United States Prevention, Pesticides EPA 738-R-09-311 Environmental Protection and Toxic Substances May 2009 Agency (7508P)



# Amended Reregistration Eligibility Decision for Methyl Bromide (soil and non-food structural uses)3 Glossary of Terms and Abbreviations

AHEF Atmospheric Health Effects Framework ai Active Ingredient ANLA American Nursery and Landscape Association APHIS Animal and Plant Heath Inspection Service APR air-purifying respirator ARS Agricultural Research Service

ATV all-terrain vehicle BEAD Biological and Econom ic Analysis Division

BrO bromine monoxide CDPR California Department of Pesticide Regulation

CFC chlorofluorocarbons CFR Code of Federal Regulations

ClO chlorine monoxide CMTF Chloropicrin Manufacturers’ Task Force

CSF Confidential Statement of Formulation CUE Critical Use Exemption

CUN Critical Use Nominations

DCI Data Call-In DNT Developmental Neurotoxicity EDSP Endocrine Disruptor Screening Program EDSTAC Endocrine Disruptor Screeni ng and Testing Advisory Committee

EEC Estimated Environmental Concentration EPA Environmental Protection Agency

EUP End-Use Product FDMS Federal Docket Management System FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FMP Fumigant Management Plan FQPA Food Quality Protection Act

ft feet GAP Good Agricultural Practices GENEEC GENeric Estimated Exposure Concentration model

GLN Guideline Number GPS Global Positioning System

ha hectare HCFC hydrochlorofluorocarbons HDPE High-density Polyethylene

HED Health Effects Division

ISCST3 Industrial Source Co mplex Short Term model

KTS Potassium Thiosulfate lb pound4 LC 50 Median Lethal Concentration. A sta tistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of a substance per weight or volume of water, air, or feed, e.g., mg/l, mg/kg, or ppm.

LD 50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of th e test animals when administered by the route indicated (oral, dermal, inhala tion). It is expr essed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level MBAO Methyl Bromide Alternatives Outreach MBIP Methyl Bromide Industry Panel MBTOC Methyl Bromide Technical Options Committee MCFA Minor Crop Farmer Alliance mg/kg/day Milligram Per Kilogram Per Day mg/L Milligram Per Liter MITC methyl isothiocyanate MOE Margin of Exposure MRID Master Record Identification Number. EPA’s system for recording and tracking studies submitted. MSHA Mine Safety and Health Administration MUP Manufacturing-Use Product

NAM National Association of Manufacturers NIOSH National Institute for Occupational Safety and Health

NOAEL No Observed Adverse Effect Level NPDES National Pollutant Discharge Elimination System OAP Office of Atmospheric Programs

OAR Office of Air and Radiation ODP ozone depletion potential OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pe sticides, and Toxic Substances ORE Occupational and Residential Exposure OSHA Occupational Safety and Health Administration

PC Pesticide Chemical PDCI Product-specific Data Call-in

PERFUM P robabilistic E xposure and R isk model for Fum igants PLHCP Physician or Other Licen sed Health Care Professional PPE Personal Protective Equipment ppm Parts Per Million PrG Pressurized gas PRZM/EXAMS Pesticide Root Zone Model/Expos ure Analysis Modeling System. A Tier II Surface Water Computer Model. PSA public service announcement psi pounds per square inch5 PVC Polyvinyl Chloride QPS Quarantine and Preshipment RED Reregistration Eligibility Decision REI Restricted Entry Interval RQ Risk Quotient

RUP Restricted Use Pesticide SAB Science Advisory Board SCBA self-contained breathing apparatus SLA State Lead Agency SRRD Special Review a nd Reregistration Division

TEAP Technical and Economic Assessment Panel TRED Tolerance Reassessment and Risk Management Decision TWA time weighted average UNEP United Nations Environment Programme

USC United States Code USDA United States Department of Agriculture UF Uncertainty Factor

UV Ultraviolet VIF Virtually Impermeable Film

WPS Worker Protection Standard6 Table of Contents

Methyl Bromide Reregistrati on Eligibility Decision Team........................................................................ .9

Abstract....................................................................................................................... ...............................10

I. Introduction................................................................................................................ ..........................12

II. Chemical Overview .......................................................................................................... ...................16 A. Chemical Identity......................................................................................................... ..................16 B. Use and Usage Profile..................................................................................................... ...............17 C. Regulatory History ........................................................................................................ .................18 III. Fumigant Overview and Agency Documents.................................................................................... ..18 A. General Overview of Soil Fumigants........................................................................................ .....18

B. Human Health Risks........................................................................................................ ...............18 C. Stratospheric Ozone Depletion............................................................................................. ..........21 D. Environmental Fate and Ecological Risks ................................................................................... ..25

1. Hazard................................................................................................................... ....................25 2. Exposure ................................................................................................................. ..................26 a. Terrestrial Exposure.................................................................................................... ........26 b. Aquatic Exposure........................................................................................................ ........26

3. Risk ..................................................................................................................... ......................27

a. Terrestrial Risk........................................................................................................ ............27 b. Aquatic Risk............................................................................................................ ............27

E. Benefits.................................................................................................................. .........................28 F. Impacts of RED Mitigation ................................................................................................. ...........29 IV. Risk Management and Reregistration Decision................................................................................ ...31

A. Determination of Reregistration Eligibility ............................................................................... ....31 B. Public Comments and Responses............................................................................................. ......35 C. Regulatory Position....................................................................................................... .................36 1. Regulatory Rationale ..................................................................................................... ...........36 a. Generic Risk Management................................................................................................. .37 1) Use Sites .............................................................................................................. .........37 2) Formulations........................................................................................................... ......37 3) Application Methods .................................................................................................... 38 4) Maximum Application Rates........................................................................................38 b. Human Health Risk Management.......................................................................................39 1) Bystander Risk Mitigation............................................................................................40

i. Buffer Zones ..........................................................................................................4 1 ii. General Buffer Zone Requirements.......................................................................41

iii. Buffer Zone Reduction Credits..............................................................................59

iv. Restriction for Schools a nd Other Difficult to Evacuate Sites ..............................65 v. Posting................................................................................................................ ....66 2) Occupational Risk Mitigation.......................................................................................69

i. Handler Definition .................................................................................................69 ii. Handler Requirements ...........................................................................................70 iii. Respiratory Protection ...........................................................................................71 iv. Tarp Perforation and Removal...............................................................................81 v. Entry Prohibitions ..................................................................................................847 3) Other Mitigation ....................................................................................................... ....89 i. Good Agricultural Practices (GAPs) .....................................................................89 ii. Fumigant Management Plans (FMPs) ...................................................................97 iii. Site Specific Response and Management ............................................................104 iv. Notice to State Lead Agencies.............................................................................111 v. Soil Fumigation Training for Applicators and Training Information for

Other Handlers.....................................................................................................112 vi. Community Outreach and Education Program....................................................117 c. Environmental Risk Management.....................................................................................122 d. Stratospheric Ozone Depletion Risk Management...........................................................123 2. Endocrine Disruptor Effects .............................................................................................. .....124 3. Endangered Species Considerations .......................................................................................1 25

D. Conclusions............................................................................................................... ...................125 V. What Registrants Need To Do ................................................................................................. ..........125 A. Manufacturing Use Products................................................................................................ ........126 1. Additional Generic Data Requirements..................................................................................126

a. Human Health Risk....................................................................................................... ....126 b. Environmental Fate and Ecological Risk..........................................................................127 c. Other Data Requirements................................................................................................. .128 2. Labeling for Manufacturing-Use Products .............................................................................130

B. End-Use Products.......................................................................................................... ...............131 1. Additional Product-Specific Data Requirements....................................................................131 2. Labeling for End-Use Products............................................................................................ ...131

APPENDICES Appendix A. Methyl Bromide PC Code 053201 Pre-plant So il Uses Eligible for Reregistration .........158 Appendix B. PERFUM Model Inputs and Outputs ................................................................................160 Appendix C. FMP Template for Methyl Bromide Soil Applications.....................................................164 Appendix D. Technical Support Documents ....................................................................................... ...177

LIST OF TABLES Table 1. Modifications from 2008 to 2009 Amended Soil Fumigant REDs ............................................13 Table 2. Implementation Schedule for So il Fumigant Risk Mitigation Measures ...................................15 Table 3. Maximum Application Rates fo r Pre-plant Soil Methyl Bromide Uses.....................................39 Table 4. Tarped Bedded Buff er Zone Distances (feet)........................................................................... ..51 Table 5. Tarped Broadcast Buffer Zone Distances (feet) ........................................................................ .53 Table 6. Deep Untarped Buff er Zone Distances (feet) ........................................................................... ..55 Table 7. Outdoor Tarped Hot Ga s Buffer Zone Distances (feet)..............................................................55 Table 8. Greenhouse Hot Gas Buffer Zone Distances (feet) ....................................................................55 Table 9. Projected Buffer Zones for Methyl Bromide Critical Use Exemptions Based on Current Typical Application Rates ...................................................................................................... ....56 Table 10. Summary of Generic Labe ling Changes for Methyl Bromide.............................................132 Table 11. Standard Tarp (no cred its) Buffer Zone Driver Table ..................................................156 Table 12. Standard Tarp (no cred its) Buffer Zone Driver Table ..................................................156 Table 13. Deep ( ≥ 18 inches) Untarp Buffer Zone Driver Table .................................................157 Table 14. Deep ( ≥ 18 inches) Untarp Buffer Zone Driver Table .................................................1578 LIST OF FIGURES Figure A. Requirements for when handlers should cease operations .......................................................76 Figure B. Requirements for when ha ndlers should put on a respirator ....................................................77 Figure C. Untarped Applications ............................................................................................... ...............86 Figure D. Tarp Broadcast Applicati ons (tarps removed before planting) ................................................87 Figure E. Tarp Bed Applications (T arps not removed before planting)...................................................88 Figure F. Tarp Bed/Broadcast Applications (T arps are not perforated until 14 days after application) ................................................................................................................... ............89 Figure G. Example Site Map for Informing Neighbors..........................................................................11 09 Methyl Bromide Reregistration Eligibility Decision Team

Office of Pesticide Programs:

Human Health Risk Assessment Jeffrey L. Dawson, Chemist/Risk Assessor Elizabeth Mendez, Ph.D., Toxicologist/Risk Assessor Toiya Goodlow, Chemist Ruth Allen, MPH, Epidemiologist Monica Hawkins, MPH, Environmental Health Scientist Michael Metzger, Branch Chief

Biological and Economic Analysis Assessment T J Wyatt, Ph.D., Senior Agricultural Economist Jonathan Becker, Ph.D., Senior Science Advisor Bill Chism, Ph.D., Senior Agronomist David Donaldson, Agricultur al Economist, Team Leader Colwell Cook, Ph.D., Entomologist Nicole Zinn, Biologist Stephen Smearman, Economist Leonard Yourman, Ph.D., Plant Pathologist John Faulkner, Ph.D., Economist Monisha Kaul, Biologist William Phillips, II, Ph.D., Agronomist Andrew Lee, Ph.D., Economist Angel Chiri, Ph.D., Entomologist, Team Leader Elisa Rim, Economist Nikhil Mallampalli, Ph.D., Entomologist Sunil Ratnayake, Ph.D., Botanist

Environmental Fate and Effects Risk Assessment Mah Shamim, Ph. D., Branch Chief Faruque Khan, Ph.D., Senior Fate Scientist James Felkel, M.S., Wildlife Biologist Gabriel Rothman, M.S., Environmental Scientist

Registration Support Mary Waller, Product Manager for Methyl Bromide and Chloropicrin Kathy Monk, Senior Advisor

Risk Management Susan Bartow, Chemical Review Manager for Methyl Bromide Andrea Carone, Chemical Review Manager for Chloropicrin Steven Weiss, Industrial Hygienist Eric Olson, Team Leader John Leahy, Senior Advisor

Office of General Council: Andrea Medici

Office of Enforcement and Compliance: David Stangel10 

### Abstract

This document presents the Environmental Prot ection Agency’s (hereafter referred to as EPA or the Agency) amended decision regarding th e reregistration eligibility of the registered soil and structural (non-food) uses of methyl bromide. This follows the 105-day public comment period on the Reregistration Elig ibility Decision provided for stakeholders to have the opportunity to review and provide comments on issues related to the implementation of the risk mitigation measures. The Agency’s risk conclusions for methyl bromide have not changed. In addition, all measures established in the July 2008 Reregistration Eligibility Document (RED) to reduce risks to bystanders and workers will st ill be required. However, the Agency has

determined that certain modifications in how a nd when some measures will be implemented are appropriate. Products containing methyl bromide uses are eligib le for reregistration provided that: (1) current data gaps are addressed; (2) the risk mitigation measures identified in the document are adopted; and (3) labels are amended to implement these measures.

The Agency has determined that methyl br omide-containing products for pre-plant soil uses that currently qualify for exemptions under the Montreal Protoc ol are eligible for reregistration provided that the risk mitigation measures identified in this document are adopted and labels are amended to implement these m easures. Throughout this document measures described as “required” are those necessary to be eligible for reregistration. Additionally, registrants must address data ga ps that have been identified.

Concurrent to EPA’s review of the soil fumi gant uses of methyl bromide, EPA assessed the risks and developed risk management decisi ons for four other soil fumigant pesticides, including: chloropicrin, dazome t, metam sodium/metam potassium, and a new active ingredient, iodomethane. Risks of a fifth soil fumigant, 1,3 -dichloropropene (1,3-D), were also analyzed along with the other soil fumigants for co mparative purposes. The RED for 1,3-D was completed in 1998. The Agency evaluated these soil fumigants concurrently to ensure that human health risk assessment approaches are co nsistent, and that risk tradeoffs and economic outcomes were considered appropriately in reachi ng risk management decisions. This review is part of EPA’s program to ensure that all pestic ides meet current health and safety standards.

The report of the Food Quality Protection Act (FQPA) Tolerance Reassessment and Risk Management Decision (TRED) fo r Methyl Bromide and RED for Methyl Bromide’s Commodity Uses was published on August 9, 2006 1 (hereafter referred to as the Methyl Bromide TRED/RED). In January 2008, re presentatives of the Methyl Bromide Industry Panel (MBIP) presented to the EPA a preliminary summary of ne w emission studies for three flour mills. The information presented by the MBIP indicates th at the new data could impact the Agency’s modeling of buffer zones for commodity uses. A final report was submitted to the Agency on April 23, 2008 2 . The Agency plans to make appropr iate updates to the Methyl Bromide

1 EPA-HQ-OPP-2005-0123-0231 The report of the Food Quality Protection Act (FQPA) Tolerance Reassessment and Risk Management Decision (TRED) for Methyl Br omide and Reregistration Eligibility Decision (RED) for Methyl Bromide’s Commodity Uses

2 MRID 47420302, Measurement of Structural and Ambient Methyl Bromide During Fumigation Activities at Food Processing Facilities: Final Report11 TRED/RED and respond to all comments upon revi ew of the new data and based on comments

submitted to the docket.

EPA has identified potential human health risks of concern associated with the registered methyl bromide uses described in this docum ent from inhalation exposure to handlers, bystanders, and workers. EPA also has concerns for risks associat ed with methyl bromide’s role in the depletion of stratospheric ozone. To reduce inhalation expos ures and to address associated risks of concern, EPA is requiring a numb er of mitigation measures, such as:

• Removing of uses with low be nefits and/or alternatives;

• Reducing maximum application rates;

• Limiting use of 98:2 formula tions to essential crops;

• Buffer zones;

• Respiratory protection and ai r monitoring for handlers;

• Restrictions on the timing of perforating and removing tarps;

• Posting;

• GAPs;

• FMPs;

• Emergency preparedness and response plans;

• Notice to state lead agencies;

• Training for applicators and other handlers; and

• Community outreach and education programs.

The focus of the Agency’s mitigation measures for this decision (and for the Methyl Bromide TRED/RED) is on reducing direct exposure to methyl bromide via the inhalation route. However, the Agency has concluded that many of these measures, combined with the methyl bromide phase-out mandated by the Montreal Prot ocol, will also furthe r reduce the potential health effects (e.g., skin cancer) fr om ozone depletion that may be attributable to methyl

bromide’s uses.

End-use products for registered pre-plant soil uses of methyl bromide also contain chloropicrin. All formulations must contain at least 2% chloropicrin as a warning agent. Chloropicrin is also formulated with methyl bromide at higher concentrations as an active ingredient. A separate amendment to the RED document has been completed for chloropicrin (see docket number EPA-HQ-OPP-2007-0350). In accordance with Agency policy, if the required risk mitigation measures differ for tw o active ingredients in a product, the more stringent mitigation measure is required on product labels.

The Agency is issuing this decision docu ment for methyl bromide as announced in a Notice of Availability published in the Federal Register

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### I. Introduction

This amends and supersedes the document, “Reregistration Eligibility Decision for Methyl Bromide,” published by the U.S. Environm ental Protection Agency (hereafter, EPA) on July 16, 2008. That day EPA opened a 60-day public comment period on the implementation aspects of the risk mitigation measures that were required as conditions of reregistration eligibility under the Fede ral Insecticide, Fungicide, and Roden ticide Act (FIFRA). EPA received requests to extend the comment period from th e MBIP, California Specia lty Crops Council, the Chloropicrin Manufacturers’ Task Force (CMTF) , the National Association of Manufacturers (NAM), the American Nursery and Landscape As sociation (ANLA), the California Strawberry Nurserymen’s Association, the Agricultural Reta ilers Association, the American Forest and Paper Association, and McDermott, Will, and Em ery LLP, on behalf of the Minor Crop Farmer Alliance (MCFA). In response to these requ ests, on August 29, 2008, EPA published a notice in the Federal Register extending the comment pe riod for an additional 45 days. The comment period closed on October 30, 2008. EPA has completed its review of public comments as well as new scientific data and other information provided and determined that all measures established in the July 2008 RED to reduce risks to bysta nders and workers will st ill be required. The Agency has determined that certain modifications in how and when some measures will be implemented are appropriate. The public co mments and EPA’s responses, as well as other supporting documents, may be found in the public docket for methyl bromide at EPA-HQ-OPP2005-0123. EPA has determined that the modificati ons described herein will achieve the same protection goals for persons potentially exposed to methyl bromide but with a greater likelihood of compliance, fewer impacts on th e benefits of methyl bromide use, and with less uncertainty regarding the protectiveness of the required measur es. Please see Table 1 for a summary of the

modifications.

FIFRA was amended in 1988 to accelerate th e reregistration of products with active ingredients registered prior to November 1, 1984. The amended Act calls for the development and submission of data to support the reregistrati on of an active ingredie nt, as well as EPA’s review of all submitted data. Reregistration involves a thorough review of the scientific database underlying a pesticide’s registrati on. The purpose of the Agency’s review is to reassess the potential risks arising from the currently registered uses of the pesticide; to determine the need for additional data on health and environmental effects; and to determine whether or not the pesticide meets the “no unreasonable a dverse effects” criteria of FIFRA.

This document presents the Agency’s amendmen t to the reregistration eligibility decision for registered soil, and non-food structural uses of methyl bromide (i.e., uses not included in the August 2006 Methyl Bromide TRED/RED). The docum ent consists of five sections. Section I contains the regulatory framework for reregistration and a synops is of modifications from the 2008 soil fumigant RED. Section II provides a prof ile of the use and usage of the chemical. Section III provides a general overview of fumi gants and summarizes methyl bromide’s human health and ecological risk assessments, as well as benefit and impact assessments. Section IV presents the Agency’s reregistration eligibility and risk management decisions. Section V summarizes label changes necessary to implemen t the risk mitigation measures outlined in Section IV. Unless otherwise noted, all Agency references in this document are available for review in the methyl bromid e docket (EPA-HQ-OPP-2005-0123) at www.Regulations.gov

.13 Table 1. Modifications from 2008 to 2009 Amended Soil Fumigant REDs Mitigation 2008 REDs 2009 Amended REDs

Buffer Zones Buffer zones based on

available data New chloropicrin data support smaller buffers and increased confidence in safety. New dazomet data support larger buffers

Buffer Credits Credits allowed based on available data; capped at

50% New data support additional credits and an increase in the cap to 80%

Rights of Way Permission from local authorities must be granted

if buffers extend onto rights of way Permission from local authorities is only required when a sidewalk or permanent walkway is present

Buffer Overlap Buffers may not overlap Bu ffers may overlap; separate applications by 12 hours and increase emergency preparedness and response measures

Structures within

Buffer Zones Monitor with devices before reentry Monitor with devices only for applications with < 20 % chloropicrin; otherwise monitor for sensory irritation before
reentry
Restrictions Around

Difficult to Evacuate

Sites 1⁄4 mile restriction around

hard to evacuate areas including day care centers, nursing homes, schools;

was to be in effect for the

duration of the buffer zone period Maintain 1⁄4 mile restriction but allow a

reduced restricted area of 1⁄8 mile for applications with smaller buffers (300 feet or less); is to be in effect during the application and for 36 hours following the start of the application

Posting Posting required at buffer zones points of entry, where people are likely to approach, and areas

between these locations The posting requirement is retained but no longer requires areas between the entry areas to be posted Information required on the signs has been simplified to encourage reuse of signs Handler Protection Described tasks that may only be performed by

handlers and situations

when 2 handlers were required to be present

while in the buffer zone Tasks that may only be performed by handlers have been updated and clarified.

The situations have been clarified requiring 2 handlers to be present based on the chemical properties of the different soil fumigants, and current label statements Respiratory

Protection Required monitoring devices to trigger

additional measures Allow sensory irritation properties to trigger additional measures for MITC and chloropicrin Monitoring with devices still required to remove respirators Monitoring with devices still required for methyl bromide formulations with <20% chloropicrin Tarp Perforation and

Removal Perforating tarps restricted to mechanical means only Perforating tarps by hand is allowed for

areas less than 1 acre in size and for flood prevention activities14 Mitigation 2008 REDs 2009 Amended REDs

Entry Prohibitions Entry for non-handlers is prohibited for the duration of the entry restricted period, until tarps have been removed, or if 14 days has passed No major changes

Restricted Use

Classification The MITC generating compounds required to be

classified as restricted use No change

GAPs Certain GAPs required for all fumigant applications Some clarifications and refinements have

been made based on stakeholder comments FMPs FMPs required to be completed before fumigant application begins and post-application summary report required following the application No major changes. Based on comments an example of an FMP has been included to illustrate how the required information may be presented effectively

Emergency Response and Preparedness If neighbors are near buffers they must be provided with information

or buffer zones must be monitored every 1-2 hours

over 48 hours with monitoring devices Same basic measures apply, however: monitoring required only during peak emission times of the day; irritation detection acceptable for MITC and chloropicrin in lieu of devices; methyl bromide requires direct read devices for formulations with <20% chloropicrin Notice to SLAs Applicators required to provide notice to the appropriate state/tribal lead agency before fumigating to facilitate compliance

assistance and assurance States may determine if they wish to

receive this information All states required to include strategies for compliance assistance and assurance for soil fumigation in their cooperative
agreements Applicator Training Certified applicators required to receive registrant soil-fumigant training every year Certified applicators required to receive registrant soil-fumigant training every three years

Community Outreach

and Education Registrants required to develop and implement community outreach and education programs along

with information for first responder in high fumigant

use areas Same basic requirement. The Agency is providing information on where registrants are required to focus these efforts

With regard to implementation timing, EPA has determined that most measures can be efficiently implemented via revi sed product labels by the 2010 use season. Other measures, in particular those related to buffer zones, will present greater compliance challenges and will require additional time for EPA to conduct the necessary outreach, and communication activities with states, tribes, other regulatory partners, fumiga nt users, and other stak eholders to facilitate

transition. EPA has determined that these meas ures will be implement ed via revised product15 labels by the 2011 use season. As a result, all meas ures described in this amended RED that are necessary for reregistration e ligibility will appear on product labels by 2011. Table 2 below

shows the measures that will be implemented in 2010 and the additional measures that will be implemented in 2011.

Table 2. Implementation Schedule for So il Fumigant Risk Mitigation Measures

Risk Mitigation Measure Currently 2010 2011

Restricted Use ● ● ● New Good Agricultural Practices ● ●

Rate reductions ● ●

Use site limitations ● ● New handler protections ● ● Tarp cutting and removal restrictions ● ● Extended worker reentry restrictions ● ● Training information for workers ● ● Fumigant Management Plans ○ ● First responder and community outreach ○ ● Applicator training ○ ● Compliance assistance and assurance measures ○ ● Restrictions on applications near sensitive areas ● Buffer zones around all occupied sites ● Buffer credits for best practices ● Buffer posting ● Buffer overlap prohibitions ● Emergency preparedness measures ●

○ = under development

● = adopt completely16 

### II. Chemical Overview

A. Chemical Identity

Chemical Structure: **H |** 

**H-C-Br |** 

**H**

Empirical Formula: CH 3 Br

Common Name: Methyl bromide

CAS Registry Number: 74-83-9

OPP Chemical Code: 053201

Case Number: 0335

Technical or Manufacturing-Use Registrants: Albemarle Corporation, ICL-IP America Inc. 3 , Great Lakes Chemical Corporation (a Chemtura Company), and TriCal. All four companies are members of the Methyl Bromide Industry Panel of the American Chemistry Council (MBIP).

3 On July 1, 2008, Ameribrom Inc. changed th e corporate name to “ICL-IP America Inc.”17 B. Use and Usage Profile

Pesticide Type: Methyl bromide is a broad- spectrum fumigant chemical that can be used as an acaricide, antimicrobial , fungicide, herbicid e, insecticide, nematicide, and verteb rate control agent.

Target pests: Methyl bromide controls a wide range of pests including spiders, mites, fungi, plants, insects, ne matodes, rodents, and snakes.

Use patterns: Methyl bromide’s most prevalen t use pattern is as a soil fumigant. It is also used as a post harvest treatment of commodities and structural fumigation. Structural non-f ood treatments (e.g., residential buildings) are reportedl y no longer performed.

Formulations: Pressurized gas (PrG) formul ations are used for all methyl bromide applications. All methyl bromide pr oducts are classified as restricted use pesticides (RUP). The “Restr icted Use” classification restricts a product, or its uses, to use by certif ied pesticide applicators or those working under the direct supervis ion of a certified applicator.

Methods of Application: Soil uses: Methyl bromid e is injected into the soil at various depths using tractors equipped with shanks of varying shapes, sizes, and orientations. Applications have historically been done with and without tarps but tarp use is prev alent. With the hot gas method, methyl bromide is forced through a heat exchanger into the drip tubing under tarps. Applications can be made to flat areas of a field or

in user created raised bed cultu re. Applications are typically accompanied by some degree of soil compaction or use of shank trace

closure devices.

Other Uses: Methyl bromide gas is injected into an enclosure, chamber, structure, or under a ta rp remotely using flexible tubing connected to pressurized gas tanks.

Application Rates: Soil uses: Common pre-plan t agricultural field us es for various crops have maximum application rates that range from 200 lb ai/acre/application up to 430 lb ai/acre/application (e.g., EPA registration numbers 5785-4 and 5785- 42). Rates as high as 2 lbs ai/100 square feet are generally reserved for more specialized applications such as hot gas appli cations and tree planting scenarios which are less prevalent.

Other Uses: Application rates fo r commodity fumigations can range

from 1 to 20 lb ai/1000 ft 3 , but most perishable goods with established

food tolerances under 40 CFR have a pplication rates in the range of 1

to 4 lb ai/1000 ft 3 (e.g., grapes).18 Annual Usage in the

U.S.: In 2007, 5,482 metric tons of met hyl bromide were applied (4,269 metric tons from newly-produced ma terial and 1,213 metric tons from pre-2005 stocks). This amount does not include quarantine and preshipment (QPS) exemption usag e. QPS production is tracked by the Agency but usage is not. EP A’s Office of Air and Radiation (OAR) reports that as of January 1, 2008, there were 6,458 metric tons of pre-2005 methyl bromide stocks. Additional information on the decline of the methyl bromide inventory can be found at: http://www.epa.gov/ozone/mbr/MeBr_FactSheet2008.html

.

C. Regulatory History

Methyl bromide was introduced as a pesticide in 1932 and first registered in the U.S. in

1961. Under the Clean Air Act and the Montreal Pr otocol on Substances that Deplete the Ozone Layer, as of January 1, 2005, U.S. production an d import of methyl bromide is banned, except for uses that qualify for (1) a critical use ex emption (CUE), (2) a QPS exemption, or (3) an emergency exemption. For more information a bout the phase out of methyl bromide, see http://www.epa.gov/ozone/mbr/

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### III. Fumigant Overview and Agency Documents

A. General Overview of Soil Fumigants

Soil fumigants are pesticides that form gasses wh en applied to soil. Once in the soil, the fumigants work by controlling pest s that can disrupt plant grow th and crop production. Soil fumigants play a very important ro le in agriculture, but they also have the potential to pose risk concerns to people involved in application of the chemicals (h andlers), workers who re-enter fumigated fields (workers), and people who may be near the treated area (bystanders).

B. Human Health Risks

The main risk of concern for handlers, worker s, and bystanders associ ated with the soil uses of methyl bromide is from acute inhalati on exposure as a result of fumigant off-gassing. Methyl bromide handlers also are at risk from direct fumigant exposure during applications. The

term handler refers to persons involved in the app lication of methyl bromide. For soil applications, handlers also include persons involved in perforati ng and removing of tarps. The

term worker in this document refers to persons performing non-handler tasks within the application block, after the fumi gation process has been complete d, such as planting. The term bystander refers to any person who lives or works in the vicinity of a fumigation site.

Estimating exposure to fumigants is differe nt from non-fumigant pesticides due to fumigants’ volatility, and thus, their increased ability to move off site during and after application. For example, pestic ide spray drift is the physical movement of pesticide particulate or droplets from the target site during the application and soon th ereafter. In the case of soil fumigants, the pesticide moves as a gas (not as particulate or dropl ets) and movement off-site can occur for an extended period afte r application. Importantly, fumi gants have a well-documented19 history of causing large-scale hum an exposure incidents up to seve ral thousand feet from treated fields. Assessing fumigant exposure takes into account the size of the fumigated field, the amount of fumigant applied, and the rate at which the fumigant escapes from the treated field.

The term “flux rate” or “emission rate” define s the rate at which a fumigant off-gasses from a treated field. Many factors influence the ra te of emissions from treated fields after the application of soil fumigants. Factors such as the application me thod, soil moisture, soil temperature, organic matter levels, water treatmen ts, the use of tarps, bi ological activity in the soil, soil texture, weather conditions, soil co mpaction, and others influence the amount of fumigant that comes off the field and is available to move off-s ite to areas where bystanders may

be located.

Neurotoxicity is a common toxic effect for methyl bromide inhalation exposure, with neurotoxic exposure effects seen in all tested species of animals. Both acute (1-day) and 90-day inhalation neurotoxicity studies in rats showed evidence of ne urotoxic effects characterized by decreased activity, tremors, ataxia and paralysis. Neurotoxic effects were also seen in the chronic/carcinogenicity inhalation study in mice (ataxia, limb paralysis, degenerative changes in the cerebellum), the developmental inhalation study in rabbits (lethargy, right side head tilt, ataxia), and the Developmental Neurotoxicity Study [DNT] (decreased motor activity). In addition, a subchronic study (5- to 7-week) showed dogs to be the most sensitive species to the

neurotoxic effects of methyl bromide.

A non-reversible acute (1 day) inhalation e ndpoint was selected from a developmental rabbit study with a LOAEL based on agenesis of the gall bladder and in creased incidence of fused sternebrae. Fetal effects are presumed to occur after one exposure. The human equivalent

concentration used for the risk assessment was 10 ppm for a 24-hour time weighted average (TWA) to assess non-occupational bystanders and 30 ppm for an 8-hour TWA to assess occupational exposures. An uncertainty fact or (UF) of 30 with a 3x for interspecies extrapolation and 10x for intraspecies variati on was employed in the human health risk assessment. Please see the Agency’s April 11, 2007 risk assessment and other human health risk

documents listed at the end of th is section for a more detailed explanation of the toxicity endpoints.

In assessing risks from methyl bromide, the Agency considered multiple lines of evidence, using the best available information fr om monitoring studies, modeling tools, and from incident reports.

• Monitoring: For the human health risk a ssessments completed for methyl bromide and the other soil fumigants with in the group, several field-sc ale monitoring studies were considered, as well as monitoring of worker s and handlers involved in various tasks. These studies quantify methyl bromide concen trations in and around fields at various times and distances during and af ter applications. Many of these data indicate that there

can be risks of concern associated with met hyl bromide use at a broad range of distances from treated fields. However, these data are limited in their utility because they provide results only for the specific conditi ons under which the study was conducted.20 • Modeling: Models enable the use of da ta from monitoring studies to estimate concentrations and potential ri sks under a wide range of c onditions and use patterns.

EPA used the Version 2.1.4 of the P robabilistic E xposure and R isk model for Fum igants (also called the PERFUM model), to evaluate potential risks at distances around treated fields. PERFUM incorporates actual weathe r data and flux distri bution estimates, and then accounts for changes and altering conditi ons. Analyses based on a variety of model outputs were used to compare the potential ri sks at a range of distances. The PERFUM model and users manual are public domain and can be downloaded at http://www.exponent.com/perfum/

.

• Bystander, handler, and worker incident reports: Incide nts for the soil fumigants generally occur at a low freque ncy relative to the total numbe r of fumigant applications performed annually. However, when incide nts occur, there are often many people

involved. Incidents involvi ng handlers and workers tend to occur more often than incidents with bystanders.

Reconstructing incidents to examine the exact factors which led to the incident can be difficult, especially when bysta nders are involved since all th e factors that contributed to the incident may not have been documented. Some of the factors that have been linked to incidents in the past have included equipmen t failure, handler accidents, applicator failure

to adhere to label recommendations and/or requirements, and temperature inversions. Incidents have occurred to bys tanders close to fields and up to two miles away from the fumigated field.

Based on these lines of evidence, and as descri bed in more detail in the risk assessments, EPA has determined that methyl bromide risks to handlers, workers, and bystanders are of concern given current labels and use practices. The human health risk a ssessments indicate that inhalation exposures to bystanders who live and work near agri cultural fields and greenhouses where methyl bromide fumigations occur have the potential to exceed the Agency’s level of concern without additional mitigation measures. Th ere are also risks of concern for occupational handlers involved in methyl bromide applications and tarp perforation/removal activities, and for workers who may re-enter treated area shortly after fumigation or tarp perforation has been completed.

For more information about the specific inform ation in the Agency’s human health risk analyses, refer to the documents listed below:

• EPA-HQ-OPP-2005-0123-0285, Methyl Bromide: Phase 5 Health Effects Division (HED) Human Health Risk Assessment for So il, Greenhouse, and Re sidential/Structural

Uses

• June 2, 2008 addenda to April 10, 2007 Phase 5 Health Effects Division (HED) Human Health Risk Assessment For Soil, Greenhouse, and Residential/Structural (DP Barcode: D350818)

• June 9, 2008 memo, Factors Which Impact So il Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Cred it Factor Approach (DP Barcode: 306857)

• EPA-HQ-OPP-2005-0123-0317, Review of Fumigants Group Incident Reports21 • EPA-HQ-OPP-2005-0123-0318, Summa ry Fumigants Group Incident Reports

• EPA-HQ-OPP-2005-0123-0319, Summary Fu migants Group Incidents

• Methyl Bromide (PC Code 053201), Chlor opicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), DP Barcode 362369

, Updated Health Effects Division Recommendations for Good Agricultural Practi ces and Associated Buffer Credits (Date May 14, 2009)

C. Stratospheric Ozone Depletion

In addition to methyl bromide’s direct effect s previously described in Section B, methyl bromide soil fumigant use poses indirect ch ronic health risks, a nd is being phased out internationally, because it depletes the stratospheric ozone layer.

Ozone-depleting substances, including methyl bromide and other halogenated gases such as chlorofluorocarbons (CFCs), halons, and hydroc hlorofluorocarbons (HCFCs), are very stable in the lower atmosphere. They eventually drift into the stratosphere, wh ere they undergo a series of cyclical reactions that destroy ozone. In th e presence of ultraviolet light, halogenated source gases react to release chlorine or bromine at oms, which quickly break down ozone molecules while producing the free radicals bromine monoxide (BrO) or chlorine monoxide (ClO). These

chemicals continue to react and eventually regenerate the original bromine or chlorine, which begin the cycle again – enabling one chlorine or bromine atom to destroy 100,000 ozone molecules before being removed from the stratosphere.

The 2006 Scientific Assessment of Ozone Depletion , produced by the U.N. Environment Programme and the World Meteorological Organi zation, is the consensus work of hundreds of atmospheric scientists, many of them U.S. experts. The Executive Summary of the 2006 Assessment, released on August 18, 2006, noted that “b romine continues to play a major role in stratospheric ozone depletion” and that “met hyl bromide abundance decreased by 14% between 1997 and 2004. This decrease was larger than e xpected and suggests that when anthropogenic emissions of bromine are reduced, its atmosphe ric abundance decreases more than previously thought.”

Thinning of the ozone layer lead s to an increase in ultraviole t (UV) radiation reaching the earth’s surface, leading to increased inciden ce of skin cancer, catar acts, immunosuppression, and other ecological and economic impacts.

The Agency has previously undertaken and pr ovided analyses of me thyl bromide’s role in stratospheric ozone depletion including estimate s of mortalities and inci dences of skin cancer.

These analyses were based in part, on the Atmospheric Health Effects Framework (AHEF). For more information about the specifi c information in the Agency’s assessment of stratospheric ozone depletion, refer to the following documents:

• EPA-HQ-OPP-2005-0123-0165, Methyl Bromide: Science of Ozone Depletion and

Health Effects Estimates22 • EPA-HQ-OPP-2005-0123-0166, Human Health Be nefits Of Stratospheric Ozone

Protection

• EPA-HQ-OPP-2005-0123-0167, Regulator y Impact Analysis, Protecting Stratospheric Ozone: Process for Exempting Critical Uses from the Phaseout of Methyl Bromide

• EPA-HQ-OPP-2005-0123-0168, OAP’s Economic Imp act Analysis For Methyl Bromide

Allocation In The United States

• EPA-HQ-OPP-2005-0123-0169, OAP’s Benefits Analysis

The AHEF model predicts mortal ity and incidence for increa sed emissions of compounds that deplete stratospheric ozone, projects impacts of increased em issions on stratospheric ozone, models resulting changes in ground-level UV radi ation, and uses a dose-response relationship to project incremental skin cancer mortality and incidence.

The AHEF model was peer-reviewed by EPA’s Science Advisory Board (SAB) several times for use in various regulatory decisions, mo st recently in 2003. The final SAB reports for the peer reviews are availabl e on the EPA’s internet site 4 . All comments of the peer reviewers were considered, and the AHEF was modified appropriately.

The starting point in the AHEF modeling perf ormed by EPA assumed the total amount of methyl bromide applied in the U.S. was 23,000,000 lbs (10,433 metric tons). Consistent with the

intent of the Montreal Protoc ol, the amount of methyl bromid e applied, produced, and stockpiled has decreased since 2004 and is expected to cont inue to decline until supplies are exhausted. The Agency modeled 5 scenarios for conti nued methyl bromide use from 2005-2037, ranging from no drawdown (continued use at 23,000,000 lb pe r year) to full phase- out of all uses by 2017. For all uses, depending on the use scenario, 125 to 797 deaths and 24,221 to 155,020

incidences of skin cancer from 2005-2100 were estimated.

Skin cancer is the most common form of cancer in the U.S., with more than 1,000,000 new cases diagnosed annually 5 . Melanoma, the most serious form of skin cancer, is also one of the fastest growing types of cancer in the U.S.; melanoma cases in this country have more than doubled in the past two decades, and the rise is expected to continue 6 . In 2007, invasive melanoma was expected to strike more th an 59,000 Americans and kill more than 8,000 7

.

Nonmelanoma skin cancers are less deadly than melanomas, but left untreated they can spread, causing disfigurement and more se rious health problems. The most common nonmelanoma skin cancer - basal cell carcinoma - gr ows slowly and rarely spreads to other parts of the body but can penetrate to the bone and cause considerable damage. Squamous cell carcinomas, by comparison, can develop into large masses and can spread to other parts of the body.

4 EPA Science Advisory Board reports, http://yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/BOARD

5 National Cancer Institute, “Common Cancer Ty pes,” at www.cancer/gov/cancertopics/commoncancers

6 Ries, L., Eisner, M.P., Kosary, C.L., et al, eds. SEER Cancer Statistics Review, 1973-1999. Vol 2003. Bethesda (MD): National Cancer Institute; 2002.

7 National Cancer Institute, “Melanomas,” at www.cancer/gov/cancertopics/types/melanoma23 Actinic keratoses are skin growths that occur on body areas e xposed to the sun, particularly the face, hands, forearms, and the “V” of the neck. Although premalignant, actinic keratoses are a risk factor for squamous cell car cinoma. Chronic exposure to the sun also causes premature aging, which over time can make the skin become thick, wrinkled, and leathery.

Research has shown that UV radiation increase s the risk of certain cataracts - a form of eye damage in which a loss of transparency in th e lens of the eye clouds vision. Other kinds of UV-related eye damage include pterygium (tissu e growth that can block vision), skin cancer around the eyes, and degeneration of the macula (the part of the retina where visual perception is most acute).

Scientists have found that overexposure to UV radiation may suppre ss proper functioning of the body’s immune system and the skin’s natu ral defenses. All people, regardless of skin color, might be vulnerable to effects including impaired response to immunizations, increased sensitivity to sunlight, and r eactions to certain medications.

Because of these impacts, methyl bromide and other ozone-depleting substances are being phased out worldwide under the Montreal Pr otocol on Substances th at Deplete the Ozone Layer, the international ag reement designed to reduce and eliminate the production and consumption of stratospheric ozone-depleting subs tances. The U.S. was one of the original signatories to the 1987 Montreal Protocol and the U.S. Senate ratified the treaty in 1988. The Clean Air Act Amendments of 1990, which include d Title VI on Stratosp heric Ozone Protection, codified as 42 U.S.C. Chapter 85, Subchapter VI, ensure that th e United States could satisfy its obligations under the Protocol.

In the United States methyl bromide is cla ssified as a “Class I” ozone-depleting substance due to its high ozone depletion potential (ODP). A substance’s ODP is a meas ure of its ability to destroy stratospheric ozone molecules. The other Class I substances, such as chlorofluorocarbons (CFCs), halons, and carbon tetr achloride, were almost completely phased out in the 1990s. Methyl bromide is the onl y remaining Class I substance still commonly produced and used in the United States.

Under the Montreal Protocol, the U.S. and other developed countries were required to reduce the quantity of methyl bromide produced and consumed, relative to a 1991 consumption baseline, by 25 percent in 1999, 50 percent in 2001, 70 percent in 2003, and 100 percent (full phase out) by 2005.

The Montreal Protocol provides some exempti ons from the phase-out. The first is an exemption permitting limited production and import of methyl bromide to meet critical uses for which technically and economically feasible alterna tives are not yet available. The critical use exemption is designed to permit the production a nd import of methyl bromide for uses that do not have technically and economically feasible alternatives. In 2004, EPA established the framework for the critical use exemption; listed the approved critical uses for 2005; and specified the amount of methyl bromide that could be s upplied in 2005 from stocks and new production or import to meet the needs of a pproved critical uses. Since th en, through the notice-and-comment rulemaking process, EPA has authorized critical uses of methyl bromide on an annual basis.24 In Decision IX/6 (1997), the Parties to the Mont real Protocol agreed th at “a use of methyl bromide should qualify as ‘critical’ only if the nominating Party determines that: (i) The specific use is critical because the lack of availability of methyl bromide for that use would result in a significant market disruption; a nd (ii) there are no technically and economically feasible

alternatives or subst itutes available to the user that are acceptable from the standpoint of environment and public health and are suitab le to the crops and circumstances of the

nomination.” These criteria ar e reflected in EPA’s definition of “critical use” at 40 CFR 82.3.

Under the annual critical use process, app licants requesting critical use exemptions provide data on the tech nical and economic feasibility of a lternatives, their use of methyl bromide, research programs into the use of alte rnatives to methyl bromide, and efforts to minimize methyl bromide use and emissions. EP A reviews this information, as well as other data from governmental and academic sources, to establish whether there are technically and economically feasible alternatives available for a particular use of methyl bromide and whether there would be a signific ant market disruption if no exemption were available. In addition, EPA reviews other parameters of the exemption applications such as dosage and emissions minimization techniques and applicants’ research or transition plans. Following this assessment,

the U.S. Government submits the critical use nomination to the United Nations Environment Programme (UNEP) Ozone Secretariat. The Methyl Bromide Technical Options Committee (MBTOC) and the Technical and Economic Asse ssment Panel (TEAP), independent advisory

bodies to Parties to the Mont real Protocol, review criti cal use nominations and make recommendations to the Parties, which then author ize critical uses and amounts. As required in Section 604(d)(6) of the Clean Air Act, for each exemption period, EPA consults with the United States Department of Agricultu re and other federal agencies, and provides an opportunity for public comment on the amounts of methyl bromid e that the Agency has determined to be necessary for critical uses and the uses that th e Agency has determined meet the criteria of the critical use exemption.

A second exemption currently in use under the Montreal Protocol is an exemption for methyl bromide that is used for QPS. QPS fumi gation is used for rapid treatment of imports and exports such as fresh fruits, vegetables, flower s, timber, and grains where necessary to meet official quarantine or sanitary requirements in other jurisdictions. An example of a quarantine use is the fumigation of commodities such as rice and spices that are subject to infestation by a specific and officially-recognized quarantine pest. Quaran tine fumigation prevents the introduction of specific quarantine pests into a defined geographical area, such as an importing country. An example of a preshipment use is application to wheat because of official phytosanitary requirements at the shipment destination.

The Montreal Protocol al so provides for a narrow “emergency use” exemption, under which a Party may produce or import up to 20 metr ic tons of methyl bromide to address an emergency event. This use, however, is to be subsequently reviewed by the Parties according to

critical use criteria. EPA’s Office of Atmo spheric Programs (OAP) has not promulgated a regulation for the implementation of an emergency use exemption.25 D. Environmental Fate and Ecological Risks

The Agency’s environmental fate and ecological effects risk assessments indicate that there are some concerns for non-target organisms that may be exposed to methyl bromide. For more information about the specific information in the Agency’s assessment of environmental fate and ecological risks, refe r to the following documents:

• EPA-HQ-OPP-2005-0123-0029, Revised Draft Methyl Bromide Environmental Fate and Ecological Risk Assessment - Following the Review of 30-Day Error Correction Comments

• EPA-HQ-OPP-2005-0123-0038, Reregist ration Environmental Risk Assessment for Methyl

Bromide

• Response to Public Comments on the 7/9/ 08 Methyl Bromide RED (DP Barcode 304616)

Since methyl bromide is highly volatile and is a gas at room temperature and standard pressure, inhalation of vapor following soil fu migation is the major exposure pathway for nontarget mammals and birds. For aquatic organism s, exposure in surface water could result from runoff with soluble methyl bromide from fumigated fields.

The acute aquatic endangered species Level of Concern (LOC) is exceeded for aquatic invertebrates. However, the PRZM model does not account for the reducti on in exposure that would likely result from using tarps. This am endment to the reregistration eligibility decision requires tarps for all methyl bromide applica tions except for California Orchard Replant.

1. Hazard

Methyl bromide is considered moderately to xic to birds (oral LD50 is 73 mg ai/kg) and mammals (oral LD 50 is 86 mg/kg) from oral exposure. No acute inhalation studies were available in registrant studies or in open literature studies for birds, so inhalation toxicity has

been estimated based on the oral and inhalation data from mammals compared to the oral data for birds. For mammals, the LC 50 for methyl bromide from the inhalation route is 780 ppm.

Methyl bromide is slightly to modera tely toxic to fish by acute exposure (LC 50 is 3.9 mg/L), and to aquatic invertebrates (LC 50 of 2.6 mg/L). The no observed adverse effect level in a chronic fish toxicity study was 0.1 ppm. An unpublished aquatic plant study performed with a single species of algae resulted in an acute LC 50 of 2.2 ppm 8

.

