Docket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) Final Work Plan (FWP) for the registration review 1 of zoxamide. Zoxamide is a non-s ystemic broad-spectrum benzamide fungicide registered for use to control fungicidal diseases ( e.g. , spot, downy mildew, rot, blight, mold, blotch) on select fruit and vegetable crop s; zoxamide is registered for use on cucurbit vegetables (melons, pumpkin, s quash, and watermelon), grapes, potatoes (white/Irish), and tomatoes. The proposed new use of zoxamide on the crop group onion, bulb, subgroup 3-07A was approved by the Agency in August 2014. Zoxamide products are used primarily in agricultural areas; zoxamide products have no re gistered residential uses. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the zoxamide registration review docke t (EPA-HQ-OPP-2014-0391) in June 2014.

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 the FIFRA standard for registration. Changes in science, public policy, and pesticide use practices occur over time. The registration review program is inte nded to make sure that, as the ab ility 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 when 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 comments. This section is followed by registration review planned data needs, risk assessments expected to be conducted, and th e projected registration review timeline for zoxamide. Lastly, th ere is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

Updates on zoxamide since the June 2014 PWP include: 1) the proposed new use of zoxamide on the crop group onion, bulb, subgroup 3-07A was appr oved by the Agency in August 2014; and 2) the storage stability data on the cucurbit and toma to have been reviewed and determined to be acceptable (i.e., MRIDs 45633801, 45633802 and 45639001).

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the z oxamide Preliminary Work Plan, which opened on June 25, 2014 and closed on August 25, 2014, the Ag ency received public comments from three

stakeholders related to zoxamide. Comments were submitted by the Center for Biological Diversity, the FIFRA Endangered Species Task Force and the Western Integrated Pest Management Center. The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns, and

1 http://www.epa.gov/oppsrrd1/registration_review/Docket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

3 trade irritants. Comments on water quality concerns were expre ssed (though no data was submitted) by the Center for Biological Diversit y. California pesticide use report data for 2012 were provided by the Western Inte grated Pest Management Center . No comments or information were received on the remaining issues.

Summarized below are public comme nts that are of a broader regul atory nature. Public comments in their entirety are located in the docket, EPA-HQ-OPP-2014-0391.

Comment/Response to the Center for Biolog ical Diversity in EPA-HQ-OPP-2014-0391-0010

Comment : The Center for Biological Diversity’s (CBD) comments focus on the EPA’s duty to

consult with the U.S. Fish and Wi ldlife Service and the National Ma rine Fisheries Service (the Services) on the registration re view of zoxamide in accordan ce with the Endangered Species Act (ESA). The CBD comments mention various aspects of the risk a ssessment process, including use of the best available data to develop endangered sp ecies risk assessments, and evaluation of effects on endangered and threatened species and their desi gnated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s pre liminary determinations regarding the effects of zoxamide on endangered and threatened (listed) sp ecies and their designated critical habitat for the zoxamide registration review.

Response : EPA has reviewed the comments from CBD on the registration review docket opening for zoxamide and plans to address many of th e 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 Scienc es (NAS) report. EPA will address concerns specific to zoxamide in connecti on with the development of its final registration review decision for this pesticide.

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 devel oped 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 of addressing scientific differenc es 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 Se rvices 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 join t Interim Approaches at the December 2013 Pesticide Program Dialogue Commit tee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agenci es also held a stakeholder wo rkshop in April 2014, allowing additional opportunities for stakeholders to co mment on the Interim Approaches. Additional workshops are planned to enhance stakeholder invol vement. As part of a phased, iterative process for developing the Interim Appro aches, 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 In terim Approaches are contained in the white paper

, Interim Approaches for National-Level Pesticide End angered Species Act Assessments Based on theDocket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

4 Recommendations of the National Acade my of Sciences April 2013 Report , dated November 1,

2013.

Given that the agencies are continuing to develo p and work toward implementation of the Interim Approaches to assess the potential risks of pesticid es to listed species and their designated critical habitat, the ecological problem formulation suppor ting this Final Work Plan for zoxamide does not describe the specific ESA an alysis, including effects determinations for specific listed species or designated critical ha bitat, to be conducted dur ing registration review. In the ecological problem formulation document for zoxamide, EPA descri bed the screening-level risk assessment to determine the potential effects of zoxamide on all taxa of non-target wildlife and plants, which will assume that listed species and their designated cr itical habitats may be present in the vicinity of the application of zoxamide. This screening-level assessment will allow EPA to focus its future evaluations on the types of species where the potentia l 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 screen ing-level risk assessment for the registration

review of zoxamide will describe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and impl emented the scientific methods necessary to complete risk assessments fo r endangered and threatened (listed) species and their designated critical habitats, these methods will be a pplied to subsequent analyses for zoxamide as part of completing this registration review.

Comments submitted by FIFRA Endangered Species Task Force in EPA-HQ-OPP-2014-
0391-0012. FESTF submitted a memo with a list of studie s that “fulfill data requirements spelled out in Pesticide Registration Notice 2000-2 and provid e the best available data necessary to support the analysis of zoxamide use and listed species locations and potential exposure.”

Comment: FESTF submitted a comment informing the Agency that the technical registrant of

zoxamide is a member of the FESTF (or a company having met its data compensation obligations) and is entitled to rely on FESTF data.

Response: The Agency thanks FESTF for its comment and will take this under consideration.

