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INTRODUCTION

Th is is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of captan

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the captan registration review docket (EPA

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. Captan is a broad spectrum fungicide registered for use on fruit and nut trees, grapes, berries, vegetables, corn, soybeans, cereal grains, and forage crops. In addition, captan is registered for use as a seed and seed piece treatment, as a pr eplant root dip, and as a post

- harvest fruit dip. Captan is also registered for use on ornamentals and turf. However, EPA’s 2004 Reregistration Eligibility Decision (RED) document for captan specifies that application to turf in residential sites, apartm ent buildings, daycare centers, playgrounds, sports fields or other residential areas is prohibited. Last, captan technical grade products are registered for formulation of fungicides and material preservatives for use in paints, plastics, and adhesives, which could be used in residential areas.

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 F IFRA 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 meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case.

Informatio n on this program is provided on the Agency’s website. 1



### The FWP begins with any update s since the PWP was issued. Next is a summary of substantive comments received during the public comment period 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 captan. Last, there is a discussion of next steps.

U PDATES SINCE THE PWP WAS ISSUED

Focus Meeting. EPA is engaging registrants and other key stakeholders early in registration review to increase the process efficiencies. T o this end, t he Agency met with several captan technical registrants on September 23 , 2013 to discuss captan use and usage, clarification of certain use patterns, and potential label amendments. Notes from th e meeting may be found in

the captan registration review docket, EPA

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SUMMARY OF COMMENTS AND AGENCY RESPONSES

D uring the 60

- day public comment period on the Captan Preliminary Work Plan, which opened

on June 26 , 2013, and closed on August 26, 2013 , the Agency received comments from the FIFRA Endangered Species Task Force (FESTF) , the Center for Biological Diversity (CBD)

, the Physicians Committee for Re s ponsible Medicine (PCRM) , the Captan Task Force, the Northwest

1 http://www.epa.gov/oppsrrd1/registration_review/

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Horticultural Council, and the Antimicrobial Exposure Assessment Task Force II (AEATF II) that primarily address the planned ecological and human health risk assessments and associated data requirements. In response to EPA’s request for comments on the specific topics of environmental justice, water quality concerns, and trade irritants , the CBD submitted comments

o n water quality and the Northwest Horticultural Council submitted comments on trade irritants. No comments were submitted on environmental justice. The CBD also submitted comments regarding the conduct of the planned endangered species assessment for cap tan.

This section summarizes public comments that resulted in changes to the registration review data needs, risk assessments, or timeline, or comments that are of a broader regulatory nature. However, this section does not capture every comment made a bout the PWP nor all of the Agency’s responses. Public comments and EPA responses in their entirety are located in the docket, EPA

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. The Agency’s response to comments on the ecological risk

assessment problem formulation and associated da ta needs are in the December 9

, 201 3 document, Response to Public Comments on the EFED Registration Review Problem Formulation for Captan.

Comments submitted by the FESTF in EPA

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Comment: Albaugh and Chemtura, two of the technical registrants for captan, are FESTF members and entitled to rely on the FESTF data.

Response: The Agency thanks FESTF for its comment and will consider the FESTF data during the captan registration review.

Comments submitted by the PCRM in EPA

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Comment: A full life

- cycle study indicated that fathead minnow (freshwater fish) growth and survival was affected at doses between 16.5 and 39.6 μg/L. The Agency likely has these data and we recommended considering whether it can be used in place of the early

- life stage test.

Response: The data mentioned in this comment appear to be from an open literature study on captan, the parent compound. The PW P lists th e fish early life stage study as an anticipated data requirement for the major degradate, THPI , not the captan parent . EPA has adequate fish data for captan, but not for THPI. This study is needed to support antimicrobial uses of captan, which involve releases to water, where captan will hydrolyze rapidly to THPI. The Agency is unable to use captan data in the assessment because captan is more toxic than TPHI, and an assessment based on captan data is likely to overestimate risk.

Comments sub mitted by the Northwest Horticultural Council in EPA

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The Northwest Horticultural Council (NHC) commented on trade irritants involving captan and the importance of captan to growers in the Pacific Northwest. NHC also provided spec ific use information for captan

, which EPA will consider during the captan registration review. Specific comments and the Agency’s response are summarized below.

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Comment: Indonesia and Saudi Arabia, who are among the top export markets for U.S. apples, do not have a maximum residue limit (MRL) for captan residues i n apples. Saudi Arabia also has no MRL for captan in pears. China has no MRL for captan in cherries. These countries are top export markets for Northwest growers; therefore, we request that
EPA harmonize MRLs for these countries with US tolerances.

Response: Du ring registration review, t he Agency will work to minimize trade irritants and

harmonize US tolerances with MRLs with its trading partners, to the extent feasible (and consistent with domestic law)

. T o facilitate this, t he Agency works with the USDA Forei gn Agricultural Service and the United States Trade Representative to identify potential trade

irritants. EPA is currently working with some of the countries identified by Northwest

Horticultural Council to assist with the develop ment of science

- based MRL s.