8 Data on the toxic effects of methyl bromide to algae ar e only available from a singl e study (Canton et al. 1980), which appears to be an internal report an d not published in the peer-reviewed literature26 2. Exposure

a. Terrestrial Exposure

The Industrial Source Complex Short Term (IS CST3) model together with historical air monitoring data were used to evaluate the range of methyl bromide ai r concentrations which might be found under different conditions of a pplication rate, weather, source size and shape (e.g., field size in acres), tarping and distance from treated fields. The PERFUM model, which is

described in the Human Health Risk section, was not used to estim ate exposures since terrestrial

acute risks of concern were not iden tified based on ISCST3 modeling (see Terrestrial Risks Section 3.a. for further details).

b. Aquatic Exposure

The aquatic exposure assessment for methyl br omide relied on Tier II aquatic models. The Pesticide Root Zone Model (PRZM versi on 3.12) simulates fate and transport on the agricultural field, while the water body is simulated with Exposure Analysis Modeling System (EXAMS version 2.98). Simulations are run for multiple (usually 30) years and the reported EECs represent the values that are expected once every ten years based on the thirty years of daily values generated during the simulation.

PRZM/EXAMS simulates a 10 hectare (ha) field immediately adjacent to a 1 ha pond, 2 meters deep with no outlet. The location of the fi eld is specific to the cr op being simulated using site specific information on the soils, weather, cropping, and management factors associated with the scenario. The crop/location scenario in a sp ecific state is intended to represent a high-end vulnerable site on which the crop is normally grown. Based on hist orical rainfall patterns, the pond receives multiple runoff events during the years simulated. PRZM has limited capabilities in capturing the amount of a volatile chemical in air, water and sediment. The estimated concentrations of chemicals like methyl bromide in surface water bodies may be upper bound.

To simulate field application of methyl bromide, multiple scenarios were selected, including Florida strawberry, California toma to and California grape scenarios that were assessed with an application rate of 400 lbs ai/A . A North Carolina tobacco scenario was also

assessed at the maximum rate of 855 lbs ai/A. The scenarios with the highest exposure of methyl

bromide were the California tomato and Florid a strawberry scenarios, even though the maximum application rate for the North Carolina tobacco scenario was more than twice as high.

There is an uncertainty in estimating methyl bromide exposure in water bodies due to post-application tarping of the trea ted area. If tarping is used to minimize the volatilization of methyl bromide, the loading of the chemical thr ough runoff will be limited until the tarp is sliced or removed from the field. The present vers ion of PRZM model has limited capabilities in simulating the transport of a volatile chemical es caping the soil after rem oval of a tarp, and the resulting surface-water concentrations should be considered upper-bound values.27 3. Risk

a. Terrestrial Risk

The most likely route of exposure to methyl bromide for terrestrial animals is through inhalation of methyl bromide vola tilizing from a treated field. The concentration of methyl bromide in air used in the assessment came from two sources. The first represented the highest concentration measured in field monitoring studi es. This value of 27 ppm was detected in a 1987 study in which air concentrations 25 feet from a treated mill were measured 5 to 90 minutes after fumigation. Available historical mon itoring after soil fumigations resulted in concentrations ranging as high as 3.35 ppm. Th e second source of concen trations used in the terrestrial risk assessment was based on air disp ersion modeling, which estimated a concentration of about 9.1 ppm adjacent to a 40-acre field tr eated with 400 lb ai/A of methyl bromide.

These concentrations were compared to acu te inhalation toxicity values to evaluate potential risk. Mammalian acute inhalation toxicity data were available, but avian acute inhalation toxicity endpo ints had to be estimated using the mammalian inhalation and oral toxicity data, avian oral toxici ty data, and a factor used to account for inhalation physiology differences between birds and mammals. The Ag ency has not set a LOC for inhalation exposure, but the resulting RQs for both estimated air concen trations were below th e standard acute LOCs of 0.1 and 0.5 used for dietary risk assessments. The Agency will require that avian inhalation acute toxicity studies be submitted to confirm the results of this risk assessment performed with estimated toxicity endpoints.

The volatility of methyl bromide causes it to di sperse quickly from a treated field when it

is not constrained to remain in the soil. However, it is possible that animals could potentially be exposed repeatedly if their range were to exte nd over several adjacent fiel ds which were treated over multiple days. Available toxicity data from the dog 5 to 7 week inhalation test resulted in a no observed effect level of 5.3 pp m, which was higher than the p eak short-term concentration

from soil treatments observed in historical data, and higher than a range of ambient air

concentrations found in hi storical monitoring data.

b. Aquatic Risk

The only aquatic risks that were above the Agency’s LOC are the acute risk to endangered or threatened aquati c invertebrates species. The acute aquatic listed species LOC (0.05) is exceeded for aquatic i nvertebrates in two of the four modeled scenarios (CA tomatoes, 0.06 and FL strawberries, 0.07), but not with CA grapes or NC tobacco. However, the PRZM

model does not account for the reduc tion in exposure that would likely result from tarping the field immediately after methyl bromide applicati on. Given the low levels of exceedence (RQs of 0.06 to 0.07), the potential effect of tarping will likely lower th e RQ values below the LOC.

Bromide ion is one degradation product of methyl bromide that is formed in soil. The risk assessment evaluated the potential for risk to aquatic organisms from bromide ion generated by methyl bromide degradation using the Tier 1 surface-water exposure model GENEEC. This assessment calculated the potential concentration from runoff that could occur from the highest28 application rate of 575 lb ai/A, assuming that 20% of applied methyl bromide is lost to volatilization, and that the remai nder of the methyl bromide degr ades to bromide ion on site. This conservative screening assessment resulted in an EEC of 5.4 ppm, which is below the most sensitive available toxicity endpoin t of 7.8 ppm, for chronic risk to freshwater invertebrates. The

next lowest bromide ion toxic ity endpoint for aquatic animals was an order-of-magnitude less

sensitive.

E. Benefits

Soil fumigation can provide benefits to both food consumers and growers. For

consumers it means more fresh fruits and ve getables can be cheap ly produced year-round because severe pest problems can be efficien tly controlled. Growers benefit because crops grown in fumigated soil produce fewer blemished pr oducts, which translates into an increase in marketable yields. Fumigation can also provi de benefits to grow ers by increasing crop management flexibility. This includes shorter crop rotational intervals (i.e., less time when fields are left fallow), improved ability to meet qua rantine requirements (which are imposed when states or other jurisdictions require a pest-free harvested product), and consistent efficacy against critical pests. The magnitude of benefits depe nds on pest pressure, which varies over space and time, and the availability and costs asso ciated with the use of alternatives.

There are a number of benefits assessments th at have been completed by the Agency to

estimate the value of these chemicals to various indus tries. Below is a list of the specific benefits assessments that include methyl bromide.

• EPA-HQ-OPP-2005-0123-0321, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Metam-Sodium, and Met hyl Bromide in Eggplant Production

• EPA-HQ-OPP-2005-0123-0322, Assessment of the Benefits Soil Fumigants (Methyl Bromide, Chloropicrin, Metam-Sodium, Dazomet) Used by Forest Tree Seedling

Nurseries

• EPA-HQ-OPP-2005-0123-0323, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, Dazomet, Metam Potassium and Metam Sodium for Use in Raspberry Nurseries, Fruit and Nut Deciduous Tree Nurseries, and Rose Bush

Nurseries in California

• EPA-HQ-OPP-2005-0123-0324, Assessment of the Benefits of Soil Fumigation with Chloropicrin and Metam-sodium In Onion Production

• EPA-HQ-OPP-2005-0123-0325, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin a nd Metam-sodium In Grape Production

• EPA-HQ-OPP-2005-0123-0326, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin and Metam-sodium In Tree Nut Production

• EPA-HQ-OPP-2005-0123-0327, Assessment of the Benefits of Soil Fumigation with Chloropicrin, and Methyl Brom ide In Pome Fruit Production

• EPA-HQ-OPP-2005-0123-0328, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, and Me tam Sodium In Stone Fruit Production

• EPA-HQ-OPP-2005-0123-0329, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-Sodium in Bell Pepper Production29 • EPA-HQ-OPP-2005-0123-0330, Assessment of the Benefits of Soil Fumigation with

Metam-sodium in Potato Production

• EPA-HQ-OPP-2005-0123-0331, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-sodium In Strawberry Production

• EPA-HQ-OPP-2005-0123-0332, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam-sodi um, and Dazomet In Strawberry Nursery

Runner Production

• EPA-HQ-OPP-2005-0123-0333, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide and Meta m-sodium In Sweet Potato Production

• EPA-HQ-OPP-2005-0123-0334, Assessment of the Benefits of Soil Fumigation with Chloropicrin In Tobacco Production

• EPA-HQ-OPP-2005-0123-0335, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Metam-sodium in Tomato Production

• EPA-HQ-OPP-2005-0123-0336, Assessment of the Benefits of Soil Fumigation with

Metam Sodium in Carrot Production

• EPA-HQ-OPP-2005-0123-0337, Assessment of the Benefits of Soil Fumigation with

Metam Sodium in Peanut Production

• EPA-HQ-OPP-2005-0123-0338, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam Sodi um and Dazomet in Ornamental Production

• EPA-HQ-OPP-2005-0123-0339, Summary of the Be nefits of Soil Fumigation with Methyl Bromide in Crop Production

• EPA-HQ-OPP-2005-0123-0340, BEAD’s Planned Imp act Assessments on Agricultural Sites with Significant Use of Soil Fumigants

F. Impacts of RED mitigation

Requirements in the July 2008 RED

The July 2008 RED acknowledged that even w ith the use of credits, there could be significant economic impacts to some growers who may not be able to accommodate large

buffers based on their current a pplication practices. However, the Agency believed that the options provided in the scalable buffer approach in the fumi gant REDs would allow growers the flexibility to modify their practices to achieve smaller buffers; for example, by treating smaller application blocks, switching to a lower emission application method, or by switching to an alternative fumigant that would require smaller bu ffers. In addition, EPA noted that pest control efficacy may be improved with high barrier tarps which may enable growers to use the buffer

zone credits and utilize lower a pplication rates resulting in furt her reductions of the buffer zone distances. Therefore, the Agency concluded that growers would be able to alter their fumigation applications, given the flexibility designed into the system, in a manner that would enable growers to minimize the impact on production. The Agency noted, however, that the buffers would significantly impact some growers by the us e of more expensive high barrier film, delays in planting due to longer fumigation operations, a dditional planning, and more trips to the field for planting and other operations if fumigating in smaller blocks resulted in staggered operations.

It was determined that some of these costs co uld be substantial in some production scenarios.30 Comments on the July 2008 RED

The July 2008 RED requested commenters to submit a description of fumigation practices and provide maps of th eir property illustrating locations of fields, offices, residences, roads, and property lines so that the Agency c ould better understand the impacts of the mitigation plan. In response, various stakeholders, incl uding several forest seedling nursery operations, submitted detailed information. From an analysis of the information submitted, including an analysis of a nursery and options they would ha ve for compliance, the Agency concludes that it had overestimated the ease with which many grower s and fumigators would be able to comply with the buffer requirements as presented in the July 2008 RED, and that potential impacts would be much greater than previously anticipa ted for some types of pr oduction. The analysis indicates that the buffer system identified in the July 2008 RED can be less flexible than expected for certain scenarios and the associated field topography, field in frastructure, and need for a consistent orientation in the application of a fumigant, which constrain how a field may be

divided.

From the Agency’s analysis, the primary driver of the impacts is the size of the buffer zones, which will require many growers to divide their fields into smaller fumigation blocks to

achieve smaller buffer zone distances. Two other contributing factor s are the prohibition on buffers overlapping in space and time and the du ration of the buffer zone. Together, these requirements could result in the lo ss of part of a grower’s field th at can be effectively fumigated. Further, there may be substantial delays in co mpleting fumigations and multiple trips to a field with fumigation equipment may often be nece ssary. Not only could there be delays in production activities in these instances, but it ma y also be difficult to maintain proper soil moisture over the period that multiple blocks would be fumigated. Soil moisture has been

identified as a critical element in controlli ng emissions. Some growers will face numerous scheduling conflicts if they rely on commercial applicators, and the Agency estimates that growers would be more likely to conduct their ow n fumigations. In addition, repeated trips to the field to fumigate small blocks will increase costs, a further incentive for growers to conduct their own fumigations.

The Agency does agree that compliance with buffer zones requirements as outlined in the July 2008 RED would be a significant challenge fo r applicators and growers. However, field flux studies, monitoring data, modeling analyses , and information from incidents involving fumigants continue to support a conclusion that methyl brom ide off-gasses and moves away

from treated fields at concentrations that have th e potential to cause advers e effects. Therefore, the Agency still believes that buffer zones that exclude bystanders are a critical aspect of mitigating risks from the use of methyl bromide.

In addition to these impacts, if emergency preparedness and response requirements were triggered due to proximity of neighbors, for exam ple, the requirement in the July 2008 RED to

monitor the buffer zone for its 48- hour duration was estimated to im pose the highest direct costs. The Agency estimates that the cost of samp ling tubes alone could range from $1,000 to over $3,000 for a field or enterprise, not including th e cost of labor. These costs would fall disproportionately on growers with small acreage. As an alternative, growers could notify their neighbors of their intent to fu migate. However, the Agency understands and appreciates the31 many comments indicating that notification may not be an attractive optio n due to the potential for neighbors to attempt to impede or block fumigant applications.

Finally, the Agency concludes that the de velopment and implementation of workable fumigation strategies, considering buffer and ot her requirements, will require substantial new information and management skills on the part of growers and applicators. While the Agency’s risk management approach provides flexibility to the grower, providing a reasonable period of time for growers to adapt would reduce impacts.

Based on this new information and EPA’s analyses, the Agency has identified modifications to the mitigation which will mainta in the important protections necessary for the health and safety of workers and bystanders, but will increase the ability of fumigant users to comply by reducing impacts associated with the mitigation. This includes allowing buffer zone overlap and changes in monitoring requirements. In addition, due to new data that have been submitted to the Agency, buffer zones distances for some scenarios have been refined for certain

chemicals and additional buffer zone credits have been provided. The Agency also anticipates receiving additional field flux data for methyl bromide that may allow refinement of these buffer zone distances in the future. Although many asp ects of the RED mitigation will appear on labels in 2010, the Agency will not require buffers until the 2011 growing season.



### IV. Risk Management and Reregistration Decision

A. Determination of Reregistration Eligibility

Section 4(g)(2)(A) of the FIFRA calls for th e Agency to determine, after submission of relevant data concerning an active ingredient, wh ether pesticides containing the active ingredient are eligible for reregistration. The Agency has previously identified and required the submission of the generic (i.e., activ e ingredient specific) data required to support reregistration of products containing methyl bromide.

The Agency has completed its assessmentof the dietary (water), residential, occupational, and ecological risks associated w ith the use of pesticides containing the active ingredient methyl bromide. Dietary (food) risks were assess ed in the 2006 Methyl Bromide

TRED/RED and associated tolerances were reassessed 1 . The TRED/RED, which covered commodity fumigation, included similar mitigati on measures required in this document (e.g., fumigation management plans, buffer zones, resp iratory protection, air monitoring). The uses covered by this document (i.e., those not incl uded in the TRED/RED) are not considered

food/feed uses and do not have a ssociated tolerances. In additi on to the risk assessments, the Agency completed benefit assessments on crops with significant methyl bromide usage 9

.

9 EPA-HQ-OPP-2005-0123-0340, BEAD’s Planned Impact A ssessments on Agricultural Site with Significant Use of Soil Fumigants32 In Phase 5, the Agency published a risk mitigation options paper 10 . This document detailed potential mitigation options and sought public comment on these options. The following is a list of potential mitigation discussed in the Agency’s paper:

• Buffer zones;

• Sealing methods;

• Timing of applications;

• Application block size limitations;

• Respiratory protection;

• Tarp cutting/removal procedures;

• Entry-restricted period;

• Application method/practice restrictions;

• FMPs;

• FMP certification;

• Responsible parties;

• Record keeping/re porting/tracking;

• Restricted Use Pesticide Classification (this option does not apply to methyl bromide, since it is already a RUP).

• Notification and posting;

• Good agricultural practices;

• Fumigant manuals; and

• Stewardship programs.

Based on a review of the methyl bromid e data base and public comments on the Agency’s assessments for the active ingredient methyl bromide, the Agency had sufficient information on the human health, ecological effect s, stratospheric ozone depletion, and benefits of methyl bromide to make decisions as part of the reregistration proce ss under FIFRA. For the purposes of determining reregistration eligibil ity, methyl bromide uses were placed into two

groups:

• Group 1 included only methyl bromide uses, users, and locations that qualify for exemptions under the Montreal Protocol (see http://www.epa.gov/ozone/mbr/cueuses.html for further details on methyl bromide us es that qualify for CUEs).

Given the high acute risks associated with methyl bromide use and methyl bromide’s status as an ozone depleting subs tance which contributes to the de struction of stra tospheric ozone and incidence of skin cancer, EPA determined in the July 2008 RED that only uses with very high benefits and no economically or technologica lly feasible alternativ es are eligible for reregistration. The robust proce sses set forth in the Montreal Protocol and EPA’s implementing regulations for determining the cr itical uses of methyl bromide, and for identifying uses with economically and technologically fe asible alternatives, provide a cl ear picture of uses for which methyl bromide has very high benefits (for furt her details see “The 2010 Critical Use Exemption Nominations from the Phaseout of Methyl Bromide” at

10 EPA-HQ-OPP-2005-0123-0282, Risk Mitigation Options to Address Bystander and Occupational Exposures from Soil Fumigant Applications33 http://www.epa.gov/ozone/mbr/cueinfo.html ). Based upon those analyses, EPA determined that the uses in Group 1, those that qualify for exempti ons under the Montreal Protocol, have benefits which justify reregistration eligibility.

Because of their high benefits, the Agency determined in the July 2008 RED that Group 1 uses of methyl bromide will not pose unreasonable risks or adverse effects to humans or the environment provided that the risk mitigation m easures and label changes outlined in the RED were implemented. Therefore, products containi ng methyl bromide for these uses were eligible for reregistration as long as they have CUE or QPS status under the Mont real Protocol. Required label changes are described in S ection V of this document. The Agency determined in the July 2008 RED that any Group 1 uses that no longe r qualify for CUE and QPS status should be canceled. The list of critical uses of methyl br omide, as well as the limiting critical conditions for its use, is found in 40 CFR Part 82, Subpart A, Appendix L.

• Group 2 uses are uses that do not qualify for ex emptions under the Montreal Protocol. The import or production of new methyl bromide for these uses is prohibited. Currently, only methyl bromide produced before 2005 and stockpiled may be used for Group 2 use-sites.

Based on a consideration of the risks and be nefits, EPA determined in the July 2008 RED that Group 2 uses were not eligible for reregist ration. Substantial inform ation available to EPA as a result of (1) the exemption processes unde r the Montreal Protocol , (2) OPP’s benefits assessments for the soil fumigants, and (3) public comments provided during OPP’s Six-Phase Public Participation Process for methyl bromid e’s reregistration review, indicated that these uses have economically and techno logically feasible alternatives.

The Agency determined that use sites in Group 2 for which no data is available to demonstrate high benefits or a lack of eff ective alternatives should be canceled following completion of the comment period on the July 2008 RED and EPA’s consideration of those

comments to determine whether sufficient benefi ts data on any additional Group 2 uses warrant reconsideration of any part of this decision. Th e RED stated that if st akeholders are able to provide new information during the comment period on this decision indicati ng that certain uses have high benefits and/or do not have feasible alternatives, EPA will consider whether to allow continued use for a finite period of time to allow for the orderly transition among users to alternate pest control pr oducts and/or methods.

Following publication of the methyl bromid e RED in July 2008, the Agency announced a public comment period for the RED and requested comments on the importance of the Group 2 uses. The Agency received comments on th e Group 2 uses during the post-RED comment period. Following review of the comments, the Agen cy has determined that the benefits of the Group 2 uses are not high enough to allow them to be eligible for reregistration. However, the Agency has determined that certain uses do provide benefits for growers and EPA will allow these uses to continue for a finite period of tim e. These uses include; caneberries, fresh market tomatoes and peppers in California, Vidalia on ions in Georgia, and ginger in Hawaii. The Agency has determined that tobacco growers, golf courses, or turf producers would not incur substantial impacts if they could not use methyl br omide. Alternative treatments to control pests appear to be available and no information was su bmitted demonstrating that the alternatives are34 prohibitively expensive. Therefore, the Agency has determined that these uses should end immediately. The Agency will work with the re gistrants to cancel the Group 2 uses under Section 6(f) of FIFRA. If registrants do notrequest voluntary cancellation, EPA will take additional regulatory action. For more details on the benefits assessment for these uses, please refer to; BEAD Response to Stakeholder Comments on Non-CUE Uses of Methyl Bromide and Methyl Bromide Rate Reductions (DP# 363545) in the methyl bromide docket.

EPA believes that eliminating Group 2 uses will reduce the total amount of methyl bromide applied in the U.S., and therefore reduc e the incidence of skin cancer resulting from stratospheric ozone depletion. While the Agen cy acknowledges that lim iting use to only Group 1 uses may slow the drawdown of the pre-2005 stoc kpile, it is reasonable to expect that new production for exempted uses will also continue to decline as there will be more pre-2005 stockpile material avai lable for critical uses.

Based on its evaluation of methyl bromide, the Agency has determined that methyl bromide products, unless labeled and used as spec ified in this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this documen t, the Agency may take regulatory action to address the risk concerns from the use of methyl bromide. If all changes outlined in this document are incorporated into the product labels, then current risks for methyl bromide will be adequately mitigated for the purposes of this determination under FIFRA.

A substantial amount of research is currently und erway or is expected to begin in the near term to (1) address current data gaps, and (2) refi ne understanding of factor s that affect fumigant emissions. Additionally, a num ber of new methods and technologies for fumigation are emerging. EPA plans to move the soil fumigant s forward in Registration Review, from 2017 to 2013, which will allow EPA to consider new data and information relatively soon, determine whether the mitigation included in this decision is effectively addressing the risks as EPA believes it will, and to include other soil fumigants which are not part of the current fumigant group review.

USDA is currently conducting eradication progr ams to eliminate the potato cyst nematode in Idaho and the golden nematode in New Yor k, federally recognized invasive, non-indigenous pests. These nematode species pose serious thre ats to the potato industr ies in these regions and can cause serious economic damage. Currentl y, limited acreage is infested with these nematodes. However, there is great concern that these pests could move into other potato growing areas. The USDA program goals in clude limiting the spread of the nematodes eradicating current infestations. These programs currently rely on use of high rates of methyl bromide. USDA supervises the fumigation of infested fields by prof essional commercial applicators. In their comments on the July 2008 REDs, USDA expressed concern that the mitigation measures as outlined in the 2008 methyl bromide RED could severely impact the effectiveness of these programs. USDA has implemented extensive outreach programs to increase community awareness in these areas, and has conducted air monitoring to help ensure early warning if methyl bromide concentrations exceed current action levels. EPA believes these steps greatly enhance the safe ty of methyl bromide use unde r these programs. While EPA believes that several of the amendments to the methyl bromide RED will reduce impacts on35 benefits that these programs provide, EPA will continue to work with USDA on these specific uses to explore alternative methods to achieve sa fety goals while ensuring the benefits of these programs continue. Additionally, the studies the MBIP has committed to conduct, described later in this document, may allow for refinement of buffer distances which could further reduce the impacts.

The Registration Review process for methyl br omide and the other soil fumigants will also include a comprehensive endangered species assessment. Once that endangered species assessment is completed, further changes to methyl bromide labels may be necessary.

B. Public Comments and Responses

The Phase 3 public comment period on the pr eliminary risk assessments and related documents lasted from July 13 thro ugh October 12, 2005. EPA-HQ-OPP-2005-0123-0284 contains the Agency responses to Phase 3 public comments related to methyl bromide soil uses.

After the Phase 3 comment period, the Agency revised the human health risk assessment, completed benefit assessments, and developed risk mitigation options. These documents were put out for public comment on May 2, 2007 a nd the comment period ended on November 3, 2007. Comments on issues which were significant to many stakeholders and directly influenced EPA’s decisions are highlighted in this decision document, as well as EPA’s responses to those comments. The following documents include the EPA’s responses to comments. These

documents are located in the met hyl bromide docket, EPA-HQ-OPP-2005-00123.

• HED Component of Response To Comments Document On Methyl Bromide Phase 5 Fumigant Risk Assessment (DP Barcode 353907)

• Review of Stakeholder Submitted Impact Assessments of Proposed Fumigant Buffers, Comments on Initial Buffer Zone Proposal, and Case Studies of the Impact of a Flexible Buffer System for Managing By-Stander Risks of Fumigants (DP Barcode 353940)

• Response to Phase 5 BEAD Related Public Co mments Received on the Reregistration of Chloropicrin, Dazomet, Metam Potassium, Meta m Sodium, and Methyl Bromide. June 25, 2008. (DP Barcode 353940)

• SRRD’s Response to Phase 5 Public Comm ents for the Soil Fumigants (July 2008)

The Agency also opened a 60-day public comment period following the publication of the methyl bromide RED on July 16, 2008. The Agency received requests to extend the comment period, so in response to these requ ests, on August 29, 2008, EPA published a notice in the Federal Register extending the comment pe riod for an additional 45 days. The comment period closed on October 30, 2008. The Agency has reviewed these public comments as well as new scientific data and other information provided and determined that all measures established in the July 2008 RED to reduce risks to bysta nders and workers will st ill be required. The Agency has determined that certain modifications in how and when some measures will be implemented are appropriate. The following do cuments include EPA’s responses to comments on the methyl bromide RED which may be found in the methyl bromide docket:36 • Response to BEAD Related Public Comments Received on the Reregistration Eligibility Decision for Chloropicrin, Dazomet, Meta m Potassium, Metam Sodium, and Methyl Bromide (DP# 363545).

• BEAD Response to Stakeholder Comments on Non-CUE Uses of Methyl Bromide and Methyl Bromide Rate Reductions (DP# 363545).

• Response to Public Comments on the 7/9/08 Completed Methyl Bromide RED (DP Barcode 304616).

• Methyl Bromide, 1,3-Dichloropropene, Chlor opicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Compone nt of Agency Response To Comments On 2008 Reregistration Eligibility Documents (Date May 14, 2009).

• Analysis of Soil Fumigant Risk Management Requirements using Geographic Information Systems: Case Studies based on a Fo rest Seedling Nursery (DP Barcode 363546)

• SRRD’s Response to Post-RED Comments for the Soil Fumigants (May 27, 2009).

C. Regulatory Position

1. Regulatory Rationale

The Agency has determined that Group 1 methyl bromide uses described above are eligible for reregistration provided the risk mitigation measures outlined in this document are adopted and label amendments are made to reflec t these measures. This decision considers the risk assessments conducted by the Agency and the significance of methyl bromide use.

As detailed in Section III, there are risk s of concern to humans and the environment resulting from methyl bromide use. Understandi ng these risks and also the benefits of methyl bromide (also outlined in Section III), the Agency ’s goal for this decision is to be protective, especially of severe and irrevers ible effects, encourage best prac tices, and to reduce the potential impacts on benefits. To reach this goal, EP A considered a range of factors including:

• characteristics of bystander and other populations exposed to methyl bromide;

• hazard characteristics of methyl bromide (t he methyl bromide endpoint is based on a severe and irreversible effect);

• hazard characteristics of chloropicrin (the ch loropicrin endpoint is based on a minor and reversible symptom, eye irritation) since all products are formulated with at least 2% chloropicrin;

• methyl bromide’s ozone depletion potential;

• the phasing out of methyl bromid e under the Montreal Protocol,

• available information on levels of exposure, f easibility, cost, and effectiveness of various risk mitigation options;

• bystander, handler and work er incident reports;

• potential impacts of mitigation on growers’ ability to produce crops;

• uncertainties and assumptions underlying the risk and benefit assessments; and

• public comments.37 Considering these factors, EPA determined that a suite of complimentary measures designed to reduce risks, along with a flexible approach allowing for some site-specific decisions, would best meet the overall objectiv e of reducing risk and minimizing impacts on

users. The following is a summary of the rationale fo r managing risks associated with the use of methyl bromide. Where labeling revisions are warranted, specific language is set forth in the summary table in Section V of this document.

a. Generic Risk Management

Mitigation measures including restricting use si tes, reducing maximum applications rates, limiting formulations with high percentages of met hyl bromide to specified crops/use sites, and only allowing untarped application with California orchard replant are described below. These mitigation measures will reduce risks for handlers, bystanders, and workers (i.e., human health) as well as ecological and st ratospheric ozone risks.

In addition, GAPs, FMPs, and a stewardshi p/training program ensure consistent achievement of sound fumigation applications which are the foundation to minimizing the potential for adverse effects to bystanders, handlers, and worker risks and are described below in

the Other Mitigation section.

1) Use Sites

Any methyl bromide uses that do not currently qualify for exemptions under the Montreal Protocol (i.e., critical use, quara ntine and pre-shipment, or other exempted uses) are not eligible for reregistration. The following descri bes the rationale for this decision:

• This preserves uses with high benefits and no alternatives, and eliminates uses with lower

benefits and/or alternatives given the risks associated with methyl bromide use;

• reconciles inconsistency between phase-out of methyl bromide production and EPA registered uses;

• does not inhibit methyl bromide use that gr owers and the interna tional community have

determined to be critical and that ar e permitted under the Montreal Protocol;

• restricts the use of stockpiled me thyl bromide to uses with high benefits, critical uses, and other exempted uses; and

• contributes along with other mitigation to the reduction of methyl bromide use and thus the reduction of stratosphe ric ozone depletion and associated skin cancers (see stratospheric ozone depletion risk management section of Section IV for further details).

2) Formulations

The Agency’s risk assessment for methyl bromide indicates that risks for the 98:2 (methyl bromide:chloropicrin) fo rmulations are higher than for other formulations. When 98:2 formulations are used, the amount of methyl br omide applied is generally higher compared to amount applied for other formulations which re sults in higher human health, ecological, and stratospheric ozone risks. Add itionally, EPA is concerned that 2% chloropicrin is not adequate38 to be an effective warning agent 11 . Therefore, the Agency has d ecided to only reregister 98:2

formulations for uses that have been de termined to be essential, which include:

• Orchard replant

• Ornamentals (hot gas method only)

• Forest seedlings

• Quarantine uses

3) Application Methods

The Agency is requiring that in all cases, except very limited circumstances, that methyl bromide applications be tarped. The human health risk assessment indicates that untarped shank applications for typical rates and application bl ocks result in bystander risks that exceed the Agency’s LOC at significant distances from the fi eld. These methods of application are rarely used in the U.S., and when they are used it is reported only for Califor nia orchard replant. Therefore, the Agency is allowing only deep (1 8 inches or greater) untarped shank applications for California orchard replant uses that quali fy for a CUE or QPS exemption and tree-hole applications with deep (18 inches or greater) injection auger probe s. EPA is requiring tarps for all other methyl bromide applications that are sh ank injected or applied with the hot-gas method.

4) Maximum Application Rates

The July 2008 methyl bromide RED required a reduction in maximum rates for certain

uses. These reductions were based on informa tion from critical use nominations (CUNs) and CUEs and acknowledgements from MBIP and other stakeholders that current methyl bromide use rates are substantially less than the curren t maximum rates on registered labels. Maximum rates for QPS and emergency exemptions uses ar e not affected by this decision but must be

identified on end use labels.

During the post-RED comment period, the Ag ency received comments from MBIP on the maximum application rates proposed in the RED. The Agency evaluated the comments and, in general, concludes that the rates proposed in the RED are in keeping with rates currently in use and should not pose significant problems to most growers. However, the rates specified in the RED are often near the average use rates and some growers may benefit from higher rates. The Agency also finds that vegetable producers may benefit if maximum rates are standardized at 200 lb methyl bromide/acre across vegetable crops as most producers plant a mix of crops. Most significantly, according to information r ecently obtained, nurseries (strawberry, orchard and forest seedlings) and some ornamental produc tion facilities in California may occasionally be required to use a rate of almost 400 lb me thyl bromide/acre in order to obtain pest-free

certification.

Based on the Agency’s review of the comments submitted by MBIP, EPA has

determined that maximum rates for certain uses s hould be higher than what was described in the

11 June 2, 2008 addenda to April 10, 2007 Phase 5 Health Effects Division (HED) Human Health Risk Assessment For Soil, Greenhouse, and Residential/Structural (DP Barcode: D350818)39 July 2008 RED. These rates are still significantly lowe r than current labeled maximum rates and the Agency believes that these reductions in appl ication rates will result in less methyl bromide applied and will help to reduce methyl bromide’s role in the depletion of stratospheric ozone. The mitigation measures described in this docum ent will address acute risks resulting from these rates and provide incentives to use the lowest efficacious rate. Therefore, the Agency believes that a majority of applications will use rates that are lower than the maximum rates. EPA’s decision regarding maximum use ra tes is presented in Table 3.

Table 3. Maximum Application Rates fo r Pre-plant Soil Methyl Bromide Uses Maximum Broadcast Equivalent Rates (lb a.i./acre) Approved Critical Uses Current Label 2008 RED RED Amendment

Cucurbits 435 200 200 Eggplant 400 170 200 Pepper, Bell 480 170 200 Tomato, Fresh Market 870 160 200 Sweet Potato Slips 870 200 200 Strawberry Fruit 870 200 235 Strawberry Nursery 870 260 400 Orchard Nursery 435 200 400 Forest Seedling Nursery 870 260 400 Orchard Replant (walnut, almond, stone fruit) 870 200 250

Orchard Replant (grape) 870 250 250

Ornamentals 870 360 400

b. Human Health Risk Management

For details on the methyl bromide human hea lth risk assessment, please refer to the

Human Health Risk Assessments and addenda for me thyl bromide described in Section III of this

document. These documents are also avai lable in the public doc ket EPA-HQ-OPP-2005-0123, located on-line in the Federal Docket Management System (FDMS) at http://www.regulations.gov

.

The human health risk assessments indicate that inhalation exposur es to bystanders who live and work near agricultural fields and green houses where methyl br omide fumigations occur and to handlers involved in the application of methyl bromide have the potential to exceed the Agency’s level of concern without additional mitigation measures.

To reduce the potential for exposure to bysta nders, handlers, and workers and to address subsequent risks of concern, EP A is requiring a number of mitig ation measures which include:

• Removing of uses with low be nefits and/or alternatives;

• Reducing maximum application rates;

• Limiting use of 98:2 formula tions to essential crops;

• Buffer zones;

• Respiratory protection and ai r monitoring for handlers;

• Restrictions on the timing of perforating and removing tarps;40 • Posting;

• Good agricultural practices;

• Fumigant management plans;

• Emergency preparedness and response plans; and

• Notice to state lead agencies.

The Agency also believes that registrant developed and implemented training and community outreach and education programs, will help reduce risk. Additionally, EPA will continue to work with registrants to identify a dditional measures that could be implemented as part of product stewardship. These additional meas ures should include efforts to assist users’ transition to the new label requirements.

Some of the required mitigation measures only address one group of potentially exposed individuals (i.e., bystanders, handlers, or workers) , while other measures will help reduce risk to more than one group. All mitigation measures are designed to work together to reduce exposures, enhance safety, and facilitate complian ce and enforcement. The Agency has based its risk mitigation decision on a flexible approach which EPA believes will be protective and allow users to make site-specific choices to reduce po tential impacts on benefits of the use. While some of these measures, buffer zones for example, can be used to estimate margin of exposures (MOEs), others such as emergency prepare dness and response and co mmunity education will contribute to bystander safety, but are difficult to express in terms of changes to quantitative risk estimates such as MOEs. However, EPA has determined that these measures, working together, will prevent unreasonable adverse effects on human health.

EPA recognizes that California has many si milar requirements for methyl bromide but also includes permits for every application which are issued and administered by County Agricultural Commissioners. Cali fornia’s approach has been eff ective at addressing bystander, handler, and worker risks.

1) Bystander Risk Mitigation

Bystanders are persons who live and/or work near fumigated fields and are potentially exposed to fumigant emissions th at travel off-site. In some cases the bystanders are workers performing agricultural tasks in nearby fields. If they are employed by the grower who has control of the fumigated field, they are more likel y to be aware that a fumigant application has

occurred.

Bystander risks for people that live near tr eated fields differ from other human health risks evaluated under FIFRA, fo r example residential and worker reentry risks. Unlike residential exposures resulting from use of pr oducts to control pests in and around the home, non-occupational bystanders receive no direct benefit from the pesticide which was applied elsewhere. These bystanders have not made a decision to purchase a pe st control product or service, and as a result they have little acces s to information about the product (e.g., hazards, safety information, first aid, etc.) or sympto ms of exposure. Additionally, non-occupational bystander exposures to fumigants are largely invo luntary and unanticipated. In this regard nonoccupational bystander exposure is similar to dietar y exposure in that people consuming foods or41 drinking water expect to be safe from possible adverse effects asso ciated with pesticide residues that could be present in their food and drinking water.

Unlike workers, non-occupational bystanders ty pically receive no safety information or training related to the pesticide to which they may be exposed. Whereas workers are generally expected to play an active role in protecting themselves from pe sticide risk, no such expectation exists for non-occupational bystanders. Work ers who experience symptoms of pesticide exposure are also more likely to link their sympto ms to the pesticide and take steps to receive appropriate treatment. Conversely, bystanders are much less likely to attribute adverse effects to pesticide exposures or to have access to informa tion needed to take appropriate steps to mitigate the effects of the exposure. Thus, EPA’s mitigat ion includes elements for site specific response and management, notice to state lead agencies, training, and community out reach and education, as well as labeling changes.

i. Buffer Zones

The human health risk assessments indicat e bystanders may be exposed to methyl bromide air concentrations that exceed the Ag ency’s level of concer n based on current label requirements. In general, the ri sk from inhalation exposures decr eases as the distance from the field where bystanders are located increases. Be cause of this relationship, the Agency has determined that a buffer zone must be established around the perimeter of each application block where methyl bromide is applied. The Agency acknowledges that buffer zones alone will not mitigate all risks or eliminate incidents caused by equipment failure, human error, adverse weather (e.g., temperature inversions), or other events. Th e Agency however does believe that buffer zones along with other mitigation measures required by this decision described below will mitigate risks so that bystanders will not experience unreasonable adverse effects.

ii. General Buffer Zone Requirements

General Requirements in the July 2008 RED

The 2008 methyl bromide RED described gene ral buffer zone requirements for methyl bromide and other soil fumigants. This included the definition of a buffer zone, the requirement

to exclude non-handlers from the buffer zone dur ing the buffer-zone period, and the definition of the application block.

The RED also did not allow buffer zones to overlap and fumigations were prohibited

within 0.25 miles of difficult to evacuate sites such as schools, state licensed day care centers, nursing homes, and hospitals, if occupied during the buffer zone period. Exemptions for vehicular and bicycle traffic were allowed on ro adways through the buffer zone. However, bus stops or other locations where persons wait for p ublic transit were not permitted within the buffer

zone. Structures within the buffer zone were al so not allowed to be occupied during the buffer zone period and air samples were required before bystanders c ould enter the structure following expiration of the buffer-zone period. In addi tion, before a buffer zone could extend onto adjacent private or public property, the applicator needed to obtain written permission from the42 owner/operator or local authority to allow the buf fer zone to extend onto the property. This was

to ensure that non-handlers woul d not enter the buffer zone and th at buffer zones did not overlap.

Comments on the July 2008 RED

During the post-RED comment period, the Agency received many comments from stakeholders concerning the buffer zone require ments. Many comments stated that the large buffer zone distances would make fumigation infeasible and the mitigation options were not flexible enough to allow some fumigations to occur; however other co mments expressed concern that buffers EPA specified would not be large enough to protect bystanders.

The Agency also received numerous comment s that buffer zone duration will present severe hardship for growers. Many commenters expressed concern that the buffer zone overlap

restriction would have the uninten ded consequence of forcing some applications to occur during less-than-optimal weather and soil conditions, because the restriction could preclude nearby application blocks from being treated when w eather and soil conditions would be optimal for reducing emissions. Hence, subsequent fumigations in adjacent fields would have an increased chance of occurring when weather and soil cond itions are more conducive to off-gassing. Examples cited by commenters where this situ ation could occur include the Southeast and Pacific Northwest where optimal soil moisture conditions occur during a limited time period.

The commenters felt that while the buffer zone is in effect, properly trained and equipped handlers should be allowed to enter adjacent appl ication blocks to make applications. Several commenters felt that providing an exception to this prohibition woul d make buffers more workable, reduce delays, allow a more efficien t use of equipment and labor, allow growers additional flexibility to achieve compliance with buffer requirements, and potentially reduce risk if applications could be made under more favor able soil and weather conditions. In addition, some comments suggested that allowing adjacent application blocks to be treated would not increase risk to bystanders since the Agency’s mitigation measures encourage users to split application blocks into smaller treatment areas which result in less fumigant being applied, less exposure, and less potential risk.

Some comments also asked for clarifica tion on various aspects of the buffer zone requirements, and some asked that EPA provide additional increments for acreages and application rates for buffer zone tables. In addition, many comments stated that buffer zone credits should be greater for the use of tarps a nd for certain environmental conditions. A number of comments indicated that obtaining written permission from local authorities for buffers to extend over roads and rights-of-way would be ex tremely difficult, and that neighbors may not provide permission. EPA also r eceived additional field emi ssions (flux) data for some fumigants, as well as additional information rega rding factors that affect fumigant emissions.

Based on EPA’s review of the comments, and new data and information, the Agency has

determined that certain amendments to the buffer zone requirements are appropriate. EPA

believes these amendments will maintain the im portant protections for bystanders but will increase the feasibility of compliance with buffe rs and will reduce potential impacts of buffers on the beneficial uses of soil fumigants. The Ag ency does agree that compliance with buffer zone requirements as outlined in the July 2008 RED would be a signifi cant challenge for applicators43 and growers. However, field flux studies, m onitoring data, modeling analyses, and information from incidents involving fumiga nts continue to support a conclu sion that methyl bromide offgasses and moves away from treated fields at c oncentrations that have the potential to cause adverse effects. Therefore, the Agency still believes that buffer zones that exclude bystanders are a critical aspect of mitigating risks from the use of methyl bromide. The Agency believes the modifications to the buffer requirements, specified below, will increase compliance feasibility and encourage further adoption of emission re duction application techniques, while still protecting human health and the environment.

Amended RED Requirements

EPA has determined that no changes to se veral aspects of the general buffer zone requirements from the 2008 RED are appropriate. This includes:

- the definition and duration of a buffer zone;

- the requirement to exclude field workers, nearby residents, pedestrians, and other bystanders from the buffer zone during the buffer zone period;

- the exemption for transit through buffer zones;

- the definition of the application block;

- the minimum buffer of 25 feet and maximum buffer of 1⁄2 mile.

- the requirement limiting entry into buffer z ones to handlers who have been properly trained and equipped according to EPA’s Worker Protection Standard;

- the prohibition on including in buffer z ones bus stops or other locations where persons wait for public transit;

- the prohibition against incl uding in buffer zones buildings under the control of the owner/operator of the application block us ed for storage such as sheds, barns, garages, etc., unless the st orage buildings are not occ upied during the buffer zone period, and the storage buildings do not share a common wall with an occupied

structure;

- the prohibition against incl uding in buffer zones residen tial areas that are not under the control of the owner/operator unless o ccupants agree in writing that they will voluntarily vacate the buffer zone un til the buffer zone period expires;

- the prohibition against incl uding in buffer zones agricultu ral areas that are not under the control of the owner/ope rator unless the owner/operato r of the other area provides written agreement that they, their employ ees, and other persons will not enter the buffer zone; and

- the prohibition against incl uding in buffer zones publicly owned and/or operated areas such as parks, sidewalks, walki ng paths, playgrounds, and athletic fields without first obtaining written perm ission from local authorities.

EPA has determined that certain other am endments to the July 2008 RED requirements are appropriate; these are discussed in great er detail below. The amended buffer zone requirements are summarized at the end of this section.44 Buffer Zone Proximity - Exception to Allow Buffer Zone Overlap

The Agency is concerned that emissions from multiple fields located close to one another could be higher than air concentrations from i ndividually treated fields. As a result, bystanders outside of buffers for individual application bl ocks could be exposed to concentrations of concern particularly if peak concentrations from multiple application blocks in proximity to each

other coincide. To reduce the potential for off-site movement of fumigant emissions beyond buffer zones for multiple fumigated fields, the July 2008 RED prohibited buffer zones from multiple application blocks from overlapping, in cluding application blocks fumigated by other
property operators.

EPA has considered the comments submitted and has determined that allowing an exception to the buffer zone overlap prohibiti on, under the conditions specified below, is reasonable and will not demonstrably alter the prot ection goals provided to bystanders in the July

2008 RED. EPA has determined that buffer zone s from nearby application blocks may overlap one another provided at least 12 hours have elap sed from the end of one application until the start of the next application. By separati ng the application times by at least 12 hours the fumigant emission peaks are less likely to occu r at the same time, which would sufficiently reduce potential exposure outside buffer zones and meets the Agency’s protection goals.

The Agency is maintaining the requirem ent for buffer zones around each application

block to be in effect for 48 hours and that on ly properly trained and equipped handlers are

allowed to enter into buffers zones.

To clarify, below are conditions when buffer zones may or may not overlap:

- A buffer zone may NOT overlap buffer zones from other application blocks that are already in effect UNLESS a minimum of 12 hou rs has elapsed from the time the first application ends until the second application begins.

EPA has determined that when fumigators exercise the exception to allow buffers to overlap, the emergency preparedness and response measures described later in this document must be implemented if there are homes, businesse s, or property not within the control of the fumigator within 300 feet of the buffer zone regardless of the size of the buffer zone.

To ensure handlers are aware that they ar e working in an existing buffer from an overlapping buffer zone area, the la bels will require the certified applicator, before beginning the application, to determine whether the application block or its resu lting buffer will overlap with a buffer that is already in effect. If so, the certified app licator must inform handlers of this and the health effects, early signs of exposure, and respiratory protection and PPE requirements for products applied in both the application bloc k in which they are working and the other application block. The Agency is requiring that all treatment areas and buffers be clearly posted with proper signage to ensure ha ndlers entering a treatment area ar e aware of previous treatments and the existence of buffers. In addition, certifie d applicators must obtai n permission from other landowners when buffers extend onto other lands, which provides an additional mechanism to ensure handlers are aware when they are work ing in a buffer zone and that they have the45 necessary information regardi ng health effects, warning pr operties, and respiratory/PPE requirements for all products to which they may be exposed.

Areas not under the control of owne r/operator of the application block

For areas not under the contro l of the owner/operator of the application block, the requirements remain unchanged except (1) air samples do not need to be taken to allow occupants to reenter buildings or homes after the buffer zone period ha s expired, and (2) buffer zones may include publicly owned and/or operated roads, including rights of ways, without first obtaining written permission from lo cal authorities; however, if a sidewalk or permanent walking path is associated with the road or right-of -way, written permission must be given by the appropriate state and/or local authorities.

In summary, areas of a buffer zone not unde r the control of the owner/operator of the application block, may not include residen tial areas (including employee housing, private property, buildings, commercial, industrial, and other areas that peopl e may occupy or outdoor residential areas, such as lawns, gardens, or play areas) unless the occupants provide written agreement that they will voluntarily vacate the bu ffer zone during the entire buffer zone period. Air samples for methyl bromide and chloropicrin do not need to be taken before the occupants can re-enter a building, home, or outdoor area th at was vacated in order to permit the fumigation to occur unless the methyl bromide product applied is formulated with less than 20% chloropicrin. The Agency determined that the concentrations of the fumigants 48 hours after completion of the application were likely to be below the Agency’s level of concern, and that the warning properties of chloropicrin would alert pe rsons reentering the site if concentrations were of concern. However, because methyl bromide is odorless and colorless, EPA is not confident that chloropicrin in low-concentration formul ations would be an effective warning agent 48 hours after treatment. Therefore, monitoring of buildings and outdoor area s after termination of the buffer zone is not necessary and will no longer be required except as noted for methyl bromide when it is applied in formula tions with less than 20% chloropicrin.

