2

Methyl Bromide 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 Assessments for Registration Review 10 

Timeline 13 

Next Steps 13 

Appendix – Additional Areas Considered in the Methyl Bromide Registration Review 14 

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency’s current position 

based on the following documents: 

1. EFED Registration Review Problem Formulation for Methyl Bromide. Rothman G., and 

B. Montague. September 18, 2013. 

2. Methyl Bromide Human Health Assessment Scoping Document in Support of Registration 

Review. Lloyd, M., W. Irwin, W. Donovan. September 13, 2013. 

3. Methyl Bromide: Review of Human Incidents. Evans, E. and S. Recore. May 22, 2013. 

4. BEAD Chemical Profile for Registration Review: Methyl Bromide (053201). Chism, W., 

C. Doucoure, and D. Berwald. May 30, 2013. 

5. Methyl Bromide (053201) Screening Level Usage Analysis (SLUA). May 30, 2012. 

6. PRD Label Data Report: Food/Feed & Non-Food/Non-Feed Uses Considered in 

Registration Review Work Planning. March 14, 2013.

These and other supporting documents for the methyl bromide registration review case may be 

found in the docket EPA-HQ-OPP-2013-0269 at http://www.regulations.gov. 
3

OVERVIEW

The docket for methyl bromide is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2013-0269). Methyl bromide is a broadspectrum fumigant chemical registered for use as an acaricide, antimicrobial, fungicide, 

herbicide, insecticide, nematicide, and vertebrate control agent. Methyl bromide products are 

registered for use for pre-plant soil fumigation, post harvest treatment of commodities, and 

structural fumigation. This Preliminary Work Plan (PWP) document explains what EPA’s 

Office of Pesticide Programs knows about methyl bromide, 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 methyl bromide. 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about methyl bromide and what types of new data 

or other information would be helpful for the Agency to receive as it moves toward a decision on 

methyl bromide. 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: 

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 methyl bromide. 

Next, it discusses the statutory and regulatory authority for registration review. Then the 

document provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for methyl bromide. Finally, the 

Appendix to this document includes identification and discussion of some areas that are 

considered generally in registration review along with some additional chemical case-specific 

information. 

 
4

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for methyl bromide. For additional discussion 

of the anticipated data needs, see the EFED Registration Review Problem Formulation for 

Methyl Bromide and Methyl Bromide Human Health Assessment Scoping Document in Support 

of Registration Review. 

Table 1: Anticipated Data Needs for the Methyl Bromide Registration Review 

Guideline 

Number1 Study Title1 

Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

850.4100 Terrestrial plant toxicity, seedling emergence (Tier II) TEP 12 

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 monitoring2 TEP 36 

Outstanding Data Requirements from GDCI-053201-266293

875.2500 Inhalation exposure (postapplication)4 TEP due 7/2011 

Outstanding Data Requirements from GDCI-053201-270075

875.1300 Inhalation exposure – outdoor 6 TEP in review 

850.4150 Vegetative vigor (Tier II) TGAI in review 

Outstanding Data Requirements from GDCI-053201-8367

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; 

 

 

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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 2

 Data from additional monitoring locations may be needed. 

3

 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. 4

 The environment in which worker activities are monitored should also be evaluated which may include monitoring 

off-gassing properties of fumigated commodities over time. 5

 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. 6

 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. 7

 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. 
5

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 

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 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.8

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. The 

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 Final Work Plan (FWP) and anticipated schedule for 

the registration review of methyl bromide. 

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for methyl bromide. 

Table 2: Chemical Facts for Methyl Bromide

PC Code 053201 

Case Number 335 

CAS Number 74-83-9 

Year First Registered 1961 

Pesticide Type Registered for use as an acaricide, antimicrobial, fungicide, 

herbicide, insecticide, nematicide, and vertebrate control agent. 

Chemical Class Fumigant 

Reregistration Eligibility 

Decision (RED) 

July 2008 and amended May 2009 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

August 2006 

 

8

 http://www.epa.gov/oppsrrd1/registration_review/ 
6

Table 2: Chemical Facts for Methyl Bromide

Cumulative Group Not applicable. Methyl bromide has not been identified as a 

member of a cumulative group that shares a common mechanism of 

toxicity. 

