<>EPA
United States Prevention, Pesticides
Environmental Protection and Toxic Substances May 2009
Agency (7508P)
Amended Reregistration Eligibility
Decision for Methyl Bromide
(soil and non-food structural uses)
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Amended Reregistration Eligibility Decision for Methyl Bromide
(soil and non-food structural uses)
List A
Case No. 0335
Approved by:
Richard P. Keigwin, Sr., Director
Special Review and Reregistration Division
Date: 5bl|Qj
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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 Economic Analysis Division
BrO
bromine monoxide
CDPR
California Department of Pesticide Regulation
CFC
chlorofluorocarbons
CFR
Code of Federal Regulations
CIO
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
ED STAC
Endocrine Disruptor Screening 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 Complex Short Term model
KTS
Potassium Thiosulfate
lb
pound
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LC
50
LD
50
LOC
LOAEL
MBAO
MB IP
MBTOC
MCFA
mg/kg/day
mg/L
MITC
MOE
MRID
MSHA
MUP
NAM
NIOSH
NOAEL
NPDES
OAP
OAR
ODP
OPP
OPPTS
ORE
OSHA
PC
PDCI
PERFUM
PLHCP
PPE
ppm
PrG
PRZM/EXAMS
PSA
psi
Median Lethal Concentration. A statistically 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/1, mg/kg, or ppm.
Median Lethal Dose. A statistically derived single dose that can be
expected to cause death in 50% of the test animals when administered by
the route indicated (oral, dermal, inhalation). It is expressed as a weight
of substance per unit weight of animal, e.g., mg/kg.
Level of Concern
Lowest Observed Adverse Effect Level
Methyl Bromide Alternatives Outreach
Methyl Bromide Industry Panel
Methyl Bromide Technical Options Committee
Minor Crop Farmer Alliance
Milligram Per Kilogram Per Day
Milligram Per Liter
methyl isothiocyanate
Margin of Exposure
Master Record Identification Number. EPA's system for recording and
tracking studies submitted.
Mine Safety and Health Administration
Manufacturing-Use Product
National Association of Manufacturers
National Institute for Occupational Safety and Health
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Office of Atmospheric Programs
Office of Air and Radiation
ozone depletion potential
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides, and Toxic Substances
Occupational and Residential Exposure
Occupational Safety and Health Administration
Pesticide Chemical
Product-specific Data Call-in
Probabilistic Exposure and Risk model for Fumigants
Physician or Other Licensed Health Care Professional
Personal Protective Equipment
Parts Per Million
Pressurized gas
Pesticide Root Zone Model/Exposure Analysis Modeling System. A Tier
II Surface Water Computer Model,
public service announcement
pounds per square inch
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PVC
Polyvinyl Chloride
QPS
Quarantine and Preshipment
RED
Reregi strati on 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 and Reregi strati on Division
TEAP
Technical and Economic Assessment Panel
TRED
Tolerance Reassessment and Risk Management Decision
TWA
time weighted average
UNEP
United Nations Environment Programme
use
United States Code
USD A
United States Department of Agriculture
UF
Uncertainty Factor
UV
Ultraviolet
VIF
Virtually Impermeable Film
WPS
Worker Protection Standard
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Table of Contents
Methyl Bromide Reregi strati 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. Regul atory Hi story 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 Reregi strati on Decision 31
A. Determination of Reregi strati on 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 Ri sk Management 39
1) Bystander Risk Mitigation 40
i. Buffer Zones 41
ii. General Buffer Zone Requirements 41
iii. Buffer Zone Reduction Credits 59
iv. Restriction for Schools and 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 84
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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 Ill
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 124
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 126
c. Other Data Requirements 128
2. Labeling for Manufacturing-Use Products 130
B. End-Use Products 130
1. Additional Product-Specific Data Requirements 130
2. Labeling for End-Use Products 131
APPENDICES
Appendix A. Methyl Bromide PC Code 053201 Pre-plant Soil Uses Eligible for Reregi strati on 132
Appendix B. PERFUM Model Inputs and Outputs 134
Appendix C. FMP Template for Methyl Bromide Soil Applications 138
Appendix D. Technical Support Documents 151
LIST OF TABLES
Table 1. Modifications from 2008 to 2009 Amended Soil Fumigant REDs 13
Table 2. Implementation Schedule for Soil Fumigant Risk Mitigation Measures 15
Table 3. Maximum Application Rates for Pre-plant Soil Methyl Bromide Uses 39
Table 4. Tarped Bedded Buffer Zone Distances (feet) 51
Table 5. Tarped Broadcast Buffer Zone Distances (feet) 53
Table 6. Deep Untarped Buffer Zone Distances (feet) 55
Table 7. Outdoor Tarped Hot Gas 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
LIST OF FIGURES
Figure A. Requirements for when handlers should cease operations 76
Figure B. Requirements for when handlers should put on a respirator 77
Figure C. Untarped Applications 86
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Figure D. Tarp Broadcast Applications (tarps removed before planting) 87
Figure E. Tarp Bed Applications (Tarps not removed before planting) 88
Figure F. Tarp Bed/Broadcast Applications (Tarps are not perforated until 14 days after
application) 89
Figure G. Example Site Map for Informing Neighbors 110
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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, Agricultural 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 Stangel
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Abstract
This document presents the Environmental Protection Agency's (hereafter referred to as
EPA or the Agency) amended decision regarding the reregi strati on eligibility of the registered
soil and structural (non-food) uses of methyl bromide. This follows the 105-day public comment
period on the Reregi strati on Eligibility 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 Reregi strati on Eligibility Document (RED) to
reduce risks to bystanders and workers will still be required. However, the Agency has
determined that certain modifications in how and when some measures will be implemented are
appropriate. Products containing methyl bromide uses are eligible for reregi strati on 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 bromide-containing products for pre-plant soil
uses that currently qualify for exemptions under the Montreal Protocol are eligible for
reregi strati on provided that the risk mitigation measures identified in this document are adopted
and labels are amended to implement these measures. Throughout this document measures
described as "required" are those necessary to be eligible for reregi strati on. Additionally,
registrants must address data gaps that have been identified.
Concurrent to EPA's review of the soil fumigant uses of methyl bromide, EPA assessed
the risks and developed risk management decisions for four other soil fumigant pesticides,
including: chloropicrin, dazomet, 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 comparative 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 consistent, and that risk tradeoffs and economic
outcomes were considered appropriately in reaching risk management decisions. This review is
part of EPA's program to ensure that all pesticides meet current health and safety standards.
The report of the Food Quality Protection Act (FQPA) Tolerance Reassessment and Risk
Management Decision (TRED) for 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, representatives of the Methyl Bromide Industry Panel (MBIP)
presented to the EPA a preliminary summary of new emission studies for three flour mills. The
information presented by the MB IP indicates that 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 appropriate 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 Bromide 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 Report
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TRED/RED and respond to all comments upon review 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 document from inhalation exposure to handlers,
bystanders, and workers. EPA also has concerns for risks associated with methyl bromide's role
in the depletion of stratospheric ozone. To reduce inhalation exposures and to address associated
risks of concern, EPA is requiring a number of mitigation measures, such as:
Removing of uses with low benefits and/or alternatives;
Reducing maximum application rates;
Limiting use of 98:2 formulations to essential crops;
Buffer zones;
Respiratory protection and air 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 Protocol, will also further reduce the potential
health effects (e.g., skin cancer) from 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 two active ingredients in a product, the more
stringent mitigation measure is required on product labels.
The Agency is issuing this decision document 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. Environmental 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 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA received
requests to extend the comment period from the MB IP, California Specialty Crops Council, the
Chloropicrin Manufacturers' Task Force (CMTF), the National Association of Manufacturers
(NAM), the American Nursery and Landscape Association (ANLA), the California Strawberry
Nurserymen's Association, the Agricultural Retailers Association, the American Forest and
Paper Association, and McDermott, Will, and Emery LLP, on behalf of the Minor Crop Farmer
Alliance (MCFA). In response to these requests, on August 29, 2008, EPA published a notice in
the Federal Register extending the comment period 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 bystanders and workers will still be required. The
Agency has determined that certain modifications in how and when some measures will be
implemented are appropriate. The public comments and EPA's responses, as well as other
supporting documents, may be found in the public docket for methyl bromide at EPA-HQ-OPP-
2005-0123. EPA has determined that the modifications 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 the benefits of methyl bromide use, and with less uncertainty
regarding the protectiveness of the required measures. Please see Table 1 for a summary of the
modifications.
FIFRA was amended in 1988 to accelerate the 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 reregistration of an active ingredient, as well as EPA's
review of all submitted data. Reregistration involves a thorough review of the scientific database
underlying a pesticide's registration. 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 adverse effects" criteria of FIFRA.
This document presents the Agency's amendment 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 document consists of five sections. Section I
contains the regulatory framework for reregistration and a synopsis of modifications from the
2008 soil fumigant RED. Section II provides a profile of the use and usage of the chemical.
Section III provides a general overview of fumigants 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 implement the risk mitigation measures outlined in
Section IV. Unless otherwise noted, all Agency references in this document are available for
review in the methyl bromide docket (EPA-HQ-OPP-2005-0123) at www.Regulations.gov.
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Table 1. Modifications from 2008 to 2009 Amended Soil Fumigant REDs
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labels by the 2011 use season. As a result, all measures described in this amended RED that are
necessary for reregi strati on eligibility 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 Soil Fumigant Risk ]V
itigation 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
o
First responder and community outreach
o
Applicator training
o
Compliance assistance and assurance measures
o
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
o = under development
= adopt completely
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II. Chemical Overview
A. Chemical Identity
Chemical Structure:
Case Number:
Technical or
Manufacturing-U se
Registrants:
H
I
H-C-Br
I
H
Empirical Formula:
Common Name:
CAS Registry Number: 74-83-9
OPP Chemical Code: 053201
CH3Br
Methyl bromide
0335
Albemarle Corporation, ICL-IP America Inc. , 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 I, 2008, Ameribrom Inc. changed the corporate name to "ICL-IP America Inc."
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B. Use and Usage Profile
Methyl bromide is a broad-spectrum fumigant chemical that can be
used as an acaricide, antimicrobial, fungicide, herbicide, insecticide,
nematicide, and vertebrate control agent.
Methyl bromide controls a wide range of pests including spiders,
mites, fungi, plants, insects, nematodes, rodents, and snakes.
Methyl bromide's most prevalent use pattern is as a soil fumigant. It
is also used as a post harvest treatment of commodities and structural
fumigation. Structural non-food treatments (e.g., residential
buildings) are reportedly no longer performed.
Pressurized gas (PrG) formulations are used for all methyl bromide
applications. All methyl bromide products are classified as restricted
use pesticides (RUP). The "Restricted Use" classification restricts a
product, or its uses, to use by certified pesticide applicators or those
working under the direct supervision of a certified applicator.
Methods of Application: Soil uses: Methyl bromide 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 prevalent. 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 culture. 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 tarp remotely using flexible tubing
connected to pressurized gas tanks.
Application Rates: Soil uses: Common pre-plant agricultural field uses 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 applications and tree planting scenarios
which are less prevalent.
Other Uses: Application rates for commodity fumigations can range
from 1 to 20 lb ai/1000 ft3, but most perishable goods with established
food tolerances under 40 CFR have application rates in the range of 1
to 4 lb ai/1000 ft3 (e.g., grapes).
Pesticide Type:
Target pests:
Use patterns:
Formulations:
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Annual Usage in the In 2007, 5,482 metric tons of methyl bromide were applied (4,269
U.S.: metric tons from newly-produced material and 1,213 metric tons from
pre-2005 stocks). This amount does not include quarantine and
preshipment (QPS) exemption usage. QPS production is tracked by
the Agency but usage is not. EPA'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 Protocol on Substances that Deplete the Ozone
Layer, as of January 1, 2005, U.S. production and import of methyl bromide is banned, except
for uses that qualify for (1) a critical use exemption (CUE), (2) a QPS exemption, or (3) an
emergency exemption. For more information about the phase out of methyl bromide, see
http://www.epa.gov/ozone/mbr/.
