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INTRODUCTION

This is the Environmental Protection Agency’s (EPA 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 (EPA-HQ-OPP-2013-0269). Methyl bromide is a broad-spectrum 

fumigant chemical registered for use as an acaricide, fungicide, herbicide, insecticide, 

nematicide, and vertebrate control 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 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. Changes in science, public policy, and pesticide use practices occur over time. 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. 

The public phase of registration review begins when 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 was issued. Next is a summary of substantive 

comments received during the public comment period 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 comments. 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 THE PWP WAS ISSUED

Drinking water assessment

The Agency has concluded that a drinking water assessment will not be required for methyl 

bromide. Based on use patterns and the volatile nature of methyl bromide, the Agency does not 

expect methyl bromide to adversely impact drinking 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 labels with risk mitigation measures identified in the 2006 Methyl 

Bromide TRED. In general, changes were made 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 commodity- and structural-use labels will be amended 

 

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 http://www.epa.gov/oppsrrd1/registration_review/ 
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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 for methyl bromide uses approved 

The Agency granted a quarantine exemption under 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 Service (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 spread of any new or recently introduced foreign 

pest(s) to any U.S. location. This exemption 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 Methyl 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 Biological Diversity, FIFRA Endangered Species Task 

Force, University of Florida, North Carolina Department of Agriculture and Consumer Services, 

American Farm Bureau Federation, Florida Fruit and Vegetable Association, Minor Crop Farmer 

Alliance, National Potato Council, Idaho Potato Commission, Northwest Horticultural Council, 

and the Almond Board of California. The comments 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, and trade irritants, but no comments or information were received 

on those issues. In addition, EPA solicited comments 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 are 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 located in the docket, EPAHQ-OPP-2013-0269. 

 Summarized public comments and Agency responses 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 the 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 the Registration Review of Methyl Bromide 

(PC Code 053201) from EPA Docket ID No. : EPA-HQ-OPP-2013-0269, DP# 337501
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 Summarized public comments and Agency responses 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 methyl bromide applications.

Response: Based on evaluation of comments regarding the deep injection requirements for 

orchard use, the Agency agrees the risk to potential adjacent crops may be minimal from 

lateral transport through soils. The Agency has confirmed that the untarped methyl bromide 

use is small, and that exposure scenarios with methyl bromide translocation 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 treated field to impact non-target 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 emergence data requirement for registration 

review. 

2. Comment: The ambient air monitoring data requirement (GDCI-053201-836) is 

mischaracterized as requiring ambient air monitoring 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 obligation 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. The required ambient air 

monitoring data are expected to represent exposures to methyl bromide from all sources, 

including facilities that frequently use methyl bromide for commodity treatments. To date, 

MBIP has not provided any information that has dispelled the Agency’s concerns regarding 

human exposure to methyl bromide. 

As the Agency has developed this plan for registration review of methyl bromide, we have 

determined that ambient air monitoring data from representative locations in Siskiyou 

County, CA, Georgia forestry nurseries, and the Maritime Exchange Region for the Delaware 

River and Bay are necessary for the human health risk assessment for all registered uses. 

 
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PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for methyl bromide based on the EFED 

Registration Review Problem Formulation for Methyl Bromide, Methyl Bromide Human Health 

Assessment Scoping Document in Support of Registration Review, 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) and Methyl Bromide. 

HED’s Response to the Methyl Bromide Preliminary 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 the Methyl Bromide Registration Review 

Guideline Number2 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 monitoring3 TGAI/TEP 36 

Outstanding Data Requirements from GDCI-053201-266294

875.2500 Inhalation exposure (postapplication)5 TEP due 7/2011 

Outstanding Data Requirements from GDCI-053201-270076

875.1300 Inhalation exposure – outdoor 7 TEP in review 

850.4150 Vegetative vigor (Tier II)8 TGAI in review 

Outstanding Data Requirements from GDCI-053201-8369

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; 

 

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 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests – 

including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; 

OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 3

 Data from additional monitoring locations are anticipated for 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 through 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 required 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 replant 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. 

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 The study listed in this section was previously required through 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.
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RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of methyl bromide. For human health, 

EPA will conduct revised dietary, residential, and occupational risk assessments during 

registration review. If toxicological endpoints or points of departure are revised based on the 

data that are required for registration 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 registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document and has been updated since the PWP to 

reflect that a drinking water risk assessment will not be included in the risk assessment for 

methyl bromide. 

Table 2: Anticipated Risk Assessments 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 stressor of concern for air and 

soil exposure. 

Incidents Will check for 

updates 

A single plant incident was identified in the 

Aggregate Incident Database. 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 bystander risk assessment may be 

necessary based on the most recent toxicological data 

and the anticipated exposure (e.g., post-harvest 

commodity worker study) data. 

Residential 
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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 applications facilitating typical 

residential post-application exposure. 

Bystander Y For soil and post-harvest commodity uses, there is the 

potential for residential 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 parameters used as the basis 

for buffer zone reduction credits as well as for 

establishing Good Agricultural 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 below. The projected timeline has been updated since the PWP to 

reflect the lengthening of the timeframe between posting of the draft risk assessment and the 

proposed decision by one quarter. 

 
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Table 3: Projected Methyl Bromide 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 

Assessments10

2018 October - December 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

2019 July - September 

Registration Review Decision and Begin Post-Decision 

Follow-up 

2020 

Total (years) 7 

NEXT STEPS

As noted previously, the Agency plans to require several studies for methyl bromide through a 

Data Call-In Notice, expected 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; see 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.