but no comments or information were received on those issues.

1 http://www.epa.gov/oppsrrd1/registration_review/3 This section only contain s a summary of comments received. Full comments

, and EPA’s response memorandum, “ EFED Response to Public Comments Regarding the Reg istration Review Problem Formulation for Sethoxydim ” dated July 23, 2015 are located in the docket,

EPA

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- 0088 , accessible at www.regulations.gov

.

Comments submitted by BASF Corporation in EPA

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- 2015

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- 0012/13

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1. Comment: BASF comments were associated with the a gency’s finding that sethoxydim is “moderately toxic” to bees based on an existing study (MRID 41510607)

. Furthermore,

BASF ’s comment also requested that the EPA remove sethoxydim from Appendix A of “EPA’s Proposal t o Mitigate Exposure to Bees from Acutely Toxic Pesticide Products” dated May 28, 2015.

Response: BASF’s intent to conduct and submit pollinator data is consistent with the

a gency’s anticipated data needs for sethoxydim. As indicated in the problem formulation

, the need for higher tier pollinator studies is contingent upon lower tier studies. H owever
, sethoxydim will maintain its current classification as “moderately toxic” to bees until new

data are submitted and evaluated. The EPA will address the inclusion of sethoxydim in Appendix A of “ EPA’s Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide

Products” dated May 28, 2015 by assessing effects associated with the acute risk mitigation
strategy (see http://www2.epa.gov/pollinator

- protection/proposal

- protect

- bees

- acutely

- toxic

pesticides )

.

Comments submitted by Center for Biological Diversity in EPA

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- 2015

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2

. 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 sethoxydim in accordance with the Endangered Species Act (ESA). The CBD comments mention 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 speci es and their designated criti cal habitat. CBD also expressed concern regarding the rigor of the EPA ’s preliminary determinations regarding the effects of sethoxydim on endangered and threatened (listed) species and their designated critical habitat for th e s ethoxydim registration review.

Response: EPA has reviewed the comments from CBD on the registration review docket opening for sethoxydim 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 listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to sethoxydim in connection with the development of its final registration review decision for s ethoxydim

.

In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. The Interim Approaches were developed joi ntly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a4 common approach to risk assessment shared by the agencies as a way of addressing scientific

differences between the EPA and the Services. The NAS report 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 presented the joint Interim Approaches at the

December 2013 Pesticide Program Dialogue Commi ttee (PPDC) and State

- FIFRA Issues Research and Evaluation Group ( SFIREG) meetings

. The agencies also held a stakeholder workshop s in April 2014 and October 2014 , allowing additional opportunities for stakeholders to comment on the Interim Approaches. 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 development 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 Assessm ents Based on the Recommendations of the National Academy of Sciences April 2013 Report,” 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 o f pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this Final Work

Plan for sethoxydim does not describe the specific ESA analysis

, includ ing effects determinations for specific listed specie s or designated critical habitat , to be conducted during registration review

. In the ecological problem formulation document for sethoxydim,

EPA described the screening

- level risk assessment to determine the potential effects of sethoxydim 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 sethoxydim . 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

ass essment for the registration review of sethoxydim 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 asses sments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for sethoxydim as part of completing this registration review.

Comments submitted by FESTF in EPA

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1. Comment: The FESTF comment indic ated that specific registrants including the technical registrants of sethoxydim ( Nufarm and BASF Corporation ) are current members of FESTF, and as such, are entitled to the FESTF data on federally

- list ed threatened and endangered species.5 Response: The Agency thanks FESTF for their comment and will consider the appropriate

information at the time of the e ndangered s pecies assessment.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for sethoxydim based on the Registration Review Problem Formulation for Sethoxydim (dated March 6, 2015)

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

.

able 1: Planned D ata Needs for the Sethoxydim Registration R eview

Guideline

Number 2 Study Title 2 Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Sethoxydim

850.1300 Aquatic invertebrate life cycle (freshwater) T GAI 12

850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12

850. 1400 Fish early

- life stage (saltwater) TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.3040 Field testing for pollinators TEP 24