III. Fumigant Overview and Agency Documents
A. General Overview of Soil Fumigants
Soil fumigants are pesticides that form gasses when applied to soil. Once in the soil, the
fumigants work by controlling pests that can disrupt plant growth and crop production. Soil
fumigants play a very important role in agriculture, but they also have the potential to pose risk
concerns to people involved in application of the chemicals (handlers), 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, workers, and bystanders associated with the soil
uses of methyl bromide is from acute inhalation 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 application of methyl bromide. For soil
applications, handlers also include persons involved in perforating and removing of tarps. The
term worker in this document refers to persons performing non-handler tasks within the
application block, after the fumigation process has been completed, 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 different from non-fumigant pesticides due to
fumigants' volatility, and thus, their increased ability to move off site during and after
application. For example, pesticide spray drift is the physical movement of pesticide particulate
or droplets from the target site during the application and soon thereafter. In the case of soil
fumigants, the pesticide moves as a gas (not as particulate or droplets) and movement off-site can
occur for an extended period after application. Importantly, fumigants have a well-documented
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history of causing large-scale human exposure incidents up to several 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" defines the rate at which a fumigant off-gasses
from a treated field. Many factors influence the rate of emissions from treated fields after the
application of soil fumigants. Factors such as the application method, soil moisture, soil
temperature, organic matter levels, water treatments, the use of tarps, biological activity in the
soil, soil texture, weather conditions, soil compaction, and others influence the amount of
fumigant that comes off the field and is available to move off-site 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 neurotoxic 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 endpoint was selected from a developmental
rabbit study with a LOAEL based on agenesis of the gall bladder and increased 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 factor (UF) of 30 with a 3x for interspecies
extrapolation and lOx for intraspecies variation 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 this 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 from monitoring studies, modeling tools, and from
incident reports.
Monitoring: For the human health risk assessments completed for methyl bromide and
the other soil fumigants within the group, several field-scale monitoring studies were
considered, as well as monitoring of workers and handlers involved in various tasks.
These studies quantify methyl bromide concentrations in and around fields at various
times and distances during and after applications. Many of these data indicate that there
can be risks of concern associated with methyl 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 conditions under which the study was conducted.
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Modeling: Models enable the use of data from monitoring studies to estimate
concentrations and potential risks under a wide range of conditions and use patterns.
EPA used the Version 2.1.4 of the Probabilistic Exposure and Risk model for Fumigants
(also called the PERFUM model), to evaluate potential risks at distances around treated
fields. PERFUM incorporates actual weather data and flux distribution estimates, and
then accounts for changes and altering conditions. Analyses based on a variety of model
outputs were used to compare the potential risks 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: Incidents for the soil fumigants
generally occur at a low frequency relative to the total number of fumigant applications
performed annually. However, when incidents occur, there are often many people
involved. Incidents involving 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 bystanders are involved since all the 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 equipment failure, handler accidents, applicator failure
to adhere to label recommendations and/or requirements, and temperature inversions.
Incidents have occurred to bystanders close to fields and up to two miles away from the
fumigated field.
Based on these lines of evidence, and as described 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 assessments indicate that
inhalation exposures to bystanders who live and work near agricultural fields and greenhouses
where methyl bromide fumigations occur have the potential to exceed the Agency's level of
concern without additional mitigation measures. There 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 information 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 Soil, Greenhouse, and Residential/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 Soil Fumigant Emissions - Evaluation for
Use in Soil Fumigant Buffer Zone Credit Factor Approach (DP Barcode: 306857)
EPA-HQ-OPP-2005-0123-0317, Review of Fumigants Group Incident Reports
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EPA-HQ-OPP-2005-0123-0318, Summary Fumigants Group Incident Reports
EPA-HQ-OPP-2005-0123-0319, Summary Fumigants Group Incidents
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 Practices and Associated Buffer Credits (Date May 14, 2009)
C. Stratospheric Ozone Depletion
In addition to methyl bromide's direct effects previously described in Section B, methyl
bromide soil fumigant use poses indirect chronic health risks, and 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 hydrochlorofluorocarbons (HCFCs), are very stable
in the lower atmosphere. They eventually drift into the stratosphere, where they undergo a series
of cyclical reactions that destroy ozone. In the presence of ultraviolet light, halogenated source
gases react to release chlorine or bromine atoms, which quickly break down ozone molecules
while producing the free radicals bromine monoxide (BrO) or chlorine monoxide (CIO). 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 Organization, 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 "bromine continues to play a major role in
stratospheric ozone depletion" and that "methyl bromide abundance decreased by 14% between
1997 and 2004. This decrease was larger than expected and suggests that when anthropogenic
emissions of bromine are reduced, its atmospheric abundance decreases more than previously
thought."
Thinning of the ozone layer leads to an increase in ultraviolet (UV) radiation reaching the
earth's surface, leading to increased incidence of skin cancer, cataracts, immunosuppression, and
other ecological and economic impacts.
The Agency has previously undertaken and provided analyses of methyl bromide's role
in stratospheric ozone depletion including estimates of mortalities and incidences of skin cancer.
These analyses were based in part, on the Atmospheric Health Effects Framework
(AHEF). For more information about the specific 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 Estimates
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EPA-HQ-OPP-2005-0123-0166, Human Health Benefits Of Stratospheric Ozone
Protection
EPA-HQ-OPP-2005-0123-0167, Regulatory 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 Impact Analysis For Methyl Bromide
Allocation In The United States
EPA-HQ-OPP-2005-0123-0169, OAP's Benefits Analysis
The AHEF model predicts mortality and incidence for increased emissions of compounds
that deplete stratospheric ozone, projects impacts of increased emissions on stratospheric ozone,
models resulting changes in ground-level UV radiation, 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, most recently in 2003. The final SAB reports for
the peer reviews are available on the EPA's internet site4. All comments of the peer reviewers
were considered, and the AHEF was modified appropriately.
The starting point in the AHEF modeling performed 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 Protocol, the amount of methyl bromide applied, produced, and stockpiled
has decreased since 2004 and is expected to continue to decline until supplies are exhausted.
The Agency modeled 5 scenarios for continued methyl bromide use from 2005-2037, ranging
from no drawdown (continued use at 23,000,000 lb per 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 annually5. 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 continue6. In 2007, invasive
melanoma was expected to strike more than 59,000 Americans and kill more than 8,0007.
Nonmelanoma skin cancers are less deadly than melanomas, but left untreated they can
spread, causing disfigurement and more serious health problems. The most common
nonmelanoma skin cancer - basal cell carcinoma - grows 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://vosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/BOARD
5 National Cancer Institute, "Common Cancer Types," 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/tvpes/melanoma
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Actinic keratoses are skin growths that occur on body areas exposed 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 carcinoma. 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 increases the risk of certain cataracts - a form of
eye damage in which a loss of transparency in the lens of the eye clouds vision. Other kinds of
UV-related eye damage include pterygium (tissue 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 suppress proper functioning
of the body's immune system and the skin's natural defenses. All people, regardless of skin
color, might be vulnerable to effects including impaired response to immunizations, increased
sensitivity to sunlight, and reactions to certain medications.
Because of these impacts, methyl bromide and other ozone-depleting substances are
being phased out worldwide under the Montreal Protocol on Substances that Deplete the Ozone
Layer, the international agreement designed to reduce and eliminate the production and
consumption of stratospheric ozone-depleting substances. 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 included Title VI on Stratospheric Ozone Protection,
codified as 42 U.S.C. Chapter 85, Subchapter VI, ensure that the United States could satisfy its
obligations under the Protocol.
In the United States methyl bromide is classified as a "Class I" ozone-depleting substance
due to its high ozone depletion potential (ODP). A substance's ODP is a measure of its ability to
destroy stratospheric ozone molecules. The other Class I substances, such as
chlorofluorocarbons (CFCs), halons, and carbon tetrachloride, were almost completely phased
out in the 1990s. Methyl bromide is the only 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 exemptions 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 alternatives are not yet available. The critical use
exemption is designed to permit the production and 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 supplied in 2005 from stocks and new production or
import to meet the needs of approved critical uses. Since then, through the notice-and-comment
rulemaking process, EPA has authorized critical uses of methyl bromide on an annual basis.
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In Decision IX/6 (1997), the Parties to the Montreal Protocol agreed that "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; and (ii) there are no technically and economically feasible
alternatives or substitutes available to the user that are acceptable from the standpoint of
environment and public health and are suitable to the crops and circumstances of the
nomination." These criteria are reflected in EPA's definition of "critical use" at 40 CFR 82.3.
Under the annual critical use process, applicants requesting critical use exemptions
provide data on the technical and economic feasibility of alternatives, their use of methyl
bromide, research programs into the use of alternatives to methyl bromide, and efforts to
minimize methyl bromide use and emissions. EPA 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 significant 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 Assessment Panel (TEAP), independent advisory
bodies to Parties to the Montreal Protocol, review critical use nominations and make
recommendations to the Parties, which then authorize 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 Agriculture and other federal agencies, and provides an opportunity for
public comment on the amounts of methyl bromide that the Agency has determined to be
necessary for critical uses and the uses that the 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 fumigation is used for rapid treatment of imports and
exports such as fresh fruits, vegetables, flowers, 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. Quarantine 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 also provides for a narrow "emergency use" exemption, under
which a Party may produce or import up to 20 metric 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 Atmospheric Programs (OAP) has not promulgated a
regulation for the implementation of an emergency use exemption.
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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, refer 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, Reregi strati on 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 fumigation is the major exposure pathway for non-
target mammals and birds. For aquatic organisms, 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 reduction in exposure that
would likely result from using tarps. This amendment to the reregi strati on eligibility decision
requires tarps for all methyl bromide applications except for California Orchard Replant.
1. Hazard
Methyl bromide is considered moderately toxic to birds (oral LD50 is 73 mg ai/kg) and
mammals (oral LD50 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 LC50 for methyl bromide from the inhalation route is 780 ppm.
Methyl bromide is slightly to moderately toxic to fish by acute exposure (LC50 is 3.9
mg/L), and to aquatic invertebrates (LC50 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 LC50 of 2.2 ppm8.
8 Data on the toxic effects of methyl bromide to algae are only available from a single study (Canton et al. 1980),
which appears to be an internal report and not published in the peer-reviewed literature
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2. Exposure
a. Terrestrial Exposure
The Industrial Source Complex Short Term (ISCST3) model together with historical air
monitoring data were used to evaluate the range of methyl bromide air concentrations which
might be found under different conditions of application 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 estimate exposures since terrestrial
acute risks of concern were not identified based on ISCST3 modeling (see Terrestrial Risks
Section 3.a. for further details).
b. Aquatic Exposure
The aquatic exposure assessment for methyl bromide relied on Tier II aquatic models.
The Pesticide Root Zone Model (PRZM version 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 field is specific to the crop being simulated using
site specific information on the soils, weather, cropping, and management factors associated with
the scenario. The crop/location scenario in a specific state is intended to represent a high-end
vulnerable site on which the crop is normally grown. Based on historical 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 tomato 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 Florida 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 treated area. If tarping is used to minimize the volatilization of
methyl bromide, the loading of the chemical through runoff will be limited until the tarp is sliced
or removed from the field. The present version of PRZM model has limited capabilities in
simulating the transport of a volatile chemical escaping the soil after removal of a tarp, and the
resulting surface-water concentrations should be considered upper-bound values.
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3. Risk
a. Terrestrial Risk
The most likely route of exposure to methyl bromide for terrestrial animals is through
inhalation of methyl bromide volatilizing 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 studies. 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 monitoring after soil fumigations resulted in
concentrations ranging as high as 3.35 ppm. The second source of concentrations used in the
terrestrial risk assessment was based on air dispersion modeling, which estimated a concentration
of about 9.1 ppm adjacent to a 40-acre field treated with 400 lb ai/A of methyl bromide.
These concentrations were compared to acute inhalation toxicity values to evaluate
potential risk. Mammalian acute inhalation toxicity data were available, but avian acute
inhalation toxicity endpoints had to be estimated using the mammalian inhalation and oral
toxicity data, avian oral toxicity data, and a factor used to account for inhalation physiology
differences between birds and mammals. The Agency has not set a LOC for inhalation exposure,
but the resulting RQs for both estimated air concentrations were below the 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 disperse 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 extend over several adjacent fields 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 ppm, which was higher than the peak short-term concentration
from soil treatments observed in historical data, and higher than a range of ambient air
concentrations found in historical monitoring data.
b. Aquatic Risk
The only aquatic risks that were above the Agency's LOC are the acute risk to
endangered or threatened aquatic invertebrates species. The acute aquatic listed species LOC
(0.05) is exceeded for aquatic invertebrates 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 reduction in exposure that would likely result from tarping the
field immediately after methyl bromide application. Given the low levels of exceedence (RQs of
0.06 to 0.07), the potential effect of tarping will likely lower the 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 highest
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application rate of 575 lb ai/A, assuming that 20% of applied methyl bromide is lost to
volatilization, and that the remainder of the methyl bromide degrades 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 endpoint of 7.8 ppm, for chronic risk to freshwater invertebrates. The
next lowest bromide ion toxicity 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 vegetables can be cheaply produced year-round
because severe pest problems can be efficiently controlled. Growers benefit because crops
grown in fumigated soil produce fewer blemished products, which translates into an increase in
marketable yields. Fumigation can also provide benefits to growers by increasing crop
management flexibility. This includes shorter crop rotational intervals (i.e., less time when fields
are left fallow), improved ability to meet quarantine 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 depends on pest pressure, which varies over space and
time, and the availability and costs associated with the use of alternatives.
