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## Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 3

ANTICIPATED DATA NEEDS

................................ ................................ ................................ ... 3

STATUT ORY AND REGULATORY AUTHORITY

................................ ................................ .... 4

CHEMICAL FACTS

................................ ................................ ................................ ....................... 5

USE AND USAGE INFORMATION

................................ ................................ ............................ 6

RECENT ACTIONS

................................ ................................ ................................ ...................... 8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ . 8

TIMELINE

................................ ................................ ................................ ................................ ... 11

NEXT STEPS

................................ ................................ ................................ ............................... 12

Appendix

– Additional Areas Considered in the Pyraclostrobin Registration Review

...... 13

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Pyraclostrobin. Koper, Christopher; Radtke, Meghan. May 22 , 2014.

2. PYRACLOSTROBIN : Human Health A ssessment Scoping Document in S upport of Registration Review. Chen, Vincent; Funk, Steve; O’Keefe, Barry ; Walls, Cassi . May 21

, 2014.

3. Revised: Pyraclostrobin: Tier I Review of Human Incidents. Evans: Elizabeth; Recore, Shanna. February 11, 2014.

4. BEAD Che mical Profile (BCP) for Registration Review: Pyraclostrobin (099100). Alsadek, Jihad; Lee, Andrew; Yourman, Leonard. February 27, 2014.

5. Pyraclostrobin (099100) Screening Level Usage Analysis (SLUA) . February 20, 2014.

6. Pyraclostrobin (099100) EFED Table 1 Report. Prieto, Rafael. April 3 , 2014.

7. Pyraclostrobin (099100) HED Master Label Report . P rieto , Rafael. April 3 , 2014.

These and other supporting documents for the pyraclostrobin registration review case may be

found in the docket EPA

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Page 3 of 15 OVERVIEW

The docket for pyraclostrobin is now open, initiating the first public comment period for this registration review (docket number EPA

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- 0051). Pyraclostrobin belongs to the strobilurin class of fungicides (β

- methoxyacrylate class of compounds). Strobilurins are synthetic analogs of a natural antifungal substance which inhibit spore germination, mycelial growth, and sporulation of the fungus on the leaf surface. Pyracl ostrobin products are registered for use in agriculture, turf grass , and residential sites

. There are registered food uses. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about pyraclostrobin , highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for pyraclostrob in.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about pyracl ostrobin and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on pyraclostrobin . The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments a nd additional information that will help the Agency’s decision

making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interest ed stakeholders could include: environmental

non

- profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for pyraclostrobin . Next, it discusses the statutory and regulatory authority for Registration Review. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for pyraclostrobin . Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in

Re gistration Review along with some additional chemical case

- specific information.

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for pyraclostrobin. For additional discussion of the anticipated data needs, see the Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Pyraclostro bin and the Human Health Assessment Scoping Document in Support of Registration

Review

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Page 4 of 15 Table 1: Anticipated Data Needs for the Pyraclostrobin Registration Review

Guideline

Number 1 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 v alidation ( ECM/ILV )

in w ater for parent and the following

metabolite: BF 500

- 3 TGAI and

metabolite : BF

500

- 3 12

850.1400 Freshwater f ish early

- life stage TGAI 12

850.1735 Whole sediment

– acute freshwater

invertebrates TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

Non

Guideline Honeybee adult acute oral toxicity TGAI and for the following

TEP: pyraclostrobin

metiram 12

Non

Guideline Honeybee adult chronic toxicity TGAI and

TEP 12

Non

Guideline Honeybee larval chronic toxicity TGAI 12

Non

guideline Residues in pollen and nectar TEP 24

850.3040 Field testing for pollinators TEP 24

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program

. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they

will not cause unreasonable risks to human h ealth or the environment when used as directed on product labeling. 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

s tatutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pes ticides to make sure that as

1 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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Page 5 of 15 change occurs, products in the marketplace can be used safely. Information on this program is provided on EPA’s website. 2

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal

Inse cticide, 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. The regulations governing registration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticid e and what additional risk analyses and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will devel op a Final Work Plan (FWP) and anticipated schedule for the registration review of pyraclostrobin.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for pyraclostrobin.

Table 2: Chemical Facts for Pyraclostrobin

PC code 099100

Case Number 7034

CAS Number 175013

- 18

- 0 Year first registered 2002 Pesticide Type Fungicide

Chemical class Strobilurin Reregistration Eligibility Decision (RED) Pyraclostrobin was registered after November 1984; therefore, it was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group 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 mech anism of toxicity finding with pyraclostrobin. P yraclostrobin does not appear to produce a toxic metabolite produced by other substances.

40 CFR Citation Tolerances for pyraclostrobin are e stablished in 40 CFR §180.582

. Dual

- use Pyraclostrobin is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses.

