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 

"jSusan Lewis c£~ Acting Director 

Antimicrobial Division 
2

Captan Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 3

Statutory and Regulatory Authority 6

Chemical Facts 6

Use and Usage Information 7

Recent Actions 8

Anticipated Risk Assessments for Registration Review 9

Timeline 11

Next Steps 11

Appendix – Additional Areas Considered in the Captan Registration Review 12

References:

This Preliminary Work Plan summarizes 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. Changoyal 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 supporting 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 is 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. However, 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 material 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 concentrates; and in water-soluble packages. 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 

information 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, by 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 nonprofit 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 captan. 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 captan. 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 summarizes anticipated 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 

Risk Scoping Document in Support of Registration Review. 
4

Table 1: Anticipated Data Needs for the Captan Registration Review1

Guideline 

Number2 Study Title

Test Material3

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.4100 Aerobic Soil Metabolism4PAIRA or TGAI 24

835.4200 Anaerobic Soil Metabolism4PAIRA or TGAI 24

835.4400 Anaerobic Aquatic Metabolism5PAIRA or TGAI 24

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 Growth6TEP 12

850.4150 Vegetative Vigor6 TEP 12

850.4500 Aquatic Plant Growth (aquatic non-vascular 

plant toxicity) 7 TGAI 12

850.6100

Environmental Chemistry Methods (ECM) 

and Associated 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 Immunotoxicity9TGAI 12

875.2100 Turf Transferable Residue8 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 

– 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

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 additional 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 require 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 analysis 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/regulating/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, primary 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 present, captan technical registrations allow formulation into 
5

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 

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

Table 2: Anticipated Data Needs for Antimicrobial Uses of Captan1

Guideline 

Number2 Study Title

Test Material3

Estimated 

Timeframe

(Months from 

receipt of 

DCI)4

Non-GDLN

(Special 

Study) 

Special Leaching Study5,6 Treated article 24

835.3110 Ready Biodegradability THPI 12

835.3220 Porous Pot Test THPI 12

835.3240 Simulation Test – Aerobic Sewage Treatment: 

A. Activated Sludge Units THPI 12

835.3280 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 EmbryoLarval 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 THPI 12

850.4150 Vegetative Vigor – Tier II (rice)6 THPI 12

850.4500 Algal Toxicity – Tier II (freshwater diatom) THPI 12

850.3300/ Activated Sludge Respiration Inhibition

(ASRI)7 TGAI, THPI 12

875.1100 Dermal Outdoor Exposure8,10 TEP 36

875.1200 Dermal Indoor Exposure9,10 TEP 36

875.1300 Inhalation Outdoor Exposure,8,10 TEP 36

875.1400 Inhalation Indoor Exposure9,10 TEP 36

875.2300 Indoor Surface Residues 11 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 becomes effective on July 8, 2013. See http://www.gpo.gov/fdsys/pkg/FR-2013-05-

08/pdf/2013-10162.pdffor 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 protocols 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.oecdilibrary.org/content/book/9789264070080-en. EPA expects that the results of the anticipated Activated Sludge 

Respiration Inhibition Test (ASRI) would determine which of the four biodegradation tests would be expected to be 

required.

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

9Anticipated to be 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.

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

11 Anticipated to be required to assess incidental oral exposures from 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 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 change occurs, products in the marketplace can be used safely. Information 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 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 captan.

CHEMICAL FACTS

Table 3 provides a summary of the chemical facts for captan.

 

http://www.epa.gov/oppsrrd1/registration_review/index.htm
7

Table 3: Chemical Facts for Captan

PC code 081301

Case Number 120

CAS Number 133-06-2

Year first registered 1951

Pesticide Type Fungicide

Chemical class Dicarboximide

Reregistration Eligibility 

Decision (RED)

1999, Amended in 2004

Cumulative group Not 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 with 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

Christina Scheltema, Scheltema.christina@epa.gov, (703)308-2201

Registration Division, 

Product Manager

Tony Kish, kish.tony@epa.gov, (703)308-9443

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 

document, 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, grapes, 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 postharvest fruit dip. Technical grade active ingredient (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 formulation of paints, 

plastics, and adhesives, there are currently no registered captan end-use 

products bearing these uses.

Summary of Usage ~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 Methods Broadcast, chemigation, dust, drip treatment (to soil), and spot 

application. Also used as seed treatment.

Technical Registrants Makhteshim-Agan of North America, Arysta Life Science, Chemtura, 

Drexel, Albaugh, RedEagle International, and United Phosphorus 

International (UPI)

No. of Registrations 67 FIFRA § 3 registrations and 10 FIFRA § 24(c) registrations 

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.

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 information, EPA expects to use conservative assumptions to approximate these 

parameters in order to conduct a quantitative risk assessment. However, the Agency will

work with registrants to clarify information on captan product labels, especially the 

maximum annual application rates for non-agricultural uses including golf courses, turf, 

and ornamentals, such as dichondra. 

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, especially use on turf and ornamentals.

Typical application interval (days).

State or local use restrictions.

Foreign 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, certain product labels are 

missing certain elements specified in the amended RED or certain labels 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. On October 2, 2012, EPA added captan 

to the inerts list at concentrations up to 8% in antifoulant paints. No registrations currently exist 
9

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 pesticide 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 EPA 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 assessments 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. The most recent comprehensive ecological 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 steelhead 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 assessments 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, the 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 assessments during registration review. EPA expects to re-evaluate the 90-

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 anticipated 

to be required for registration review, they will be considered in the new assessments, as well as 

any changes to the standard operating procedures or default exposure assumptions.

Table 5 summarizes the anticipated registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document.
10

Table 5: Anticipated 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.

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 handler and postapplication 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

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 tolerance 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 Incidents
11

TIMELINE

EPA has 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 Period 2013 – June

Close Public Comment 2013 – August

Case Development

Final Work Plan 2013 – November

Issue DCI 2014 July – September

Data Submission 2017 July – September

60-day Public Comment Period for Draft Risk 

Assessments1

2018 January – March

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2018 July – September

Registration Review Decision and Begin Post-Decision 

Follow-up

2020

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 60 calendar day public comment period generally for draft risk assessments.

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 captan.
12

Appendix – Additional Areas Considered in the Captan 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:

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, no Total Maximum Daily Loads (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 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 Process5in 

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 captan 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.

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.htm
13

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

conducted for captan. The ecological risk assessment planned 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 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 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 section 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 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. Captan was included on 

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

required 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 policies 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:

Occupational and Residential

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 Handlers 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 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.

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 Health (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 

developed. 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 they 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.