2 

### Chloropicrin 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 10

Anticipated Risk Assessment s for Registration Review 10

Timeline 13

Next Steps 13

Appendix

– Additional Areas Considered in the Chloropicrin Registration Review 14

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 Chloropicrin

. Gelmann, Elyssa; Mostaghimi, Siroos; et. al

. DP Barcode D410110. August 28 , 2013.

2. Chloropicrin Registration Review Human

- Health Assessment Scoping Document

. Smith, Charles; Schlosser, Christopher; et. al

. DP Barcode D410119. September 3 , 2013

.

3. Chloropicrin: Review of Human Incidents. DP Barcode D414490. Recore, Shannon; Evans, Elizabeth. August 29, 2013

.

4. BEAD Chemical Profile (BCP) for Registration Review: Chloropicrin (081501). Chandgoyal, Tara; Doucoure, Cynthia; Lee, Andrew. April 29 , 201 3

.

5. Usage Data. Chl oropicrin (081501) Screening Level Usage Analysis (SLUA)

. April 20,

2012.3 6. PRD Label Data Report: Food/Feed & Non

- Food/Non

- Feed Uses Considered in Registration Review Work Planning; Chloropicrin (081501). May 1, 2013

.

7. Amended Reregistration Eligibility Decision (RED) for Chloropicrin. May 2009

. EPA

- HQ

OPP

- 2007

- 0350

- 0396.

8. Revised Screening Ecological Risk Assessment for the Reregistration of Chloropicrin. DP Barcode 348669. April 16, 2008. EPA

- HQ

- OPP

- 2007

- 0350

- 0175

.

9. Ch loropicrin: Third Revision of the HED Human Health Risk Assessment. D P Barcode

348637. A pril 30

, 2009. EPA

- HQ

- OPP

- 2007

- 0350

- 0398

.

Unless noted above, these and other supporting documents for the chloropicrin registration

review case may be found in the docket EPA

- HQ

- OPP

- 2013

- 0153 at http://www.regulations.gov

.4 OVERVIEW

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

- HQ

- OPP

- 2 013

- 0153 )

. Chloropicrin is a non

- selective

f umigant with fungicidal, herbicidal, insecticidal, and nematicidal properties registered for use as

a pre

- plant soil fumigant for a variety of agricultural field crops and greenhouses, and for tree replant . Chl oropicrin is also an active ingredient in antimicrobial wood preservative products. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs

knows about chloropicrin

, 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 chloropicrin

.

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

. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will hel p 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. Inter ested 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 chloropicrin

. 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 anticip ated risk assessments, and a projected registration review timeline for chloropicrin

. 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 addition al chemical case

- specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for chloropicrin . 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 Chloropicrin and Chloropicrin Registration Review Human

- Health Assessment Scoping Document

.

Table 1: Anticipated Data Needs for the Chloropicrin Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4300 Aerobic aquatic metabolism TGAI 24

850.4 5 00 Aquatic non

- vascular plant studies TGAI 12

850.61 00 Environmental chemistry methods and associated independent laboratory validation

studies in air and water TGAI 12

Non

guideline Acute vapor exposure h oney bee study TGAI 24

Outstanding Data Requirements from GDCI

- 081501

- 28905 2

850.4100 Seedling emergence (Tier II) TGAI TBD*

850.4150 Vegetative Vigor (Tier II) TGAI TBD*

Non

guideline (listed in DCI

as SS

- 2 ) Avian acute inhalation TGAI TBD*

Outstanding Data Requirements from GDCI

- 081501

- 1155 3

Non

guideline Ambient Air Monitoring TEP Due May 15,

2015
TGAI = technical grade active ingredient; TEP = typical end

- use product ; * T he registrant submitt ed data to the Agency that were determined to be insufficient to satisfy the data requirement; the Agency is following up with the registrants to address these remaining data gaps.

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850

– Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 These studies listed in this section w ere previousl y required through a generic data call

- in issued in Ma rch 201 0

and are still outstanding. Th ese stud ies will not be included in the anticipated Registration Review DCI because

t hey are already required through the earlier DCI

. 3 The study listed in this s ection w as previously required through a generic data call

- in issued in May 2012 and is

still outstanding. This study will not be included in the anticipated Registration Review DCI because it is already required through the earlier DCI.6 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

t o 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

. Informatio n 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

. T he Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses

and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of chlorop icrin

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for chloropicrin

.