There are a number of benefits assessments that have been completed by the Agency to
estimate the value of these chemicals to various industries. 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 Methyl 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 and 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 Bromide In Pome Fruit Production
EPA-HQ-OPP-2005-0123-0328, Assessment of the Benefits of Soil Fumigation with
Methyl Bromide, Chloropicrin, and Metam Sodium In Stone Fruit Production
EPA-HQ-OPP-2005-0123-0329, Assessment of the Benefits of Soil Fumigation with
Chloropicrin, Methyl Bromide, and Metam-Sodium in Bell Pepper Production
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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 Metam-sodium In Strawberry Production
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
EPA-HQ-OPP-2005-0123-0333, Assessment of the Benefits of Soil Fumigation with
Chloropicrin, Methyl Bromide and Metam-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 Sodium and Dazomet in Ornamental Production
EPA-HQ-OPP-2005-0123-0339, Summary of the Benefits of Soil Fumigation with
Methyl Bromide in Crop Production
EPA-HQ-OPP-2005-0123-0340, BEAD'S Planned Impact 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 with 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 application practices. However, the Agency believed that the
options provided in the scalable buffer approach in the fumigant 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 buffers. 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 application rates resulting in further 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 use of more expensive high barrier film, delays
in planting due to longer fumigation operations, additional 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 could be substantial in some production scenarios.
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Comments on the July 2008 RED
The July 2008 RED requested commenters to submit a description of fumigation
practices and provide maps of their property illustrating locations of fields, offices, residences,
roads, and property lines so that the Agency could better understand the impacts of the mitigation
plan. In response, various stakeholders, including 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 have for compliance, the Agency concludes that it
had overestimated the ease with which many growers 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 anticipated for some types of production. 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 infrastructure, 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 factors are the prohibition on
buffers overlapping in space and time and the duration of the buffer zone. Together, these
requirements could result in the loss of part of a grower's field that can be effectively fumigated.
Further, there may be substantial delays in completing fumigations and multiple trips to a field
with fumigation equipment may often be necessary. Not only could there be delays in
production activities in these instances, but it may 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 controlling 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 own 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 for applicators and growers. However, field
flux studies, monitoring data, modeling analyses, and information from incidents involving
fumigants continue to support a conclusion that methyl bromide off-gasses and moves away
from treated fields at concentrations 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.
In addition to these impacts, if emergency preparedness and response requirements were
triggered due to proximity of neighbors, for example, the requirement in the July 2008 RED to
monitor the buffer zone for its 48-hour duration was estimated to impose the highest direct costs.
The Agency estimates that the cost of sampling tubes alone could range from $1,000 to over
$3,000 for a field or enterprise, not including the 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 fumigate. However, the Agency understands and appreciates the
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many comments indicating that notification may not be an attractive option due to the potential
for neighbors to attempt to impede or block fumigant applications.
Finally, the Agency concludes that the development and implementation of workable
fumigation strategies, considering buffer and other 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 maintain 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 aspects 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 the Agency to determine, after submission of
relevant data concerning an active ingredient, whether pesticides containing the active ingredient
are eligible for reregistration. The Agency has previously identified and required the submission
of the generic (i.e., active ingredient specific) data required to support reregistration of products
containing methyl bromide.
The Agency has completed its assessment of the dietary (water), residential,
occupational, and ecological risks associated with the use of pesticides containing the active
ingredient methyl bromide. Dietary (food) risks were assessed in the 2006 Methyl Bromide
TRED/RED and associated tolerances were reassessed1. The TRED/RED, which covered
commodity fumigation, included similar mitigation measures required in this document (e.g.,
fumigation management plans, buffer zones, respiratory protection, air monitoring). The uses
covered by this document (i.e., those not included in the TRED/RED) are not considered
food/feed uses and do not have associated tolerances. In addition to the risk assessments, the
Agency completed benefit assessments on crops with significant methyl bromide usage9.
9 EPA-HQ-OPP-2005-0123-0340, BEAD'S Planned Impact Assessments on Agricultural Site with Significant Use
of Soil Fumigants
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In Phase 5, the Agency published a risk mitigation options paper10. 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/reporting/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 bromide 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 effects, stratospheric ozone depletion, and benefits
of methyl bromide to make decisions as part of the reregi strati on process under FIFRA. For the
purposes of determining reregi strati on eligibility, 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 uses that qualify for CUEs).
Given the high acute risks associated with methyl bromide use and methyl bromide's
status as an ozone depleting substance which contributes to the destruction of stratospheric ozone
and incidence of skin cancer, EPA determined in the July 2008 RED that only uses with very
high benefits and no economically or technologically feasible alternatives are eligible for
reregi strati on. The robust processes set forth in the Montreal Protocol and EPA's implementing
regulations for determining the critical uses of methyl bromide, and for identifying uses with
economically and technologically feasible alternatives, provide a clear picture of uses for which
methyl bromide has very high benefits (for further 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 Applications
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http://www.epa.gov/ozone/mbr/cueinfo.htmn. Based upon those analyses, EPA determined that
the uses in Group 1, those that qualify for exemptions under the Montreal Protocol, have benefits
which justify reregi strati on 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 measures and label changes outlined in the RED
were implemented. Therefore, products containing methyl bromide for these uses were eligible
for reregi strati on as long as they have CUE or QPS status under the Montreal Protocol. Required
label changes are described in Section V of this document. The Agency determined in the July
2008 RED that any Group 1 uses that no longer qualify for CUE and QPS status should be
canceled. The list of critical uses of methyl bromide, 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 exemptions 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 benefits, EPA determined in the July 2008 RED
that Group 2 uses were not eligible for reregi strati on. Substantial information available to EPA
as a result of (1) the exemption processes under 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 bromide's reregi strati on review, indicated that these
uses have economically and technologically 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 effective 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 benefits data on any additional Group 2 uses warrant
reconsideration of any part of this decision. The RED stated that if stakeholders are able to
provide new information during the comment period on this decision indicating 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 products and/or methods.
Following publication of the methyl bromide 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 the Group 2 uses during the post-RED comment
period. Following review of the comments, the Agency has determined that the benefits of the
Group 2 uses are not high enough to allow them to be eligible for reregi strati on. 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 time. These uses include; caneberries, fresh market
tomatoes and peppers in California, Vidalia onions 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 bromide. Alternative treatments to control pests
appear to be available and no information was submitted demonstrating that the alternatives are
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prohibitively expensive. Therefore, the Agency has determined that these uses should end
immediately. The Agency will work with the registrants to cancel the Group 2 uses under
Section 6(f) of FIFRA. If registrants do not request 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 reduce the incidence of skin cancer resulting from
stratospheric ozone depletion. 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 there will be more pre-2005
stockpile material available for critical uses.
Based on its evaluation of methyl bromide, the Agency has determined that methyl
bromide products, unless labeled and used as specified 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 document, 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 underway or is expected to begin in the near
term to (1) address current data gaps, and (2) refine understanding of factors that affect fumigant
emissions. Additionally, a number of new methods and technologies for fumigation are
emerging. EPA plans to move the soil fumigants 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 programs to eliminate the potato cyst nematode
in Idaho and the golden nematode in New York, federally recognized invasive, non-indigenous
pests. These nematode species pose serious threats to the potato industries in these regions and
can cause serious economic damage. Currently, 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 include 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 professional 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 safety of methyl bromide use under these programs. While EPA
believes that several of the amendments to the methyl bromide RED will reduce impacts on
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benefits that these programs provide, EPA will continue to work with USD A on these specific
uses to explore alternative methods to achieve safety goals while ensuring the benefits of these
programs continue. Additionally, the studies the MB IP 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 bromide 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 preliminary risk assessments and related
documents lasted from July 13 through 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 and 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 methyl 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 Comments Received on the Reregi strati on of
Chloropicrin, Dazomet, Metam Potassium, Metam Sodium, and Methyl Bromide. June 25,
2008. (DP Barcode 353940)
SRRD's Response to Phase 5 Public Comments 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 requests, on August 29, 2008, EPA published a notice in
the Federal Register extending the comment period 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 bystanders and workers will still be required. The
Agency has determined that certain modifications in how and when some measures will be
implemented are appropriate. The following documents include EPA's responses to comments
on the methyl bromide RED which may be found in the methyl bromide docket:
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Response to BEAD Related Public Comments Received on the Reregi strati on Eligibility
Decision for Chloropicrin, Dazomet, Metam 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, Chloropicrin, Dazomet, Metam Sodium/Potassium,
MITC: Health Effects Division (HED) Component of Agency Response To Comments On
2008 Reregi strati on Eligibility Documents (Date May 14, 2009).
Analysis of Soil Fumigant Risk Management Requirements using Geographic Information
Systems: Case Studies based on a Forest 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 reregi strati on provided the risk mitigation measures outlined in this document are
adopted and label amendments are made to reflect 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 risks of concern to humans and the environment
resulting from methyl bromide use. Understanding 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 irreversible effects, encourage best practices, and to reduce the potential
impacts on benefits. To reach this goal, EPA considered a range of factors including:
characteristics of bystander and other populations exposed to methyl bromide;
hazard characteristics of methyl bromide (the methyl bromide endpoint is based on a
severe and irreversible effect);
hazard characteristics of chloropicrin (the chloropicrin 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 bromide under the Montreal Protocol,
available information on levels of exposure, feasibility, cost, and effectiveness of various
risk mitigation options;
bystander, handler and worker incident reports;
potential impacts of mitigation on growers' ability to produce crops;
uncertainties and assumptions underlying the risk and benefit assessments; and
public comments.
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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 objective of reducing risk and minimizing impacts on
users.
The following is a summary of the rationale for 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 sites, reducing maximum applications rates,
limiting formulations with high percentages of methyl 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 stratospheric ozone risks.
In addition, GAPs, FMPs, and a stewardship/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, quarantine and pre-shipment, or other exempted uses) are not eligible
for reregi strati on. The following describes 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 growers and the international community have
determined to be critical and that are permitted under the Montreal Protocol;
restricts the use of stockpiled methyl 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 stratospheric 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) formulations are higher than for other formulations. When 98:2
formulations are used, the amount of methyl bromide applied is generally higher compared to
amount applied for other formulations which results in higher human health, ecological, and
stratospheric ozone risks. Additionally, EPA is concerned that 2% chloropicrin is not adequate
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to be an effective warning agent11. Therefore, the Agency has decided to only reregister 98:2
formulations for uses that have been determined 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 blocks result in bystander risks that exceed the
Agency's LOC at significant distances from the field. These methods of application are rarely
used in the U.S., and when they are used it is reported only for California orchard replant.
Therefore, the Agency is allowing only deep (18 inches or greater) untarped shank applications
for California orchard replant uses that qualify for a CUE or QPS exemption and tree-hole
applications with deep (18 inches or greater) injection auger probes. EPA is requiring tarps for
all other methyl bromide applications that are shank 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 information from critical use nominations (CUNs) and
CUEs and acknowledgements from MB IP and other stakeholders that current methyl bromide
use rates are substantially less than the current maximum rates on registered labels. Maximum
rates for QPS and emergency exemptions uses are not affected by this decision but must be
identified on end use labels.
During the post-RED comment period, the Agency received comments from MB IP 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 recently obtained, nurseries (strawberry, orchard
and forest seedlings) and some ornamental production facilities in California may occasionally
be required to use a rate of almost 400 lb methyl bromide/acre in order to obtain pest-free
certification.
Based on the Agency's review of the comments submitted by MB IP, EPA has
determined that maximum rates for certain uses should 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)
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July 2008 RED. These rates are still significantly lower than current labeled maximum rates and
the Agency believes that these reductions in application 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 document 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 rates is presented in Table 3.
Table 3. Maximum Application Rates for Pre-
jlant Soil Methyl Bromide Uses
Approved Critical Uses
Maximum I
iroadcast Equivalent Rates (lb a.i./acre)
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 health risk assessment, please refer to the
Human Health Risk Assessments and addenda for methyl bromide described in Section III of this
document. These documents are also available in the public docket 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 exposures to bystanders who
live and work near agricultural fields and greenhouses where methyl bromide 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 bystanders, handlers, and workers and to address
subsequent risks of concern, EPA is requiring a number of mitigation measures which include:
Removing of uses with low benefits and/or alternatives;
Reducing maximum application rates;
Limiting use of 98:2 formulations to essential crops;
Buffer zones;
Respiratory protection and air monitoring for handlers;
Restrictions on the timing of perforating and removing tarps;
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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 additional measures that could be implemented as
part of product stewardship. These additional measures 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 compliance 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 potential 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 preparedness and response and community 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 similar requirements for methyl bromide but
also includes permits for every application which are issued and administered by County
Agricultural Commissioners. California's approach has been effective 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 that 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 likely to be aware that a fumigant application has
occurred.
