2 

### Triallate Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 3

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 4

STATUT ORY 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 summarize s 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 Incident s . 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 r egistered for agricultural use o n 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. Thi s 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 conduct ing 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 Agenc y intends, b y 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 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 groups; pesticide manufacturers; agri cultural 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 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 triallate

. Finally, the Appendix to

thi s 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.4

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for triallate and for the d egradate 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 TCPS A 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 s ent 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 Do cument in Support of Registration Review

.

Table 1: Anticipated Data Needs for the Triallate Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Triallate

835.4400 Anaerobic aquatic metabolism TGAI 24

850.6100 Environmental chemistry methods and associated

independent laboratory v alidation s for water and

soil TGAI and

the d egradate
2,3,3

- trichloro

2

- propenesulfonic acid (TCPSA) 12

850.1025 2 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 A vailability” 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 ne cessary. 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

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

guideline (GDLN) Special Study Honeybee adult chronic oral toxicity TGAI 12

Non

GDLN Special Study Honeybee larval acute o ral toxicity TGAI 12

Non

GDLN Special Study Honeybee larval chronic oral toxicity TGAI 12

Non

GDLN Special Study Whole sediment: chronic invertebrates

freshwater, Chironomus dilutus TGAI 24

Non

GDLN Special Study Whole sediment: chronic invertebrates

freshwater, Hyalella azteca TGAI 24

Non

GDLN 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 envi ronment 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

s ure that as change occurs, products in the marketplace can be used safely. Informatio n 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, Fungicid e, 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

. T he 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 F inal W ork P lan (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

R eregistration Eligibility Decision (R E D) 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;

howe ver, 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 no n

- 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 regis tered for agricultural use in certain crops to control certain types of weeds such as wild oat, bromegrass, Japanese brome, cheat, downy brome, yellow foxtail, pigeongras s, 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 mos t recent years for which EPA has data, an average of approximat ely 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

p o unds of a.i

. There are no reported usage data for non

agricultural use sites.8 Table 3 : Triallate Use and Usage Information

Formulation Type(s) Triallate products are formulated as e mulsifiable conce ntrates 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 Reg istrant (s) Gowan Company. No. of Registrations Four Section 3 products 4

. 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.

 The tri allate 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 label s prior to the initiation of the registration

review risk assessment.

 C onfirmation 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

.

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

.

 M edian and 90 th percentile reported 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

.

 Typical application interval (days)

.

 S tate or local use restrictions

.

 F oreign 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 Produ ct Label System (PPLS) w ebsite ( http://oaspub.epa.gov/pestlabl/ppls.home ).9

RECENT ACTIONS

There are no recent or pending actions for tri allate. The mo st 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 assess ment for triallate was completed in

2008 in support of a request for a new use on Bermuda grass

. T he most recent ecological and

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

conclusions from these risk as sessments are summarized in the Registration Review Problem Formulation for Triallate and the Triallate Human Health Risk Assessment S co ping 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 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 residentia l 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 operat ing p rocedures 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 factor s, or safety factors.

T able 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

Eco logical 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 antici pated registration

review D ata C all

- I n 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 asses sment 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 updat ed drinking water assessment during registration review to incorp orate updated estimated drinking water

concentrations. Occupational Handlers (mixers, loaders, applicators) No The most recent occupational exposure asses sment
was conducted for the 2008 human health risk assessment. All of the handler exposure and post

application 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 asses sment 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 off

site 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.

Other11

Aggregate No An aggregate assessment e valuates the combined risk from dietary and residential exposures.

The most recent aggregate asses sment was conducted

for the 2008 human health risk assessment. No risks of concern were identified. EPA does not anticipate

conduct ing an updated aggregate risk assessment for registration review unless there are significant changes to the toxicological points of departure, uncertainty factors, di etary 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 sh ould 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 thiocarbam ates, 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 T he t olerance 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 t his 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 analys is 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 Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particula r 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.

 Ec ological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

 Water quality m onitoring 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

6 0

- day Public Comment Period for Draft Risk

Assessments 5 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 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 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 conv entional pesticides, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk assessment s

.13



### Appendix

– Additional Areas Considered in the Triallate 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 additional inform ation 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 Agency

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 or dispariti es 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

se ction 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 q uality 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 Process 9 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 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 an y 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

- populat ions 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

7 http://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.htm14

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, th e 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

tr iallate

, 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 estr ogen, 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 ef fect.

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 iner t ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 10 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists

should be construed as a list of kn own 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 differ ent pesticides, comprise generic pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Database

. EPA has reviewed all the studies supporting

these multi

- pesticide generic exposu re 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. 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

.

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