Table 2: Chemical Facts for Chloropicrin

PC code 081501

Case Number 0040

CAS Number 76

- 06

- 2

Year first registered 1975 Pesticide Type N onselective soil fumigant with fungicidal, herbicidal, insecticidal, and nematicidal properties

, and an antimicrobial for remedial wood

treatment.

Chemical class Fumigant

R eregistration Eligibility Decision (R E D) RED

, July 2008 ; Amended RED

, May 2009

4 http://www.epa. gov/oppsrrd1/registration_review/7 Table 2: Chemical Facts for Chloropicrin

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Not applicable. Chloropicrin has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

40 CFR Citation There are no tolerances established for chloropicrin. All registered food uses are pre

- plant. 5

Dual

- use Yes. Registered for conventional and antimicrobial uses

Non

- pesticidal uses Used as a warning agent for some structure fumigations

Pesticide Re

- evaluation Division, Chemical Review Manager Carolyn Schroeder schroeder.carolyn@epa.gov

703

- 308

- 2961
Antimicrobial Division,

Chemical Review Manager S and r a O’Neill

on eill

. s and r a@epa.gov (703)

- 34 7

- 0141 Registration Division, Product Manager Hope Johnson johnson.hope@epa.gov

703

- 305

- 5410

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for chloropicrin

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Chloropicrin (081501) in the registration

review docket for more details

.

Table 3: Chloropicrin Use and Usage Information

Summary of Use Chloropicrin is a broad spectrum fumigant with fungicidal, herbicidal, insecticidal, and nematicidal properties registered for

use in pre

- plant fumigation

. Chloropicrin is also an active ingredient in antimicrobial wood treatment products

. Use Sites Conventional Uses : Pre

- plant s oil use on agricultural c rops including beans, beets, bell peppers, caneberries, carrots, citrus, cole crops, cucumber, cucurbit vegetables such as melons, deciduous fruit trees, eggplant, field crops such as co rn , soybeans, and sugar beets, fruits unspecified, ginger, grapes, hops, legume

veget ables, lettuce, mint, onions, orchards, peanuts, pepper, pineapple, potatoes, radish, stone fruit, strawberry, sweet potatoes,

5 Chloropicrin ’s volatility in the environment and results of metabolism studies in plants assure that there is no reasonable expectation of finite residues to be incurred in/on any raw agricultural commodity when these pr oducts are applied according to label directions. Therefore, this fumigant does not require food tolerances a nd is not subject to the amendments to the FFDCA promulgated under the Food Quality Protection Act of 1996. (See the Chloropicrin: Third Revision of the HED Human Health Risk Assessment . April 30, 2009. )8 Table 3: Chloropicrin Use and Usage Information

tomatoes, tree nuts, yams, and other vegetables.

N on agricultural/non

- food sites include Christmas tree plantations, conifers, f orest nursery plantings (for transplant purposes), forest plantings (reforestation programs), golf course turf, nonagricultural uncultivated areas/soils, nursery stock, ornamental and/or shade

trees, ornamental grasses, ornamental herbaceous plants,

orname ntal lawns and turf, ornamental nonflowering plants, ornamentals unspecified, ornamental woody shrubs and vines, potting soil/top soil, recreation area lawns, preplant soil, tobacco, and wood protection treatment to buildings/products outdoor, forest produ cts (seasoned), and a quatic structures/items.

Antimicrobial Uses : P reservative to prevent internal decay in wooden poles /timbers

, pilings and glue

- laminated beams ; in

- place treatment of wood piles, poles, and timbers ; poles piles, and timbers

in terrestr ial sites ; and treatment of in

- service wood in aquatic sites. Summary of Usage Conventional Uses: Based on usage data from 2007

- 2011, chloropicrin 's annual agricultural usage averaged 12 million pounds of active ingredient, treating an average of approximately 200 ,000 acres, for an average application rate of 136 pounds a ctive

i ngredient per acre. For the same time period, strawberries (33 %)

, tobacco (20%), tomatoes (17%), and peppers (11 %) accounted for the largest percentages of usage in terms of total pounds of a ctive

i ngredient applied

.

Based on available usage data from 2009, nursery and floriculture applied approximately 434 ,000 pounds of a ctive i ngredient for an average applicatio n rate of 105 pounds of a ctive i ngredient per acre.

Antimicrobial Uses: Usage data are not available for the antimicrobial use of chloropicrin. Formulation Type(s) Conventional Use s : Chloropicrin is commonly formulated alone or

with methyl bromide or 1 ,3

- dichloropropene as an emulsifiable concentrate, soluble concentrate/liquid, liquid ready to use, or as pressurized gas

.