Bystander risks for people that live near treated fields differ from other human health
risks evaluated under FIFRA, for example residential and worker reentry risks. Unlike
residential exposures resulting from use of products 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 pest control product or
service, and as a result they have little access to information about the product (e.g., hazards,
safety information, first aid, etc.) or symptoms of exposure. Additionally, non-occupational
bystander exposures to fumigants are largely involuntary and unanticipated. In this regard non-
occupational bystander exposure is similar to dietary exposure in that people consuming foods or
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drinking water expect to be safe from possible adverse effects associated with pesticide residues
that could be present in their food and drinking water.
Unlike workers, non-occupational bystanders typically 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 pesticide risk, no such expectation
exists for non-occupational bystanders. Workers who experience symptoms of pesticide
exposure are also more likely to link their symptoms 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 information needed to take appropriate steps to mitigate
the effects of the exposure. Thus, EPA's mitigation includes elements for site specific response
and management, notice to state lead agencies, training, and community outreach and education,
as well as labeling changes.
i. Buffer Zones
The human health risk assessments indicate bystanders may be exposed to methyl
bromide air concentrations that exceed the Agency's level of concern based on current label
requirements. In general, the risk from inhalation exposures decreases as the distance from the
field where bystanders are located increases. Because 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. The 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 general 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 during 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 roadways through the buffer zone. However, bus
stops or other locations where persons wait for public transit were not permitted within the buffer
zone. Structures within the buffer zone were also not allowed to be occupied during the buffer
zone period and air samples were required before bystanders could enter the structure following
expiration of the buffer-zone period. In addition, before a buffer zone could extend onto
adjacent private or public property, the applicator needed to obtain written permission from the
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owner/operator or local authority to allow the buffer zone to extend onto the property. This was
to ensure that non-handlers would not enter the buffer zone and that 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 requirements. 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 comments expressed concern
that buffers EPA specified would not be large enough to protect bystanders.
The Agency also received numerous comments that buffer zone duration will present
severe hardship for growers. Many commenters expressed concern that the buffer zone overlap
restriction would have the unintended 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 weather 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 conditions are more conducive to off-gassing.
Examples cited by commenters where this situation 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 application blocks to make applications. Several
commenters felt that providing an exception to this prohibition would make buffers more
workable, reduce delays, allow a more efficient 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 favorable 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 clarification 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 and 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 extremely difficult, and that neighbors may not
provide permission. EPA also received additional field emissions (flux) data for some
fumigants, as well as additional information regarding 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 important protections for bystanders but will
increase the feasibility of compliance with buffers and will reduce potential impacts of buffers on
the beneficial uses of soil fumigants. The Agency does agree that compliance with buffer zone
requirements as outlined in the July 2008 RED would be a significant challenge for applicators
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and growers. However, field flux studies, monitoring data, modeling analyses, and information
from incidents involving fumigants continue to support a conclusion that methyl bromide off-
gasses and moves away from treated fields at concentrations 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 reduction application techniques, while still
protecting human health and the environment.
Amended RED Requirements
EPA has determined that no changes to several 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 V2 mile.
- the requirement limiting entry into buffer zones to handlers who have been properly
trained and equipped according to EPA's Worker Protection Standard;
- the prohibition on including in buffer zones bus stops or other locations where
persons wait for public transit;
- the prohibition against including in buffer zones buildings under the control of the
owner/operator of the application block used for storage such as sheds, barns,
garages, etc., unless the storage buildings are not occupied during the buffer zone
period, and the storage buildings do not share a common wall with an occupied
structure;
- the prohibition against including in buffer zones residential areas that are not under
the control of the owner/operator unless occupants agree in writing that they will
voluntarily vacate the buffer zone until the buffer zone period expires;
- the prohibition against including in buffer zones agricultural areas that are not under
the control of the owner/operator unless the owner/operator of the other area provides
written agreement that they, their employees, and other persons will not enter the
buffer zone; and
- the prohibition against including in buffer zones publicly owned and/or operated
areas such as parks, sidewalks, walking paths, playgrounds, and athletic fields
without first obtaining written permission from local authorities.
EPA has determined that certain other amendments to the July 2008 RED requirements
are appropriate; these are discussed in greater detail below. The amended buffer zone
requirements are summarized at the end of this section.
43
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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 individually treated fields. As a result, bystanders
outside of buffers for individual application blocks 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, including 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 prohibition, under the conditions specified below, is
reasonable and will not demonstrably alter the protection goals provided to bystanders in the July
2008 RED. EPA has determined that buffer zones from nearby application blocks may overlap
one another provided at least 12 hours have elapsed from the end of one application until the
start of the next application. By separating the application times by at least 12 hours the
fumigant emission peaks are less likely to occur 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 requirement for buffer zones around each application
block to be in effect for 48 hours and that only 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 hours 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, businesses, 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 are working in an existing buffer from an
overlapping buffer zone area, the labels will require the certified applicator, before beginning the
application, to determine whether the application block or its resulting buffer will overlap with a
buffer that is already in effect. If so, the certified applicator 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 block 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 handlers entering a treatment area are aware of previous treatments
and the existence of buffers. In addition, certified applicators must obtain permission from other
landowners when buffers extend onto other lands, which provides an additional mechanism to
ensure handlers are aware when they are working in a buffer zone and that they have the
44
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necessary information regarding health effects, warning properties, and respiratory/PPE
requirements for all products to which they may be exposed.
Areas not under the control of owner/operator of the application block
For areas not under the control 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 has expired, and (2) buffer
zones may include publicly owned and/or operated roads, including rights of ways, without first
obtaining written permission from local 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 under the control of the owner/operator of the
application block, 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 the occupants provide written
agreement that they will voluntarily vacate the buffer 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 that 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 persons 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 formulations would be an effective warning agent 48
hours after treatment. Therefore, monitoring of buildings and outdoor areas 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 formulations 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 block 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 amended requirements for overlapping buffers. In
addition, the applicator must still receive written permission from 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 buffer overlap provisions, will stay out of the buffer
zone during the entire buffer zone period. The goal of this agreement is to ensure that a property
owner of an agricultural field 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 ensure that persons on the 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 take any appropriate safety measures they deem
necessary. The Agency believes that requiring the applicator to obtain written permission will be
an enforceable measure that will meet the goal of protecting workers and bystanders on adjacent
properties that fall within a buffer zone.
45
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In addition, buffer zones still may include publicly owned and/or operated areas such as
parks, sidewalks, walking paths, playgrounds, and athletic fields only if the area is not occupied
during the buffer zone period and entry by non-handlers is prohibited during the buffer zone
period. Written permission from the appropriate state 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 has determined that these may be included
in buffers, subject to local laws and regulations, as long as it is posted according to the
requirements of this amended RED. If, as discussed 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 location. In such circumstances EPA believes 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 laws and regulations vary from jurisdiction to
jurisdiction and that the requirement to post points of entry into buffer zones may necessitate
additional steps on the part of fumigant applicators before a road or right-of-way can be included
in a buffer.
Maximum Application Block Sizes
The maximum application block sizes allowed in the 2008 RED for methyl bromide
applications were:
100 acres for tarped bedded and broadcast applications,
40 acres for untarped deep applications (e.g., California orchard replant),
10 acres for outdoor hot gas applications, and
45,000 square feet for greenhouse hot gas applications.
These block size limits were based on the upper 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 - Requirements in the July 2008 RED
Because the methyl bromide target air concentration 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 information on the PERFUM model. EPA believes the
buffer zone distances that achieve this result will be protective of all potentially exposed
bystanders including females at a critical phase of pregnancy. MOEs for non-pregnant
bystanders would be higher.
As discussed in the July 2008 RED, the buffer zones distances were not based on the
selection of a specific percentile or distribution from the PERFUM modeling results. Rather,
EPA used a weight of evidence approach to set the buffers which included consideration of the
46
-------
hazard profile of methyl bromide, information 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 Model12). 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 were 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 methyl 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 practices because of the
flexibility and options provided to modify buffers by altering certain aspects of fumigation
practices.
For the 2008 RED, the Agency developed buffer zone distances that were scaled based
on application method, application rate, and application block size. For each of the outdoor pre-
plant 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 relationship between the 10%, 25%,
50%), 75%) and 100% maximum rates (e.g., distance at 37.5% rate = [distance 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 the lookup tables are not
model outputs, although as described above the model outputs were used to inform the selection
of buffer zone distances.
The risks associated with the buffer zone distances, which are presented in Tables 4, 5, 6,
7 and 8, are characterized as follows:
For outdoor and greenhouse pre-plant soil applications, the buffer zone distances result in
MOEs ^ 30 at the upper percentiles (usually 95th percentile or greater) on the maximum
distance and whole field distributions for all weather stations modeled.
The risk level corresponding to the buffer zone distances at the 95th percentile maximum
distribution is equivalent to saying a person at the location on the perimeter of the buffer
zone where the maximum concentration occurs during the worst case 24 hour period
following the fumigation of a specific field during 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 that 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 99th percentile air
concentrations at the distances selected exceed 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 agricultural workers in nearby fields or other
work areas are likely to be present.
12 http://www.epa.gov/scram001/dispersion alt.htm#isc3
47
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It was assumed that methyl bromide air concentrations 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 concentrations. However, there is insufficient
data to quantify differences between indoor and outdoor concentrations.
The use of GAPs, FMPs, and other mitigation measures required by this decision will
contribute to an additional decrease in risk.
Minimum and Maximum Distances
A minimum buffer zone of 25 feet was required in the July 2008 RED regardless of site-
specific application parameters. In some instances 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 modeling; 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 V2 mile (2,640 feet) were prohibited. EPA
believes that for areas where methyl bromide is used, buffers greater than V2 mile are not
practical and difficult to enforce.
"Greenhouse" Uses
The "greenhouse" industry sector is extremely varied because of the diversity of the
facilities that are used across the country and because of the nature of the products that are
produced. As a result, some clarification is required to interpret the required buffer zone
distances for "greenhouses". In typical "greenhouse" operations, many types of containerized
ornamental plants and vegetable starter 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 black shade cloth). In the latter type of operation, cultural practices
related to methyl bromide use are essentially identical to the pre-plant field uses except they
typically occur on a smaller scale (e.g., 1 acre applications or less). As a result, the minimum
buffer zone distances for these types of use patterns 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-plant 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 associated with chloropicrin. In accordance with
Agency policy, when a pesticide contains more than one active ingredient, the product labeling
shall bear the more restrictive measures of pesticides in the mixture. Generally, formulations
with higher concentrations of methyl bromide will have buffers zone distances based on methyl
bromide, while the formulations with higher concentrations of chloropicrin will have buffers
zone distances based on chloropicrin. However, the user must consult the label for the specific
formulation intended for use to ensure the required buffer zone distances for the particular
product are employed.
48
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The July 2008 RED also provided detailed descriptions of the PERFUM model inputs
and outputs. These descriptions have not changed and are included in this Amended RED in
Appendix B.
Comments on the July 2008 RED Buffer Distances and Amended RED Determinations
Additional Acreage and Rate Increments
During the post-RED comment period, the Agency received comments requesting buffer
zone distances for additional acreage increments for small fields and additional application rate
increments for tarped bedded and tarped broadcast 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 for these use scenarios (Tables 4 and 5), and will
provide additional options for growers to achieve more workable buffers.
Although the Agency added additional acreage and rate increments, not all increments
may be captured by the tables presented. If the tables do not capture a specific acreage or rate,
round up to the nearest acre or rate. 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 letter committing to conduct
new field flux studies for methyl bromide that may allow EPA to further refine the buffer zone
distances specified in the tables below. The studies will be conducted in San Joaquin Valley and
Ventura County, California, and in Plant City, Florida. Emissions from various application
methods will be conducted including:
Broadcast shallow tarped under standard high-density polyethylene (HDPE)
Broadcast shallow tarped under virtually 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 conducted in spring 2009 through winter 2010 and final
reports are scheduled to be submitted to the Agency by March 2010. As noted above, the
information from these studies may enable EPA to refine buffer zone distances that will appear
on labels in 2011. See letter from Tracy Heinzman, Wiley Rein, LLP, to Debbie Edwards,
"Methyl Bromide Reregi strati on ~ Development of New Data to Calculate Flux Rates/Emission
Factors and Update EPA's By-Stander Exposure Assessment," March 31, 2009, located in the
methyl bromide docket.
