Docket Number EPA-HQ-OPP-2014-0576 

www.regulations.gov 

Triclopyr Preliminary Work Plan 

Registration Review: Initial Docket 

Case Number 2710 

Approved by: 

Date: 

December 2014 · 

~tJIClA~ct p ~U- ~ 

Richard P. KeigWiJ;,; 

Director 

Pesticide Re-evaluation Division 
Triclopyr 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 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8 

TIME LINE .................................................................................................................................... 10 

NEXT STEPS ............................................................................... ................................................. 10 

Appendix - Additional Areas Considered in the Triclopyr Registration Review .................... 11 

References: 

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

based on the following documents: 

1. Registration Review: Preliminary Problem Formulation for Environmental Fate and 

Ecological Risk, Endangered Species and Drinking Water Assessments for Triclopyr. 

Montague, Brian and Liu, Larry. November 13, 2014. 

2. Triclopyr; Triclopyr, Triethylamine Salt (TEA); and Triclopyr, Butoxyethyl Ester (BEE). 

Human Health Assessment Scoping Document in Support of Registration Review. Tyler, 

Jennifer; Perron, Monique M.; Venkateshwara, Lata. November 12, 2014. 

3. Triclopyr, salt and esters: Review of Human Incidents. Evans, Elizabeth and Recore, 

Shanna. April29, 2013. 

4. BEAD Chemical Profile (BCP) for Registration Review: Triclopyr Case. March 13, 2014. 

5. Triclopyr Case Screening Level Usage Analysis (SLUA). April19, 2013. 

6. Environmental Fate and Effects Division Spreadsheet: PC Codes: 116001, 116002, and 

116004. April 11 , 2014. 

7. Health Effects Division Master Label Spreadsheet: PC Codes: 116001, 116002, and 

116004. May 16, 2014. 

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

the docket EPA-HQ-OPP-2014-0576at http://www.regulations.gov. 

2 
OVERVIEW 

The docket for the triclopyr acid and its salts and esters case is now open, initiating the first 

public comment period for this registration review (docket number EPA-HQ-OPP-2014-0576). 

This case includes the following active ingredients: triclopyr acid, triclopyr triethylamine salt 

(TEA), and triclopyr butoxyethyl ester. Triclopyr acid and its salts and esters (which will be 

collectively referenced to as triclopyr throughout the PWP) are systemic herbicides within the 

pyridine carboxylic acid chemical family registered for the control of a number of woody plant 

and weed species. They are registered for use on a number of agricultural crops including rice 

and for nonagricultural use on range and pasture land, forests, rights of way, on turf (commercial 

and homeowner), and numerous aquatic areas for aquatic weed control. This Preliminary Work 

Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about triclopyr, 

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 triclopyr. 

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 triclopyr and what types of new data or other 

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

triclopyr. 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 PWP begins by listing the anticipated data needs for triclopyr. 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 triclopyr. 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. 

3 
ANTICIPATED DATA NEEDS 

Table 1 below summarizes anticipated data needs for triclopyr. For additional discussion of the 

anticipated data needs, see: 

• Registration Review; Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure 

Assessments for Triclopyr [Triclopyr Acid (PC Code 116001), Triclopyr Triethylamine 

Salt (PC Code 116002), and Triclopyr Butoxyethyl Ester (PC Code 116004)} 

• Triclopyr; Triclopyr, Triethylamine Salt (TEA); and Triclopyr, Butoxyethyl Ester (BEE). 

Human Health Assessment Scoping Document in Support of Registration Review. 