Antimicrobial Use s : Chloropicrin is formulated alone as a ready

- to

use liquid solution. Application Method(s) Conventional Use s : Chloropicrin is applied to soil using tractor

mounted fumigation injection equipment including shanks, chisels,

and plowsoles, as well as through drip irrigation and hand operated soil injection equ ipment

.

Antimicrobial Uses: Chloropicrin is applied as a wood preservative by injecting or pouring directly into pre

- drilled holes or through9 Table 3: Chloropicrin Use and Usage Information

encapsulated vials

. Chloropicrin is predominantly packaged into prefilled vials which are later injected into the center of the timber. The certified applicator drills a hole in the wood timber, inserts a vial containing the liquid chloropicrin deep into the drilled hole of the timber and then permanently caps or seals the hole in the

timber. The vials slowly degrade over time and the chloropicrin vapor then releases into the wood timber. Technical Registrant (s) Conventional Uses : Great Lakes Chemical Corporation; Niklor Chemical Co., Inc.; Trinity Manufacturing, Inc.; Ashta Chemicals

, Inc.

Antimicrobial Uses : Osmose Railroad Services, Inc. No. of Registrations Conventi onal Uses : 6 0 Section 3 6

, 4 Section 24 c

Antimicrobial Uses : 1 Section 3

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.

• C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per s eason ; and geographic limitations on use

.

• U se distribution (e.g., a creage and geographical distribution of relevant use sites )

.

• M edian and 90 th pe rcentile reported use rates (pounds of a ctive i ngredient per acre ) from usage data

– national, state, and county

.

• Typical a pplication timing (date of first application)

– national, state, and county

.

• Usage/use information for non

- agricultural uses

.

• S tate or local use restrictions

.

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

market

.

In addition, the Agency will continue t he dialogue with stakeholders about label issues that have evolved during the RED label implementation process.

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

( http://oaspub.epa.gov/pestlabl/ppls.home ).10 RECENT ACTIONS

A Reregistration Eligibility Decision (RED) was completed for chloropicrin in July 2008 and amended in May 2009. The Agency determined that chloropicrin products were eligible for reregistration provided a number of risk mitigation measures adopted and la bel amendments are

made to reflect these measures. For details on the mitigation measures, see the Amended Reregistration Eligibility Decision (RED) for Chloropicrin, dated May 2009 . Additionally, the Agency’s Soil Fumigant Toolbox website contains information on these and other soil fumigants: http://www.epa.gov/pesticides/reregistration/soil_fumigants/

.

T he product reregistration process , which starts af ter completion of a RED, is still ongoing for chloropicrin products.

A dditionally , the Agency plans to work with stakeholders to determine if chloropicrin fumigant product labels should be reorganized or revised in order to clarify the G ood Agricultural

Practices and b uffer z ones that correspond to each of the various application methods

.

Since publication of the 2008 RED, the following products with antimicrobial wood preservative

uses were cancelled: TM

- 442, EPA registration number 66330

- 47, cancelled on 2

- 20

- 13 (77 FR 72343 (12

- 5

- 12)); and Timberfume, EPA registration number 75341

- 3, cancelled on 7

- 27

- 12 (77 FR 44229 (7

- 27

- 12)). The Agency is anticipating the submission of a label amendment for Timberfume II, EPA registration number 7534 0

- 1 . This label amendment will adopt risk mitigation measures identified in the RED.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for chloropicrin was complete d in April 2009 in preparation for the amended Reregistration Eligibility Decision. An a ddendum to

the asse ssment was completed in January 2011. The most recent antimicrobial occupation al and residential exposure assessment was com pleted in April 2007. The most recent ecological and

environme ntal fate risk assessment was completed in April 2008 for the Reregistration Eligibility

Decision completed in July 2008 . Findings and conclusions from these risk assessments are

summarized in t he Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of the Registration Review of Chloropicrin and the Chloropicrin Registration Review Human

- Health Assessment Scoping Document

.

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 chloropicrin

. For human health, EPA does not anticipate the need to conduct revised dietary and occupational risk assessment s during registration review . However, i f new field volatility studies

become available or points of departure or uncertainty factors change, they will be considered in

the new assessment s
, as well as any changes to the standard operating p rocedures or defa ult exposure assumptions

.11 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 Chloropicrin Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed

include terrestrial and aquatic organisms ), including endangered species Y The primary stressor of ecological concern is chloropicrin. Chloropicrin’s photodegration products ( phosgene and nitrosyl chloride ) are expected to quickly degrade, and for this reason, only chloropicrin will be considered as a stressor of

concern. Incidents Will check for updates For a discussion of reported ecological incidents for chloropicrin , see page 19 of th e Problem

Formulation.

