2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) Final Work Plan (FWP) for the registration review of quinoxyfen. This wo rk plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the quinoxyfen registration review docket (EPA-HQ-OPP-2013-0771). Quinoxyfen is a fungicide registered for use for protection against powdery mildew diseases in a variety of crops. There are no residential or non-agricultural uses registered for quinoxyfen.

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 science, public policy, and pesticide use 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 was issued. Next is a summary of comments received during the public comm ent period for the PWP concerni ng anticipated data needs, expected risk assessments, or the estimated timeline identified in the PWP, and a summary of the Agency’s responses to those comments. This sec tion is followed by registration review planned data needs, risk assessments expected to be conducted, and the projec ted registration review timeline for quinoxyfen. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

The planned data needs have changed from what was included in the PWP. The table of planned data needs in the FWP has been updated to clar ify that the registrant will have the option to choose a tiered approach to conducting the re quired chronic sediment toxicity tests.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on th e quinoxyfen Preliminary Work Plan, which opened on December 20, 2013 and closed on February 18, 2014, the Agency received public comment submissions from three groups. Comments were submitted by the Center for Biological Diversity (CBD), the Washington State Pest Ma nagement Resource Service of Washington State University Tri-Cities (WSPMRS), and the FIFRA Endangered Species Task Force (FESTF). The comments do not address the timeline or data requ irements described in the PWP, but they do address the planned ecological a nd human health risk assessments. In the PWP, EPA also solicited comments on the specific t opics of environmental justice, water quality concerns, and trade irritants; no comments or inform ation were received on these issues.

Summarized below are public comments and Agen cy responses. Public comments in their entirety are located in the docket, EPA-HQ-OPP-2013-0771.

1 http://www.epa.gov/oppsrrd1/registration_review/3 Comments submitted by CB D in EPA-HQ-OPP-2013-0771-0010

1. Comment: The Center for Biological Diversity ’s (CBD) comments focus on the EPA’s independent duty under the Endangered Species Ac t (ESA) to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of quinoxyfen.

Response: EPA has reviewed the comments fr om CBD on the registration review docket opening for quinoxyfen 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 Ac ademy of Sciences (NAS) report. EPA will address concerns specific to quinoxyfen in connection with the development of its registration review de cision for quinoxyfen.

At this time, EPA has not fully developed its risk assessment process for listed species. In November 2013, the EPA, along with the Services and the U.S. Department of Agriculture (USDA) released a summary of their joint Inte rim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the Agencies in response to the National Academy of Scien ces’ (NAS) recommendations and reflect a 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, available at http://www.nap.edu/catalog.php?record_id=183 44, outlines recommendations on specific

scientific and technical issues related to the development of pesticide risk assessments that

EPA and the Services must conduct in connect ion with their obliga tions under the ESA and FIFRA. The joint Interim Approaches were rele ased prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presente d the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues

Research and Evaluation Gr oup (SFIREG) meetings, allowi ng additional opportunities for stakeholders to comment on the Interim Appro aches. As part of a phased, iterative process for developing the Interim Approaches, the Agen cies will also consider public comments on the Interim Approaches in connection with the developm ent of upcoming Registration Review decisions. The details of the joint Inte rim Approaches are contained in the white paper “Interim Approaches for National- Level Pesticide Endangered Species Act

Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013, available at http://www.epa.gov/espp/2013/nas.html

.

Comments submitted by WSPMRS in EPA-HQ-OPP-2013-0771-0011 and EPA-HQ-OPP2013-0771-0012

2. Comment: The WSPMRS submitted a letter outlining the importance of quinoxyfen for integrated pest manage ment (IPM) programs.

Response: The Agency thanks WSPMRS fo r the comment regarding the importance of quinoxyfen for IPM programs and will consider the information during registration review.4 3. Comment: The WSPMRS also submitted 2011 California use data for quinoxyfen.

Response: The Agency thanks WSPMRS for th e use data and will consider the information during registration review.

Comments submitted by FE STF in EPA-HQ-OPP-2013-0771-0013

4. Comment: “The technical registrant, as identified on the fact sheet included in the Registration Review work plan, is Dow Agr oSciences, LLC, which is an FESTF member and is entitled to rely on FESTF data.”

Response: The Agency thanks FESTF for the comment and will consider this information during registration review.5 PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for quinoxyfen based on the Registration Review: Preliminary Problem Formulation for Environmen tal Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Quinoxyfen

and Quinoxyfen. Human-Health Assessment Scop ing Document in Support of Registration

Review as well as changes to the data needs since the PWP was issued.

The planned data needs have changed from what was included in the PWP as follows: the table below has been updated to clarify that the regi strant will have the option to choose a tiered approach to conducting the required chronic sediment toxicity tests. As a result, the table below

now lists both acute sediment toxi city tests and chronic sediment t oxicity tests, instead of chronic sediment tests only. However, the acute sediment t oxicity tests will be op tional. The registrant may opt to first conduct acute sediment toxicity tests before then proceeding to the chronic sediment toxicity tests, if the ch ronic sediment toxicity tests are tr iggered. If this tiered approach is taken, the results of the acute tests will determ ine whether chronic tests are required or can be waived. This determination will be based on a comparison of estimated environmental concentrations (EEC) in pore water with toxicity results from the acu te sediment toxicity studies. If the chronic level of concern (L OC) is exceeded in the acute studi es, then the registrant will be required to conduct the chronic studies.

