2

Ethofumesate Preliminary Work Plan – Table of Contents 

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

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

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

CHEMICAL FACTS ...................................................................................................................... 7

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

RECENT ACTIONS ....................................................................................................................... 9

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

TIMELINE .................................................................................................................................... 11

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

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

References:

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

based on the following documents: 

1. Ethofumesate: Registration Review: Preliminary Problem Formulation for Environmental 

Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments. 

Ryan Mroz and Faruque Khan, Ph.D. February 18, 2016. 

2. Ethofumesate. Human Health Assessment Scoping Document in Support of Registration 

Review. William Irwin, Ph.D., Peter Savoia, and Kelly M. Lowe. February 22, 2016. 

3. Ethofumesate: Tier I (Scoping) Review of Human Incidents and Epidemiology. Elizabeth 

Evans and Shanna Recore. December 8, 2015. 

4. BEAD Chemical Profile for Registration Review: Ethofumesate: (PC Code: 110601). 

Sunil Ratnayake Ph.D., Jihad Alsadek, Ph.D., and Stephen Smearman. March 14, 2016.

5. Ethofumesate (110601) Screening Level Usage Analysis (SLUA). July 20, 2015.
3

6. Environmental Fate and Effects Division Label Data Report. PC Code 110601. July 20, 

2015.

7. Health Effects Division Master Label Report Spreadsheet: Ethofumesate PC Code 110601. 

July 20, 2015.

These and other supporting documents for the ethofumesate registration review case may be 

found in the docket EPA-HQ-OPP-2015-0406 at http://www.regulations.gov. 
4

OVERVIEW 

The docket for ethofumesate is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0406). Ethofumesate is a pre- and postemergence herbicide used to control annual grasses and broadleaf weeds. The major use of 

ethofumesate is for sugar beets with other food uses including onions, carrots, and garlic. Nonfood uses include treatments for seed crops, turf, and sod farms. This Preliminary Work Plan 

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

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 ethofumesate. 

 

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 ethofumesate and what types of new data or 

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

ethofumesate. 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 ethofumesate. 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 ethofumesate. 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. 
5

ANTICIPATED DATA NEEDS 

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

the anticipated data needs, see the Ethofumesate: Registration Review: Preliminary Problem 

Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water 

Exposure Assessments and Ethofumesate. Human Health Assessment Scoping Document in 

Support of Registration Review. 

Table 1: Anticipated Data Needs for the Ethofumesate Registration Review 

Guideline 

Number1 Study Title Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Anticipated Data Needs for the Parent Ethofumesate

835.4100 Aerobic soil metabolism TGAI or 

PAIRA 24 

835.4200 Anaerobic soil metabolism TGAI or 

PAIRA 24 

835.4300 Aerobic aquatic metabolism TGAI or 

PAIRA 24 

835.4400 Anaerobic aquatic metabolism TGAI or 

PAIRA 24 

850.1010 Freshwater invertebrate acute toxicity TGAI 12 

850.1350 Estuarine/marine invertebrate life cycle; mysid 

shrimp (Mysidopsis bahia) TGAI 12 

850.2100 Avian oral toxicity; passerine species TGAI 12 

850.3040 Tier III field testing for pollinators2 TEP 24 

850.4500 Algal toxicity (freshwater and marine diatom) TGAI 12 

850.4550 Cyanobacteria (Anabaena flos-aquae) toxicity TGAI 12 

860.1340 Residue analytical method (livestock) TGAI and 

degradates3 24 

875.2100 Dislodgeable foliar residue and turf transferable 

residues TEP 24 

Nonguideline Tier I honeybee adult chronic oral toxicity TGAI 12 

Nonguideline/

OECD 237 

Tier I honeybee larval acute oral toxicity TGAI 12 

 

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 2 The need for Tier II and Tier III pollinator data is contingent upon the results of lower tier testing. 3

 Degradates of concern are NC 8493, NC 9607, and NC 20645 
6

Table 1: Anticipated Data Needs for the Ethofumesate Registration Review 

Guideline 

Number1 Study Title Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Nonguideline Tier I honeybee larval chronic oral toxicity TGAI 12 

Nonguideline Tier II residues in pollen and nectar2 TEP 24

Nonguideline Tier II semi-field testing for pollinators (tunnel 

and colony feeding studies)2 TEP 24 

Anticipated Data Needs for the Degradate NC 8493 

850.2200 Avian dietary toxicity; bobwhite quail or mallard 

duck Degradate 12 

PAIRA = pure active ingredient radio-labeled; TGAI = technical grade active ingredient; TEP = typical end-use 

product 

STATUTORY AND REGULATORY AUTHORITY 

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.4

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

 

4

 http://www2.epa.gov/pesticide-reevaluation 
7

CHEMICAL FACTS 

Table 2 provides a summary of the chemical facts for ethofumesate. 