Non

- pesticidal uses There are no identified non

- pesticidal uses of pyraclostrobin

Pesticide Re

- evaluation Division, Chemical Review Manager Matthew Manupella, manupella.matthew@epa.gov

, (703)347

- 0411

Registration Division, Product Manager Tony Kish, kish.tony@epa.gov , (703)308

- 9443

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Page 6 of 15 USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for pyraclostrobin . Please see the BEAD Chemical Profile (BCP) for Registration Review: Pyraclostrobin (0 99100) in the registration review docket for

more details.

Table 3: Pyraclos trobin Use and Usage Information

Summary of Use Pyraclostrobin is a strobilurin fungicide and is thought to inhibit mitochondrial respiration in fungal cells. It inhibits spore germination and is an antisporulant. In addition to being systemic, pyraclostrobin is “surface systemic,” or “mesosystemic” meaning

that it exhibits transla minar activity and can move from the sprayed side to the unsprayed side of a given leaf.

Use Sites Agricultural Use Sites : include Belgian endive , 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 vegetables 1B (except sugarbeets ) , persimmon, alfalfa, barley, beans, berries, citrus, co nifer, cor n, cotton, cucurbits,

currant, flax, fruiting vegetables, ginseng, grapes, hops, leafy vegetables, lentils, melons, mint, mustard, nut trees, o ats, oil crops, okra ,olives, parsley, peas, pome fruits, rapese ed root crops, rye, safflowers, smal l fruits, sorghum, soybeans, stone fruits, sugar beets

, sugarcane, sunflowers, triticale, tropical fruits, turmeric, vegetable crops, and wheat. The complete list of food crops is listed in 40

CFR 180.582

. Non

- agricultural Use Sites : ornamentals including shrubs and bushes, residential fruit and nut trees, landscape gardens, turf , lilies, tulips, and roses

. Summary of Usage Based on private market usage data from 2002

- 2012, usage in agriculture averaged approximately one million pounds active ingredient ( a.i.) applied annually on approximately 15 million acres treated. The average a.i. rate over this time period was 0.067 pounds a.i./acre. A supplemental label for pyraclostrobin was approved for use for "plant health" in 2008. The use for this

purpose may have resulted in an increase in pyraclostrobin use around 2008, on wheat, corn, soybean, and possibly sugar beet

, for possible enhanced postharvest benefits.

The most recent data on use of pyraclostrobin for non

- agriculture is from 2011. There were approximately 33,000 pounds used by professional turf management and horticulture, 39,000 pounds a.i. on golf courses, and 1,000 pounds a.i. on institutional turf facilities.Docket Number EPA

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Table 3: Pyraclos trobin Use and Usage Information

There were approximately 900,000 l b a.i. used in 2009 on nursery

and floriculture. Formulation Type(s) Pyraclostrobin is formulated as granul ar , flowable concentrate, water dispersible granules, emulsifiable concentrate, soluble concentrate,

and ready

- to

- use solutions

. Application Method (s) Applications are made aerially

, by ground ( airblast, broadcast, band, direct spray, chemigation, soil in

- furrow , soil drench, and spot treatment) and also as a spray treatment for seeds. Technical Registrant BASF Corporation No. of Registrations  31 Section 3 product registrations

 6 active SLNs

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of particular interest to EPA, are described below.

The Agency currently does not have certain important information about pyraclostrobin. Our databases do not survey certain registered crops such as: currant, tropical fruits, hops, mustard, safflowers, turmeric, okra, conifer, parsley, lentils, alfalfa, barley, oats, rye, triticale, ginseng, flax, mint, olives, sorghum, sugar beet

, sugarcane, sunflowers, rapeseed, lilies, tulips, roses
, t omato transplants grown for the home consumer market, Belgian en dive, persimmon, oilseed crops

, turnip greens , and homeowner ornamen tals and landscape gardens

. Information such as typical rates, pounds applied, application methods and timing may be useful in future assessments if risks are indicated and may improve future assessments conducted by the Agency related to the

use and benef

its of pyraclostrobin. Information r egarding recent incidences of resistance to pyraclostrobin leading to any failures in disease management will help in benefits assessments.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maximum application rates; frequency of application, application intervals, and maximum number of applications per season; and geographic

limitations on use.

 Use distribution (e.g., acreage and geographical distribution of relevant use sites).

 Median and 90th percentile reported use rates (lbs ai/A) from usage data

– national, state, and county.

 Typical application timing (date of first application and application intervals)

– national, state, and county.

 Usa ge/use information for non

- agricultural uses.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply technical pyraclostrobin to the US

market.Docket Number EPA

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Page 8 of 15 RECENT ACTIONS

The Agency has recei ved requests for new uses currently under review for herb subgroup 19A; dill; and crop conversions for stone fruit, group 12

- 12 and tree nut, group 14

- 12.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive h uman 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 purpose. Findings and conclusions from these r isk

assessments are summarized in the Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Pyraclostrobin, and

PYRACLOSTROBIN. Human Health Assessment Scoping Document in Support of Registration Review

documents

During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of pyraclostrobin . F or human health, EPA anticipates the need to conduct revised dietary, residential, and occupational risk

assessmen ts during registration review. 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. A ny changes to the standard operating procedures or default exposure assumptions will be considered in any new assessments that may be conducted

.

