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 Assessment s 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 summarize s 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

- d ichloropropene 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 c ontrol
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 vineya rds. 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 compon ent 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 1,3

- d ichloropropene and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a
decision on 1,3

- d ichloropropene

. 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: environ mental 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

- d ichloropropene

. 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 1,3

- d ichloropropene

. 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 ca se

- specific
information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for 1,3

- d ichloropropene . 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
Number 1 Study Title 1 Test Material Estimated
Timeframe
(Months from receipt of DCI)

Anticipated D ata 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 A erobic Soil Metabolism TGAI 24
835.8100 Field Volatility TEP 12

Non

guideline Terrestrial Plant Vapor Phase Exposure TEP 12

Non

guideline Acute Avian Inhalation TGAI 24

Non

guideline Honey Bee Acute Vapor Phase Exposure TGAI 24

Non

guideline Ambient Airshed Monitoring TEP 36

Anticipated Data Needs for the 1,3

- D Degradate 3

- chloroallyl alcohol (CAAL)

835.4100 A erobic 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 A erobic 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 00285 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 envi ronment 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

s ure 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 Agen cy 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 wha t 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 F ina l W ork P lan (FWP) and anticipated schedule for the registration review of 1,3

- d ichloropropene

.

CHEMICAL FACTS

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

- d ichloropropene

.

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

R eregistration Eligibility Decision (R E D) 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

- d ichloropropene are established in 40 CFR §
180.636.
Dual

- use 1,3

- d ichloropropene 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

- d ichl oropropene

. 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) 5 64

- 5 557

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 an d 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 cr ops), ornamental lawns and turf, golf course turf, ornamental and/or shade trees, ornamental herbaceous and non

flowering 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
marke t 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 19987 Table 3: 1,3

- Dichloropropene Use and Usage Information

to 201 1, 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%),

co tton (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 products 3 and 2 3 Section 24c registration s Restricted Use Yes

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 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 c hloropicrin /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 90 th percentile reported use rates (lbs ai/A) from usage data

– national, state, and county.

• Typical application ti ming : 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 Produ ct 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 s ince the 1998 RED

. First, t he prohibition of use in areas overlying karst geology was changed to prohibit application within 100 feet of karst topographical features. Second, t he 300 foot buffer from occupied structures was changed to 100 feet from occupied structures for s ome 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

v ineyards . 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 Cod e: 029001

. T he most recent ecological risk assessment for 1,3

- D

was a 2008 endangered species study entitled Risks of Telone Use to the Feder ally Threatened California Red

- L egged Fro g

. 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 Scopi ng Document in Support of Registration Review

.

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 1,3

- d ichloropropene

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

, and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised, they will be considered in the new assessment s , as well as any changes to
th e standard operating p rocedures or default exposure assumptions

.

T able 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

- D ichloropropene 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 See Table 1 for anticipated data needs.9 Incidents Will check for updates For a discussion of reported ecological incidents for 1,3

- d ichloropropene

, 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 (m ixer s, loader s, applicators ) Y Handler exposure may be assessed.

Post

- application Y Post

- application exposure may be assessed depending on results of any additional a mbient 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. Post

application exposures may be assessed depending on results of any additional a mbient 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

- d ichloropropene are established in 40 CFR § 180.636 and will be m odified
to reflect the new Interim Guidance on Tolerance Expressions

. Incidents Will check for updates For a discussion of reported human incidents for 1,3

- dichloropro pene , see page 11 of the Scoping

Document and the Telone (1,3

- D): Review of Human
Incidents report

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

• 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)

.

• 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 fol lowing estimated timeline for the completion of the 1,3

- d ichloropropene registration review in Table 5 below

.

Table 5: Projected 1,3

- D ichloropropene Registration Review Timeline

Activities Estimated Dat e 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
Assessments 4 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 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 1,3

- d ichloropropene

.12 

### Appendix

– Additional Areas Considered in the 1,3

- D ichloropropene 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 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 harmoni ze 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:

1,3

- D ichloropropene 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 1,3

- d ichloropropene

. 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

R isk 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 o n 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

- d ichloropropene compared to the general population. Please comment if you are aware of a ny 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.htm13 ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determination has not been
conducted for 1,3

- d ichloropropene

. The ecological risk assessment planned during registration
review will allow t he Agency to determine whether use of 1,3

- d ichloropropene 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 Service s), 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 Envi ronmental 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 o n over 100 endangered and th reatened 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, neurotoxici ty, 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 maturati on, 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 sub ject 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 simil ar 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 fo r 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, 2013 9 and includes some pesticides scheduled for Registration Revi ew and chemicals found in water

. For further information on the status of the EDSP, the policies and procedures, the list s of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 10

In the interim, EPA i s 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

- S pecific Human S tudies

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/