Human Health Dietary

Food N The agricultural uses of chloropicrin are considered

non

- food uses, since there is no reasonable expectation of finite residues in/on food crops when it is used as a pre

- plant fumigant. A dietary assessment is not anticipated in registration review. Drinking water N Based on environmental fate data, the residual contents in soils, and monitoring data, the Agency does not expect chloropicrin to adversely impact drinking water sources such as surfa ce water and ground water, so a drinking water assessment is not anticipated in registration review. Occupational Handlers (m ixer s, loader s, applicators ) N New occupational handler exposure assessments are not anticipated unless new studies become available or points of departure or uncertainty factors change.

Post

- application N New occupational post

- application exposure assessments are not anticipated unless new studies become available or points of departure or uncertainty factors change.

Residential

Handlers N Chloropicrin is restricted use. There are no registered uses for applications by residential

handlers

. Post

- application N Chloropicrin is restricted use. There are no registered uses for applications facilitating typical

post

- application exposure.12 Bystanders Y For soil uses, there is the potential for residential bystander inhalation exposure to chloropicrin after a soil fumigation application of chloropicrin

. A revised residential risk assessment is anticipated in registration review to update risk to bystanders during and f ollowing soil fumigant uses of chloropicrin products.

Additionally, the Agency anticipates updating the fumigant factors document, which provides a discussion of values and parameters used as the basis for buffer zone reduction credits (i.e., tarps) as well as for establishing Good Agricultural Practices (GAP s) for the fumigants. This document impacts all of the soil fumigants including chloropicrin.

Buffer zones and GAPs were specified by the 2009 amended RED as measures to mitigate occupational and bystander risk.

Other Aggregate N E valuates the combined risk from dietary and residential exposures. No dietary risk is anticipated

from chloropicrin . Therefore, an aggregate assessment is not anticipated.

Cumulative N N ot a member of a cumulative group

Tolerances N Chloropicrin is a preplant soil fumigant s o there are

no tolerances established for this chemical

. Incidents Will check for updates For a discussion of reported human incidents for chloropicrin , see page 9 of the Scoping Document

and the Chloropicrin : Review of Human Incident s

.

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) n ot already reported to the Agency

.

• Water quality m onitoring data (see Appendix for further details)

.13 TIMELINE

EPA has created the following estimated timeline for the completion of the chloropicrin registration review in Table 5 below

.

Table 5: Projected Chloropicrin 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 201 6 April

– June

6 0

- day Public Comment Period for Draft Risk

Assessments 7 201 8 October

– December

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2 019 April

- June

Registration Review Decision and Begin Post

- Decision

Follow

- up 20 19

Total (years) 6

NEXT STEPS

After the 6 0

- day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration

review of chloropicrin

.

7 The regulations governing Registration Review genera lly require the Agency to provide a public comment period

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, t he Agency plans to provide a 60 calendar day public comment period generally for dr aft risk assessment s

.14 

### Appendix

– Additional Areas Considered in the Chloropicrin 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 harmonize tolerances and international maximum r esidue 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 market s, providing as much specificity as possible regarding

the nature of the concern. Because chloropicrin is not registered for food/feed uses in the U.S.,

it has no U.S. tolerances ; therefore, the Agency does not anticipate any trade irritant issues for it

.

Water Quality:

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

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

. 9 More information on impaired water bodies

and TMDLs can be found at the Agency’s website

. 10 The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 11 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessmen ts.

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 environmenta l 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 chloropicrin compared to the general population. Please

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

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

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

11 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm15 comment if you are aware of any sub

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

ENDANGERED SPECIES :

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

conducted for chloropicrin

. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of chloropicrin 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, reproductiv e, 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 regist ration decision for chloropicrin, 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), chloropicrin is subject to the endo crine 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 syste ms 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

e stablish 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 of16 chemicals identified for EDSP screening was published on June 14, 2013 12 and includes some pesticides scheduled for Registration Review and chemi cals 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. 13

In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of chloropicrin . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

HUMAN STUDIES :

Chloropicrin

- specific Human St udies

Past chloropicrin risk assessments have relied in part on a human stud y which involved intentional exposure to chloropicrin. In the course of registration review EPA will reconsider

th is stud y
, as well as any other research involving intentional exposure of human subjects to chloropicrin 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 t o
, the requirements for EPA ethics review and Human Studies Review Board review of certain research involving intentional exposure of human subjects.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

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