49
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In addition, new fumigant data submitted during the post-RED comment period has also
allowed the Agency to refine and update buffer zone credits for tarps, certain application
techniques, and environmental conditions. As a result, although the buffer zone distances
specified in the tables in the July 2008 RED for methyl bromide have not changed except as
noted to add rate and acreage increments, buffers for growers who use emission-reducing tarps
or application methods, or have site conditions that 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 barrier tarps that may enable growers to use the
buffer zone credits and utilize lower application rates, resulting in further reductions of the buffer
zone distances. Some growers in the Southeast are commonly using high barrier tarps and lower
rates. The amended credits are discussed 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, summarized the required buffer zone distances and
corresponding PERFUM modeling results for the pre-plant soil uses that qualify for critical use
exemptions with typical application 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 row of Table 9), the buffer zone is 185 feet for a
10 acre application block in the Southeast at a rate of 120 lbs ai/A. At 185 feet, the PERFUM
model predicts greater than the 99.9th percentile for the whole field distribution and greater than
the 95th percentile for the maximum field distribution for the worst 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 99.9th percentile whole
field distribution is equivalent to saying a person at any location on the perimeter of the buffer
zone during the 24 hour period following the fumigation of a specific field during a 5-year period
would have at least a 99.9 percent chance of having of an exposure below the level of concern
(i.e., MOE of 30 or higher). The risk level corresponding to the buffer zone distances at the 95th
percentile maximum distribution is equivalent to saying a person at the location on the perimeter
of the buffer zone where the maximum concentration occurs during the worst case 24 hour
period following the fumigation of a specific field during a 5-year period 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 concentrations to predict MOEs
at the 99th percentile, at 185 feet for these application parameters, the MOE at the 99th percentile
is greater than 40 for the worst case weather station modeled (i.e., Bradenton, Florida).
50
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_2_
25
25
25
25
25
25
25
25
25
27
28
30_
Jl
_33
34
36
ii
_39
il
42
44
48
_52_
_57
il
65
70
74
78
_83_
87
Table 4. Tarped Bedded Buffer Zone Distances (feet)
Application Block Size (acres)
25
25
25
25
25
25
25
25
25
28
31
34
38
41
44
47
50
53
56
59
63
69
76
83
89
96
103
110
116
123
130
25
25
25
25
25
25
25
25
25
30
34
39
44
48
53
58
63
67
72
77
81
90
100
109
118
127
136
145
154
163
173
25
25
25
25
25
25
25
25
25
31
38
44
50
56
63
69
75
81
94
100
112
123
135
146
158
169
181
192
204
215
25
25
25
25
25
25
25
25
25
33
41
49
57
65
73
80
96
104
112
120
133
145
158
171
183
196
209
222
234
247
25
25
25
25
25
25
25
25
25
35
44
54
63
73
83
92
102
111
121
130
140
154
168
182
195
209
223
237
251
265
278
25
25
25
25
25
25
25
25
25
36
48
59
70
81
93
104
115
126
138
149
160
175
190
205
220
235
250
265
280
295
310
25
25
25
25
25
25
25
25
25
38
51
64
77
90
103
115
128
141
154
167
180
196
212
228
245
261
277
293
309
325
342
10
25
25
25
25
25
25
25
25
25
40
54
69
83
98
113
127
142
156
171
185
200
217
235
252
269
287
304
321
338
356
373
15
25
25
25
25
25
25
25
25
25
46
67
108
129
150
171
192
213
233
254
275
295
315
336
356
376
396
416
437
457
477
20
25
25
25
25
25
25
25
25
25
52
79
106
133
160
188
215
242
269
296
323
350
373
396
419
442
465
488
512
535
558
581
25
25
25
25
25
25
25
25
25
25
56
119
150
181
213
244
275
306
338
369
400
427
454
481
508
535
562
588
615
642
669
30
25
25
25
25
25
25
25
25
25
60
96
131
167
202
238
273
308
344
379
415
450
481
512
542
573
604
635
665
696
727
758
35
25
28
31
34
38
41
44
47
50
123
159
196
232
269
305
342
378
415
451
488
521
555
588
622
656
689
723
757
790
824
40
25
31
38
44
50
56
63
69
75
113
150
188
225
263
300
338
375
413
450
488
525
562
598
635
671
708
744
781
817
854
890
50
25
34
44
53
63
72
81
91
100
144
188
231
275
319
363
406
450
494
538
581
625
665
705
744
784
824
864
904
943
983
1023
60
25
38
50
63
75
100
113
125
175
225
275
325
375
425
475
525
575
625
675
725
768
811
854
897
940
983
1027
1070
1113
1156
70
25
41
56
72
103
119
134
150
204
258
313
367
421
475
529
583
638
692
746
800
895
943
990
1038
1085
1133
1180
1228
1275
51
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Table 4. Tarped Bedded 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
100
180
46
91
137
182
227
260
292
325
358
390
497
604
696
788
858
927
1063
1199
1323
1446
1556
1666
185
48
96
143
191
238
272
306
340
374
408
517
627
723
819
891
963
1103
1242
1370
1498
1613
1728
190
50
100
150
200
250
285
320
355
390
425
538
650
750
850
925
1000
1143
1285
1418
1550
1670
1790
195
56
108
159
211
263
298
333
369
404
440
556
673
776
879
957
1035
1185
1334
1471
1608
1735
1861
200
63
116
169
222
275
311
347
383
418
454
575
696
802
908
990
1071
1227
1383
1525
1667
1799
1932
205
69
123
178
233
288
324
360
396
433
469
594
719
828
938
1022
1106
1269
1433
1579
1725
1864
2003
210
75
131
188
244
300
337
373
410
447
483
613
742
854
967
1054
1142
1312
1482
1633
1783
1928
2073
215
81
139
197
255
313
350
387
424
461
498
631
765
880
996
1086
1177
1354
1531
1686
1842
1993
2144
220
88
147
206
266
325
363
400
438
475
513
650
788
906
1025
1119
1213
1396
1580
1740
1900
2058
2215
225
94
155
216
277
338
375
413
451
489
527
669
810
932
1054
1151
1248
1439
1629
1794
1958
2122
2286
230
100
163
225
288
350
388
427
465
503
542
688
833
958
1083
1183
1283
1481
1678
1848
2017
2187
2357
235
106
170
234
298
363
401
440
479
518
556
706
856
984
1113
1216
1319
1523
1728
1901
2075
2251
2428
240
113
178
244
309
375
414
453
493
532
571
725
879
1010
1142
1248
1354
1565
1777
1955
2133
2316
2498
245
119
186
253
320
388
427
467
506
546
585
744
902
1036
1171
1280
1390
1608
1826
2009
2192
2380
2569
250
125
194
263
331
400
440
480
520
560
600
763
925
1063
1200
1313
1425
1650
1875
2063
2250
2445
2640
52
-------
J_
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
Table 5. Tarped Broadcast Buffer Zone Distances (feet)
Application Block Size (acres)
25
25
25
25
25
25
25
28
31
34
36
39
42
45
48
51
53
56
61
66
72
77
82
87
92
97
102
107
113
25
25
25
25
25
25
25
31
36
42
48
53
59
65
70
76
82
98
108
118
128
139
149
159
169
180
190
200
25
25
25
25
25
25
25
34
42
51
59
76
85
93
102
110
119
134
149
165
180
195
211
226
241
257
272
288
25
25
25
25
25
25
25
36
48
59
70
82
93
105
116
127
139
150
170
191
211
232
252
273
293
314
334
355
375
25
25
25
25
25
25
25
39
53
67
81
95
110
124
138
152
166
180
202
225
247
269
291
314
336
358
380
403
425
25
25
25
25
25
25
25
42
59
75
92
109
126
143
160
176
193
210
234
258
282
306
330
355
379
403
427
451
475
25
25
25
25
25
25
25
45
64
103
123
142
162
181
201
220
240
266
292
318
344
370
395
421
447
473
499
525
25
25
25
25
25
25
25
47
70
92
114
136
159
181
203
225
248
270
298
325
353
381
409
436
464
492
520
547
575
10
25
25
25
25
25
25
25
50
75
100
125
150
175
200
225
250
275
300
330
359
389
418
448
477
507
536
566
595
625
15
25
25
25
25
25
25
25
59
93
127
161
195
230
264
298
332
366
400
438
475
513
550
588
625
663
700
738
775
813
20
25
25
25
25
25
25
25
111
155
198
241
284
327
370
414
457
500
545
591
636
682
727
773
818
864
909
955
1000
25
25
27
29
31
33
35
38
138
188
238
288
338
388
438
488
538
588
639
690
741
792
843
894
945
997
1048
1099
1150
30
25
29
33
38
42
46
50
107
164
220
277
334
391
448
505
561
618
675
732
789
845
902
959
1016
1073
1130
1186
1243
1300
35
25
35
46
56
67
77
149
210
272
333
394
456
517
578
640
701
763
824
885
947
1008
1069
1131
1192
1253
1315
1376
1438
40
25
42
58
75
92
108
125
191
257
323
389
455
520
586
652
718
784
850
916
982
1048
1114
1180
1245
1311
1377
1443
1509
1575
50
25
48
71
94
117
140
163
236
310
384
458
532
606
753
827
901
975
1053
1130
1208
1286
1364
1441
1519
1597
1675
1752
1830
60
25
54
83
113
142
171
200
282
364
445
527
609
691
773
855
936
1018
1100
1190
1279
1369
1458
1548
1637
1727
1816
1906
1995
2085
70
25
63
100
138
175
213
250
339
427
516
605
693
782
870
959
1048
1136
1225
1325
1426
1526
1627
1727
1828
1928
2029
2129
2230
2330
80
25
71
117
163
208
254
300
395
491
586
682
777
873
968
1064
1159
1255
1350
1461
1573
1684
1795
1907
2018
2130
2241
2352
2464
2575
90
25
77
129
181
233
285
338
442
547
651
756
860
965
1069
1174
1278
1383
1488
1608
1728
1849
1969
2090
2210
2331
2451
2572
2692
2813
53
-------
335
345
355
365
375
385
395
405
415
425
435
Table 5. Tarped Broadcast Buffer Zone Distances (feet)
Application Block Size (acres)
126
140
153
167
181
194
208
222
235
249
263
218
236
255
273
291
309
327
345
364
382
400
310
333
356
378
401
424
447
469
492
515
538
402
430
457
484
511
539
566
593
620
648
675
452
480
507
534
561
589
616
643
670
698
725
502
530
557
584
611
639
666
693
720
748
775
552
580
607
634
661
689
716
743
770
798
825
602
630
657
684
711
739
766
793
820
875
10
652
680
707
734
761
789
816
843
870
925
15
847
915
949
983
1017
1051
1085
1119
1153
1188
20
1041
1082
1123
1164
1205
1245
1286
1327
1368
1409
1450
25
1195
1241
1286
1332
1377
1423
1468
1514
1559
1605
1650
30
1350
1400
1450
1500
1550
1600
1650
1700
1750
1800
1850
35
1495
1553
1611
1669
1727
1785
1843
1901
1959
2017
2075
40
1641
1707
1773
1839
1905
1970
2036
2102
2168
2234
2300
50
1907
1984
2060
2137
2214
2291
2368
2445
2521
2598
2675
60
2173
2260
2348
2436
2524
2611
2699
2787
2875
2962
3050
70
2426
2522
2618
2715
2811
2907
3003
3099
3195
3291
3388
80
2680
2784
2889
2993
3098
3202
3307
3411
3516
3620
3725
90
2924
3035
3147
3258
3369
3481
3592
3703
3815
3926
4038
100
3168
3286
3405
3523
3641
3759
3877
3995
4114
4232
4350
54
-------
Table 6. Deep Untarped Buffer Zone Distances (feet)
Block
Size
(acres)
Broadcast Equivalent Application Rate (lb ai/acre)
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
211
25
88
150
295
440
585
725
865
1,000
1,140
1,275
1,410
1,540
1,670
1,800
3ฉ
25
125
225
410
590
770
950
1,125
1,300
1,475
1,650
1,825
2,000
2,175
2,350
4ฎ
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)
Block
Size
(acres)
Broadcast Equivalent Application Rate (lb ai/acre)
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)
Block Size
Broadcast Equivalent Application Rate (lb ai/100 square feet)
(square
feet)
0.25
0.5
0.75
1
5,(MM)
25
25
50
100
10,000
25
50
125
200
15,000
25
100
175
250
2ฎ, 000
25
125
225
300
25,00ฎ
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
500
55
-------
Table 9. Projected Buffers Zones for Methyl Bromide Critical Use Exemptions Based on Current Typical Application
Rates
Buffer
Maximum
MOE for 99th
Broadcast
Zones
Distribution
Percentile Air
Equivalent
Block
without
Percentile where
Concentration from
Application
Rate (lb
Sixe
credits
MOE reaches 302
PERFUM2 output
Crop
Region
Method1
ai/A)
(acres)
(ft)
Bradenton
Ventura
Bradenton
Ventura
MI
Tarped
Shank
Bedded
200
10
454
>95
>95
>40
>45
Cucurbits
20
696"
>95
>97
>40
15
Southeast
Tarped
Shank
Bedded
120
10
185
>95
>97
>40
>45
20
323
>95
>97
4Q7
Eggplant
Southeast
Tarped
Shank
Bedded
120
10
185
>95
>97
>40
45
20
323
>95
>97
40
Tarped
Shank
Broadcast
236
10
389
>99
>99.9
>45
>50
Forest
Southeast
20
636
>99
>97
>45
>50 :
Seedlings
350
10
707
>97
>99
>50
>60
20
1.123
>99
>97
>50
>60
Nursery,
Fruit, Nut,
and Rose
National
Tarped
Shank
Broadcast
180
10
225
>99
>99.9
>45
>50
40
652
>99
>99.9
>45
""-">50"-"
Stone Fruit,
Tree Nut
Orchard
CA
Tarped
Shank
Broadcast
182
10
225
>99
>99.9
>45
>50
Replant,
Grape
40
652
>99
>99.9
>45
>50
Vineyards
CA
Tarped
Shank
Broadcast
235
10
359
>99
>99.9
>45
>50
Ornamentals
"'.'20
>99
'":>97;'7.