Table 1: Anticipated Data Needs for the Triclopyr Registration Review 

Estimated 

Guideline Timeframe 

Number1 Study Title1 

Test Material (Months from 

receipt of 

DCI) 

Anticipated Data Needs for Triclopyr 

835.2240 Aqueous photolysis TGAI (acid) 12 

835.4200 Anaerobic soil metabolism TGAI (acid, 12 TEA, and BEE) 

835.4300 Aerobic aquatic metabolism TGAI(BEE) 12 

835.4400 Anaerobic aquatic metabolism TGAl (BEE) 12 

850.1300 Freshwater invertebrate lifecycle TGAI(BEE) 12 

850.1350 Estuarine/marine invertebrate lifecycle TGAI (BEE) 12 

850.1730 Fish BCF TGAI(BEE) 12 

850.2100 Avian oral toxicity - Passerine TGAI (acid) 12 

870.3465 Subchronic (90-day) inhalation toxicity study TGAI 12 

860.1340 Residue analytical rriethods2 TGAI 12 

875.2100 Turf transferable residue study TEP 12 

Non-GDLN 

(OECD 

Test Honey bee adult acute oral toxicity TGAI (acid) 12 

Guideline 

213) 

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, 20 12. 

http://www.regulations.gov/# !documentDetail;D=EP A-HO-OPPT -2009-0154-0028 2 The results of a radio-validation study are needed to ensure the ability of the GC/MS method GRM97.02 to recover 

aged residues. 

4 
Table 1: Anticipated Data Needs for the Triclopyr Registration Review 

Estimated 

GuideHne Timeframe 

Number Study Title1 

Test Material (Months from 

receipt of 

DCI) 

Non-GDLN 

(OECD 

Test Honey bee larvae acute oral toxicity TGAI(acid) 12 

Guideline 

237) 

Non-GDLN Honey bee adult chronic oral toxicity TGAI (acid) 12 

Non-GDLN Honey bee larvae chronic oral toxicity TGAI (acid) 12 

Non-GDLN 

(OECD 

Test Semi-field testing for pollinators TEP 24 

Guidance 

75) 

Anticipated Data Needs for TCP Degradate 

850.1400 Fish Early Life Stage3 TCP 12 

TGAI = techmcal grade active mgredtent; TEP = typical end-use product 

3 Data requirement pending review of submitted study. 

5 
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.4 

The Agency is implementing the registration review program pursuant to Section 3(g) ofthe 

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 triclopyr. 

CHEMICAL FACTS 

Table 2 provides a summary of the chemical facts for triclopyr 

Table 2: Chemical Facts for Triclopyr 

PC code 116001 (triclopyr), 116002 (triclopyr, triethylamine salt, TEA), 

116004 (triclopyr, butoxyethyl ester, BEE) 

Case Number 2710 

CAS Number 57213-69-1, 57213-69-1, 64700-56-7 

Year first registered 1979 (TEA), 1980 (BEE), 2005 (triclopyr) 

Pesticide Type Herbicide 

Chemical class Pyridine 

Reregistration Eligibility October 1998 

Decision (RED) 

Tolerance Reassessment Not applicable. Tolerance reassessment was included in the RED. 

Eligibility Decision 

(TRED) 

4 http://www.epa.gov/oppsrrd 1/registration_review/ 

6 
Table 2: Chemical Facts for Triclopyr 

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

cumulative group that shares a common mechanism of toxicity 

40 CFR Citation Tolerances for triclopyr are established in 40CFR 180.417. 

Dual-use Triclopyr 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 triclopyr. 

Pesticide Re-evaluation Brittany Pruitt, pruitt.brittany@epa.gov, 703-347-0289 

Division, Chemical 

Review Manager 

Registration Division, Kathryn Montague, montague.kathryn@epa.gov, 703-305-1243 

Product Manager 

~ 

USE AND USAGE INFORMATION 

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

Profile (BCP) for Registration Review: Triclopyr Case in the registration review docket for more 

details. 

Table 3: Triclopyr Use and Usage Information 

Summary of Use Triclopyr is a systemic herbicide that belongs to the pyridine 

carboxylic acid family and it is 4sed as a post-emergence 

herbicide to control annual and perennial broadleaf weeds and 

woody plant species in many agricultural and non-agricultural use 

sites. 