40 CFR Citation Tolerances for inorganic bromides are established in 40 CFR 

§180.123. Tolerances for methyl bromide are established in 40 

CFR §180.124. 

Dual-use Yes - methyl bromide is registered for conventional pesticidal uses 

and antimicrobial uses. 

Non-pesticidal Uses Methyl bromide is used as a brominating agent for pharmaceuticals. 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Susan Bartow, bartow.susan@epa.gov, 703-603-0065 

Antimicrobials Division, 

Chemical Review 

Manager 

Jaclyn Pyne, pyne.jaclyn@epa.gov, 703-347-0213 

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 methyl bromide. Please see the BEAD 

Chemical Profile for Registration Review: Methyl Bromide (053201) in the registration review 

docket for more details. 

Table 3: Methyl Bromide Use and Usage Information

Summary of Use Broad-spectrum fumigant registered for use to control a wide range 

of pests including spiders, mites, fungi, plants, insects, nematodes, 

rodents, and snakes. Two methyl bromide product labels include 

antimicrobial claims (i.e., “...some bacteria (e.g., Salmonella 

spp.)...”). The antimicrobial applications are not separate 

treatments, and the antimicrobial action occurs during the 

conventional methyl bromide treatment. 

Soil uses of methyl bromide also have chloropicrin co-applied (as a 

warning agent or another active ingredient). 

Use Sites Pre-plant soil fumigant, post harvest treatment of commodities, 

durable goods, and structural fumigation. Not currently registered 

for residential uses. 

Summary of Usage Because methyl bromide is an ozone depleting substance, its 

production is controlled under the Montreal Protocol on Substances 

that Deplete the Ozone Layer (Protocol) and the Clean Air Act 

(CAA). All uses except critical use exemptions (CUEs) and 

quarantine and pre-shipment (QPS) uses were phased out in January 

1, 2005 and, as such, the use of methyl bromide has significantly 
7

Table 3: Methyl Bromide Use and Usage Information

decreased over time. For the year 2013, the United States 

government was approved to consume (production plus imports 

minus exports) approximately 1.2 million lbs. for CUEs. The U.S. 

consumes approximately 4 million lbs. of methyl bromide every 

year for QPS uses; the production of which is not controlled by the 

Montreal Protocol and is expected to continue. 

Formulation Type(s) Pressurized gas. 

Application Methods Soil uses: shank injection, hot gas method, handheld application 

wand. Tarps are required for all soil uses except (1) California 

orchard replant for CUE use using the deep broadcast application 

method and (2) hand held tree-hole applications. 

Post-harvest commodity and durable good uses as well as structural 

fumigation: injected into an enclosure, chamber, structure, or under 

a tarp remotely using flexible tubing connected to pressurized gas 

tanks. 

Technical Registrants Albemarle Corporation, Bromine Compounds Ltd., Great Lakes 

Chemical Corporation (a Chemtura Company), and Mebrom 

Corporation 

No. of Registrations 47 active Section 3 registrations9 and 7 Section 24(c) registrations 

(CA, FL, MO) 

Restricted Use Yes 

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described below. 

 Additional information on typical postharvest, quarantine, and non-agricultural uses of 

methyl bromide would improve future assessments of the importance of methyl bromide 

and may be required as part of the registration review for this pesticide. Useful data 

would include, but not limited to, usage data such as application timing, application rate, 

application method, target pests, application frequency, speed of control, costs, etc.. Of 

particular value is information regarding use and importance of methyl bromide for postharvest and QPS uses. 

 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. 

 Use distribution (e.g., acreage and geographical distribution of relevant use sites). 

 Median and 90th percentile reported use rates (lbs ai/A) from usage data – national, state, 

and county. 

 Typical application timing (date of first application and application intervals) – national, 

state, and county. 

 

9

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
8

 Usage/use information for non-agricultural uses. 

 State or local use restrictions. 

