2

1,3-Dichloropropene Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 6

Recent Actions 8

Anticipated Risk Assessments for Registration Review 8

Timeline 10

Next Steps 11

Appendix – Additional Areas Considered in the 1,3-Dichloropropene Registration Review

12

References:

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

based on the following documents:

1. Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, 

and Drinking Water Exposure Assessments in Support of the Registration Review of 1,3-

Dichloropropene (Telone). William P. Eckel, Elizabeth Riley, and Andrew Shelby. 

September 3, 2013.

2. 1,3-Dichloropropene. Human Health Assessment Scoping Document in Support of Registration 

Review. Ideliz Negrón-Encarnación, Linda Taylor, and Matthew Lloyd. September 5, 2013.

3. Telone (1,3-D): Review of Human Incidents. Elizabeth Evans and Shanna Recore. May 15, 

2013.

4. BEAD Chemical Profile for Registration Review: 1,3-Dichloropropene (1,3-D) (029001).

Derek Berwald, Carl Chen, and Cynthia Doucoure. March 25, 2013.

5. Telone [Dichloropropene] (029001) Screening Level Usage Analysis (SLUA). June 22, 

2012.
3

6. Telone (029001) PRD Label Data Report. February 28, 2013.

7. 1,3-Dichloropropene: Proposed New Use for Drip Irrigation in Vineyards: Revised HED 

Human Health Risk Assessment; DP Barcode: D347789, PC Code: 029001. Christine 

Olinger, Elizabeth Mendez, Jeff Dawson, and Dana Vogel. January 24, 2008.

These and other supporting documents for the 1,3-dichloropropene registration review case may 

be found in the docket EPA-HQ-OPP-2013-0154 at http://www.regulations.gov.

OVERVIEW

The docket for 1,3-dichloropropene (1,3-D) is now open, initiating the first public comment 

period for this registration review (docket number EPA-HQ-OPP-2013-0154). 1,3-

Dichloropropene (PC code 029001) is a non-selective soil fumigant registered for use to control 

various soil-borne diseases, nematodes, and/or garden symphylans. It is registered for preplant 

use with a range of agricultural and non-agricultural crops. There is also a registered post-plant 

food use through drip irrigation to established vineyards. 1,3-D has no residential uses. This 

Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs 

knows about 1,3-dichloropropene, 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 1,3-

dichloropropene.

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 1,3-dichloropropene and what types of new 

data or other information would be helpful for the Agency to receive as it moves toward a 

decision on 1,3-dichloropropene. 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 1,3-dichloropropene. 

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 1,3-dichloropropene. 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 1,3-dichloropropene. For additional 

discussion of the anticipated data needs, see the Problem Formulation for the Environmental 

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

Support of the Registration Review of 1,3-Dichloropropene (Telone) and 1,3-Dichloropropene. 

Human Health Assessment Scoping Document in Support of Registration Review.

Table 1: Anticipated Data Needs for the 1,3-Dichloropropene Registration Review

Guideline 

Number1 Study Title1

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Anticipated Data Needs for the Parent Chemical 1,3-Dichloropropene

850.1350 Aquatic Invertebrate Life Cycle (Saltwater) TGAI 12

850.1400 Fish Early-Life Stage (Freshwater) TGAI 12

850.1400 Fish Early-Life Stage (Saltwater) TGAI 12

835.4100 Aerobic Soil Metabolism TGAI 24

835.8100 Field Volatility TEP 12

NonguidelineTerrestrial Plant Vapor Phase Exposure TEP 12

NonguidelineAcute Avian Inhalation TGAI 24

NonguidelineHoney Bee Acute Vapor Phase Exposure TGAI 24

Nonguideline Ambient Airshed Monitoring TEP 36

Anticipated Data Needs for the 1,3-D Degradate 3-chloroallyl alcohol (CAAL)

835.4100 Aerobic Soil Metabolism CAAL 24

835.4400 Anaerobic Aquatic Metabolism CAAL 24

850.6100 Environmental Chemistry Methods and Associated 

Independent Laboratory Validation (Soil & Water) CAAL 12

Anticipated Data Needs for the 1,3-D Degradate chloroacrylic acid (CAAC)

835.4100 Aerobic Soil Metabolism CAAC 24

835.4400 Anaerobic Aquatic Metabolism CAAC 24

850.6100 Environmental Chemistry Methods and Associated 

Independent Laboratory Validation (Soil & Water) CAAC 12

TGAI = technical grade active ingredient; TEP = typical end-use product;

 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 1,3-dichloropropene.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for 1,3-dichloropropene.

Table 2: Chemical Facts for 1,3-Dichloropropene

PC code 029001

Case Number 0328

CAS Number 542-75-6

Year first registered 1954

Pesticide Type Broad spectrum fumigant with nematicidal, fungicidal, herbicidal, and 

insecticidal properties.

Chemical class Soil Fumigant

Reregistration Eligibility 

Decision (RED)

December 1998

Tolerance Reassessment 

Eligibility Decision 

(TRED)

Not applicable

 2 http://www.epa.gov/oppsrrd1/registration_review/
6

Table 2: Chemical Facts for 1,3-Dichloropropene

Cumulative group 1,3-D is not a member of a cumulative group and no cumulative 

risk assessment is planned.