'7"->45'-'7;;
7>5Q..
FL
Tarped
390
10
816
>99
>97
>55
>60
Shank
Broadcast
-2o:-
"J,28:6:"
>99
'":>97;'7.
'7"-^55'77*
""-">60"'""
MI
Tarped
Shank
Bedded
200
10
454
>95
>95
>40
>45
Pepper, Bell
20
696
>95
>97
>40
>45 :
Southeast
Tarped
Shank
Bedded
120
10
185
>95
>97
>40
>45
20
323
>95
>97
>40
CA
Tarped
175
10
200
>99
>99.9
>45
>50
Strawberry
Broadcast
'".'20"v;
":327T '
>99
>99.9
>45
"-">50-"-:
Fruit
FL
Tarped
Shank
Bedded
120
10
185
>95
>97
>40
>45
'".'20"v;
"-323 7
>95
>97
CA
Tarped
Shank
Broadcast
235
10
359
>99
>99.9
>45
>50
'".''20"v;
'""pi":
-99
>97
>45
""-">'50'-'"-':"
Strawberry
Tarped
Shank
Bedded
235
10
556
>95
>97
>35
>40
Nursery
NC
-----20------
"856"";
'7>97;"7
'7>35-7'
Tarped
Shank
Broadcast
235
10
359
>99
>99.9
>45
>50
2d
51>I
45
ฆ5(1=7
Tomato,
Fresh
Southeast
Tarped
10
185
>95
>97
>40
>45
Shank
Bedded
120
2d
^2 i
<>5
>35
4(i
1 Broadcast (flat fume) may be applied as strips with non-treated areas in between (e.g., for forest seedlings and orchards).
2 The whole field percentile where MOEs reach 30 is >99.9 for all of the weather stations modeled.
56
-------
The Agency believes that the buffer zone distances 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 MB IP which may
allow the Agency to determine if buffer zones of different sizes would meet or exceed the level
of protection that the Agency established 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 different from the distances
provided in this document.
Amended Buffer Zone Requirements
The following describes the general buffer zone 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 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 transit (see
exemptions section).
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.
An "application block" is a field 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 application blocks may not overlap UNLESS:
o A minimum of 12 hours have elapsed from the time the earlier application(s) for
which a buffer is in place end(s) until the latter application begins, and
o Emergency preparedness and response measures 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 feet 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 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).
57
-------
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.
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, exclusive of the sidewalk or shoulder even if 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.
(This definition is based on the definition of roadway 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 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 common wall with an occupied structure.
See the Posting section of this document 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 voluntarily vacate the buffer zone
during the entire buffer zone period, and
2. Reentry by occupants and other non-handlers must not occur until,
ฐ the buffer zone period has ended,
ฐ Sensory irritation is not experienced, and
ฐ for structures in buffer zones for methyl bromide applications with less than 20%
chloropicrin: Two consecutive air samples for 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 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 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 under the control of the
owner/operator of the application block) provides 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.
58
-------
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 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 additional requirements that may apply.
iii. Buffer Zone Reduction Credits
Requirements in the July 2008 RED
In preparing for the July 2008 RED, the Agency undertook a significant effort to evaluate
available empirical data results, modeling, and scientific studies reported 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 researchers 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 data, the 2008 methyl bromide RED gave buffer
zone reduction credits for high barrier tarps, soils 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 application rates, increase efficacy, and reduce 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 environmental 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: 306857
59
-------
additive effect in reducing emissions when multiple factors were combined. As a result, EPA
has updated the buffer reduction credits and determined that the 45% credit cap should be
increased to 80%. The new credits for individual factors and the cap on credits are detailed
below. For details on the Agency's analysis 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 Codes 039003 & 039002), MITC (PC Code 068103), DP
Barcode 362369, Updated Health Effects Division Recommendations For Good Agricultural
Practices and Associated Buffer Credits", in the methyl bromide docket.
ฆ 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 high barrier tarps: Bromostopฎ (1.38 mil), IPM Clear VIF (1.38
mil), and Eval/Mitsui (1.38 mil). The Agency believed 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 (USDA-ARS) and other organizations 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 the credit for certain tarps and increased the
number of tarps that are given credits. The Agency has determined that the tarps tested can be
divided into two groups based on results in the emissions tests mentioned 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, Bromostopฎ (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, which will be given a buffer credit of 60%.
It is important to note, however, that when considering the credits selected for high-
barrier tarps for each fumigant, a number of issues must be taken into account, including:
different tarp and fumigant combinations result in different degrees of emission control;
difficulty in determining the exact impact that high-barrier tarps have on emissions in a full field
flux study unless a co-located field is also monitored in the same vicinity using a standard tarp;
and the lack of a standard fumigant tarp testing procedure.
The Agency is currently validating a standard fumigant tarp testing procedure, developed
at USD A, that measures the mass transfer coefficients of tarps. The purpose of this research is to
develop a standardized method of testing and rating permeability of tarps based on mass transfer
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coefficients. From these results a permeability database and a standardized method for testing
tarp permeability will be developed. The database will allow the Agency to evaluate potential
buffer zone credits for additional tarps. In addition, 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 Practices and Associated Buffer Credits".
The Agency has also co-funded a grant with USDA-ARS to conduct several flux studies
in the southeastern U.S. These studies will provide field data on the emission reduction potential
of certain barrier films to further enhance EPA's understanding of the emission reduction value
of various agricultural films, and possibly support additional buffer reduction credits and an
affordable and reliable hybrid field/lab test to evaluate the many barrier films available to
growers.
ฆ Soil conditions
Credits in the July 2008 RED
Like high barrier tarps, inherent soil conditions (e.g., organic matter and soil type) do
have an impact on fumigant emissions. However, while the use of high barrier tarp is a choice
an applicator can make, soil conditions are factors 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 conditions can reduce fumigant emissions, and is
offering credits for these conditions where they exist.
In the July 2008 RED, the Agency determined that a 10 percent buffer zone credit was
appropriate if the application block contains soil with organic matter 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% for soils that were composed of approximately
1.5% organic matter compared to soils that were 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 matter
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in soil on emission would be relevant to other fumigants in addition to chloropicrin. This is
based on modeling with CHAIN2D that shows the impact of changes in organic content is not
fumigant specific. A 10% credit will be given if methyl bromide 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 that would result in changes to the credit for
soil type. Therefore, the credit for clay content of greater than 27% will remain at 10%.
ฆ 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 data 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 moisture because the Agency could not justify credits
based on the available data. The Agency established 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 10-15% range. When this study was
compared to previous studies done with the same application methods at much lower field
capacities, in the 35-55% range, and all other factors being relatively equal, a 3-4 fold reduction
in emissions was observed.
Credits for the Amended RED
There are currently not sufficient data available to provide a credit for field capacity for
methyl bromide. However, the MB IP has committed to conducting a number of new field flux
studies in 2009/2010 for methyl bromide. These studies may provide more information about
the effect of soil moisture on methyl bromide emissions. Soil moisture credit/GAP decisions for
methyl bromide may be revisited if necessary after review of these data.
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ฆ 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 fumigation. In the 2008 RED, if KTS was used in
conjunction with one of the approved high barrier tarps, the buffer zone could be reduced by
45%. If KTS was used with any other tarp, 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 and 2008 research were published by the California
Strawberry Commission titled, "Reduce Fumigant Emissions Using Impermeable Film and
Water Seal in Strawberry Raised Beds. California Strawberry Commission 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 combination resulted in an approximate reduction of peak
flux of 36% and total mass loss was reduced by approximately 20% at Salinas when compared to
the standard tarp water seal scenario. The water seal/KTS combination resulted in an
approximate reduction of peak flux of 32% and total mass loss was reduced by approximately
10%) at the Oxnard site when compared to the standard tarp scenario. Because laboratory data
looking at all halogenated fumigants, including methyl bromide, methyl 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 Vi to '/2 inch of water over 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 Bromostopฎ (1.38 mil) which qualifies for a 60% credit, the total credit
would be 75%). If KTS is used with another tarp, the credit is 15%.
ฆ Water seals
Credits in the July 2008 RED
The July 2008 RED did not give credits for the application 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 study published by the California
Strawberry Commission titled; "Reduce Fumigant Emissions Using Impermeable Film and
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Water Seal in Strawberry Raised Beds. California Strawberry Commission Annual Production
Research Report 2007-2008," show that that applying a water seal 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 resulted in an approximate reduction 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 Vi to '/2 inch of water is applied over 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 when a
water seal is applied over Bromostopฎ (1.38 mil) which qualifies for a 60% credit, the total
credit would be 75%. If a water seal is used with another tarp, the credit is 15%.
ฆ 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 MB IP 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 temperature typically corresponds to increased
fumigant emissions. This is not a factor that growers can manipulate in the field but is directed
more at different regions in the country where low soil temperatures may be typical during the
fumigation season.
ฆ 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 tarp could be added to a 10 % credit for organic
matter and to a 10% credit for clay content to achieve a total credit of 45%. The Agency placed
a limit, or "credit cap," of 45% on the total size of the credit allowed for methyl bromide.
Comments on the July 2008 RED
During the comment period, the Agency received 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 should be raised. Some suggested that the 45% cap
would be a disincentive to growers considering whether to adopt emission-reducing application
methods.
Credits for the Amended RED
Upon review of the new data and public comments, the Agency has decided to raise the
credit cap to 80%. The Agency has reviewed the new studies to evaluate the extent to which the
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various factors that reduce emissions act independently, and has reconsidered the earlier studies.
As a result of this evaluation, the Agency concludes 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 adoption of emission reduction techniques, result
in lower off-site fumigant concentrations, and will allow for reduced application rates for various
tarps.
ฆ 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 rate of 120 lbs ai/A is 200 feet without any credits (see last row
in Table 7). If the grower uses Bromostopฎ (1.38 mil) high barrier tarp, the buffer zone can be
reduced by 60%. The resulting buffer zone distance for this case is 80 feet. If the organic matter
in the application block is two percent and Bromostopฎ (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 40 feet.
ฆ Other buffer zone credits considered
The Agency's revised document; "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 Practices and Associated Buffer Credits (5/14/09)",
reviewed several other factors such as field 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 qualitatively evaluated the impact of potential
emission control measures on bystander risk. The Agency recognizes that there is substantial
research being conducted by stakeholders to further 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 additional emission credits in the future.
iv. Restriction for Schools and Other Difficult to Evacuate Sites
Certain types of sites are difficult to evacuate should an incident 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 occupants and address potential challenges associated
with an accident. There were many comments on this 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 the places included on this list so
that facilities such as research universities were excluded; suggestions to shorten the duration of
the requirement so applicators may be able to take advantage of weekends to fumigate; questions
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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 lower-emission application methods.
This mitigation measure has been refined such that compliance is more effective in achieving the
protection goal. Modifications to this requirement include: shortening the duration of the
restriction so weekends may be used to fumigate near schools and day care centers; clarifying the
types of schools that are covered by this requirement; 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-patient clinics;" and reducing the restricted area from Vi mile to
Vs mile for application blocks with less than 300 foot buffers. The Vs 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 provide an incentive for some users to adopt lower-
emission application methods or practices. The revised measures are summarized below.
"Difficult-to-evacuate" sites include schools (preschool to grade 12), state licensed day care
centers, nursing homes, assisted living facilities, hospitals, in-patient clinics, and prisons.
No fumigant application with a buffer zone greater than 300 feet is permitted within ]A mile
(1,320 feet) of the sites listed above unless the site is not occupied 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 Vs mile
(660 feet) of the sites listed above unless the site is not occupied during the application and
the 36-hour period following the start of application.
v. Posting
Posting is an effective means of informing workers and bystanders about areas where
certain hazards and restrictions exist. Current soil fumigant labels require treated areas to be
posted and handlers are required to wear specific PPE when they are 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 Handler 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. Therefore, 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.
