Docket Number EPA-HQ-OPP-20 14-0576 www.regulations.gov



# Triclopyr Preliminary WorkPlan Registration Review: Initial Docket Case Number 2710

Approved by:

Date: 

# December 2014 ·**~tJIClA~ct** 

## p**~U- ~**  Richard P. KeigWiJ;,; Director Pest icide Re

-evaluation Division

### Triclopyr Preliminary WorkPlan- Table ofContents

OVERVIEW
....................... ....... .................................................:..... .............................................. 3 ANTICIPATED DATA NEEDS
.................. .......................................................... ........................ 4 STATUTORY AND REGULATORY AUTHORITY
...................................................... ............. 6 CHEMICAL FACTS

................. ..................................................................................................... 6 USE AND USAGE INFORMATION

............. .................................... .. ...... .. ....... .......................... 7 ANTICIPATED RISK ASSESSMENTS FORREGISTRATION 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 currentposition based on the following documen ts: 1. Registration Review: PreliminaryProblem Formulation for EnvironmentalFate and Ecological Risk, EndangeredSpecies andDrinking WaterAssessments for Triclopyr. Montague, Brian and Liu, Larry. November 13, 2014. 2. Triclopyr; Triclopyr , Triethylamine Salt (TEA); and Triclopyr , Butoxyethyl Ester (BEE). Human HealthAssessmentScopingDocument in Supportof RegistrationReview. Tyler, Jennifer; Perron, Monique M.; Venkateshwara, Lata. November 12, 2014. 3. Triclopyr , saltandesters: Review of Human Incidents. Evans, Elizabeth and Recore, Shanna. April29, 2013. 4. BEAD Chemical Profile (BC P)for Registration Review: Triclopyr Case. March 13, 2014. 5. Triclopyr Case ScreeningLevel Usage Analysis (SLUA). April19, 2013. 6. Environmental Fate andEffects 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, 20 14.

These and other supporting documents for the triclopyrregistration review case maybe found in the docket EPA

-HQ-OPP

-2014-0576athttp://www.regulations.gov.

2OVERVIEW The docket for the triclopyr acid and its salts and esters case is now open, initiating the first public comment period forthis 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 ofa number ofwoody plant and weed species. They are registered for use on a number ofagricultural crops including rice and for nonagricultural use onrange 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 ofPesticide Programs knows about triclopyr, highlighting anticipated data and assessment needs, identifying the types ofinformation that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for triclopyr. Theregistration 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 ofwhat itknows about triclopyr and what types ofnew 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 informationthat will help the Agency's decisionmaking process for this chemical. In addition to general areas on whichpersons may wish to comment, there are some areas identified inthe PWP and Appendix aboutwhich 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, institutiona l, residential, and other users ofpesticides; orthe 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 reviewtimeline for triclopyr. Finally, the Appendix to this document includes identification and discussion ofsome areas that are considered generally in registration review along with some additional chemical case-specific information.

3ANTICIPATED DATA NEEDS Ta ble 1 below summarizes anticipated data needs for triclopyr. For additional discussion of the anticipated data need s, se e : • Registration R eview; Preliminary Pr ob l em Form ulation for Environmental Fate, Ecological Risk , Endangere d Species , and Human Health Drinking Water Exposure Assessments for Triclo p yr [Triclopyr Acid (PC Code 116001 ), Triclopyr Triethylamine Salt (PC Code 116002) , and T r iclopyr Butoxyethyl Ester (PC Code 116004)} • Triclopyr ; Triclopyr, Triethylamine Salt (TEA); and Triclopyr, Bu t oxyethyl Ester (BEE). Human Health Assessment Scoping Do c ument in Support of R egistration Review. Table 1: Anticipated Data Needs for the Triclopyr Registration Review Estimated Guideline Timeframe

Number 1 Study Ti tle 1 Test Material (Months fromreceipt of DCI) Anticipated Data Needs for Triclopyr 835.2240 Aqueous photolysis TGAI (ac id) 12 835.4200 Anaerobic so il metabolism TGAI (acid, 12 TEA, and BEE) 835.4300 Aerobic aquatic metaboli sm TGA I(BEE) 12 835.4400 A n ae r obic aqu a t i c metabolism TGAl ( BEE) 12 850.1300 Freshwate r invertebrate lifecycle TG AI(BEE) 12 850.1350 Estuarine/ma rine inv e rt e bra te lifecycle T GAI ( BEE) 12 850.1 7 30 F i s h BCF TG AI(BEE) 12 850.2100 Avian o ral toxicity