40 CFR Citation Tolerances for 1,3-dichloropropene are established in 40 CFR §

180.636.

Dual-use 1,3-dichloropropene 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 1,3-dichloropropene.

Pesticide Re-evaluation 

Division, Chemical 

Review Manager

Margaret Hathaway, hathaway.margaret@epa.gov,

(703) 305-5076

Registration Division, 

Product Manager

Hope Johnson, johnson.hope@epa.gov, (703) 564-5557

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for 1,3-dichloropropene. Please see the 

BEAD Chemical Profile for Registration Review: 1,3-Dichloropropene (1,3-D) (029001) in the 

registration review docket for more details.

Table 3: 1,3-Dichloropropene Use and Usage Information

Summary of Use 1,3-dichloropropene is a soil fumigant registered for use to combat 

nematodes and various soil-borne pathogens. It has no residential 

uses but is registered as a preplant soil fumigant for a variety of 

agricultural and non-agricultural settings. 1,3-D also has a 

registered post-plant use for drip irrigation in established grape 

vineyards. 1,3-D is often formulated with chloropicrin both as a 

warning agent and to enhance plant pathogen and weed control.

Use Sites Approved preplant agricultural uses include the soils of various 

fruiting, leafy, and root vegetable crops as well as on soils of 

legumes such as beans, peanuts, and soybeans; flavoring and spice 

crops such as hops and mint; field crops such as corn and tobacco; 

fiber crops such as cotton; fruit crops such as citrus and pineapple; 

and nut crops.

1,3-D is also registered for use on the soils of nonagricultural crops 

including nursery crops (ornamental, non-bearing fruit/nut trees and 

forestry crops), ornamental lawns and turf, golf course turf, 

ornamental and/or shade trees, ornamental herbaceous and nonflowering plants, and ornamental woody shrubs and vines.

Summary of Usage Available data on use of 1,3-D in the U.S., as found in private 

market surveys, show that the overall pounds active ingredient

applied increased between 1998 and 2011. The total area treated 

with 1,3-D increased steadily until 2006, after which the acre 

treatments declined with slight increases around 2010. From 1998 
7

Table 3: 1,3-Dichloropropene Use and Usage Information

to 2011, approximately 27,000,000 pounds of 1,3-D were applied 

on average annually to 310,000 acres at an overall average 

application rate of 87 lbs ai/acre. There is substantial variation in 

application rates in different crops.

For agricultural usage, approximately 32,000,000 pounds of 1,3-D 

were applied on average annually between 2007-2011. The top 

crops in terms of pounds of active ingredient applied during this 

period were potatoes (45%), tobacco (14%), strawberries (6%), 

cotton (4%), and onions (4%). 

For non-agricultural usage, a 2009 USDA NASS survey reported 

319,000 pounds of 1,3-D was applied to nursery and floriculture 

sites at an average rate of 236.7 pounds per acre.

Formulation Type(s) Pressurized gas, liquid ready to use, emulsifiable concentrate, or a 

flowable concentrate.

Application Method(s) Products can be applied as a soil fumigant via soil injection or drip 

irrigation. 

Technical Registrant(s) Dow AgroSciences

No. of Registrations 20 Section 3 products3 and 23 Section 24c registrations

Restricted Use Yes

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 1,3-D labels are unclear with respect to application parameters such as the size of 

the treated area or maximum annual application rates. In the lack of further information, 

EPA expects to use conservative assumptions to approximate these parameters in order to 

conduct its anticipated risk assessments. However, the Agency will work with registrants 

to clarify information on 1,3-D product labels, including differing use restrictions 

between 1,3-D only labels and combination chloropicrin/1,3-D labels.

• 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.

• 1,3-D use as a post-plant soil treatment.

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

• Median and 90th percentile reported use rates (lbs ai/A) from usage data – national, state, 

and county.

• Typical application timing: date of first application and typical application intervals.

• Usage/use information for non-agricultural uses.

• State or local use restrictions.

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

(http://oaspub.epa.gov/pestlabl/ppls.home).
8

• Foreign technical registrants not listed above who supply technical 1,3-dichloropropene 

to the US market.

RECENT ACTIONS

A new post-plant use for drip irrigation in vineyards was registered in 2008. The associated 

grape tolerance for this use was established in a February 13, 2008 FR notice. 

