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 Re gistration Review 14

References:

This Preliminary Work Plan summarizes the En vironmental Protection Ag ency’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 Sc oping 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 & N on-Food/Non-Feed Uses Considered in Registration Review Work Planning . March 14, 2013.

These and other supporting documents for the met hyl 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, ini tiating 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 us e as an acaricide, antimicrobial, fungicide, herbicide, insecticide, nematicide, and vertebra te control agent. Meth yl bromide products are registered for use for pre-plant soil fumiga tion, 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 inform ation that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review fo r methyl bromide.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t methyl bromide and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on methyl bromide. The Agency encourages all in terested stakeholders to review the PWP and Appendix and to provide comments and addition al 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 iden tified in the PWP and Appendix about which the Agency specifically seeks comments and informa tion. Interested stakeholders could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, 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 identifica tion and discussion of some areas that are considered generally in registration review al ong with some additional chemical case-specific

information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipa ted data needs for methyl brom ide. 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 th e Methyl Bromide Registration Review

Guideline

Number 1 Study Title 1 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 monitoring 2 TEP 36
Outstanding Data Requirements from GDCI-053201-26629 3

875.2500 Inhalation exposure (postapplication) 4 TEP due 7/2011
Outstanding Data Requirements from GDCI-053201-27007 5

875.1300 Inhalation exposure – outdoor 6 TEP in review
850.4150 Vegetative vigor (Tier II) TGAI in review
Outstanding Data Requirements from GDCI-053201-836 7

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

TGAI = technical grade active ingredie nt; 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 Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;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 th rough a generic data call-in issued in July 2009 and is

still outstanding. This study will not be included in the anticipated Registra tion 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 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 th rough 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 th rough a generic data call-in issued in March 2011 and is

still outstanding. This study will not be included in the anticipated Registra tion 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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website. 8

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration 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 docke t 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 ch emical 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 inorgani c 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 regist ered 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 Registrati on 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 us e to control a wide range of pests including spiders, mites, fu ngi, plants, insects, nematodes, rodents, and snakes. Two methyl bromide product labels include antimicrobial claims (i.e ., “...some bacteria (e.g., Salmonella

spp. )...”). The antimicrobial app lications are not separate treatments, and the antimicrob ial 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 fumi gation. 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-shipme nt (QPS) uses were ph ased out in January 1, 2005 and, as such, the use of methyl bromide has significantly7 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 enclos ure, chamber, structure, or under a tarp remotely using flexible t ubing connected to pressurized gas

tanks. Technical Registrants Albemarle Corporat ion, Bromine Compounds Ltd., Great Lakes Chemical Corporation (a Chem tura Company), and Mebrom Corporation No. of Registrations 47 ac tive Section 3 registrations 9 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 part icular interest to EPA, are described below.

 Additional information on typical postharvest, quarantine, and non-agricultural uses of methyl bromide would improve future assessm ents of the importance of methyl bromide and may be required as part of the registration review for th is pesticide. Useful data would include, but not limited to, usage data such as application tim ing, application rate, application method, target pests, application fr equency, speed of contro l, costs, etc.. Of particular value is informa tion regarding use and importan ce of methyl bromide for postharvest and QPS uses.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

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

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

 Typical application timing (date of first applic ation and application in tervals) – national, state, and county.

9 Section 3 product labels can be obtained from th e 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 tech nical methyl bromide to the
US market.

In addition, the Agency will contin ue the dialogue with stakeholders on label issues that have evolved during the RED labe l implementation process.

RECENT ACTIONS

Prior to the registration review process, the mo st recent Agency regulatory evaluations were the Tolerance Reassessment and Risk Management D ecision (TRED) and Reregistration Eligibility Decision (RED) for methyl bromide’s commod ity uses which was issued in August, 2006 10 and the RED for methyl bromide’s soil and non-food st ructural uses which wa s issued in July, 2008 and amended in May, 2009 11

.

Since the 2006 Methyl Bromide TRED, EPA has worked with methyl bromide registrants, represented by the Methyl Bromide Industry Pane l (MBIP), to update the product labels. In general, changes were made to conform to change s 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 commod ity and structural uses have been updated:

 The respiratory protection langua ge was updated to provide great er clarity and flexibility for fumigation workers while still ensuri ng 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 specifi c 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 met hyl bromide commodity manual instead of the EPA label to simplify the application process in Californi a. 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 th ese 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=false9  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 fo r the methyl bromide soil labels.