- Passerine TGAI (acid) 12 870 .34 65 S ubchr o nic (90-day) inhala t ion toxicity study TGAI 12 860.1340 R esid ue ana l yt ical rrieth ods 2 TGAI 12 875.2100 Tu r f tra n s ferable residue s tud y TE P 12 No n- GDLN ( OECD T est Honey bee adult acute oral toxicity T GA I (acid) 12 Guideline 213) 1 On J une 27, 2012, EPA announced certa i n revision s in harmonized guideline se ri es 850 - Eco l ogical Effects Tests - including r enumber i ng and other designation s or changes for some guideli ne stud i es. See " Final Test Guidelines; OCSPP 850 Series; Notic e of Availability " 77 F R 38282, June 27, 20 1 2. http: // www.regulations.gov /# !documentDetail;D = EP A- HO-OPPT -2009-0154 -0 028 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. 4Table 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 adul t chronic oral toxici ty TGAI (acid) 12 Non

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

-GDLN (OECD

Test Semi

-field testing for pollina tors TEP 24 Guida nce 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 pendingreview ofsubmitted study

. 

### 5STATUTORY AND REGULATORY AUTHORITY The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides dis tr ibut ed or sold in the United States (U .S .) generally must be registered by the Environme ntal Protection Agency (EPA or the Agency), based on scientific data showing that they will not cause unreasonable risk s 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 practice s change, all regi s tered 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 reevalua tes 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 purs uant to Section 3(g) ofthe Federal Insecticide , Fungici de , and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet t h e FIFRA standard for registration. T he regulations governing registration review begin at 40 CF R 155.40. The Agency will consider benefits information and data as required by F IFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the

Agency's opportunity to state what it knows about the pesticide and what additional risk analyses and data or inform ation it believes are needed to make a registration review decision. After reviewing and responding t o comments and data received in the docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and ant i cipated schedule for the registration review of triclopyr. CHEMICAL FACTS Table 2 provides a s ummary of the chemical facts for triclopyr Table 2: Chemical Facts for Triclopyr PC code 116001 (triclopyr) , 116002 (triclopyr , triethylamine salt, TE A), 116004 (triclopyr , butoxyethyl ester , BEE) Case Number 27 10 CAS Number 57213 - 69-1, 57213-69-1, 64700-56-7 Year first register ed 1979 (TEA), 1980 (BEE), 2005 (triclopyr) Pesticide Type Herbicide Chemical class Pyridine Reregistration E ligibilit y October 1998 Decision (RED) To lerance Reasses sme nt Not applicable. To l erance reassessment was included in the RED. Eligibility Decision (T RED) 4 http: // www.epa.gov / oppsrrd 1 / registration_review / 6Table 2: Chemical Facts for Triclopyr Cumulative group Not applicable. Triclopyr has not been identified as a member ofa cumulative group that shares a common mechanism oftoxicity 40 CFR Citation Tolerances for triclopyr are established in 40CFR 180.417. Dual-use Triclopyr is registered for conventional pesticidal uses only and has noregistered antimicrobial orbiopesticidal uses. Non-pesticidal uses There are no identified non-pesticidal uses oftriclopyr

. 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 RegistrationReview: Triclopyr Case inthe registrat ion review docket for more details.
Table 3: Triclopyr Use and Usage Information

Summary ofUse Triclopyr is a systemic herbicide that belongs to the pyridine carboxylic acid family and itis 4sed as a post-emergence herbicide to control annual and perennial broadleafweeds 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 ofUsage 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.
7Table 3: Triclopyr Use and Usage Information Technical Registrant(s) Nufarm Limi ted; Albaugh, Inc.; Dow AgroSciences, LLC . ; Repar Crop; Celsius Property No. ofRegistrations 142 Section 3 prodticts 5 ; 9 Section 24(c) Specia l 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 particu lar 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," re t reatment 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 registran t s to clarify information on triclopyr product labels, especially the maximum annual application rates for non agricultural uses including go lf courses , turf , and ornamental lawns. • Confirmation of the following label information: sites of application; form ulation s; application methods and equipment; maximum application rates; frequency of application, applicatio n 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 90 1 h pe r centile reported use rates (lbs ail A) from usage data- national , state , and county. • Typica l application timing (date of first app li cation and application intervals)- national , state, and county. • Usage / use information for non-agricultural uses. • Typical application interval (days). • State or loc al use restrict i ons. • Foreign technical r egistrants 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 n ew use request on aquatic sites. The most recent eco l ogical and environmenta l fate risk assessment was comple ted in 2002 for the same reason. Findings and conclusions from these risk assessments are s ummarized in: • Registra tion Review; Preliminary Problem Formula tion 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 Ass e ssment 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). 8During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses oftriclopyr. For human health, EPA anticipates the need to conduct revised dietary, residential, occupational and aggregate risk assessments during registration review