 Foreign technical registrants not listed above who supply technical methyl bromide to the 

US market. 

In addition, the Agency will continue the dialogue with stakeholders on label issues that have 

evolved during the RED label implementation process. 

RECENT ACTIONS

Prior to the registration review process, the most recent Agency regulatory evaluations were the 

Tolerance Reassessment and Risk Management Decision (TRED) and Reregistration Eligibility 

Decision (RED) for methyl bromide’s commodity uses which was issued in August, 200610 and 

the RED for methyl bromide’s soil and non-food structural uses which was issued in July, 2008 

and amended in May, 200911. 

Since the 2006 Methyl Bromide TRED, EPA has worked with methyl bromide registrants, 

represented by the Methyl Bromide Industry Panel (MBIP), to update the product labels. 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. Once MBIP and EPA have agreed to the label changes, all commodity- and 

structural-use labels will be amended, and a summary will be found in docket EPA-HQ-OPP2005-0123. 

The following sections of the labeling for commodity and structural uses have been updated: 

 The respiratory protection language was updated to provide greater clarity and flexibility 

for fumigation workers while still ensuring workers will be protected from unsafe 

concentrations. 

 The Fumigation Management Plan (FMP) section was updated to be more enforceable 

and to include statements similar to those currently on other commodity and structural 

fumigant product labels. 

 A terms section was added to define specific terms used in labeling and improve label 

organization. 

 A provision was added to allow applicators in California to follow certain requirements 

specified in California’s methyl bromide commodity manual instead of the EPA label to 

simplify the application process in California. These areas include buffer distances, 

buffer zone entry restrictions, respirator requirements, work-time restrictions and 

emergency response measures. EPA determined that following the California regulations 

and restricted materials permit process for these measures will provide protection at least 

equivalent to the federal label. 

 

10 Available: http://www.epa.gov/oppsrrd1/REDs/methyl_bromide_tred.pdf 11 Available: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2005-0123-0716;oldLink=false
9

 More specific guidance on how to calculate buffer zones was added to the label. EPA 

also removed the option for applicators to model their own site-specific buffers since 

guidance on how this would be done is not available. 

 The Community Notification measures in the TRED were replaced with Emergency 

Preparedness Measures, similar to what is specified for the methyl bromide soil labels. 

Some labeling topics have not been resolved and will be addressed in registration review and/or 

when certain studies are complete. Those topics include: 

 FMP measures, to ensure they are clear and enforceable, similar to the FMPs measures 

for the soil fumigants. EPA will also, in registration review, update FMP measures for 

other structural and commodity fumigants. 

 Treated commodity notification restrictions, to help ensure off-site workers who open 

containers of treated commodities have adequate information to protect themselves from 

concentrations of methyl bromide that have off-gassed during transit. 

 Best Management Practices (BMPs), to protect workers in cold storage facilities as well 

as other BMPs for post-harvest and structural fumigations. 

 The option to monitor concentrations of methyl bromide on a site-specific basis to 

potentially reduce the aeration time needed for treated commodities. 

A RED was completed for soil uses of methyl bromide in July 2008 and amended in May 2009. 

The Agency determined that methyl bromide products were eligible for reregistration provided a 

number of risk mitigation measures adopted and label amendments are made to reflect these 

measures. For details on the mitigation measures, see the Amended Reregistration Eligibility 

Decision (RED) for Methyl Bromide (soil and non-food structural uses), 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/. More 

information on the reregistration process can be found on the following website: 

http://www.epa.gov/pesticides/reregistration/index.htm. 

The product reregistration process, which starts after completion of a TRED or RED, is still 

ongoing for methyl bromide products. 