Table 2: Chemical Facts for Ethofumesate

PC code 110601 

Case Number 2265 

CAS Number 26225-79-6 

Year first registered 1977 

Pesticide Type Herbicide 

Chemical class Benzofuranes 

Reregistration Eligibility 

Decision (RED) 

Issued 2005; revised 2007 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

Not applicable. Tolerance reassessment included in RED. 

Cumulative group No cumulative risk assessment is required at this time as the 

Agency has not made a determination regarding a common mode 

of action. 

40 CFR Citation Tolerances for ethofumesate are established in 40 CFR § 180.345. 

Dual-use Ethofumesate 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 ethofumesate.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Jordan Page; page.jordan@epa.gov; 703.347.0467 

Registration Division, 

Product Manager 

Heather Garvie; garvie.heather@epa.gov; 703.308.0034 

USE AND USAGE INFORMATION 

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

Chemical Profile for Registration Review: Ethofumesate: (PC Code: 110601) in the registration 

review docket for more details. 

Table 3: Ethofumesate Use and Usage Information

Summary of Use Selective herbicide applied as pre-plant, pre-emergence, and postemergence treatments to control broadleaf and grassy weeds. 

Ethofumesate acts as a seedling shoot inhibitor, affecting 

developing leaves at growing points. 

Use Sites Agricultural use sites include sugar beets, garden beets, table 

beets, carrots, shallots, garlic, and onions. Non-agricultural use 

sites include grasses grown for seed, ornamental lawns, turf, and 

ornamental sod farms. 
8

Table 3: Ethofumesate Use and Usage Information

Summary of Usage Based on market data from 2009-2013, usage averaged 

approximately 35,000 pounds a.i. applied annually on 104,000 

acres at 0.34 pounds a.i./acre. 

Formulation Type(s) Flowable liquid concentrate, emulsifiable concentrate, soluble 

concentrate/liquid 

Application Method(s) banded, broadcast, soil band treatment, soil band broadcast 

treatment, soil incorporated treatment, spray, impregnated dry 

bulk fertilizer treatment 

Technical Registrant(s) Bayer Cropscience LP, Etho Tech, Willowood Ethofumesate, 

LLC 

No. of Registrations 16 Section 3 products5

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 ethofumesate labels are unclear with respect to application parameters such as 

maximum annual application rates, applications allowed per year and single application 

rates in terms of lbs a.i./A (see Ethofumesate: Registration Review: Preliminary Problem 

Formulation for Environmental Fate, Ecological Risk, Endangered Species, and 

Drinking Water Exposure Assessments). 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 ethofumesate product labels. 

o There is no annual maximum application rate stated or the maximum 

application use rate is stated in terms of crop growing season rather than the 

annual rate for the following Registration #s: 264-612, 264-613, 264-615, 

70506-106, 70506-107, 70506-283, 87290-1, 87290-2 

o Labels are not clear on number of applications allowed per year for 

registration #s: 264-612, 264-613, 264-615, 70506-106 and 87290-1. In the 

absence of yearly information, multiple seasons or crop cycles may be 

assumed for some crops when performing the risk assessment. 

o Single application rates are listed on the label in terms of volume of product 

instead of lbs a.i./A for registration #s: 264-612, 264-613, 264-615, 70506-

106, 70506-107, 70506-283, 87290-1 and 87290-2. 

o The Agency recommends stating all single, seasonal, and/or annual 

application rates in terms of lbs a.i./A. 

 Data on pounds a.i. applied and percent crop treated on registered crops. 

 Usage/use information for non-agricultural uses. 

 Foreign technical registrants not listed above who supply technical ethofumesate to the 

US market. 

 

5

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
9

RECENT ACTIONS 

There are no current or pending registration actions for ethofumesate. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent ecological and environmental fate risk assessment for ethofumesate was 

completed in 2004 in preparation for the Reregistration Eligibility Decision. The most recent 

comprehensive human health risk assessment was completed in 2006 for the same purpose. 

Findings and conclusions from these risk assessments are summarized in the Ethofumesate: 

Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered 

Species, and Drinking Water Exposure Assessments and Ethofumesate. Human Health 

Assessment Scoping Document in Support of Registration Review. 

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

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

ethofumesate. For human health, EPA anticipates the need to conduct revised residential postapplication, aggregate, and occupational risk assessments during registration review to 

incorporate updated exposure and residue data, and updated toxicological endpoints or points of 

departure, if revised based on the data that are anticipated to be required for registration review. 