Buffer zones may still not include agricultural areas owned/operated by persons other than the owner/operator of the application bloc k unless the owner/operator of the application block can ensure that the buffer zone will not overlap with a buffer zone from any adjacent property owners, taking into account the ame nded requirements for overlapping buffers. In addition, the applicator must st ill receive written permission fr om the owner/operator of areas

that are not under the control of the applicator stating that the owner, their employees, and other persons other than handlers, consistent with buffe r overlap provisions, will stay out of the buffer zone during the entire buffer zone period. The goal of this agreemen t is to ensure that a property owner of an agricultural fi eld adjacent to an area that will be treated with a fumigant is aware when the fumigation will occur. This will allow the applicator to post on the adjacent property and take other required safety measures to en sure that persons on th e property will not be exposed to a fumigant at levels above the Agency’s level of concern. Informing the property owner of the adjacent field will enable them to ta ke any appropriate safety measures they deem necessary. The Agency believes that requiring th e applicator to obtain written permission will be an enforceable measure that will meet the goal of protecting workers an d bystanders on adjacent properties that fall wi thin a buffer zone.46 In addition, buffer zones still may include publ icly owned and/or ope rated areas such as parks, sidewalks, walking paths, playgrounds, and athletic fields onl y if the area is not occupied during the buffer zone period a nd entry by non-handlers is prohi bited during the buffer zone period. Written permission from the appropriate st ate and/or local authorities to include these public areas in the buffer zone is also still required.

However, for roads and rights-of-ways, EPA ha s determined that these may be included in buffers, subject to local laws and regulati ons, as long as it is posted according to the requirements of this amended RED. If, as di scussed above, the road or right-of-way has an associated sidewalk or permanent walking path, then written permission would also be required to include the area in the buffer zone. The Agency believes that if a town or county has invested resources into building a sidewalk or establishing a walking path, it is reasonable to anticipate pedestrian traffic at that locati on. In such circumstances EPA be lieves a local authority would be best positioned to make a determination about the practicality of preventing non-handlers from entering the buffer zone. EPA acknowledges that la ws and regulations vary from jurisdiction to jurisdiction and that the requireme nt to post points of entry into buffer zones may necessitate additional steps on the part of fumigant applicator s before a road or right-of-way can be included

in a buffer.

Maximum Application Block Sizes

The maximum application block sizes allo wed in the 2008 RED for methyl bromide applications were:

• 100 acres for tarped bedded and broadcast applications,

• 40 acres for untarped deep applicati ons (e.g., California orchard replant),

• 10 acres for outdoor hot gas applications, and

• 45,000 square feet for greenhous e hot gas applications.

These block size limits were based on the uppe r end of the range of acres treated under current practices and constraints of modeling for these scenarios. No comments were provided regarding these limits.

Buffer zone distances - Requi rements in the July 2008 RED

Because the methyl bromide target air concen tration is based on a severe, irreversible effect, EPA believes it is important that the buffer zones required for methyl bromide result in an MOE of 30 (the target MOE) at high percentiles of the of the outputs from PERFUM model Version 2.1.4, one of the resources EPA used to help inform decisions regarding buffer zone distances. See Appendix B for more informa tion on the PERFUM model. EPA believes the

buffer zone distances that achie ve this result will be protec tive of all potentially exposed bystanders including females at a critical pha se of pregnancy. MO Es for non-pregnant bystanders would be higher.

As discussed in the July 2008 RED, the bu ffer zones distances were not based on the selection of a specific percent ile or distribution from the PERF UM modeling results. Rather, EPA used a weight of evidence approach to set the buffers which included consideration of the47 hazard profile of methyl bromide, informa tion from incident reports, monitoring data, stakeholder comments along with comprehensive analysis of results from PERFUM modeling and consideration of results using other models (e.g., Industrial Source Complex Model 12 ). The analysis of PERFUM results considered distances at various percentiles of the whole field and maximum distance distributions, and predicted MOEs for various distances. The risk assessment characterizes additional types of analysis that we re performed. EPA’s goal for risk management

was to achieve buffer distances where associated risks were at or above target concentration levels at high percentiles of exposure. For meth yl bromide, the buffers specified in the July 2008 RED achieved this goal for protection. EPA also believed that the 2008 RED buffer zone distances would be manageable for most growers using existing cultural pr actices because of the flexibility and options provided to modify buffe rs by altering certain aspects of fumigation practices.

For the 2008 RED, the Agency developed buffe r zone distances that were scaled based on application method, application rate, and appli cation block size. For each of the outdoor preplant soil emission profiles for the July 2008 RED, distances were first chosen for the rates

identified in the risk assessment as the 10% , 25%, 50%, 75% and 100% of the maximum rates (i.e., 25, 63, 125, 188, and 250 lb ai/A for tarped bedded were provided in the tables) with application block sizes of 1, 5, 10, 20, 30, 40, 60, 80, and 100 acres. Distances for the other rates

in the buffer zone tables were scaled by assuming a linear re lationship between the 10%, 25%, 50%, 75% and 100% maximum rates (e.g., distance at 37.5% rate = [dista nce at 25% rate + distance at 50% rate]/2 ). This scaling was necessary to provide an incremental spread of rates

and buffer zone distances. It should be noted that the distances in th e lookup tables are not model outputs, although as describe d above the model outputs were used to inform the selection

of buffer zone distances.

The risks associated with the buffer zone dist ances, which are presented in Tables 4, 5, 6, 7 and 8, are characterized as follows:

• For outdoor and greenhouse pre-pl ant soil applications , the buffer zone di stances result in

MOEs ≥ 30 at the upper percentiles (usually 95 th percentile or great er) on the maximum

distance and whole field distributions for all w eather stations modeled.

• The risk level corresponding to th e buffer zone distances at the 95 th percentile maximum distribution is equivalent to saying a person at the location on the perimeter of the buffer

zone where the maximum concentration o ccurs during the wors t case 24 hour period following the fumigation of a specific field durin g a 5 year period would have at least a 95 percent chance of having of an acceptable level of exposure (i.e., MOE of ≥ 30).

• The PERFUM model Version 2.1.4 provides outputs th at show air concentrations at each of the modeled ring distances. The Agency has used this information to estimate the MOEs at

various distances for each of the five weather stations. MOEs for the 99 th percentile air

concentrations at the distances selected ex ceed 30 for all the weather stations modeled.

• The exposure time frame for which buffer zone distance modeling was performed was 24 hours, which is longer than the duration that ag ricultural workers in ne arby fields or other work areas are likely to be present.

12 http://www.epa.gov/scram001/ dispersion_alt.htm#isc348 • It was assumed that methyl bromide air con centrations inside homes and other occupied structures are equal to outside concentrations. These structures could act as a barrier which could in some cases reduce potential inside air c oncentrations. However, there is insufficient data to quantify differences between indoor and outdoor concentrations.

• The use of GAPs, FMPs, and other mitigati on measures required by this decision will

contribute to an additi onal decrease in risk.

Minimum and Maximum Distances

A minimum buffer zone of 25 feet was required in the July 2008 RED regardless of sitespecific application parameters. In some instan ces the PERFUM model predicts that the risks reach the target at the edge of the field. While modeling may support no buffer zone in some cases, a minimum buffer was required because of variability in the emission rates over a field

and other factors not accounted for in the modeli ng; as such the Agency determined that a 25 foot minimum buffer zone was a good agricultural practice. Also, in the 2008 RED, application scenarios requiring buffer zone distances of more than 1⁄2 mile (2,640 feet) were prohibited. EPA believes that for areas where methyl bromide is used, buffers greater than 1⁄2 mile are not practical and difficult to enforce.

“Greenhouse” Uses

The “greenhouse” industry sector is extremel y varied because of the diversity of the

facilities that are used across the country and because of th e nature of the products that are produced. As a result, some clar ification is required to interpret the required buffer zone distances for “greenhouses”. In typical “gr eenhouse” operations, many types of containerized ornamental plants and vegetable st arter sets are produced in either closed structures that will be referred to as “greenhouses” or in other related nursery operations such as small fields, or in what are commonly known as “shade” houses (i.e., essentially fields with an overhead sunblock, typically a semi-translucent blac k shade cloth). In the latter t ype of operation, cultural practices related to methyl bromide use are essentially id entical to the pre-plant field uses except they typically occur on a smaller scale (e.g., 1 acre applications or le ss). As a result, the minimum buffer zone distances for these types of use patte rns must be determined from the applicable outdoor pre-plant soil lookup tables (i.e., Tables 4, 5, and 7).

Methyl Bromide – Chloropicrin Formulations

Methyl bromide formulations used for pre-plan t soil uses are always formulated with at least 2 percent chloropicrin. The Agency has also completed a RED for chloropicrin which

includes buffer zone distances based on risks asso ciated with chloropicr in. In accordance with Agency policy, when a pesticide contains more than one active ingredie nt, the product labeling shall bear the more restrictive measures of pes ticides in the mixture. Generally, formulations with higher concentrations of methyl bromide w ill have buffers zone distances based on methyl bromide, while the formulations with higher concentrations of ch loropicrin will have buffers zone distances based on chloropicrin. However, th e user must consult the label for the specific formulation intended for use to ensure the requi red buffer zone distances for the particular product are employed.49 The July 2008 RED also provided detailed descriptions of the PERFUM model inputs and outputs. These descriptions have not cha nged and are included in this Amended RED in Appendix B.

Comments on the July 2008 RED Buffer Dist ances and Amended RED Determinations

Additional Acreage and Rate Increments

During the post-RED comment period, the Ag ency received comments requesting buffer zone distances for additional acreage increments for small fields and additional application rate increments for tarped bedded and tarped broa dcast scenarios. In response, the Agency

determined buffer distances for smaller block sizes (1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 acres) as well as more application rates for tarped bedded and tarped broadcast scenarios. EPA believes this will help to better refine the buffer distances fo r these use scenarios (Tables 4 and 5), and will provide additional options for growers to achieve more workable buffers.

Although the Agency added additi onal acreage and rate incr ements, not all increments may be captured by the tables pres ented. If the tables do not capt ure a specific acreage or rate, round up to the nearest acre or ra te. For example, when applying to a 9.5 acre field, round up to

10 acres.

New Flux (Emissions) Studies

Since the RED was published in July 2008, the Agency has received new flux data that have allowed the Agency to refine buffer zone distances for certain fumigants. While no new methyl bromide studies were submitted, the MB IP has submitted a lett er committing to conduct

new field flux studies for methyl bromide that may allow EPA to further refine the buffer zone distances specified in th e tables below. The studies will be conducted in San Joaquin Valley and Ventura County, California, and in Plant City, Fl orida. Emissions from various application methods will be conducted including:

• Broadcast shallow tarped under standa rd high-density polyethylene (HDPE)

• Broadcast shallow tarped under vi rtually impermeable film (VIF)

• Broadcast shallow tarped under VIF with potassium thiosulfate soil spray

• Deep, tarped strip under VIF

• Bedded tarp shank injection with VIF

• Bedded tarp shank injection with VIF and additional emissions reduction treatment

• Bedded tarp shank injection with metalized film

The studies are scheduled to be conducte d in spring 2009 through winter 2010 and final reports are scheduled to be submitted to th e Agency by March 2010. As noted above, the information from these studies may enable EPA to refine buffer zone distan ces that will appear on labels in 2011. See letter from Tracy Hein zman, Wiley Rein, LLP, to Debbie Edwards, “Methyl Bromide Reregistration 

### -- Development of New Data to Calculate Flux Rates/Emission Factors and Update EPA’s By-Stander Expos ure Assessment,” March 31, 2009, located in the methyl bromide docket.50 In addition, new fumigant data submitted during the post-RED comm ent period has also allowed the Agency to refine and update buffe r zone credits for tarp s, certain application techniques, and environmental conditions. As a result, although the buffer zone distances specified in the tables in the July 2008 RED fo r methyl bromide have not changed except as noted to add rate and acreage increments, buffe rs for growers who use emission-reducing tarps or application methods, or have site conditions th at qualify for credits will have smaller buffers than those specified in the 2008 RED. Available data indicate that for some crops and regions, pest control efficacy may be improved with high ba rrier tarps that may enable growers to use the

buffer zone credits and utilize lowe r application rates, resulting in further reductions of the buffer zone distances. Some growers in the Southeas t are commonly using high barrier tarps and lower

rates. The amended credits are disc ussed in detail below in the section, Buffer Zone Reduction

Credits

.

Methyl bromide buffer distances, amended as noted above , are specified in Tables 4-8 below. Table 9, from the July 2008 RED, summar ized the required buffer zone distances and corresponding PERFUM modeling results for the pre- plant soil uses that qualify for critical use exemptions with typical applic ation rates (based on information identified in the Agency’s benefits assessments). The buffer zone distances have been updated to incorporate additional rates. Focusing on tomatoes as an example (last ro w of Table 9), the buffer zone is 185 feet for a 10 acre application block in the Southeast at a ra te of 120 lbs ai/A. At 185 feet, the PERFUM model predicts greater than the 99.9 th percentile for the whole fiel d distribution and greater than

the 95 th percentile for the maximum field distribution for the wors t case weather station modeled (i.e., Bradenton, Florida). (See Appendix B for more details on the PERFUM model inputs and outputs.) The risk level corresponding to this buffer zone distance at the 99.9 th percentile whole field distribution is equi valent to saying a person at any lo cation on the perimeter of the buffer zone during the 24 hour period following the fumiga tion of a specific field during a 5-year period would have at least a 99.9 per cent chance of having of an expos ure below the level of concern (i.e., MOE of 30 or higher). The risk level co rresponding to the buffer zone distances at the 95 th
percentile maximum distribution is equivalent to saying a person at the location on the perimeter

of the buffer zone where the maximum concen tration occurs during the worst case 24 hour period following the fumigation of a specific fi eld during a 5-year pe riod would have a 95 percent chance of having of an exposure below the level of concern (i.e., MOE of 30) for these typical use scenarios. Using the PERFUM model outputs of air concentra tions to predict MOEs

at the 99 th percentile, at 185 feet for these app lication parameters, the MOE at the 99 th percentile is greater than 40 for the wo rst case weather station modele d (i.e., Bradenton, Florida).51Table 4. Tarped Bedded Buffer Zone Distances (feet)Application Block Size (acres)1 2 3 45 6 7 8 910 1520 2530 3540 5060 7080 901002525 25 25 2525 25 25 25 2525 2525 2525 2525 2525 2525 25253025 25 25 25 25 25 25 25 25 25 25 25 25 25 28 31 34 38 41 44 45 473525 25 25 25 25 25 25 25 25 25 25 25 25 25 31 38 44 50 56 63 66 694025 25 25 25 25 25 25 25 25 25 25 25 25 25 34 44 53 63 72 81 86 914525 25 25 25 25 25 25 25 25 25 25 25 25 25 38 50 63 75 88 100 106 1135025 25 25 25 25 25 25 25 25 25 25 25 25 25 41 56 72 88 103 119 127 1345525 25 25 25 25 25 25 25 25 25 25 25 25 25 44 63 81 100 119 138 147 1566025 25 25 25 25 25 25 25 25 25 25 25 25 25 47 69 91 113 134 156 167 1786525 25 25 2525 25 25 25 2525 2525 2525 5075 100125 150175 1882007025 27 28 30 31 33 35 36 38 40 46 52 56 60 86 113 144 175 204 233 249 2657525 28 31 34 38 41 44 48 51 54 67 79 88 96 123 150 188 225 258 292 311 3318025 30 34 39 44 49 54 59 64 69 88 106 119 131 159 188 231 275 313 350 373 3968525 31 38 44 50 57 63 70 77 83 108 133 150 167 196 225 275 325 367 408 435 4629025 33 41 48 56 65 73 81 90 98 129 160 181 202 232 263 319 375 421 467 497 5279525 34 44 53 63 73 83 93 103 113 150 188 213 238 269 300 363 425 475 525 559 59310025 36 47 58 69 80 92 104 115 127 171 215 244 273 305 338 406 475 529 583 621 65810525 38 50 63 75 88 102 115 128 142 192 242 275 308 342 375 450 525 583 642 683 72311025 39 53 67 81 96 111 126 141 156 213 269 306 344 378 413 494 575 638 700 744 78911525 41 56 72 88 104 121 138 154 171 233 296 338 379 415 450 538 625 692 758 806 85412025 42 59 77 94 112 130 149 167 185 254 323 369 415 451 488 581 675 746 817 868 92012525 44 63 81100 120 140 160 180200 275350 400450 488525 625725 800875 93098513027 48 69 90 112 133 154 175 196 217 295 373 427 481 521 562 665 768 848 927 987 104713529 52 76 100 123 145 168 190 212 235 315 396 454 512 555 598 705 811 895 979 1044 110914031 57 83 109 135 158 182 205 228 252 336 419 481 542 588 635 744 854 943 1031 1101 117114533 61 89 118 146 171 195 220 245 269 356 442 508 573 622 671 784 897 990 1083 1158 123315035 65 96 127 158 183 209 235 261 287 376 465 535 604 656 708 824 940 1038 1135 1215 129515537 70 103 136 169 196 223 250 277 304 396 488 562 635 689 744 864 983 1085 1187 1272 135716038 74 110 145 181 209 237 265 293 321 416 512 588 665 723 781 904 1027 1133 1238 1328 141816540 78 116 154 192 222 251 280 309 338 437 535 615 696 757 817 943 1070 1180 1290 1385 148017042 83 123 163 204 234 265 295 325 356 457 558 642 727 790 854 983 1113 1228 1342 1442 1542

Broadcast Equivalent Application Rate (lb ai/A)17544 87 130 173 215 247 278 310 342 373 477 581 669 758 824 890 1023 1156 1275 1394 1499 160452Table 4. Tarped Bedded Buffer Zone Distances (feet)Application Block Size (acres)1 2 3 45 6 7 8 910 1520 2530 3540 5060 7080 9010018046 91 137 182 227 260 292 325 358 390 497 604 696 788 858 927 1063 1199 1323 1446 1556 166618548 96 143 191 238 272 306 340 374 408 517 627 723 819 891 963 1103 1242 1370 1498 1613 172819050 100 150 200250 285 320 355 390425 538650 750850 9251000 11431285 14181550 1670179019556 108 159 211 263 298 333 369 404 440 556 673 776 879 957 1035 1185 1334 1471 1608 1735 186120063 116 169 222 275 311 347 383 418 454 575 696 802 908 990 1071 1227 1383 1525 1667 1799 193220569 123 178 233 288 324 360 396 433 469 594 719 828 938 1022 1106 1269 1433 1579 1725 1864 200321075 131 188 244 300 337 373 410 447 483 613 742 854 967 1054 1142 1312 1482 1633 1783 1928 207321581 139 197 255 313 350 387 424 461 498 631 765 880 996 1086 1177 1354 1531 1686 1842 1993 214422088 147 206 266 325 363 400 438 475 513 650 788 906 1025 1119 1213 1396 1580 1740 1900 2058 221522594 155 216 277 338 375 413 451 489 527 669 810 932 1054 1151 1248 1439 1629 1794 1958 2122 2286230100 163 225 288 350 388 427 465 503 542 688 833 958 1083 1183 1283 1481 1678 1848 2017 2187 2357235106 170 234 298 363 401 440 479 518 556 706 856 984 1113 1216 1319 1523 1728 1901 2075 2251 2428240113 178 244 309 375 414 453 493 532 571 725 879 1010 1142 1248 1354 1565 1777 1955 2133 2316 2498245119 186 253 320 388 427 467 506 546 585 744 902 1036 1171 1280 1390 1608 1826 2009 2192 2380 2569250125 194 263 331400 440 480 520 560600 763925 10631200 13131425 16501875 20632250 2445264053Table 5. Tarped Broadcast Buffer Zone Distances (feet)Application Block Size (acres)1 2 3 4 5 6 7 8 9 10 15 20 25 30 35 40 50 60 70 80 90 1004525 25 25 2525 25 25 25 2525 25 25 2525 2525 25 25 25 25 25255525 25 25 25 25 25 25 25 25 25 25 25 27 29 35 42 48 54 63 71 77 836525 25 25 25 25 25 25 25 25 25 25 25 29 33 46 58 71 83 100 117 129 1427525 25 25 25 25 25 25 25 25 25 25 25 31 38 56 75 94 113 138 163 181 2008525 25 25 25 25 25 25 25 25 25 25 25 33 42 67 92 117 142 175 208 233 2589525 25 25 25 25 25 25 25 25 25 25 25 35 46 77 108 140 171 213 254 285 31710525 25 25 2525 25 25 25 2525 2525 3850 88125 163200 250300 33837511525 28 31 34 36 39 42 45 47 50 59 68 88 107 149 191 236 282 339 395 442 48912525 31 36 42 48 53 59 64 70 75 93 111 138 164 210 257 310 364 427 491 547 60213525 34 42 51 59 67 75 84 92 100 127 155 188 220 272 323 384 445 516 586 651 71614525 36 48 59 70 81 92 103 114 125 161 198 238 277 333 389 458 527 605 682 756 83015525 39 53 68 82 95 109 123 136 150 195 241 288 334 394 455 532 609 693 777 860 94316525 42 59 76 93 110 126 142 159 175 230 284 338 391 456 520 606 691 782 873 965 105717525 45 65 85 105 124 143 162 181 200 264 327 388 448 517 586 680 773 870 968 1069 117018525 48 70 93 116 138 160 181 203 225 298 370 438 505 578 652 753 855 959 1064 1174 128419525 51 76 102 127 152 176 201 225 250 332 414 488 561 640 718 827 936 1048 1159 1278 139820525 53 82 110 139 166 193 220 248 275 366 457 538 618 701 784 901 1018 1136 1255 1383 151121525 56 88 119150 180 210 240 270300 400500 588675 763850 9751100 12251350 1488162522525 61 98 134 170 202 234 266 298 330 438 545 639 732 824 916 1053 1190 1325 1461 1608 175523525 66 108 149 191 225 258 292 325 359 475 591 690 789 885 982 1130 1279 1426 1573 1728 188424525 72 118 165 211 247 282 318 353 389 513 636 741 845 947 1048 1208 1369 1526 1684 1849 201425525 77 128 180 232 269 306 344 381 418 550 682 792 902 1008 1114 1286 1458 1627 1795 1969 214326525 82 139 195 252 291 330 370 409 448 588 727 843 959 1069 1180 1364 1548 1727 1907 2090 227327525 87 149 211 273 314 355 395 436 477 625 773 894 1016 1131 1245 1441 1637 1828 2018 2210 240228525 92 159 226 293 336 379 421 464 507 663 818 945 1073 1192 1311 1519 1727 1928 2130 2331 253229525 97 169 241 314 358 403 447 492 536 700 864 997 1130 1253 1377 1597 1816 2029 2241 2451 266130525 102 180 257 334 380 427 473 520 566 738 909 1048 1186 1315 1443 1675 1906 2129 2352 2572 279131525 107 190 272 355 403 451 499 547 595 775 955 1099 1243 1376 1509 1752 1995 2230 2464 2692 2920

Broadcast Equivalent Application Rate (lb ai/A)32525 113 200 288375 425 475 525 575625 8131000 11501300 14381575 18302085 23302575 2813305054Table 5. Tarped Broadcast Buffer Zone Distances (feet)Application Block Size (acres)1 2 3 4 5 6 7 8 9 10 15 20 25 30 35 40 50 60 70 80 90 10033534 126 218 310 402 452 502 552 602 652 847 1041 1195 1350 1495 1641 1907 2173 2426 2680 2924 316834543 140 236 333 430 480 530 580 630 680 881 1082 1241 1400 1553 1707 1984 2260 2522 2784 3035 328635552 153 255 356 457 507 557 607 657 707 915 1123 1286 1450 1611 1773 2060 2348 2618 2889 3147 340536561 167 273 378 484 534 584 634 684 734 949 1164 1332 1500 1669 1839 2137 2436 2715 2993 3258 352337570 181 291 401 511 561 611 661 711 761 983 1205 1377 1550 1727 1905 2214 2524 2811 3098 3369 364138580 194 309 424 539 589 639 689 739 789 1017 1245 1423 1600 1785 1970 2291 2611 2907 3202 3481 375939589 208 327 447 566 616 666 716 766 816 1051 1286 1468 1650 1843 2036 2368 2699 3003 3307 3592 387740598 222 345 469 593 643 693 743 793 843 1085 1327 1514 1700 1901 2102 2445 2787 3099 3411 3703 3995415107 235 364 492 620 670 720 770 820 870 1119 1368 1559 1750 1959 2168 2521 2875 3195 3516 3815 4114425116 249 382 515 648 698 748 798 848 898 1153 1409 1605 1800 2017 2234 2598 2962 3291 3620 3926 4232435125 263 400 538675 725 775 825 875925 11881450 16501850 20752300 26753050 33883725 4038435055 Table 6. Deep Untarped Buffer Zone Distances ( feet ) Broadcast Equivalent Application Rate ( lb ai/acre ) Block

Size ( acres ) 43 75 108 134 161 188 215 242 269 296 323 350 377 403 430

1 25 25 25 25 25 25 25 45 65 85 100 135 165 200 225

5 25 25 25 85 140 195 250 315 375 440 500 560 615 770 725

10 25 25 25 135 240 345 450 545 640 735 825 910 990 1,070 1,150

20 25 88 150 295 440 585 725 865 1,000 1,140 1,275 1,410 1,540 1,670 1,800

30 25 125 225 410 590 770 950 1,125 1,300 1,475 1,650 1,825 2,000 2,175 2,350

40 25 163 300 515 725 940 1,150 1,365 1,575 1,790 2,000 2,215 2,425 2,640 2,850

Table 7. Outdoor Tarped Hot Gas Buffer Zone Distances ( feet ) Broadcast Equivalent Application Rate ( lb ai/acre ) Block

Size ( acres ) 43 75 108 134 161 188 215 242 269 296 323 350 377 403 430

1 25 25 25 85 140 195 250 285 325 345 375 415 450 490 525

5 25 150 275 385 490 595 700 790 875 965 1,050 1,140 1,225 1,315 1,400

10 50 250 450 610 765 920 1,075 1,210 1,340 1,470 1,600 1,735 1,865 1,995 2,125

Table 8. Greenhouse Hot Gas Buffer Zone Distances ( feet ) Broadcast Equivalent Application Rate ( lb ai/100 square feet ) Block Size

( square

feet ) 0.25 0.5 0.75 1 5,000 25 25 50 100 10,000 25 50 125 200 15,000 25 100 175 250 20,000 25 125 225 300 25,000 25 150 250 350 30,000 25 175 300 400 35,000 50 200 350 450 40,000 50 225 375 475 45,000 75 250 400 50056 Table 9. Projected Buffers Zones for Methyl Bromide Crit ical Use Exemptions Based on Current Typical Application

Rates

Maximum

Distribution

Percentile where

MOE reaches 30 2 MOE for 99 th

Percentile Air

Concentration from PERFUM2 output Crop Region Application

Method 1 Broadcast Equivalent

Rate (lb

ai/A) Block

Sixe (acres) Buffer

Zones

without

credits

(ft) Bradenton Ventura Bradenton Ventura

10 454 >95 >95 >40 >45 MI Tarped

Shank

Bedded 200 20 696 >95 >97 >40 >45

10 185 >95 >97 >40 >45 Cucurbits

Southeast Tarped

Shank

Bedded 120 20 323 >95 >97 >35 >40

10 185 >95 >97 >40 >45 Eggplant Southeast Tarped

Shank

Bedded 120 20 323 >95 >97 >35 >40

10 389 >99 >99.9 >45 >50 236 20 636 >99 >97 >45 >50

10 707 >97 >99 >50 >60 Forest Seedlings Southeast Tarped

Shank

Broadcast 350 20 1,123 >99 >97 >50 >60

10 225 >99 >99.9 >45 >50 Nursery, Fruit, Nut,

and Rose National Tarped

Shank

Broadcast 180 40 652 >99 >99.9 >45 >50

10 225 >99 >99.9 >45 >50 Stone Fruit,

Tree Nut
Orchard Replant,

Grape Vineyards CA Tarped

Shank

Broadcast 182

40 652 >99 >99.9 >45 >50

10 359 >99 >99.9 >45 >50 CA Tarped

Shank

Broadcast 235 20 591 >99 >97 >45 >50

10 816 >99 >97 >55 >60 Ornamentals

FL Tarped

Shank

Broadcast 390 20 1,286 >99 >97 >55 >60

10 454 >95 >95 >40 >45 MI Tarped

Shank

Bedded 200 20 696 >95 >97 >40 >45

10 185 >95 >97 >40 >45 Pepper, Bell

Southeast Tarped

Shank

Bedded 120 20 323 >95 >97 >35 >40

10 200 >99 >99.9 >45 >50 CA Tarped

Shank

Broadcast 175
20 327 >99 >99.9 >45 >50

10 185 >95 >97 >40 >45 Strawberry

Fruit

FL Tarped

Shank

Bedded 120 20 323 >95 >97 >35 >40

10 359 >99 >99.9 >45 >50 CA Tarped

Shank

Broadcast 235 20 591 >99 >97 >45 >50

10 556 >95 >97 >35 >40 Tarped

Shank

Bedded 235 20 856 >95 >97 >35 >35

10 359 >99 >99.9 >45 >50 Strawberry

Nursery

NC Tarped

Shank

Broadcast 235 20 591 >99 >97 >45 >50

10 185 >95 >97 >40 >45 Tomato,

Fresh Southeast Tarped

Shank

Bedded 120 20 323 >95 >97 >35 >40

1 Broadcast (flat fume) may be applied as strips with non-treated areas in between (e.g., for fo rest seedlings and orchards).

2 The whole field percentile where MOEs reach 30 is >99.9 for all of the weather stations modeled.57 The Agency believes that the buffer zone dist ances described above, combined with other risk mitigations described herein, will provide protection against unreasonable adverse effects. The Agency is anticipating new emissions data from studies conducted by MBIP which may allow the Agency to determine if buffer zones of different sizes would meet or exceed the level of protection that the Agency es tablished in the July 2008 RED. Reports from these studies are scheduled to be submitted to the Agency by March 2010. Therefore, buffer zone distances that are scheduled to be on methyl bromide labels in 2011 may be differe nt from the distances provided in this document.

Amended Buffer Zone Requirements

The following describes the general buffer z one requirements, as amended, for methyl

bromide:

• “Buffer zone” is an area established around the perimeter of each application block or greenhouse where a soil fumigant is applied. The buffer zone must extend from the edge of the application block or greenhouse pe rimeter equally in all directions.

• All non-handlers including field workers, nearby residents, pedestrians, and other bystanders, must be excluded from the buffer zone during the buffer zone period except for transit (see exemptions section).

• The “buffer zone period” starts at the moment when any fumigant is delivered/dispensed to the soil within the applicati on block and lasts for a minimum of 48 hours after the fumigant has stopped being delivered/ dispensed to the soil.

• An “application block” is a fiel d or portion of a field treated with a fumigant in any 24-hour period. See exception provided in the Buffer zone proximity section below. (See Figures 1 and 2 of Appendix B for further explanation.)

Buffer zone proximity

• To reduce the potential for off-site movement from multiple fumigated fields, buffer zones from multiple methyl bromide applica tion blocks may not overlap UNLESS:

o A minimum of 12 hours have elapsed from th e time the earlier application(s) for which a buffer is in place end(s) un til the latter application begins, and

o Emergency preparedness and response meas ures specified later in this document have been implemented if there are any homes, businesses, or property not within the control of the fumigator within 300 f eet of each buffer zone, regardless of the

size of the buffer zone.

Buffer zone distances

• Buffer zone distances must be based on look-up tables on product labels. Twenty-five feet is the minimum buffer distance regardless of site-specific application parameters.

• For selective replant fumigation in an orch ard using hand held application methods (e.g., deep injection auger probes), the minimum bu ffer zone will be 25 feet measured from the center of each injection site (i.e., tree hole).58 Authorized entry to buffer zones

• Only authorized handlers who have been prope rly trained and equippe d according to EPA’s Worker Protection Standard (WPS) and label re quirements may be in the buffer zone during the buffer zone period.

Exemptions for transit through buffer zones

• Vehicular and bicycle traffic on public and pr ivate roadways through the buffer zone is permitted. “Roadway” means that portion of a street or highway improved, designed or ordinarily used for vehicular travel, exclusiv e of the sidewalk or shoulder even if such sidewalk or shoulder is used by persons riding bicycles. In th e event a highway includes two or more separated roadways, the term “roadway” shall refer to any such roadway separately. (This definition is based on the definition of ro adway in the Uniform Vehicle Code prepared by the National Committee on Uniform Traffic Laws and Ordinances. See http://www.ncutlo.org/ for more details)

• Bus stops or other locations where persons wait for public transit are not permitted within the

buffer zone.

• See the Posting section of this document for add itional requirements that may apply.

Structures under the control of owne r/operator of the application block

• Buffer zones may not include buildings used for storage such as sheds, barns, garages, etc., UNLESS,

1. The storage buildings are not occupi ed during the buffer zone period, and

2. The storage buildings do not share a common wall with an occupied structure.

• See the Posting section of this document for add itional requirements that may apply.

Areas not under the control of owne r/operator of the application block

• Buffer zones may not include residentia l areas (including employee housing, private property, buildings, commercial, industrial, and other areas that people may occupy or outdoor residential areas, such as lawns, gardens, or play areas) UNLESS,

1. The occupants provide written agreement that they will voluntarily vacate the buffer zone during the entire buffer zone period, and

2. Reentry by occupants and other non -handlers must not occur until,

° the buffer zone period has ended,

° Sensory irritation is not experienced, and

° for structures in buffer zones for methyl bromide applications with less than 20% chloropicrin: Two consecutive air samples fo r methyl bromide taken in the structure at least 1 hour apart show concentrations of methyl bromide are less than 1 ppm.

• Buffer zones may not include agricultural ar eas owned/operated by pe rsons other than the owner/operator of the application block, UNLESS,

1. The owner/operator of the application bloc k can ensure that the buffer zone will not overlap with a buffer zone from any adjacent property owners, except as provided for above, and

2. The owner/operator of the adjacent areas (i.e ., areas that are not unde r the control of the owner/operator of the application block) provide s written agreement to the applicator that they, their employees, and other persons will stay out of the buffer zone during the entire buffer zone period.59 • Buffer zones must not include roads and rights of way UNLESS, 1. The area is not occupied dur ing the buffer zone period, and 2. Entry by non-handlers is prohibi ted during the buffer zone period. 3. Applicators must comply with all local laws and regulations.

• For all other publicly owned and/or operated areas such as parks, side walks, walking paths, playgrounds, and athletic fields, buffer zones must not include these areas UNLESS, 1. The area is not occupied during the buffer zone period, 2. Entry by non-handlers is prohibite d during the buffer zone period, and 3. Written permission to include the public area in the buffer zone is granted by the appropriate state and/or local authorities responsible for management and operation of the

area. 4. Applicators must comply with all local laws and regulations.

• See the Posting section of this document for add itional requirements that may apply.

iii. Buffer Zone Reduction Credits

Requirements in the July 2008 RED

In preparing for the July 2008 RED, the Agen cy undertook a significant effort to evaluate available empirical data results, modeling, and sc ientific studies reporte d in the literature regarding the factors and control methods that may reduce emissions from soil fumigants. For details on the Agency’s analysis, please see the June 9, 2008 memo, “Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach,” 13 in the methyl bromide docket. The Agency also coordinated and led fora to discuss this issue at the 2006 and 2007 Methyl Bromide Alternatives Outreach (MBAO) Conferences with leading resear chers and other stakeholders. A general description of the

MBAO sessions can be found at http://mbao.org

.

Based on the Agency’s analysis of the da ta, the 2008 methyl bromide RED gave buffer zone reduction credits for high barrier tarps, soil s with high organic matter, and for soils with high clay content. The RED noted that changing current use practices or site conditions to utilize these credits may be a challenge. The Agency did determine, however, that in addition to reducing bystander risk and the size of buffer zones, the credit for high barrier tarps had the potential to decrease applicati on rates, increase efficacy, and re duce depletion of stratospheric ozone. The methyl bromide RED stated that buffer zone credits were additive but could not exceed 45 percent in total (i.e., 25 percent credit for listed tarps, 10 percent for > 3 percent organic content, and 10 percent for ≥ 27 percent clay content).

Comments on the July 2008 RED

Data were submitted since the July 2008 RED was issued that show greater reductions in emissions from the use of tarps and environmenta l conditions than what was determined in the July 2008 RED. In addition, the information submitted during the comment period indicated an

13 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach, June 9, 2008, DP Barcode: 30685760 additive effect in reducing emissions when multip le factors were combined. As a result, EPA has updated the buffer reduction credits and dete rmined that the 45% credit cap should be

increased to 80%. The new cred its for individual factors and th e cap on credits are detailed below. For details on the Agency’s analys is please see the May 14, 2009 memo; “Methyl Bromide (PC Code 053201), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Code s 039003 & 039002), MITC (PC Code 068103), DP

Barcode 362369, Updated Health Effects Division Recommendations For Good Agricultural

Practices and Associated Buffer Cred its”, in the methyl bromide docket.

 High barrier tarps

Credits in the July 2008 RED

The July 2008 RED determined that a 25% buffer credit for methyl bromide was appropriate for the following hi gh barrier tarps: Bromostop ® (1.38 mil), IPM Clear VIF (1.38 mil), and Eval/Mitsui (1.38 mil). The Agency be lieved that the actual reduction for tarps could be higher for certain conditions but that a 25% credit was appropriate based on uncertainties in

the available data.

Comments on the July 2008 RED

Since the RED was published, data have been submitted by the United States Department of Agriculture- Agricultural Research Service (U SDA-ARS) and other orga nizations that have shown a greater reduction in emissions for a larger number of tarps.

Credits for the Amended RED

From these data, the Agency has increased th e credit for certain tarps and increased the number of tarps that are given cr edits. The Agency has determined that the tarps tested can be divided into two groups based on re sults in the emissions tests me ntioned above. The first group includes the Canslit Heatstrip Silver and Canslit Metalized high-barrier tarps, which will be given a buffer credit of 30%. The second group includes the Olefinas Embossed VIF, Klerks VIF, Pliant Blockade, Bromostop® (1.38 mil), Eval/Mitsui TIF (1.38 mil), Hytiblock 7 Black (0.00125”), XL Black Blockade (0.00125”), Hytiba r (1.5 mil), and IPM Clear VIF (1.38 mil) high barrier tarps, which will be given a buffer credit of 60%.

It is important to note, however, that wh en considering the credits selected for highbarrier tarps for each fumigant, a number of i ssues must be taken into account, including: different tarp and fumigant combinations resu lt in different degrees of emission control; difficulty in determining the exact impact that hi gh-barrier tarps have on emissions in a full field flux study unless a co-located field is also monitore d in the same vicinity using a standard tarp;

and the lack of a standard fumi gant tarp testing procedure.

The Agency is currently validating a standard fumigant tarp testing procedure, developed at USDA, that measures the mass transfer coefficients of tarps. The purpose of this research is to develop a standardized method of testing and ra ting permeability of tarps based on mass transfer61 coefficients. From these results a permeability database and a standardized method for testing tarp permeability will be developed. The databa se will allow the Agency to evaluate potential buffer zone credits for additional tarps. In a ddition, the method can be used by other laboratories or tarp manufacturers to test the permeability of their tarps which could augment the number of tarps that receive buffer credits. For more details on USDA’s research, please refer to the Agency’s May 14, 2009 memo; “ Methyl Bromide (PC Code 053201 ), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), DP Barcode 362369, Updated Health Effects Division Recommendations For Good Agricultural Prac tices and Associated Buffer Credits ”.

The Agency has also co-funded a grant w ith USDA-ARS to conduct several flux studies in the southeastern U.S. These studies will pr ovide field data on the emission reduction potential

of certain barrier films to further enhance EP A’s understanding of the emission reduction value of various agricultural films, and possibly s upport additional buffer re duction credits and an affordable and reliable hybrid field/lab test to evaluate the many barrier films available to

growers.

 Soil conditions

Credits in the July 2008 RED

Like high barrier tarps, inhe rent soil conditions (e.g., orga nic matter and soil type) do have an impact on fumigant emissions. However, while the use of high ba rrier tarp is a choice an applicator can make, soil conditions are f actors essentially beyond a grower’s ability to change. Although a grower may not be able to manipulate organic matter or soil type, the Agency’s factors document indicates that soil co nditions can reduce fumigant emissions, and is offering credits for these conditions where they exist.

In the July 2008 RED, the Agency determin ed that a 10 percent buffer zone credit was appropriate if the application bl ock contains soil with organic ma tter of greater than 3 percent and/or for clay content of at least 27 percent. This was based on the review of literature available before the July 2008 RED and modeling with the CHAIN_2D model.

Comments on the July 2008 RED

Since the July 2008 RED, information from the CMTF has been submitted that has allowed the Agency to reevaluate credits for soil organic matter. Analysis of peak emissions of chloropicrin in five studies with very similar soil factors, except for organic matter, concluded that peak flux was reduced by approximately 50% fo r soils that were composed of approximately 1.5% organic matter compared to soils that we re composed of approximately 0.5% organic

matter.

Credits for the Amended RED

From these studies the Agency has determined that a credit can be given when applying methyl bromide in soils with certain levels of organic matter because the affect of organic matter62 in soil on emission would be relevant to other fu migants in addition to chloropicrin. This is based on modeling with CHAIN2D that shows the im pact of changes in organic content is not fumigant specific. A 10% credit will be given if methyl bromid e is applied in soils with an organic matter range of >1% - 2% ; a 20% credit for soils with an organic matter range of >2% - 3%; and a 30% credit for soils with an organic matter range of >3%. No credit will be given for soils with less than 1% organic matter.

The Agency has not received any new data th at would result in changes to the credit for soil type. Therefore, the credit for clay c ontent of greater than 27% will remain at 10%.

 Soil moisture

Credits in the July 2008 RED

The Agency’s document; “Factors Which Impact Soil Fumigant Emissions - Evaluation For Use In Soil Fumigant Buffer Zone Credit Factor Approach. DP Barcode D306857 (6/9/08)”, reviewed data examining the effects of proper soil moisture levels prior to application on fumigant emissions. Through review of these da ta it was determined that soil moisture is a critical parameter to reduce emissions for certain fumigants. However, in the July 2008 RED, the Agency did not provide a credit for soil moistu re because the Agency could not justify credits based on the available data. The Agency es tablished mandatory GAPs for soil moisture

conditions.

Comments on the July 2008 RED

The Agency received comments that buffer zone credits should be considered for soil moisture. For chloropicrin in particular, this fact was further supported by a chloropicrin field flux study (performed in Wasco, CA) recently submitted to the Agency by CMTF. This study was conducted at soil moisture field capacities in the 70-75% range. When this study was compared to previous studies done with the sa me application methods at much lower field capacities, in the 35-55% ra nge, and all other factors being rela tively equal, a 3-4 fold reduction

in emissions was observed.

Credits for the Amended RED

There are currently not sufficient data availabl e to provide a credit for field capacity for methyl bromide. However, the MBIP has co mmitted to conducting a number of new field flux studies in 2009/2010 for methyl bromide. Thes e studies may provide more information about the effect of soil moisture on methyl bromide em issions. Soil moisture credit/GAP decisions for methyl bromide may be revisited if n ecessary after review of these data.63  Potassium thiosulfate (KTS) and tarps

Credits in the July 2008 RED

EPA gave a 5% credit for applications of KTS. The KTS credit was based on a field study conducted by Dr. Husein Ajwa that indicated reductions in chloropicrin emissions when KTS is applied to the top of tarps after the fu migation. In the 2008 RED, if KTS was used in conjunction with one of the approved high barrie r tarps, the buffer zone could be reduced by 45%. If KTS was used with any other ta rp, the buffer zone reduction credit was 5%.

Comments on the July 2008 RED

The Agency received comments that buffer zone credits should be greater than 5% for KTS. In addition, results from Ajwa’s 2007 a nd 2008 research were publ ished by the California Strawberry Commission titled, “ Reduce Fumigant Emissions Using Impermeable Film and Water Seal in Strawberry Raised Beds. California Strawberry Co mmission Annual Production Research Report 2007-2008,” show that applying a water seal/KTS combination over the bedded tarped field resulted in a reduction in the peak flux of chloropicrin and the total mass of chloropicrin lost. The water seal/KTS combinati on resulted in an approximate reduction of peak flux of 36% and total mass loss was reduced by appr oximately 20% at Salinas when compared to the standard tarp water seal scenario. Th e water seal/KTS combination resulted in an approximate reduction of peak flux of 32% a nd total mass loss was reduced by approximately

10% at the Oxnard site when co mpared to the standard tarp s cenario. Because laboratory data looking at all halogenated fumigant s, including methyl bromide, me thyl iodide, chloropicrin, and 1,3-D (Wang et. al., 2000), support application of an emission reduction credit for KTS to these compounds, EPA has determined that a credit for KTS would also apply to methyl bromide.

Credits for the Amended RED

Based on the data, the Agency determined that a conservative credit of 15% is appropriate for KTS when applied with 1⁄4 to 1⁄2 inch of water ove r a tarp. When used with one of the high-barrier tarps listed above , the 15% credit will be added to the tarp credit. For example if KTS is applied over Bromostop® (1.38 mil) which qualifies for a 60% credit, the total credit

would be 75%. If KTS is used w ith another tarp, the credit is 15%.

 Water seals

Credits in the July 2008 RED

The July 2008 RED did not give credits for the applicati on of water seals.

Comments on the July 2008 RED

The Agency received comments that buffer zone credits should be considered for water seals. In addition, results from Ajwa’s 2008 research st udy published by the California Strawberry Commission titled; “ Reduce Fumigant Emissions Using Impermeable Film and64 Water Seal in Strawberry Raised Beds. California Strawberry Co mmission Annual Production Research Report 2007-2008,” show that that appl ying a water seal over the bedded tarped field resulted in a reduction in the peak flux of chlor opicrin and the total mass of chloropicrin lost. The water seal resulted in an approximate reduc tion of peak flux of 30% and total mass loss was reduced by approximately 39% at Salinas when compared to the standard tarp scenario.

Credits for the Amended RED

Based on the data, the Agency determined that a conservative credit of 15% is appropriate when 1⁄4 to 1⁄2 inch of water is applie d over a tarp. When used with one of the highbarrier tarps listed above, the 15% credit will be added to the tarp credit. For example when a water seal is applied over Bromostop® (1.38 mil) which qualifies for a 60% credit, the total

credit would be 75%. If a water seal is used with another ta rp, the credit is 15%.

 Soil temperature

A credit for soil temperature will currently not be given for methyl bromide based on its extremely high vapor pressure. As with soil moisture, a soil temperature credit for methyl bromide may be revisited if the MBIP studies discussed above provide more information around the effect of soil temperature on methyl bromide emissions. Based on review of available data with certain soil fumigants, increased soil te mperature typically corresponds to increased fumigant emissions. This is not a factor that growers can manipulat e in the field but is directed more at different regions in th e country where low soil temperat ures may be typical during the fumigation season.

 Buffer zone credit cap

Credits in the July 2008 RED

In the July 2008 RED, the Agency determined that credits would be additive. This meant, for example, that a 25% credit for a ta rp could be added to a 10 % credit for organic matter and to a 10% credit for clay content to ac hieve a total credit of 45%. The Agency placed a limit, or “credit cap,” of 45% on the total si ze of the credit allowed for methyl bromide.

Comments on the July 2008 RED

During the comment period, the Agency rece ived new data concerning a number of factors that impact fumigant emissions as well as a number of comments indicating that there should not be a cap on credits or that the cap shou ld be raised. Some s uggested that the 45% cap would be a disincentive to grow ers considering whether to adopt emission-reducing application

methods.

Credits for the Amended RED

Upon review of the new data and public comme nts, the Agency has decided to raise the credit cap to 80%. The Agency has reviewed the new studies to evaluate the extent to which the65 various factors that reduce emissions act independ ently, and has reconsidered the earlier studies. As a result of this evaluation, the Agency conclu des that credits be additive up to a cap of 80% for all fumigants. This revised credit cap is based on studies that show a greater-than-50%

reduction in emissions when two or more factors are combined. Further, EPA believes that increasing the credit cap to 80% will encourage a doption of emission reduction techniques, result in lower off-site fumigant concentrations, and wi ll allow for reduced application rates for various
tarps.