Comments submitted by Western Integrated Pest Management Center in EPA-HQ-OPP2014-0391-0013

Comment: The USDA Office of Pest Management Po licy has submitted California’s pesticide use report data for 2012 on a multiple active ingredient product (Gavel ® 75 DF Fungicide).

Response: The Agency thanks the Western IPM Ce nter for its comment and will take this under

consideration.

PLANNED DATA NEEDS
Table 1 below summarizes the planned data needs for zoxamide based on the Registration Review Problem Formulation for Zoxamide and Human Health Scoping Document in Support of Registration Review . The table has been updated since the PWP to reflect completion of recentDocket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

5 data reviews by the Agency for the outstanding st orage stability studies originally listed in the PWP. The data were acceptable.

Table 1: Anticipated Data Needs for the Zoxamide Registration Review

Guideline

Number 2 Study Title 2 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Zoxamide
835.4100 Aerobic soil metabolism (two soils) TGAI/PAIRA 3 24 835.4400 Anaerobic aquatic metabolis m (two sediments) TGAI/PAIRA 3 24

850.1735 Whole sediment acute t oxicity invertebrates (freshwater) – 2 species 4 TGAI 12

850.1740 Whole sediment acute t oxicity invertebrates (marine) – 1 species 5 TGAI 12

850.2100 Avian acute oral toxi city test, passerine 6 TGAI 12

850.4100 Seedling emergence and seedling growth (two species 7 ) TEP 12

Non-GLN Acute honey bee larvae feeding study 8 TGAI 12
TGAI = technical grade active ingred ient; TEP = typical end-use product

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Ag ency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of zoxamide. For human health, EPA does not anticipate the need to conduct revised dietary and occupational risk assessments during registration review. An updated residentia l exposure assessment will be required if spray drift and volatilization risk assessments are deemed necessary for off-site

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 Test substance should be technical grade or a pure active ingredient radiolabelled

4 Acute sediment tests with the midge Chironomus dilutus and freshwater amphipod Hyalella azteca

5 Acute sediment test with the estuarine/marine amphipod Leptocheirus plumulosus

6 The anticipated DCI will require submission of a protocol prior to study initiation.

7 Seedling emergence testing is anticipated for corn and ryegrass only. For corn, a study that defines a NOAEC ( i.e.

, a concentration that is not statistically different from the negative control for all assessed endpoints) is needed. For ryegrass, a Tier II test is anticipated to be needed.

8 For reference material on the screening-level risk assessment process for honey bees, see the following: “White Paper in Support of the Proposed Risk Assessment Process for Bees” as submitted to the FIFRA Scientific Advisory Panel: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-0004 Guidance on assessing risks to pollinators: http://www2.epa.gov/sites/ production/files/2014- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdfDocket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

6 transport characterization of non-residential uses of zoxamide. If toxicological endpoints or points of departure are revised based on th e data that are anticipated to be 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. Furt hermore, during the Registration Review process,

EPA will evaluate whether or not the US is able to harmonize tolerances with Codex.

Table 2 below summarizes the anticipated registration review risk assessments based on the Registration Review Problem Formulation for Zoxamide and Human Health Scoping Document in Support of Registration Review

.Docket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

7 Table 2: Anticipated Risk Assessments for the Zoxamide Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological including endangered species Yes Species to be assessed include terrestrial and aquatic organisms. The assessment will be quantitative, whereby all degradates will be included in the total toxic residues approach.

Incidents Will check for updates For a discussion of ecological incident databases see page 17 of the Problem Formulation. Currently, there are no reported ecological incidents.

Human Health Dietary Food No Dietary (food and drinking water) exposure

assessment did not exceed the level of concern for the general U.S. population, infants, and children. Updated drinking water a nd dietary exposure risk assessments are not anticipated to be needed at this

time. Drinking water

Occupational Handlers (mixers, loaders, applicators) No Existing occupational ha ndler dermal exposure and

risk assessments reflect curre nt policy and procedures for the existing agricultura l uses. Updates are not anticipated to be needed at this time. Post-application

Residential Handlers No An updated resident ial exposure assessment may be required if spray drift and volatilization risk assessments are deemed necessary for off-site transport characterization of non-residential uses of

zoxamide Post-application

Other Aggregate No Evaluates the combined risk from dietary and residential exposures.

Cumulative No EPA has not assumed that zoxamide has a common mechanism of toxicity with other substances Tolerances No During the Registra tion Review process, HED will

evaluate whether or not the US is able to harmonize

with Codex.

Incidents Will check for updates For a discussion of human incident information for zoxamide, see page 6 of the Scoping Document and

the Zoxamide: Tier I Revi ew of Human Incidents

. Currently, there are no reported human incidents.Docket Number EPA-HQ-OPP-2014-0391 www.regulations.gov

8 TIMELINE

EPA has created the following estimated timeline fo r the completion of the zoxamide registration

review in Table 3 below.

Table 3: Registration Review for Zoxamid e – 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 Dec. 2014 - Completed

Issue DCI 2015: Jan.- March

Data Submission 2017: Jan.- March 60-day Public Comment Period for Draft Risk Assessments 9 [1] 2018: July – Sept. Registration Review Decision 60-day Public Comment Period fo r Proposed Registration Review

Decision 2019: April - June

Registration Review Decision a nd Begin Post-Decision Follow-up 2020 Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for zoxamide through a Da ta Call-In Notice, expected to be issued in

Jan-March 2015.

9 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.