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Comments received in response to the July 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 comments, EPA has slightly revised the posting
requirements and provided additional clarification as described below.
EPA had included two exceptions for the buffer zone posting requirement. The first
exception did not require posting in situations where the land 300 feet from the edge of the
buffer was under the control of the property operator. Based on comments that this measure was
too complicated and confusing this exception has been removed. There were also comments that
the examples provided in the description of a physical 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 entry 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. Many 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 configuration of the field. EPA agrees that signs posted
in areas where there is low likelihood of workers or others approaching or accessing the buffer
provide little risk reduction, but can add substantially to the challenges of compliance. As a
result, the Agency has revised the criteria for location of signs since the areas that are of most
concern are those where people are most likely to enter (e.g., roads, footpaths), and at likely
routes of approach such as the perimeter of a buffer that faces a housing development.
Comments also indicated that the requirement 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 needed 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; therefore certain application-
specific details on the posted signs, 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 simplified by removing the distance criteria, the example
has been removed from this document. There were no substantive comments suggesting a
change to the exception for posting multiple contiguous blocks and no changes have been made
in this Amendment.
The revised posting requirements are listed below and have been included in the revised
label table.
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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 include, 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 buffer 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 ง170.120).
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. 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 blocks' buffer zones may be posted. The signs must remain posted
until the last buffer zone period expires and signs 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 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 entry-restricted
period.
Signs must meet the general standards in the WPS for placement, text size, and location
(40 CFR ง170.120).
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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 during the Phase 5 comment period, the July
2008 RED clarified fumigation tasks that meet EPA's definition of handler activities, as
currently defined in the WPS and on fumigant labels. During the post-RED comment period the
Agency received some comments from stakeholders who were concerned 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 language from the July 2008 RED so it is clear that
the Agency is just clarifying the existing definition and not writing a new definition. Below is
the revised language.
The following activities are prohibited from being 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 WPS (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 supervisors, loaders, drivers, tractor co-pilots,
shovelers, cross ditchers, or as other direct application participants (note: 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;
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Cleaning, handling, adjusting, or repairing the parts of fumigation equipment that 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 or crop advising 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 complete if they will not be removed within
14 days after application.
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
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 certified applicator who may not necessarily be
on-site. Since many incidents are caused by human error and equipment failure, EPA believes
the presence of on-site trained personnel will help to reduce these risks. Therefore, to address
these risks, the July 2008 RED required that a certified applicator maintain visual contact with
any fumigant handler while the fumigant is being incorporated into the soil. The Agency also
stated that the certified applicator supervising the fumigation may also perform fumigant handler
tasks.
During the post-RED comment period the Agency 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. Other stakeholders stated that the Agency should
modify the requirement to ensure that the certified applicator is on-site, while others commented
EPA should require that all handlers are certified applicators, which 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 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 entry restricted period expires, the certified
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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).
The July 2008 RED also required that certified applicators complete a registrant
administered methyl bromide training program within the preceding 12 months before they apply
a methyl bromide product. The Agency is still requiring that certified applicators complete the
registrant training; however, the Agency is now requiring that certified applicators 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 applicator 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 mitigation 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 receive 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. Comments 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 monitoring and the role of chloropicrin's warning
properties for methyl bromide-chloropicrin products. The combination of air monitoring,
chloropicrin warning properties and respiratory protection along with the use of GAPs, FMPs,
and other mitigation measures is expected to reduce 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 colorimetric tubes or other real-time monitoring
devices every two hours as a means of determining 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 ppm), chloropicrin levels were
above the Agency's LOC (0.15 ppm), or if any handler experienced sensory irritation indicative
of chloropicrin exposure, then handlers were required to wear air-purifying respirators.
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The Agency's decision to require respiratory protection only if certain triggers were
reached took into consideration current label requirements14, the identified risks, and stakeholder
comments that respirators are not necessary because (1) chloropicrin's warning properties are
sufficient to alert handlers if there are unsafe concentrations; (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, comments focused on the feasibility,
reliability, and protectiveness of using colorimetric tubes due to the current sensitivity and
accuracy of the tubes, and the cost of the tubes. Other comments stated that handlers should
have the option of ceasing the application until air concentrations of methyl bromide and
chloropicrin are less than the action level. Comments also suggested 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 handlers can leave the field and
surrounding buffer zone in lieu of putting on a respirator. If handlers remain in the field, EPA
has determined that respiratory protection requirements 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 chloropicrin including colorimetric tubes from
manufacturers including: Matheson/Kitagawa, Sensidyne, and Drager. 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 trigger to put on respiratory 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 chloropicrin. EPA's action level is typically at
the lower end of the range for which the devices are rated, in fact, some of these action levels are
at or near the device's detection limits. Additionally, colorimetric devices provide snapshot
measurements of the environment in which individuals are working. In conditions that are likely
to be more static (e.g., monitoring 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 characteristic of outdoor field fumigation where exposure
concentrations could shift because of weather changes or stratification in soil conditions across a
single treated field. Furthermore, commenters' experience indicates that handlers will likely
experience early sensory irritation before the air samples show concentrations at or above the
action level. As such, the Agency 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 costs to fumigations, please see (,Analysis of Soil Fumigant Risk
Management Requirements using Geographic Information 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.
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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 devices that are currently available will
generally be reliable at higher concentrations 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 use of respirators has been triggered and
respirators are being worn. This will enable handlers to detect concentrations that would exceed
the upper working limit of the respirator. Additionally monitoring will still be required to help
enable handlers to determine if concentrations have decreased and whether it is safe to either
remove respirators or to resume the application 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 currently 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 applications (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 requirements below, the Agency
believes that GAPs, FMPs, and other mitigation 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 chloropicrin that is formulated with methyl bromide. Certain criteria apply
if applications involve less 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 Eligibility Decision for Chloropicrin for
detailed information regarding the chloropicrin action levels.
As the amount and percentage of chloropicrin applied increases, there is a greater likelihood
handlers will immediately experience sensory irritation if exposed to air concentrations above the
Agency's level of concern. Respiratory protection is required whenever handlers experience
sensory irritation.
The EPA assumes that air-purifying respirators have a protection factor of between 10
and 50 depending on whether a half-face or full-face respirator is used. The current upper limit
of air-purifying respirator cartridges available for methyl 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.
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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 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 irritation was 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.
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 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 samples 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
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air monitoring procedures must be followed to ensure that the upper protection limit of the
respirator plus respirator cartridge is not exceeded (i.e., 5 ppm for methyl bromide and 1.5 ppm
for chloropicrin):
Air monitoring samples for methyl bromide and 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 until
corrective action has been taken.
In order to resume work activities:
ฐ 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.
ฐ During the collection of samples an air purifying respirator must be worn by the handler
taking air samples.
ฆ 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 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
greenhouse/treated areas for a minimum of 48 hrs after the fumigant has stopped being
delivered/dispensed to the soil.
ฆ Deep probe injection
No exposure data were provided 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 holes 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 handlers cease operations. Figure B
provides an illustration of the requirements when handlers put on a respirator.
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Figure A. Requirements for when handlers should cease operations.
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Figure B. Requirements for when handlers should put on a respirator.
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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-NIOSH) for protection against chloropicrin
specifically, NIOSH/OSHA does recommend respirators with organic 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 bromide 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 requirements 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 when 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 irritation if a half-face respirator is worn.
Therefore, EPA has determined that when handlers 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 clarification to address the
concerns brought up in the comments. This was the 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 intention to imply a change 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-Dichloropropene, Chloropicrin, Dazomet,
Metam Sodium/Potassium, MITC: Health Effects Division (HED) Component of Agency
Response To Comments On 2008 Reregistration 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 respirators with organic-vapor cartridges when
respirators are necessary.
If methyl bromide concentrations exceed 5 ppm operations must cease.
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Tarp Repair
The July 2008 RED required handlers to wear APRs if they perform tarp repair
operations before the entry-restricted period has ended. The requirements were different from
other handling activities because the duration of tarp repair activities was believed to be shorter
than other handling tasks and therefore tarp repair activities would not trigger the initial
monitoring requirement. Upon consideration of comments the Agency received on this
requirement, which are addressed in detail in Methyl Bromide, 1,3-Dichloropropene,
Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HEP)
Component of Agency Response To Comments On 2008 Reregistration Eligibility Documents
(Date May 14, 2009)., EPA has determined that respiratory protection for tarp repair activities
should be handled consistently with other handler activities, i.e., handlers repairing tarps are not
required to wear respirators unless sensory irritation 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 respiratory protection. EPA will reevaluate this
measure during Registration Review or sooner if such devices are available in the short term.
Respirator fit testing, training, and medical qualification
To ensure that respirators are mitigating inhalation risk, the July 2008 RED respirator
requirements included fit testing, respirator training, and an annual medical evaluation. Without
these requirements, it is unclear whether the reduction in inhalation exposure that is assumed by
the use of respirators will be achieved.
During the comment period the Agency received a variety of comments ranging from full
support of the requirement, to comments about the cost and time burden associated with fit-
testing, training, and medical exams. The Agency also received several comments regarding the
details of this requirement, for example, some commenters questioned who conducts the fit-
testing 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 associated with the fit-testing, training, and
medical exam requirements, the Agency still believes these are necessary to ensure respirators
perform as intended. Also note that, 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 wearing a respirator and continuing fumigation
activities. Only handlers who will wear a respirator 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 with the respirator requirement, while maintaining
the same level of protection for the handlers that wear respirators. The following revised
language takes into account the new cease operations option and must be added to product
labels:
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"Employers must also ensure that any handler who uses a respirator is:
Fit-tested and fit-checked using a program that conforms to OSHA's requirements (see
29CFR Part 1910.134)
Trained using a program that confirms to OSHA's requirements (see 29CFRPart 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 (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 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."
Respirator cartridges used with air purifying respirators
Currently, there are no air-purifying respirator cartridges certified by the Mine Safety and
Health Administration-National Institute for Occupational Safety and Health (MSHA-NIOSH)
for protection against methyl bromide. While NIOSH does not have a test procedure to certify
air-purifying filters for protection against methyl bromide, the 3M 60928 is a NIOSH-approved
combination organic vapor/acid gas chemical cartridge/PlOO particulate filter, this combination
cartridge is recommended by 3M for use against 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 Technical 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 Model 60928 Organic Vapor/Acid Gas/PlOO 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 other manufacturers will also be considered by the
Agency, provided written certification of their efficiency 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 purifying respirator with organic vapor
cartridges, the maximum chloropicrin air concentration allowed is 1.5 ppm. For further details
regarding chloropicrin respiratory protection requirements, see the chloropicrin RED
(chloropicrin docket EPA-HQ-OPP-2007-0350).
15 http://multimedia.mmm.com/mws/mediawebserver.dyn76666660Zjcf61Vs6EVs666BraCOrrrrQ-
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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-purifying respirator and cartridge is immediately available for
each handler who will wear one. The Agency is requiring that at minimum two handlers have
the appropriate respirator and cartridges available 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 use. This change was made to
clarify the Agency's previous requirement, and the following language must be added to product
labels:
The fumigation handler employer must confirm and document in the FMP that at least
one air rescue device (e.g., SCBA) is on-site 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, punching, or slicing) and removal of tarps, and notes potential
for increased risk when high barrier tarps are used. To address 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 perforation, 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 least 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 application 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 particular 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 irrigation for flood prevention; the
difficulty implementing the 24 hour period between tarp perforation and removal; and concerns
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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 data 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 with higher application rates and no significant emphasis on using
the GAPs as defined in the RED. Data indicate that high barrier tarps are effective measures to
reduce fumigant emissions (See Factors Which Impact SoilFumigant Emissions - Evaluation
For Use In Soil Fumigant Buffer Zone Credit Factor Approach. DP Barcode D306857 (6/9/08)
and 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 Practices and Associated Buffer Credits (5/14/09)). While this reduction decreases
the risk to bystanders, it could increase the risk to handlers perforating or removing tarps because
more fumigant could be trapped between the soil surface and the tarpcurrently California
Department of Pesticide Regulation (CDPR) prohibits the use of methyl bromide with certain
high barrier tarps due to worker concerns.
Based on CDPR's prohibition and stakeholder'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 lower application rates and reduce bystander risk
associated with offgassing. New studies currently underway which involve use of high barrier
tarps may enable EPA to refine estimates of handler risk in the future. EPA will consider these
data during Registration Review, 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 these handlers when the reduced rates
are considered in conjunction with 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 stakeholders 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 proper drainage, tarps must be
manually cut, soil removed, and then tarps retucked. 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 address this situation.