Note, if the tiered approach is chosen, th e 24 month timeframe for completing the chronic sediment studies will remain unchanged. The chroni c sediment toxicity tests must be completed with 24 months from receipt of the DCI, even if the registrant opts to first conduct acute tests before proceeding to the chronic te sts. If the registrant does not wi sh to use the tiered approach, the acute studies will not be required, but th e chronic studies will be required and must be completed within 24 months from receipt of the DCI.6 Table 1: Planned Data Needs for the Quinoxyfen Registration Review

Guideline (GDLN)

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

850.6100 Environmental chemistry methods and associated independent laboratory validations for soil and

water TGAI 12

850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12

850.1735 3 Whole sediment: acute freshwater invertebrates,

Chironomus dilutus and Hyalella azteca TGAI 12

850.1740 3 Whole sediment: acute marine invertebrates, Leptocheirus plumulosus TGAI 12

NonGDLN Special Study Whole sediment: chronic invertebrates freshwater, Chironomus dilutus and Hyalella

azteca TGAI 24 4

NonGDLN Special Study Whole sediment: chronic invertebrates marine, Leptocheirus plumulosus TGAI 24 4

NonGDLN Special Study Honey bee larval toxicity test TGAI 12

TGAI = technical grade active ingredient

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 “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

3 The acute sediment toxicity tests will be optional. The re gistrant may opt to choose a tiered approach and to first conduct acute sediment toxicity tests before proceeding to the chronic sediment toxicity tests, if chronic sediment toxicity tests are triggered. If this tiered approach is taken, the results of the acute tests will determine whether chronic tests are required or can be waived. This dete rmination will be based on a comparison of estimated environmental concentrations (EEC) in pore water with toxi city results from the acute sediment toxicity studies. If the chronic level of concern (LOC) is ex ceeded in the acute studies, then the re gistrant will be required to conduct

the chronic studies.

4 Note, if the tiered approach is chosen, the 24 month timeframe for completing the chronic sediment studies will remain unchanged. The chronic sediment to xicity tests must be completed with 24 months from receipt of the DCI, even if the registrant opts to first conduct acute tests before proceeding to the chronic tests.7 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of quinoxyfen. For human health, EPA does not anticipate the need to conduct revised dietary and occupational risk assessments during registration review; however, the Agency plans to update the resi dential post-application risk assessment and examine the need for spray drif t and volatilization assessm ents for quinoxyfen. If toxicological endpoints or points of departur e are revised based on the data that are required for registration review, they will be considered in the new assessments, as will 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 Docume nt and the planned assessments have not changed from what was included in the PWP.8 Table 2: Planned Risk A ssessments for the Quinoxyfen 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 Yes EPA anticipates conducting an updated comprehensive ecological risk assessment during registration review. The new assessment will incorporate the most up-to-date modeling methodologies, updated toxico logical endpoints, and

data submitted under the anticipated registration

review data call-in.

Incidents Will check for updates For a discussion of reporte d ecological incidents for quinoxyfen, see page 16 of th e Problem Formulation.

Human Health Dietary Food No Given that the most recent dietary assessment was conducted in 2013, the Agency does not anticipate the need to update the dietary risk assessment during registration review. Drinking water No

Occupational Handlers (mixers, loaders, applicators) No The most recent occupational handler assessment covered the relevant exposu re scenarios and did not result in risk estimates of concern. The Agency does not anticipate the need to conduct updated occupational handler assessm ents during registration

review. Post-application No The Agency does not anticipate the need to conduct a quantitative occupational pos t-application assessment during registration review.

Residential Handlers No There are currently no registered uses of quinoxyfen

that would result in residential exposure. Post-application Yes There are current ly no registered uses of quinoxyfen

that would result in reside ntial exposure. However, the need for spray drift a nd volatilization assessments for quinoxyfen will be examined during registration

review.

Other Aggregate No Evaluates the combined risk from dietary and residential exposures. Give n that the most recent aggregate risk assessment was conducted in 2013, the Agency does not anticipate the need to update the aggregate risk assessment during registration review. Cumulative No Not applicable. Quinoxyfen has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.9 Tolerances No The HED Metabolism Assessment Review Committee (MARC) has determined that the residue of concern for purposes of tolerance enforcement and risk assessment is the parent compound only.

Incidents Will check for updates For a discussion of reported human incidents for quinoxyfen, see page 9 of the Scoping Document and

the Quinoxyfen: Tier 1 Review of Human Incidents

.

TIMELINE

EPA has created the following estimated ti meline for the completion of the quinoxyfen registration review in Table 3 below. The projected timeline ha s not changed since the PWP.

Table 3: Registration Review for Quinoxyfen – Projected Registra tion Review Timeline

Activity Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period Dec. 2013 – Completed Close Public Comment Period Feb. 2014 – Completed Case Development Final Work Plan June 2014 – Completed Issue DCI 2014 July – Sept. Data Submission 2016 July – Sept. 60-day Public Comment Period for Draft Risk

Assessments 5 2018 Jan. – March

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2018 July – Sept.

Registration Review Decisi on and Begin Post-Decision Follow-up 2019

Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to requ ire several environmenta l fate and ecological effects studies for quinoxyfen through a Data Call-In Notice, expected to be issued in summer or

fall of 2014.

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