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 
10

Table 4: Anticipated Risk Assessments for the Ethofumesate 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 will conduct a comprehensive 

ecological risk assessment including an endangered 

species assessment during registration review. 

Incidents Will check for 

updates 

For a discussion of reported ecological incidents for 

ethofumesate, see page 16 of the Problem 

Formulation. 

Human Health 

Dietary 

Food N Not unless anticipated residues on food or revised 

estimated drinking water concentrations are 

significantly greater than those used in the most 

recent assessment. 

Drinking water N 

Occupational 

Handlers (mixers, loaders, 

applicators) 

Y Updated assessments will be conducted to reflect 

current occupational residential exposure policies, 

the revised dermal absorption factor, and/or updated 

toxicological inhalation points of departure (POD). 

Post-application Y 

Residential 

Handlers N The Agency assumes that applications by residential 

handlers are made with handheld equipment only. 

Ethofumesate labels prohibit the use of handheld 

equipment and therefore residential handler 

exposures are not anticipated. 

Post-application Y A revised residential post-application assessment 

may be necessary using the revised 2012 Residential 

SOPs, the revised dermal absorption factor, new turf 

transferable data, and any potential changes to the 

toxicological PODs. The need for spray drift and 

volatilization risk assessments for ethofumesate will 

be considered. 

Other 

Aggregate Y An updated aggregate assessment will be performed 

to reflect any updates to the dietary and non-dietary 

assessments, as well as any potential updates to the 

toxicity PODs and uncertainty factors. 

Cumulative N EPA has not made a common mechanism of toxicity 

finding for ethofumesate and any other substances. 
11

Tolerances N The current tolerance for ethofumesate on sugar beet 

tops should be revoked as this commodity is no 

longer a significant livestock feed item or a 

recognized human food item. There are no Codex or 

Mexican maximum residue limits (MRLs) for 

residues of ethofumesate. Canadian MRLs for 

ethofumesate have been established, and they are 

harmonized with U.S. tolerance levels. 

Incidents Will check for 

updates 

For a discussion of reported human incidents for 

ethofumesate, see page 9 of the Scoping Document 

and Ethofumesate: Tier I (Scoping) Review of 

Human Incidents and Epidemiology. 

Guidance for Commenters: Additional ecological information requested for this registration 

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

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

mammalian mortalities) 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 ethofumesate 

registration review in Table 5 below. 

Table 5: Projected Ethofumesate Registration Review Timeline

Activities Estimated Date

Opening the Docket 

Open Docket and 60-day Public Comment Period March 2016 

Close Public Comment May 2016 

Case Development 

Final Work Plan August 2016 

Issue DCI October-December 2016 

Data Submission October-December 2018 

60-day Public Comment Period for Draft Risk 

Assessments6

April-June 2020 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

January-March 2021 

Registration Review Decision and Begin Post-Decision 

Follow-up 

2021 

 

6

 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 
12

Table 5: Projected Ethofumesate Registration Review Timeline

Activities Estimated Date

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 ethofumesate. 

 
13

Appendix – Additional Areas Considered in the Ethofumesate 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) as needed 

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: 

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

under section 303(d) of the Clean Water Act.7

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for ethofumesate.8 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.9 The Agency invites submission of water 

quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A 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 Process10 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 ethofumesate 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.

 

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

8

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

group_name=PESTICIDES 9 http://www.epa.gov/owow/tmdl/

10 http://www2.epa.gov/pesticide-reevaluation/opp-guidance-submission-state-and-tribal-water-quality-monitoringdata
14

ENDANGERED SPECIES: 

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

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

will allow the Agency to determine whether use of ethofumesate 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 reregistration decision for ethofumesate, 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), ethofumesate 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.11 A second list 

of chemicals identified for EDSP screening was published on June 14, 201312 and includes some 

pesticides scheduled for registration review and chemicals found in water. Ethofumesate does 

 

11 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2004-0109-0080 for the final initial list of 

chemicals. 12 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 
15

not appear on either of the lists. 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.13

HUMAN STUDIES: 

Occupational and Residential 

Past ethofumesate risk assessments rely in part on data from studies in which adult human 

subjects were intentionally exposed to a pesticide to determine their dermal and inhalation 

exposure. Many such studies, involving exposure to many different pesticides, comprise generic 

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

Agricultural Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task 

Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide 

generic exposure databases, and has found no clear and convincing evidence that the conduct of 

any of them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

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

 

13 http://www2.epa.gov/endocrine-disruption