 Buffer zone credit example

Focusing on tomatoes grown in the Southeast as an example, the buffer zone distance for a 10 acre application block at a ra te of 120 lbs ai/A is 185 feet w ithout any credits (see last row in Table 9). If the grower uses Bromostop ® (1.38 mil) high barrier tarp, the buffer zone can be reduced by 60%. The resulting buffer zone distance for this case is 74 feet. If the organic matter in the application block is two percent and Bromostop ® (1.38 mil) high barrier tarp is used, the total credit would be 80% (60% for the tarp and 20% for orga nic content), and the resulting

buffer zone distance would be 37 feet.

 Other buffer zone credits considered

The Agency’s revised document; “Methyl Bromide (PC Code 053201), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Meta m Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), DP Barcode 362369, Updated Health Effects Division Recommendations for Good Agricultural Practice s and Associated Buffer Credits (5/14/09)”,

reviewed several other factors such as fi eld preparation and compaction. The Agency

determined that those factors could not be used to justify credits based on the available data. However, EPA has established mandatory GAPs for these conditions. See the GAP section of

this document for further discussion.

The Agency has used the best available data to estimate potential methyl bromide bystander risks and has both quantitatively and quali tatively evaluated the impact of potential emission control measures on bystander risk. Th e Agency recognizes that there is substantial research being conducted by stakeholders to furt her quantify emission reductions. The Agency will consider such data in future decisions if new data become available. Such data may also support the Agency’s decisions on additio nal emission credits in the future.

iv. Restriction for Schools and Ot her Difficult to Evacuate Sites

Certain types of sites are diffi cult to evacuate should an incide nt occur. EPA determined that additional measures to reduce the potential need to evacuate these types of sites were necessary to reduce risk of exposure to occupant s and address potential challenges associated with an accident. There were many comments on th is measure including: requests to delete this requirement; suggestions to reduce the size of the restricted area; a proposal to use a scalable approach to calculate the distance; requests to define and refine th e places included on this list so

that facilities such as research universities were excluded; sugges tions to shorten the duration of the requirement so applicators may be able to ta ke advantage of weekends to fumigate; questions66 about how to determine where these sites are located, and other suggestions to change the required measures.

Based on a review of the comments, the Agency has retained this mitigation measure to ensure the protection goals are still achieved and encourage lo wer-emission application methods. This mitigation measure has been refined such that compliance is more effective in achieving the protection goal. Modifications to this requ irement include: shortening the duration of the restriction so weekends may be used to fumigate near schools and day car e centers; clarifying the types of schools that are covered by this requi rement; removing the term “elder care facilities” from the list since many of the same facilities are included in the terms, “ assisted living facilities, nursing homes, and in-p atient clinics;” and reducing the restricted area from 1⁄4 mile to

1⁄8 mile for application blocks with less than 300 foot buffers. The 1⁄8 mile (660 feet) distance is more than twice the required buffer distance and remains protective of people who may be difficult to evacuate while reducing the potential challenges of complying with the restrictions for some users who may be fumigating in close proximity to these types of institutions. EPA has

determined that these modifications achieve the same protection goals as the 2008 RED but provide additional clarity and flexibility that will enhance users’ ability to practically and effectively comply with the requirements. EPA also believes that reducing the restricted area for blocks with buffers less than 300 feet will prov ide an incentive for some users to adopt loweremission application methods or practices. The revised measures are summarized below.

• “Difficult-to-evacuate” sites in clude schools (preschool to grade 12), state licensed day care centers, nursing homes, assisted liv ing facilities, hospitals, in-patient clinics, and prisons.

• No fumigant application with a buffer zone gr eater than 300 feet is permitted within 1⁄4 mile (1,320 feet) of the sites listed a bove unless the site is not occ upied during the application and the 36-hour period following the application.

• No fumigant application with a buffer zone of 300 feet or less is permitted within 1⁄8 mile (660 feet) of the sites listed above unless the si te is not occupied dur ing the application and the 36-hour period following th e start of application.

v. Posting

Posting is an effective means of informi ng workers and bystanders about areas where

certain hazards and restrictions exist. Current so il fumigant labels requ ire treated areas to be posted and handlers are required to wear specific PPE when they ar e in a treated area. For buffer zones to be effective risk mitigation, bystanders , including agricultural workers in nearby areas, need to be informed of the location and timing of the buffer zone to ensure they do not enter designated areas.

In addition to alerting bystanders, posting a buffer zone will help handlers determine where and when they are required to use PPE. As described in the Handle r section, handlers working in treated areas or buffers during the buffer zone period must use label-specified PPE and meet other requirements under the WPS. Ther efore, EPA has determined that to ensure the protectiveness of buffer zones for bystanders and handlers, the perimeter of the fumigant buffer zones must be posted.67 Comments received in response to the Ju ly 2008 RED decisions recommended some changes to the posting requirements to make them easier to understand and implement. Based on

EPA’s review and consideration of these comm ents, EPA has slightly revised the posting requirements and provided additional cl arification as described below.

EPA had included two exceptions for the buffe r zone posting requirement. The first exception did not require posting in situations where the land 300 feet fr om the edge of the

buffer was under the control of th e property operator. Based on comments that this measure was too complicated and confusing this exception has b een removed. There were also comments that the examples provided in the description of a phy sical barrier may lead to misinterpretation of the requirement. EPA agrees and believes that a performance standard is a more effective means of communicating the requirement. Therefore, to reduce the potential for confusion, the examples have been removed.

In the 2008 RED, signs were required to be posted at usual points of entry and likely routes of approach to buffer zones. If there were no usual points of en try or likely routes of approach, then posting was required in the corners of buffer zones, and between the corners, so signs could be viewed from one another. Ma ny comments expressed concern over the burden and potential confusion with the number of signs that may need to be posted and how many signs may need to be posted depending on the configura tion of the field. EPA ag rees that signs posted

in areas where there is low likelihood of work ers or others approaching or accessing the buffer provide little risk reduction, but can add substantially to the cha llenges of compliance. As a result, the Agency has revised the criteria for lo cation of signs since the areas that are of most concern are those where people ar e most likely to enter (e.g., ro ads, footpaths), and at likely routes of approach such as the perimeter of a buffer that faces a housing development.

Comments also indicated that the requiremen t to include certain application-specific information on the posted signs would make reuse of the signs more difficult and would also substantially increase the amount of time n eeded to prepare signs before posting. These comments stated that the primary purpose of signs is to communicate to bystanders the buffer zone locations. EPA generally agrees with these comments; therefor e certain applicationspecific details on the posted si gns, like the date and time of the fumigation and buffer zone restrictions, have also been reduced to allow the signs to be reused more easily.

Comments also stated that the posting example included in the 2008 RED was confusing. Since the posting restrictions have been simplif ied by removing the distance criteria, the example

has been removed from this document. Ther e were no substantive comments suggesting a change to the exception for posting multiple con tiguous blocks and no changes have been made

in this Amendment.

The revised posting requirements are listed belo w and have been incl uded in the revised

label table.68 Requirements

• Posting of a buffer zone is required unless there is a physical barrier that prevents bystander access to the buffer zone.

• Buffer zone posting signs must:

o Be placed at all usual points of entry and along likely routes of approach from areas where people not under the land operator’s control may approach the buffer zone.

o Some examples of points of entry incl ude, but are not limited to, roadways, sidewalks, paths, and bike trails.

o Some examples of likely routes of approach are the area between a buffer zone and a roadway, or the area between a buffe r zone and a housing development.

• Buffer zone posted signs must meet the following criteria:

o The printed side of the sign must face away from the treated area toward areas from which people could approach.

o Signs must remain legible during entire posting period and must meet the general

standards outlined in the WPS for text size and legibility (see 40 CFR §170.120).

o Signs must be posted before the applicati on begins and remain posted until the buffer zone period has expired.

o Signs must be removed within 3 days after the end of the buffer zone period.

o Registrants must provide ge neric buffer zone posting signs which meet the criteria above at points of sale for applicators to use. The Agency is requiring registrants to submit proposals for these materials through the data call-ins that will accompany this

RED.

Exception: If multiple contiguous blocks are fumigated within a 14-day period, the entire periphery of the contiguous bl ocks’ buffer zones may be posted. The signs must remain posted until the last buffer zone period expires and si gns may remain posted up to 3-days after the buffer zone period for the last block has expired.

Additional requirements for treated-area posting:

• The treated area posted signs must remain pos ted for no less than the duration of the entry restricted period after treatment.

• Treated area signs must be removed within 3 days after the end of the entry-restricted period.

• Signs must meet the general standards in the WPS for placement, text size, and location (40 CFR §170.120).69 Contents of Signs

The treated area sign (currently required for fumigants) must state the following: -- Skull and crossbones symbol

-- “DANGER/PELIGRO,” -- “Area under fumigation, DO NOT ENTER/NO ENTRE,”

-- “Methyl Bromide Fumigant in USE,” -- the date and time of fumigation, -- the date and time entry prohibition is lifted -- Name of this product, and -- name, address, and telephone number of the certified applicator in charge of the fumigation. The buffer zone sign must include the following: -- Do not walk sign

-- “DO NOT ENTER/NO ENTRE,” -- “Methyl Bromide OR [Name of product] Fumigant BUFFER ZONE,”

-- contact information for the certified applicator in charge of the fumigation

2) Occupational Risk Mitigation

i. Handler Definition

Based on stakeholder comments provided durin g the Phase 5 comment period, the July 2008 RED clarified fumigation tasks th at meet EPA’s definition of handler activities, as currently defined in the WPS a nd on fumigant labels. During the post-RED comment period the Agency received some comments from stakehol ders who were concerne d that the Agency was redefining handlers . It was not the Agency’s intention to change the current definition. As a result, the Agency has slightly changed the langu age from the July 2008 RED so it is clear that the Agency is just clarifying the existing defini tion and not writing a ne w definition. Below is the revised language.

The following activities are prohibited from be ing performed in the fumigant application block or surrounding buffer zone during the buffe r zone period by anyone other than persons who have been appropriately trained and equipped as handlers in accordance with the requirements in the WPS (40 CFR Part 170), from the start of the application until the entryrestricted period ends. Those activities include those persons:

• Participating in the application as supervis ors, loaders, drivers, tractor co-pilots, shovelers, cross ditchers, or as other direct a pplication participants (note: the application

starts when the fumigant is first in troduced into the soil and ends after the fumigant has stopped being delivered/dispensed to the soil);

• Using devices to take air samples to monitor fumigant air concentrations;

• Persons cleaning up fumigant spills (thi s does not include emergency personnel not associated with the fumigation application);

• Handling or disposing of fumigant containers;70 • Cleaning, handling, adjusting, or repairing the parts of fu migation equipment that may contain fumigant residues;

• Installing, repairing, or operating irrigation eq uipment in the fumigant application block or surrounding buffer zone dur ing the buffer zone period;

• Entering the application site or surrounding buffer zone during the buffer zone period to perform scouting or crop advi sing, or monitoring tasks;

• Installing, perforating (cutting, punching, slicing, poking), removing, repairing, or monitoring tarps:

o until 14 days after application is complete if tarps are not perforated and removed during those 14 days, or

o until tarp removal is complete if tarps are both perforated and removed less than 14 days after application; or

o until 48 hours after tarp perforation is comp lete if they will not be removed within 14 days after application.

In addition to the above, persons outside th e perimeter of the buffer zone who monitor fumigant air concentrations must also be trained and equipped as handlers in accordance with the requirements in the WPS (40 CFR Part 170).

ii. Handler Requirements

Currently, methyl bromide labels require that all handlers involved in a methyl bromide application must be under the supervision of a ce rtified applicator who may not necessarily be on-site. Since many incidents are caused by hum an error and equipment failure, EPA believes the presence of on-site trained pe rsonnel will help to reduce these risks. Therefore, to address these risks, the July 2008 RED required that a cer tified applicator maintain visual contact with any fumigant handler while the fu migant is being incorporated in to the soil. The Agency also stated that the certified applicator supervising the fumigation may also pe rform fumigant handler

tasks. During the post-RED comment period the Ag ency received many comments that stressed the difficulty of implementing a requirement that mandates certified applicators to maintain

visual contact with handlers. The commenters also indicated that for longer applications this requirement would be a significant burden. Othe r stakeholders stated that the Agency should modify the requirement to ensure that the certif ied applicator is on-site , while others commented EPA should require that all handle rs are certified applicators, wh ich would eliminate the need for direct handler supervision.

The Agency has considered the comments and has determined that the revisions outlined below accomplish the same handler-protection goals as the July 2008 RED mitigation while somewhat reducing the burden on users. The revised language is:

• For all applications, from the start of the application until the fumi gant has stopped being delivered/dispensed into the soil, i.e., after th e soil is sealed, the certified applicator must be at the fumigation site and must direc tly supervise all persons performing handling

activities.

• For fumigant handling activities that ta ke place after the fumigant has been delivered/dispensed into the soil until the entry restricted period expires, the certified71 applicator does not have to be on-site, but must have communicated in writing to the site owner/operator and handlers the information necessary to comply with the label and procedures described in the FMP (e.g., em ergency response plans and procedures).

The July 2008 RED also required that certif ied applicators complete a registrant administered methyl bromide trai ning program within the precedi ng 12 months before they apply a methyl bromide product. The Agency is still requiring that certified ap plicators complete the registrant training; however, the Agency is now requiring that certified ap plicators successfully complete the training every 36 months. Please see Soil Fumigation Training for Applicators and

Other Handlers section for further details.

In addition to the certified a pplicator supervision requirement , the Agency also required in the July 2008 RED that a minimum of two WPS trained handlers were on-site during all fumigation handling activities. This mitigati on measure addresses the concern that handlers could be overcome with fumigant vapors and be unable to leave the area while they are performing handler tasks. The Agency did re ceive some comments offering suggestions and others asking clarifying questions . The Agency has modified the language of the requirement for clarity; however, the mitigation measure itself is not changing. Commen ts related to this requirement are more fully addressed in the following document; SRRD’s Response to Post-RED Comments for the Soil Fumigants (May 27, 2009). The revised language for this mitigation

measure is as follows:

• For all fumigant handling tasks at least two handlers trained under the provisions of the WPS 40 CFR 170.230 must be present.

iii. Respiratory Protection

The Agency’s human health risk assessment indicates that inhalation risks exceed the Agency’s level of concern without respirator protection for many handler activities. The addendum to the April 10, 2007 risk assessment (DP 350818) contains additional risk characterization regarding the use of air monito ring and the role of chloropicrin’s warning properties for methyl bromide-chloropicrin pr oducts. The combination of air monitoring, chloropicrin warning properties and respiratory protection alo ng with the use of GAPs, FMPs, and other mitigation measures is expected to re duce methyl bromide inhalation risks to levels

that are below EPA’s level of concern.

To address acute, short-, and intermediate -term inhalation risks the July 2008 methyl bromide RED required air monitoring with colo rimetric tubes or other real-time monitoring devices every two hours as a means of determini ng when respirators may be needed. The tubes were required to have a sensitivity of at least 1 ppm for methyl bromide and 0.15 ppm for chloropicrin, which is the level that corresponds to early signs of exposure. If air samples indicated methyl bromide levels were above the Agency LOC (5 pp m), chloropicrin levels were above the Agency’s LOC (0.15 ppm), or if any ha ndler experienced sensor y irritation indicative of chloropicrin exposure, then handlers were required to wear air- purifying respirators.72 The Agency’s decision to require respiratory protection only if cer tain triggers were reached took into consideration current label requirements 14 , the identified risks, and stakeholder comments that respirators are not necessary beca use (1) chloropicrin’s warning properties are

sufficient to alert handlers if there are unsafe concentrati ons; (2) respirators inhibit

communication which could increase the risk of an accident; and (3) in warm weather respirators

can cause heat stress and other ailments.

During the post-RED comment period, the Agency received several comments on the Respiratory Protection section. For methyl bromide, co mments focused on the feasibility, reliability, and protectiv eness of using colorimetric tubes due to the current sensitivity and accuracy of the tubes, and the cost of the tube s. Other comments stat ed that handlers should have the option of ceasing the application until air concentrations of methyl bromide and chloropicrin are less than the ac tion level. Comments also sugge sted that tractor drivers do not need to be monitored if occupants are in an enclosed cab that meets certain specifications.

After reviewing the comments, the Agency is adding a stop work option for formulations of methyl bromide with 80 % or less methyl bromide where ha ndlers can leave the field and surrounding buffer zone in lieu of putting on a respir ator. If handlers rema in in the field, EPA has determined that respiratory protection requi rements are still needed to mitigate risks if concentrations reach a certain level. However, EPA is revising the required procedures for determining when respirators must be used due to technological limitations of the monitoring devices that are currently available for field use. The Agency is aware of several commercial systems for monitoring methyl bromide and chlo ropicrin including colo rimetric tubes from manufacturers including: Mathes on/Kitagawa, Sensidyne, and Dräg er. While these tubes have detection limits that are less than 0.15 ppm, the Agency has opted not to require monitoring with

colorimetric tubes or other devices as a tri gger to put on respirator y protection because EPA believes that these devices are not consistently reliable at fumigant concentrations at or just below 0.15 ppm, the Agency’s action level for chlo ropicrin. EPA’s action level is typically at the lower end of the range for whic h the devices are rated, in fact, some of these action levels are

at or near the device’s detection limits. Add itionally, colorimetric de vices provide snapshot

measurements of the environment in which individua ls are working. In conditions that are likely to be more static (e.g., monitoring an indoor fumiga tion such as a grain mill or warehouse) it is likely that minute to minute changes in conditions would not be as great as those anticipated for the more dynamic conditions characteristic of outdoor field fumigation where exposure

concentrations could shift because of weather ch anges or stratification in soil conditions across a single treated field. Furthermor e, commenters’ experience indicat es that handlers will likely experience early sensory irritation before the air samples show concentrations at or above the action level. As such, the Agen cy does not believe that initial monitoring to trigger the use of respirators significantly reduces handler risks. In addition EPA is aware that monitoring with these devices adds significant co sts to fumigations, please see ( Analysis of Soil Fumigant Risk Management Requirements using Geographic Inform ation Systems: Case Studies based on a Forest Seedling Nursery (DP Barcode 363546) ) for more details. EPA is also concerned that monitoring with devices that are not reliable could cause handlers to believe that concentrations

14 Current methyl bromide labels require respirators when the air concentration exceeds 5 ppm for methyl bromide and 0.1 ppm for chloropicrin but do not require that any measurements be taken.73 are below the action level despite other indications such as eye irritation. As a result, the Agency is removing the initial monitoring requirement.

EPA does believe, however, that monitoring de vices that are currently available will generally be reliable at higher co ncentrations of chloropicrin and that there is high value in air monitoring using currently available devices in certain situations. As a result, EPA is maintaining the monitoring requirement once us e of respirators has been triggered and respirators are being worn. This will enable handle rs to detect concentrations that would exceed the upper working limit of the respirator. Additi onally monitoring will still be required to help

enable handlers to determine if concentrations ha ve decreased and whether it is safe to either remove respirators or to resume the applic ation if the fumigator has opted to cease the application rather than have handlers wear respirators.

The Agency is modifying the procedures for respiratory protection because of technological limitations of current ly available devices. However, the Agency does believe that quantitative air monitoring would enhance worker safety if the appropriate technology were available. Some equipment manufacturers have indicated interest in developing devices that

would be more functional and reliable for field fumigation applic ations (e.g., badge-type monitors). EPA encourages such efforts and plans to stay abreast of developments and improvements in monitoring devices and will consider this issue again in Registration Review or

sooner should such monitors become available in the short term.

Respiratory Requirements

Based on the Agency’s review of the comments as described above in the Respiratory

Protection section, EPA has amended the requirements that trigger the need for respiratory protection. In addition to the revised respiratory protection re quirements below, the Agency believes that GAPs, FMPs, and other mitigati on measures will reduce inhalation risks to

concentrations below the EPA’s level of concern. There are two regimens which differ based on

the concentration of chlor opicrin that is formulated with met hyl bromide. Certain criteria apply if applications involve le ss than or equal to 80 percent methyl bromide and other criteria apply if applications involve greater than 80 percent methyl bromide relative to the amounts of chloropicrin used. See the Amended Reregistration Eligibil ity Decision for Chloropicrin for detailed information regarding the chloropicrin action levels.

As the amount and percentage of chloropicrin applied increases, ther e is a greater likelihood handlers will immediately experien ce sensory irritation if exposed to air concentrations above the Agency’s level of concern. Respiratory protec tion is required whenever handlers experience sensory irritation.

The EPA assumes that air-purifying respirator s have a protection factor of between 10 and 50 depending on whether a half-face or full-face re spirator is used. The current upper limit of air-purifying respirator cartridges available for met hyl bromide is 5 ppm (see respirator cartridges used with air purifying respirators section below for further details). A self-contained breathing apparatus (SCBA) has a protection factor of 1,000 but must only be used for brief

durations to take actions to reduce air concentration levels or in case of an emergency.74 The following procedures must be followed for all formulations with 80 % or less methyl bromide :

• If at any time any handler experiences sens ory irritation (tearing, bur ning of the eyes or nose) then either:

o An air-purifying respirator (APR) must be worn by all handlers who remain in the application block and surrounding buffer zone, or

o Operations must cease and handlers not w earing respiratory protection must leave the application block and surrounding buffer zone.

• Handlers can remove respirators or resume ope rations if two consecu tive breathing-zone samples taken at the handling site at least 15 minutes apart show that levels of methyl bromide have decreased to less than 1 ppm and levels of chloropicrin have decreased to less than 0.15 ppm, provided that handlers do not experience sensory irritation. Samples

must be taken where the irr itation was first experienced.

• When respirators are worn, air monitoring sa mples must be collected at least every 2 hours in the breathing zone of a handler pe rforming a representative handling task.

• If at any time: (1) a handler experiences any sensory irritation when wearing a respirator, or (2) a methyl bromide air sample is greater than 5 ppm or a chloro picrin air sample is greater than or equal to 1.5 ppm, then all handler activities must cease and handlers must be removed from the application block and surrounding buffer zone. If operations cease the emergency plan detailed in the FMP must be implemented.

• Handlers can resume work activities without respiratory protection if two consecutive breathing-zone samples taken at the handling site at least 15 minutes ap art show levels of methyl bromide have decreased to 1 ppm and levels of chloropicrin have decreased to less than 0.15 ppm, provided that handl ers do not experience sensory irritation.

• During the collection of air samples an air- purifying respirator must be worn by the handler taking the air samples. Samples must be taken where the irritation is first experienced.

• Work activities may resume if the foll owing conditions exist provided that the appropriate respirator y protection is worn:

o two consecutive breathing zone samples fo r methyl bromide taken at the handling site at least 15 minutes apar t must be less than 5 ppm,

o two consecutive breathing zone samples for chloropicrin taken at the handling site at least 15 minutes apart mu st be less than 1.5 ppm,

o handlers do not experience sensory ir ritation while wearing the APR,

o cartridges have been changed, and

o during the collection of air samples an air-purifying resp irator must be worn by the handler taking the air samples. Sample s must be taken where the irritation is first experienced.

The following procedures must be followed for all formulations with more than 80 % methyl bromide :

If the fumigant applied contains greate r than 80 percent methyl bromide (e.g., 98:2 formulations), air purifying respirators must be worn during all handle r tasks and the following75 air monitoring procedures must be followed to ensure that the upper protection limit of the respirator plus respirator cartr idge is not exceeded (i.e., 5 pp m for methyl bromide and 1.5 ppm for chloropicrin):

• Air monitoring samples for methyl bromide and ch loropicrin must be collected at least every hour in the breathing zone of a handler performing a representative handling task.

• If at any time (1) a handler experiences any se nsory irritation while w earing a respirator, or (2) any air sample is greater than or equal to 5 ppm for methyl bromide, or (3) any air sample is greater than or equal to 1.5 ppm for chloropi crin, then all handler act ivities must cease and handlers must be removed from the applic ation block and surrounding buffer zone until

corrective action has been taken.

• In order to resume work activities:

° Two consecutive air samples for methyl bromid e and chloropicrin taken in the treatment area at least 15 minutes apart must be less th an 5 ppm for methyl bromide and less than 1.5 ppm for chloropicrin.

° During the collection of samples an air purifyi ng respirator must be worn by the handler taking air samples.

 Hot gas tarped applications

During hot gas applications in greenhouses , the fumigant must be introduced from outside of the greenhouse. For outdoor hot gas applications, the fumigant must be introduced from outside of the application block. Once the fumigation has started, if entry into the greenhouse enclosure or the outdoo r treatment area is required to perform a function necessary for the application, a SCBA must be worn. Handlers must wear SCBA to reenter the greenhouse/treated areas for a minimum of 48 hrs after the fumigant has stopped being delivered/dispensed to the soil.

 Deep probe injection

No exposure data were provide d for using handheld equipment to apply methyl bromide. This method of application is done primarily with 98:2 formulations. The methyl bromide risk assessment indicates that the fumigation of tree ho les was one of the factors identified in the more serious incident cases. Since air purifying respirators may only be used for concentrations up to 5 ppm, EPA is requiring that SCBA be worn when applying methyl bromide with handheld equipment.

Figure A provides an illustration of the requirements when handl ers cease operations. Figure B provides an illustration of the requirements when handlers put on a respirator.76 Figure A. Requirements for when handlers should cease operations.

Handler activity begins. Handlers are NOT wearing APRs.

Sensory Irritation

Certified applicator in charge decides to cease operations rather than continue with respirators.

Handlers must stop work and leave application block and buffer

zone.

If 2 samples taken at least 15 minutes apart (by a handler wearing an APR)

show concentrations are less than 1.0 ppm (methyl bromide) and less than 0.15 ppm (chloropicrin) and NO sensory

irritation

, then

Resume operations.77 Figure B. Requirements for when handlers should put on a respirator.

Handler activity begins. Handlers are NOT wearing APRs.

Sensory Irritation

Certified applicator in charge decides to continue operations.

All handlers in the application block and buffer zone put on an APR. Air monitoring program

b egins.

Feel irritation through APR, OR monitoring indicates concentrations above 5 ppm (methyl bromide) and

1.5 ppm ( chloro p icrin )

.

Handlers must stop work and leave application block and buffer

zone.

If, 2 consecutive samples taken at least 15 minutes apart, by a handler wearing an APR are above 1 ppm (methyl bromide) and 0.15 ppm (chloropicrin) BUT below 5 ppm (methyl bromide) and 1.5 ppm (chloropicrin), no sensory irritation is felt, and the cartridge is

chan g ed

, then If 2 consecutive samples taken at least 15 minutes apart, by a handler wearing an APR, are less than 1 ppm (methyl bromide) and 0.15 ppm (chloropicrin) and NO

senso r y irritation

, then

Resume operations wearing an APR. Air monitoring continues. Resume operations without an APR or remove respirator.78 Respiratory Protection Equipment

The purpose of this section in the July 2008 RED was to establish general conditions and requirements for respiratory protection equipment. Below is a summary of what was included in the July 2008 RED.

• The Agency required half-face respirators with organic vapor cartridges when respirators are necessary. In the RED EPA noted that although currently there are no APR cartridges certified by the Mine Safety and Health Administration-National Institute for Occupational Safety and Health (MSHA-NIOS H) for protection against chloropicrin specifically, NIOSH/OSHA does recommend resp irators with organi c vapor cartridges for chloropicrin use. EPA also stated that it would consider other APR-cartridge combinations, provided written certification of their efficacy against chloropicrin is submitted to the Agency.

• EPA assumes half-face respirators have a protection factor of 10, therefore these respirators are protective up to methyl br omide concentrations of 5 ppm; and if concentrations exceed 5 ppm operations must cease.

• SCBA has a protection factor of 1,000, but, due to practical limitations, SCBA should only be used for short durations.

EPA is making revisions to the requireme nts above taking into consideration the

comments and the revisions to the Respiratory Requirements section. Since the Agency is relying on the warning properties of chloropicrin to indicate wh en an air-purifying respirator must be worn, the Agency does not believe that a half-face respirator would be appropriate because the handler would still experience eye i rritation if a half-face respirator is worn. Therefore, EPA has determined that when handl ers opt to continue operations when the action level for respiratory protection is triggered (i.e., sensory irritation is recognized), handlers must wear a full-face respirator.

The Agency received additional comments regarding the cartridge recommendations, SCBA use, and the respirator protection factor. EPA is providing a clarif ication to address the concerns brought up in the comments. This was th e Agency’s intention in the July 2008 RED. Others remarked that use of goggles should be prohibited. The Agency agrees with the comments regarding goggles and it was not EPA’s in tention to imply a cha nge in current label language with regard to closed goggles in the July 2008 RED. For more detailed responses on the above comments please see Methyl Bromide, 1,3-Dichloropr opene, Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effe cts Division (HED) Component of Agency Response To Comments On 2008 Reregi stration Eligibility Documents (Date May 14, 2009).

As a result of the changes discussed above the amended requirements are listed below:

• The Agency is requiring full-face respirat ors with organic-vapor cartridges when respirators are necessary.

• If methyl bromide concentrations exceed 5 ppm operations must cease.79 Tarp Repair

The July 2008 RED required handlers to w ear APRs if they perform tarp repair operations before the entry-restricted period ha s ended. The requirement s were different from other handling activities because th e duration of tarp repair activi ties was believed to be shorter than other handling tasks and th erefore tarp repair activities would not trigger the initial monitoring requirement. Upon consideration of comments the Agency received on this requirement, which are a ddressed in detail in Methyl Bromide, 1,3-Dichloropropene, Chloropicrin, Dazomet, Metam Sodium/Potassi um, MITC: Health Effects Division (HED) Component of Agency Response To Comments On 2008 Reregistration E ligibility Documents (Date May 14, 2009)., EPA has determined that resp iratory protection for ta rp repair activities should be handled consistently w ith other handler activit ies, i.e., handlers re pairing tarps are not required to wear respirators unless sensory irri tation is experienced. Additionally, the Agency believes that tarp repair like other handling activities described above would benefit from the development of sensitive monitoring devices to reliably inform handlers if and when

concentrations are above the action level for re spiratory protection. EPA will reevaluate this measure during Registration Review or sooner if such devices ar e available in the short term.

Respirator fit testing, trai ning, and medical qualification

To ensure that respirators are mitigating inhalation risk, the July 2008 RED respirator requirements included fit testing, respirator trai ning, and an annual medical evaluation. Without these requirements, it is unclear whether the redu ction in inhalation expos ure that is assumed by the use of respirators will be achieved.

During the comment period the Agency receiv ed a variety of comments ranging from full support of the requirement, to comments about th e cost and time burden associated with fittesting, training, and medical exam s. The Agency also received several comments regarding the details of this requirement, for example, so me commenters questioned who conducts the fittesting and medical exam and what the medical exam entails. Detailed responses to these comments are included in the following document, SRRD’s Response to Post-RED Comments for the Soil Fumigants (May 27, 2009).

While EPA recognizes that there is a cost a ssociated with the f it-testing, training, and medical exam requirements, the Agency still beli eves these are necessary to ensure respirators perform as intended. Also note th at, in response to suggestions from several fumigators, EPA is now allowing fumigators the option to cease operations and have handlers leave the application block and surrounding buffer zone in lieu of w earing a respirator and continuing fumigation activities. Only handlers who will wear a respir ator must be fit-tested, trained, and medically examined. For fumigators who exercise the cease operations option, the Agency believes that

this revision will reduce the cost associated w ith the respirator requirement, while maintaining the same level of protection fo r the handlers that wear respir ators. The following revised language takes into account the new cease operations option and must be added to product

labels:80 “Employers must also ensure that an y handler who uses a respirator is:

• Fit-tested and fit-checked us ing a program that conforms to OSHA’s requirements (see 29CFR Part 1910.134)

• Trained using a program that confirms to OSHA’s requirements (see 29CFR Part 1910.134)

• Examined by a qualified medical practitioner to ensure physical ability to safely wear the style of respirator to be wo rn. A qualified medical practitio ner is a physician or other licensed health care professional (PLHCP) who will evaluate the ability of a worker to wear a respirator. The initial evaluation consists of a questionnaire that asks about medical conditions (such as a heart condition) that w ould be problematic for respirator use. If concerns are identified, then additional evaluations, such as a physical exam, might be necessary. The initial evaluation must be done before respirator use begins. Handlers must be reexamined by a qualified medical practitioner at least annually or if their health status or respirator style or us e-conditions change.”

Respirator cartridges used w ith air purifying respirators

Currently, there are no air-purifying respirator cartridges certified by the Mine Safety and

Health Administration-National Institute for O ccupational Safety and Health (MSHA-NIOSH) for protection against methyl brom ide. While NIOSH does not have a test procedure to certify air-purifying filters for protection against me thyl bromide, the 3M 60928 is a NIOSH-approved combination organic vapor/acid gas chemical car tridge/P100 particulate fi lter, this combination cartridge is recommended by 3M for use agains t radioiodine or methyl bromide at ambient concentrations up to 5 ppm and for not more than one shift. For further details on the 3M’s recommendations, see February 2001 “3M Tech nical Data Bulletin #146 Use Recommendations for 3M 60928 Cartridge/Filter” 15 . The EPA has decided that the use of 3M air purifying respirators (APRs) equipped with 3M Mode l 60928 Organic Vapor/Acid Gas/P100 cartridges may be used for concentrations up to 5 ppm, and not for more than one work shift per day. Respirator APR-cartridge combinations for othe r manufacturers will also be considered by the Agency, provided written certification of their e fficiency against methyl bromide is provided.

The maximum chloropicrin air concentration that handlers may be exposed to without respiratory protection is 0.15 ppm. When wearing an air purify ing respirator with organic vapor cartridges, the maximum chloropicrin air concentr ation allowed is 1.5 ppm. For further details regarding chloropicrin respiratory protection requirem ents, see the chloropicrin RED (chloropicrin docket EPA-HQ-OPP-2007-0350).

15 http://multimedia.mmm.com/mws/mediawebserver.dyn?6666660Zjcf6lVs6EVs666BraCOrrrrQ-81 Respirator Availability

The July 2008 RED required that every handler had the appropriate respiratory protection equipment available. This requirement has been slightly modified as a result of the cease operations option. The new language requires that the handler’s employer must confirm and document in the FMP that an air-p urifying respirator a nd cartridge is immedi ately available for each handler who will wear one. The Agency is requiring that at minimum two handlers have the appropriate respirator and cartridges availabl e and that these handlers are fit-tested, trained, and medically examined.

Air-Rescue Device Availability

EPA slightly altered the air-rescue device availability language from the July 2008 RED

to include that the device is not only on-site, but also ready to us e. This change was made to clarify the Agency’s previous requirement, and the following language must be added to product

labels:

• The fumigation handler employe r must confirm and document in the FMP that at least one air rescue device (e.g., SCBA) is on-si te and is ready for use in case of an

emergency.

iv. Tarp Perforation and Removal

The Agency’s risk assessment indicates that there is a risk concern for handlers during the perforation (cutting, poking, punchi ng, or slicing) and removal of tarps, and notes potential for increased risk when high ba rrier tarps are used. To addr ess these risks EPA required the following mitigation in the July 2008 RED:

• Tarps cannot be perforated until a minimum of 5 days (120 hours) after fumigation was complete.

• Tarps cannot be removed until 24 hours after tarp perforation is complete.

• If tarps are not removed after perforati on, planting cannot start until 48 hours after perforation is complete.

• If tarps are left intact for at least 14 days after the fumigation is complete then planting can take place as tarps are being perforated.

• Broadcast tarps could be removed before 5 days if adverse weather compromised the integrity of the tarp provided that at l east 48 hours had passed since the fumigation was completed, the buffer zone was extended until 24 hours after the tarp removal was complete, and untreated areas in the applicati on block are not treated for at least 24 hours after tarp removal is complete.

• Tarp perforation must be done using mechanical methods.

• Each broadcast tarp panel must be perforated using a lengthwise cut.

During the post-RED comment period the Agency received comments on the tarp perforation and removal requirements. In par ticular the Agency received comments on: the adequacy of the 5 day requirement for high barrier tarps to protect workers; the feasibility of leaving tarps down for 5 days in areas that use seepage irri gation for flood prevention; the difficulty implementing the 24 hour period between tarp perforation and removal; and concerns82 regarding the weather condition exceptions, mechanical perforation, and broadcast panel perforation.

There is some uncertainty regarding potential risks if high barrier tarps are perforated after 5 days. This is because worker exposure da ta used in the risk assessments are generally based on what has been the industry standard tarping technology, i.e ., low or high density polyethylene tarps, typically wi th higher application rates and no significant emphasis on using

the GAPs as defined in the RED. Data indicate th at high barrier tarps are effective measures to reduce fumigant emissions (See Factors Which Impact Soil Fumi gant Emissions - Evaluation For Use In Soil Fumigant Buffe r Zone Credit Factor Approach . DP Barcode D306857 (6/9/08)

and Methyl Bromide (PC Code 053 201), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (P C Codes 039003 & 039002), MITC (PC Code 068103), DP Barcode 362369, Updated Health E ffects Division Recommendations for Good Agricultural Practices and Associated Buffer Credits (5/14/09)). While th is reduction decreases the risk to bystanders, it could increase the risk to handlers perf orating or removing tarps because more fumigant could be trapped between the soil surface and the tarp—currently California Department of Pesticide Regula tion (CDPR) prohibits the use of methyl bromide with certain high barrier tarps due to worker concerns.

Based on CDPR’s prohibition and stakeholde r’s comments, EPA considered requiring a longer interval such as 10 days before allowing high barrier tarps to be perforated. However, EPA was concerned that adding such a requirement could discourage fumigators from using high barrier tarps which potentially allow for lowe r application rates a nd reduce bystander risk associated with offgassing. New studies curr ently underway which invol ve use of high barrier tarps may enable EPA to refine estimates of handl er risk in the future. EPA will consider these data during Registration Revi ew, or sooner as the information becomes available.

Since the Agency has designed the mitigation measures to work together and believes

that measures to address handler risks are likely to protect thes e handlers when the reduced rates are considered in conjunction wi th other measures such as respiratory protection, GAPs, FMPs, and training, EPA is not increasing the number of days before high barrier tarps can be perforated.

In the comment period EPA learned from stake holders that leaving the tarps on for 5 days would pose problems for current flood prevention activities. According to the comment, for flood prevention fields must be properly drained. To ensure pr oper drainage, tarps must be manually cut, soil removed, and then tarps retu cked. The Agency understands that the 5 day requirement before tarps can be perforated and the restriction on manual tarp perforation would be difficult for this situation and the Agency has added language to ad dress this situation.

During earlier comment periods EPA heard from various stake holders that windy conditions sometimes caused tarps to blow off fields and create ot her hazards, e.g., to motorists on nearby roadways. As a result, in the July 2008 RED the Agency provided an exception to allow tarps to be removed after 48 hours unde r adverse weather conditions. During the postRED comment period EPA received comments that th is exception did not fully address the issue since the mitigation required waiting a minimu m of 48 hours after fumigation but tarps could83 blow of fields sooner than that. Commenters al so said waiting 24 hours be tween tarp perforation and removal and the requirement to cut every broad cast tarp panel added to the potential for tarps

to blow off fields and create other hazards: once tarps are cu t they are prone to blowing off when windy conditions occur. To decrease the potential of tarps blow ing off commenters also suggested that the Agency add flexibility to th e 24 hour requirement by giving tarp removers the option to remove tarps 2 hours af ter tarp perforation if monito ring indicated levels below the Agency’s LOC. Commenters also suggested that every 1-3 tarp panels should be cut based on the professional judgment of the handler.

Upon review of the comments the Agency agre es that the mitigation should be revised somewhat to allow for tarp removal at any time if the tarp is no longer performing its intended function and it is creating other types of risk. Therefore, EPA is revising the exception outlined

in the RED to address these comments. EPA not es that handlers undertaking these tasks must follow the respiratory protecti on procedures detailed in the Respiratory Protection section; this change still provides handler pr otection while reducing the unin tended consequences of tarps creating other hazards.

The Agency believes cutting every panel allows the fumigant trapped beneath each panel to offgas before the tarp is removed. If each pane l is not cut, it is not likely that necessary offgassing can take place to reduce risks to handlers removing tarps. The Agency understands that the main concern for not cutting every panel is du e to the potential for tarps to blow off and has

determined that this concern is best addre ssed by modifying the 24-hour wait period. Tarps may be removed 2 hours after tarp perforation is co mplete provided that ta rp removers follow the procedures set forth in the Respiratory Protection section; therefore the risk to handlers will not

increase as a result of this modification.

The Agency received comments supporting the requirement for mechanical tarp perforation, though other commenters stated that for some situati ons mechanical cutting is not feasible. Examples cited included at the start of a row when a mechanical device such as an ATV will be used to cut the tarps on the fiel d, during flood prevention activities and for small fields. Based on comments, EPA believes these ar e necessary short-durati on activities. Provided the respiratory protection procedures for ha ndlers are followed, thes e activities would not increase the risk to handlers. With regard to small fields where mechanical cutting is not feasible, the Agency considered the duration of the activity and the respiratory protection considerations and will permit manual perforation only for application blocks that are 1 acre or

less in size.

As a result of the Agency’s review a nd consideration of comments, the following summarizes the revised mitigation measures to a ddress inhalation risks from tarp perforation and

removal activities:

• As described in the Handler Definition section (link the document) tarp perforators and removers are considered handlers for a specifi ed duration and every handler must adhere to the respiratory protection procedures outlined in the Respiratory Protection section.

• Tarps must not be perforated until a minimu m of 5 days (120 hours) have elapsed after the fumigant injection into the soil is comp lete (e.g., after injec tion of the fumigant product and tarps have been laid or after drip lines have been purged and tarps have been84 laid), unless a weather conditi on exists which necessitates th e need for early perforation or removal. (See Early Tarp Removal for Broadcast Applications Only and Early Tarp Perforation for Flood Prevention Activities sections below.)

• If tarps will be removed before planting, ta rp removal must not be gin until at least 2 hours after tarp perforation is complete and two air monitoring samples are less than 1 ppm methyl bromide. (If two air monito ring samples have methyl bromide levels between 1 ppm and 5 ppm, then respirator prot ection is required befo re tarp removal can begin.)

• If tarps will not be removed before planti ng, planting or transpla nting must not begin

until at least 48 hours after the ta rp perforation is complete.

• If tarps are left intact for a minimum of 14 da ys after fumigant injection into the soil is complete, planting or transplanting may take place while the tarps are being perforated.

• Each tarp panel used for broadcas t fumigation must be perforated.

• Tarps used for fumigations may be perforated manually ONLY for the following

situations:

o At the beginning of each row when a coulter blade (or other device which performs similarly) is used on a mo torized vehicle such as an ATV.

o In fields that are 1 acre or less.

o During flood prevention activities.

• In all other instances tarps mu st be perforated (cut, punche d, poked, or sliced) only by

mechanical methods.

• Tarp perforation for broadcast fumigations must be completed before noon.

• For broadcast fumigations tarps must not be pe rforated if rainfall is expected within 12

hours.

• Early Tarp Removal for Broadcast Applications Only:

o Tarps may be removed before the required 5 days (120 hours) if adverse weather conditions have compromised the integr ity of the tarp, provided that the compromised tarp poses a safety hazard. Adverse weather includes high wind, hail, or storms that blow tarps off the fi eld and create a hazard, e.g., tarps blowing into power lines and onto roads. A compromised tarp is a tarp that due to an adverse weather condition is no longer performing its intended function and is creating a hazard.

o If tarps are removed before the require d 5 days have elapsed due to adverse weather, the events must be documented in the post fumigation summary section

of the FMP.

• Early Tarp Perforation for Flood Prevention Activities

o Tarp perforation is allowed before the 5 days (120 hours) have elapsed.

o Tarps must be immediately retucked and packed after soil removal.

v. Entry Prohibitions

Current methyl bromide labels allow reentry to the treated field by workers 48 hours after application. The methyl bromide risk assessmen t indicates that risks exceed EPA’s LOC for workers entering fields after 48 hours. However, the risk assessment indicates that extending this period decreases workers’ risks. In addition, stakeholde r comments prior to the July 200885 RED indicated that non-handler entry to perfor m post-application (i.e., non-handler) tasks is generally not needed for at le ast 10 to 14 days following the completion of the application.

Due to the volatile nature of methyl bromid e and the potential for wo rker exposure, in the July 2008 RED the Agency restricted entry into the treated area by anyone other than a properly trained and protected handler. This restriction differs from Restrict ed Entry Intervals (REIs) that are currently required for most conventional pesticides where de rmal exposure is the primary pathway of exposure. Under the WPS, exceptions allow certain tasks to take place before the REI has expired as long as dermal contact with treated surfaces will be limited; however for fumigants where inhalation exposure is the primary ri sk concern, entry to a treated area is further

restricted.

During the post-RED comment period the Agency received some comments that expressed concern that extending the entry-restricted period for fumigants could prevent certain important activities from taki ng place, contrary to the comm ents received during earlier comment periods. Based on discussions with st akeholders, EPA’s review of public comments,

and the risks identified in EPA’s risk assessmen t, EPA does not believe any change to the entryrestricted period is warranted. EPA’s review of comments indicates that extending the entryrestricted period to protect workers will not have a substantial impact on agricultural operations. Therefore, the Agency is not making any changes to this section of the July 2008 RED. The mitigation is listed below.

EPA believes that risks will not exceed th e Agency’s LOC provided entry (including early entry that would otherwise be permitted under the WPS) by any person – other than a correctly trained and PPE-equippe d handler who is performing a handling task – is prohibited from the start of the application until:

• 5 days (120 hours) after applic ation has ended for untarped a pplications (see Figure C),

or

• after tarps are perforat ed and removed if tarp removal is completed less than 14 days after application (see Figure D), or

• 48 hours after tarps are perforat ed if they will not be re moved prior to planting (see Figure E), or

• 5 days (120 hours) after applica tion is complete if tarps are not perforated and removed until 14 days after the application is complete (see Figure F).

Figures C, D, E, and F provide illustrations of tarp perforation/removal and entry prohibition mitigation required for various methyl bromide applications. The intervals depicted are the

minimum that must be followed.86 Figure C. Untarped Applications

48 hours

Buffer Zone

Period Begins

Entry
Restricted

Period Begins Application

Ends Buffer Zone

Period Ends

Entry
Restricted

Period Ends Application Begins 5 da y s ( 120 hours )87Figure D. Tarp Broadcast Applications (tarps removed before planting)TarpPerforationBeginsBuffer ZonePeriodBeginsEntryRestrictedPeriodBeginsApplicationEndsBuffer ZonePeriod EndsTarpPerforationEndsEntryRestrictedPeriod EndsTarpRemovalBeginsTarpRemovalEndsApplicationBegins2 hours48 hours5 days (120 hours)88Figure E. Tarp Bed Applications(Tarps not removed before planting)ApplicationBeginsBuffer ZonePeriodBeginsEntryRestrictedPeriodBeginsApplicationEndsBuffer ZonePeriod EndsTarpPerforationBeginsTarpPerforationEndsPlanting CanBeginEntryRestrictedPeriod Ends48 hours48 hours5 days (120 hours)89 Figure F. Tarp Bed/Broadcast Applications (Tarps are not perforated until 14 days after application)

3) Other mitigation

Below are requirements for FMPs, GAPs, em ergency preparedness and response, notice to state lead agencies, training, and community outreach that the Ag ency concludes are needed to mitigate risks and the likelihood of incidents caused by human error, equipment failure, and weather events such as temperature inversions.

i. Good Agricultural Practices (GAPs)

Since the application methods and work practices of fumiga tors have direct impacts on the amount of fumigant applied and emitted, the Agency determined that labeling should require proven practices that will reduce risks to handlers, bystanders, and the environment. Registrants, applicators, growers, and other stakeholders have consistently reported to the Agency that GAPs are a key mitigation measure to reduce the amount of fumigants applied and fumigant emissions.

The purpose of this section in the July 2008 RED wa s to specify GAPs that were required for soil applications of methyl bromide. The practices specified cont ribute to reducing emissions and thereby are expected to reduce poten tial for worker and bystander exposures.