Use Sites Registered agricultural use sites include alfalfa, almonds, apples, 

asparagus, beans, beech nut, blackberries, brazil nut, cashews, 

chestnuts, cole crops, citrus trees, conifer release, , com (field, 

pop, and sweet), flax, hazelnuts, lentils, macadamia nuts, mint, 

oats, onions, pastures, peas, pecans, pistachio nuts, potatoes, rice, 

safflower, sorghum, soybeans, strawberries, sugar beets, 

sunflower, vegetable crops, walnuts, wheat, and yucca. 

Registered non-agricultural use sites include agricultural 

buildings, airports, cabins, camp sites, canals, Christmas tree 

plantings, domestic dwellings, patios, fencerows, forest lands, 

industrial sites, ornamental woody plants, ornamental lawns, 

ornamental turf, ornamental trees, farm buildings, aquatic areas, 

wetlands, rights-of-way, and recreational areas. 

Summary of Usage The major uses include pasture and hay with minor use in 

orchards or vineyards. 

Formulation Type(s) Soluble concentrate, emulsifiable concentrate, liquid (pressurized 

and ready-to-use), granular, wettable powder, and pelleted. 

Application Method(s) Ground (granular) application, tree trunk or stump injection, bark 

treatment, foliar spray, soil injection, and aerial applications. 

7 
Table 3: Triclopyr Use and Usage Information 

Technical Registrant(s) Nufarm Limited; Albaugh, Inc.; Dow AgroSciences, LLC.; Repar 

Crop; Celsius Property 

No. ofRegistrations 142 Section 3 prodticts5

; 9 Section 24(c) Special Local Needs 

(SLNs) products. 

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 triclopyr labels are unclear with respect to application parameters such as the size 

of the treated area, the extent of a treated "spot," 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 

triclopyr product labels, especially the maximum annual application rates for nonagricultural uses including golf courses, turf, and ornamental lawns. 

• 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 l;lSe. 

• Use distribution (e.g., acreage and geographical distribution of relevant use sites). 

• Median and 901

h percentile reported use rates (lbs ail 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. 

• Typical application interval (days). 

• State or local use restrictions. 

• Foreign technical registrants not listed above who supply technical triclopyr to the U.S. 

market. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent quantitative human health risk assessment was performed in 2002 for a new use 

request on aquatic sites. The most recent ecological and environmental fate risk assessment was 

completed in 2002 for the same reason. Findings and conclusions from these risk assessments are 

summarized in: 

• Registration Review; Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure 

Assessments for Triclopyr, Triclopyr Triethylamine Salt, and Triclopyr Butoxyethyl Ester 

• Triclopyr; Triclopyr, Triethylamine Salt (TEA), and Triclopyr Butoxyethyl Ester (BEE). 

Human Health Assessment Scoping Document in Support of Registration Review. 

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

(http:/ I oaspub .epa. gov /pest lab 1/ppls.home). 

8 
During registration review, the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of triclopyr. 

For human health, EPA anticipates the need to conduct revised dietary, residential, occupational 

and aggregate risk assessments during registration review. 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 4 below summarizes the anticipated registration review risk assessments based on the 

Preliminary Problem Formulation and Human Health Assessment Scoping Document. 

Table 4: Anticipated Risk Assessments for the Triclopyr Registration Review 

Type of Risk Assessment Conduct? Notes 

-..,.- . . · ud Eaviromaeatal Fate 

Comprehensive ecological y 

(species to be assessed include 

terrestrial and aquatic 

organisms), including 

endangered species 

Incidents Will For a discussion of reported ecological incidents for triclopyr, 

check for see page 33 of the Preliminary Problem Formulation. 

updates 

BIIIUDHealda 

Dietary 

Food y 

Drinking water y 

Occupational 

Handlers (mixers, loaders, y 

applicators) 

Post-application y 

Residential 

Handlers y 

Post-application y 

Other 

Aggregate y Evaluates the combined risk from dietary and residential 

exposures. 