Some labeling topics have not been resolved and will be addressed in regi stration review and/or when certain studies are comp lete. 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 adequa te information to protect themselves from concentrations of methyl bromide th at have off-gassed during transit.

 Best Management Practices (BMPs), to protect workers in cold storage facilities as well as other BMPs for post-harves t and structural fumigations.

 The option to monitor concentr ations 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 produc ts were eligible for reregistration provided a number of risk mitigation measures adopted a nd 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/pes ticides/reregistration/soil_fumigants/ . More information on the reregistration proce ss can be found on the following website: http://www.epa.gov/pesticides /reregistra tion/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 (u se 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 course s and athletic/recrea tional 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 dete rmined 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 impor ted 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 ex emptions 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 exem ption. For more information about pesticide emergency exemptions please see: http://www.epa.gov/opprd001/section18/

.

ANTICIPATED RISK ASSESSMENT S 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 comp leted July 8, 2004 for the RED and on December 28, 2011 relating to assessment of the risk to th e federally endangered sp ecies, 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 Sc oping Document in Support of Registration

Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an endangere d species assessment, fo r all uses of methyl bromide. For human health, EPA anticipates the n eed to conduct revised dietary, residential, and occupational risk assessments during registration re view. If toxicologica l endpoints or points of departure are revised based on the data that are an ticipated 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 regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.

Table 4: 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.11 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 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 bys tander 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 applic ations facilitating typical post-application exposure.12 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

.

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 alr eady reported to the Agency.

 Water quality monitoring data (s ee 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 Prac tices (GAPs) for soil uses.

 Confirmation of aeration methods and equipment.

 Clarification of the orch ard replant use pattern.

 Information about recent advances in real -time monitoring devi ces and respiratory protection.13  Available ambient exposure data (other than data available through California Department of Pesticide Regulation’s monito ring 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 Bromid e 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

Assessments 12 2018 October - December

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 April - June

Registration Review Decisi on 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 i ssue 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; 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.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 submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, 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, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

Methyl bromide is not identified as a cause of imp airment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 13 In addition, no Tota l 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 Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 16 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high expos ure to methyl bromide compar ed 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

14 http://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.htm15 Potential areas of environmental justice concerns , to the extent possible, are considered during the development of human health risk assessm ents, in accordance with U.S. Executive Order 12898, "Federal Actions to Addre ss Environmental Justice in Minority Populations and LowIncome Populations," http://www.epa.gov/compliance/resour ces/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 ri sk assessments, including, but not limited to, people who obtain drinking water fro m sources near agricultural areas, and the variability of
diets within the United States. Should these hi ghest 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 unhealth y levels of methyl bromide to be applied near schools populated by mostly Latino children. The compla int 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 parent s. U.S. EPA entered into an Agreement 17 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 n ear 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 whet her use of methyl bromide has “no effect” or “may affect” federally listed threatened or endang ered species (listed species) or their designated

critical habitats. When an assessment conclude s that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Ag ency will consult with the U.S. Fish and Wildlife
Service and/or National Marine Fisheries Se rvice (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM :

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, 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/civilr ights/TitleVIcases/title6-c-factsheet.pdf16 susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most rece nt registration decisi on for methyl bromide, EPA
reviewed these data and select ed 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 scre ening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pest icide active ingredients and 9 inert ingredients. A second list of
chemicals identified for EDSP scr eening was published on June 14, 2013 19 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, pleas e 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. Befo re completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

HUMAN STUDIES:

Past methyl bromide risk assessments have re lied in part on several human studies which may have involved intentional exposure to methyl bromid e. 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 deci des to rely on any of these studies, EPA will ensure that all applicab le regulatory requirement s are met, including, but not limited to, the requirements for EPA ethics review and Human Studies Review Board review of certain research involving inten tional 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 ch emicals 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 Nati onal Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and H ealth (NIOSH). Designe d 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 focu ses particularly on fa rmers' 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 he alth 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 ca n 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.