Docket Number EPA-HQ-OPP-2013-0296 www.regulations.gov



## Captan Preliminary Work Plan

Registration Review: Initial Docket

Case Number 120

June 2013

Approved by:

### ~a..<-cl P 

# :C '

Richard P. Keigwin, Jr.

Director

Date: Pesticide Re-evaluation Division

# "j**c£ ~**  Susan Lewis Acting Director

Antimicrobial Division2 

### Captan Preliminary Work Plan

– Table of Contents

Overview 3

Anticipated Data Needs 3

Statutory and Regulatory Au thority 6

Chemical Facts 6

Use and Usage Information 7

Recent Actions 8

Anticipated Risk Assessment s for Registration Review 9

Timeline 1 1

Next Steps 11

Appendix

– Additional Areas Considered i n the Captan Registration Review 1 2

References:

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

1. Registration Review Problem Formulation for Captan

. Sternberg et al

. May 2

, 2013.

2. Captan: Human Health Risk Scoping Document in Support of Registration Review.

Kidwell et al. May 1, 2013.

3. Captan: Review of Human Incidents. Recore and Evans. February 20, 2013

.

4. BEAD Chemical Profile for Registration Review: Captan

. Chango yal et al. December 11,

2012.

5. Captan Screening Level Usage Analysis. June 12, 2012.

6. PRD Label Data Report:Food/Feed and Non

- food/Non

-

feed Uses to be Considered in Registration Review Work Planning for Captan

. September 10, 2012.

These and other suppor ting documents for the captan registration review case may be found in

the docket EPA

- HQ

- OPP

- 2013

- 0296 at http://www.regulations.gov

.3

OVERVIEW

The docket for captan is now open , initiating the first public comment period for this registration

review (docket number EPA

- HQ

- OPP

- 2013

- 0296 )

. 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 i s registered for use as a seed and seed piece treatment

, as a preplant root dip

, and as a post

- harvest fruit dip. Captan is also registered for use on ornamentals

and turf

. H owever
, EPA’s 2004 Reregistration Eligibility Decision (RED) document for captan specifies that application to turf in residential sites, apartment buildings, daycare centers, playgrounds, sports fields or other residential areas is prohibited. Last, captan technical grade products are registered for formulation of fungicides and mate rial preservatives for use in paints, plastics, and adhesives , which could be used in residential areas.

Captan is formulated as a dust, granular, wettable powder, or water

- dispersible granule; as

flowable and soluble concentrate s ; and in water

- soluble p ackages. Captan may be applied by a variety of methods.

This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs

knows about captan

, highlighting anticipated data and assessment needs, identifying the types of

informatio n that would be especially useful to the Agency in conducting the review , and providing an anticipated timeline for completing the registration review for captan.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, b y sharing this information in the docket, to inform the public of what it knows about captan and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on captan

. 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 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. Interested stakeholders could include: environmental non

profit or interest gr oups; 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 captan

. Next, it discusses the statutory and regulatory authority for R egistration R eview. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for captan

. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally

in R egistration R eview along with some additional chemical case

- specific information.

ANTICIPATED DATA NEEDS

Table 1 summarizes ant icipated data needs for the conventional uses of captan in agriculture and

on ornamentals . For additional discussion of the anticipated data needs, see the following

documents: Registration Review Problem Formulation for Captan and Captan Human Health

Ri sk Scoping Document in Support of Registration Review

.4 Table 1: Anticipated Data Needs for the Captan Registration Review 1

Guideline

Number 2 Study Title Test Material 3 Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic Soil Metabolism 4 PAIRA or TGAI 24

835.4200 Anaerobic Soil Metabolism 4 PAIRA or TGAI 24

835.4400 Anaerobic Aquatic Metabolism 5 PAIRA or TGAI 24

850.2100 Avian Acute Oral Toxicity (upland game and

passerine species ) TGAI 12

850.2200 Avian Dietary Toxicity (upland game a nd

waterfowl species) TGAI 24

850.4100 Seedling Emergence and Seedling Growth 6 TEP 12

850.4150 Vegetative Vigor 6 TEP 12

850. 4 5 00 A quatic Plant Growth (aquatic non

- vascular

plant toxicity) 7 TGAI 12

850.6100 Environmental Chemistry Methods (ECM)

and Ass ociated Independent Laboratory Validation (ILV) for water TGAI 12

Non

- GDLN (Special Study) Honey Bee

– Oral Toxicity (Adult) 8 TGAI 12

Non

- GDLN (Special Study) Honey Bee

– Oral Toxicity (Larvae ) 8 TGAI 12

870.7800 Immunotoxicity 9 TGAI 12

875.2100 Turf Tr ansferable Residue 8 TEP 24

1 The anticipated data requirements listed in this table are for only the conventional uses of captan.

2 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850

– Ecological Effects Tests

– includi ng 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

3 PAIRA

– Pure active ingredient radiolabeled; TGAI

– technical grade active ingredient; TEP

– typical end

- use product

4 Data are anticipated to be required for two additiona l soil types.

5 Data are anticipated to be required for two additional sediments

. 6 Tier II definitive dose

- response data are anticipated to be required.