Application Begins

Buffer Zone

Period Begins

Entry
Restricted

Period Begins Application

Ends Buffer Zone

Period Ends

Entry
Restricted

Period Ends

Tarp
Perforation & Planting 5 days (120 hours)

48 hours

14 days90 The Agency received comments regarding the GAPs outlined in the July 2008 RED. These comments addressed a range of topics:

• making the GAPs voluntary rather than mandatory label requirements,

• buffer zone credits associated with GAP implementation,

• wind speed requirements and the desc ription of inversion conditions,

• crop residue requirements,

• application equipment requirements,

• soil moisture and temperature requirements,

• flexibility in the event that new GAPs are developed,

• enforceability of GAPs, and

• university research exemptions.

These comments are addressed in detail in the Special Review and Reregistration Division’s response to comments document. Ba sed on the comments, the Agency has revised

some of the GAPs.

The GAPs outlined in the RED, and this RED amendment, have been shown to reduce emissions and bystander exposures and will continue to be mandatory label requirements. Buffer zone credits have been reanaly zed and additional credits have been calculated for various GAPs depending on the soil fumigant used (see buffer zone credit section).

The Agency has clarified the language regarding inversions and wind speed requirements. The Agency agrees that erosion co ntrol is an important co nsideration. However, removing the crop residue prior to fumigation is important to limit the natural “chimneys” that will occur in the soil when crop residue is present. These “chimneys” allow the soil fumigants to move through the soil quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. To accommodate both of these important considera tions (erosion control and human health protection), the Agency encourages that the field be cleared of crop residu e as close to the timing of the fumigation as possible to limit the length of time that the soil would be exposed to potentially erosive weather conditions.

Requirements for soil temperature monitoring ha ve been revised from “air temperatures have been above 100 degrees F for more than three hours in any of the three days prior to application” to “air temperatures have been abov e 100 degrees F in any of the three days prior to application.”

The GAPs outlined below must be followed duri ng all fumigant applications. Registrants may develop additional optional GAPs to include on product labels provided they do not conflict with the required practices. A ll measurements and other documenta tion necessary to ensure that the mandatory GAPs are achieved must be recorded in the FMP and/or the post-application summary report as described in the FMP section.91  Tarps

Required for all applications except for deep sh ank orchard replant [Ca lifornia only] and hand held tree-hole applications:

• Tarps must be installed prior to starting hot gas applications.

• Tarps must be installed immediately after the fu migant is applied to the soil for bedded or broadcast applications.

• A written tarp plan must be developed a nd included in the FMP that includes:

o schedule and procedures for checking tarp s for damage, tears, and other problems

o plans for determining when and how repairs to tarps will be made, and by whom

o minimum time following injection th at tarp will be repaired

o minimum size of tarp damage that will be repaired

o other factors used to determine how and when tarp repair will be conducted

o schedule, equipment, and methods used to perforate tarps

o aeration plans and procedures following perfor ation of tarp, but pr ior to tarp removal or planting/transplanting

o schedule, equipment, and procedures for tarp removal.

 Weather conditions

The Agency is concerned with off gassing o ccurring during temperat ure inversion. In many reported incidents, a temperature inversion is often given as a potential contributing factor. To address this concern in the July 2008 RED, the Agency prohibited applications during periods of temperature inversion, or when the wind speed is less than 2 mph, which can sometimes be an indication an inversion is occurring. In addi tion, the Agency provided additional information on the label as guidance to applicators in determining if an inversion exists.

The Agency received many comments related to the inversion label language including

concern that some of the charac teristics of inversion conditions (like misty conditions or clear skies at night) do not always indi cate the presence of an inversi on; relying on a weather forecast to predict inversions is unreli able and not enforceable; and that prohibiting a pplication during

inversions does not address concerns of inversions during the off-gassing period.

Based on these comments the Agency has revised the weather conditions section of the GAPs that relates to temperature in versions to clarify that parts of the weather conditions that are requirements and those that are included to help guide the applicator to identify temperature inversions. The measures have also been upda ted to prohibit applica tion only if temperature inversion conditions are forecasted to persist for more than 18 of the 48 hours after the start of the application since this will filter out condi tions when diurnal temperature inversions may occur, though even diurnal temperature inversio ns could contribute to exposures to fumigant concentrations outside buffers. As such, EPA be lieves that the measures described below in the emergency preparedness and response section of this document are important to address potential risks associated with shorter-term diurnal inversions. The Agency is also changing the wind speed requirement so winds may either be 2 m ph at the start of application or be forecasted to reach 5 mph during the applicat ion. These changes are designed to prevent applications when inversion conditions are predicted to occur after the application ha s begun, since this is the time92 when the peak off-gassing is expected to occu r. In summary, EPA has determined that applicators must (1) check the weather forecast and make a decision whether to proceed with a planned fumigation, based on conditi ons that are predicted, (2) only begin a fumigant application if wind speed is a minimum of 2 mp h at the start of the application or forecasted to reach at least 5 mph during the application, and (3 ) not fumigate if there will be a persistent low-level local inversion or an air stagnation ad visory is in effect. EPA be lieves advisory language providing more detailed information on how to identify inversions and adverse weather conditions will increase the likelihood that applicators will pr oceed with applications only when weather

conditions are or are forecast to be favorable for safe fumigations. See below and the label table

in Section V of this document for label statements.

Stakeholders also questioned where the inve rsion conditions must exist and to what extent the temperature inversion must exist that would prevent an application. The Agency has provided additional temperature inversion details and has added a prohibition for application during an air-stagnation adviso ry. Air-stagnation advisories are issued through the National Weather Service and usually capture long periods of air stillness that may remain in an area from one to several days. EPA has determined that th ese modifications achieve the same goals as the July 2008 RED since they provide additional clarity that will enhance users’ ability to practically comply with the requirements. The revised statements are stated below.

Prior to fumigation the weather forecast for the day of the applic ation and the 48-hour period following the fumigation must be checked to determine if unfavorable weather conditions exist or are predicted a nd whether fumigation should proceed.

Wind speed at the application site must be a minimum of 2 mph at the start of the application or forecasted to reach at least 5 mph during the application.

Do not apply if a shallow, compressed (low-l evel) temperature inversion is forecast to persist for more than 18 consecutive hours for the 48-hour period after the start of application, or if there is an air-stagnation advisory in e ffect for the area in which the fumigation is planned.

Detailed local forecasts for weather conditions, wind speed, and air stagnation advisories may be obtained on- line at: http://www.nws.noaa.gov . For further guidance, contact your local National Weather Service Forecasting Office.

Unfavorable Weather Conditions

Unfavorable weather conditions block upwar d movement of air, which results in trapping fumigant vapors near the ground. Th e resulting air mass can move off-site in unpredictable directions a nd cause injury to humans, an imals or property. These conditions typically exist prior to sunset and continue past sunrise and persist as late

as noontime. Unfavorable conditions are common on nights with limited cloud cover and light to no wind and their presence can be indicated by ground fog or smog and can also be identified by smoke from a ground source that flattens out below a ceiling layer and moves laterally in a concentrated cloud.”93  Soil temperature

• The maximum soil temperature at the depth of in jection shall not exceed 90 degrees F at the beginning of the application.

o If air temperatures have b een above 100 degrees F in any of the three days prior to application, then soil temperature shall be measured and recorded in the FMP.

 Soil moisture

• The soil must be moist 9 inches below the surfac e. The amount of moisture needed in this zone will vary according to soil type and sh all be determined using the USDA Feel and Appearance Method for testing (see below). Su rface soil generally dries rapidly and must

not be considered in this determination.

• If there is insufficient moisture 9 inches below the surface, the soil moisture must be adjusted. If irrigation is not available and ther e is adequate soil moisture below 9 inches, soil moisture can be adjusted by discing or plowi ng before fumigant inj ection. To conserve existing soil moisture, pretreatme nt irrigation or pretreatment tillage should be done as close to the time of application as possible.

• Measure soil moisture at a depth of 9 inches at either end of the field, no more than 48 hours prior to application.

Soil moisture determination

The soil shall contain at the time of application enough moisture at 9 inches below the surface to meet the following criteria defined in the USDA Feel and Appearance method for estimating soil

moisture as appropriate for the soil texture.

• For coarse textured soils (fine sand and loamy fine sand), the soil is moist enough (50 to 75 percent available soil water moisture) to form a weak ball with loose and clustered sand grains on fingers, darkened color, modera te water staining on fi ngers, will not ribbon.

• For moderately coarse textured soils (sandy loam and fine sandy loam), the soil is moist enough (50 to 75 percent available soil water mo isture) to form a ball with defined finger marks, very light soil/water staining on fingers, darkened color will not stick.

• For medium textured soils ( sandy clay loam, loam, and silt loam), the soil is moist enough (50 to 75 percent available soil water moisture) to form a ball, very light st aining on fingers, darkened color, pliable, and forms a weak ribbon between the thumb and forefinger.

• For fine textured soils (clay, clay loam, and silty clay loam), the soil is moist enough (50 to 75 percent available soil water moisture) to fo rm a smooth ball with defined finger marks, light soil/water staini ng on fingers, ribbons between thumb and forefinger.

• For fields with more than one soil texture , soil moisture content in the lightest textured (most sandy) areas must comply with this soil mo isture requirement. Whenever possible, the

field should be divided in to areas of similar soil texture a nd the soil moisture of each area94 should be adjusted as needed. Coarser textur ed soils can be fumigated under conditions of higher soil moisture than finer textured soils; however, if the soil moisture is too high, fumigant movement will be retarded and eff ectiveness of the treatment will be reduced. Previous and/or local experience with the soil to be treated or the crop to be planted can often serve as a guide to conditions that will be accepta ble. If there is uncertainty in determining the soil moisture content of the area to be treated, a local extension service or soil conservation service specialist or pest contro l advisor (agriculture consultant) should be

consulted for assistance.

 Soil preparation

• Soil shall be properly prepared a nd at the surface generally be fr ee of clods that are golf ball size or larger. The area to be fumigated sh all be tilled to a depth of 5 to 8 inches.

• Field trash must be properly managed. Residue from a previous crop must be worked into the soil to allow for decomposition prior to fu migation. Little or no crop residue shall be present on the soil surface. Crop residue that is present must not interfer e with the soil seal. Removing the crop residue prior to fumigation is important to limit the natural “chimneys” that will occur in the soil when crop residue is present. These “chimneys” allow the soil fumigants to move through the soil quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. However, crop residue on the fiel d serves to prevent soil erosion from both wind and water and is an important consideration. To accommodate erosion control, fumigant efficacy, and human health protec tion, clear fields of crop residue as close to the timing of the fumigation as possible to limit the length of time that the soil would be exposed to potentially erosive weather conditions.

 Soil sealing

• For Broadcast Untarped Applications: Use a disc or similar equipment to uniformly mix the soil to at least a depth of 3 to 4 inches to eliminate the chisel or plow traces. Following elimination of the chisel trace, the soil surf ace must be compacted with a cultipacker, ring roller, and roller in combination with tillage equipment.

• For Bedded Applications : Preformed beds shall be sealed by disruption of the chisel trace using press sealers, bed shapers, cultipack ers, or by re-shaping (e.g., relisting, lifting, replacing) the beds immediately following injection. Beds formed at the time of application shall be sealed by disrupting the chisel trace using press sealers, or bed shapers.

• Soil Sealing for Tarped Applications : The use of a tarp does not eliminate the need to minimize chisel traces prior to application of the tarp, such as by using a nobel plow or other injection shank equipment that disrupts the chisel traces.

Methyl Bromide Bedded and Broadcast Shank Applications: Additional GAPs

In addition to the GAPs required for all soil fu migation applications, the following GAPs apply for injection applications:95 Tarps

• Tarps must be installed immediately after the fumigant is applied to the soil.

Soil Preparation

• Trash pulled by the shanks to the ends of the field must be covered with tarp, or soil, depending on the application method before making the turn for the next pass.

Application Depth

• For Tarped-Broadcast and Tarped-Bedded Applications: The injection point shall be a

minimum of 8 inches from the nearest final soil/ air interface. For tarp ed bedded applications the injection depth must not be deeper than the lowest point of the tarp (i.e., the lowest point of the tuck).

• For Untarped-Bedded Applications : The injection point shall be a minimum of 12 inches

from the nearest final soil/air interface.

• For Untarped-Broadcast Applications (CA orchard replant only): The injection point shall

be a minimum of 18 inches from the nearest final soil/air interface.

Prevention of End Row Spillage

• Do not apply fumigant to, or allow fumigant to drain onto, the soil surface. For each injection line either a check valve must be locat ed as close as possible to the final injection point, or equipment must drain/ purge the line of any remaini ng fumigant prior to lifting injection shanks from the ground.

• Do not lift injection shanks from the soil unt il the shut-off valve has been closed and the fumigant has been depressurized (passively dr ained) or purged (actively forced out via air compressor) from the system.

Calibration, Set-up, Repair, and Ma intenance for Application Rigs

• Brass, carbon steel or stainle ss steel fittings must be used throughout. Polyethylene tubing, polypropylene tubing, Teflon® tubing or Teflon® - lined steel braided tubing must be used for all low pressure lines, drain lines, and comp ressed gas or air pressure lines. All other tubing must be Teflon® -lined steel braided.

• Galvanized, PVC, nylon or aluminum pipe fittings must not be used.

• All rigs must include a filter to remove any pa rticulates from the fumigant, and a check valve to prevent backflow of the fumigant into the pressurizing cylinder or the compressed air
system.

• Rigs must include a flowmeter or a constant pres sure system with orifice plates to insure the proper amount of fumigant is applied.

• To prevent the backflow of fumigant into the compressed gas cylinde r (e.g., nitrogen, other inert gas or compressed air), if used, applicators must:

o Ensure that positive pressure is maintained in the cylinder at not less than 200 psi during the entire time it is connected to the application rig, if a compressed gas96 cylinder is used. ( This is not required for a compresse d air system that is part of the application rig because if the compressor syst em fails the application rig will not be operable )

o Ensure that application rigs are equipped with properly functioning check valves between the compressed gas cylinder or co mpressed air system and the fumigant cylinder. The check valve is best placed on the outlet side of the pressure regulator, and is oriented to only allow compresse d gas to flow out of the cylinder or compressed air out of the compressed air system.

o Always pressurize the system with comp ressed gas or by use of a compressed air system before opening the fumigant cylinder valve.

• Before using a fumigation rig for the first time, or when preparing it for use after storage, the operator must check the following items carefully:

o Check the filter, and clean or replace the filter element as required.

o Check all tubes and chisels to make sure they are free of debris and obstructions.

o Check and clean the orifice plates and screen checks, if installed.

o Pressurize the system with compressed gas or compressed air, and check all fittings, valves, and connections for leaks using soap solution.

• Install the fumigant cylinder, and connect and secure all tubing. Slowly open the compressed gas or compressed air valve, and increase the pres sure to the desired level. Slowly open the fumigant cylinder valve, al ways watching for leaks.

• When the application is complete, close th e fumigant cylinder valve and blow residual fumigant out of the fumigant lines into the so il using compressed gas or compressed air. At the end of the application, disc onnect all fumigant cylinders fro m the application rig. At the end of the season, seal all tubing openings with tape to prevent the entry of insects and dirt.

• Application equipment must be calibrated and a ll control systems must be working properly. Proper calibration is essential for application equipment to deliver the correct amount of fumigant uniformly to the soil. Refer to the manufacturer’s instructions on how to calibrate your equipment, usually the equipment manuf acturer, fumigant dealer, or Cooperative Extension Service can provide assistance.

Hot Gas Soil Applications (Greenhouse and Outdoor): Mandatory GAPs

• All delivery tubes shall be placed under the tarp in such a way that they do not move during the application of methyl bromide.

• The fumigant must be introduced from outsi de of the greenhouse/ap plication block (see entry
restrictions and respiratory protection sections for further details).

• All fittings, connections, and valves must be checked for methyl bromide leaks prior to fumigation. If cylinders are replaced during the fumigation process, the connections and valves must be checked for leaks prior to continuing the job.

Tree Replant Application: Mandatory GAPs

In addition to the GAPs required for all so il fumigation applications, the following GAPs apply for tree replant applicati ons. This application method is used when methyl bromide is applied to individual tree sites in an existing orchard where shank application are not possible:97 Site Preparation

• Each individual tree-site must remove the tree stump and primary root system with a back-hoe or other similar equi pment, for example an auger.

• The hole must be backfilled with soil before application.

Application Depth

• The fumigant must be injected at least 18 inches into the soil.

System Flush

• Before removing the application wand from the soil the wand must be cleared using nitrogen or compressed air.

Soil Sealing

• After the wand is cleared and removed from th e soil, the injection hole must be either covered with soil and tamp or the soil must be compacted over the injection hole.

ii. Fumigant Management Plans (FMPs)

As noted elsewhere in this document, soil fumigation is a complex site-specific activity. Failure to adhere to label requirements and proced ures for safe use has le d to accidents affecting workers involved in fumigations as well as bysta nders. Information from various sources shows that health and safety plans, FMPs in this context, typically redu ce workplace injuries and accidents by prescribing a series of operational requirements and criteria. In fact, plans like these are widely implemented in a variety of industries and are recommended as standard approaches for occupational health and safe ty management by groups such as American Industrial Hygien e Association 16 (i.e., through “Administrative” and “Workplace” controls). The Centers for Disease Control pr ovides guidance for developing health and safety plans in agricultural settings. 17 The effectiveness of similar plan s has also been evaluated in the literature. Examples include “lookback” revi ews conducted by the Occupational Safety and Health Administration (OSHA) which essentiall y implemented standards in various industries then reviewed their effectiveness in this proce ss as they are required to determine whether the standards should be maintained without change, rescinded or modified. OSHA is required by Section 610 of the Regulatory Fl exibility Act (5 U.S.C. 610) and Executive Order 12866 to

conduct the “lookback” reviews. These reviews are conducted to make the subject final

standards more effective or less burdensome in achieving their objectives , to bring them into better alignment with the objectiv es of Executive Order 12866, and to make them consistent with

16 Ignacio and Bullock (2006) A Strategy For Assessing and Managing Occupational Exposures (Third Edition), American Industrial Hygiene Association, AIHA Press 2700 Prosperity Avenue, Suite 250 Fairfax VA 22031 (ISBN 1-931504-69-5)

17 Karsky (2002) Developing a Safety and Health Progra m to Reduce Injuries and Accident Losses, Centers For Disease Control National Ag Safety Database, av ailable at http://www.cdc.gov/nasd/docs/d001501-

d001600/d001571/d001571.html98 the objectives of the Regulatory Flexibility Act. Two examples of “lookback” reviews that support the use of FMPs for soil fumigant health and safety management include: ethylene oxide use as a fumigant/sterilant, and grai n handling facilities requirements. 18

In the July 2008 RED, EPA required FMPs to be completed before a fumigant application occurs. EPA concluded that FMPs will reduce potential risks to bystanders as well as handlers by requiring that applicat ors have carefully planned, in writing, each major element of the fumigation. In this context, an FMP is a set of performan ce criteria for each application, including how the fumigator intends to comply w ith label requirements. As added benefits, the Agency determined that FMPs would ensure di rections on the product la bels were followed and that the conditions under which fumigation occurre d were documented. EPA also concluded that FMPs would help ensure an appropriate response by the applicator or others involved in the application should an incident occur since a proper and prompt re sponse would reduce the potential risk to bystanders from potential high exposure situations (e.g., readily available first responder contact information could reduce respons e times to impacted bystanders and carefully thought out emergency response plans can help ensu re appropriate actions are taken in case of unforeseen events).

The July 2008 RED provided a list of each major element FMPs would need to address. These included general site and applicator information, applicati on procedures, and a description of how the fumigator planned to comply with label requirements for GAPs, buffer zones, monitoring, worker protection, post ing, and providing notif ication to the state or tribal lead agency. FMPs also were required to include plans for communication between the applicator

and others involved in the fumigation, documentation, and handling emergency situation. Additionally, EPA required that a pplicators complete a post fumi gation summary that described any deviations from the FMP, measurements take n to comply with GAPs, and information about any problems such as complaints or incidents that occurred as a result of the fumigation. The RED also specified requirements for record k eeping and that FMPs must be provided, upon request, to enforcement officials and handlers involved in the fumigation.

According to stakeholder comm ents in earlier comment periods, much of the information required for the site-specific FMP was already being documented by users, and most industry stakeholders supported mandatory FMPs provided th ey are not too restrictive or complex and do

not result in an excessive administrative burden.

During the post-RED comment period, EPA r eceived several comments regarding FMPs. Several comments from industry and user st akeholders expressed concern that FMP requirements would increase paperwork burden w ithout providing significant risk reduction, though others supported FMPs provi ded they did not result in an excessive administrative burden. A number of comments suggested that the level of detail EPA had required was too great and could result in voluminous, resource-i ntensive plans. Some of these comments suggested that a checklist format would be more efficient and far less burdensome. Some comments expressed reservations about the ability of FMPs to enhance compliance with label requirements. Some commenters were concerned about the feasib ility of providing a copy of the

18 United States Department of Labor, Occupational Safety and Health Administration (2008) Lookback Reviews available at http://www.osha.gov/dea/lookback.html99 FMP to on-site handlers or enforcement personn el, though others said th at copies of the FMP should be provided to workers in area s adjacent to the application block.

Following EPA’s review of the post-RED comments, the Agency still believes that FMPs will reduce potential risks to bystanders as well as handlers and are a key component of the package of measures to reduce risks. EPA believes that FMPs will also enhance compliance by requiring that applicators veri fy and document compliance with the label requirements during and after application events are completed. In cases where errors may have occurred, a post-application summary may also prevent sim ilar problems from occurring during future applications. However, in response to comments, the Agency has somewhat

modified the list of elements that must be addr essed in the FMP (as described below) to make

it more streamlined and thus less burdensome to applicators and grower s. In addition, the Agency has developed a sample template in which many of the elements are covered in checklist format, which fumigators have the op tion of downloading and modifying to meet the needs of their specific fumigation situations. See [http://www.epa.gov/pesticides/reregistration/soil _fumigants/]. EPA will also continue to work with stakeholders to refine the FMP temp late and potentially develo p others so it is a more useful tool for ensuring the sa fe application of methyl bromide.

The Agency estimates that, if a certified appl icator decides not to use the FMP template and decides to prepare a narrative FMP, a carefu lly designed FMP could take several days to develop the first time. Subsequent FMPs s hould require substantially less time to develop

because much of the information can be reused fr om the initial plan. In addition, an enterprise fumigating multiple application blocks as part of a larger fumigation may format their FMP in a manner whereby all of the information that is co mmon to all the application blocks is captured once, and any information unique to a particular application block or blocks is captured in subsequent, separate sections.

Amended FMP Requirements

Consistent with the July 2008 RED, the Agency is not requiring FMPs to be submitted to state or local agencies. They must, however be maintained by the applicator and grower (if the grower is not the applicator) for a period of 2 years.

The Agency agrees with comments that having both the applicator and the owner/operator provide copies of the FMP to handlers is unnece ssarily duplica tive and that providing each worker with a hard copy of the FMP wastes paper. The Agency also agrees that it is not necessary for the FMP to be provided to the workers in areas adjacent to the application block. Workers in adjacent areas will be notified of the fumigation by buffer posting requirements and, in the case of neighbors whose land is part of a buffer zone, the adjoining neighbor has responsibility for workers in areas adjacent to the application for which permission was granted to use as part of a fumigation buffer. The Agency has revised the following requirement that was included in the 2008 RED, “Once the application begins, the certified applicator and owner/operator of the application block must provide a copy of the FMP to handlers involved in the fumigation, workers in adjacent areas to the application block, and federal/state/local enforcement personnel, upon request.” The RED Amendment requires the100 certified applicator to make a copy of the FMP available for viewing by handlers involved in the fumigation. The certified applicat or or the owner/operator of the application block must provide a copy of the FMP to any federal, state, tribal , or local enforcement personnel who request the FMP. In the case of an emergency, the FMP must be made available when requested by federal/state/local emergency re sponse and enforcement personnel.

The Agency agrees with comments that the term “etc.” complicates enforcement

activities and has removed that term from the label tables.

Each site-specific FMP must contain the following elements:

 Applicator information (name, phone number , license number, employer name, employer address, date of completing registra nt methyl bromide training program)
 General site information
3⁄4 Application block location (e.g., address or gl obal positioning system (GPS) coordinates)
3⁄4 Name, address, and, phone number of ow ner/operator of the application block
3⁄4 Map, aerial photo, or detailed sketch showing field location, dimensions, buffer zones, property lines, roads, rights-o f-ways, sidewalks, permanen t walking paths, bus stops, water bodies, wells, nearby application blocks , surrounding structures (occupied and nonoccupied), locations of posted signs for buffers, and sites requiring 1⁄4 or 1⁄8 mile buffer zones (e.g., schools, state licensed day care centers, nursing homes, assisted living facilities, hospitals, in-patient clinics, and pr isons) with distances from the application site

labeled
 General application information (target applic ation date/window, brand name of fumigant, EPA registration number)
 Tarp information and procedures for repair, perforation and removal(if tarp is used)
3⁄4 Brand name, lot number, thickness
3⁄4 Name and phone number of person responsible for repairing tarps
3⁄4 Schedule for checking tarps for dama ge, tears, and other problems
3⁄4 Maximum time following notificatio n of damage that the pers on(s) responsible for tarp repair will respond
3⁄4 Minimum time following application that tarp will be repaired
3⁄4 Minimum size of damage that will be repaired
3⁄4 Other factors used to determine when tarp repair will be conducted
3⁄4 Name and phone number of person responsible fo r cutting and/or removing tarps (if other that certified applicator)
3⁄4 Equipment/methods used to cut tarps
3⁄4 Schedule and target dates for cutting tarps
3⁄4 Schedule and target dates for removing tarps
 Soil conditions (description of soil texture in application bl ock, method used to determine soil moisture)
 Weather conditions (summary of forecasted condi tions for the day of th e application and the 48-hour period following the fumigant application)
3⁄4 Wind speed
3⁄4 Inversion conditions (e.g., shallow, compre ssed (low-level) temperature inversion)
3⁄4 Air stagnation advisory101  Buffer zones
3⁄4 Application method
3⁄4 Application rate from lookup table on the label (lb ai/A)
3⁄4 Application block size from l ookup table on the label (acres)
3⁄4 Credits applied
3⁄4 Buffer zone distance
3⁄4 Description of areas in the buffer zone that are not under the control of the owner/operator of the application block
 Respirators and other persona l protective equipment (PPE) for handlers (handler task, protective clothing, respirator type , respirator cartridge type, re spirator cartridge replacement schedule, eye protecti on, gloves, other PPE)
 Emergency procedures (evacuation routes, loca tions of telephones, contact information for first responders, local/state/federal contacts, key personnel and emergency procedures/responsibilities in case of an incide nt, equipment/tarp/seal failure, complaints or

elevated air concentration leve ls outside buffer zone suggestin g potential problems, or other emergencies).
 Posting procedures (person(s) who will post signs, location of posting signs, procedures for sign removal)
 Site-specific response and ma nagement (if applicable)
3⁄4 Fumigant site monitoring

 Description of who, when, where, and procedures for monitoring buffer zone perimeter
3⁄4 Response information for neighbors

 List of residences, businesses, and neighboring property owners informed

 Name and phone number of person doing notification

 Method of providing the information
 State and tribal lead agency no tification (If state and/or tribal lead agency requires notice, provide a list of contacts that we re notified and date notified.)
 Plan describing how communication will take pl ace between applicator, land owner/operator, and other on-site handlers (e.g., ta rp cutters/removers, irrigato rs) for complying with label requirements (e.g., buffer zone location, buffer zone start/stop times, timing of tarp cutting and removal, PPE).
3⁄4 Name and phone number of persons contacted
3⁄4 Date contacted
 Authorized on-site personnel
3⁄4 Names, addresses and phone numbers of all handlers
3⁄4 Employer name, addresses, and phone numbers for all handlers
3⁄4 Tasks that each handler is auth orized and trained to perform
3⁄4 Date of PPE training for each handler
3⁄4 For handlers designated to wear respirators respiratory protection is required (minimum of 2 handlers), date of medical qualification to wear a respirator and da te of fit testing for respirator.
 Air monitoring plan
3⁄4 For buffer zone monitoring:

 Name, address, and, phone number of handl er to perform monitoring activities

 Location and timing of monitoring for the buffer zone102 3⁄4 For handlers without re spiratory protection:

 If sensory irritation is experienced, indi cate whether operations will be ceased or operations will continue with respiratory protection

 If intend to cease operations when sensory i rritation is experienced, provide the name, address, and phone number of the handler that will perform monitoring activities prior to operations resuming
3⁄4 For handlers with respiratory protection:

 Representative handler tasks to be monitored

 Monitoring equipment to be us ed and timing of monitoring
3⁄4 For buffer zone monitoring when using methyl bromide formulations with < 20% chloropicrin :

 Name, address, and phone number of person(s) to perform sampling

 Identify areas or structures to be monitored before reentry is permitted

 Monitoring equipment to be used and timing of the monitoring
3⁄4 For monitoring the breathing zone when using methyl bromide formulations with < 20% chloropicrin :

 Representative handler tasks to be monitored

 Monitoring equipment to be used and timing of the monitoring
 Good Agricultural Practices (GAPs)
3⁄4 Description of applicable mandatory GAPs (re gistrants may also include optional GAPs)
3⁄4 Measurements and documentation to ensure GAPs are achieved (e.g., measurement of soil and other site conditions)
 Description of hazard communication. (The buf fer zone around the application block has been posted in accordance with the label. Pest icide product labels and material safety data sheets are on-site and readily available for employees to review.)
 Record-keeping procedures (the owner/operato r of the application block, as well as the certified applicator, must keep a signed copy of the site-specific FMP and the post application summary for 2 years fr om the date of application).

For situations where an initial FMP is deve loped and certain elements do not change for multiple fumigation sites (e.g., applicator inform ation, authorized on-site personnel, record keeping procedures, emergency pr ocedures) only elements that ha ve changed need to be updated in the site-specific FM P provided the following:

• The certified applicator superv ising the application has verifi ed that those elements are current and applicable to the application bl ock before it is fumigated and has documented the verification in the site-specific FMP.

• Recordkeeping requirements are followed for the entire FMP (including elements that do not change).

Once the application begins, the certified applic ator must make a copy of the FMP available for viewing by handlers involved in the fumigation. Th e certified applicator or the owner/operator of the application block must provi de a copy of the FMP to any federal, state, tribal, or local enforcement personnel who request the FMP. In the case of an emergency, the103 FMP must be made available when requested by federal/state/local emergency response and enforcement personnel.

Within 30 days of completing the applicati on portion of the fumigation process, the certified applicator supervising the application must complete a post fumigation application summary that describes any devia tions from the FMP that have occurred, measurements taken to comply with GAPs as well as any complaints an d/or incidents that ha ve been reported to

him/her.

Specifically the Post-Application Summary must contain the following elements:

 Actual date of the applicati on, application rate, and size of application block fumigated
 Summary of weather conditions on the day of the application and during the 48-hour period following the fumigant application
 Soil temperature measurement (if air temperatur es were above 100 degrees F in any of the 3 days prior to the application)
 Tarp damage and repair information (if applicable)
3⁄4 Location and size of tarp damage
3⁄4 Description of tarp/tarp s eal/tarp equipment failure
3⁄4 Date and time of tarp repair
 Tarp removal details (if applicable)
3⁄4 Description of tarp removal (i f different than in the FMP)
3⁄4 Date tarps were cut
3⁄4 Date tarps were removed
 Complaint details (if applicable)
3⁄4 Person filing a complaint (e.g., on-site handler, person off-site)
3⁄4 If off-site person, name, address, and phone number of person filing a complaint
3⁄4 Description of control measures or emerge ncy procedures followed after a complaint
 Description of incidents, equi pment failure, or other emergency and emergency procedures followed (if applicable)
 Details of elevated air concen trations monitored on-site or outside the buffer zone (if applicable)
3⁄4 Location of elevated air concentration levels
3⁄4 Description of control measures or emergency procedures followed
3⁄4 Air monitoring results

 When sensory irritation experienced:

• Date and time of sensory irritation

• Handler task/activity

• Handler location where irritation was observed

• Resulting action (e.g., cease operations, c ontinue operations with respiratory protection)

 When using a direct read instrument:

• Type of sample (e.g., area, breathing zone, structure)

• Sample date and time

• Handler task/activity (if applicable)104 • Handler location or structure location

• Air concentration

• Sampling method
 Date of buffer zone sign removal
 Any deviations from the FMP

In addition to recordkeeping requiremen ts from 7 CFR part 110 “Recordkeeping Requirements for Certified Applicators of Federa lly Restricted Use Pesticides,” this decision requires that both the applicator and owner/operator of the app lication block keep a signed copy of the site-specific FMPs and the post-applicatio n summary record for 2 years from the date of application.

Applicators and other stakehol ders have the flexibility to use EPA’s template, prepare their own FMPs templates, or use other commerci ally available software with certain elements

listed above in check-list and/or fill in the blank format. Below are examples of other FMP templates available on the internet for structural fumigations that may be useful to users when developing FMPs for methyl bromide soil applications:

• http://www.cardinalproproducts .com/Misc/FMP%20Version%203.pdf

• http://www.pestcon.com/tech library/fum_m gmt_plan.doc

• http://www.agr.state.ne.us/divi sion/bpi/pes/fum igation_plan.pdf

• http://www.agr.state.ne.us/divi sion/bpi/pes/fum igation_plan2.pdf

• http://nmdaweb.nmsu.edu/pesticides/Man agement%20Plans%20R equired%20for%20Fu migations.html

iii. Site Specific Response and Management

EPA believes measures for ensuring prepare dness for situations when accidents or emergencies occur are an important part of the su ite of measures necessary to address risks posed by fumigants. Therefore, EPA is requiring such measures at the community level in the form of educational materials for first responders, and measures for specific sites to ensure early detection and quick and appropriate res ponse to situations as they arise.

Although EPA believes buffers and other mitigati on will prevent many future incidents, it is likely that some incidents w ill still occur due to accidents, e rrors, and/or unforeseen weather conditions such as diurnal inversions. Early de tection and appropriate response to accidental

chemical releases is an effective means of reduc ing risk, as well as addressing the source of the release. Reducing risks associated with incidents that may occur in the future is a key part of EPA’s soil fumigant decisions. By combini ng buffers with GAPs, FMPs, and effective emergency response, EPA is able to reach a “no unreasonable adverse effects” finding under

FIFRA.

To ensure that appropriate response mechanis ms are in place in the event of a fumigant exposure incident, EPA is requiri ng that registrants provide trai ning information, in the context of their community outreach and education progra ms to first responders in high-fumigant use areas and areas with signifi cant interface between communities and fumigated fields. In105 addition, for situations in which people, homes, or other structures are in close proximity to buffer zones, applicators must either monitor bu ffer zone perimeters or, alternatively, provide emergency response information dire ctly to neighbors. Each elem ent is discussed in more detail

below.

First Responder Education

EPA is requiring registrants through their community outreach and education programs (see the Community Outreach and Education section), to ensure that emergency responders have the training and information that they need to effectively identify a nd respond to fumigant exposure incidents. EPA believes this will help ensure, in the case of a fumigant accident or incident that first responders recognize th e exposure as fumigant related and respond appropriately. Additional details are included in the Community Outreach and Education section

of this document.

Emergency Preparedness and Respons e Considerations for the 2008 RED

Prior to the July 2008 RED the EPA received comments from many stakeholders about the Agency’s emergency preparedness and re sponse option. Users have commented that notification is burdensome and that it is unnecessary if buffer zones are also required. However, community groups have commented on the importance of bystanders being informed when fumigations are occurring, since this group of pesticides, compar ed to other pesticides, has a greater potential to move off site and affect people not involved in th e application. State regulators have different views on this requirem ent. Some support the sharing of information with neighbors, and some states have notific ation requirements for fu migations with certain products or for certain application methods. In addition, some states require notification to chemically sensitive individuals in proximity to pe sticide applications. Others also had concerns about the enforceability of this t ype of measure and the possible bur den on the states to enforce a notification requirement.

California currently requires no tification of persons within 3 00 feet of a methyl bromide buffer zone. California strawberry growers cons ider the 300 foot notification area for methyl bromide applications to be an extension of the buffer zone. In areas where a large number of people would need to be notified about a plan ned methyl bromide a pplication, strawberry growers indicated that they would rather not use methyl bromide because some communities could mobilize to prevent the fumigation from taki ng place. Some stakeholders also commented that it would be protective and less burdensome if EPA required the user to monitor fumigant air concentrations at the edge of the buffer for 24 hour s after the application to ensure the fumigant does not move beyond the buffer at concentrations that exceed EPA’s level of concern. If concentrations of concern were detected, the us er would be required to implement the emergency response measures specified in the fumigant management plan.

EPA has concluded that bystande rs could take steps to prot ect themselves if they had basic information about fumigati ons and the appropriate steps to take if they experienced symptoms of exposure. In a number of fumigant incidents that have occurred, the magnitude and severity of the incident could have been signi ficantly reduced if people had such information.106 Similarly, having on-site monitoring will enable si te managers to take remedial action (i.e., activate the control plan in the FMP) to lower emissions soone r, also resulting in fewer and less severe exposures. And, if necessary, site managers would activate the emergency response

elements of the FMP.

Providing communities with information about local chemical releases is an important part of emergency preparedness programs and is recognized as an effective means of addressing

risk at the local level. Some states, like Florida and Wisconsin, have requirements for providing information to chemically-sensitive individuals about chemicals used nearby so they can take steps to protect themselves from potentially harmful exposures (see http://edis.ifa s.ufl.edu/pi004

and http://www.legis.state.wi.us/rsb/code/atcp/atcp029.pdf ). The requirements in Florida do not apply to agricultural chemical a pplications. Wisconsin also requires fumigators applying metam sodium products through chemigation to provide written notice to the county public health agency and to every individual or household with in 1⁄4 miles of the chemigation application site (see http://www.legis.state.wi.us/rsb/code/atcp/atcp030.pdf ). EPA agrees that information about how to recognize and address exposures can help citizens reduce potential risk.

EPA understands that difficult challenges exist when agricultural land borders urban or

suburban communities. While EPA’s decisions for the fumigants will not alleviate challenges that already exist, EPA is allowing options for ensuring emergency preparedness in an effort to lessen potential impact on growers, while ma intaining the Agency’s protection goals.

EPA is not requiring a specific method of pr oviding the information to neighbors, but rather that it be done in a way that effectively communicates, in a manner the recipients will understand. Some methods may not result in docume ntation that would be retained. To address concerns about enforcement, EP A is requiring that information on how and when the emergency response information was delivered, and to whom, be included in the FMP.

Emergency Preparedness and Response Revisions

To reduce risks to people who may be near a buffer zone (e.g., at their home, working in a nearby field) in the July 2008 RED, EPA require d applicators to either monitor buffer zone perimeters or, alternatively, provide emergency res ponse information directly to neighbors. This measure is intended to ensure protection in pl aces people may be found. Whether measures are required depends on the size of the buffer zone a nd how close land, not with in the control of the owner/operator of the application block (e.g., residential properties), may be to the buffer zone.

The Agency received many comments about the Emergency Preparedness and Response requirements that suggested the requirements were too complex and confusing. To address these concerns, EPA has revised the structure and content of the requirements in the RED Amendment to improve clarity. As was outlined in the 2008 RE D, it is important to note that site-specific Emergency Preparedness and Response measures ar e only required if there are people, homes or businesses within a specified distance from the edge of the buffer zone.

Some comments were receive d that questioned the rationale behind scaling the Emergency Preparedness and Response measures. EPA believes that scaling the size of the107 Emergency Preparedness and Response area will be protective. Generally the larger the buffer distance the higher the applic ation rate or the size of the treate d area translates to a greater total amount of fumigant being applied and potentia lly higher exposure in the area surrounding the application block. The buffer distances fo r triggering the Emergency Preparedness and Response requirements are scaled to allow the amount of fumigant us ed (a surrogate for potential exposure) to determine the applicable distance for implementing this requirement. When the area is scaled to the size of the buffer, small buffers which result from applications to small areas, at low application rates, and/or using low-emission applicat ion techniques, will have small or no areas to monitor or inform, while larger app lications will have larger areas to monitor or inform. In addition, to create additional incentiv e to achieve the smallest buffer possible, EPA has included an exception for app lication blocks with the smallest required buffer (25 feet) which would not be subject to this requ irement, since they are most likely using lower application rates, applying to smaller areas, and/or using lower emission application methods. Based on changes

to the buffer zone section regarding overlapping buffer zones, any buffer zone that overlaps with

another buffer zone must use the maximum distance in the Emerge ncy Preparedness and Response measures to determine if monitoring or providing information to neighbors is needed. None of the other distances have changed.

Many stakeholders also expressed concer n over the potential bur den the July 2008 RED requirements may have on applicators and grower s. Specifically, the frequency and cost of monitoring using sampling devices such as colorime tric tubes were of concern. Several of these comments noted concerns with the reliability of su ch devices at low concentration. Stakeholders felt the inherent warning properties of chloropicr in and MITC (i.e., eye irritation) were better indicators of exposure than available devices. Additionally, several stakeholders indicated that monitoring is most appropriate and effective at dawn and dusk, the times of day when off-site movement of concentrations is most likely. Based on these comments, the Agency has revised the requirement so monitoring is required during those periods when risk of high concentrations of fumigant moving beyond buffers is greatest (i.e., at dawn and dusk). As a precaution, monitoring is also required once dur ing the night and during the day.

Additionally, as noted in the Respiratory Protection section of this document, due to limitations on currently available technology for monitoring, use of sampling devices such as colorimetric tubes will not be required at this time unless methyl bromide constitutes more than 80% of the product. EPA believes that currently av ailable devices are likely to be more reliable at fumigant concentrations which exceed EPA’s ac tion level concentrations . In fact, some of

these action levels are at or near the detec tion limits for the devices available for some fumigants. Additionally, colorimetric devices provide snapshot measurements. In conditions that are likely to be more static (e.g., monito ring an indoor fumigation such as a grain mill or warehouse) it is likely that minute to minute changes in conditions would not be as great as those anticipated for the more dynamic conditions ch aracteristic of outdoor field fumigation where exposure concentrations could shift because of weather changes or stratification in soil conditions across a single field.

The Agency is modifying the procedures fo r monitoring buffer zones because there are technological limitations of curre ntly available MITC and chlor opicrin monitoring devices such that these devices are neither pr actical nor reliable for field use. However, the Agency does108 believe that quantitative air mon itoring would enhance safety if the appropriate technology were available as it is for methyl bromide. Some e quipment manufacturers have indicated interest in developing devices that would be more functional and reliable fo r field fumigation applications (e.g., badge-type monitors). EPA encourages su ch efforts and plans to stay abreast of developments and improvements in monitoring de vices and will consider this issue again in Registration Review or sooner should such monitors become available in th e short term. In the interim, buffer monitoring for chloropicrin and the MITC generating chemicals will rely on sensory indicators (e.g., eye and/or nose irritation) to trigger a re sponse instead of using tubes. Monitoring tubes are still require d for measuring products that c ontain more than 80 % methyl

bromide.

Finally some comments provided suggestions to increase flexibility in how a grower may comply with these measures as well as the eff ectiveness of the option to provide information to neighbors. EPA agrees with the importance of us ers being able to comply with these measures and has modified some aspects of the requirements for this option to reduce the number of notices an applicator may need to provide to a given neighbor. Also, to enhance the effectiveness of the information neighbors would r eceive, EPA is requiring that the information is provided close to when the application is planned to take place and early enough for neighbors

to make use of the information. EPA believes these modifications will enhance compliance and effectiveness of the information if the emerge ncy response criteria are met and applicators exercise this option.

Emergency Preparedness and Response Requirements

When are Emergency Preparedness and Response Measures Needed?

If

the buffer zone is: AND There is land (e.g., residential properties and businesses) NOT in the control of the property operator within this

distance from the edge of the buffer zone:

25 feet < Buffer ≤ 100 feet 50 feet

100 feet < Buffer ≤ 200 feet 100 feet

200 feet < Buffer ≤ 300 feet 200 feet

Buffer > 300 feet or buffer zones overlap 300 feet

Then either monitoring of the buffer zone pe rimeter or providing emergency response information to neighbors is required.

If the buffer zone is 25 feet, the minimal buffer zone size, then the Emergency Preparedness and Response requirements are not a pplicable. Also, if a ll of the land within 300 feet of the edge of the buffer zone is under th e control of the property operator, then no site monitoring or informing neighbors would be requi red regardless of the size of the buffer zone.109 Fumigation Site Monitoring

EPA has determined that monitoring of the buffer zone perimeter for fumigants moving beyond buffers is an effective approach to protect ing bystanders. Under this approach, if the person monitoring the buffer perimeter experiences eye or nasal irritation, an early sign of exposure to concentrations that exceed the Agency’s action leve l, then the emergency response plan specified in the FMP must be implemented. If other problems occur, such as a tarp coming loose, then the appropriate control plan must be activated. Because data indicate that peak

concentrations sometimes occur on the second da y following applications, and the greatest potential for concentrations out side buffers may be observed at dawn and dusk, EPA has decided that this monitoring must be done at least four times per day during the full buffer zone period at dawn, dusk, and once during the ni ght and during the day, to en sure concentrations do not

exceed the action level which will be specified on product labels.

Specific requirements include:

• Monitoring must take place beginning on the day the application begins until the buffer zone period expires.

• Monitoring must be conducted by a certified ap plicator or someone under his/her supervision.

• Monitoring for air concentrations above the ac tion level for the fumigant, as determined by sensory irritation, must take pl ace in areas between the buffer zone perimeter and residences or other occupied areas that trigger this requir ement. Air concentrations of methyl bromide must be measured using a direct-read instru ment if the methyl bromide product applied contains less than 20% chloropicrin.

• The persons monitoring for perc eptible levels must start monitoring approximately 1 hour before sunset of the day the application begi ns and continue once during the night, once at 1 hour after sunrise, and once during the day until the end of the buffer zone period.

• If at any time the person monitoring the air concentrations experien ces sensory irritation, then the emergency response plan stated in the FMP must be immediately implemented.

• If other problems occur, such as a tarp coming loose, then the appropria te control plan must

be activated.

• The location and results of the air monitoring must be recorded in the FMP.

While protective, this site monitoring might be burdensome for users fumigating in areas with few people. Therefore, EPA is allo wing users the alterna tive option of providing emergency response informati on directly to neighbors.

Response Information for Neighbors

As an alternative to on-site monitoring, the certified applicat or supervising the fumigation (or someone under his/her direct su pervision) would need to ensure that residences, businesses,

or other sites that meet the criteria outlined be low have been provided the required information at least one week prior to the fumiga nt application in a specified fi eld. If after four weeks, the fumigation has not yet taken place, the information must be delivered again.

• Information that must be provided includes:

o The general location of the application block,110 o Fumigant(s) applied including the active ingredient, name of the fumigant products(s), and the EP A Registration number,

o Contact information for the appli cator and property owner/operator,

o Time period in which the fumigation is planned to take place (must not range more than 4 weeks),

o Early signs and symptoms of exposure to the fumigant(s) applied, what to do, and what emergency responder phone number to call (911 in most cases), and

o How to find additional info rmation about fumigants.

The method for distributing information to ne ighbors must be described in the FMP and may be accomplished through mail, telephone, door hangers, or through other methods that can be reasonably expected to effectively inform people at residences a nd businesses within the required distance from the edge of the buffer zone.

To clarify this measure, the following example is provided (see Figure G):

• If the buffer zone is 125 feet , then these requirements apply to residences within 100 feet of the buffer zone. Either the applicator mu st monitor the area be tween the dotted house

and the buffer zone or residents of the dotted house must be provided emergency response information.

• The location of the cross-hatched house would not prompt any action.

If there are no residences or other occupied structures within 300 feet of the edge of the buffer zone, or if the buffer distance is the mi nimum of 25 feet, neithe r site monitoring nor providing information to neighbors is required.

Figure G. Example Site Map for Informing Neighbors

Treated field Buffer zone 45 ft

288 ft 125 ft 100 ft111 iv. Notice to State Lead Agencies

Ensuring fumigant users understand and comply with the new label requirements is an important component of the fumigant risk m itigation package since these requirements are designed to mitigate risks of concern for bystander s, handlers, and workers. Knowledge of the location and timing of fumigant applications allows enforcement officials to focus their compliance assistance and inspection effort s around periods when, and places where, fumigations are expected to occur. Therefore, in the July 2008 RED, the Agency required written notification of the appropria te state or tribal lead agency prior to fumigant applications.