Two other regulatory updates have occurred since the 1998 RED. First, the prohibition of use in 

areas overlying karst geology was changed to prohibit application within 100 feet of karst 

topographical features. Second, the 300 foot buffer from occupied structures was changed to 100 

feet from occupied structures for some 1,3-D products combined with chloropicrin.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for 1,3-dichloropropene was 

completed on January 24, 2008 in response to a proposed new use for drip irrigation in 

vineyards. The details of this assessment are available in 1,3-Dichloropropene: Proposed New 

Use for Drip Irrigation in Vineyards: Revised HED Human Health Risk Assessment; DP 

Barcode: D347789, PC Code: 029001. The most recent ecological risk assessment for 1,3-D 

was a 2008 endangered species study entitled Risks of Telone Use to the Federally Threatened 

California Red-Legged Frog. Findings and conclusions from these risk assessments are 

summarized in the Problem Formulation for the Environmental Fate, Ecological Risk, 

Endangered Species, and Drinking Water Exposure Assessments in Support of the Registration 

Review of 1,3-Dichloropropene (Telone) and 1,3-Dichloropropene. 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 1,3-

dichloropropene. For human health, EPA may conduct revised dietary, residential, and 

occupational risk assessments during registration review. If toxicological endpoints or points of 

departure are revised, they will be considered in the new assessments, as well as any changes to 

the standard operating procedures or default exposure assumptions.

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

EFED Problem Formulation and HED Scoping Document.

Table 4: Anticipated Risk Assessments for the 1,3-Dichloropropene 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 See Table 1 for anticipated data needs.
9

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

1,3-dichloropropene, see page 26 of the 1,3-D 

Problem Formulation.

Human Health

Dietary

Food Y Dietary exposure assessments may be needed to

consider the most recent food consumption data and 

any change in the point of departure.

Drinking water Y Dietary exposure assessments may be needed to 

include newly estimated drinking water 

concentrations based on refined drinking water 

assessments and/or from updated drinking water 

monitoring data. 

Occupational

Handlers (mixers, loaders, 

applicators)

Y Handler exposure may be assessed.

Post-application Y Post-application exposure may be assessed depending 

on results of any additional ambient airshed 

monitoring data that may be required.

Residential

Handlers N 1,3-D is a restricted pesticide with no residential uses.

Post-application Y Although 1,3-D has no residential uses, residential 

bystanders around treated areas may be exposed as a 

result of 1,3-D agricultural applications. Postapplication exposures may be assessed depending on 

results of any additional ambient airshed monitoring 

data that may be required.

Other

Aggregate Y Evaluates the combined risk from dietary and 

residential exposures. Any change in endpoint for the 

dietary or inhalation routes of exposure may require a 

revised aggregate risk assessment.

Cumulative N 1,3-D is not a member of a cumulative group and no 

cumulative risk assessment is planned.

Tolerances Y The tolerances for 1,3-dichloropropene are 

established in 40 CFR § 180.636 and will be modified 

to reflect the new Interim Guidance on Tolerance 

Expressions.

Incidents Will check for 

updates

For a discussion of reported human incidents for 1,3-

dichloropropene, see page 11 of the Scoping 

Document and the Telone (1,3-D): Review of Human 

Incidents report.
10

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).

• Impacts on endangered species.

Guidance for Commenters: Additional human health information requested for this 

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

• Information is sought on the impact of 1,3-D on drinking water.

TIMELINE

EPA has created the following estimated timeline for the completion of the 1,3-dichloropropene

registration review in Table 5 below.

Table 5: Projected 1,3-Dichloropropene Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2013 – September

Close Public Comment 2013 – November

Case Development

Final Work Plan 2014 – February

Issue DCI 2014 April - June

Data Submission 2017 April - June

60-day Public Comment Period for Draft Risk 

Assessments4

2018 Oct. – Dec.

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2019 April - June

Registration Review Decision and Begin Post-Decision 

Follow-up

2020

Total (years) 7

 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.
11

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 1,3-dichloropropene.
12

Appendix – Additional Areas Considered in the 1,3-Dichloropropene

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:

1,3-Dichloropropene 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 1,3-dichloropropene.

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 1,3-dichloropropene 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 1,3-dichloropropene. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether use of 1,3-dichloropropene 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.

On June 5, 2013, the Center for Biological Diversity and the Pesticide Action Network North 

America filed an amended complaint in its lawsuit in the United States District Court for the 

Northern District of California, against the Environmental Protection Agency (EPA) for 

allegedly failing to undergo consultation with the United States Fish and Wildlife Service and the 

National Marine Fisheries Service regarding the effects of 50 pesticides, including 1,3-D on over 

100 endangered and threatened species throughout the United States (Center for Biological 

Diversity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.).

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 1,3-D, 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), 1,3-D 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. 
14

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 scheduled for Registration Review and chemicals found in water. 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

In the interim, EPA is making no human health or environmental safety findings associated with 

the EDSP screening of 1,3-D. Before completing this Registration Review, the Agency will 

make an EDSP FFDCA section 408(p) determination.

HUMAN STUDIES:

Chemical-Specific Human Studies

Past 1,3-D risk assessments have relied in part on several human studies which may have 

involved intentional exposure to 1,3-D. In the course of registration review EPA will reconsider 

these studies, as well as any other research involving intentional exposure of human subjects to 

1,3-D brought to its attention. If EPA decides to rely on any of these studies, EPA will ensure 

that all applicable regulatory requirements are met, including, but not limited to, the 

requirements for EPA ethics review and Human Studies Review Board review of certain 

research involving intentional exposure of human subjects.

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

chemicals.

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