Sethoxydim Preliminary Work Plan – Table of Contents

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

ANTICIPATED DATA NEEDS .................................................................................................... 5

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

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

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

RECENT ACTIONS ....................................................................................................................... 8

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

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

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

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

References:

This Preliminary Work Plan summarizes 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. 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. Ronnie Bever, Seyed Tadayon, Peter Savoia, and Katelynn King. March 11,

2015. 

3. Sethoxydim: Tier I Review of Human Incidents. Elizabeth Evans and Shanna Recore.

October 23, 2014.

4. BEAD Chemical Profile for Registration Review: Sethoxydim (121001). Sunil Ratnayake,

Cynthia Doucoure and Stephen Smearman. September 08, 2014.

2
5. 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.

3
OVERVIEW

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

crops. Sethoxydim is registered for use on a variety of residential sites and agricultural crops 

including various grains, fruits, tree nuts, vegetables, and herbs, in addition to several nonagricultural 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 EPA'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, by 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 comment, there are some areas identified in the PWP and Appendix about which the 

agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for sethoxydim. 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 sethoxydim. Finally, the Appendix 

to this document includes identification and discussion of some areas that are considered 

generally in Registration Review along with some additional chemical case-specific information.

4
ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for 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 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Sethoxydim

850.1300 Aquatic invertebrate life cycle 

(freshwater) TGAI 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-SO2)

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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028

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.

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. 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 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 

Reregistration Eligibility 

Decision (RED)

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 established for sethoxydim [63FR54066 (10/8/1998)]

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

6

 
Table 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

Pesticide 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-ofway, along fences, and hedgerows, in addition to public and 

commercial buildings/structures and agricultural crops (including 

various grains, fruits, herbs, tree nuts, vegetables, peas and etc.).

Summary of Usage Based on proprietary data sources 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 annually), 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).

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Table 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 products3

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 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, the agency will work with registrants to clarify information on 

sethoxydim product labels, especially the maximum annual application rates for nonagricultural uses including recreational areas, 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 use.

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

• Median and 90th percentile reported use rates (lbs. a.i./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 sethoxydim to the US 

market.

RECENT ACTIONS

There have been no recent decisions for sethoxydim. However, a request has been submitted to 

the agency for new use of sethoxydim on: (fescue, bushberry (subgroup 13-07B), low growing 

berry (subgroup 13-07H), small fruit vine climbing (subgroup 13-07F), rapeseed (subgroup 

20A), sunflower (subgroup 20B, except safflower), cottonseed (subgroup 20C)), crop group 

conversions (citrus fruit (group 10-10), pome fruit (group 11-10), caneberry (subgroup 13-07A), 

bulb vegetable (group 3-07) and fruiting vegetable (group 8-10) is pending for EPA registrations 

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

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

8

 
7969-56 (technical) and 7969-58 (end-use), in addition to establishing 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 request 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-2014-

0161). The most recent ecological risk assessment was completed on December 19, 2014 in 

response to the same new use request as 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, the 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 combined scoping and risk assessment 

document which assesses dietary, residential, and occupational risks 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 

9
sethoxydim. However, at the end of the data submission phase of the sethoxydim registration 

review schedule (see Table 6), the agency will determine whether any additional human health 

analyses are warranted. 

Table 5 below summarizes the anticipated registration review risk assessments needed based on 

previously cited support documents.

10
Table 5: Anticipated Risk Assessments for the Sethoxydim Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate

Comprehensive ecological 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Y The agency anticipates conducting a quantitative

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 Evaluates 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 anticipated 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 

mechanism 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. 

11
Incidents Will check for 

updates

For a discussion of reported human incidents for 

sethoxydim, see the Sethoxydim: Tier I Review of 

Human Incidents.

Guidance for Commenters: Additional ecological information requested for this

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

• Any additional data which may inform the agency with respect to the pollinators and/or 

toxicity of the degradate(s).

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

mammalian mortalities) not already reported to the agency.

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

TIMELINE

EPA has created the following estimated timeline for the completion of the sethoxydim

registration review in Table 6 below.

Table 6: Projected Sethoxydim Registration Review Timeline

Activities Estimated Date

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.

60-day Public Comment Period for Draft Risk 

Assessments4

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 60-day public comment period closes, the agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of 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, the 

agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.

12

 
Appendix – Additional Areas Considered in the Sethoxydim Registration 

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the agency

where your comments, data submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants:

Through the registration review process, the agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The agency

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern. 

Water Quality:

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, no Total Maximum Daily Loads 

(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 

Process8 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 sethoxydim 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.

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

13

 
ENDANGERED SPECIES:

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

conducted for sethoxydim. The ecological risk assessment planned during registration review 

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 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 most recent registration decision for sethoxydim, 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), 

sethoxydim is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals 

identified for EDSP screening was published on June 14, 20139 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.

14

 
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.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 generic 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 conduct of any of them was either 

fundamentally unethical or significantly deficient relative to the ethical standards prevailing at 

the time the research was conducted. All applicable requirements of EPA’s Rule for the 

Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no 

regulatory barrier to continued reliance on these studies.

Occupational

The 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 generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the 

Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting 

these multi-pesticide generic exposure databases, and has found no clear and convincing 

evidence that the conduct of any of them was either fundamentally unethical or significantly 

deficient relative to the ethical standards prevailing at the time the research was conducted. All 

applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 

CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on 

these studies.

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 the 

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/

15

 
nearly 90,000 farmers and their families in Iowa and North Carolina 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 can 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