2 INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of pyraclostrobin. This wo rk plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the pyraclostrobin registration review docket (EPA-HQ-OPP-2014 -0051). Pyraclostrobin belongs to the strobilurin class of fungicides ( β -methoxyacrylate class of compounds). Strob ilurins are synthetic analogs of a natural antifungal substance which inhibit spore germin ation, mycelial growth, and sporulation of the fungus on the leaf surface. Pyraclostrobin products ar e registered for use in agriculture, turf grass, and residential sites. There are registered food uses.

The Agency is implementing the registration review pr ogram 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 intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to me et 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 was 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 the projected registration review timeline for pyraclostrobin. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on pyraclostrobin since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Pyraclostrobin Preliminary Work Plan, which opened on June 25, 2014 and closed on August 25, 2014, the Agency received 6 public comments. Comments were submitted by The Arizona Universi ty Pest Management Center, The Center for Biological Diversity, The FIFRA Endangered Sp ecies Task Force (FESTF), The National Alfalfa and Forage Alliance, The University of Hawaii, 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 trade irritants, but no

comments or information were received on those issues.

Summarized below are public comments that resulte d 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-HQ-OPP-2014-0051.

1 http://www.epa.gov/oppsrrd1/registration_review/3 Comments submitted by the FIFRA Endangered Species Task Force (FESTF) in EPA-HQOPP-2014-0051-0012

Comment: FESTF submitted a comment informing the Agency that the technical registrant of Pyraclostrobin is a member of the FESTF (or a company having met its data co mpensation obligations) and is entitled to rely on

FESTF data.

Response: The Agency thanks FESTF for its comment.

Comments submitted by the Center for Biolog ical Diversity (CBD) in EPA-HQ-OPP-2014-

0051-0010

Comment: The Center for Biological Diversity’s (CBD) comme nts focus on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheri es Service (the Services) on the registration review of pyraclostrobin in accordance with the Endangered Spec ies Act (ESA). The CBD comments mention various aspects of the risk assessment process, including use of the best av ailable data to develop endang ered species risk assessments, and evaluation of effects on endangered and threatened species and their desi gnated critical habitat. CBD also expresses concern regarding the ri gor of the Agency’s preliminary determination s regarding the effects of pyraclostrobin on endangered and threatened (listed) sp ecies and their designated critical habi tat for the pyraclostrobin registration

review

.

Response: EPA has reviewed the comments from CBD on the registration review docket opening for pyraclostrobin 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 Academ y of Sciences (NAS) report. EPA will address concerns specific to pyraclostrobin in connection with the development of its final registration review decision for pyraclostrobin.

In November 2013, the EPA, along with the Serv ices 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 jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendat ions and reflect a common approach to risk assessment shared by the agencies as a way of a ddressing 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 assessm ents 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 Committee (PPDC) and State -FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder workshop in April and October 2014, allowing additional opportunities for stakeholde rs to comment on the Interim Approaches. Additional workshops are planned to enhance stak eholder involvement. As part of a phased, iterative process for developing the Interim Appr oaches, the agencies will also consider public comments on the Interim Approaches in conn ection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the4 white paper “Interim Approaches for National-Leve l Pesticide Endangered Species Act Assessments 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 of pesticid es to listed species and their designated critical habitat, the ecological problem formulation supporti ng this Final Work Plan for pyraclostrobin does not describe the specific ESA analysis, including ef fects determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem formulation document for pyraclostrobin, EPA described the screening-level risk assessment to determine the potential effects of pyraclostrobin 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 pyraclostrobin. 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 pyraclostrobin 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 pyraclostrobin as part of completing this registration review.

BENEFIT AND USE COMMENTS

The Agency received public comments from The Ar izona University Pest Management Center, The National Alfalfa and Forage Alliance, The Univer sity of Hawaii, and The Western Integrated Pest Management Center on the benefits of uses of pyraclostrobin in agricultural production.

Comments: Comments relating to the benefits and uses of pyraclostrobin were submitted by agricultural commodity associations, and agricultural extension services. These comments varied in content, but provided a range of points to be c onsidered by the Agency in favor of the continued registration of pyraclostrobin. Topics of discussi on included use and usage, benefits in yield, and integrated pest management.

Response: The Agency appreciates the offer from various stakeholders for assistance with information, and will keep this in mind moving forward in the registration review process.

PLANNED DATA NEEDS

The planned data needs have been updated from what was included in the PWP. An acute larval toxicity study with both the technical grade active ingredient (TGAI) and typical end-use product (TEP), a honeybee adult acute oral toxicity study wi th a pyraclostrobin-triticonazole formulation, and a chronic larval honeybee study using TEP are anticipated to be required. Since the PWP was posted the Agency has received a passerine oral toxicity study and a honeybee adult acute oral toxicity study with a pyraclostrobin-triticonazole fo rmulation. The data needs may be satisfied once

the studies have been reviewed.5 Table 1: Anticipated Data Needs for th e Pyraclostrobin Registration Review

Guideline

Number 2 Study Title 1 Test Material Estimated

Timeframe (Months from receipt of DCI) 835.4400 Anaerobic Aquatic Metabolism TGAI 24

