2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of chloropicrin . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the chloropicrin registration review docket (EPA

- HQ

- OPP

- 2013

- 0153 ). Chloropicrin is a non

- selective fumigant with fungicidal, herbicidal, insecticidal, and nematicidal properties registered for use as a pre

- plant soil fumigant for a variety of agricultural field crops an d greenhouses, and for tree replant. Chloropicrin is also an active ingredient in antimicrobial wood preservative products.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science, public policy, and pesticide use practices occur over time. The registration r eview 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. The public phase of registration review begins when the initial dock et is opened for each case.

Informatio n on this program is provided on the Agency’s website

. 1

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive

comments received during the public comment period for the PWP concer ning anticipated data

needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration

review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for chloropicrin

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

EPA approved a label amendment for a product with antimicrobial wood preservative u ses: Timberfume II, EPA registration number 75340

- 1. This label amendment adopted the risk mitigation measures identified in the 2009 Amended RED.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Chloropicrin Prel iminary Work Plan , which opened on September 25, 2013 a nd closed on November 25, 201 3 , t he Agency received 1 2 unique public comments in the chloropicrin docket

. In addition, 2 comments related to chloropicrin were submitted to dockets for other fumigant active ingredients. Comments submitted by the registrant, agricultural associations, non

- profit organizations, and one state agriculture department address the registration review process and /or utility of soil fumigants in agriculture. Two comments were submitted by the Pesticide Action Network of North America (PANNA) : one mass comment campaign which received 5,645 signatures, and one with signatures from representatives from 34 organizations. These comments along with an additional

1 http://www.epa.gov/oppsrrd1/registration_review/3 comment from an ind ividual , in part, request the Agency re

- evaluate risk assessment levels of

concern
, buffer zone distances imposed by the 2008 reregistration eligibility decision , and the carcinogenicity of chloropicrin

. In the PWP, EPA also solicited comments on the spec ific topics of environmental justice, water quality concerns, and trade irritants, but no comments or information were received on those issues. Public comments in their entirety are located in chloropicrin docket, EPA

- HQ

- OPP

- 2013

- 0153. In addition, the following response

- to

- comment documents are located in the chloropicrin docket:

• C omments and Agency responses related to the anticipated ecological risk assessment or data needs are in the Environmental Fate and Effects Division’s Response to Comments

on the Chloropicrin Problem Formulation for Registration Review

.

• Comments and Agency responses regarding the anticipated human health risk assessment

or data needs are in The Health Effects Division’s Response to Pesticide Action Network

North America on the Chloropicrin Registration Review Scoping Document for Human

Risk Assessment

.

• EPA’s responses to comments not addressed in the previously mentioned documents are

in the Responses to Public Comments on the Chloropicrin Preliminary Work Plan

.

The Agency co nsidered the issues and concerns raised by each of the comments submitted, but the registration review timeline, data

- requirements, and anticipated risk assessment needs did not change as a result of these comments.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for chloropicrin based on the Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of the Registration Review of Chloropicrin ; Chlor opicrin Registration Review Human

- Health Assessment Scoping Document ; and r esponse to PWP c omments documents

. T he planned data needs have not changed from

what was included in the PWP

. The agency does not anticipate the need to require additional

data for the wood preservative uses.

Table 1: Planned Data Needs for the Chloropicrin Registration Review for Soil Pre

- plant Uses Only

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4300 Aerobic aquatic metabolism TGAI 24

850.4500 Aquatic non

- vascular plant studies TGAI 12

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

– Ecological Effects Tests

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

- HQ

- OPPT

- 2009

- 0154

- 00284 Table 1: Planned Data Needs for the Chloropicrin Registration Review for Soil Pre

- plant Uses Only

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

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 3

850.4100 Seedling emergence (Tier II) TGAI TBD*

850.4150 Vegetative v igor (Tier II) TGAI TBD*

Non

guideline (listed in DCI

as SS

- 2) Avian acute inhalation TGAI TBD*

Outstanding Data Requirements from GDCI

- 081501

- 1155 4

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.

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessmen t, including an endangered species assessment, for all uses of chloropicrin

. For human health, EPA anticipates the need to conduct revised residential bystander risk assessment during registration

review for soil fumigant uses. EPA does not anticipate th e need to conduct revised dietary and occupational risk assessments during registration review. However, if new field volatility studies become available or points of departure or uncertainty factors change, they will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions

.

3 These studies listed in this section w ere previously 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

. 4 The study listed in this section 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.5 Table 2 summarizes the planned registration review risk assessments based on the EFED

Problem Formulation and HED Scoping Document and the planned assessments have not changed from what was included in the PWP

.

Table 2: Planned 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 the 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 surface 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.6 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 following 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 zon e reduction credits (i.e., tarps) as well as for establishing Good Agricultural Practices (GAPs) 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 meas ures 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 Chloropicrin is n ot a member of a cumulative group

. Tolerances N Chloropicrin is a preplant soil fumigant so 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 Incidents

.7 TIMELINE

EPA has created the following estimated timeline for the completion of the chloropicrin registration review in Table 3 below

. The projected timeline has been updated to reflect the lengthening of the timeframe between posting of the draft risk assessment and the proposed decision by one quarter. The PWP inaccurately provided the wrong date for the 60

- day public comment period f or the draft risk assessments. It has been corrected in Table 3.

Table 3: Registration Review for Chloropicrin

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period Sept. 2013

- Completed

Close Public Comment Nov. 2013

- Completed Case Development

Final Work Plan March 2014

- Completed

Issue DCI 2014 : April

- June

Data Submission 2016: April

– June

60

- day Public Comment Period for Draft Risk Assessments 5 2017 : Oct.

– Dec. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision 2018: July

– Sept.

Registration Review D ecision and Begin P ost

- D ecision F ollow

up 2019

Total ( years ) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects,

and human health studies for chloropicrin through a D ata C all

- I n Notice , expected to be issued by June 2014

.

5 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 6 0 calendar day public comment period generally for draft risk assessments.