Comment: Captan has long been used in the Pacific Northwest for control of diseases such as apple scab, bull’s eye rot in pome fruit, and Coryneum blight on stone fruit. These diseases are of significant economic concern . In addition, control of bull’s eye rot is especially critical for fruit exported to China, due to China’s strict import requirements involving this pathogen.

Response: EPA will consider this information during the captan registration review.

Comme nts submitted by the AEATF II in EPA

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Comment: The AEATF II, described in Pesticide Registration (PR) Notice 2009

- 1, is generating data that will satisfy the anticipated data requirements for worker and post

application exposure

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he Task Force submitted a description of its work, a copy of PR Notice information 2009

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, and a list of current AEATF II member companies.

Response: EPA thanks AEATF for the submission of this information. Captan registrants

may rely on the Task Force data or they may choose other options for submitting data, as required, including generation and submission of their own data.

PLANNED DATA NEEDS

Table 1 summarizes planned data needs for the conventional uses of captan in agric ulture and on

ornamentals . For additional discussion of the data needs, see the following documents: Registration Review Problem Formulation for Captan and Captan Human Health Risk Scoping Document in Support of Registration Review

.

Table 1: Planned Data Needs for the Conventional Uses of Captan in Registration Review

Guideline

Number 1 Study Title Test Material 2 Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic Soil Metabolism PAIRA or TGAI 24

835.4200 Anaerobic Soil Metabolism PAIRA or TGAI 24

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Table 1: Planned Data Needs for the Conventional Uses of Captan in Registration Review

Guideline

Number 1 Study Title Test Material 2 Estimated

Timeframe

(Months from receipt of DCI)

835.4400 Anaerobic Aquatic Metabolism PAIRA or TGAI 24

85 0 .6 1 00 Environmental Chemistry Methods (ECM)

and Associated Independent Laboratory Validation (ILV) for water TGAI 12

850.2100 Avian Acute Oral Toxicity (upland game and

passerine species) TGAI 12

850.2200 Avian Dietary Toxicity (upland game and

waterfowl species) TGAI 24

850.4100 Seedling Emergence and Seedling Growth TEP 12

850.4150 Vegetative Vigor TEP 12

850.4500 Aquatic Plant Growth (aquatic non

- vascular

plant toxicity) TGAI 12

Non

- GDLN (Special Study) Honey Bee

– Acute Oral Toxicity (Adult) TGAI 12

Non

- GDLN (Special Study) Honey Bee

– Acute Oral Toxicity (Larvae ) TGAI 12

870.7800 Immunotoxicity TGAI 12

875.2100 Turf Transferable Residue TEP 24

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

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2 PAIRA

– Pure active ingredient radiolabeled; TGAI

– technical grade active ingredient; TEP

– typical end

- use product



### Table 2 summarizes the planned data needs to support the registration review of the antimicrobial uses of captan. At present, captan tec hnical registrations allow formulation into end use products for in

- can preservation of paints and stains, for preservation of plastics and

adhesives , and for fungicides in paint to protect painted surfaces

. For additional discussion of the data needs, se e the December 9, 2013 memo, Captan

- Anticipated Antimicrobial Risk Assessments and Data Needs for Registration Review

.

Table 2: Planned Data Needs for the Antimicrobial Uses of Captan in Registration Review

Guideline

Number 1 Study Title Test Material 2 Estimated

Timeframe

(Months from receipt of DCI)

Non

- GDLN (Special Study) Special Leaching Study 3 Treated article 24

8 35 .3110 Ready Biodegradability T HPI 12

8 35 .3220 Porous Pot Test T HPI 12

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Table 2: Planned Data Needs for the Antimicrobial Uses of Captan in Registration Review

Guideline

Number 1 Study Title Test Material 2 Estimated

Timeframe

(Months from receipt of DCI)

8 35 .3240 Simulation Test

– Aerobic Sewage Treatment : A.

Activated Sludge Units T HPI 12

8 35 .3280 Simulation Test to Assess the Biodegradability of

Chemicals Discharged to Wastewater THPI 12

850.1025 or 850.1055 Acute Toxicity Estuarine/Marine Organisms

–

Mollusk (Oyster Shell Deposition or Embryo

Larval Toxicity) THPI 12

850.1075 Acute Toxicity Estuarine/Marine Organisms

–

Fish ( preferred Silverside sp.) THPI 12

850.1400 Fish Early

- Life Stage Toxicity Test (freshwater) THPI 12

850.4100 Seedling Emergence and Seedling Growth

– Tier

II (rice) THPI 12

850.4150 Vegetative Vigor

– Tier II (rice) THPI 12

850.4500 Algal Toxicity

– Tier II ( freshwater diatom) THPI 12

850. 3300 Activated Sludge Respiration Inhibition (ASRI) 4 TGAI , THPI 12

875.1100 Dermal Outdoor Exposure 5 TEP 36

875.1200 Dermal Indoor Exposure 6 TEP 36

875.1300 Inhalation Outdoor Exposure 5 TEP 36

875.1400 Inhalation Indoor Exposure 6 TEP 36

875.2300 Indoor Surface Residues 7 Treated article 24

1 On May 8, 2013. EPA promulgated the Final Rule establishing Data Requirements for Antimicrobial Pesticides on May 8, 2013; the regulation become s effective on July 8, 2013. See http://www.gpo.gov/fdsys/pkg/FR

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for de tails.