Following publication of the July 2008 REDs, the Agency received feedback from some states that were interested in receiving the notice because it would e nhance their ability to provide technical assistance and assure complia nce. However, the Agency also received

comments from states that were concerned abou t the notification requirement largely due to

resource constraints. Some states also indicate d that they are already well-informed about when and where fumigations take place, and receiving specific notice of applications would create a paperwork burden rather than aid their compliance assistance and assurance programs. Some states recommended that, in lieu of receiving not ice of fumigations, states could modify their cooperative agreements with EPA to incorporate specific strategies for assuring compliance with the new fumigant labels. States also suggested that rather th an providing notice directly to states, fumigators could enter applica tion information into a regist rant-developed and maintained database. They suggested this would be an a ppropriate mechanism because it would standardize and streamline the process for applicators to pr ovide the required inform ation, and states could access and utilize information more quickly, with greater ease, and using fewer state resources.

Based on consideration of public comments, the Agency still believes that compliance

assistance and assurance is a cri tical component of the soil fumigant mitigation. EPA agrees that some states already have mechanis ms in place to provide them with information needed to assist and assure compliance with new fu migant requirements, but other st ates are in need of additional information to accomplish this objective. The Ag ency also believes that all states in which fumigants are used will need to modify thei r cooperative agreements, to some extent, to incorporate strategies for compliance assistance and assurance to aid the transition from current labels to labels that reflect the new mitigation.

While the Agency will continue to work with a ll state and tribal lead agencies on efficient ways to obtain the information needed to pl an and implement compliance assistance and assurance activities, the Agency is currently re taining the notification requirement only for state and tribal lead agencies that choo se to be notified of fumigant applications. The Agency plans to provide a website listing these state and tribal lead agencies and how and when these agencies want applicators to provide to them the following information:

o Applicator and property owner/operator contact information (name, telephone number, and applicator license number)

o Location of the appl ication block(s)

o Name of fumigant(s) produc ts(s) applied in cluding EPA Registration number

o Time period in which fumigation may occur112 The Agency will work with all states to am end their cooperative agreements to include strategies for compliance assistance and assuran ce, which will be particul arly important over the next several years as the new mitigation measur es are implemented. For states that do not choose to be notified of fumiga nt applications, modification of their cooperative agreements must include the methods these agencies will us e to survey fumigation application periods and

locations.

v. Soil Fumigation Training for Applicators and Training Information

for Other Handlers

Soil fumigation is an inherently complex activity involving specia lized equipment and application techniques. Additionally, the mitigati on measures required as part of these decisions will introduce new requirements in the form of more detailed instructions and restrictions on soil fumigations. Failure to adequately manage fumi gant applications increases risks to handlers involved in the fumigation, nearby workers, and other bystanders. Incident data show that a number of fumigant incidents are the result of misapplications, failure to follow label requirements and other safety precautions, and other er rors on the part of fumigant applicators. Although states have certification programs, so me of which include a specific category or subcategory for soil fumigation, there currently is not a consistent sta ndard across states and regions where soil fumigation is done. Additiona lly, the federal certific ation program currently has no category for soil fumigation, and while EPA is considering the development of a category for soil fumigation, the potential changes to the federa l certification program and worker safety regulations to include a soil fumigation category are not anti cipated in the near future.

EPA believes that training is an effectiv e way to increase applicators’ skill and knowledge so they are better prepared to e ffectively manage the complexities and risks associated with soil fumigation. Further, training is a means of ensuring fumigators are able to understand and comply with revised fumigant labe ling. Therefore, EPA determined that training designed to establish a national baseline for safe fumigant us e, developed and implemented by registrants, will help enhance fumigators’ ability to adequately manage the complexities of soil fumigation and enhance compliance with fumigant product labeling. EPA also determined that providing additional safety information to other fumigant handlers will help them understand and adhere to practices that will help handlers protect themselves from risks of exposure.

Soil Fumigation Training Considerations

In comments on fumigant risk manageme nt options, stakeholders were broadly supportive of additional training for applicators and handlers. During the Phase 5 and post-RED comment periods, the majority of stakeholde rs, including growers, community groups, farm workers, states, and registrants expressed str ong support for increased tr aining for applicators

and other handlers. Several comm ents noted that fumigant inci dents affecting both fumigant workers and bystanders could have been prevented or mitigated if applicators had better training about correct practices and procedures.

The Agency agrees that additional training for fumigant applicators and handlers will help educate and inform these workers, thus decreasing the likelihood of both incidents and113 noncompliance. EPA believes fumigant-specific tr aining for applicators a nd additional training information for handlers also will help re duce the magnitude and frequency of exposure incidents and, coupled with the other mitigation m easures described in this decision, will address

risks of unreasonable adverse effect s from the use of soil fumigants.

It is important to note that training devel oped and provided by regi strants as required by this RED is separate and distinct from state cer tification programs. EPA encourages registrants, in developing their training proposals, to work with states where their products are used to identify opportunities to build on and compleme nt state programs. However, the training programs required as part of this decision are inte nded to be separate from the state certification process and will be developed and administered by registrants. Individual state regulatory agencies have the option of working with regist rants on these activities, but are not required to do so. It is important to note that some fu migant registrants have already developed soil fumigant training programs that will serve as a good basis for this expanded effort.

As noted above, several states have high-qua lity certification programs for fumigators that include exams to test the competency of fu migators. EPA recognized that for applicators to become certified in those states, they must acqui re the knowledge and skill necessary to pass the

exam. But several stakeholders commented th at training opportunities are varied across the country, and the scope and detail of information provided in availa ble training is not consistent.

EPA is also concerned that information in ex isting programs will need to be substantially updated as a result of new requi rements associated with this decision and the label changes which will implement it. Although EPA is consider ing revisions to the federal certification and training program in the future to include a soil fumigation category/subcategory, EPA believes that registrants have access to resources and mate rials to best develop and deliver training in the

interim.

EPA stresses that registrant tr aining programs will be separate from the state certification process and will be developed and administered by registrants in coordination with EPA. EPA will, however, work with state organizations a nd training experts to explore opportunities for the registrant programs to supplement any existing state programs to provi de additional training resources for fumigators working in those states. EPA will also work with state lead agencies and extension programs to review training progr am proposals, the conten t for the programs and materials, and proposed vehicles for delivery.

During the post-RED comment period, the Ag ency received comments from several states asking that the applicator training re quirements be coordinated with existing state certification and training programs. The Agency agrees that for states that have existing soil fumigation certification program s that address the same training elements required of the registrant soil fumigant training programs, as outlined in this section of the RED addendum, applicators should be able to complete the stat e certification program in lieu of completing the registrant soil fumigation training. For the stat e soil fumigation certification program to qualify, both EPA and the state must agree that the progr am satisfies the appli cator training elements required in the RED.114 Pesticide labels will state that “Before applying the product, the certified applicator supervising that applic ation must successfully complete a methyl bromide training program made available by the registrant wi thin the last 36 months. The Fumigant Management Plan (see details elsewhere on this label) must document when and where the registrant-provided training program or state certification was completed. This requirement for registrant-provided applicator training does not supersede or fulfill st ate requirements, unless the state has expressly acknowledged that the registrant traini ng may substitute for state requirements.”

Training for Applicators Supervising Fumigations

The July 2008 RED required registrants to develop and implement training programs for applicators in charge of soil fumigations on the proper use of and best management practices for soil fumigants. During the public comment period on the proposed mitigation measures and the post-RED comment period, stakeholders were br oadly supportive of a dditional training for fumigators, but concerns were ra ised with regard to implementa tion of the training. The Agency also received comments from state represen tatives and pesticide applicator training organizations, such as the Associ ation of American Pesticide Cont rol Operators, Association of American Pesticide Safety Educators, and Certification & Traini ng Assessment Group, expressing concern over EPA’s decision to impl ement the training via labeling and raising questions over compliance and state enforcemen t of such a requirement and the potential for conflict or redundancy with state certification and training progr ams. Various stakeholders recommended that, rather than a label-mandate d training requirement, the Agency, instead, should require registrants to de velop and implement training for soil fumigant applicators as a condition of registration.

The Agency’s goal in requiring soil fumigation tr aining for applicators is to ensure that all applicators in charge of so il fumigations understand the safe use of soil fumigants and in how to apply products in compliance with new pr oduct labeling, including pr ovision required by the RED. Given the unique properties of soil fumigant s and their application and safety procedures compared with other agricultural and non-agricu ltural pest control pr actices, the inherent complexities involved in soil fumigant applicat ions, and the additional complexities that will arise with the implementation of the REDs, the Agency feels that additional training, beyond that available currently, will be need ed. The states that currently have certification programs that include soil fumigation categories will not have requirements pertaining to the new mitigation and their programs will need to be modified. EPA agrees that making the required training programs a condition of registration is an importa nt means of ensuring that such training is ultimately developed and implemented. However, it would not ensure that all individuals in charge of soil fumigant applicati ons avail themselves of the trai ning. The Agency believes that making successful completion of the training a conditi on of use is also important to achieve this goal. Therefore, EPA has decided that developm ent and delivery of training will be included in the DCI that accompanies this RED and successf ul completion of the training will remain a

condition of use.

Each registrant must develop and implement training programs for applicators in charge of soil fumigations on the proper use of and best practices for soil fumigants. In addition, registrants will be required to submit proposals for these programs as data requirements that will115 accompany this RED. EPA will review each pr ogram and determine whether it adequately addresses the requirements specified in the DC I. The proposal must address, among other elements, both the content and the format for de livering training. The Agency acknowledges the value of hands-on training in the fi eld, but recognizes that may not be feasible in all instances. The Agency welcomes and is actively seeking participation from state lead agencies and extension programs in the evalua tion of the registrant training proposals and materials that are

submitted.

The training programs must a ddress, at a minimum, the following elements: (1) how to correctly apply the fumigant, including how to co mply with new label requirements; (2) how to protect handlers and bystanders; (3) how to determine buffer zone distances; (4) how to develop a FMP and complete the post-fumigation appli cation summary; (5) how to determine when weather and other site-specific factors are not favo rable for fumigant application; and (6) how to comply with required GAPs and how to document compliance with GAPs in the FMP. In addition, based on comments received during th e post-RED comment period, the Agency is adding a seventh training element—training progr ams must also include information on how to develop and implement emergency response plans—to ensure that applicator s are prepared in the event that a problem develops during or shortly after the fumigant application. EPA is also requiring registrants to incorporat e a mechanism for evaluating the effectiveness of their training programs at conveying the required information to participants and for determining whether participants have successfully completed the training program.

To assist states in enforcing these training re quirements, the registrants will be required to (1) develop a database to track which certified applicators have successfully completed the training, (2) make this database available to state and/or federal enforcement entities upon request, and (3) provide documentation (e.g., a card) to each training participant who successfully completes the training. This docum entation shall include the applicator’s name, address, license number, and the da te of completion. Applicators mu st provide to federal, state, or local enforcement personnel, upon request, this documentation that verifies successful completion of the appropriate training program(s).

In the July 2008 RED, the Agency require d applicators supervising fumigations to complete the training annually. During the post-RED public comment period, the Agency

received comments from various stakeholders indicating that the subs tance and content of training would not change signifi cantly from year to year, and that an annual training requirement for applicators would be excessi ve and burdensome to both applicators and registrants and was unnecessary. As a result of these comments, the Agency has decided to require applicators supervising fumigations to have successfully completed the program within the preceding 36 months and to document when and where the training program was completed in their FMPs. This may be accomplished, for example, by simply attaching a copy of the training documentation provided by the registrant to the FMP. The registrant also must be able to provide to federal, state, or local enforcem ent personnel, upon request, the names, addresses, and certified applicator license numbers of persons who successfully completed the training program, as well as the date of completion.116 Based on questions received during the post-RED comment period, the Agency is clarifying that the applicator tr aining requirements are active i ngredient-specific rather than product-specific. That is, appl icators who apply more than one of the soil fumigant active ingredients (i.e., methyl bromide, chloropicri n, metam sodium/potassium, or dazomet) will be required to complete training for each soil fumigant active ingredient they apply, but not for each different product containing the same active ingr edient(s). Further, EPA encourages the soil fumigant registrants to join tly develop programs to reduce the redundancy of this training requirement. For example, a substantial portion of the required training is universal to all soil fumigants. Therefore modules addressing the in formation common to all could be generic and each fumigator would participate in those modul es, while separate modules addressing active ingredient-specific content could be provided to those fumigators supervising applications with those active ingredients only. Documentation pr ovided to trainees could indicate the active ingredient modules completed. While EPA sees effi ciencies in such an a pproach, it will be the registrants’ choice as to how they will comply with the requirement to develop and implement training programs.

Training Materials for Handlers

EPA is requiring registrants to prepare and disseminate training information and materials for other fumigant handlers, i.e., thos e working under the supervision of the certified applicator in charge of fumigations. The Agency is requiring registrants to submit proposals for these materials through the data call-ins that wi ll accompany this RED. EPA will review these materials to determine whether they adequately address the requirements specified in the DCI. The Agency welcomes and is actively seeking participation from state lead agencies and extension programs in the evaluation of these handler training materials.

The training materials must address, at minimum, the following elements: (1) what fumigants are and how they work, (2) safe applic ation and handling of soil fumigants, (3) air monitoring and respiratory protec tion requirements for handlers, (4 ) early signs and symptoms of exposure, (5) appropriate steps to take to m itigate exposures, (6) what to do in case of an emergency, and (7) how to report incidents. Regi strants must provide th is training information through channels open to the public (e.g., via a we bsite). Pesticide labe ls will require that applicators supervising fumigati ons provide this training inform ation to handlers under their supervision before they perform any fumigant ha ndling task, or they must ensure that handlers have been provided the required information within the preceding 12 months. The label will also require that the training inform ation be provided in a manner th at the handler can understand. Applicators supervising fumigati ons must ensure the FMP incl udes how and when the required training information was provided to the handlers under their supervision.

“The certified applicator must provide fu migant safe handling information to each handler involved in the app lication in a manner that they can understand prior to performing any fumigant handling task or c onfirm that each handler participating in the application has received fumigant sa fe handling information in the past 12

months.”117 During the post-RED comment period, no s ubstantive comments were received that resulted in changes to the RED requirements for tr aining materials for handlers, as a result, these requirements are identical to those published in the July 2008 RED. However, during the comment period, the Agency received comments i ndicating that there was some confusion about whether fumigant handlers working under the su pervision of the certifie d applicator would be required to be trained, i.e., participate in a training program developed by the soil fumigant registrant(s), or whether handler s would need only to be provided with training information and materials. The Agency wishes to clarify that handler participation in a registrant training program, per se, is not required. As noted above , applicators supervisi ng a soil fumigation will be required to provide the regi strant-developed, EPA-approved tr aining information to handlers in a manner that they can understand prior to performing any fumigant handling task, or applicators must ensure that th e handler has been provided the required information within the proceeding 12 months.

vi. Community Outreach and Education Programs

EPA understands from public comments, site visits, and stakeholder meetings, conducted as part of the soil fumigant review, that there is often a fundamental lack of information and communication about soil fumigants within communities where soil fumigation occurs, which has raised health and safety concerns among comm unity members. This lack of information and communication has led to inappropriate responses in cases where fumigants have moved off site and into communities. This also has led, in some cases, to unwarranted concern and anxiety among communities about the risks associated with the use of fumigants. The Agency believes

that outreach and education to communities where soil fumigation occurs is an important component of the overall package of measures to address bystander ris k. Community outreach will address the risk of acute bystander expos ure by informing community members in high-use

areas about buffer zones and thei r characteristics a nd purpose, the meaning of posted warning signs, the importance of not ente ring buffer zones, how to rec ognize early signs of fumigant exposure, and how to respond approp riately in case of an incident.

In the July 2008 RED, the Agency require d registrants to develop and implement community outreach and education programs to a ddress these needs. At a minimum, these programs were to include the following elements : (1) what soil fumigants are and how they work, (2) what buffer zones are, (3) early signs and symptoms of exposure, (4) appropriate steps to take to mitigate exposures, (5) what to do in case of an emergency, and (6) how to report an incident as well as a plan for evaluating the effe ctiveness of these programs. Few details on how the programs would be implemented were provide d in the RED. Rather, during the post-RED comment period, the Agency sought feedback from the registrants and other stakeholders on how best to design and target programs to commun ity members in high-use areas. The Agency encouraged the registrants to work with exis ting community resources, such as community health networks, for disseminating information and implementing community outreach

programs.

During the post-RED comment period, the Agency received some comments from stakeholders that suggested that having regist rants develop and implement a community outreach and education program is unnecessary and likely to needlessly raise heath and safety concerns118 among community members, and such a requirem ent could draw scarce resources from other registrant stewardship efforts. As noted prev iously, the Agency believes that providing basic information about soil fumigants and buffer zones as well as information on what to do in the

event that an incident occurs to communities in high fumigant use areas is an important component of the overall package of risk mitiga tion measures to address bystander risk. EPA’s community outreach requirements do not preclude other voluntary stewardship programs or activities targeted to community members or th e applicator/grower comm unity, but rather are meant to help ensure that community members in high fumigant usage ar eas are informed about soil fumigant safety and better able to respond ap propriately if an incident were to occur.

Few recommendations and no specific proposals for these programs were received during the post-RED comment period. Therefore, the Ag ency is identifying minimum requirements that each registrant must fulfill when developing it s community outreach programs in response to a DCI that will be issued. The Agency remains open to considering additional registrant outreach program elements that address the same needs and goals as the program requirements described below in their response to the DCI. EPA notes that some stakeholders have suggested that programs focusing on specific targ et audiences may be more e ffective in providing useful information in a meaningful way than broadcas t messages to entire communities. Registrants have indicated that they will provide proposals for such progra ms in late May 2009. EPA looks forward to these proposals and will consider the extent to which th ey contribute to meeting the goals of the community outreach programs required by the RED.

In the absence of acceptable alternative proposals, registrants, will be required to provide

information to communities in the form of monthly public service announcements (PSAs)

distributed via local radio stations or news papers in high-use fumi gant areas during the fumigation season(s) in those area s. As per the requirements incl uded in the July 2008 RED, at a minimum, registrants must include the following information in their community outreach messages: (1) what soil fumigants are and how th ey work, (2) what buffer zones are, (3) early signs and symptoms of exposure to methyl bromid e, (4) appropriate steps to take to mitigate exposures to methyl bromide, (5) what to do in case of an emergency, and (6) how to report an incident as well as a plan for evaluating th e effectiveness of these programs. Based on comments, EPA has decided that information on the meaning of posted warning signs is also important to help ensure the signs convey th e needed information about the importance of staying out of buffer z ones and treated areas.

The Agency is requiring registrants to im plement their outreach programs in communities located in areas where there is high soil fumiga nt use. For the purposes of the RED addendum, high-use areas are considered at the county level. To identify these areas, the Agency is proposing a process for identifying high-use area s in the subsection following the section on information for first responders. However, the Agency is willing to consider alternative proposals for identifying high so il fumigant-use areas, based on additional data sources and alternate approaches identified by the registrant(s) and other stakeholders.119 Information for First Responders

In the July 2008 RED, the Agency required regi strants to ensure that first responders in areas with high fumigant usage ha ve the training and information th at they need to effectively identify and respond to fumigant exposure incident s. Specifically, the regi strants were required to provide information and/or training to first responders, wh ich at a minimum, included the following elements: (1) how to r ecognize the early signs and symp toms of fumigant exposure, (2) how to treat fumigant exposures, and (3) how fumigant exposure differs from other pesticide exposure. In addition, the registra nts were required to provide mate rial safety data sheets to first responders for the fumigant applied. Few de tails on how the education programs would be implemented were provided in the RED. Rath er, during the post-RED comment period, the Agency sought feedback from the registrants an d other stakeholders on how best to design and target programs to first responde rs in high-use areas. The Agency encouraged the registrants to work with state and local emerge ncy response coordinators to id entify needs and opportunities to supplement any information already included in stat e and local training for first responders about soil fumigants specifically.

During the post-RED comment period, the Ag ency received comments from several registrants indicating that rather than requiri ng registrants to implem ent face-to-face training programs, the Agency should consider allowing the required first responde r training information to be conveyed via written materials to stat e and local emergency response agencies, which would provide these agencies th e ability to incorporate this information into their existing training programs. Other comments indicated that even if training progr ams were developed, it would be difficult to ensure participation of fi rst responders. The Agency’s goal for the first responder training program is to ensure that fi rst responders in high use fumigant areas have access to the information that they need to be able to quickly and effectively identify an exposure that is fumigant related and re spond appropriately. The Agency ag rees that this goal can be met by requiring the soil fumigant registrants to develop informational materials on the soil fumigants and distribute this information to firs t responders (i.e., police, fire, rescue, emergency medical services, and others who respond to “911” calls) in high soil fumigant-use areas. This would then provide the first res ponder entities the ability to in corporate this information into their existing first responder training programs as they best see fit. This recommendation has been incorporated into the RED am endments for the soil fumigants.

The Agency is willing to consider additional registrant proposals so long as they address the same needs and achieve the same goals as th e program requirements described below. At a minimum, registrants will be required to de velop and disseminate chemical-specific soil fumigant training materials to first responders (i.e., police, fire, rescue, emergency medical services, and others who respond to “911” calls) operating in high fumi gant-use areas. As a data requirement in the DCIs that will accompany the REDs, registrants must submit proposals detailing how they will (1) identify the first responder entities in high so il fumigant-use areas to which they will disseminate the training materi als, and (2) provide materials to the first responders in these areas. Additionally registra nts must provide draft copies of the training materials for EPA review and approval. As pe r the requirements include d in the July 2008 RED, at a minimum, the materials must convey the foll owing information to first responders: (1) how to recognize the early signs and symptoms of methyl bromide fumigant exposure, (2) how to120 treat methyl bromide fumigant exposures, and (3) how methyl bromide fumigant exposures differ from other pesticide exposures as well as (4) copies of material safety data sheet(s) for the fumigant applied as well as for the active com pound generated, if applicable. Training materials can take a number of forms (e.g., brochures, f act sheets, CDs, vide os, web-based training materials) as long as these mate rials incorporate, at a minimu m, the information requirements

identified above.

The Agency is requiring registrants to target their first responder training information to those communities located in high soil fumigant-u se areas. For the purposes of the RED, highuse areas are considered at the county level. To identify these areas, th e Agency is proposing the following process. However, the Agency is wi lling to consider altern ative proposals in the registrants’ response to the DCIs for identifying and targeting hi gh-use soil fumigant areas, based on additional data sources and alternate appr oaches identified by the registrant(s).

Process for Identifying High-Use Fumigant Areas:

Identifying high-use areas for methyl bromid e is a two-step process because reliable fumigant use data is not availabl e at the county level from either publicly available data sources or EPA proprietary data sources. First, the states with high us e of methyl bromide have been identified by the Agency using EPA proprietary data. Second, the high-use counties for methyl

bromide within those states must be identified. The second step, identifying high-use counties, will be the registrant’s responsibilit y, using the process defined below.

• Step 1: Identifying States w ith High Use of Methyl Bromide: The Agency is defining states with high usage of methyl bromide as those states where, on average, more than 100,000 lbs of methyl bromide or chloropicrin are applied annually. To determine those states where, on average, more than 100,000 lb s of methyl bromide or chloropicrin have been applied annually, the Agency obtained data on the average number of pounds of methyl bromide and chloropicrin applied in all states across a ten–year period (1999- 2008) using EPA proprietary data. To view the Agency’s analysis of this data, please see the Biological and Econom ic Analysis Division’s ( 05/14/09) memo, “Process for Defining High-Use Fumigation Areas at the State and County Levels (DP# 364647)” and supporting documentation located in the methyl bromide docket at EPA-HQ-OPP-2005- 0123. The states identified for methyl br omide and chloropicrin are Washington, Oregon, Idaho, South Carolina, Georgia, No rth Carolina, California, Florida, and Michigan.

• Step 2: Identifying Counties with High Use of Methyl Bromide: For each of the high-use states that the Agency identified in Step 1, th e registrants will be re quired to identify the counties where use of methyl bromide may be high. Because county-level fumigant usage data is not publicly available and EPA pr oprietary data are not appropriate for this level of specificity, crop acreag e should be used as a surr ogate indicator for fumigant usage. Crop acreage can be obtained for ma jor use sites of methyl bromide from the publicly available 2007 USDA Census of Ag riculture. Crop acreages for each of the major use sites for methyl bromide should be and then summed by county. All counties making up at least the top 90% of acreage in a state are considered high-use areas.121 Registrants will be required to target each of these high-use counties for community outreach programs.

For the purposes of this analysis, the Agency defines a “major use site” as any crop that has more than 5% crop treated annually or more than 100,000 lb of methyl bromide or chloropicrin applied annually. The crops id entified for methyl br omide are cantaloupes, peppers, squash, strawberries, tomatoes, and watermelons.

Example Identifying High-Use Fumigant Areas for Metam Sodium in California:

To help explain the process for identifyi ng high-use fumigant areas for methyl bromide the Agency is providing the following example, which identifies the high-use counties for the soil fumigant, metam sodium, usage in California.

• Step 1: Identify States wi th High Use of Metam Sodium:

o Based on its analysis of pr oprietary data, the Agency has identified the following high-use states for metam sodium: Ca lifornia, Washington, Idaho, Oregon, Wisconsin, Michigan, Florida, Minnesot a, North Carolina, Virginia, Arizona, Nevada, Georgia, Colorado, and North Da kota. This example will focus only on identifying the counties in California with high use of metam sodium. The same process would be applied to other high-use states.

• Step 2: Identify the Counties in Calif ornia with High Use of Metam Sodium:

o EPA has identified the following as the major use sites of metam sodium/potassium: artichokes, cabbage, cantaloupes, carrots, onions, peanuts, peppers, potatoes, spinach, squash, tomatoes, and watermelons.

o Using the 2007 USDA Census of Agricult ure, registrants wi ll need to obtain harvested crop acreage data for each of th e 12 major use sites for metam sodium identified above for each county in California. (An example of this analysis is provided as a supporting document to th e Biological and Economic Analysis Division’s (05/14/09) memo, “ Process for Defining High-Use Fumigation Areas at the State and County Levels (DP# 364647),” which is located in the metam sodium docket at EPA-HQ-OPP-2005-0125.

o Registrants will then need to sum the total number of combined crop acres for these major use sites for each county in Ca lifornia and then select all the counties that make up at least the top 90% of acr eage in the county. [An example of this analysis is also provided as a s upporting document to the Biological and Economic Analysis Division’s (05/14/09) memo, “ Process for Defining High-Use Fumigation Areas at th e State and County Levels (DP# 364647),” which is located in the metam sodium docket at EPA-HQ-OPP-2005-0125.]

As with the training for fumigant applicat ors and handlers and the community outreach program that the Agency is requ iring, the first responde r training requirements are intended to be part of the registrants’ long-te rm product stewardship. The Agen cy encourages registrants to work with appropriate state emergency response entities in these areas to ensure that the122 appropriate first responder entiti es are being targeted and that the information being provided to first responders is both useful and presented appropriately.

c. Environmental Risk Management

In the July 2008 RED, EPA addressed the conc erns for both aquatic and terrestrial risks which are mentioned in Section III.D. The July 2008 RED also stated that EPA believed that mitigation measures detailed in the Human Health Risk Mitigation section would also reduce ecological risks. The Agency stated that al though buffer zones and GAPs do not directly reduce the potential risk to ecological organisms, these mitigation measures do provide an incentive to reduce fumigant application rates an d individual treatment areas whic h in turn will contribute to lower exposure and risks for non-target organisms.

In the July 2008 RED, EPA deviated from the Label Review Manual language because dissipation of methyl bromide in aquatic e nvironments is predominately dependent on volatilization and to a lesser extent on leaching a nd degradation. In addition, as discussed in the Human Health Risk Mitigation section managing soil moisture is an important factor that may be used to reduce peak emissions. Due to the importa nce of adequate soil mois ture as described in

the GAP section and the knowledge that volatilization is methyl brom ide’s most important route of dissipation, EPA required the following langu age in the July 2008 RED taking these factors into consideration , “While methyl bromide has certain properties and characteristics in common

with chemicals that have been detected in groundwater (methyl bromide is highly soluble in water and has low adsorption to so il), volatilization is this chemi cal's most important route of dissipation.”

The Agency still believes th at a deviation from the recommended language in the Label Review Manual is necessary due to the importa nce of soil moisture and methyl bromide’s volatility. While the Agency believes that volati lization is this chemical’s most important route of dissipation, it is being removed from the gr oundwater statement becau se volatilization is addressed in other areas of the mitigation pack age. The new language will state, “Methyl bromide has certain properties and characterist ics in common with chemicals that have been detected in groundwater (methyl bromide is highl y soluble in water and has low adsorption to soil).”

EPA also discussed, in the July 2008 RED, th e potential for methyl bromide to leach into groundwater when tarps are used in broadcast ap plications: falling temp eratures typically found in the late afternoon and evening would not pr omote dissipation of remaining methyl bromide under the perforated tarp and rainfall may cause remaining methyl bromide under the perforated tarp to leach into groundwater. For raised bed ap plications, rainfall is not a factor since planting occurs with the tarp in place and perforation and/or tarp removal occurs after methyl bromide has dissipated. In the 2008 RED, EP A required that tarps for broa dcast applications must be perforated before noon and only when rainfall is not expected within 12 hours. The Agency is keeping this requirement in the amended RED. The language is included in the Tarp Perforation

and Removal section of this document.123 The July 2008 RED also discussed the poten tial for methyl bromide to leach into groundwater and surface water if a rainfall event o ccurs after an untarped application. Methyl bromide may impact surface water quality due to runoff of rain water. This is especially true for poorly draining soils and soils with shallow ground water.

The Agency modified this language in the July 2008 RED due to the importance of soil moisture and methyl bromide’s volatility. The Agency required the following language in the July 2008 RED, “For untarped applications of methyl bromide, potential leaching into groundwater and runoff into surface water can be reduced by avoiding applications when heavy

rainfall is forecasted to occur within 24 hours.”

During the post-RED comment period comme nters stated that the above July 2008 RED language was not clear or enforceable. EPA would like to clarify that the statement was meant to be advisory and not mandatory. However in an e ffort to clarify the requirement the Agency has revised the July 2008 RED language as follows, “For untarped applications, leaching, and runoff may occur if there is heavy rainfall after soil fumi gation.” This is more likely in areas with poor draining soils. The revised statement is base d on information presented in a 2007 article by Zhang and Wang. 19

In addition to the changes above, EPA is re quiring several ecologi cal fate and effect studies to address data gaps iden tified in the ecological risk asse ssment. See Section V of this

document for details for revised label language and the studies.

d. Stratospheric Ozone De pletion Risk Management

While a quantitative reduction of methyl brom ide’s role in the depletion of stratospheric ozone resulting from the mitigation measures required by this decision can not be estimated, EPA believes that when looking at the mitigation as a whole, it can be qualitatively determined

that a reduction will result. The following supports this conclusion:

19 Zhang, Y. and Wang, D. 2007. Emi ssion, distribution, and leaching of meth yl isothiocyanate and chloropicrin under different surface containments. Chemosphere, 2007 Jun; 68(3): 445-454.124 Required Mitigation

Measure Rationale for expecting a reduction of Stratospheric Ozone Depletion

• Removal of uses with low

benefits and/or available alternatives (i.e., ineligibility for uses that do not qualify for exemptions from the Montreal Protocol) ► While the Agency acknowledges that limiting use to only Group 1 uses may slow the drawdown of the pre-2005 stockpile, it is reasonable to expect that new production for exempted uses will also

continue to decline as th ere will be more pre-2005 stockpile material availabl e for critical uses. The Agency believes that that this measure could

contribute to the reduc tion of methyl bromide applied annually.

• Reducing maximum application

rates; ► The Agency is limiting the labeled maximum application rates for CUE uses based rates from the most recent CUNs. Any reduction in application rate will result in less methyl bromide applied.

• Limiting use of 98:2 formulations to essential crops ► When 98:2 formulations are used, the amount of methyl bromide applied is generally higher compared to amount applied for other formulations. Limiting the use of 98:2 formulations to only essential crops will result in less methyl bromide applied.

• Buffer zones ► To achieve manageable buffer zone distances, many growers will be required to change their current cultural practices, including lowering rates, using high barrier tarps, using more efficacious application methods, usi ng alternatives, etc. Overall, these changes will result in lower application rates and less methyl bromide volatilizing into the atmosphere.

• GAPs and FMPs ► GAPs and FMPs will both result in better planning of fumigations and increase the likelihood of a safe and effective application. The Agency believes that these measures will also, to some degree, result in less methyl bromide volatilizing into the atmosphere.

2. Endocrine Disruptor Effects

EPA is required under the FFDCA, as ame nded by FQPA, to develop a screening program to determine whether certain substanc es (including all pes ticide active and other ingredients) “may have an effect in humans that is sim ilar to an effect pro duced by a naturally occurring estrogen, or other such endocrine effe cts as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of the program, androgen and thyroid hormone syst ems, in addition to the estrogen hormone125 system. EPA also adopted EDSTAC’s recommenda tion that the Program include evaluations of potential effects in wildlife. When the appropr iate screening and/or testing protocols being considered under the Agency’s Endocrine Disr upter Screening Program (EDSP) have been developed and vetted, methyl bromide may be subjected to additional screening and/or testing to

better characterize effects rela ted to endocrine disruption.

3. Endangered Species Considerations

The Agency has not conducted a risk asse ssment that supports a complete endangered species determination. The ecological risk as sessment planned during registration review will allow the Agency to determine whether methyl bromide use has “no effect” or “may affect” federally listed threatened or endangered specie s (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fi sheries Services (the Services), as appropriate.

D. Conclusions

The Agency has determined that Group 1 uses of methyl bromide are eligible for reregistration as long as they have CUE or QPS status under th e Montreal Protocol, and provided the risk mitigation measures outlined above ar e adopted and label amendments are made to

reflect these measures. Where la beling revisions are warranted, spec ific language is set forth in

the label table in Section V of this document. Any Group 1 uses that no longer qualify for CUE and QPS status should be canceled. Group 2 uses are not eligible for reregistration.



### V. What Registrants Need to Do

EPA recognizes that the extent of the mitigat ion needed for methyl bromide and the other soil fumigants will require continued coordi nation among state regulatory agencies, EPA, registrants, growers and other stakeholders to ensure that all provisions of the RED are understood, that data are developed and evaluate d expeditiously, and that bystander and worker protection measures are impleme nted as soon as practicable.

When the soil fumigant REDs were issued in July, 2008, EPA specifically requested comment on the mechanisms and timing of impl ementing the provisions of the REDs. After considering stakeholder comments largely focu sed on the challenges of implementing many new measures simultaneously, EPA has de veloped the following schedule:

July 2008 Methyl Bromide RED issued October 2008 Comment period closed May 2009 EPA responds to comments, amends RED as appropriate Mid 2009 EPA issues product and generic DCIs September 1, 2009 Registrants must submit revised labels to EPA , reflecting phase one of the mitigation measures as outlined in Ta ble 2: restricted use, GAPs, rate reductions, limitations on use sites, new handler protecti on measures, tarp cutting and removal restrictions, exte nded worker re-entry restrictions,126 training information for workers, an d relevant portions of the FMP requirements. December, 2009 EPA reviews/approve s new labeling for 2010 use season. During 2009-10 EPA works with registrants, stat es and stakeholders to develop and begin implementation of first responder an d community outreach, applicator training, and compliance assistance and assurance measures. September 1, 2010 Registrants must submit revise d labels to EPA refl ecting all remaining mitigation measures outlined in Table 2 including: applicator training, restri ctions on applications near sensitive sites, buffer zones, buffer credits, buffer zone pos ting and buffer overlap prohibitions and exceptions, and the full FMP requirements. 2009-2012 Registrants develop data per DCIs. 2013 EPA begins Registration Review fo r methyl bromide and other fumigants.

Labeling

Registrants must submit labeling reflecting phase one mitigation measures by September 1, 2009. All measures will need to be reflected on labels submitted to EPA by September 1, 2010. Because of the relatively large amounts of product shipped under a single label, e.g., 50 gallon drums and railroad tank cars, changes to fumigant labeling can be adopted relatively quickly. Therefore, the Agency anticipates that labeling appr oved late in 2009 would begin to appear on products used for the 2010 fumigation season.

A. Manufacturing Use Products

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of methyl bromide’s preplant soil uses

has been reviewed and determined to be substant ially complete. However, the data listed below are necessary to confirm the reregistration e ligibility decision documented in this RED.

a. Human health risk

Toxicity: none

Dietary Exposure: none

Occupational and Residential Exposure (ORE):

The following data are needed on methyl br omide for human health risk assessment:

• Field Emissions/Volatility: The current estimates of emissi ons which are critical in the calculation of modeling estimates used to define buffer zones are limited only to California OPPTS Guideline Number Data Requirement Study type

OPPTS Guideline 835.8100 Field volatility from soil Field Emissions127 and are not based on the most current cultural practices. These data will enable a more refined inhalation risk assessment to be comple ted for buffer zone determinations that will allow evaluations to be completed in all of th e major use regions of th e country and that are reflective of the most current cultural practices. It is believed that a pplication practices have rapidly evolved over the last few years to ac count for the requirements of the Montreal Protocol implementation and phase out strategy for methyl bromide.

b. Environmental fate and ecological risk

Environmental fate: none

Ecological effects:

The following data are needed on methyl bromid e (and the bromide ion, where indicated) for ecological risk assessment 20.

• Avian acute inhalation. The current estimate of avian risk is based largely on the mammal assessment. This study will enable an inha lation risk assessment specific to birds.

• Acute Fish Toxicity - bluegill trout. RQs for bluegill trout approach the EPA’s LOC. The risk assessment is currently relying on a S upplemental study for rainbow trout and various general literature toxicity values for other species.

• Acute Marine/Estuarine Fish. Given the use patterns of meth yl bromide, marine/estuarine species could be exposed. This study w ill enable a risk assessment specific for marine/estuarine species exposure.

• Acute Marine/Estuarine Mollusk. Given the use patterns of methyl bromide, marine/estuarine species could be exposed. Th is study will enable a ri sk assessment specific for marine/estuarine species exposure. It wi ll also improve certainty with the endangered species risk assessment, as this test speci es may be more representative of endangered

freshwater mussels than the freshwater Daphnia.

20 EPA-HQ-OPP-2005-0123-0038, Reregistration Environmental Risk Assessment for Methyl Bromide, June 8, 2004, DP Barcode 304641 OPPTS Guideline Number Data Requirement Study type

Special Avian acute inhalation ECO

850.1075 Acute Fish Toxicity - bluegill trout ECO

850.1075 Acute Marine/Estuarine Fish ECO

850.1025 Acute Marine/Estuarine Mollusk ECO

850.1035 Acute Marine/Estuarine Shrimp ECO

850.4225 Seedling Emergence – Tier II ECO

850.4250 Vegetative Vigor – Tier II ECO

850.4400 Aquatic Plant Growth – Tier II ECO

850.3020 Honeybee Acute Contact ECO128 • Acute Marine/Estuarine Shrimp. Given the use patterns of methyl bromide, marine/estuarine species could be exposed. This study w ill enable a risk assessment specific for marine/estuarine species exposure.

• Seed Germination/Seedling Emergence - Tier II. Methyl bromide is used in part due to its phytotoxicity at the applicati on site, and a wide range of open literature and other nonguideline studies indicate the potential for plant damage. This study will enable the assessment of risk to nontarge t terrestrial plants off-site.

• Vegetative Vigor - Tier II. Me thyl bromide is used in part due to its phytotoxicity at the application site, and a wide ra nge of open literature and ot her non-guideline studies indicate the potential for plant damage. This study will enable the asse ssment of risk to non-target terrestrial plants off-site.

• Aquatic Plant Growth - Tier II. Methyl bromide is used in part due to its phytotoxicity at the application site, and a wide ra nge of open literature and ot her non-guideline studies indicate the potential for plant damage. This study will enable the asse ssment of risk to non-target aquatic plants off-site. The current assessmen t used a non-guideline ope n literature toxicity

value.

• Honeybee Acute contact - This basic study is now being requested for virtually all outdoor uses, and will help determine the need fo r, and specifics of, bee hazard labeling.

c. Other data requirements

• Special Study - Community Outreach and Education Program

The Agency is requiring registrants to develop and implement community outreach programs, including programs for first responders, to address these needs. Community outreach programs must include the following elements, at minimum: (1) what soil fumigants are and how they work, (2) what buffer zones are, (3 ) early signs and symptoms of exposure, (4) appropriate steps to take to mitigate exposures, (5 ) what to do in case of an emergency, (6) how to report an incident, (7) information on how to develop and implement emergency response plans, and (8) a mechanism for evaluating the effectiveness of their training programs at conveying the required information to participants and for determining whether participants have successfully completed the training program. EP A expects registrants’ proposals for the first responder programs described in Section IV will also be designed to integrate with existing local first-response and emergency preparedness networks. OPPTS Guideline Number Data Requirement Study type

Special Community Outreach and Education Program Special

Special Training for Applicators Supervising Fumigations Special

Special Training Materials for Handlers Special129 • Special Study - Training for App licators Supervising Fumigations

EPA has determined that training, developed and implemented by registrants to foster product stewardship, will help reduce potential risk s associated with failure to adequately manage the complexities of fumigation, and failure to comply with fumigant product labeling. Additionally, EPA believes that providing safety information to other fumigant handlers will help them understand and adhere to practices th at will help handlers protect themselves from risks of exposure.

Registrants are required to de velop and implement training programs for applicators in charge of soil fumigations on the proper use of and GAPs for soil fumigants. EPA is requiring registrants to submit proposals for these program s. The training programs must address, at minimum, the following elements: how to correc tly apply the fumigant; how to protect handlers and bystanders; how to determine buffer zone di stances; how to develop a FMP and complete the post fumigation application summary; how to dete rmine when weather and other site-specific

factors are not favorable for fu migant application; how to comply with required GAPs and document compliance in the FMP. The training pr ogram must be made available to applicators at least annually. The registrant shall provide documentation, such as a card or certificate, to each applicator who successfully completes the training. This documentation shall include the applicator’s name, address, licen se number, and the date of comp letion. The registrant must be able to provide to federal, state, or local enforcement personnel, upon request, the names, addresses, and certified applic ator license numbers of person s who successfully completed the training program, as well as the date of comple tion. Applicators superv ising fumigations must have successfully completed the program within the preceding 36 months and must document when and where the training program was comple ted in the FMP. The registrants will be required to (1) develop a databa se to track which certified applicators have successfully completed the training and (2) make this database available to state and/or federal enforcement entities upon request. In additi on, the applicator must provide to Federal, State, or local enforcement personnel, upon request, documentation th at verifies completion of the appropriate training program(s).

• Special Study - Training Materials for Handlers

EPA has determined that registrants must prepare and disseminate training information and materials for other fumigant handlers, i. e., those working under the supervision of the certified applicator in charge of fumigations. The training materi als must address, at minimum, the following elements: (1) what fumigants ar e and how they work, (2) safe application and handling of soil fumigants, (3) air monitori ng and respiratory prot ection requirements for handlers, (4) early signs and symp toms of exposure, (5) appropria te steps to take to mitigate exposures, (6) what to do in case of an emergenc y, and (7) how to report incidents. Registrants must provide this training info rmation through channels open to the public (e.g., via a website). Pesticide labels will require that applicator s supervising fumigations provide this training information to handlers under their supervision be fore they perform any fumigant handling task, or they must ensure that handlers have been provided the required information within the preceding 12 months. The label will also require that the training information be provided in a manner that the handler can understand. Applicat ors supervising fumigations must ensure the130 FMP includes how and when the required trai ning information was provided to the handlers under their supervision.

Special Study – Buffer Zone Posting Signs

EPA has determined that registrants must prepare and disseminate generic buffer zone posting signs which meet the following criteria: (1) signs must remain legible during the entire posting period, and (2) signs must meet the gene ral standards outlined in the WPS for text size and legibility (see 40 CFR §170.120). The requireme nts for the contents of the sign are as

follows:

The treated area sign (currently required for fumigants) must state the following: -- Skull and crossbones symbol

-- "DANGER/PELIGRO," -- "Area under fumigation, DO NOT ENTER/NO ENTRE,"

-- "Methyl Bromide fumigant in USE," -- the date and time of fumigation, -- the date and time entry prohibition is lifted -- Name of this product, and -- name, address, and telephone number of the certified applicator in charge of the fumigation. The buffer zone sign must include the following: -- Do not walk sign

-- "DO NOT ENTER/NO ENTRE," -- “Methyl Bromide OR [Name of product] Fumigant BUFFER ZONE,”

-- contact information for the certified applicator in charge of the fumigation

Registrants must capture all of the informa tion above, excluding the contact information for the certified applicator in charge of fu migating. However, regi strants must provide appropriate space on the sign, and the sign must be made of material appr opriate for applicators

to write in this information on the buffer zone posting signs. Registra nts must provide buffer zone posting signs at the point of sale for applicators to use. EPA is requiring registrants to submit proposals that must address their strate gy for development and dissemination of the buffer zone posting signs.

2. Labeling for Manufacturing-Use Products

In order to be eligible for reregistration, am end all product labels to incorporate the risk mitigation measures outlined in Section IV. Also, various use and safety information will be required for labeling of all end-use products containing methyl bromide.131 B. End-Use Products

1. Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Ag ency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made. The Registrant must review previous data submissions to ensure that they meet curren t EPA acceptance criteria and if not, commit to conduct new studies. If a regi strant believes that previously submitted data meet current testing standards, then the study MRID numbers must be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining specific data requirements.

2. Labeling for End-Use Products

In order to be eligible for reregistration, am end all product labels to incorporate the risk mitigation measures outlined in Section IV.132 Table 10. Summary of Generic Labe ling Changes for Methyl Bromide

Description Amended Labeling Language Placement on

Label

Manufacturing Use Products

For all Manufacturing Use

Products “Only for formulation into a pre-plant soil fumigant for the following use-sites: Uses, users, and locations that qua lify for exemptions und er the Montreal Prot ocol (e.g., critical use exemption or Quarantine and preshipment exemption uses). All end use products that contain directions for use as for crops/use sites that do not qualify for exemptions under the

Montreal Protocol must be ch anged to remove those crops/us e sites. All structural/space

uses have been cancelled.”

“Methyl bromide formulated into end-use products containing 98% methyl bromide must contain directions for use only for the following uses: orchard replant, ornamentals (hot gas method only), forest seedlings, and quarantine uses. All other use sites and use patterns are prohibited and must be removed from the end-use product labeling.”

“Methyl bromide cannot be formulated into end-use products labeled for pre-plant uses without the use of tarps with the exception of California orchard replant for CUE use using the deep broadcast application method.”

“Methyl bromide cannot be formulated into end-use products labeled for pre-plant or pretransplant uses unless the registrant makes av ailable to certified a pplicators who purchase or apply the end-use product a training program approved by EPA that provides information on how to correctly apply the fumigant including: how to protect themselves and other handlers and bystanders, how to determine buffer zone distances, how to develop a Fumigant Management Plan, how to determine when weather and other site-specific factors are not favorable for fumigant application, and how to develop an emergency response plan. The training program must be made available at least annually to the certified applicators. Certified applicators mu st take the training every 36 months. The registrant must be able to provide, upon request, the names, addresses, and certified applicator license number of persons who su ccessfully complete the training program.”

“Methyl bromide cannot be formulated into end-use products labeled for pre-plant or pre-transplant uses unless the registrant assures warning signs suitable for posting buffer zones are available to end-use product users at the point of sale.
The buffer zone sign must meet the following standards:

o Signs must remain legible during entire posting period.

o The size and type of the buffer zone signs must follow the requirements in the Worker Protection Standard for Agricultural Pesticides for treated area posting.

