### Sethoxydim Preliminary Work Plan

– Table of Contents

OVERVIEW ................................................................................................................................... 4

ANT ICIPATED DATA NEEDS .................................................................................................... 5

S TATU TORY AND REGULATORY AUTHORITY ................................................................... 6

CH EMICAL FACTS ...................................................................................................................... 6

US E AND USAGE INFORMATION ............................................................................................ 7

R ECENT ACTIONS ....................................................................................................................... 8

ANT ICIPATED R ISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ 9

TI MELINE .................................................................................................................................... 12

N EXT STEPS ............................................................................................................................... 12

A ppendix – Additional Areas Considered in the Sethoxydim Registration Review ................ 13

References:

T his Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. EFED Registration Review Problem Formulation for Sethoxydim

. Christina Wendel and
James Lin. 03/06/2015.

2. Se thoxydim: Human Health Risk Assessment for Registration Review and to Support the Section 3 Registration of Proposed Uses on High Bush Blueberry and Fine Fescue
Grasses . Ronnie Bever, Seyed Tadayon, Peter Savoia, and Katelynn King

. March 11,
2015.

3. Se thoxydim: Tier I Review of Human Incidents . Elizabeth Evans and Shanna Recore. October 23, 2014.

4. B EAD Chemical Profile for Registration Review: Sethoxydim (121001). Sunil Ratnayake, Cynthia Doucoure and Stephen Smearman. September 08, 2014.

25. Sethoxydim (121001) Screening Level Usage Analysis (SLUA)

. May 19, 2014

.

6. Sethoxydim EFED Label Data Report

. September 22, 2014

.

7. Sethoxydim HED Master Label Report

. September 22, 2014

.

These and other supporting documents for the sethoxydim registration review case may be found
in the docket EPA

- HQ

- OPP

- 2015

- 0088 at http://www.regulations.gov

.

3OVERVIEW

The docket for sethoxydim is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0088 )

. Sethoxydim is a post

emergence herbicide registered for use to control annual and perennial grass weeds in broadleaf

crops. Sethoxydim is r egistered for use on a variety of residential sites and agricultural crops including various grains, fruits, tree nuts, vegetables, and herbs, in addition to several non

agricultural sites, including ornamentals and flowering plants, recreational areas, right

- of

- way , along fences, hedgerows and public and commercial buildings/structures. Sethoxydim products are used primarily in agricultural areas , however are also registered for residential use

. This Preliminary Work Plan (PWP) document explains what EP A's Office of Pesticide Programs
knows about sethoxydim

, 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 sethoxydim

.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The agency intends, b y sharing this information in the docket, to inform the public of what it knows about sethoxydim and what types of new data or other information would be helpful for the agency to receive as it moves toward a decision on sethoxydim

. 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 comm ent, 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 lab or 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 sethoxydim. 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 sethoxydim

. Finally, the Appendix
to this 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.

4ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs f or sethoxydim . For additional discussion of the anticipated data needs, see the EFED Registration Review Problem Formulation for Sethoxydim document

.

Table 1: Anticipated Data Needs for the Sethoxydim Registration Review

Guideline
Number 1 Study Title 1 Test Material Estimated
Timeframe
(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Sethoxydim

850.1300 Aquatic invertebrate life cycle (freshwater) T GAI 12

850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12

850. 1400 Fish early

- life stage (saltwater) TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.3040 Field testing for pollinators TEP 24

850.3030 Honey bee toxicity of residues on foliage TEP 12

850.4100 Seedling Emergence TEP 12

850.4150 Vegetative Vigor TEP 12

Non

- guideline Semi

- field testing for pollinators TEP 24

Non

- guideline Acute oral toxicity to adult bees TGAI 12

Non

- guideline Acute oral toxicity to larval honey bees TGAI 12

Non

- guideline Chronic oral toxicity to adult honey bees TGAI 12

Non

- guideline Chronic oral toxicity to larval honey bees TGAI 12

Non

- guideline Field trial of residues in pollen and nectar TEP 24
Anticipated Data Needs for Sulfone ( the Terminal Degradate , M2

- SO 2 )

Non

- guideline Aquatic vascular plant toxicity study with a grass species DEG 12

TGAI = technical grade active ingredient; TEP = typical end

- use product ; DEG = degradate

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

5STATUTORY 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 cau se 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 p esticides 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 age ncy periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 2

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

. 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

comme nt period, the agency will develop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of sethoxydim

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for sethoxydim

.

