Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

Page 2 of 15

Contents

OVERVIEW ................................................................................................................................... 3

ANTICIPATED DATA NEEDS ................................................................................................... 3

STATUTORY 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 Assessment Scoping Document in Support 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 Chemical 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. Prieto, Rafael. April 3, 2014.

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

found in the docket EPA-HQ-OPP-2014-0051at http://www.regulations.gov.
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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-HQ-OPP-2014-0051). 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. Pyraclostrobin 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 pyraclostrobin.

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 pyraclostrobin 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 and additional information that will help the Agency’s decisionmaking 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. Interested 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 

Registration 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 

Pyraclostrobin and the Human Health Assessment Scoping Document in Support of Registration 

Review.
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

Page 4 of 15

Table 1: Anticipated Data Needs for the Pyraclostrobin Registration Review

Guideline 

Number1 Study Title1

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 

TEP: 

pyraclostrobinmetiram 

12

NonGuideline

Honeybee adult chronic toxicity TGAI and 

TEP 12

NonGuideline

Honeybee larval chronic toxicity TGAI 12

Nonguideline

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 health 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 

statutory 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 pesticides 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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 

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. 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 pesticide 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 develop 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 mechanism of toxicity finding with 

pyraclostrobin. Pyraclostrobin does not appear to produce a toxic 

metabolite produced by other substances.

40 CFR Citation Tolerances for pyraclostrobin are established 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

 

2 http://www.epa.gov/oppsrrd1/registration_review/
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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 (099100) in the registration review docket for 

more details.

Table 3: Pyraclostrobin 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 translaminar 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, conifer, corn, cotton, cucurbits, 

currant, flax, fruiting vegetables, ginseng, grapes, hops, leafy 

vegetables, lentils, melons, mint, mustard, nut trees, oats, oil crops, 

okra ,olives, parsley, peas, pome fruits, rapeseed root crops, rye, 

safflowers, small 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-HQ-OPP-2014-0051

www.regulations.gov

Page 7 of 15

Table 3: Pyraclostrobin Use and Usage Information

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

and floriculture.

Formulation Type(s) Pyraclostrobin is formulated as granular, 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, tomato 

transplants grown for the home consumer market, Belgian endive, persimmon, oilseed crops, 

turnip greens, and homeowner ornamentals 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 benefits of pyraclostrobin. Information regarding 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.

 Usage/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-HQ-OPP-2014-0051

www.regulations.gov

Page 8 of 15

RECENT ACTIONS

The Agency has received 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 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 purpose. Findings and conclusions from these risk 

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. For 

human health, EPA anticipates the need to conduct revised dietary, residential, and occupational risk 

assessments 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. Any changes to the standard operating procedures or 

default exposure assumptions will be considered in any new assessments that may be conducted.

Table 4 below summarizes the anticipated registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document.
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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 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 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 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.

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 postapplication assessments are not expected to be 

conducted during Registration Review; however, the 
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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 

mechanism of toxicity finding with pyraclostrobin. 

Pyraclostrobin 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 Scientific Advisory Panel, proposes a screening-level risk 

assessment process that includes acute and chronic toxicity tests with adult and larval bees. 

Pyraclostrobin acute toxicity data is needed for larval honeybees 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 

Formulation for more detail):
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

Page 11 of 15

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 absence 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 information, 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 

registration 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 conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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-HQ-OPP-2014-0051

www.regulations.gov

Page 13 of 15

Appendix – Additional Areas Considered in the Pyraclostrobin 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 residue 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 markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality:

Pyraclostrobin is 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 addition, 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 extent 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 Process6in 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 atypical, 

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

4http://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/

6 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

Page 14 of 15

ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been 

conducted for pyraclostrobin. The ecological risk assessment planned during registration review 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 use “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 required 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, developmental, 

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, fertility, 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 different taxonomic groups. As part of its 

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), pyraclostrobin 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 estrogen, 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 effect. 

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 inert ingredients. A second list of chemicals 

identified for EDSP screening was published on June 14, 20137and includes some pesticides 

scheduled for registration review and chemicals found in water. Neither of these lists should be 

construed as a list of known 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-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.
Docket Number EPA-HQ-OPP-2014-0051

www.regulations.gov

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 guidelines 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 multipesticide generic 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/