. Contents of Sign

-- "DO NOT ENTER/NO ENTRE," -- "Methyl Bromide [name of product] Fumigant BUFFER ZONE,” Directions for

Use133 -- space for contact information for the certified applicator in charge of the fumigation

One of these statements may be

added to a label to

allow reformulation of the product for a specific use or all

additional uses supported by a

formulator or user. “This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding su pport of such use(s).”

“This product may be used to formulate products for any additional use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding su pport of such use(s).” Directions for

Use

Environmental

Hazards Statements “This pesticide is toxic to mammals, birds, fish, and aquatic invertebrates. Do not discharge effluent contai ning this product into lakes, str eams, ponds, estuaries, oceans, or

other waters unless in accordance with the re quirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharg e effluent containing this product to sewer systems without previously notifying the lo cal sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.” Precautionary

Statements

End Use Products

Restricted Use Requirement for all products that contain

soil use “Restricted Use Pesticide due to acute inhalati on toxicity to humans. For retail sale to and use by certified applicators or persons under their direct supervision and only for those uses covered by the certified applicator’s certification.” Top of the front panel

For pre-plant soil

use.

Certified applicator training program “The certified applicator supervising the app lication must successfully complete a methyl bromide training program made available by the registrant within the last 36 months. The Fumigant Management Plan (see details elsewhere on this label) must document when and where the training program was completed.” Directions for

Use

For pre-plant soil

use.

Fumigation Handlers “The following activities are prohibited from be ing performed in the fumigant application block or surrounding buffer zone during the buffer zone period by anyone other than persons who have been appropriately trained and equipped as handlers in accordance with the requirements in the Worker Protection Sta ndard (40 CFR Part 170), from the start of the application until the entry-restricted period ends. Those activities include those

persons:

• Participating in the application as supervis ors, loaders, drivers, tractor co-pilots, shovelers, cross ditchers, or as other direct application participants (the application starts when the fumigant is first introduced into the soil and ends after the fumigant has stopped being delivered/dispensed to the soil);

• Using devices to take air samples to monitor fumigant air concentrations;

• Persons cleaning up fumigant spills (this does not include emergency personnel not associated with the fumigation application);

• Handling or disposing of fumigant containers;

• Cleaning, handling, adjusting, or repairing the parts of fumigation equipment that In the Precautionary

Use Section134 may contain fumigant residues;

• Installing, repairing, or operating irrigation equipment in the fumigant application block or surrounding buffer zone during the buffer zone period;

• Entering the application site or surrounding buffer zone during the buffer zone period to perform scouting, crop advising, or monitoring tasks;

• Installing, perforating (cutting, punching, slicing, poking), removing, repairing, or monitoring tarps:

o until 14 days after application is comp lete if tarps are not perforated and removed during those 14 days, or

o until tarp removal is complete if tarps are both perforated and removed less than 14 days after application; or

o until 48 hours after tarps perforation is complete if they will not be removed within 14 days after application. NOTE: see Tarp Perforation and Removal section on this labeling for requirements about when tarps are allowed to be perforated.”

• In addition, to the above, persons outside the perimeter of the buffer zone who monitor fumigant air concentrations must also be trained and equipped as handlers in accordance with the requir ements in the WPS (40 CFR Part 170).

For pre-plant soil

use.

Supervision of

Handlers “For all applications: from the start of the application until the fumigant has stopped being delivered/dispensed into the soil, i.e., after the soil is sealed, the certified applicator must be at the fumigation site and must directly supervise all persons performing handling

activities.

For fumigant handling activities that take place after the fumigant has been delivered/dispensed into the soil until the entr y restricted period expires, the certified applicator does not have to be on-site, but must have communicated in writing to the site owner/operator and handlers the information necessary to comply with the label and procedures described in the FMP (e.g., emergency response plans and procedures).

IMPORTANT: this requirement does not override the requirements in the Worker Protection Standard for Agricultural Pesticides for information exchange between owners/operators of agricultural establishmen ts and commercial pesticide applicators.

The certified applicator must provide fumigant safe handling information to each handler involved in the application or confirm that each handler partic ipating in the application has received fumigant safe handling info rmation in the past 12 months.

For all fumigant handling tasks at least two handlers trained under the provisions of the WPS 40 CFR 170.230 must be present.” Directions for

Use
Under the

section “protection for

handlers”

For pre-plant soil

use.

Exclusion of Non

Handlers from Application Block

and Buffer Zone “The certified applicator supervising the application and the owner/operator of the establishment where the fumiga tion is taking place must make sure that all persons who are not trained and PPE-equipped and who are not performing one of the handling tasks defined in this labeling are:

• excluded from application block during the entry-restricted period, and

• excluded from the buffer zone during the buffer zone period.” Directions for

Use
Under the

section “protection for

handlers”

For pre-plant soil use

Providing, cleaning, and maintaining PPE “The employer of any fumigant handler (as stated in this label) must make sure that all handlers are provided and correctly wear the required PPE. The PPE must be cleaned and maintained as required by the Worker Protection Standard for Agricultural Pesticides.” Directions for

Use
Under the

section “protection for

handlers”135 Air-rescue deviceavailability for preplant soil uses.

Pic and MeBr only “The fumigation handler employer must confirm and document in the FMP that at least one air rescue device (e.g., SCBA) is on-site an d is ready for use in case of an emergency.” Directions for

Use
Under the

section “protection for

handlers” Respiratoravailability for preplant soil uses. “The fumigation handler employer must confirm and document in the FMP that an airpurifying respirator and appropriate cartridges of the type specified in the PPE section of this labeling are immediately available for each handler who will wear one. At a minimum two handlers have the appropria te respirator and cartridge s available and that these handlers are fit-tested, trained, and medically examined.”

PPE Requirements Established by the

RED for all

Formulations with 80% or less methyl

bromide.

This will change

based on chemical “Personal Protective Equipment (PPE)

Some materials that are chemi cal-resistant to this product ar e [registrant inserts correct material(s)].” For more options, follow the instructions for category [insert A, B, C, D, E, F, G or H] on the chemical-resi stance category selection chart.

All fumigant handlers must wear:

• Long-sleeved shirt and long pants,

• Chemical-resistant footwear and so cks when in the treated field,

• Shoes and socks for all other handlers

• Chemical-resistant gloves when handling liquid,

• Chemical-resistant apron when handling liquid, and

• Protective eyewear when handling liquid (Do NOT wear goggles)

In addition, when a respirator is requ ired, fumigant handlers must wear a:

• NIOSH-approved full-face, or hood-style re spirator with a cartr idge or canister certified by the manufacturer for protection from exposure to methyl bromide at concentrations up to 5 ppm (e.g., a 3M air-purifying respirator equipped with 3M Model 60928 Organic Vapor/Acid Gas/P100 cartridges),

IMPORTANT; an air-supplying respirator [i.e., a respirator connected directly to a clean air source or a self-contained breathing apparatus (SCBA)] is not permitted for routine fumigant handler tasks. Such respirators are only permitted in emergencies such as a spill

or leak or when corrective action is needed to reduce air levels to acceptable levels.” Immediately following/belo

w Precautionary

Statements:

Hazards to

Humans and

Domestic

Animals

For pre-plant soil

use.

Respiratory Protection and Stop Work Triggers “Respiratory Protection and Stop Work Triggers: The following procedures

must be followed for all formulations with 80 % or less methyl bromide :

• If at any time any handler experiences sensory irritation (tearing, burning of the eyes or nose) then either:

o An air-purifying respirator (APR) must be worn by all handlers who remain in the application block and surrounding buffer zone, or

o Operations must cease and handlers not wearing respiratory protection must leave the application block and surrounding buffer zone.

• Handlers can remove respirators or resume operations if two consecutive breathing-zone samples taken at the handli ng site at least 15 minutes apart show that levels of methyl bromide have decreased to less than 1 ppm and levels of chloropicrin have decreased to less than 0.15 ppm, provided that handlers do not experience sensory irritation. Samples mu st be taken where the irritation is first experienced.

• When respirators are worn, air monitoring samples must be collected at least every 2 hours in the breathing zone of a handler performing a representative handling task. Directions for

Use136 • If at any time: (1) a handler experiences any sensory irrita tion when wearing a respirator, or (2) a methyl bromide ai r sample is greater than 5 ppm or a chloropicrin air sample is greater than or equal to 1.5 ppm, then all handler

activities must cease and handlers must be removed from the application block and surrounding buffer zone. If operations cease the emergency plan detailed in the FMP must be implemented.

• Handlers can resume work activities without respiratory protection if two consecutive breathing-zone samples taken at the handling site at least 15 minutes apart show levels of methyl bromide have decreased to 1 ppm and levels of chloropicrin have decreased to less than 0.15 ppm, provided that handlers do not experience sensory irritation.

• During the collection of air samples an air-purifying respirator must be worn by the handler taking the air samples. Samples must be taken where the irritation is first experienced.

• Work activities may resume if the following conditions exist provided that the appropriate respiratory protection is worn:

o two consecutive breathing zone samples for methyl bromide taken at the handling site at least 15 minutes apart must be less than 5 ppm,

o two consecutive breathing zone samp les for chloropicrin taken at the handling site at least 15 minutes apart must be less than 1.5 ppm,

o handlers do not experience sensory irritation while wearing the APR,

o cartridges have been changed, and

o during the collection of air samples an air-purifying respirator must be worn by the handler taking the air samples. Samples must be taken where the irritation is first experienced.

The following procedures must be followed for all formulations with more than 80 % methyl bromide :

If the fumigant applied contains greater than 80 percent methyl bromide (e.g., 98:2 formulations), air purifying respirators must be worn during all handler tasks and the following air monitoring procedures must be followed to ensure that the upper protection limit of the respirator plus respirator cart ridge is not exceeded (i.e., 5 ppm for methyl bromide and 1.5 ppm for chloropicrin):

• Air monitoring samples for methyl bromide an d chloropicrin must be collected at least every hour in the breathing zone of a handler performing a representative handling

task.

• If at any time (1) a handler experiences any sensory irritation while wearing a respirator, or (2) any air sample is greater than or equal to 5 ppm for methyl bromide, or (3) any air sample is greater than or equal to 1.5 ppm for chloropicrin, then all

handler activities must cease and handlers must be removed from the application block and surrounding buffer zone.

• In order to resume work activities:

° Two consecutive air samples for methyl bromide and chloropicrin taken in the treatment area at least 15 minutes apart must be less than 5 ppm for methyl bromide and less than 1.5 ppm for chloropicrin.

° During the collection of samples an air purifying respirator must be worn by the handler taking air samples.

 Hot gas tarped applications

Once the fumigation has started, if entry into the greenhouse enclosure or the outdoor treatment area is required to perform a function necessary for the application, a

SCBA must be worn. Handlers must wear SCBA to reenter the gr eenhouse/treated areas137 for a minimum of 48 hrs after the fumigant has stopped being delivered/dispensed to the

soil.

 Deep probe injection

EPA is requiring that SCBA be worn when applying methyl bromide with handheld equipment.

PPE Requirements Established by the

RED 1

For Formulations with > 80% methyl bromide (i.e., 98:2)

(This is different

from the

formulations with 80% or less methyl

bromide because

handlers must wear air-purifying respirators when performing handling

tasks and the monitoring requirements are different.) “ All handlers must wear:

• Long-sleeved shirt and long pants,

• Chemical-resistant footwear and so cks when in the treated field,

• Shoes and socks for all other handlers

• Chemical-resistant gloves when handling liquid,

• Chemical-resistant apron when handling liquid, and

• Protective eyewear when handling liquid (Do NOT wear goggles)

• NIOSH-approved half-face, full -face, or hood-style respir ator with a cartridge or canister certified by the manufacturer for protection from exposure to methyl bromide at concentrations up to 5 ppm (e.g., a 3M air-purifying respirator equipped with 3M Model 60928 Organic Vapor/Acid Gas/P100 cartridges), and

IMPORTANT: an air-supplying respirator (i.e., a respirator connected directly to a clean air source or a self-contained breathing apparatus (SCBA) is not permitted for routine fumigant handler tasks. Such respirators are only permitted in emergencies such as a spill

or leak or when corrective action is needed to reduce air levels to acceptable levels. Immediately following/

below Precautionary

Statements:

Hazards to

Humans and

Domestic

Animals

Fumigant Air Monitoring for all

Formulations with > 80% methyl bromide
(i.e., 98:2) “Fumigant Air Monitoring Requirements: The following air monitoring procedures must be followed to ensure that the upper protection limit of the respirator plus respirator cartridge or canister is not exceeded (i.e ., 5 ppm for methyl br omide and 1.5 ppm for chloropicrin)

• Air monitoring samples for methyl bromide an d chloropicrin must be collected at least every hour in the breathing zone of a handler performing a representative handling

task.

• To monitor air concentration levels, a direct reading detection device, such as a Matheson-Kitagawa, Draeger, or Sensidyne device must be used. The devices must have sensitivity of at least 5 ppm for methyl bromide and 1.5 ppm for chloropicrin

• If at any time (1) a handler experiences any sensory irritation while wearing a respirator, or (2) any air sample is greater than or equal to 5 ppm for methyl bromide, or (3) any air sample is greater than or equal to 1.5 ppm for chloropicrin, then all

handler activities must cease and handlers must be removed from the application block and surrounding buffer zone until corrective action has been taken.

• During the corrective actions if methyl brom ide air concentrations are greater than or equal to 5 ppm or if chloropicrin air concentrations are greater than or equal to 1.5 ppm, then a self-contained breathing apparatus (SCBA) must be worn.

• In order to resume work activities:
3⁄4 Two consecutive air samples for methyl bromide and chloropicrin taken in the treatment area at least 30 minutes apart, must be less than 5 ppm for methyl bromide and less than 1.5 ppm for chloropicrin.
3⁄4 During the collection of samples an air purifying respirator must be worn by the handler taking air samples. Immediately following/belo

w Precautionary

Statements:

Hazards to

Humans and

Domestic

Animals

User Safety Requirements “Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from Precautionary

Statements:138 other laundry.”

“Discard clothing and other absorbent materi als that have been drenched or heavily contaminated with this product’s concentrate. Do not reuse them.” Hazards to

Humans and

Domestic

Animals immediately following the

PPE requirements

PPE Requirements Established by the

RED

For pre-plant soil

uses. “Respirator fit testing, medical qualification, and training Employers must ensure that any hand ler that uses a respirator is:

• Fit-tested and fit-checked us ing a program that conforms to OSHA’s requirements (see 29 CFR Part 1910.134)

• Trained using a program that confirms to OSHA’s requirements (see 29 CFR Part 1910.134)

• Examined by a qualified medical practitioner to ensure physical ability to safely wear the style of respirator to be worn. A qualified medical practitioner is a physician or other licensed health care professional who w ill evaluate the ability of a worker to wear a respirator. The initial evaluation consists of a questionnaire that asks about medical conditions (such as a heart condition) that would be problematic for respirator use. If concerns are identified, then additional evaluations, such as a physical exam, might be necessary. The initial evaluation must be done before respirator use begins. Handlers must be reexamined by a qualified medical practitioner at least annually or if their health status or respirator style or use-conditions change.” Directions for

Use Under the

section

“Protection for

Handlers”

For pre-plant soil

use.

Application Requirements, when tarps are used: Tarp

Perforation and/or

Removal “Tarp Perforation and/or Removal

IMPORTANT: Persons perforating, repairing, removing, and/or monitoring tarps are defined, within certain time limitations, as fumigant handlers (see fumigant handlers as stated in this labeling) and must be provided the PPE and other protections for handlers as required on this labeling and in the Worker Protection Standard for Agricultural Pesticides.

• Tarps must not be perforated until a minimum of 5 days (120 hours) have elapsed after the fumigant injection into the soil is complete (e.g., after injection of the fumigant product and tarps have been laid or after drip lines have been purged and tarps have been laid), unless a weather condition exists which necessitates the need for early perforation or removal See Early Tarp Removal for Broadcast Applications Only and Early Tarp Perforatio n for Flood Prevention sections.

• If tarps will be removed before planting, tarp removal must not begin until at least 2 hours after tarp perforation is complete and 2 air monitoring samples are less than 1 ppm methyl bromide. (If 2 air monitoring samples have methyl bromide levels between 1 ppm and 5 ppm, then respirator protection is required before tarp removal can begin.)

• If tarps will not be removed before planting, planting or transplanting must not begin until at least 48 hours after the tarp perforation is complete.

• If tarps are left intact for a minimum of 14 days after fumigant injection into the soil is complete, planting or transplanting may take place while the tarps are being perforated.

• Each tarp panel used for broadcast fumigation must be perforated.

• Tarps used for fumigations may be perforated manually ONLY for the following

situations:

o At the beginning of each row when a coulter blade (or other device which performs similarly) is used on a motorized vehicle such as an

ATV.

o In fields that are 1 acre or less. Directions For

Use139 o During flood prevention activities.

• In all other instances tarps must be perforated (cut, punched, poked, or sliced) only by mechanical methods.

• Tarp perforation for broadcast fumigations must be completed before noon.

• For broadcast fumigations tarps must not be perforated if rainfall is expected

within 12 hours.

• Early Tarp Removal for Broadcast Applications Only:

o Tarps may be removed before the required 5 days (120 hours) if adverse weather conditions have compromised the integrity of the tarp, provided that the compromised tarp poses a safety hazard. Adverse weather includes high wind, hail, or storms that blow tarps off the field and create a hazard, e.g., tarps blowing into power lines and onto roads. A compromised tarp is a tarp that due to an adverse weather condition is no longer performing its intended function and is creating a hazard.

o If tarps are removed before the required 5 days have elapsed due to adverse weather, the events must be documented in the post fumigation summary section of the FMP.

• Early Tarp Perforation for Flood Prevention Activities

o Tarp perforation is allowed before the 5 days (120 hours) have elapsed if rain necessitates field drainage.

o Tarps must be immediately retucked and packed after soil removal.

o Subsequent tarp perforations must not occur until the original 5 days have elapsed.

o The events must be documented in the post fumigation summary section

of the FMP.”

Monitoring Air

Concentration Levels “MONITORING AIR CONCENTRATION LEVELS Monitoring Air Concentrations in the Buffer Zone Areas: When air concentration levels must be monitored (i.e., as specified in the general buffer zone requirements section), use a direct reading detection devi ce, such as a Matheson-Kitagawa, Draeger, or Sensidyne device. The devices must have sensitivity of at least 1 ppm for methyl bromide and 0.15 ppm for chloropicrin.” Directions for

Use under the heading

“General

Buffer Zone Requirements

”
Agriculture Use Requirements box Agricultural Use Requirements
After the standard paragraphs for the Agricultural Use Requirements box, substitute the following text for the standard restricted-entry interval and double notification requirements:

“For the entry restricted period an d notification requirements, see the Application Block Entry Restricted Period and Notification section of this labeling.” Agricultural

Use Requirements

box

For pre-plant soil

use.

Entry Restricted

Period “Entry Restricted Period
Entry (including early entry that would otherwise be permitted under the WPS) by any person – other than a correctly trained and PPE-equipped handler who is performing a handling task listed on this labeling – is PR OHIBITED - from the st art of the application

until:

• 5 days (120 hours) after the application is complete for untarped applications, or

• 5 days (120 hours) after application is complete if tarps are not perforated and removed for at least 14 days following application, or

• 48 hours after tarp perforation is complete if they will not be removed for at least 14 days following application, or

• until tarp removal is completed if tarps are both perforated and removed less than Directions for

Use under the heading “Entry

Restricted

Period and

Notification”140 14 days after application.

NOTE: see Tarp Perforation and Removal secti on on this labeling for requirements about when tarps are allowed to be perforated.”

For pre-plant soil

use.

Notification Requirement for the

treated area “NOTIFICATION: Notify workers of the application by warning them orally and by posting fumigant warning signs. The signs must bear the skull and crossbones symbol and

state: -- “DANGER/PELIGRO,” -- “Area under fumigation, DO NOT ENTER/NO ENTRE,”

-- “Methyl Bromide Fumigant in USE,” -- the date and time of fumigation, -- the date and time entry prohibition period is over, -- Name of this product, and -- Name, address, and telephone number of the certified applicator in charge of the fumigation.

Post the fumigant warning sign instead of th e WPS sign for this application but follow all WPS requirements pertaining to location, legibility, size, and timing of posting and

removal.

Post the fumigant warning signs at all entrances to the application block (i.e., the greenhouse or field or portion of a field treated with a fumigant in any 24-hour period)” Direction for

Use under the heading “Entry

Restricted

Period and

Notification”

For pre-plant soil

use.

Mandatory Good Agricultural

Practices for all

formulations “ Mandatory Good Agricultural Practices (GAPs)

The following GAPs must be followed during all fumigant applications. All measurements and other documentation planned to ensure that the mandatory GAPs are achieved must be recorded in the FMP and/or the post-application summary report.

Tarps (required for all applications except for deep shank orchard replant [California only] and hand held tree-hole applications)

• Tarps must be installed prior to starting hot gas applications.

• Tarps must be installed immediately after the fumigant is applied to the soil for bedded or broadcast applications.

• A written plan for tarpping must be developed and included in the FMP that address the following:

o schedule and procedures for checking tarps for damage, tears, and other problems

o plans for determining when and how repairs to tarps will be made, and by whom

o minimum time following injection that tarp will be repaired

o minimum size of tarp damage that will be repaired

o other factors used to determine how and when tarp repair will be conducted

o schedule, equipment, and methods used to perforate tarps

o aeration plans and procedures following perforation of tarp, but prior to tarp removal or planting/transplanting

o schedule, equipment, and pro cedures for tarp removal.

Weather Conditions

• Prior to fumigation the weather forecast for the day of the application and the 48-hour period following the fumigation must be checked to determine if unfavorable weather conditions exist (see Identifying Unfavora ble Weather Conditions section) or are predicted and whether fumigation should proceed.

• Wind speed at the application site must be a minimum of 2 mph at the start of the application or forecasted to reach at least 5 mph during the application. Directions for

Use under “Mandatory

Good Agricultural

Practices”141 • Do not apply if a shallow, compressed (low-l evel) temperature inversion is forecast to persist for more than 18 consecutive hours for the 48-hour period after the start of application, or if there is an air-stagnation advisory in effect for the area in which the fumigation is planned.

• Detailed local forecasts for weather cond itions, wind speed, and air stagnation advisories may be obtained on-line at: http://www.nws.noaa.gov . For further guidance, contact your local Nationa l Weather Service Forecasting Office.

Identifying Unfavorable Weather Conditions

• Unfavorable weather conditions block upwa rd movement of air which results in trapping fumigant vapors near the ground. The resulting air mass can move off-site in unpredictable directions and cause injury to humans, animals or property. These conditions typically exist prior to sunset and continue past sunrise and persist as late as noontime. Unfavorable conditions are common on nights with limited cloud cover and light to no wind and their presence can be indicated by ground fog or smog and can also be identified by smoke from a ground source that flattens out below a ceiling layer and moves laterally in a concentrated cloud.

Soil Temperature

• The maximum soil temperature at the depth of injection shall not exceed 90 degrees F at the beginning of the application.

o If air temperatures have been above 100 degrees F in any of the three days prior to application, then soil temperature shall be measured and recorded in the FMP.

Soil Moisture

• The soil must be moist 9 inches below the su rface. The amount of moisture needed in this zone will vary according to soil type and shall be determined using USDA Feel and Appearance Method for testing (see below). Surface soil generally dries rapidly

and must not be considered in this determination.

• If there is insufficient moisture 9 inches below the surface, the soil moisture must be adjusted. If irrigation is not available and there is adequate soil moisture below 9 inches, soil moisture can be adjusted by discing or plowing before fumigant injection. To conserve existing soil moisture, pretreatment irrigation or pretreatment tillage should be done as close to the time of application as possible.

• Measure soil moisture at a depth of 9 inches at either end of the fiel d, no more than 48 hours prior to application.

Soil moisture determination The soil shall contain at the time of application enough moisture at the point of injection below the surface to meet the follow ing criteria defined in the USDA Feel and Appearance method for estimating soil moisture as appropriate for the soil texture

.

• For coarse textured soils (fine sand and loamy fine sand), the soil is moist enough (50 to 75 percent available soil water moisture) to form a weak ball with loose and clustered sand grains on fingers, darkened color, moderate water staining on fingers,

will not ribbon.

• For moderately coarse textured soils (sandy loam and fine sandy loam), the soil is moist enough (50 to 75 percent available soil water moisture) to form a ball with defined finger marks, very light soil/water st aining on fingers, darkened color will not

stick.

• For medium textured soils ( sandy clay loam, loam, and silt loam), the soil is moist enough (50 to 75 percent available soil water moisture) to form a ball, very light142 staining on fingers, darken ed color, pliable, and form s a weak ribbon between the thumb and forefinger.

• For fine textured soils (clay, clay loam, and silty clay loam), the soil is moist enough (50 to 75 percent available soil water moisture) to form a smooth ball with defined finger marks, light soil/water staining on fingers, ribbons between thumb and forefinger.

• For fields with more th an one soil texture , soil moisture content in the lightest textured (most sandy) areas must comply with this soil moisture requirement. Whenever possible, the field should be divided into areas of similar soil texture and the soil moisture of each area should be adjust ed as needed. Coarser textured soils can be fumigated under conditions of higher soil moisture than finer textured soils; however, if the soil moisture is too high, fumigant movement will be retarded and

effectiveness of the treatment will be reduce d. Previous and/or local experience with the soil to be treated or the crop to be pl anted can often serve as a guide to conditions that will be acceptable. If there is uncerta inty in determining the soil moisture content of the area to be treated, local extension se rvice or soil conservation service specialist or pest control advisor (agriculture consultant) should be consulted for assistance.

Soil Preparation

• Soil shall be properly prepared and at the surface generally be free of clods that are golf ball size or larger. The area to be fumigated shall be tilled to a depth of 5 to 8

inches.

• Field trash must be properly managed. Residue from a previous crop must be worked into the soil to allow for decomposition prior to fumigation. Little or no crop residue shall be present on the soil surface. Crop resi due that is present must not interfere with the soil seal. Removing the crop residue prior to fumigation is important to limit the natural “chimneys” that will occur in the soil when crop residue is present. These “chimneys” allow the soil fumigants to move through the soil quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. However, crop residue on the field serves to prevent soil erosion from both wind and water and is an important

consideration. To accommodate erosion c ontrol, fumigant efficacy, and human health protection, clear fields of crop residue as close to the timing of the fumigation as possible to limit the length of time that the soil would be exposed to potentially

erosive weather conditions.

Soil Sealing

• For Broadcast Untarped Applications: Use a disc or similar equipment to uniformly mix the soil to at least a depth of 3 to 4 in ches to eliminate the chisel or plow traces. Following elimination of the chisel trace, the soil surface must be compacted with a cultipacker, ring roller, and roller in combination with tillage equipment.

• For Bedded Applications : Performed beds shall be sealed by disruption the chisel trace using press sealers, bed shapers, cultipackers, or by re-shaping (relisting, lifting and replacing, etc.) the beds immediately follo wing injection. Beds formed at the time of application shall be sealed by disrupting the chisel trace using press sealers, or bed shapers.

• Soil Sealing for Tarped Applications : The use of a tarp does not eliminate the need to minimize chisel traces prior to application of the tarp, such as by using a nobel plow or other injection shank that disrupts the chisel traces.

Bedded and Broadcast Shank Applications: Additional Mandatory GAPs In addition to the GAPs required for all soil fumigation applications, the following GAPs apply for injection applications:143 Tarps

• Tarps must be installed immediately after the fumigant is applied to the soil.

Soil Preparation

• Trash pulled by the shanks to the ends of the field must be covered with tarp, or soil, depending on the application method before making the turn for the next pass.

Application Depth

• For Tarped-Broadcast and Tarped-Bedded Applications: The injection point shall be

a minimum of 8 inches from the nearest fina l soil/air interface. For tarped bedded applications the injection depth must not be deeper than the lowest point of the tarp (i.e., the lowest point of the tuck).

• For Untarped-Bedded Applications : The injection point shall be a minimum of 12

inches from the nearest final soil/air interface.

• For Untarped-Broadcast Applications (CA orchard replant only): The injection point

shall be a minimum of 18 inches from the nearest final soil/air interface.

Prevention of End Row Spillage

• Do not apply or allow fumigant to drain onto the soil surface. For each injection line either have a check valve located as close as possible to the final injection point, or drain/purge the line of any remaining fumigant prior to lifting injection shanks from the ground.

• Do not lift injection shanks from the soil until the shut-off valve has been closed and the fumigant has been depressurized (passively drained) or purged (actively forced out via air compressor) from the system.

Calibration, Set-up, Repair, and Maintenance for Application Rigs

• Brass, carbon steel or stainless steel fittings must be used throughout. Polyethylene tubing, polypropylene tubing, Teflon® tubing or Teflon® -lined steel braided tubing must be used for all low pressure lines, drain lines, and compressed gas or air pressure lines. All other tubing must be Teflon® -lined

steel braided.

• Galvanized, PVC, nylon or aluminum pipe fittings must not be used.

• All rigs must include a filter to remove any particulates from the fumigant, and a check valve to prevent backflow of the fumigant into the pressurizing cylinder or the compressed air system.

• Rigs must include a flowmeter or a constant pressure system with orifice plates to insure the proper amount of fumigant is applied.

• To prevent the backflow of fumigant into the compressed gas cylinder (e.g. nitrogen, other inert gas or compressed air), if used, applicators must:

o If a compressed gas cylinder is used, make sure that positive pressure is maintained in the cylinder at not less than 200 psi during the entire time it is connected to the application rig. ( This is not required for a compressed air system that is part of the application rig because if the compressor system fails the application rig will not be operable )

o Ensure that application rigs are equipped with properly functioning check valves between the compresse d gas cylinder or compressed air system and the fumigant cylinder. Th e check valve is best placed on the outlet side of the pressure regulator, and is oriented to only allow compressed gas to flow out of the cylinder or compressed air out of the compressed air system.

o Always pressurize the system with compressed gas or by use of a compressed air system before opening the fumigant cylinder valve.

• Before using a fumigation rig for the first time, or when preparing it for use after storage, the operator must check the following items carefully:144 o Check the filter, and clean or repl ace the filter element as required.

o Check all tubes and chisels to make sure they are free of debris and

obstructions.

o Check and clean the orifice plates and screen checks, if installed.

o Pressurize the system with compressed gas or compressed air, and check all fittings, valves, and connections for leaks using soap solution.

• Install the fumigant cylinder, and connect and secure all tubing. Slowly open the compressed gas or compressed air valve, and increase the pressure to the desired level. Slowly open the fumigant cylinder valve, always watching for leaks.

• When the application is complete, close the fumigant cylinder valve and blow residual fumigant out of the fumigant lines into the soil using compressed gas or compressed air. At the end of the application, disconnect all fumigant cylinders from the application rig. At the end of the season, seal all tubing openings with tape to prevent the entry of insects and dirt.

• Application equipment must be calibrated and all control systems must be working properly. Proper calibration is essential for application equipment to deliver the correct amount of fumigant uniformly to the soil. Refer to the manufacturer's instructions on how to calibrate your equipment, usually the equipment manufacturer, fumigant dealer, or Cooperative Extension Service can provide assistance.

Hot Gas Soil Applications (Greenhouse and Outdoor): Mandatory GAPs

• All delivery tubes shall be placed under the tarp in such a way that they do not move during the application of methyl bromide.

• The fumigant must be introduced from outside of the greenhouse/application block (see entry restrictions and respiratory protection sections for further details).

• All fittings, connections, and valves must be checked for methyl bromide leaks prior to fumigation. If cylinders are replaced duri ng the fumigation process, the connections

and valves must be checked for l eaks prior to continuing the job.

Tree Replant Application: Mandatory GAPs In addition to the GAPs required for all soil fumigation applications, the following GAPs apply for tree replant applications. This application method is used when methyl bromide is applied to individual tree sites in an existing orchard where shank application are not possible:

Site Preparation

• Each individual tree-site must remove the tree stump and primary root system with a back-hoe or other similar equipment, for example an auger.

• The hole must be backfilled with soil before application.

Application Depth

• The fumigant must be injected at least 18 inches into the soil.

System Flush

• Before removing the application wand from the soil the wand must be cleared using nitrogen or compressed air.

Soil Sealing

• After the wand is cleared and removed from the soil, the injection hole must be either covered with soil and tamp or the soil must be compacted over the injection

hole.145 For pre-plant soil

use.

Site-Specific Fumigation Management Plans “ Site-Specific Fumigation Management Plan (FMP) Prior to the start of fumigation, the certifie d applicator supervising the application must verify that a site-specific fumigation manageme nt plan (FMP) exists for each application block (i.e., a greenhouse or field or portion of a field treated with a fumigant in any 24- hour period). In addition, a farm operation fumigating multiple application blocks may format the FMP in a manner whereby all of the information that is common to all the application blocks is captured once, and any information unique to a particular application block or blocks is captured in subsequent sections. The FMP may be prepared by the certified applicator, the site owner/operator, registrant, or other party. The certified applicator must verify in writing the site-specific FMPs reflects current site conditions before the start of fumigation.

Each site specific FMP must contain the following elements:
 Applicator information (name, phone nu mber, license number, employer name, employer address, date of completing registrant methyl bromide training program)
 General site information
3⁄4 Application block location (e.g., address or global positioning system (GPS) coordinates)
3⁄4 Name, address, and, phone number of owner/operator of the application block
3⁄4 Map, aerial photo, or detailed sketch showing field location, dimensions, buffer zones, property lines, roads, rights-of-ways, sidewalks, permanent walking paths, bus stops, water bodies, wells, nearby application blocks, surrounding structures (occupied and non-occupied), locations of posted signs for buffers, and sites requiring 1⁄4 or 1⁄8 mile buffer zones (e.g., schools, state licensed day care centers, nursing homes, assisted living facilities, hospitals, in-patient clinics, and prisons) with distances from the application site labeled
 General application information (target application date/window, brand name of fumigant, EPA registration number)
 Tarp information and procedures for repair, perforation and removal(if tarp is used)
3⁄4 Brand name, lot number, thickness
3⁄4 Name and phone number of person responsible for repairing tarps
3⁄4 Schedule for checking tarps for damage, tears, and other problems
3⁄4 Maximum time following notification of damage that the person(s) responsible for tarp repair will respond
3⁄4 Minimum time following application that tarp will be repaired
3⁄4 Minimum size of damage that will be repaired
3⁄4 Other factors used to determine when tarp repair will be conducted
3⁄4 Name and phone number of person responsible for cutting and/or removing tarps (if other that certified applicator)
3⁄4 Equipment/methods used to cut tarps
3⁄4 Schedule and target dates for cutting tarps
3⁄4 Schedule and target dates for removing tarps
 Soil conditions (description of soil texture in application block, method used to determine soil moisture)
 Weather conditions (sum mary of forecasted conditions fo r the day of the application and the 48-hour period following the fumigant application)
3⁄4 Wind speed
3⁄4 Inversion conditions (e.g., shallow, compressed (low-level) temperature inversion)
3⁄4 Air stagnation advisory
 Buffer zones
3⁄4 Application method
3⁄4 Application rate from lookup table on the label (lb ai/A)
3⁄4 Application block size from lookup table on the label (acres)
3⁄4 Credits applied
3⁄4 Buffer zone distance
3⁄4 Description of areas in th e buffer zone that are no t under the control of the In the

Directions for

Use for Preplant soil fumigation

under theheading, “SiteSpecific Fumigation Management Plan (FMP)”146 owner/operator of the application block
 Respirators and other personal protective equipment (PPE) for handlers (handler task, protective clothing, respirator type, respir ator cartridge type, respirator cartridge replacement schedule, eye protection, gloves, other PPE)
 Emergency procedures (evacuation rout es, locations of telephones, contact information for first responders, local/sta te/federal contacts, key personnel and emergency procedures/responsibilities in cas e of an incident, equipment/tarp/seal failure, complaints or elevated air concentration levels outside buffer zone suggesting potential problems, or other emergencies).
 Posting procedures (person(s) who will post signs, location of posting signs, procedures for sign removal)
 Site-specific response and management (if applicable)
3⁄4 Fumigant site monitoring

 Description of who, when, where, and procedures for monitoring buffer zone perimeter
3⁄4 Response information for neighbors

 List of residences, businesses, and neighboring property owners informed

 Name and phone number of person doing notification

 Method of providing the information
 State and tribal lead agency notification (If state and/or tribal lead agency requires notice, provide a list of contacts th at were notified and date notified.)
 Plan describing how communication w ill take place between applicator, land owner/operator, and other on-site handlers (e.g., tarp cutters/removers, irrigators) for complying with label requirements (e.g., buffer zone location, buffer zone start/stop times, timing of tarp cutting and removal, PPE).
3⁄4 Name and phone number of persons contacted
3⁄4 Date contacted
 Authorized on-site personnel
3⁄4 Names, addresses and phone numbers of all handlers
3⁄4 Employer name, addresses, and phone numbers for all handlers
3⁄4 Tasks that each handler is auth orized and trained to perform
3⁄4 Date of PPE training for each handler
3⁄4 For handlers designated to wear respirators respiratory protection is required (minimum of 2 handlers), date of medical qualification to wear a respirator and date of fit testing for respirator.
 Air monitoring plan
3⁄4 For buffer zone monitoring:

 Name, address, and, phone number of handler to perform monitoring

activities

 Location and timing of monitoring for the buffer zone
3⁄4 For handlers without respiratory protection:

 If sensory irritation is experienced, indicate whether operations will be ceased or operations will continue with respiratory protection

 If intend to cease operations when sens ory irritation is experienced, provide the name, address, and phone number of the handler that will perform monitoring activities prior to operations resuming
3⁄4 For handlers with respiratory protection:

 Representative handler tasks to be monitored

 Monitoring equipment to be used and timing of monitoring
3⁄4 For buffer zone monitoring when using methyl bromide formulations with < 20% chloropicrin :

 Name, address, and phone number of person(s) to perform sampling

 Identify areas or structures to be monitored before reentry is permitted

 Monitoring equipment to be used and timing of the monitoring
3⁄4 For monitoring the breathing zone when using methyl bromide formulations with < 20% chloropicrin :147  Representative handler tasks to be monitored

 Monitoring equipment to be used and timing of the monitoring
 Good Agricultural Practices (GAPs)
3⁄4 Description of applicable mandatory GAPs (registrants may also include optional GAPs)
3⁄4 Measurements and documentation to ensure GAPs are achieved (e.g., measurement of soil and other site conditions)
 Description of hazard communication. (The buffer zone around the application block has been posted in accordance with the label. Pesticide product labels and material safety data sheets are on-site and readily available for employees to review.)
 Record-keeping procedures (the owner/operator of the application block, as well as the certified applicator, must keep a signed c opy of the site-specific FMP and the post application summary for 2 years from the date of application).

For situations where an initial FMP is developed and certain elements do not change for multiple fumigation sites (e.g., applicator information, authorized on-site personnel, record keeping procedures, emergency procedures) only elements that have changed need to be updated in the site-specific FMP provided the following:

• The certified applicator supervising the application has verified that those elements are current and applicable to the application block before it is fumigated and has documented the verification in the site-specific FMP.

• Recordkeeping requirements are followed fo r the entire FMP (including elements that do not change).

Once the application begins, the certified applicator must make a copy of the FMP available for viewing by handlers involved in the fumigation. The certified applicator or the owner/operator of the application block must provide a copy of the FMP to any federal, state, tribal, or local enfor cement personnel who request the FMP. In the case of an emergency, the FMP must be made available when requested by federal/state/local emergency response and enforcement personnel.

Within 30 days of completing the application portion of the fumigation process, the certified applicator supervising the application must complete a post fumigation application summary that describes any deviations from the FMP that have occurred, measurements taken to comply with GAPs as well as any complaints and/or incidents that have been reported to him/her.

Specifically the Post-Application Summary must contain the following elements:

 Actual date of the application, application rate, and size of application block fumigated
 Summary of weather conditions on the day of the application and during the 48-hour period following the fumigant application
 Soil temperature measurement (if air temperat ures were above 100 degrees F in any of the 3 days prior to the application)
 Tarp damage and repair information (if applicable)
3⁄4 Location and size of tarp damage
3⁄4 Description of tarp/tarp seal/tarp equipment failure
3⁄4 Date and time of tarp repair
 Tarp perforation/removal details (if applicable)
3⁄4 Description of tarp removal (if different than in the FMP)
3⁄4 Date tarps were perforated
3⁄4 Date tarps were removed
 Complaint details (if applicable)148 3⁄4 Person filing a complaint (e.g., on-site handler, person off-site)
3⁄4 If off-site person, name, address, and phone number of person filing a complaint
3⁄4 Description of control measures or emergency procedures followed after a complaint
 Description of incidents, equipment failure, or other emergency and emergency procedures followed (if applicable)
 Details of elevated air concentrations monito red on-site or outside the buffer zone (if applicable)
3⁄4 Location of elevated air concentration levels
3⁄4 Description of control measures or emergency procedures followed
3⁄4 Air monitoring results

 When sensory irritation experienced:

• Date and time of sensory irritation

• Handler task/activity

• Handler location where irritation was observed

• Resulting action (e.g., cease operatio ns, continue operations with respiratory protection)

 When using a direct read instrument:

• Type of sample (e.g., area , breathing zone, structure)

• Sample date and time

• Handler task/activity (if applicable)

• Handler location or structure location

• Air concentration

• Sampling method
 Date of buffer zone sign removal
 Any deviations from the FMP

In addition to recordkeeping requirements from 7 CFR part 110 “Recordkeeping Requirements for Certified Applicators of Fe derally Restricted Use Pesticides,” this decision requires that both the applicator and owner/operator of the application block keep a signed copy of the site-specific FMPs an d the post-application summary record for 2 years from the date of application.

For pre-plant soil

use.

General Buffer Zones requirements

for all formulations “General Buffer Zone Requirements A “buffer zone” must be established for every fumigant application The following describes the general buffer zone requirements:

• “Buffer zone” is an area established around the perimeter of each application block or greenhouse where a soil fumiga nt is applied. The buffer zone must extend from the edge of the application block perimeter equally in all directions.

• All non-handlers including field workers, nearby residents, pedestrians, and other bystanders, must be excluded from the buffer zone during the buffer zone period except for certain persons in tr ansit (see exemptions section).

• An “application block” is a greenhouse or fi eld or portion of a field treated with a fumigant in any 24-hour period (see Figures 1 and 2 above for further explanation).

• The “buffer zone period” starts at the moment when any fumigant is delivered/dispensed to the soil within the application block and lasts for a minimum of 48 hours after the fumigant has stopped being delivered/dispensed to the soil.

Authorized entry to buffer zones

• Only authorized handlers who have been properly trained and equipped according to EPA’s Worker Protection Standard (WPS) and label requirements may be in the buffer zone during the buffer zone period. In the

Directions for

Use for Preplant soil fumigation

under the heading

“General

Buffer Zone Requirements”149 Buffer zone proximity

• Before the application begins, the certifie d applicator must determine whether the application block or its resulting buffer will overlap with a buffer that is already in

effect.

• A buffer zone may NOT overlap buffer zones from other application blocks which are already in effect UNLESS a minimum of 12 hours have elapsed from the time the first application ends until the second application begins.

• Emergency preparedness and response measures have been implemented if there are homes, businesses, or property not within th e control of the fumiga tor within 300 feet

of each buffer zone.

Exemptions for transit through buffer zones

• Vehicular and bicycle traffic on public and private roadways through the buffer zone is permitted. "Roadway" means that portion of a street or highway improved, designed or ordinarily used for vehicular travel, ex clusive of the sidewalk or shoulder even though such sidewalk or shoulder is used by persons riding bicycles. In the event a highway includes two or more separated roadways, the term "roadway" shall refer to any such roadway separately.

• Bus stops or other locations where persons wait for public transit are not permitted

within the buffer zone.

• See posting section for additional requirements that may apply.

Structures under the control of owner/operator of the application block

• Buffer zones may not include buildings used for storage such as sheds, barns, garages,

etc., UNLESS,

1. The storage buildings are not occupied during the buffer zone period, and

2. The storage buildings do not share a comm on wall with an occupied structure.

• See posting section for additional requirements that may apply.

Areas not under the control of owner/operator of the application block

• Buffer zones may not include residential areas (including employee housing, private property, buildings, commercial, industrial, and other areas that people may occupy or outdoor residential areas, such as lawns, gardens, or play areas, UNLESS,

1. The occupants provide written agreement that they will volu ntarily vacate the buffer zone during the entire buffer zone period, and

2. Reentry by occupants and other non-handlers must not occur until,

° The buffer zone period has ended, and

° For formulations with less than 80% me thyl bromide, sensory irritation is not experienced.

° For formulations with greater than 80% methyl bromide, the certified applicator or someone under his/her supervision has monitored the structures and has not experienced any sensory irritation. Entry by occupants and other non-handlers must not occur until,

° Two consecutive air samples for methyl bromide have been taken in the structure at least 1 hour apart must i ndicate less than 1 ppm methyl bromide,

and

° Two consecutive air samples for chloropicrin have been taken in the structure at least 1 hour apart must indicate than less than 0.15 ppm chloropicrin is
present.

• Buffer zones may not include agricultural areas owned/operated by persons other than the owner/operator of the application block, UNLESS,

1. The owner/operator of the application block can ensure that the buffer zone will not overlap with a buffer zone fr om any adjacent property owner, and

2. The owner/operator of the areas that are not under the control of the application150 provides written agreement to the certifie d applicator supervising the fumigant application that they, their employees, and other persons will stay out of the buffer zone during the entire buffer zone period.

• Buffer zones must not include roads and rights of way UNLESS,

1. The area is not occupied during the buffer zone period, and 2. Entry by non-handlers is prohibited during the buffer zone period. 3. Applicators must comply with all local laws and regulations.

• For all other publicly owned and/or operated areas such as parks, side walks, walking paths, playgrounds, and athletic fields, buffer zones must not include these areas UNLESS, 1. The area is not occupied during the buffer zone period, 2. Entry by non-handlers is prohibited during the buffer zone period, and 3. Written permission to include the public area in the buffer zone is granted by the appropriate state and/or local authorities re sponsible for management and operation of

the area. 4. Applicators must comply with all local laws and regulations.

• See the Posting Section for additional requirements that may apply.

Maximum Application Block

Sizes for all

formulations “Maximum Application Block Sizes

The maximum application block sizes allowed for methyl bromide applications are:

• 100 acres for tarped bedded and broadcast applications

• 40 acres for untarped deep applications (i.e., California orchard replant)” Directions for

Use (see next row

for 98:2 formulations)

Maximum Application Block

Sizes for Hot Gas Applications (98:2 formulations only) “The maximum application block sizes allowed for methyl bromide hot gas applications

are:

• 10 acres for outdoor hot gas applications 45,000 square feet for greenhouse hot gas applications” Directions for

Use immediately

after above

row Pre-plant Application

Restrictions for all

formulations “Maximum Application Rates for Critical Us e Exemptions (CUEs) under the Montreal

Protocol Maximum Application Rates for Pre-plant Soil Methyl Bromide CUEs Crop Maximum Broadcast Equivalent Rates (lb ai/A) Eggplant 200
Cucurbits (including muskmelons, cantaloupe, watermelon, cucumber, squash, pumpkin, and gourds) 200

Forest Nursery Seedlings 400
Orchard Nursery Seedlings (raspberry, deciduous trees, roses) 400

Strawberry Nurseries 400
Orchard Replant 1 (walnuts, almonds, stone fruit, table and raisin grapes, wine grapes) 250

Orchard Replant (grapes) 250

Ornamentals 400
Pepper, Bell 200
Strawberry Fruit 235
Sweet Potato Slips 200
Tomato (grown for fresh market) 200 In the

Directions for

Use for Preplant soil fumigation

under the heading

“Maximum Application

Rates for

Critical Use Exemptions

under the

Montreal

Protocol”

within its own

box

(see below

row for 98:2 formulations)151 1 The maximum application rate when applying methyl bromide to individual tree holes using handheld equipment is 1.5 lb ai/100 ft 2

The maximum application rate for greenhouse hot gas applications is 1 lb ai/100 ft2 and the application block may not exceed 45,000 ft2.” Pre-plant Application

Restrictions for 98:2

formulations “The maximum application rate when applying methyl bromide to individual tree holes using handheld equipment is 1.5 lb ai/100 ft 2 ”

“The maximum application rate for greenhouse hot gas applications is 1 lb ai/100 ft 2 and the application block may not exceed 45,000 ft 2 ” Directions for

Use immediately

after above

row Pre-plant Application

Restrictions “Quarantine Uses

This product may be used as a soil fumigant as part of a quarantine program established by the United States Department of Agriculture-Animal and Plant Heath Inspection Service (USDA-APHIS) under the Plant Protection Act (7 U.S.C. 7701 et seq.). Limitations including but not limited to application rates and methods and crops and cropping practices shall be in accordance with those established by the USDA-APHIS quarantine program.” In the

Directions for

Use for Preplant soil fumigation

under the heading

“Maximum Application

Rates for Quarantine

Uses
” within its

own box For pre-plant soil

use.