7 Data are anticipated to be required for a freshwater diatom species.

8 The anticipated DCI will re quire the submission and EPA review of a protocol prior to study initiation.

9 Recently, OPP published the findings of its retrospective analysis of immunotoxicity studies submitted to the Agency, concluding that none of the studies included in the analy sis resulted in a Point of Departure (POD) that is lower than the PODs selected from other available guideline toxicology studies ( http://www.epa.gov/pesticides/regulat ing/immunotoxicity

- retro

- analysis.pdf )

. EPA will consider requests for waivers for this study, particularly in light of the retrospective analysis. A weight

- of

- evidence rationale will be considered relative to the chemical’s toxicological profile, prima ry target organ system(s) and mode of toxic action, and any immuno

- related data available from structurally

- related compounds.

Table 2 summarizes the anticipated data needs to support the registration review of the antimicrobial uses of captan. At prese nt, captan technical registrations allow formulation into5

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

. If the technical registrants

inte nd to support this use, these data will be required for registration review.

Table 2: Anticipated Data Needs for Antimicrobial Uses of Captan 1

Guideline

Number 2 Study Title Test Material 3 Estimated

Timeframe

(Months from receipt of DCI) 4

Non

- GDLN
(S pecial Study) Special Leaching Study 5 ,6 Treated article 24

8 35 .3110 Ready Biodegradability T HPI 12

8 35 .3220 Porous Pot Test T HPI 12

8 35 .3240 Simulation Test

– Aerobic Sewage Treatment :

A. Activated Sludge Units T HPI 12

8 35 .3280 Simulation Test to Ass ess 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) 6 T HPI 12

850.4150 Vegetative Vigor

– Tier II (rice) 6 T H P I 12

850.4500 Algal To xicity

– Tier II ( freshwater diatom) T HPI 12

850. 3300/ Activated Sludge Respiration Inhibition

(ASRI) 7 TGAI , THPI 12

875.1100 Dermal Outdoor Exposure 8

, 10 TEP 36

875.1200 Dermal Indoor Exposure 9 ,10 TEP 36

875.1300 Inhalation Outdoor Exposure , 8,10 TEP 36

875.1400 Inhalation Indoor Exposure 9 ,10 TEP 36

875.2300 Indoor Surface Residues 1 1 Treated article 24

1 The anticipated data requirements listed in this table are for only the antimicrobial uses of captan.

2 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

- 2013

- 05

- 08/p df/2013

- 10162.pdf

for details.

3 TGAI

– technical grade active ingredient; TEP

– typical end

- use product ; THPI

– degradate of captan; treated

article

– article containing captan as a material preservative.

4 Estimated timeframe allows time for review of p rotocol s by EPA’s Human Studies Review Board (HSRB) and /or the Institutional Review Board (IRB).

5 Anticipated to be required for paints and plastics containing captan

. 6 The anticipated DCI will require the submission and EPA review of a protocol prior to study initiation.

7 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/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

-6

0021 . OECD Test Guideline 209 can also be used as guidance for this study, available online at http://www.oecd

ili brary.org/content/book/9789264070080

- en . 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.

8 Anticipated to be req uired to assess exposures from airless spray application of captan treated paints.

9 Anticipated to be required to assess exposures from open pouring of wettable powder (WP) formulations during material preservation treatment of paints, plastics and adhesiv es and during the brush and roller application of

captan

- treated paints.

10 The anticipated DCI will require the submission and review of a protocol by the HSRB prior to study initiation.

1 1 Anticipated to be required to assess incidental oral exposures f rom toddlers mouthing plastic toys and household objects treated with or containing captan.

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 prod uct 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 t o 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 change occurs, products i n the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 1

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

, and w ill 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

. T he Agency will consider benefits information and dat a 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 inform ation 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 F inal W ork P lan (FWP) and anticipated schedule fo r the registration review of captan

.