850.3030 Honey bee toxicity of residues on foliage TEP 12

850.4100 Seedling Emergence (Tier I/II) TEP 12

850.4150 Vegetative Vigor (Tier I/II) TEP 12

Non

- guideline Semi

- field testing for pollinators TEP 24

Non

- guideline Acute oral toxicity to adult bees TGAI 12

Non

- guideline Acute oral toxicity to larval honey bees TGAI 12

Non

- guideline Chronic oral toxicity to adult honey bees TGAI 12

Non

- guideline Chronic oral toxicity to larval honey bees TGAI 12

Non

- guideline Field trial of residues in pollen and nectar TEP 24

Anticipated Data Needs for Sulfone ( the Terminal Degradate , M2

- SO 2 )

Non

- guideline Aquatic vascular plant toxicity study with a grass species DEG 12

TGAI = technical grade active ingredient; TEP = typical end

- use product ; DEG = degradate

2 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 “F inal Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00286 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he EPA will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of sethoxydim

. For human health, the EPA recently completed a complete risk assessment in connection with a rece nt sethoxydim action (see FRL

- 9928

- 20). The risk assessment completed in connection with this action incorporates the most recent review of the human health toxicity and exposure data base, and up

to

- date assumptions and methodologies. Based upon this, a t this time, the EPA does not anticipate conducting a new human health risk assessment for sethoxydim for registration

review.

Table 2 below summarizes the planned registration review risk assessments based on the EFED

Problem Formulation and recent HED S coping /Risk assessment d ocument

. The planned

assessment for sethoxydim ha s not changed from what was identified in the PWP

.7 Table 2: Planned Risk Assessments for the Sethoxydim Registration Review

Type of Risk Assessment Conduct Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The agency anticipates conducting a quantitative ecological risk assessment for all registered sethoxydim uses.

Incidents Will check for updates For a discussion of reported ecological incidents for sethoxydim , see page 25 of the Problem Formulation.

Human Health Dietary

Food N A dietary analysis (food and drinking water) was completed as part of the scoping exercise/ new use risk assessment for sethoxydim and no additional dietary analysis is anticipated for registration review. Drinking water N

Occupational Handlers (mixers, loaders, applicators) N An occupational analysis was completed as part of the scoping/ new use risk assessment for sethoxydim and no additional occupational analysis is anticipated for registration review. Post

- application N

Residential

Handlers N A residential analysis was co mpleted as part of the scoping/ new use risk assessment for sethoxydim and no additional occupational analysis is anticipated for registration review. Post

- application N

Other Aggregate N Aggregate analyses were co mpleted as part of the scoping/ new use risk assessment for sethoxydim and no additional aggregate analysis are anticipated for registration review.

Cumulative N Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to sethoxydim and any other substances.

Tolerances N Currently, there are no Mexican or Codex MRLs for sethoxydim. Canadian MRLs and U.S. tolerances are currently harmonized to the extent possible.

Incidents Yes The EPA has completed a human health incidents report for registration review. For a discussion of reported human incidents for sethoxydim , see the Sethoxydim: Tier I Review of Human Incidents dated October 23, 2014 at www.regulations.gov in docket

number EPA

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- 0161.8 TIMELINE

EPA has created the following estimated timeline for the completion of the sethoxydim registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Sethoxydim

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period March 2015

– Completed

Close Public Comment May 2015

– Completed Case Development

Final Work Plan September 2015

– Completed

Issue DCI 2015 Oct.

– Dec.

Data Submission 2017 Oct.

– Dec.

60

- day Public Comment Period for Draft Risk Assessments 3 2019 April

- June Registration Review Decision

60

- day Public Comment Period for Proposed Registration

Review D ecision 2020 January

- March

Registration Review D ecision and Begin P ost

- D ecision F ollow

up 2021

Total ( years ) 6

NEXT STEPS

As noted previously, the EPA plans to require several environmental fate, and ecological effects,

studies for sethoxydim through a D ata C all

- I n Notice , expected to be issued in 2015

.

3 The regulations governing Registration Review generally require the a gency 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

a gency plans to provide a 60 calendar day public comment period generally for draft risk assessments.