Buffer Zone

Distances “ Buffer Zone Distances

Buffer zone distances must be calculated us ing the application rate and the size of the application block.

Figure 1. Broadcast Application

Figure 2. Bedded Application

In Figures 1 and 2, the dashed line represents the perimeter of the field, the shaded area is the portion of the field that is treated, and the un-shaded area is the area of the field that is untreated. Assuming both fields are 10 acres, and only 50% of field in figure 2 is fumigated, the rate per treated acre is 400 lbs ai/A for both Figure 1 and 2. The broadcast

rate for figure 1 is 400 lb ai/A but the effective broadcast equivalent rate for Figure 2 is

200 lbs ai/A. The minimum buffer zone distances must be based on the broadcast or effective broadcast equivalent rates.” In the

Directions for

Use for Preplant soil fumigation

under the heading “

Buffer Zone

Distances”152 Note to registrant: Labels may express rates as lbs pe r treated acre under the application instructions but they must identify buffer zone distances based on the broadcast or effective broadcast equivalent rates.

Buffer zone distances

• Buffer zone distances must be based on look-up tables on product labels (25 feet is the smallest distance regardless of site -specific application parameters).

• If the buffer zone, if after applying all applic able buffer zone credits, is greater than 1⁄2 mile then the application is prohibited.

• For selective replant fumigation in an orchard using hand held application methods (e.g., deep injection auger probes), the minimum buffer zone will be 25 feet measured from the center of each injection site (i.e., tree hole).

“For selective replant fumigation in an orchard using hand-held application methods (e.g., deep injection auger probes), the minimum buffer zone will be 25 feet measured from the center of each injection site (i.e., tree hole). For all other applications, the amended RED tables must be used to determine the minimum buffer distances. Round-up to the nearest rate and block size, where applicable.”

“Buffer Zone Look-up Table fo r Shank Bedded with Tarps” [See driver tables 11 and 12 for each formulati on. If methyl bromide is the driver, insert Table 4 from Methyl Bromide RED. If chloro picrin is the driver, insert appropriate chloropicrin look-up table for shank bedded with tarps from chloropicrin RED.]

“Buffer Zone Look-up Table for Shank Broadcast with Tarps” [See driver tables 11 and 12 for each formulati on. If methyl bromide is the driver, insert Table 5 from Methyl Bromide RED. If chloro picrin is the driver, insert appropriate chloropicrin look-up table for shank broa dcast with tarps from chloropicrin RED.]

“Shank Broadcast without Tarps (CA orchard replant only)” [See driver tables 13 and 14 for each formulati on. If methyl bromide is the driver, insert Table 6 from Methyl Bromide RED. If chloro picrin is the driver, insert appropriate chloropicrin look-up table for shank deep br oadcast with tarps from chloropicrin RED.]

Buffer Zone

Distances for Hot Gas Applications (98:2 formulations only) “Outdoor Hot Gas with Tarps” [insert from Table 7 from Methyl Bromide RED]

“Greenhouse Hot Gas with Tarps” [insert from Table 8 from Methyl Bromide RED] In the

Directions for

Use for Preplant soil fumigation

under the heading

“Buffer Zone

Distances” For pre-plant soil

use.

Buffer Zone Credits “Buffer Zone Credits The buffer zone distances for methyl bromide applications may be reduced by the percentages listed below. Credits may be added, but credits cannot exceed 80%. Also the minimum buffer zone distance is 25 feet regardless of buffer zone credits available. The maximum buffer zone is 0.5 mile (2,640 feet), with or without credits.

• 30% reduction in buffer zone distance, IF using Canslit Heatstrip Silver and Canslit Metalized high-barrier tarps

• 60% reduction in buffer zone distance, IF using Olefinas Embossed VIF, Klerks VIF, Pliant Blockade, Bromostop® (1.38 mil), Eval/Mitsui TIF (1.38 mil), Hytiblock 7 Black (0.00125”), XL Black Blockade (0.00125”), Hytibar (1.5 mil), and IPM Clear VIF (1.38 mil) high barrier tarps In the

Directions for

Use for Preplant soil fumigation

under the heading

“Buffer Zone

Credits”153 • The tarp brand name, manufacturer, lot number, batch number, part number, and

thickness must be recorded in the FMP.

• 15% reduction in buffer zone distance, IF pot assium thiosulfate (KTS) is applied with 1⁄4 to 1⁄2 inch of water over a tarp

• 10% reduction in buffer zone distance, IF the organic content of the soil in the application block is >1% - 2%; a 20% reduction is buffer zone distance, IF the organic content of the soil in the application block is >2% - 3%; and a 30% reduction in the buffer zone distance, IF the organic content of the soil in the application block is >3%. No credit will be given for soils with less than 1% organic matter. Record the measurements taken to verify the organic content in the FMP.

• 10% reduction in buffer zone distance, IF the clay content of the soil in the application block is greater than 27%. Record the meas urements taken to verify the clay content

in the FMP.

Example of Buffer Calculation if a Credit is Applicable If the buffer zone distance for a 10 acre application block at a rate of 120 lbs ai/A is 185 feet without any credits (see last row in Table 9). If the grower uses Bromostop ® (1.38 mil) high barrier tarp, the buffer zone can be reduced by 60%. The resulting buffer zone distance for this case is 74 feet. If the organic matter in the application block is two percent and Bromostop ® (1.38 mil) high barrier tarp is used, the total credit would be 80% (60% for the tarp and 20% for organic content), and the resulting buffer zone distance

would be 37 feet.” Application

Restrictions “Restrictions for Schools and Other Difficult to Evacuate Sites

• If the calculated buffer zone for a fumigant application is greater than 300 feet , then no fumigant applications will be permitted within 1/4 mile (1,320 feet) of schools (preschool to grade 12), state licensed day ca re centers, nursing homes, assisted living facilities, hospitals, in-patient clinics and prisons if occupied for a period of time that begins when the fumigant is first introduced into the soil and continues for 36 hours after delivery of the fumigant product has stopped.

• If the calculated buffer zone for a fumigant application is 300 feet or less , then no fumigant applications will be permitted within 1/8 mile (660 feet) of schools (preschool to grade 12), state licensed day ca re centers, nursing homes, assisted living facilities, hospitals, in-patient clinics and prisons if occupied for a period of time that begins when fumigant is first introduced into the soil and continues for 36 hours after delivery of the fumigant product has stopped.” In the

Directions for

Use under the heading

“Restrictions

for Schools

and Other

Difficult to

Evacuate
Sites”

For pre-plant soil

use.

Posting “Posting Fumigant Buffer Zones

• Posting of a buffer zone is required unless there is a physical barrier that prevents bystander access to the buffer zone.

• Buffer zone posting signs must:

o Be placed at all usual points of entr y and along likely routes of approach from areas where people not under the land operator’s control may approach

the buffer zone.

o Some examples of points of entry include, but are not limited to, roadways, sidewalks, paths, and bike trails.

o Some examples of likely routes of ap proach are the area between a buffer zone and a roadway, or the area be tween a buffer zone and a housing development.

• Buffer zone posted signs must meet the following criteria:

o The printed side of the sign must f ace away from the treated area toward areas from which people could approach. In the

Directions for

Use for Preplant soil fumigation

under the heading “Posting”154 o Signs must remain legible during entire posting period and must meet the general standards outlined in the WPS for text size and legibility (see 40 CFR §170.120).

o Signs must be posted before the application begins and remain posted until the buffer zone period has expired.

o Signs must be removed within 3 days after the end of the buffer zone period.

o Registrants must provide generic buffer zone posting signs which meet the criteria above at points of sale for applicators to use.

Exception: If multiple contiguous blocks are fumigated within a 14-day period, the entire periphery of the contiguous blocks’ buffer zones may be posted. The signs must remain posted until the last buffer zone period expires and signs may remain posted until 3-days after the buffer zone period for the last block has expired.

Additional requirements for treated area posting:

• The treated area posted signs must remain posted for no less than the duration of

the entry restricted period after treatment.

• Treated area signs must be removed within 3 days after the end of the entryrestricted period.

• Signs must meet the general standards in the WPS for placement, text size, and location (40 CFR §170.120).”

Contents of Signs

The treated area sign must state the following: -- Skull and crossbones symbol

-- "DANGER/PELIGRO," -- "Area under fumigation, DO NOT ENTER/NO ENTRE,"

-- "[ Methyl bromide ] Fumigant in USE," -- the date and time of fumigation, -- the date and time entry prohibition is

lifted -- brand name of this product, and -- name, address, and telephone number of the certified applicator in charge of the fumigation. The buffer zone sign must state the following: -- Do not walk sign

-- "DO NOT ENTER/NO ENTRE," -- "[Methyl Bromide] [Name of product] Fumigant BUFFER ZONE,”

-- contact information for the certified applicator in charge of the fumigation

For pre-plant soil

use.

Site specific response and management “Emergency Preparedness and Response”

• If the buffer zone is greater than 25 feet or less than or equal to 100 feet , and there are

residences and businesses within 50 feet from the edge of the buffer zone

• If the buffer zone is greater than 100 feet but less than or equal to 200 feet , and there

are residences and businesses within 100 feet from the edge of the buffer zone

• If the buffer zone is greater than 200 feet but less than or equal to 300 feet , and there

are residences and businesses within 200 feet from the edge of the buffer zone

• If the buffer zone is greater than 300 feet or the buffer zones overlap , and there are In the

Directions for

Use for Preplant soil fumigation

under the heading “Emergency Preparedness and Response”155 residences and businesses within 300 feet from the edge of the buffer zone

Then the certified applicator must either follow the directions under the “fumigant site monitoring” section or follow the directions under the “response information for neighbors” section below.

If the buffer zone is 25 feet then the Emer gency Preparedness and Response requirements are not applicable.

Fumigation Site Monitoring

From the beginning of the fumigant application until the buffer zone period expires, a certified applicator or someone under his/her supervision must:.

• Monitor for air concentrations of methyl bromide and chloropicrin in areas between the buffer zone perimeter and the areas (such as residences and businesses) that trigger this requirement.

• Monitoring the air concentration levels must begin the evening on the day of application and continue until the buffer zone period expires with a minimum of at least 8 samples during the buffer zone period, including these periods: - once, 1 hour before sunset, - once, during the night, - once, 1 hour after sunrise, and - once, during the day.

If at any time the person monitoring the air c oncentrations experiences sensory irritation, then the emergency response plan stated in the FMP must be immediately implemented. If other problems occur, such as a tarp coming loose, then the appropriate control plan

must be activated. The location and results of the air monitoring must be recorded in the post application summary report.

Response Information for Neighbors

The certified applicator (or someone under his/her supervision) supervising the fumigation must ensure that residences and owners/operato rs of businesses that meet the criteria below have been provided the emergency response information at least 1 week before fumigation occurs. The information provided may include application dates that range for no more

than 4 weeks . After 4 weeks, the information must be delivered again.

Information that must be included:

• The general location of the application block

• Fumigant(s) applied including the active ingredient, name of the fumigant product(s), and the EPA Registration number

• Contact information for the applicator and property owner/operator

• Time period in which the fumigation is planned to take place (must not range more than 4 weeks)

• Early signs and symptoms of exposure to the fumigant(s) applied, what to do, and who to call if you believe you are being exposed (911 in most cases).

• How to find additional information about fumigants.

The method used to share the response information for neighbors must be described in the FMP and may be accomplished through mail, door hangers, or through other methods that will effectively inform people in residences and businesses within the required distance from the edge of the buffer zone.”

Notice to State and “Notice to State and Tribal Lead Agencies Directions for156 Tribal Lead Agencies If your state and/or tribal lead agency require s notice, information must be provided to the appropriate state or tribal lead agency prior to the application. Please refer to http://www.epa.gov/pesticides/r eregistration/soil_fumigants/ for a list of states and tribal lead agencies that require notice and info rmation on how to submit the information.

The information that must be provided to state and trial lead agencies includes the following:

o Location of the application blocks,

o Fumigant(s) applied including EPA Registration #,

o Applicator and property owner/ operator contact information,

o Time period that fumigation may occur.” Use under

“Notice to

State and

Tribal Lead Agencies”

Environmental

Hazards “This pesticide is toxic to mammals and birds. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwaters or rinsate.

Methyl bromide has certain properties and ch aracteristics in common with chemicals that have been detected in groundwater (methyl bromide is highly soluble in water and has low adsorption to soil), volatilization is this chemical's most important route of dissipation.

For untarped applications of methyl bromide, leaching and ru noff may occur if there is heavy rainfall after soil fumigation.” Precautionary

Statements immediately following the User Safety

Recommendat

ions

General Application

Restrictions “Do not apply this product in a way that w ill contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application.” Place in the

Direction for Use directly

above the Agricultural

Use Box.

BUFFER ZONE DRIVER TABLES

Table 11. Standard Tarp (no credits) Buffer Zone Driver Table

Formulation Application

Method 98:2 80:20 75:25 67:33 57:43 50:50 45:55 33:67

Broadcast Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Chloropicrin

Bed Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide

Table 12. Standard Tarp (no credits) Buffer Zone Driver Table

Formulation Application

Method 98:2 80:20 75:25 67:33 57:43 50:50 45:55 33:67

Broadcast Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Chloropicrin Chloropicrin Chloropicrin

Bed Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Chloropicrin157 Table 13. Deep ( ≥ 18 inches) Untarp Buffer Zone Driver Table

Formulation Application

Method 98:2 80:20 75:25 67:33 57:43 50:50 45:55 33:67

Broadcast Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Methyl

Bromide Chloropicrin Chloropicrin

Table 14. Deep ( ≥ 18 inches) Untarp Buffer Zone Driver Table

Formulation Application

Method 98:2 80:20 75:25 67:33 57:43 50:50 45:55 33:67

Broadcast Methyl

Bromide Methyl

Bromide Methyl

Bromide Chloropicrin Chloropicrin Chloropicrin Chloropicrin Chloropicrin158 APPENDIX A Methyl Bromide PC Code 053201 Pre-plant Soil Uses Eligible for Reregistration159 Appendix A. Methyl Bromide PC Code 053201 Pre- plant Soil Uses Eligible for Reregistration

Use Site Formulation Method of Application Maximum Application Rate Use

Limitations Eggplant Pressurized gas with 80% or less methyl bromide Shank Injected 170 lb ai/A

Cucurbits (including muskmelons, cantaloupe, watermelon, cucumber, squash, pumpkin, and gourds) Pressurized gas with 80% or less methyl bromide Shank Injected 200 lb ai/A

Forest Nursery Seedlings Pressurized gas (all methyl bromide: chloropicrin ratios including 98:2) Shank Injected 260 lb ai/A

Orchard Nursery Seedlings (raspberry, deciduous trees, roses) Pressurized gas with 80% or less methyl bromide Shank Injected 200 lb ai/A

Strawberry Nurseries Pressurized gas with 80% or less methyl bromide Shank Injected 260 lb ai/A

Orchard Replant (walnuts, almonds, stone fruit, table and raisin grapes, wine grapes) Pressurized gas (all methyl bromide: chloropicrin ratios including 98:2) Shank Injected 200 lb ai/A

Orchard Replant (grapes) Pressurized gas (all methyl bromide: chloropicrin ratios including 98:2) Shank Injected 250 lb ai/A

Orchard Replant (individual tree holes using) Pressurized gas (all methyl bromide: chloropicrin ratios including 98:2) handheld equipment 1.5 lb ai/

100 ft 2

Ornamentals Pressurized gas with 80% or less methyl bromide Shank Injected 360 lb ai/A

Ornamentals Pressurized gas with 98% methyl

bromide Hot Gas 360 lb ai/A

Pepper, Bell Pressurized gas with 80% or less methyl bromide Shank Injected 170 lb ai/A

Strawberry Fruit Pressurized gas with 80% or less methyl bromide Shank Injected 200 lb ai/A

Sweet Potato Slips Pressurized gas with 80% or less methyl bromide Shank Injected 200 lb ai/A

Tomato (grown for fresh market) Pressurized gas with 80% or less methyl bromide Shank Injected 160 lb ai/A

Quarantine uses Pressurized gas (all methyl bromide: chloropicrin ratios including 98:2) Use sites defined as part of a quarantine program established by the United States Department of Agriculture-Animal and Plant Heath Inspection Service (USDA-APHIS) under the Plant Protection Act (7 U.S.C. 7701 et seq.). Limitations including but not limited to application rates and methods and crops and cropping practices shall be

in accordance with those established by the USDA-APHIS quarantine

program. See applicable

GAPs from

label table160 APPENDIX B PERFUM Model Inputs and Outputs161 Appendix B. PERFUM Model Inputs and Outputs

Inputs for PERFUM Model

The major input parameters for the fumiga nt emission and dispersion modeling were: application rates, applicati on block sizes, application method emission profiles, weather conditions, and the target air co ncentration (based on acute inha lation endpoint and uncertainty factors).

 Rates

The Agency modeled up to 430 lb ai/acre for broadcast applications and 250 lbs ai/acre effective broadcast rate for bedded applications in the July 2008 RED. Although labels permit higher broadcast equivalent rates, such values were not evaluated because the rates considered were found to be the upper bound of methyl bromid e rates used. According to EPA proprietary data for 2004-2005, approximately 95% of methyl brom ide was applied at a rate of 250 lb ai/acre or less. This is illustrated in the Agency’s be nefits assessments by crop and region that include a more detailed analysis of use rates. These a ssessments are available for review in the methyl bromide docket (EPA-HQ-OPP-2005-0123) at www.Regulations.gov. Values assumed for rates were based largely on recent critical use nomina tions (CUNs) and applications by grower groups for critical use exemptions (CUEs).

Rates for bedded or strip applications (lb ai per treated area) were converted to broadcast equivalent application rates to determine the mi nimum buffer zone distance. In Figures 1 and 2 (shown below), the dashed line re presents the perimeter of the field, the shaded area is the portion of the field that is treated, and the un-shaded area is the area of the field that is untreated. Assuming that both fields are 10 ac res, and only 50% of the field in Figure 2 is fumigated, the rate per treated acre is 400 lbs ai/A for bot h Figure 1 and 2. The broadcast rate for Figure 1 is

400 lb ai/A but the effective broadcast equivalent rate for Figure 2 is 200 lbs ai/A.

Labels may express rates as lbs per treated acre under the application instructions but they must identify buffer zone distances based on the broadcast or effectiv e broadcast equivalent rates. [Note: In the risk assessment, a 60 pe rcent value of field tr eated was used in the calculations.]

Figure 1. Broadcast Application Figure 2. Bedded Application162  Block sizes

The Agency had limited information available on the size of application blocks typically treated in a given day, but estimate s that each crew or application rig treats less than 40 acres for most treatment methods. However, several co mmercial applicators have indicated they sometimes use multiple rigs and crews to treat blocks of more than 80 acres per day.

The application block size pertai ns to size of the field and no t the size of the area treated. The area inside the dashed lines in both Figures 1 and 2 is the application block. In this example the application block size for both figures is 10 acres. For both figures, 10 acres would be used

to determine the buffer zone distance.

 Emission profiles

The Agency’s risk assessment for the July 2008 RED included modeling of 5 outdoor pre-plant soil application methods : (1) tarped broadcas t, (2) tarped bedded, (3) shallow untarped broadcast, (4) deep untarped broadcast, and (5) tarped hot gas. The modeling performed by EPA was based on 5 emission profiles developed by the California Department of Pesticide Regulation (CDPR) derived from 17 studies conducted in Calif ornia from 1992 to 1999. Buffer zone distances for other applic ation methods were also derived by the EPA from these profiles (e.g., buffer zone distances for strip applications were derived from broadcast emission profile). It should be noted that the profiles modeled do no t reflect the performance of today’s high barrier tarps. The profiles also may not be represen tative of some methods /equipment used outside California. In the U.S., tarped bedded and ta rped broadcast are the most common methods, hot gas and deep untarped use is somewhat limited, while shallow untarped a pplication is reportedly no longer used. Note that only tarped uses will be allowed henceforth except in limited

circumstances as described in the Gene ric Risk Management sections above.

In the July 2008 RED, the Agency mode led greenhouse pre-plan t soil applications scenarios using a conservative estimate of the emission profile (see the June 2, 2008, addenda to April 10, 2007, Phase 5 Health Effects Divisi on (HED) Human Health Risk Assessment For Soil, Greenhouse, and Residential/Struc tural in the methyl bromide docket).

 Weather

The largest methyl bromide use in the U.S. occurs in Florida and California followed by Michigan. Based on these high-us e areas, five weather data sets were modeled in the 2008 RED (Ventura, California; Bakersfield, California; Bradenton, Florida; Ta llahassee, Florida; and Flint, Michigan). The California and Florida locations are intended to represent inland and coastal weather conditions. Each modeling run used fi ve years of weather Data (e.g., 1,825 potential application days) for each weather location. Ge nerally, Ventura, and Bradenton weather data result in the largest buffer zone distances, fo llowed by Bakersfield and Tallahassee. Flint, Michigan, data resulted in significantly smaller buffers compared to the other four locations. The methyl bromide RED addendum used the same weather data sets as inputs to the PERFUM

model.163  Target air concentration

As described in Section III, a non-reversible acute inhalation endpoi nt was selected from a developmental rabbit study with a LOAEL base d on agenesis of the gall bladder and fused sternebrae. The human equivalent concentratio n is 10 ppm for a 24-hour TWA with uncertainty factor of 30 (i.e., target MOE of 30 and a target air concentrati on of 0.33 ppm). Based on several factors including the severity, irre versibility of the effect, and th e quality of the hazard database,

the buffer zone distances chosen focused on achie ving an MOE of 30 at upper percentiles of both

whole field and maximum distan ce distributions (these terms are described below) from PERFUM modeling outputs, as well as achie ving an MOE of 30 or greater at the 99 th percentile air concentration from PERFUM outputs. This endpoint and concentration was used in the methyl bromide RED addendum.

PERFUM Model Outputs

The PEFRUM model outputs are presented in percentiles for “whole field” and the

“maximum distance” distributions. The model al so provides outputs as distributions of air concentrations from which margins of expos ure (MOEs) can be estimated. The following summarizes the key points for each of these output parameters.

The maximum distance distribution is a compila tion of the farthest predicted distances (i.e., the farthest downwind points) over 5 years of weather. Th e whole field distribution differs because it includes all points around the perimeter of the application block for the same period. Another way to consider the difference between the distributions is that maximum distance

results are a subset of the w hole field results and that maxi mum distances allow for more resolution at the upper percentiles of this distribution. Version 2.1.4 of PERFUM also allows for

direct consideration of air conc entrations at various distances around treated fields. These air

concentrations and MOEs were also cons idered in the decision making process.

An analysis based on a variety of PERFUM outputs was used in the buffer distance

determinations. This involved consideration of the typical maximum a nd whole-field results, which are predictions of the distances where a ta rget concentration of concern is achieved at varying percentiles of exposure. In addition, a complementary approach, which determined the percentiles of exposure for maximum and whole-fi eld buffers at predetermined buffer distances, was employed. Air concentration da ta were also used to calculate risk estimates (i.e., MOEs) at predefined buffer distances and varied percentiles of exposure.

This overall approach allowed the Agency to utilize more of the information available from PERFUM so that a more comprehensive view of the risks could be considered. Buffer distances indicated by this type of analysis along with informa tion from monitoring studies and incidents were valuable in determining buffer di stances to manage potential risks from methyl bromide use when coupled with other mitigation measures.164 APPENDIX C FMP Template for Methyl Bromide Soil Applications165 FUMIGANT MANAGEMENT PLAN Certified Applicator Sup ervising the Fumigation
Name and phone number: License number: Commercial applicator

Private applicator

Employer name and address: Date of completing registrant training program:

General Site Information
Application block location, address, or global positioning system (GPS) coordinates:

Name, address, and phone number of owner/operator of application block:

General Application Information
Target application date/window: Brand name of fumigant: EPA Registration Number:

Tarps (check here if section is not applicable )

Brand name: Lot #: Thickness:

Name and phone number of contact person responsible for repairing tarps:

Schedule for checking tarps for damage, tears, and other problems:

Maximum time following notification of damage that the person(s) responsible for tarp repair will respond:

Minimum time following application that tarp will be repaired: Minimum size of damage that will be repaired:

Other factors used to determine when tarp repair will be conducted:

Name and phone number of contact person responsible for cutting and/or removing tarps (if other than certified applicator): Equipment/methods used to cut tarps:

Schedule and target dates for cutting tarps: Schedule and target dates for removing tarps:

Soil Conditions
Description of soil texture and moisture in application block: Description of method used to determine soil moisture level:166 Weather Conditions
Summary of the weather forecast for the day of the application and the 48-hour period following the fumigant application (may a ttach a copy of printed forecast to FMP):

Buffer Zones

Application method:

Bedded

Broadcast Hot gas - outdoor Hot gas - greenhouse Hand held probes Rate from lookup table on label (lb ai/A): Block size from lookup

table on label (acres): Credits applied: high barrier film _____________ % organic content _____________ % clay content _____________ % other: _____________ % Total credits _____________ % Buffer zone

distance:

__________ ft

List and describe areas in the buffer zone that are not unde r the control of owner/operator of the application block:

Personal Protective Equipment for Handlers

Handler Task Clothing Respirator Type, Filter Cartridge Type and Change-out Schedule Eye

Protection Gloves Other

Emergency Response Plan
Description of evacuation routes:

Locations of telephones:

Contact information for first responders: Local/state/federal contacts: Other contact information for emergencies:

Emergency procedures/responsibilities in case of an incident, equi pment/tarp/seal failure, complaints or elevated air concentra tion levels outside buffer zone suggesting potential problems, or other emergencies).

Posting Signs
Name and phone number of person that is doing posting:

Location of posting signs:

Procedures for posting and sign removal:167 Site Specific Response and Management Fumigation Site Monitoring or Response Information for Neighbors

If Response Information for Neighbors has been selected, completed the following:

If buffer zone is 25-100 ft: Neighbors within 50 ft of buffer zone No neighbors within 50 ft of buffer zone

If buffer zone is 100-200 ft: Neighbors within 100 ft of buffer zone No neighbors within 100 ft of buffer zone

If buffer zone is 200-300 ft: Neighbors within 200 ft of buffer zone No neighbors within 200 ft of buffer zone

If buffer zone is > 300 ft: Neighbors within 300 ft of buffer zone No neighbors within 300 ft of buffer zone If buffer zones overlap Neighbors within 300 ft of buffer zone No neighbors within 300 ft of buffer zone List of residences and businesses informed (neighboring property owners):

Name, address, and phone number of person providing information:

Method used to provide information:

Notice to State Lead Tribal Agencies
If your state and/or tribal lead agency requires notice, list contacts that were notified: Date notified:

Communication Between Applicator, Land Ow ner/Operator, and Other On-site Handlers
Plan for communicating to the land owner/operator and all on-site handlers (e.g., tarp cutters/r emovers, irrigators) requiremen ts to comply with label including location and start/stop times of buffer zones; timing of tarp cutting/removal, and PPE:

Names and phone numbers of persons contacted: Date contacted:

Comments/notes:168 Site Map

Location of application block: _______________________________________________________________________________

Map Legend

Application block Buffer zone Property lines Roads Right-of-way Walkway, sidewalk, path

B Bus stop WB Water body DC Daycare facility Sch School NAB Nearby application block

IPC Inpatient clinic P Prison Well Nursing home ALF Assisted living facility NH169Handler InformationHandler Name, Address, and PhoneNumberEmployer Name, Address, and PhoneNumberTasks They are Trained andAuthorized to PerformDate of PPETrainingDate ofMedicalQualification toWear aRespiratorDate of FitTesting forRespirator170 Air Monitoring Plan

For Buffer Zone Monitoring: (check here if section is not applicable )

Name of handler performing monitoring

activities Handler address Handler phone

number Location of monitoring Timing

For Handlers without Respiratory Protection: (check here if section is not applicable )

If sensory irritation is experienced: Intend to cease operations Intend to continue operations with respiratory protection If intend to continue operations with respiratory protection, complete section for Handlers with Respiratory Protection below.

If intend to cease operations - Name, address, and phone number of handler to perform monitoring activities prior to operations resuming: Monitoring equipment:

For Handlers with Respiratory Protection: (check here if section is not applicable )
Representative Handler Tasks to be Monitored Monitoring Equipment Timing171 Air Monitoring Plan for Methyl Bromide Formulation with < 20% Chloropicrin

For Buffer Zone Monitoring: (check here if section is not applicable ) Name, address, and phone number of person(s) to perform sampling:

Area or Structure to be Monitored Before Reentry is Permitted Monitoring Equipment Timing

For Handlers with Respiratory Protection:
Representative Handler Tasks to be Monitored Monitoring Equipment Timing172 Methyl Bromide FMP Check List

General Site Information A map, aerial photo, or detailed sketch is attached to this FM P that shows each of the following with distances from the applic ation site labeled: field location, application block dimensions, buffer zo nes, property lines, roads, bus stops, water bodies, wells, rig hts-of-ways, nearby application blocks, surrounding structures, and sites requiring 1⁄8 and 1⁄4 mile buffer zones. Supervision of Handlers An on site certified applicator will directly supervis e the handlers participating in the application starting when the fumigant is first introduced into the soil and ending after the fumigant has stopped being delivered/dispensed to the soil and the soil is sealed. After the application is complete, and before leaving the application block, the certified applicator has provided the owner/op erator and handlers with written information necessary to comply with the label and procedures outlined in the FMP. Fumigant safe handling information has been provided to each handler involved in the application or confirm that each handler participating in the application has received fumigant safe handling information in the past 12 months.

For all fumigation handling tasks, at least 2 WPS-trained handlers must be present.

Weather Conditions Wind speed at the application site is a minimum of 2 mph at the start of the application or forecasted to reach at least 5 mph during the application.
A shallow, compressed (low-level) temperature inversion is no t forecast to persist for more than 18 consecutive hours during th e 48-hour period after the application. An air-stagnation advisory is not in effect for the area where the application site is located. If air temperatures have been above 100 degrees F in any of the 3 days prior to application, then soil temperature will be meas ured and recorded in the post application summary report.

Soil Conditions The soil has been properly prepared and the surface has been checked to ensure that it is free of clods that are golf ball size or larger. The area to be fumigated has been tilled to a depth of 5 to 8 inches. Field trash has been properly managed (e.g., residue from a previous crop has been worked into the soil to allow for decomposit ion prior to fumigation, little or no crop residue is present on the soil su rface, and crop residue that is present does not interfere wi th the soil seal).
The soil temperature at the depth of injection ≤ 90 degrees F at the beginning of the application.

The soil moisture at 9 inches below the surface is sufficient (field capacity is 50 to 80 percent). Trash pulled by the shanks to the ends of the field will be cove red with tarp or soil before making the turn for the next pass.
Shank Applications (check here if section is not applicable )

For tarped-broadcast and -bedded applications, injection points wi ll be at least 8 inches from the nearest final soil/air inter face. For tarped-bedded applications, the injection depth will not be as deep as the lowest point of the tarp (i.e., the lowest point of the tuck). For untarped-bedded applications, the injection points will be at least 12 inches from the nearest final soil/air interface. For untarped-broadcast applications, the injection points will be at least 18 inches from the nearest final soil/air interface.
For broadcast untarped applications, a disc or similar equipment will be used to uniformly mix the soil to at least a depth of 3 to 4 inches to eliminate the chisel or plow traces and will following elimin ation of the chisel trace, the soil surface will be compacted w ith a cultipacker, ring roller, and roller in combination with tillage equipment. For performed bed applications, the soil will be sealed by disr uption of the chisel trace using press sealers, bed shapers, cul tipackers, or by re-shaping (e.g., relisting, lifting, replacing) the beds immediately following injection. For beds formed at the time of application, the soil will be sealed by disrupting the chisel tr ace using press sealers, or bed shapers.
For shanked bedded and broadcast applications, tarps will be inst alled immediately after fumigant is injected into the soil.
Applicators have been trained and instructed not to apply or allow fumigant to drain onto the soil surface. For each injection line a check valve been located as close as possible to the final injection point, or applicators will drain /purge the line of any remaining fumigant prior to lifting injection shanks from the ground. Applicators have been trained and instructed not to lift injection shanks from the soil until the shut-off valve has been close d and the fumigant has been depressurized (passively drained) or pur ged (actively forced out via air compressor) from the system.
Brass, carbon steel, or stainless steel fittings must be used throughout application rigs. Polyethylene tubing, polypropylene tubing, Teflon® tubing or Teflon® -lined steel braided tubing have been used for all low pre ssure lines, drain lines, and compressed gas or air pressure lines and is all other tubing Teflon® -lined steel braided.
Application equipment been inspected to ensure that application rigs do not contain galvanized, PVC, nylon, or aluminum pipe fi ttings. All rigs include a filter to remove any particulates from the fumi gant, and a check valve to prevent backflow of the fumigant i nto the pressurizing cylinder or the compressed air system. All rigs include a flowmeter or a constant pressure system with orifice plates to insure the proper amount of fumigant is appli ed. Applicators have been trained and instructed to ensure that positive pressure is maintained in the cylinder at not less than 20 0 psi during the entire time it is connected to the application rig, if a compressed gas cylinder is used. (This is not required for a comp ressed air system that is part of the application rig because if the compressor system fails the application rig will not be operable). Application rigs are equipped with properly functioning check valv es between the compressed gas cylinder or compressed air syst em and the fumigant cylinder. Applicators have been trained and instructed to always pressurize the system with compressed gas or by use of a compressed air system before opening the fumigant cylinder valve.173 Before using a fumigation rig for the first time, or when prepari ng it for use after storage, applicators have been trained and instructed to:

° Check the filter, and clean or replace the filter element as required.

° Check all tubes and chisels to make sure they are free of debris and obstructions.

° Check and clean the orifice plates and screen checks, if installed.

° Pressurize the system with compressed gas or compressed air, and check all fittings, valves, and connections for leaks using so ap solution.
Applicators have been trained and instructed to:

° Install the fumigant cylinder, and connect and secure all tubing. Slowly open the compressed gas or compressed air valve, and increase the pressure to the desired level. Slowly open the fumigant cylinder valve, always watching for leaks.

° When the application is complete, close the fumigant cylinder valv e and blow residual fumigant out of the fumigant lines into t he soil using compressed gas or compressed air. At the end of the application, disconnect all fumigant cylinders from the applica tion rig. At the end of the season, seal all tubing opening s with tape to prevent the entry of insects and dirt.

° Calibrate all application equipment and ensure that all control systems must be working properly.
Hot Gas Applications (check here if section is not applicable )

Tarps have been installed prior to starting the application. All delivery tubes have been placed under the tarp in such a way that they do not move during the application of methyl bromide

. The fumigant will be introduced from outside of the greenhouse. All fittings, connections, and valves have been checked for leak s prior to fumigation and if cylinders are replaced during the fumigation process, the connections and valves were checked for leaks prior to continuing the job.
Tree Replant (non-shank) Application (check here if section is not applicable )

For each individual tree-site, the tree stump and primary root syst em have been removed and the tree hole has been backfilled w ith soil before application. The fumigant will be injected at a depth of at least 18 inches into the soil. The wand will be cleared using nitrogen or compressed air before removing it from the soil and after the wand is cleared and re moved from the soil, the injection hole will be covered with soil and tamp or the soil will be compacted over the injection hole.

Buffer Zones
There are no difficult to evacuate sites within 1⁄4 (or 1⁄8 ) miles of the application block that will be occupied during the buffer zone period.
There are no bus stops or other locations where pers ons wait for public transit within the buffer zone. There are no buildings used for storage such as sheds, barns, gara ges, within the buffer zone that are occupied or that share a common wall with an occupied structure.

For areas in the buffer zone that are not under the control of owner/operator of the application block, written agreement has b een obtained from occupants that they will voluntarily vacate the buffer zone during the entire buffer zone period. For nearby agricultural areas that are in the buffer zone the owner/operator of that property provided written agreement that t hey, their employees, or other persons will stay out of the buffer zone during the entire buffer zone period. For publicly owned and/or operated areas (e.g., parks, rights of way, side walks, walking paths, playgrounds, athletic fields) written permission has been given to include the public area in the buffer zone from the appropriate local and/or state officials.

Buffer Zones Overlap (check here if section is not applicable )
A minimum of 12 hours has elapsed from the time the 1 st application ends until the 2 nd application begins.
If a structure exists within 300 feet of the buffer zone, appropr iate emergency preparedness and response procedures are follow ed. Certified applicator has informed handlers of the overlapping buffers and associated health protection requirements. Personal Protective Equipment for Handlers At least 1 air rescue device (e.g., SCBA) is on-site in case of an emergency.

All of the handler’s PPE has been cleaned and maintain ed as required by the WPS for Agricultural Pesticides.

Hazard Communication
The application area buffer zone has been posted in accordance with the label. Pesticide product labels and material safety data sheets are on-site and readily available for employees to review.
Recordkeeping
The owner/operator of the application block has been informed that he/she as well as the certified applicator must keep a signe d copy of the site-specific FMPs and the post-application summar y record for 2 years from the date of application.

I have verified that this site-specific FMP reflects current site conditions and product label directions before beginning the fumigation.

_

______________________________________________ ___________________________________ Signature of certified applicator supervising the fumigation Date174 Post-Application Summary

General Application Information
Application date and time: Application rate: Size of application block:

Weather Conditions
Summary of the weather on the day of the application:

Summary of the weather during the 48-hour period following the fumigant application:

Soil Conditions (check here if section is not applicable )
Soil temperature if air temperatures were above 100 degrees F in any of the 3 days prior to the application:

Tarp Damage and Repair (check here if section is not applicable )
Location and size of tarp damage:

Description of tarp/tarp seal/tarp equipment failure:

Date and time of tarp repair:

Additional comments or other deviations from FMP (if applicable):

Tarp Removal (check here if section is not applicable )
Description of tarp removal (if different than in the FMP):

Date tarps were cut: Date tarps were removed:

Complaints (check here if section is not applicable )
Person filing complaint:

On-site handler

Person off-site If off-site person, name, address, and phone number of person filing complaints:

Description of control measures or emergency procedures followed after complaint:

Additional comments:175 Description of Incidents (check here if section is not applicable )
Description of incident, equipment failure, or other emergency: Date and time:

Description of emergency procedures followed:

Additional comments:

Elevated Air Concentration Levels (check here if section is not applicable )

On-site

Outside buffer zone Location of elevated air concentration levels: Date and time:

Description of elevated air concentration levels: (provide air monitoring results on next page)

Description of control measures or emergency procedures followed:

Description of deviations from FMP (if applicable):

Posting Signs
Date of sign removal:

Description of deviations from FMP (if applicable):

Other

Additional comments/notes:176 Air Monitoring Results

When Respiratory Protection is Not in Use – Sensory Irritation Experienced (check here if section is not applicable )

Date and Time Handler Task/Activity Handler Location Where

Irritation Was Observed Resulting Action Comments Cease operations Respiratory protection
Cease operations Respiratory protection Cease operations Respiratory protection
Cease operations Respiratory protection Cease operations Respiratory protection
When Respiratory Protection is in Use – Direct Read Instrument Air Monitoring (check here if section is not applicable )

Sample Type Sample

Number Sample

Date/Time Handler Task/Activity (not applicable for

structural monitoring) Handler

Location/

Structure

Location Air

Concentration Sampling

Method Comments (e.g., sensory irritation experienced while wearing respirator)

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

Area Breathing Zone

Structure

I have verified that this post applica tion summary reflects the actual site conditio ns during the fumigation and an accurate description of deviations from the FMP (if applicable).

_

______________________________________________ ___________________________________ Signature of certified applicator supervising the fumigation Date177 APPENDIX D Technical Support Documents178 Appendix D. Technical Support Documents

Additional documentation in support of this RED is maintained in the OPP docket, located in room S-4400, One Potomac Yard (Sout h Building), 2777 S. Crystal Drive, Arlington, VA 22202. It is open Monday through Friday, excl uding legal holidays, from 8:30 am to 4 pm.

All documents, in hard copy form, may be viewed in the OPP docket room or

downloaded or viewed via the In ternet at the following site: http://www.regulations.gov . These

documents include:

Human Health

1. EPA-HQ-OPP-2005-0123-0285, Methyl Bromide: Phase 5 Health Effects Division (HED) Human Health Risk Assessment for Soil, Gree nhouse, and Residentia l/Structural Uses.

2. June 2, 2008 addenda to April 10, 2007 Phase 5 Health Effects Division (HED) Human Health Risk Assessment For Soil, Greenhouse, and Residential/Structural (DP Barcode: D350818).

3. June 9, 2008 memo, Factors Which Impact Soil Fu migant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Fa ctor Approach (DP Barcode: 306857).

4. EPA-HQ-OPP-2005-0123-0317, Review of Fumigants Group Incident Reports.

5. EPA-HQ-OPP-2005-0123-0318, Summa ry Fumigants Group Incident Reports.

6. EPA-HQ-OPP-2005-0123-0319, Summary Fu migants Group Incidents.

Stratospheric Ozone Depletion

7. EPA-HQ-OPP-2005-0123-0165, Methyl Br omide: Science of Ozone Depletion and Health

Effects Estimates.

8. EPA-HQ-OPP-2005-0123-0166, Human Hea lth Benefits Of Strato spheric Ozone Protection.

9. EPA-HQ-OPP-2005-0123-0167, Regulator y Impact Analysis, Protecting Stratospheric Ozone: Process for Exempting Critical Uses from the Phaseout of Methyl Bromide.

10. EPA-HQ-OPP-2005-0123-0168, OAP’s Economic Imp act Analysis For Methyl Bromide

Allocation In The United States.

11. EPA-HQ-OPP-2005-0123-0169, OAP’s Benefits Analysis.

Environmental Fate and Ecological Risk

12. EPA-HQ-OPP-2005-0123-0029, Revised Draft Methyl Bromide Environmental Fate and Ecological Risk Assessment - Following the Re view of 30-Day Error Correction Comments.

13. EPA-HQ-OPP-2005-0123-0038, Reregist ration Environmental Risk Assessment for Methyl

Bromide.

Benefits

14. EPA-HQ-OPP-2005-0123-0321, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Metam-Sodium, and Met hyl Bromide in Eggplant Production.

15. EPA-HQ-OPP-2005-0123-0322, Assessment of the Benefits Soil Fumigants (Methyl Bromide, Chloropicrin, Metam-Sodium, Dazome t) Used by Forest Tree Seedling Nurseries.

16. EPA-HQ-OPP-2005-0123-0323, Assessment of the Bene fits of Soil Fumigation with Methyl Bromide, Chloropicrin, Dazomet, Metam Potassium and Metam Sodium for Use in179 Raspberry Nurseries, Fruit and Nut Deciduous Tr ee Nurseries, and Rose Bush Nurseries in

California.

17. EPA-HQ-OPP-2005-0123-0324, Assessment of the Benefits of Soil Fumigation with Chloropicrin and Metam-sodium In Onion Production.

18. EPA-HQ-OPP-2005-0123-0325, Assessment of the Bene fits of Soil Fumigation with Methyl Bromide, Chloropicrin and Metam-sodium In Grape Production.

19. EPA-HQ-OPP-2005-0123-0326, Assessment of the Bene fits of Soil Fumigation with Methyl Bromide, Chloropicrin and Metam-sodium In Tree Nut Production.

20. EPA-HQ-OPP-2005-0123-0327, Assessment of the Benefits of Soil Fumigation with Chloropicrin, and Methyl Brom ide In Pome Fruit Production.

21. EPA-HQ-OPP-2005-0123-0328, Assessment of the Bene fits of Soil Fumigation with Methyl Bromide, Chloropicrin, and Metam Sodium In Stone Fruit Production.

22. EPA-HQ-OPP-2005-0123-0329, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-Sodium in Bell Pepper Production.

23. EPA-HQ-OPP-2005-0123-0330, Assessment of the Bene fits of Soil Fumigation with Metamsodium in Potato Production.

24. EPA-HQ-OPP-2005-0123-0331, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-sodium In Strawberry Production.

25. EPA-HQ-OPP-2005-0123-0332, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam-sodium , and Dazomet In Strawberry Nursery Runner

Production.

26. EPA-HQ-OPP-2005-0123-0333, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide and Meta m-sodium In Sweet Potato Production.

27. EPA-HQ-OPP-2005-0123-0334, Assessment of the Benefits of Soil Fumigation with Chloropicrin In Tobacco Production.

28. EPA-HQ-OPP-2005-0123-0335, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Metam-sodium in Tomato Production.

29. EPA-HQ-OPP-2005-0123-0336, Assessment of the Bene fits of Soil Fumigation with Metam

Sodium in Carrot Production.

30. EPA-HQ-OPP-2005-0123-0337, Assessment of the Bene fits of Soil Fumigation with Metam

Sodium in Peanut Production.

31. EPA-HQ-OPP-2005-0123-0338, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam Sodi um and Dazomet in Ornamental Production.

32. EPA-HQ-OPP-2005-0123-0339, Summary of the Benefits of Soil Fumigation with Methyl Bromide in Crop Production.

33. EPA-HQ-OPP-2005-0123-0340, BEAD’s Planned Impact Assessments on Agricultural Sites with Significant Use of Soil Fumigants.

Risk Management

34. SRRD’s Response to Phase 5 Public Comments for the Soil Fumigants. Rice, M. and McNally, R.; July 2008.

35. EPA-HQ-OPP-2005-0128-0031, Risk Mi tigation Options to Address Bystander and Occupational Exposures from Soil Fumigant Applications.

36. Analysis of Soil Fumigant Risk Management Requirements using Geographic Information Systems: Case Studies based on a Fore st Seedling Nursery (DP#363546). May 13, 2009.180 37. Process for Defining High-Us e Fumigation Areas at the State and County Levels (DP#364647) May 14, 2009.

38. Methyl Bromide (PC Code 053201), Chloropi crin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (P C Codes 039003 &039002), MITC (PC Code 068103), DP Barcode 362369, Updated Health E ffects Division Recommendations for Good Agricultural Practices and Associ ated Buffer Credits. May 14, 2009.

Response to Comments

39. HED Component of Response To Comments Document On Methyl Bromide Phase 5 Fumigant Risk Assessment (DP Barcode 353907).

40. Review of Stakeholder Submitted Impact Assessments of Proposed Fumigant Buffers, Comments on Initial Buffer Zone Proposal, and Case Studies of the Impact of a Flexible Buffer System for Managing By-Stander Risks of Fumigants (DP Barcode 353940).

41. Response to Phase 5 BEAD Related Public Co mments Received on the Reregistration of Chloropicrin, Dazomet, Metam Potassium, Meta m Sodium, and Methyl Bromide. June 25, 2008. (DP Barcode 353940).

42. SRRD’s Response to Phase 5 Public Comm ents for the Soil Fumigants (July 2008).

43. BEAD Response to Stakeholder Comments on Non-CUE Uses of Methyl Bromide and Methyl Bromide Rate Reductions (DP# 363545) (May 7, 2009).

44. Methyl Bromide, 1,3-Dichloropropene, Chlor opicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Compone nt of Agency Response To Comments On 2008 Reregistration Eligibility Documents (Date May 14, 2009).

45. Response to Public Comments on the 7/9/08 Completed Methyl Bromide RED. (Rothman, G. and Felkel, J. March 3, 2009).

46. Response to BEAD Related Public Comments Received on the Reregistration Eligibility Decision for Chloropicrin, Dazomet, Meta m Potassium, Metam Sodium, and Methyl

Bromide (DP# 363545) May 14, 2009.

47. SRRD’s Response to Post-RED Comments for the Soil Fumigants (May 27, 2009).