Table 2: Chemical Facts for Sethoxydim

PC code 121001
Case Number 2600
CAS Number 74051

- 80

- 2
Year first registered June 16, 1994 Pesticide Type Conventional Chemical
Chemical class Cyclohexanedione / cyclohexenone

R eregistration Eligibility Decision (R E D) September 30, 2005

Tolerance Reassessment Eligibility Decision (TRED) Not applicable; The completion of the sethoxydim RED did not result in any additional tolerances being reassessed since all existing tolerances (85) were reassessed at the time a new food
use was establish ed for sethoxydim [63FR54066 (10/8/1998)]

2 http://www.epa.gov/oppsrrd1/registration_review/

6Table 2: Chemical Facts for Sethoxydim
Cumulative group Not applicable; Sethoxydim has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.
40 CFR Citation Tolerances for sethoxydim are established in 40 CFR §180.412 for the combined residues of sethoxydim [2

- [1

- (ethoxyimino) butyl]

- 5

- [2

- (ethylthio) propyl]

- 3

- hydroxy

- 2

- cyclohexen

- 1

- one] and its metabolites containing the 2

- cyclohexene

- 1

- one moiety (calculated as sethoxydim) in or on numerous plant

, animal, food
and feed commodities

.

Dual

- use Sethoxydim 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 sethoxydim
Pesticid e Re

- evaluation Division, Chemical Review Manager James Parker, Parker.James@epa.gov , (703) 306

- 0469

Registration Division

, Product Manager Mindy Ondish

, Ondish.Mindy@epa.gov

, ( 703) 605

- 0723

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for sethoxydim

. Please see the BEAD Chemical Profile for Registration Review: Sethoxydim (121001) in the registration review docket
for more details

.

Table 3 : Sethoxydim Use and Usage Information

Summary of Use Sethoxydim is registered for use as a post

- emergent herbicide for selective control of annual and perennial grass weeds in broadleaf crops. Sethoxydim is currently registered for use on several
different types of residential sites (including lawns, ornamental
flowers , recreational areas

, flowering plants and etc.)

, rights

- of

way, along fences, and hedgerows, in addition to public and commercial buildings/structures and agricultural crops (including various grains, fruits, herbs, tree nuts, veg etables, peas and etc.).

Summary of Usage Based on proprietary data source s an average of 357,000 pounds of sethoxydim is used annually . From 1998 through 2012 sethoxydim usage has significantly decreased by more than 50 percent. Crops with the highest reported use of sethoxydim include dry beans (approx. 100,000 lbs. used ann ually), soybeans (approx. 30,000 lbs. used annually), and alfalfa and peanuts (approx. 10,000 lbs. used annually on each). Crops with the highest average percent crop treated (PCT) include dry beans (30 PCT), and watermelon and green beans (10 PCT each).

7Table 3 : Sethoxydim Use and Usage Information
Formulation Type(s) Sethoxydim is formulated as an emulsifiable concentrate , and
soluble concentrate

. Application Method(s) Products can be applied by handheld sprayers, ground boom

sprayers, or with aerial equipment

. Technical Registrant (s) BASF Corporation No. of Registrations 7 Section 3 products 3

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.

• Certain sethoxydim 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, t he agency will work with registrants to clarify information on sethoxydim product labels, especially the maximum annual application rate s for non

agricultural uses including recreational areas , turf, and ornamental lawns

.

• 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

. a

. i

. / A

. ) from usage data

– national, state, and county

.

• Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

• Usage/use information for non

- agricultural uses

.

• Typical application interval (days)

.

• S tate or local use restrictions

.