On August 20, 2010, the members of the Methyl Bromide Industry Panel signed a Memorandum 

of Agreement with the Agency that resulted in the phase-out of certain uses (e.g., fresh market 

tomatoes and peppers grown in California (use allowed until December 31, 2012), Vidalia 

onions grown in Georgia (use allowed until December 31, 2012), ginger grown in Hawaii (use 

allowed until December 31, 2012), golf courses and athletic/recreational fields for 

resurfacing/replanting of turf (use allowed until December 31, 2013), caneberries (use allowed 

until December 31, 2014), and tobacco seedling trays (use allowed until December 31, 2014)) 

that were not eligible for reregistration, but determined to provide sufficient benefits for growers 

to support allowing the uses to continue for a limited period of time while users transition to 

other pest controls (FRL-8872-2). 
10

Tolerances for residues of methyl bromide in or on cotton, undelinted seed were established on 

June 13, 2012, because there is a need for imported undelinted cottonseed for use as additional 

feed for dairy cattle in the United States (FRL-9352-4). 

Ongoing Actions 

There are existing FIFRA Section 18 emergency exemptions for methyl bromide uses. EPA is 

working with USDA/APHIS to (1) transition uses from the FIFRA Section 18 emergency 

exemption registration to active FIFRA Section 3 registrations, and (2) phase in some mitigation 

measures from the 2006 Methyl Bromide TRED in the current USDA crisis exemption issued in 

accordance with FIFRA Section 18 quarantine exemption. For more information about pesticide 

emergency exemptions please see: http://www.epa.gov/opprd001/section18/. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for methyl bromide was 

completed on June 2, 2008 in preparation for the RED. The most recent ecological and 

environmental fate risk assessments were completed July 8, 2004 for the RED and on December 

28, 2011 relating to assessment of the risk to the federally endangered species, California tiger 

salamander (San Francisco Bay). Findings and conclusions from these risk assessments are 

summarized in the EFED Registration Review Problem Formulation for Methyl Bromide and 

Methyl Bromide Human Health Assessment Scoping Document in Support of Registration 

Review. 

During registration review, the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of methyl 

bromide. For human health, EPA anticipates the need to 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 anticipated to be required for registration review, 

they will be considered in the new assessments, as well as any changes to the standard operating 

procedures or default exposure assumptions. 

Table 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 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. 
11

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 revisions to the methyl bromide 

drinking water assessment, or updated crop uses. 

Drinking water Y Methyl bromide surface water exposure is not 

expected. However, leaching, diffusion, or movement 

of methyl bromide through re-charge to groundwater 

and resultant transport to wells nearby treated fields is 

possible due to its high water solubility. The relative 

importance of methyl bromide drinking water dosing 

concentrations with methyl bromide inhalation doses 

will be determined. As a result of this determination, 

drinking water assessments addressing methyl 

bromide soil applications will be conducted on an as 

needed basis. 

Occupational 

Handlers (mixers, loaders, 

applicators) 

Y An occupational handler risk assessment may be 

necessary based on the most recent toxicological and 

exposure (e.g., deep probe application study) data. 

Post-application Y An occupational bystander risk assessment may be 

necessary based on the most recent toxicological and 

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

commodity worker study) data. 

Residential 

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 

post-application exposure. 
12

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. 

Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below. 

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency. 

 Water quality monitoring data (see Appendix for further details). 

Guidance for Commenters: Additional human health information requested for this 

registration review, and of particular interest to EPA, is described below. 

 Information regarding emission factors for soil uses. 

 Additional Good Agricultural Practices (GAPs) for soil uses. 

 Confirmation of aeration methods and equipment. 

 Clarification of the orchard replant use pattern. 

 Information about recent advances in real-time monitoring devices and respiratory 

protection. 
13

 Available ambient exposure data (other than data available through California 

Department of Pesticide Regulation’s monitoring activities and the ambient data required 

by GDCI-053201-836). 

 BMPs for post-harvest uses (e.g., commodities, timber, cut flowers, durable goods) and 

structural uses. 

 Information regarding off-gassing of treated commodities. 

 Available worker monitoring data, especially data associated with commodity/structural 

uses. 

TIMELINE

EPA has created the following estimated timeline for the completion of the methyl bromide 

registration review in Table 5 below. 

Table 5: Projected Methyl Bromide Registration Review Timeline

Activities Estimated Date

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 

Assessments12

2018 October - December 

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 

NEXT STEPS

After the 60-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 methyl bromide. 

