2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) Final Work Plan (FWP) for the registration review of methyl bromide. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the methyl bromide registration review docket (E PA-HQ-OPP-2013-0269). Methyl bromide is a broad-spectrum fumigant chemical registered for use as an acaricide, fungicide, herb icide, insecticide, nematicide, and vertebrate contro l agent. Methyl bromide products are registered for use for preplant soil fumigation, post-harvest treatment of commodities, and structural fumigation.

The Agency is implementing the registration revi ew 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 th e FIFRA standard for registration. Changes in scienc e, public policy, and pesticide us e practices occur over time. The registration review program is intended to make su re that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard. The public phase of registration review begins wh en the initial docket is opened for each case. Information on this program is provided on the Agency’s website. 1

The FWP begins with any updates since the PWP wa s issued. Next is a summary of substantive comments received during the public comment peri od for the PWP concerning anticipated data needs, expected risk assessments, or the estimated timeline identified in the PWP, and a summary of the Agency’s responses to those comme nts. This section is followed by registration review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline for methyl bromide. Lastly, there is a discussion of next steps.

UPDATES SINCE TH E PWP WAS ISSUED

Drinking water assessment The Agency has concluded that a drinking wate r assessment will not be required for methyl bromide. Based on use patterns and the volatile na ture of methyl bromide, the Agency does not expect methyl bromide to adversely impact dr inking water sources (i.e., surface water, ground water).

Removal of antimicrobial claims The registrants for both methyl bromide products with antimicrobial claims removed the claims

from their labels in November 2013.

Post-harvest label table agreement On February 12, 2014, the Methyl Bromide Industry Panel (MBIP) and EPA agreed to the label changes to update the product labe ls with risk mitigation measures identified in the 2006 Methyl Bromide TRED. In general, changes were ma de to conform to changes in the Agency’s approach to fumigant risk mitigation as well as new information and data which have become

available since the TRED was issued. All commod ity- and structural-use la bels will be amended

1 http://www.epa.gov/oppsrrd1/registration_review/3 to add the risk mitigation measures, and a summary of the changes will be placed in docket EPAHQ-OPP-2005-0123.

Section 18 emergency exemptions fo r methyl bromide uses approved The Agency granted a quarantine exemption unde r the provisions of FIFRA section 18 to the Plant Protection and Quarantine (PPQ) division of the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Se rvice (APHIS), for the post harvest use of methyl bromide on certain imported and domestic commodities that do not appear on registered product labels to prevent the introduction or spre ad of any new or recently introduced foreign pest(s) to any U.S. location. This exempti on is effective March 1, 2014 and expires March 1,

2017.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Me thyl Bromide Preliminary Work Plan, which opened on September 25, 2013, and closed on November 25, 2013, the Agency received 13

submissions from 12 commenters. Comments were submitted by the Methyl Bromide Industry Panel (MBIP) (2 submissions), Center for Biol ogical Diversity, FIFRA Endangered Species Task Force, University of Florida, North Carolina De partment of Agriculture and Consumer Services, American Farm Bureau Federation, Florida Frui t and Vegetable Associat ion, Minor Crop Farmer Alliance, National Potato Council, Idaho Potato Commission, Northwest Horticultural Council,

and the Almond Board of California. The commen ts do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns, a nd trade irritants, but no comments or information were received on those issues. In addition, EPA solicited comme nts on the number of untarped applications and the number of applications each year to a field. The MBIP provided information for those

issues.

This section does not capture every comment made about the PWP nor all of the Agency’s responses. Summarized below ar e public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public comments and EPA responses in their entirety are locat ed in the docket, EPAHQ-OPP-2013-0269.

 Summarized public comments and Agency respon ses related to the anticipated ecological

risk assessment or data needs are in the EFED Response to Methyl Bromide Industry Panel (MBIP) Comments Regarding Data Call-In and Problem Formulation on the Registration Review of Methyl Bromide (DP Barcode: D416688).

 Public comments and responses relevant to th e anticipated human health risk assessment

or data needs are in the Methyl Bromide. HED’s Response to the Methyl Bromide Preliminary Work Plan Comments Submitted by the Methyl Bromide Industry Panel (MBIP); D417431

.