• F oreign technical registrants not listed above who supply technical sethoxydim to the US
market

.

RECENT ACTIONS

There have been n o recent decisions for sethoxydim . However, a request has been submitted to the agency for new use of sethoxydim o n: ( fescue, bushberry (subgroup 13

- 07B )

, low growing berry ( subgroup 13

- 07H )

, small fruit vine climbing (s ubgroup 13

- 07F )

, rapeseed (s ubgroup
20A )

, sunflower (s ubgroup 20B

, except safflower), cottonseed (s ubgroup 20C) ) , crop group conversions ( citrus fruit (g roup 10

- 10 )

, p ome f ruit (g roup 11

- 10 )

, c aneberry (s ubgroup 13

- 07A )

, bulb vegetable ( g roup 3

- 07 ) and fruiting vegetable (g roup 8

- 10 ) is pending for EPA registrations

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

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

87969

- 56 (technical) and 7969

- 58 (end

- use), in addition to estab lishing the following tolerances
listed below in table 4

.

Table 4 : Pending Sethoxydim Tolerances Commodity Parts per million Berry, low growing, subgroup 13

- 07H, except strawberry 2.5 Bushberry, subgroup 13

- 07B 4.0 Caneberry, subgroup 13

- 07A 5.0 Cottonseed , subgroup 20C 5.0 Fruit, citrus, group 10

- 10 0.5 Fruit, pome, group 11

- 10 0.2 Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F 1.0 Rapeseed, subgroup 20A 35 Sunflower, except safflower, subgroup 20B
7.0 Vegetable, bulb, group 3

- 07 1.0 Vegetable, fruiting, group 8

- 10 4.0

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for sethoxydim was completed on March 11, 2015

, Sethoxydim: Human Health Risk Assessment for Registration Review and to Support the Section 3 Registration of Proposed Uses on High Bush Blueberry and Fine Fescue
Grasses

, as a joint document addressing

, (i) the human health scoping for registration review ; and (ii) a reque st to establish new uses and crop group conversions for EPA registrations 7969

- 56 and 7969

- 58, in addition to establishing new tolerances

, (PP 4E8239; EPA

- HQ

- OPP

- 2 014

- 0161)

. T he most recent ecological risk assessment was completed on December 19, 2014 in response to the same new use request a s well as crop group conversions for EPA registrations
7969

- 56 and 7969

- 58 , in addition to establishing new tolerances (PP4E8239). A decision regarding these new uses and crop group conversions requests are still pending with the Registration Division of the Office of Pesticide Programs in the EPA. Findings and conclusions
from these risk assessments are summarized in the EFED Registration Review Problem Formulation for Sethoxydim

, and in the Human Health Risk Assessment for Registration Review and to Support the Section 3 Registration of Proposed Uses on High Bush Blueberry and Fine
Fescue Grasses

.

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 sethoxydim

. For human health, EPA has completed a combine d scoping and risk assessment
document which assesses dietary, residential

, and occupational risk s from all currently registered

uses in addition to a request to establish new uses and crop group conversions for EPA registrations 7969

- 56 and 7969

- 58, (PP 4E8239 ). Based upon this, the agency does not anticipate conducting any new human health assessments for the registration review of

9sethoxydim. However, at the end of the data submission phase of the sethox y dim registration review schedule (see Table 6 )

, the agency will determine whether any additional human health analyses are warranted.

T able 5 below summarizes the anticipated registration review risk assessments needed based on previously cited support documents

.

10Table 5 : Anticipated Risk Assessme nts for the Sethoxydim 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 Y The agency anticipates conducting a q uantitative assessment for all registered sethoxydim uses.