2 TGAI

– technical grade active ingredient; TEP

– typical end

- use product ; THPI

– degradate of captan; treated

article

– article containing captan as a material preservative. 3 R equired for paints and plastics containing captan

. 4 EPA published draft guidance under guideline OPPTS 850.6800 and has since published final guidance for this under guideline OCSPP 850.3300 : http://www.regulations.gov/#!document Detail;D=EPA

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. OECD Test Guideline 209 can also be used as guidance for this study, available online at http://www.oecd

ilibrary.org/content/book/9789264070080

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. EPA expects that the results of the anticipated Activated Sludge Respiration Inhibition Test (ASRI) w ould determine which of the four biodegradation tests would be expected to be required.

5 Required to assess exposures from airless spray application of captan treated paints.

6 Required to assess exposures from open pouring of wettable powder (WP) formulations during material preservation treatment of paints, plastics and adhesives and during the brush and roller application of captan

- treated paints.

7 Required to assess incidental oral exposures from toddlers mouthing plastic toys and household objects treated with or containing captan.



### RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all registered uses of
captan

. For human health, EPA anticipates the need to conduct revised dietary (drinking water)

and occupational risk assessment s during registration review

. EPA expects to re

- evaluate the 90

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day inhalation study for captan to determine the potential for use in inhalation risk assessment. If toxicological endpoints or points of departure are revised based on the data that are anticipate d

to be required for registration review

, they will be considered in the new assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

T able 3 summarizes the planned registration review risk assessments base d on the EFED

Problem Formulation

, the HED Scoping Document , and the memo on Risk Assessment and Data

Needs for antimicrobial uses of captan.

Table 3 : Planned Risk Assessments for the Captan 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 ecological risk assessment will consider both
captan parent and THPI, the major captan degradate

. EPA expects captan parent to be the predominant

residue associated with conventional uses and THPI to be the predominant residue associated with

antimicrobial uses , although there is also potential for exposure to captan under certain conditions.

Incidents Will check for updates For a discussion of reported ecological incidents for

captan, see page 22 of the Problem Formulation.

Human Health Dietary

Food Yes Although the previous assessments showed no dietary

risks of concern, EPA may update the dietary assessment to reflect the new carcinogenicity classification and any potential changes to toxicological points of departure (PODs), uncertainty factors, or percent crop treated

. Drinking water Yes EPA anticipates conducting a new drinking water assessment that considers both captan parent and its THPI degradate. The previous drinking water assessment considered THPI only. Occupational Handlers (mixers, loaders, applicators) Yes EPA anticipates conducting new han dler and post

application assessments for ornamentals, turf, and the antimicrobial uses of captan. These assessments are expected to consider new SOPs and any new data. Post

- application Yes

Residential

Handlers Yes EPA anticipates conducting new residential handler and post application assessments for ornamentals, turf, and antimicrobial uses (use of treated paints and plastics). These assessments are expected to consider new SOPs and any new data. Post

- application Yes

Other

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

Cumulative No Although captan and folpet share the common metabolite thiophosgene, its role in captan and folpet’s toxicity has not been determined because thiophosgene is transient and not easily measurable. Therefore, the EPA has not assumed that captan has a common mechanism of toxicity with folpet or any other

substances.

Tolerances Yes EPA expects to update the captan tolerance expression

in accordance with current policy. In addition, EPA anticipates modifying tolerance levels where feasible

for international harmonization purposes

. Incidents Will check for updates For a discussion of reported human incidents for

captan, see page 16 of the Scoping Document and the February 20, 2013 memo, Captan: Review of Human

Incidents



### TIMELINE

EPA has created the following estimated timeline for the completion of the captan registration

review in Table 4

. The projected timeline has been updated since the PWP to reflect impacts of recent Agency actions shortening the timeframe between the FWP and DCI issuance and adding three months between posting draft risk assessments and proposed decisions.

Table 4 : Projected Captan Registration Review Timeline 1

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2013

– June (Completed)

Close Public Comment Period 2013

– August (Completed) Case Development

Final Work Plan 2013

– December (Completed)

Issue DCI 2014

– Jan

- March

Data Submission 2 201 7

– Jan

- March

60

- day Public Comment Period for Draft Risk Assessments 1 201 8

– July

- Sept Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 201 9 July

- Sept

Registration Review Decision & Begin Post

- Decision Follow

- up 20 20 Total (years) 7

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 6 0 calendar day public comment period generally for draft risk assessments.

2 The time fram e for data submission allows 3 years for human exposure monitoring studies , to allow for

r eview by the Human Studies Review Board.

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NEXT STEPS

The Agency plans to require several environmental fate, ecological effects, and human health studies for captan through a Data Call

- In Notice expected to be issued in early 2014.