CHEMICAL FACTS

Table 3 provides a summary of the chemical facts for captan

.

http://www.epa.gov/oppsrrd1/registration_review/index.htm7 Table 3 : Chemical Facts for Captan

PC code 081301

Case Number 120

CAS Number 133

- 06

- 2

Year first registered 1951 Pesticide Type Fu ngicide

Chemical class Dicarboximide

R eregistration Eligibility Decision (R E D) 1999, Amended in 2004

Cumulative group No t applicable. Captan has not been identified as a member of a cumulative group of pesticides sharing a common mechanism of toxicity.

40 CFR Citation Tolerances for captan are established in 40 CFR § 180.103

. Dual

- use Captan technical grade active ingredient is registered for both

conventional and antimicrobial use. No captan antimicrobial end

- use products are currently registered wi th EPA.

Non

- pesticidal uses None
Antimicrobials Division, Chemical Review Manager Seiichi Murasaki

, Murasaki.seiichi@epa.gov , (703)347

- 0163

Pesticide Re

- evaluation Division, Chemical Review Manager Chri stina Scheltema, Scheltema.christina@epa.gov , (703)308

- 2201

Registration Division

, Product Manager Tony Kish

, kish.tony@epa.gov , (703)30 8

- 9443

Antimicrobials Division

, Product Manager Marshall Swindell, Swindell.marshall@epa.gov , (703)308

- 6341

USE AND USAGE INFORMATION

Table 4 summarizes the use and usage information for captan

. Please see the December 11, 2012

docum ent, BEAD Chemical Profile for Registration Review: Captan

, in the registration review

docket for more details

.

Table 4 : Captan Use and Usage Information

Summary of Use Broad

- spectrum fungicide registered for use on a variety of tree and nut

crops, gra pes, berries, vegetables, corn, soybeans, cereal grains, forage

crops, and ornamentals. Also registered for use as a seed and seed piece

treatment for numerous crops, as a preplant root dip, and as a post

harvest fruit dip. Technical grade active ingredie nt (TGAI) is registered as an antimicrobial for use in formulation of paints, plastics, and

adhesives.

Use Sites Apples, strawberries, peaches, almonds, plums, cherries are the primary use sites for captan. Captan is also registered for use on turf and ornamentals and as a seed and seed piece treatment. Although captan technical products allow use of captan in the formulati on of paints, plastics, and adhesives, there are currently no registered captan end

- use products bearing these uses. Summary of Usa ge ~2.8 million lbs active ingredient per year applied to ~ 1.5 million acres

between 2001 and 2011.8 Table 4 : Captan Use and Usage Information

Formulation Types Dust; granular; wettable powder; water dispersible granules; flowable and soluble concentrates; water soluble packages. Application M ethods Broadcast, chemigation, dust, drip treatment (to soil), and spot application. Also used as seed treatment. Technical Registrant s Makhteshim

- Agan of North America, Arysta Life Science

, Chemtura, Drexel, Albaugh, RedEagle International , and United Phosphorus International (UPI) No. of Registrations 6 7 FIFRA § 3 registrations and 10 FIFRA § 24(c) registrations

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

Certain captan labels are unclear with respect to application parameters such as the size of the treated area, retreatment intervals, or maximum annual application rates

. Without

further informatio n, EPA expects to use conservative assumptions to approximate these parameters in order to conduct a quantitative risk assessment. However, t he Agency will work with registrants to clarify information on captan product labels, especially the

maximum annua l application rates for non

- agricultural uses including golf courses, turf,

and ornamental s, such as dichondra.

C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application ra tes ; frequency of application, application intervals, and maximum number of applications per season ; and geographic limitations on use

. U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

. M edian and 90 th percentile reporte d use rates (lbs ai/ A ) from usage data

– national, state, and county

. Typical a pplication timing (date of first application and application intervals)

– national, state, and county

. Usage/use information for non

- agricultural uses , especially use on turf an d ornamentals

. Typical application interval (days)

. S tate or local use restrictions

. F oreign technical registrants not listed above who supply technical captan to the US

market

.

RECENT ACTIONS

The amended RED for captan was completed in 2004. However, c ertain product labels are missing certain elements specified in the amended RED or certain label s are unclear, especially with regard to use on turf and ornamentals . EPA will be working with the affected captan registrants to amend labels to correct these deficiencies.

