2

Triallate Preliminary Work Plan – Table of Contents

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

ANTICIPATED DATA NEEDS .................................................................................................... 4

STATUTORY AND REGULATORY AUTHORITY................................................................... 6

CHEMICAL FACTS ...................................................................................................................... 6

USE AND USAGE INFORMATION............................................................................................ 7

RECENT ACTIONS....................................................................................................................... 9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW................................ 9

TIMELINE.................................................................................................................................... 12

NEXT STEPS ............................................................................................................................... 12

Appendix – Additional Areas Considered in the Triallate Registration Review...................... 13

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents:

1. Registration Review Problem Formulation for Triallate. Zhong, He; Khan, Faruque; Seifu, 

Edom. August 21, 2014.

2. Triallate Human Health Risk Assessment Scoping Document in Support of Registration 

Review. LaMay, Alexandra; Savoia, Peter; Irwin, William. August 8, 2014.

3. Triallate Tier I Review of Human Incidents. Evans, Elizabeth. May 8, 2014.

4. BEAD Chemical Profile (BCP) for Registration Review: Triallate (078802). Phillips, Bill; 

Alsadek, Jihad; Smearman, Stephen. September 15, 2014.

5. Triallate (078802) Screening Level Usage Analysis (SLUA). January 14, 2014.

These and other supporting documents for the triallate registration review case may be found in

the docket EPA-HQ-OPP-2014-0573 at http://www.regulations.gov.
3

OVERVIEW

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

registration review (docket number EPA-HQ-OPP-2014-0573). Triallate is a pre-emergent 

herbicide registered for agricultural use on barley, Bermuda grass (grown for seed and hay),

lentils, peas (dried and succulent), triticale, sugar beets, and wheat to control certain types of 

weeds such as wild oat, bromegrass, Japanese brome, cheat, downy brome, yellow foxtail, 

pigeon grass, green foxtail, and annual ryegrass. This Preliminary Work Plan (PWP) document 

explains what EPA's Office of Pesticide Programs knows about triallate, 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 triallate.

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 triallate and what types of new data or other 

information would be helpful for the Agency to receive as it moves toward a decision on 

triallate. 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 triallate. 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 triallate. 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.
4

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for triallate and for the degradate 2,3,3-

trichloro-2-propenesulfonic acid (TCPSA). In addition, submittal of analytical reference 

standards is anticipated to be required for TCPSA. The current stock of TCPSA standards 

available in the EPA National Pesticide Standards Repository has expired. Analytical reference 

standards of TCPSA are anticipated to be required to be provided to the Repository with an 

updated certificate of analysis (COA), or new materials sent to the Repository. For additional 

discussion of the anticipated data needs or the required submittal of analytical reference 

standards, see the Registration Review Problem Formulation for Triallate and Triallate Human 

Health Risk Assessment Scoping Document in Support of Registration Review.

Table 1: Anticipated Data Needs for the Triallate Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Triallate

835.4400 Anaerobic aquatic metabolism TGAI 24

850.6100

Environmental chemistry methods and associated 

independent laboratory validations for water and 

soil

TGAI and 

the degradate 

2,3,3-trichloro2-

propenesulfonic 

acid (TCPSA)

12

850.10252 Acute toxicity estuarine and marine organisms 

(oyster shell growth) TGAI 12

850.1035 Acute toxicity estuarine and marine organisms 

(mysid) TGAI 12

850.1045 Acute toxicity estuarine and marine organisms

(penaeid) TGAI 12

850.1055 Acute toxicity estuarine and marine organisms

(bivalve) TGAI 12

850.1075 Acute toxicity estuarine and marine organisms

(saltwater fish) TGAI 12

850.1350 Saltwater invertebrate life cycle TGAI 12

850.1400 Saltwater fish early-life stage TGAI 12

850.4550 Cyanobacteria toxicity TGAI 12

850.2100 Avian acute oral toxicity (passerine species) TGAI 12

850.2300 Avian reproduction (waterfowl) TGAI 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-HQ-OPPT-2009-0154-0028

2 Data for only one invertebrate mollusk is necessary. Data maybe generated for either the oyster (GLN 850.1025), 

penaeid (850.1045), or bivalve (850.1055). 
5

Table 1: Anticipated Data Needs for the Triallate Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Nonguideline

(GDLN) 

Special 

Study

Honeybee adult chronic oral toxicity TGAI 12

NonGDLN 

Special 

Study

Honeybee larval acute oral toxicity TGAI 12

NonGDLN 

Special 

Study

Honeybee larval chronic oral toxicity TGAI 12

NonGDLN 

Special 

Study

Whole sediment: chronic invertebrates 

freshwater, Chironomus dilutus TGAI 24

NonGDLN 

Special 

Study

Whole sediment: chronic invertebrates 

freshwater, Hyalella azteca TGAI 24

NonGDLN 

Special 

Study

Whole sediment: chronic invertebrates marine, 

Leptocheirus plumulosus TGAI 24

TGAI = technical grade active ingredient; TEP = typical end-use product;
6

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.