850.6100 Environmental chemistry method and independent laboratory validation (ECM/ILV) in water for parent and the following

metabolite: BF 500-3 TGAI and

metabolite: BF

500-3 12

850.1400 Freshwater fish early-life stage TGAI 12

850.1735 Whole sediment – acute freshwater

invertebrates TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

NonGuideline Honeybee adult acute oral toxicity TGAI and for the following

TEPs:pyraclostrobinmetiram; andpyraclostrobintriticonazole 12

NonGuideline Honeybee adult chronic toxicity TGAI and

TEP 12

NonGuideline Honeybee larval acute toxicity TGAI and

TEP 12

NonGuideline Honeybee larval chronic toxicity TGAI and

TEP 12

Nonguideline Residues in pollen and nectar TEP 24

850.3040 Field testing for pollinators TEP 24

RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for pyraclostrobin was completed in 2013 in preparation for a new use request. The most recent ecological and environmental fate risk assessment was completed in 2013 for the same purpos e. Findings and conclusions from these risk

assessments are summarized in the Registration Review: Preliminary Pr oblem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drin king Water Exposure Assessm ents for Pyraclostrobin, and

PYRACLOSTROBIN Human Health Assessment Scoping Document in Support of Registration Review

documents

2 On June 27, 2012, EPA announced certain revisions in ha rmonized guideline series 850 – Ecological Effects Tests –

including renumbering and other designat ions or changes for some guideline stud ies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availab ility” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!docum entDetail;D=EPA-HQ-OPPT-2009-0154-00286 During registration review, the Ag ency anticipates the need to c onduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of pyraclostrobin. For human health, EPA does not anticipate the need to conduct a revised dietary risk assessment during registration review. However, since the toxicolo gical endpoints for short- and intermediate-term inhalation exposures were derived using older calcul ation methods, the Agency will need to reassess these exposures using the Agency’s current risk assessment procedures. The Agency will assess whether recent changes to inhalation risk assessm ent methods will affect risk estimates. These updates were not included in the PWP but are now reflected in Table 2. The Agency will also

examine the need for a volatilization assessment during Registration Review for pyraclostrobin based on the potential for exposure to bystanders from agricultural applications. Any changes to the standard operating procedures or default expo sure assumptions will be considered in any new assessments that may be conducted.

Table 2 below summarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document.

Table 2: Anticipated Risk Assessments fo r the Pyraclostrobin 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 The most recent comprehensive risk assessment was completed on April 17, 2013 for the following uses: tomato transplants grown for home consumer market, sugarcane, artichoke, Belgian endive, persimmon, citrus, oilseed crops, bulb vegetable group, bushberry and caneberry groups, fruiting vegetable group, low growing berry subgroup (except cranberry), pome fruit group, small fruit/vine climbing subgroup (except fuzzy kiwifruit), root veg etables 1B (except sugarbeets) turnip greens, and homeowner ornamentals and landscape gardens.

Incidents Will check for updates For a discussion of reported ecological incidents for pyraclostrobin, see page 16 of the Problem

Formulation.

Human Health Dietary

Food No7 Table 2: Anticipated Risk Assessments fo r the Pyraclostrobin Registration Review

Type of Risk Assessment Conduct? Notes

Drinking water No A new dietary ex posure assessment is not anticipated to be needed during Registration Review unless there are changes to the drinking water exposure estimates that need to be incorporated. Partially refined acute and chronic dietary exposure assessments were recently performed including all existing uses of pyraclostrobin. The resulting risk estimates do not exceed EPA’s level of concern. The assumptions used in these assessments incorporated conservative inputs for %CT, residue levels in crops, and estimated residues in drinking water, and therefore, are not expected to have underestimated the dietary exposure and risks posed by pyraclostrobin. Occupational Handlers (mixers, loaders, applicators) Yes There is sufficient information available to assess occupational handler and post-application exposures. Updated occupational post-application exposure assessments are not expected to be needed during Registration Review. Due to recent changes in inhalation risk assessment methods, updated occupational handler exposure assessments may be needed during Registration Review. Post-application No

Residential Handlers Yes Due to recent changes in inhalation risk assessment methods, updated residential handler exposure assessments may be needed during Registration Review. Residential post-application assessments are not expected to be conducted during Registration Review; however, the Agency will examine the needfor a volatilization assessment to assess postapplication residential risk from pyraclostrobin during Registration Review based on the potential for exposure to bystanders from agricultural applications. Post-application No

Other Aggregate Yes Evaluates the combined risk from dietary and residential exposures. Cumulative NA 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 with pyraclostrobin. Pyraclostrobin does not appear to produce a toxic metabolite produced by other substances.8 Table 2: Anticipated Risk Assessments fo r the Pyraclostrobin Registration Review

Type of Risk Assessment Conduct? Notes

Tolerances Yes The current tolerance expression as listed in the 40 CFR § 180.582 have been updated to reflect current policy. There are numerous pyraclostrobin maximum residue limits (MRLs)/tolerances. The US and Canada residue definitions are effectively harmonized, but differ from the Codex definition. The possibility for harmonization will be discussed during registration

review.

Incidents Will check for updates For a discussion of reported human incidents for pyraclostrobin, see page 8 of the Scoping Document and the Revised: Pyraclostrobin: Tier I Review of

Human Incidents.

TIMELINE

EPA has created the following estimated time line for the completion of the pyraclostrobin registration review in Table 3 below. The proj ected timeline has not changed since the PWP.

Table 3: Projected Pyraclostrob in Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period June 2014 – Completed Close Public Comment August 2014 – Completed Case Development Final Work Plan November 2014 – Completed Issue DCI 2015 Jan. - March Data Submission 2017 Jan. - March 60-day Public Comment Period for Draft Risk

Assessments [1] 2018 July – Sept.

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 April - June

Registration Review Decision and Begin Post-Decision Follow-up 2020

Total (years) 6

[1] The regulations governing Registration Re view generally require the Agency to provide a public comment period of at least 30 calendar days for draft risk assessments; see 40 CF R Part 155.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public commen t period generally for draft risk assessments.9 NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects studies for pyraclostrobin through a Data Call-In No tice, expected to be i ssued early in 2015.