. Iftoxicological endpoints orpoints of departure are revised based onthe datathat 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 ordefault 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 RiskAssessments for the TriclopyrRegistration Review Type ofRisk 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 ofreported ecological incidents for triclopyr, check for see page 33 ofthe 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 ofa cumulative group that shares a common mechanism oftoxicity. 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 ofreported human incidents for triclopyr, see check for page 13 ofthe Human Health Assessment Scoping Document

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

. 9Guidance 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 20 1 5 Jul y- Sept. Data Submission 20 1 7 July- Sept. 60 - day Public Comment Period for Draft Ri s k 20 19 Jan. - March Assessments 6 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 da ys for draft risk assessments ; see 40 CFR Part 155.53(c) . For co nventional 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 ofspecial interestto the Agency where your comments, data submissions, or reference to sources ofadditional information could be ofparticular use. Trade Irritants: Throughthe registration review process, the Agency intends to solicit information ontrade irritants and, to the extent feasible, take steps toward facilitating irritantresolution. 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 inkey export markets, providing as much specificity as possible regarding the nature ofthe concern. Water Quality: Triclopyr is not identified as a cause ofimpairment for any water bodies listed as impaired under section 303(d) ofthe 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 TheAgency invites submission ofwater quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A ofthe OPPStandard OperatingProcedure: Inclusion of Impaired Water BodyandOther Water Quality Data in OP P 's Registration ReviewRiskAssessment andManagement Process10 in order to ensure they canbe used quantitatively or qualitatively inpesticide risk assessments
. Triclopyr is identified as a cause ofimpairment, as defined under section 303( d) ofthe 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 onimpaired water bodies and TMDLs canbe found at EPA' s website. 13 TheAgency invites submission ofwater 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

7 http:// iaspub.epa.gov/tmdl waters10/attains nation cy.cause detail 303d?p cause group id=885 8http:// iaspub.epa.gov/tmdl waters 1Of 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/oppsrrd1/registration review/water quality sop.htm 11 http:// iaspub.epa.gov /tmdl

_waters1**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/ 11Data in OP P ' s Registration

**Revie~** Risk Assessment and Management Process 14 in order to ensure they can be used quantitatively or quali tatively in pesticide risk assessments . Environmental Justice: EPA seeks to achieve environmental justice, the fair treatment and meaningfu l involvement of all people, regardless of race, co lor , national origin, or income, in the development, implementation, and enforcement of environmenta l laws, regulat i ons, and policies. To help ad dr ess potential environmental justice issues , the Agency seeks information on any g roup s or segme n ts of the population who, as a result of their location , cultural practices, or other facto r s, may have atypical, unusually high exposure to t riclopyr compare d 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 ecologica l 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 li ste d spec ies 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 chemica l s. · Collective l y, these studies includ e acute, subchronic and chronic toxicity, includin g assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general o r systemic toxicity. These studies include endpoints which may be susce ptible to endocrine influence, including effects on endocrine target organ histopathology , organ weights, estrus cyclicity, sexual maturation , fertility, pregnancy r ates, reproductive l oss, 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 reregistra tion decision for triclopyr, EPA reviewed these data and selected the most sensi tive **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 ce rtain 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 /re gistration review / water gualitv sop.htm 1 2may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists ofa battery of 11 screening assays to identify the potential ofa chemical substance to interact with the estrogen, androgen, orthyroid (E, A, orT) hormonal systems. Chemicals tha t 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 ofthe EDSP where EPA will determine which, ifany, ofthe Tier 2 tests are necessary based onthe available data. Tier2 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, orT 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 of67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list ofchemicals identified for EDSP screening was published on June 14,2013 15 and includes some pesticides scheduled for registration review and chemicals found in water. Neither ofthese lists should be construed 

### as a list ofknown orlikely endocrine disruptors. For further information onthe status ofthe EDSP, thepolicies 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 andResidential Pasttriclopyr 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 ofany 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 ofHuman Subjects ofResearch'(40 CFRPart 26) have been satisfied, and there is no regula tory barrierto continued reliance onthese 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