On August 9, 2012, EPA granted a FIFRA §24(c) registration for use of captan to control botrytis and leaf spot on strawberries grown in Florida. O n October 2, 2012, EPA added captan to the inerts list at concentrations up to 8% in antifo ulant paints

. No registrations currently exist9

with captan as an inert, but if the Agency finds that captan is an inert ingredient of a registered product and that additional review of an individual product's registration is needed, it will review the pes ticide product label, confidential statement of formula, product

- specific data, and other pertinent data or information, as appropriate, to determine whether the registration of the individual product meets the FIFRA standard for registration or whether EP A needs to obtain additional information about the product. Most recently, EPA approved the registration of a new captan technical grade product

, UPI Captan Technical ( EPA Reg No. 70506

- 297) , on May 30,

2013.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment s for captan were completed in

1999 in preparation for the captan RED document. The occupational risk assessment was updated in 2004 for the RED amendment. T he most recent comprehensive ec ological and

environmental fate risk assessment was also completed in 1999 and amended in 2004 for the captan RED. The Agency conducted endangered species assessments evaluating the effects of registered uses of captan on Pacific Anadromous salmon and ste elhead in 2003 and effects on the

California Red

- Legged Frog in 2007. These assessments were conducted to support formal

consultations with the National Marine Fisheries Service and US Fish and Wildlife Service

. EPA also conducted ecological risk assessm ents to support applications for use of captan on ginseng in 2006 and on Florida strawberries in 2012. Findings and conclusions from these risk

assessments are summarized in the May 2 , 2013 Registration Review Problem Formulation for Captan and the May 1, 2013, Captan: Human Health Risk Scoping Document in Support of 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 re gistered 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

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

to be required for registration review

, they will be considered in the new assessment s
, as well as

an y changes to the standard operating p rocedures or default exposure assumptions

.

T able 5 summarizes the anticipated registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Document

.10 Table 5 : Anticipated Risk Assessmen ts 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.

In cidents 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 d ietary 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

as sessment 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 handler and post

application assessme nt s 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 applicat ion 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 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 reassessing toleranc e levels for international

harmonization.

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 Incidents11

TIMELINE

EPA ha s created the following estimated timeline for the completion of the captan registration

review in Table 6

.

Table 6 : Projected Captan Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Peri od 2013

– June

Close Public Comment 2013

– August Case Development

Final Work Plan 2013

– November

Issue DCI 2014 July

– September

Data Submission 201 7 July

– September

60

- day Public Comment Period for Draft Risk

Assessments 1 201 8 January

– March

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 201 8 July

– September

Registration Review Decision and Begin Post

- Decision

Follow

- up 20 20

Total (years) 7

1 The regulations governing Registration Revie w 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 generall y for draft risk assessments.

NEXT STEPS

After the 6 0

- 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 captan

.12



### Appendix

– Additional Areas Considered in the Captan Registration Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of add itional information c ould 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 A gency will work to harmonize tolerances and international maximum residue limits (MRL s ) 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 o r 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:

Captan is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 2 In addition, n o Total Maximum Daily Load s (TMDL) have been developed for captan

. 3 More information on impaired water bodies and TMDLs can

be found at the Agency’s website

. 4 The Agency invites submission of wa ter 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 Ris k Assessment and Management Process 5 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 al l 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 captan compared to the general population. Please comment if you are aware of any sub

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

ENDANGERED SPECIES :

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

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

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

5 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm13

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

conducted for captan

. The ecological risk assessment pla nned during registration review will allow the Agency to determine whether use of captan 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 SCREENIN G 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, sex ual 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 the most recent reregistration eligibility decision for captan

, 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 s ection 408(p),

captan 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 potentia l 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

- re lated 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 t est orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Captan was included on

that list and all captan registrants received an order to conduct the Tier 1 testing. Once all

re quired Tier 1 and Tier 2 data have been received and reviewed, the endpoints and safety factors used for risk assessment purposes will be examined and a new risk assessment performed if

necessary. For further information on the status of the EDSP, the pol icies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit

our website

. 6

6 http://www.epa.gov/endo/14

HUMAN STUDIES :

Occupationa l and Residentia l

Past captan risk assessments rely 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 Ha ndlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database , and the Outdoor Residential Exposure Task Force (ORETF) Database

. EPA has reviewed all the studies supporting these multi

- pesticide generic exposure databases, and ha s 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. A ll applicable requirements of

EPA’ s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been

satisfied , and t here is no regulatory barrier to continued reliance on these studies

.

AGRICULTURAL HEALTH STUDY :

Captan is among several agricultural chemicals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaboration of the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and Hea lth (NIOSH). Designed as a large long

- term epidemiological study, the AHS collects and analyzes data on the health and work practices of nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study before any disease

devel oped. The study focuses particularly on farmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall health outcomes for people who differ in whether the y have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they can show some statistical associations. More information on the AHS can be

found at: http://aghealth.nci.nih.gov . EPA is monitoring the results of the AHS and will consider this study in the registration review of captan as appropriate.