Cumulative N Triclopyr has not been identified as a member of a cumulative 

group that shares a common mechanism of toxicity. 

Tolerances y During registration review, the Agency will evaluate the need 

to harmonize tolerances with Canadian MRLs and the need to 

update the current tolerance expressions. 

Incidents Will For a discussion of reported human incidents for triclopyr, see 

check for page 13 of the Human Health Assessment Scoping Document 

updates and the Triclopyr, salts and esters: Tier I Review of Human 

Incidents. 

9 
Guidance for Commenters: Additional ecological information requested for this 

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

• Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) nqt already reported to the Agency. 

• Water quality monitoring data (see Appendix for further details). 

TIME LINE 

EPA has created the following estimated time line for the completion of the triclopyr registration 

review in Table 5 below. 

Table 5: Projected Triclopyr Registration Review Timeline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period 2014 - December 

Close Public Comment 2015 - February 

Case Development 

Final Work Plan 2015 -May 

Issue DCI 2015 July- Sept. 

Data Submission 2017 July- Sept. 

60-day Public Comment Period for Draft Risk 20 19 Jan. - March 

Assessments6 

Registration Review Decision 

60-day Public Comment Period for Proposed 20 19 Oct. - Dec. 

Registration Review Decision 

Registration Review Decision and Begin Post-Decision 2020 

Follow-up 

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 oftriclopyr. 

6 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. 

10 
Appendix - Additional Areas Considered in the Triclopyr 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 ofMRLs 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: 

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

section 303(d) of the Clean Water Act. 7 In addition, no Total Maximum Daily Loads (TMDL) 

have been developed for triclopyr.8 More information on impaired water bodies and TMDLs can 

be found at the Agency's website.9 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 ofthe OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other 

Water Quality Data in OP P 's Registration Review Risk Assessment and Management Process10 

in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments. 

Triclopyr is identified as a cause of impairment, as defined under section 303( d) of the Clean 

Water Act, for one water body in California, based on information provided at EPA's website. 11 

In addition, Total Maximum Daily Loads (TMDL) have been developed for triclopyr in two 

impaired water bodies in Alabama and one in Louisiana, based on information provided at the 

website. 12 More information on impaired water bodies and TMDLs can be found at EPA's 

website. 13 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 

7 http://iaspub.epa.gov/tmdl waters10/attains nation cy.cause detail 303d?p cause group id=885 

8http://iaspub.epa.gov/tmdl waters 1 Of attains nation.tmdl pollutant detail?p pollutant group id=885&p pollutant 

group name=PESTICIDES 

9 http://www.epa.gov/owow/tmdl/ 10 http://www.epa.gov/oppsrrd 1/registration review/water quality sop.htm 11 http://iaspub.epa.gov/tmdl_ waters 1 0/attains~nation cy.cause detail 303d?p cause group id=885 12http://iaspub.epa.gov/tmdl waters 1 0/attains nation.tmdl pollutant detail?p pollutant group id=885&p pollutant 

group name=PESTICIDES 13 http://www.epa.gov/owow/tmdl/ 

11 
Data in OP P 's Registration Revie~ Risk Assessment and Management Process14 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 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 triclopyr 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: 

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

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

allow the Agency to determine whether use of triclopyr 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. 

A previous endangered species assessment for the California red-legged frog was conducted for 

triclopyr in October 2009. 

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 for triclopyr, EPA reviewed these data 

and selected the most sensitive en~points for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p ), triclopyr 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 

14 http://www.epa.gov/oppsrrd I /registration review/water gualitv sop.htm 

12 
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 14,201315 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. 

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. 16 

HUMAN STUDIES: 

Occupational and Residential 

Past triclopyr 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 ofResearch'(40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies. 

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

chemicals. 

t6 http://www.epa.gov/endo/ 

13