 Summarized public comments and Agency responses related to use and usage are in Responses to Public Comments Concerning th e Registration Review of Methyl Bromide (PC Code 053201) from EPA Docket ID No. : EPA-HQ-OPP-2013-0269, DP# 3375014  Summarized public comments and Agency resp onses related to the registration review process and policy issues are in Responses to Public Comments on the Methyl Bromide Preliminary Work Plan

.

Comments submitted by Methyl Bromide Industry Panel in EPA-HQ-OPP-2013-0269-0015 (pre-plant comments).

1. Comment: The Agency’s concerns about the risk of seedling exposure via soil diffusion are misplaced due to the establishment of buffer zones around the application area and the use of tarps for most of the me thyl bromide applications.

Response: Based on evaluation of comments regard ing the deep injection requirements for orchard use, the Agency agrees the risk to potential adjacent crops may be minimal from lateral transport th rough soils. The Agency has confirmed that the untarped methyl bromide use is small, and that exposure scenarios with methyl bromide transl ocation via runoff would be limited. In addition, the Agency agrees that exposure due to diffusion alone will not likely occur over large enough distances from the treate d field to impact non-ta rget plant seeds off

the treated field. This conclusion is not affected by either the potential presence of road beds around application sites or the required buffer zone of 25 ft or more, as suggested by the

comment.

Therefore, the Agency will not conduct an assessment of exposure to plant seeds off of the treated field and will remove the seedling em ergence data requirement for registration

review.

2. Comment: The ambient air monitoring data requirement (GDCI-053201-836) is mischaracterized as requiring ambient air m onitoring near commodity fumigation sites. Until such time as EPA issues a new DCI for monitoring studies for post-harvest commodity or structural uses, there is no legal obligati on for the registrants to conduct such studies.

Response: The Agency’s position as stated in the PWP remains unchanged. As we have explained previously, the Agency has concerns regarding the potential for community-based methyl bromide exposures to cause unreasonable adverse effects. Th e required ambient air monitoring data are expected to represent exposures to methyl bromide from all sources, including facilities that freque ntly use methyl bromide for commodity treatments. To date, MBIP has not provided any information that ha s dispelled the Agency’s concerns regarding human exposure to methyl bromide.

As the Agency has developed this plan for regi stration review of methyl bromide, we have determined that ambient air monitoring data from representative locations in Siskiyou County, CA, Georgia forestry nurseries, and th e Maritime Exchange Region for the Delaware River and Bay are necessary for the human health risk assessment for all registered uses.5 PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for methyl bromide based on the EFED Registration Review Problem Fo rmulation for Methyl Bromide

, Methyl Bromide Human Health Assessment Scoping Document in Support of Registration Review, EFED Response to Methyl Bromide Industry Panel (MBIP) Comments Regar ding Data Call-In and Problem Formulation on the Registration Review of Methyl Bromide (DP Barcode: D416688) and Methyl Bromide. HED’s Response to the Methyl Bromide Prelim inary Work Plan Comments Submitted by the Methyl Bromide Industry Panel (MBIP); D417431 . The table has been updated since the PWP to reflect public comments which resulted in changes to the data needs.

Table 1: Anticipated Data Needs for th e Methyl Bromide Registration Review

Guideline Number 2 Study Title Test

Material Estimated Timeframe
(Months from receipt of DCI)

850.6100 Environmental chemistry methods and associated independent laboratory
validations in air TGAI 12

Non-Guideline Honeybee vapor toxicity TGAI 24
Non-Guideline Terrestrial plant toxicity air exposure TEP 12
Non-Guideline Ambient air monitoring 3 TGAI/TEP 36
Outstanding Data Requirements from GDCI-053201-26629 4

875.2500 Inhalation exposure (postapplication) 5 TEP due 7/2011
Outstanding Data Requirements from GDCI-053201-27007 6

875.1300 Inhalation exposure – outdoor 7 TEP in review
850.4150 Vegetative vigor (Tier II) 8 TGAI in review
Outstanding Data Requirements from GDCI-053201-836 9

Non-guideline (listed in DCI as SS-1076) Ambient air monitoring TEP due 3/2014

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

2 On June 27, 2012, EPA announced certain revisions in harm onized 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/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

3 Data from additional monitoring locations are anticipated fo r Siskiyou County, CA, Georgia forestry nurseries, and the

Maritime Exchange Region for the Delaware River and Bay.