 

 

12 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. 
14

Appendix – Additional Areas Considered in the Methyl Bromide Registration 

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

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 residue limits (MRLs) 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: 

Methyl bromide is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.13 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for methyl bromide.14 More information on impaired water 

bodies and TMDLs can be found at the Agency’s website.15 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 Process16 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 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 methyl bromide compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population. 

 

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

14http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES

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

16 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
15

Potential areas of environmental justice concerns, to the extent possible, are considered during 

the development of human health risk assessments, in accordance with U.S. Executive Order 

12898, "Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations," 

http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pdf. The Office of 

Pesticide Programs (OPP) typically considers the highest potential exposures from the legal use 

of a pesticide when conducting human health risk assessments, including, but not limited to, 

people who obtain drinking water from sources near agricultural areas, and the variability of 

diets within the United States. Should these highest exposures indicate potential risks of 

concern, OPP further refines the risk assessments to ensure that the risk estimates are based on 

the best available information. 

The civil rights complaint Angelita C. v. California Department of Pesticide Regulation alleged 

that California’s Department of Pesticide Regulation (CDPR) discriminated against Latino 

school children by allowing unhealthy levels of methyl bromide to be applied near schools 

populated by mostly Latino children. The complaint alleged that this pattern and practice of 

allowing methyl bromide to be applied near schools caused an unhealthy and racially 

discriminatory condition for Latino school children and their parents. U.S. EPA entered into an 

Agreement17 with the California Department of Pesticide Regulation (CDPR) to resolve a civil 

rights complaint filed under Title VI of the Civil Rights Act of 1964 (Title VI)18. CDPR has 

volunteered through this Agreement to expand on-going monitoring of methyl bromide air 

concentrations by adding a monitor at or near one of the schools named in the original 

complaint. The purpose of the additional monitor is to confirm that there will be no recurrence 

of earlier conditions. CDPR also has agreed to share the monitoring results with EPA and the 

public and will also increase its community outreach and education efforts to schools that are in 

high methyl bromide usage areas. EPA will consider any monitoring data provided during 

registration review. 

ENDANGERED SPECIES:

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

conducted for methyl bromide. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether use of methyl bromide 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, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

 

17 Available: http://www.epa.gov/civilrights/TitleVIcases/ 

18 Available: http://www.epa.gov/civilrights/TitleVIcases/title6-c-factsheet.pdf 
16

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 registration decision for methyl bromide, 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), 

methyl bromide is subject 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 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 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. 

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 of 

chemicals identified for EDSP screening was published on June 14, 201319 and includes some 

pesticides scheduled for Registration Review and chemicals 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.20 

In the interim, EPA is making no human health or environmental safety findings associated with 

the EDSP screening of methyl bromide. Before completing this Registration Review, the 

Agency will make an EDSP FFDCA section 408(p) determination. 

HUMAN STUDIES:

Past methyl bromide risk assessments have relied in part on several human studies which may 

have involved intentional exposure to methyl bromide. In the course of registration review EPA 

will reconsider these studies, as well as any other research involving intentional exposure of 

human subjects to methyl bromide 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. 

 

19 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 

20 http://www.epa.gov/endo/
17

AGRICULTURAL HEALTH STUDY:

Methyl bromide is among several agricultural chemicals included in the Agricultural Health 

Study (AHS). The AHS began in 1993 and is a collaboration of the National Institute of 

Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the EPA, and the 

National Institute for Occupational Safety and Health (NIOSH). Designed as a large long-term 

epidemiological study, the AHS collects and analyzes data on the health and work practices of 

nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study 

before any disease developed. The study focuses particularly on farmers' exposure to 50 

chemicals including many of the most widely used pesticides. As data are collected over a 

period of years, scientists can compare overall health outcomes for people who differ in whether 

they have had exposure to various chemicals. While these comparisons cannot conclusively 

demonstrate how exposure affects health, they can show some statistical associations, however, 

not necessarily causality. More information on the AHS can be found at: 

http://aghealth.nci.nih.gov. EPA is monitoring the results of the AHS and will consider this 

study in the registration review of methyl bromide as appropriate.