Table 4 bel ow summarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document.Docket Number EPA

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Page 9 of 15 Table 4: Anticipated Risk Assessments for 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 vegetables 1B (except sugarbeets) turnip greens, and homeowner ornamentals a nd 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 No A new dietary exposure 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 w ere 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 ris ks posed by pyraclostrobin. Drinking water No

Occupational Handlers (mixers, loaders, applicators) No There is sufficient information available to assess occupational handler and post

- application exposures. Updated occupational handler and post

- application

exposure assessments are not expected to be needed during Registration Review. Post

- application No

Residential

Handlers No Residential handler and conventional residential post

application assessments are not expected to be conducted during Registration Review; however, theDocket Number EPA

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Page 10 of 15 Post

- application No Agency will examine the need for a volatilization

assessment to assess post

- application residential risk from pyraclostrobin during Registration Review based on the potential for exposure to bystanders from agricultural applications.

Other Aggregate No 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

mech anism of toxicity finding with pyraclostrobin

. P yraclostrobin does not appear to produce a toxic metabolite produced by other substances.

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.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 The “White Paper in Support of the Proposed Risk Assessment Process for Bees” as

submitted to the FIFRA Scient ific Advisory Panel, proposes a screening

- level risk assessment process that includes acute and chronic toxicity tests with adult and larval bees. Pyraclostrobin a cute toxicity da ta is needed for larval honey bees and chronic toxicity data is

needed for both adult and larval honeybees.

 Ecological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency.

 Water quality monitoring data (see Appendix for further details).

 The EPA is interested in exploring pesticide resistance management concerns with pyraclostrobin . Please submit any information you have that could help EPA examine this

issue.

 Certain pyraclostrobin labels are unclear with respect the maximum single application rate, the application interval, and the annual maximum rate allowed (lb ai/A/year). For pyraclostrobin, several label issues were identified (see Appendix 1 in the Problem

Formu lation for more detail):Docket Number EPA

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o Pillar G Fungicide (registration number 7969

- 304) is a granular formulation. Information on the size of the granule and the amount of pyraclostrobin contained within the granule is needed to complete the risk assessment.

o Seasonal, rather than yearly application information is provided for all of the uses (except for alfalfa, golf course turf, ornamentals, and tomato). The number of applications and the maximum application rate would be useful in

our risk assessment . In the absenc e of yearly information, multiple seasons or crop cycles will be assumed for some crops when performing the risk

assessment.

o A maximum single application rate on a pounds per acre basis was not

identified for the seed treatments. In the absence of this in formation, the highest expected seeding rate will be used to estimate this value.

o Many uses were missing the maximum number of applications that are allowed and some uses did not identify a minimum re

- treatment interval. In

the absence of this information , the maximum number of applications was

calculated based on maximum use rates and re

- treatment intervals will be

assumed based on other labeled uses.

TIMELINE

EPA has created the following estimated timeline for the completion of the pyraclostrobin

reg istration review in Table 5 below.

Table 5: Projected Pyraclostrobin Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2014

– June

Close Public Comment 2014

– August

Case Development

Final Work Plan 2014

– November

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

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Page 12 of 15 NEXT STEPS

After the 60

- day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration review of pyraclostrobin.Docket Number EPA

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### Appendix

– Additional Areas Considered in the P yraclostrobin Registration

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency will work to

harmonize tolerances and international maximum r esidue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export market s, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

Pyraclostrobin i s not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 3 In additi on, no Total Maximum Daily Loads (TMDL) have been developed for pyraclostrobin

. 4 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 5 The Agency invites submission of water quality data for this pesticide. To the ext ent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 6 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypi cal, unusually high exposure to pyraclostrobin compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

4 http://iaspub. epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

5 http://www.epa.gov/owow/tmdl/

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Page 14 of 15 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determina tion has not been conducted for pyraclostrobin . The ecological risk assessment planned during registration revie w will allow the Agency to determine whether use of pyraclostrobin has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s us e “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As require d by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, develo pmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertil ity, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in differen t taxonomic groups. As part of it s most recent registration decision for pyraclostrobin , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), pyraclostrobi n is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to

interact with the estr ogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which , if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any

adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship between the dose and the E, A, or T ef fect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 iner t ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 7 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be

construed as a list of kn own or likely endocrine disruptors. Pyraclostrobin in not included in either the first or second tier of the EDSP screening.

7 See http://www.regulations.gov/#!documentDetail;D=EPA

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Page 15 of 15 For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test gui delines and the Tier 1 screening battery, please visit our website. 8

HUMAN STUDIES:

The risk assessments which have been previously conducted for pyraclostrobin relied in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED), the Outdoor Residential Exposure Task Force (ORETF), and the Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting these multi

pesticide gen eric exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

8 http://www.epa.gov/endo/