3

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 triallate.

CHEMICAL FACTS

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

Table 2: Chemical Facts for Triallate

PC code 078802

Case Number 2695

CAS Number 2303-17-5

Year first registered 1961

Pesticide Type Herbicide (pre-emergent)

Chemical class Thiocarbamates

Reregistration Eligibility 

Decision (RED)

March 2001

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable; tolerance reassessment was included in the RED.

 

3 http://www.epa.gov/oppsrrd1/registration_review/
7

Table 2: Chemical Facts for Triallate

Cumulative group Not applicable. Triallate has not been identified as a member of a 

cumulative group that shares a common mechanism of toxicity. 

Triallate is a member of the thiocarbamate class of pesticides; 

however, EPA has determined that the thiocarbamate pesticides 

should not undergo cumulative assessments since chemicals in the 

group do not act the same way in the body. In late 2001 and early 

2002, EPA provided an opportunity for the public to comment on 

the Agency’s common mechanism determinations for the 

thiocarbamates, which also belong to the carbamate group of 

pesticides. EPA determined that the thiocarbamates do not share 

a common mechanism of toxicity. Therefore, a cumulative risk 

assessment has not been performed.

40 CFR Citation Tolerances for triallate are established in §180.314.

Dual-use Triallate 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 triallate.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Katherine St. Clair, stclair.katherine@epa.gov, 703-347-8778

Registration Division, 

Product Manager

Kable Davis, davis.kable@epa.gov, (703) 306-0415

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for triallate. Please see the BEAD Chemical 

Profile (BCP) for Registration Review: Triallate (078802) in the registration review docket for 

more details.

Table 3: Triallate Use and Usage Information

Summary of Use Triallate is a pre-emergent herbicide registered for agricultural 

use in certain crops to control certain types of weeds such as wild 

oat, bromegrass, Japanese brome, cheat, downy brome, yellow 

foxtail, pigeongrass, green foxtail, and annual ryegrass.

Use Sites Barley, Bermuda grass (grown for seed and hay), lentils, peas 

(dried and succulent), dry bean, sugar beets, triticale, and wheat.

Summary of Usage Based on private market usage data from 1998-2012, the most 

recent years for which EPA has data, an average of approximately 

874,000 pounds of active ingredient (a.i.) were applied annually 

on approximately 792,000 acres treated. The usage of triallate 

between the years 2008 and 2012 averaged less than 160,000 

pounds of a.i. There are no reported usage data for nonagricultural use sites.
8

Table 3: Triallate Use and Usage Information

Formulation Type(s) Triallate products are formulated as emulsifiable concentrates or 

as a granular product. The granular product is a co-formulation 

with trifluralin.

Application Method(s) Depending on the crop, triallate may be applied before or after 

planting, either by ground or aerial equipment. Application is 

typically made either in the fall or in the spring, before targeted 

weed species germinate.

Technical Registrant(s) Gowan Company.

No. of Registrations Four Section 3 products4.

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 triallate labels are unclear with respect to certain application parameters. There are 

two major issues. First, the average granular size and a.i. are not specified on the 

granular product labels. Second, the minimum application intervals, maximum annual 

application rates (lbs a.i. per acre), and maximum number of applications per year are not 

specified on all registered product labels. 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 the registrants to 

clarify information on triallate product labels prior to the initiation of the registration 

review risk assessment.

 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.

 Typical application interval (days).

 State or local use restrictions.

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

market.

 Information on crops that are registered, but that EPA databases do not survey, such as 

lentils, triticale, and Bermuda grass grown for seed or hay. Information that would be 

helpful for these crops/use sites includes pounds a.i. applied, percent crop treated, 

application rates, and where and when triallate is used.

 

4 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home).
9

RECENT ACTIONS

There are no recent or pending actions for triallate. The most recent new use request was for 

Bermuda grass grown for seed and hay (petition 8F7334). This request was Conditionally 

Registered in June 2009.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for triallate was completed in 

2008 in support of a request for a new use on Bermuda grass. The most recent ecological and 

environmental fate risk assessment was completed in 2008 for the same purpose. Findings and 

conclusions from these risk assessments are summarized in the Registration Review Problem 

Formulation for Triallate and the Triallate Human Health Risk Assessment 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 uses of triallate.

For human health, EPA anticipates the need to conduct an updated drinking water assessment 

and will also consider the need for a residential bystander 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 will any changes to the

standard operating procedures or default exposure assumptions. EPA does not anticipate 

conducting updated dietary, residential, occupational, or aggregate assessments during 

registration review, unless there are significant changes to the points of departure, estimated 

drinking water concentrations, uncertainty factors, or safety factors. 