4 The study listed in this section was previously required th rough a generic data call-in issued in July 2009 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 The environment in which worker activities are monitored should also be evaluated which may include monitoring offgassing properties of fumigated commodities over time.

6 The studies listed in this section were previously require d through a generic data call-in issued in March 2010 and are

still outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required through the earlier DCI.

7 The study should measure handler exposure during tree replan t application using hand held equipment (e.g., deep probe

injection) using 98 percent methyl bromide at the maximum rate. Information to fulfill this data requirement was received on August 23, 2013 and is under review.

8 A study was submitted on July 12, 2013 and is under review.

9 The study listed in this section was previously required th rough a generic data call-in issued in March 2011 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 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species a ssessment, for all uses of methyl bromide. For human health, EPA will conduct revised dietary, residential, and occupational risk assessments during registration review. If toxico logical endpoints or points of de parture are revised based on the data that are required for registra tion review or other new information, they will be considered in the new assessments, as will any changes to the Agency’s standard operating procedures or default exposure assumptions.

Table 2 below summarizes the planned registrati on review risk assessments based on the EFED Problem Formulation and HED Scoping Docume nt and has been updated since the PWP to reflect that a drinking water risk assessment w ill not be included in the risk assessment for methyl bromide.

Table 2: Anticipated Risk A ssessments for the Methyl Bromide Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The ecological risk assessment will focus on methyl

bromide as the main stresso r of concern for air and soil exposure.

Incidents Will check for updates A single plant incident was identified in the Aggregate Incident Databa se. For a discussion of reported ecological incidents for methyl bromide, see page 26 of the Problem Formulation.

Human Health Dietary Food Y An updated dietary assessment may be required to incorporate any updated crop uses. Drinking water N The Agency will not conduct a quantitative drinking water assessment for methyl bromide because limited exposure is anticipated. Occupational Handlers (mixers, loaders, applicators) Y An occupational handler risk assessment may be necessary based on the most recent toxicological and exposure data. Post-application Y An occupational bys tander risk assessment may be necessary based on the most recent toxicological data and the anticipated expos ure (e.g., post-harvest commodity worker study) data.

Residential7 Handlers N Methyl bromide is restricted use. There are no registered uses for applications by residential

handlers. Post-application N Methyl bromide is restricted use. There are no registered uses for applic ations facilitating typical residential post-application exposure. Bystander Y For soil and post-harvest commodity uses, there is the potential for resident ial bystander (anyone not involved in the application) inhalation exposure to methyl bromide after a methyl bromide fumigation. A revised residential risk assessment is anticipated in registration review to update risk to bystanders during and following use of methyl bromide products.

Additionally, the Agency anticipates updating the fumigant factors document, which provides a discussion of values and para meters used as the basis

for buffer zone reduction credits as well as for establishing Good Agricultura l Practices (GAPs) for the soil fumigants. Buffer zones and GAPs were specified by the 2009 amended RED as measures to mitigate occupational and bystander risk.

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures. Cumulative N Methyl bromide is not a member of a cumulative

group. Tolerances Y All tolerances listed under 40 CFR §180.123 for inorganic bromides should be moved to §180.124 for methyl bromide.

Incidents Will check for updates For a discussion of reported human incidents for methyl bromide, see page 16 of the Scoping

Document and the Methyl Bromide: Review of Human

Incidents

.

TIMELINE

EPA has created the following estimated timeline for the completion of the methyl bromide registration review in Table 3 be low. The projected timeline has been updated since the PWP to reflect the lengthening of the timeframe between posting of the draft ri sk assessment and the proposed decision by one quarter.8 Table 3: Projected Methyl Bromid e Registration Review Timeline

Activities Estimated Date Opening the Docket 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 2017 April - June 60-day Public Comment Period for Draft Risk

Assessments 10 2018 October - December

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 July - September

Registration Review Decisi on and Begin Post-Decision Follow-up 2020

Total (years) 7

NEXT STEPS

As noted previously, the Agency plans to requ ire several studies for methyl bromide through a Data Call-In Notice, expect ed to be issued in 2014.

10 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; s ee 40 CFR Part 155.53(c). For pesticides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.