Incidents Will check for updates For a discussion of reported ecological incidents for sethoxydim , see page 25 of the Problem Formulation.
Human Health Dietary
Food and Drinking Water N A dietary analysis (food and drinking water) was completed as part of the scoping exercise/ proposed use risk assessment for sethoxydim and no additional dietary analysis is anticipated for registration review. Drinking water N

Occupational Handlers (mixers, loaders, applicators) N An occupational analysis was completed as part of the scoping / proposed use risk assessment for sethoxydim and no additional occupational analysis is anticipated for registration review

. Post

- application N

Residential
Handlers N A residential analysis was completed as part of the scoping / proposed use risk assessment for sethoxydim and no additional occupational analysis is anticipated for registration review. (Note: dermal toxicity was not quantitatively assessed) Post

- application N

Other Aggregate N E valuates the combined risk from dietary and residential exposures. Aggregate analyses were completed as part of the scoping / proposed use risk

assessment for sethoxydim and no additional aggregate analysis are antic i pated for registration
review

. See page 31 of the human health risk

assessment. Cumulative N Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common
mechani sm of toxicity, EPA has not made a common mechanism of toxicity finding as to sethoxydim and any other substances

. Tolerances N Currently, there are no Mexican or Codex MRLs for sethoxydim . Canadian MRLs and U.S. tolerances are currently harmonized to the extent possible.

11Incidents Will check for updates For a discussion of reported human incidents for sethoxydim , see the Sethoxydim: Tier I Review of
Human Incidents

.

Guidance for Comme nte rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• Any addit io nal data which may inform the agency with respect to the pollinators and/or toxicity of the degradate (s)

.

• 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 sethoxydim registration review in Table 6 below

.

Table 6 : Projected Sethoxydim Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2015

– March
Close Public Comment 2015

– May Case Development
Final Work Plan 2015

– August
Issue DCI 2015 Oct.

– Dec.
Data Submission 2017 Oct.

– Dec.

6 0

- day Public Comment Period for Draft Risk
Assessments 4 2019 April

- June

Registration Review Decision
60

- day Public Comment Period for Proposed Registration Review Decision 2020 Jan.

- March

Registration Review Decision and Begin Post

- Decision
Follow

- up 2021

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 sethoxydim

4 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, t he

agency plans to provide a 60 calendar day public comment period generally for draft risk as sessment s

.

12

### Appendix

– Additional Areas Considered in the Sethoxydim 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 information c ould be of particular use.

Trade Irritants:

Through the registration review pro cess, 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 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:

Sethoxydim is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 5 In addition, n o Total Maximum Daily Load s (TMDL) have been developed for sethoxydim

. 6 More information on impaired water bodies and
TMDLs can be found at the agency ’s website

. 7 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
Process 8 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 popula tion who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to sethoxydim compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unus ually high exposure compared to the general population.

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

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

group_name=PESTICIDES

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

8 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm

13ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determination has not been
conducted for sethoxydim. The ecological risk assessment planned during registration revi ew will allow the agency to determine whether use of sethoxydim 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 poten tial 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 stu dies 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 offspri ng. 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 most recent registration decision for sethoxydim

, EPA
reviewed t hese 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), sethoxydim is subject to the endocrine screening part of the Endocrine Disruptor Sc reening 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 ot her 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 wher e 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 act ive ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 9 and includes some pesticides

9 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

14scheduled 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
web site. 10

HUMAN STUDIES :

Residential

Past sethoxydim 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 gen eric pesticide exposure databases such as 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 c onduct 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 Resea rch (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued reliance on these studies.

Occupational

The sethoxydim risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed t o 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 Ha ndlers 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 signifi cantly 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 regulato ry barrier to continued reliance on
these studies

.

AGRICULTURAL HEALTH STUDY :

Sethoxydim is among several agricultural chemicals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaboration of the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the EPA, and th e National Institute for Occupational Safety and Health (NIOSH). Designed as a large long

- term epidemiological study, the AHS collects and analyzes data on the health and work practices of

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

15nearly 90,000 farmers and their families in Iowa and North Carolin a who enrolled in the study before any disease developed. The study focuses particularly on farmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall health outcomes for people who differ in whether they have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they can show some statistical associations. More
information on the AHS ca n be found at: http://aghealth.nci.nih.gov . EPA is monitoring the results of the AHS and will consider this study in the registration review of sethoxydim as appropriate.

16