Table 4 on the following page summarizes the anticipated registration review risk assessments 

based on the EFED Problem Formulation and HED Scoping Document.
10

Table 4: Anticipated Risk Assessments for the Triallate 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 EPA anticipates conducting an updated 

comprehensive ecological risk assessment during 

registration review. The new assessment will 

incorporate the most up-to-date modeling 

methodologies, updated toxicological endpoints, and 

data submitted under the anticipated registration 

review Data Call-In Notice. 

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

triallate, see page 14 of the Problem Formulation.

Human Health

Dietary

Food No The most recent dietary exposure assessment was 

conducted for the 2008 human health risk 

assessment. No dietary risks of concern were 

identified. EPA does not anticipate conducting an 

updated dietary assessment for registration review

unless there are significant changes to the drinking

water estimated concentrations or if there are 

significant changes to the points of departure, 

uncertainty factors, or safety factors.

Drinking water Yes EPA anticipates conducting an updated drinking 

water assessment during registration review to 

incorporate updated estimated drinking water 

concentrations.

Occupational

Handlers (mixers, loaders, 

applicators)

No The most recent occupational exposure assessment 

was conducted for the 2008 human health risk 

assessment. All of the handler exposure and postapplication exposure non-cancer risk estimates were 

below the level of concern with the PPE required on 

triallate labels. EPA does not anticipate conducting 

an updated occupational assessment during 

registration review unless warranted by any changes 

to policy or points of departure.

Post-application No

Residential

Handlers No There are no residential uses registered for triallate.

Post-application Yes Residential bystander exposure resulting from offsite transport (i.e., spray drift or volatilization) may 

occur as a result of occupational applications of 

triallate. The need for a bystander risk assessment 

will be considered during registration review.

Other
11

Aggregate No An aggregate assessment evaluates the combined risk

from dietary and residential exposures. 

The most recent aggregate assessment was conducted 

for the 2008 human health risk assessment. No risks 

of concern were identified. EPA does not anticipate 

conducting an updated aggregate risk assessment for 

registration review unless there are significant 

changes to the toxicological points of departure, 

uncertainty factors, dietary exposure estimates, or 

estimated drinking water concentrations.

Cumulative No Not applicable. Triallate has not been identified as a 

member of a cumulative group that shares a common 

mechanism of toxicity. 

Triallate is a member of the thiocarbamate class of 

pesticides; however, EPA has determined that the 

thiocarbamate pesticides should not undergo 

cumulative assessments since chemicals in the group 

do not act the same way in the body. In late 2001 

and early 2002, EPA provided an opportunity for the 

public to comment on the Agency’s common 

mechanism determinations for the thiocarbamates, 

which also belong to the carbamate group of 

pesticides. EPA determined that the thiocarbamates 

do not share a common mechanism of toxicity. 

Therefore, a cumulative risk assessment has not been 

performed.

Tolerances Update The tolerance expressions for triallate should be 

revised during registration review. Please refer to 

page 12 of the HED Scoping Document.

Incidents Will check for 

updates

EPA has evaluated the available incident data and 

concludes that there does not appear to be a concern 

at this time that would warrant further investigation, 

since there were no incidents involving triallate 

reported to either IDS or SENSOR-Pesticides. The 

Agency will continue to monitor the incident 

information and if a concern is triggered, additional 

analysis will be included in the risk assessment. 

See page 12 of the Scoping Document and the 

Triallate Tier I Review of Human Incidents.
12

Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below.

 If any empirical environmental fate data related to TCPSA are available, the EPA 

encourages the registrant to provide them during the comment period. Additional 

environmental fate and physiochemical properties of TCSPA can reduce the uncertainties 

for drinking water assessments.

 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).

TIMELINE

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

review in Table 5 below.

Table 5: Projected Triallate Registration Review Timeline

Activity Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2014 – September 

Close Public Comment 2014 – November 

Case Development

Final Work Plan 2015 – February

Issue DCI 2015 – April-June

Data Submission 2017 – April-June

60-day Public Comment Period for Draft Risk 

Assessments5

2018 – Oct.-Dec.

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2019 – July-Sept.

Registration Review Decision and Begin Post-Decision 

Follow-up

2020

Total (years) 6

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 triallate.

 

5 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.
13

Appendix – Additional Areas Considered in the Triallate 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:

Triallate is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act.

6

 In addition, no Total Maximum Daily Loads (TMDL) 

have been developed for triallate.

7

 More information on impaired water bodies and TMDLs can 

be found at the Agency’s website.

8 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 Process9in 

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 triallate 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:

 

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

7http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

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

9 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
14

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

conducted for triallate. The ecological risk assessment planned during registration review will 

allow the Agency to determine whether use of triallate 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 reregistration decision and most recent registration decision for 

triallate, 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), triallate 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, 201310 and 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. 

 

10 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.
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.11

HUMAN STUDIES:

Occupational

Past triallate 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) and the 

Agricultural Reentry Task Force (ARTF) 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.

 

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