During earlier comment periods EPA heard from various stakeholders that windy
conditions sometimes caused tarps to blow off fields and create other 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 under adverse weather conditions. During the post-
RED comment period EPA received comments that this exception did not fully address the issue
since the mitigation required waiting a minimum of 48 hours after fumigation but tarps could
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blow of fields sooner than that. Commenters also said waiting 24 hours between tarp perforation
and removal and the requirement to cut every broadcast tarp panel added to the potential for tarps
to blow off fields and create other hazards: once tarps are cut they are prone to blowing off
when windy conditions occur. To decrease the potential of tarps blowing off commenters also
suggested that the Agency add flexibility to the 24 hour requirement by giving tarp removers the
option to remove tarps 2 hours after tarp perforation if monitoring 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 agrees 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 notes that handlers undertaking these tasks must
follow the respiratory protection procedures detailed in the Respiratory Protection section; this
change still provides handler protection while reducing the unintended 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 panel is not cut, it is not likely that necessary off-
gassing can take place to reduce risks to handlers removing tarps. The Agency understands that
the main concern for not cutting every panel is due to the potential for tarps to blow off and has
determined that this concern is best addressed by modifying the 24-hour wait period. Tarps may
be removed 2 hours after tarp perforation is complete provided that tarp 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 situations 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 field, during flood prevention activities and for small
fields. Based on comments, EPA believes these are necessary short-duration activities. Provided
the respiratory protection procedures for handlers are followed, these 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 and consideration of comments, the following
summarizes the revised mitigation measures to address 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 specified duration and every handler must adhere
to the respiratory protection procedures outlined in the Respiratory Protection section.
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
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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
Perforation for Flood Prevention Activities sections below.)
If tarps will be removed before planting, tarp removal must not begin 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 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.
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.
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 assessment 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, stakeholder comments prior to the July 2008
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RED indicated that non-handler entry to perform post-application (i.e., non-handler) tasks is
generally not needed for at least 10 to 14 days following the completion of the application.
Due to the volatile nature of methyl bromide and the potential for worker 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 Restricted Entry Intervals (REIs) that
are currently required for most conventional pesticides where dermal 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 risk 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 taking place, contrary to the comments received during earlier
comment periods. Based on discussions with stakeholders, EPA's review of public comments,
and the risks identified in EPA's risk assessment, EPA does not believe any change to the entry-
restricted period is warranted. EPA's review of comments indicates that extending the entry-
restricted 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 the 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-equipped handler who is performing a handling task - is prohibited
from the start of the application until:
5 days (120 hours) after application has ended for untarped applications (see Figure C),
or
after tarps are perforated and removed if tarp removal is completed less than 14 days after
application (see Figure D), or
48 hours after tarps are perforated if they will not be removed prior to planting (see
Figure E), or
5 days (120 hours) after application 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.
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Figure C. Untarped Applications
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Figure D. Tarp Broadcast Applications (tarps removed before planting)
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Figure E. Tarp Bed Applications (Tarps not removed before planting)
Application
Begins
Buffer Zone
Period
Begins
5 days (120 hours)
Entry
Restricted
Period Ends
Tarp
Perforation
Begins
Tarp
Perforation
Ends
48 hours
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Figure F. Tarp Bed/Broadcast Applications (Tarps are not perforated until 14 days after
application)
ti
ti
I
I
I
I
ti
ti
ti
ti
I
14 days
Tarp
Perforation
& Planting
3) Other mitigation
Below are requirements for FMPs, GAPs, emergency preparedness and response, notice
to state lead agencies, training, and community outreach that the Agency 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 fumigators 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 was to specify GAPs that were required for soil
applications of methyl bromide. The practices specified contribute to reducing emissions and
thereby are expected to reduce potential for worker and bystander exposures.
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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 description 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 Reregi strati on
Division's response to comments document. Based 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 reanalyzed 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 control is an important consideration. 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 considerations (erosion control and human health
protection), the Agency encourages that the field be cleared 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.
Requirements for soil temperature monitoring have 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 above 100 degrees F in any of the three days prior to
application."
The GAPs outlined below must be followed during all fumigant applications. Registrants
may develop additional optional GAPs to include on product labels provided they do not conflict
with the required practices. All measurements and other documentation 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.
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ฆ 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 tarp plan must be developed and included in the FMP that includes:
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 procedures for tarp removal.
ฆ Weather conditions
The Agency is concerned with off gassing occurring during temperature 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 addition, 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 characteristics of inversion conditions (like misty conditions or clear
skies at night) do not always indicate the presence of an inversion; relying on a weather forecast
to predict inversions is unreliable and not enforceable; and that prohibiting application 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 inversions 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 updated to prohibit application 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 conditions when diurnal temperature inversions may
occur, though even diurnal temperature inversions could contribute to exposures to fumigant
concentrations outside buffers. As such, EPA believes 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 mph at the start of application or be forecasted
to reach 5 mph during the application. These changes are designed to prevent applications when
inversion conditions are predicted to occur after the application has begun, since this is the time
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when the peak off-gassing is expected to occur. 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 conditions that are predicted, (2) only begin a fumigant application
if wind speed is a minimum of 2 mph 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 advisory is in effect. EPA believes advisory language providing
more detailed information on how to identify inversions and adverse weather conditions will
increase the likelihood that applicators will proceed 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 inversion 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 advisory. 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 these 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 application and the 48-hour
period following the fumigation must be checked to determine if unfavorable weather
conditions exist 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.
Do not apply if a shallow, compressed (low-level) 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 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 upward 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."
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ฆ 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.
ฆ Soil moisture
The soil must be moist 9 inches below the surface. The amount of moisture needed in this
zone will vary according to soil type and shall be determined using the USD A 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 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, 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 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 staining 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 form a smooth ball with defined finger marks,
light soil/water staining 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 moisture requirement. Whenever possible, the
field should be divided into areas of similar soil texture and the soil moisture of each area
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should be adjusted 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 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 acceptable. 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 control advisor (agriculture consultant) should be
consulted for assistance.
ฆ 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 residue 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 control, 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.
ฆ 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 surface 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, cultipackers, 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 fumigation applications, the following GAPs apply
for injection applications:
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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-BeddedApplications: The injection point shall be a
minimum of 8 inches from the nearest final 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-BeddedApplications: 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 located as close as possible to the final injection
point, or equipment must 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, Teflonฎ tubing or Teflonฎ -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 Teflonฎ -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 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 gas
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cylinder is used. (This is not requiredfor 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 compressed gas cylinder or compressed 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 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:
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 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 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 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:
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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.
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 procedures for safe use has led to accidents affecting
workers involved in fumigations as well as bystanders. Information from various sources shows
that health and safety plans, FMPs in this context, typically reduce 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 safety management by groups such as American
Industrial Hygiene Association16 (i.e., through "Administrative" and "Workplace" controls). The
Centers for Disease Control provides guidance for developing health and safety plans in
agricultural settings.17 The effectiveness of similar plans has also been evaluated in the
literature. Examples include "lookback" reviews conducted by the Occupational Safety and
Health Administration (OSHA) which essentially implemented standards in various industries
then reviewed their effectiveness in this process 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 Flexibility 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 objectives of Executive Order 12866, and to make them consistent with
16Ignacio 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 Program to Reduce Injuries and Accident Losses, Centers For
Disease Control National Ag Safety Database, available at http://www.cdc.gov/nasd/docs/d001501-
dOO 1600/d00157 l/d001571 .html
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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 grain 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 applicators have carefully planned, in writing, each major element of
the fumigation. In this context, an FMP is a set of performance criteria for each application,
including how the fumigator intends to comply with label requirements. As added benefits, the
Agency determined that FMPs would ensure directions on the product labels were followed and
that the conditions under which fumigation occurred 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 response would reduce the
potential risk to bystanders from potential high exposure situations (e.g., readily available first
responder contact information could reduce response times to impacted bystanders and carefully
thought out emergency response plans can help ensure 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, application procedures, and a description
of how the fumigator planned to comply with label requirements for GAPs, buffer zones,
monitoring, worker protection, posting, and providing notification 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 applicators complete a post fumigation summary that described
any deviations from the FMP, measurements taken 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 keeping and that FMPs must be provided, upon
request, to enforcement officials and handlers involved in the fumigation.
According to stakeholder comments 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 they are not too restrictive or complex and do
not result in an excessive administrative burden.
During the post-RED comment period, EPA received several comments regarding FMPs.
Several comments from industry and user stakeholders expressed concern that FMP
requirements would increase paperwork burden without providing significant risk reduction,
though others supported FMPs provided 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-intensive 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 feasibility 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.html
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FMP to on-site handlers or enforcement personnel, though others said that copies of the FMP
should be provided to workers in areas 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 verify 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 similar problems from occurring
during future applications. However, in response to comments, the Agency has somewhat
modified the list of elements that must be addressed in the FMP (as described below) to make
it more streamlined and thus less burdensome to applicators and growers. In addition, the
Agency has developed a sample template in which many of the elements are covered in
checklist format, which fumigators have the option 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 template and potentially develop others so it is a
more useful tool for ensuring the safe application of methyl bromide.
The Agency estimates that, if a certified applicator decides not to use the FMP template
and decides to prepare a narrative FMP, a carefully designed FMP could take several days to
develop the first time. Subsequent FMPs should require substantially less time to develop
because much of the information can be reused from 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 common 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 unnecessarily duplicative and that
providing each worker with a hardcopy 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 the
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certified applicator to 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 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 response 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 registrant methyl bromide training program)
~~~ General site information
> Application block location (e.g., address or global positioning system (GPS) coordinates)
> Name, address, and, phone number of owner/operator of the application block
> 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 ]A or Vs 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)
> Brand name, lot number, thickness
> Name and phone number of 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 person responsible for cutting and/or removing tarps (if other
that 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 in application block, method used to determine
soil moisture)
~~~ Weather conditions (summary of forecasted conditions for the day of the application and the
48-hour period following the fumigant application)
> Wind speed
> Inversion conditions (e.g., shallow, compressed (low-level) temperature inversion)
> Air stagnation advisory
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Buffer zones
> Application method
> Application rate from lookup table on the label (lb ai/A)
> Application block size from lookup table on the label (acres)
> Credits applied
> Buffer zone distance
> Description of areas in the buffer zone that are not under the control of the
owner/operator of the application block
Respirators and other personal protective equipment (PPE) for handlers (handler task,
protective clothing, respirator type, respirator cartridge type, respirator cartridge replacement
schedule, eye protection, gloves, other PPE)
Emergency procedures (evacuation routes, locations of telephones, contact information for
first responders, local/state/federal contacts, key personnel and emergency
procedures/responsibilities in case 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)
> Fumigant site monitoring
ฆ Description of who, when, where, and procedures for monitoring buffer zone
perimeter
> Response information for neighbors
ฆ List of residences, businesses, and neighboring property owners informed
ฆ Name and phone number of person doing notification
ฆ 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 that were notified and date notified.)
Plan describing how communication will 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).
> Name and phone number of persons contacted
> Date contacted
Authorized on-site personnel
> Names, addresses and phone numbers of all handlers
> Employer name, addresses, and phone numbers for all handlers
> Tasks that each handler is authorized and trained to perform
> Date of PPE training for each handler
> 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
> For buffer zone monitoring:
ฆ Name, address, and, phone number of handler to perform monitoring activities
ฆ Location and timing of monitoring for the buffer zone
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> For handlers without respiratory protection:
ฆ If sensory irritation is experienced, indicate whether operations will be ceased or
operations will continue with respiratory protection
ฆ If intend to cease operations when sensory irritation is experienced, provide the name,
address, and phone number of the handler that will perform monitoring activities
prior to operations resuming
> For handlers with respiratory protection:
ฆ Representative handler tasks to be monitored
ฆ Monitoring equipment to be used and timing of monitoring
> For buffer zone monitoring when using methyl bromide formulations with < 20%
chloropicrin:
ฆ Name, address, and phone number of person(s) to perform sampling
ฆ Identify areas or structures to be monitored before reentry is permitted
ฆ Monitoring equipment to be used and timing of the monitoring
> For monitoring the breathing zone when using methyl bromide formulations with
< 20% chloropicrin:
ฆ Representative handler tasks to be monitored
ฆ Monitoring equipment to be used and timing of the monitoring
~~~ Good Agricultural Practices (GAPs)
> Description of applicable mandatory GAPs (registrants may also include optional GAPs)
> 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 copy 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 for 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 enforcement personnel who request the FMP. In the case of an emergency, the
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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 temperatures were above 100 degrees F in any of the 3
days prior to the application)
~~~ Tarp damage and repair information (if applicable)
> Location and size of tarp damage
> Description of tarp/tarp seal/tarp equipment failure
> Date and time of tarp repair
~~~ Tarp removal details (if applicable)
> Description of tarp removal (if different than in the FMP)
> Date tarps were cut
> Date tarps were removed
~> Complaint details (if applicable)
> Person filing a complaint (e.g., on-site handler, person off-site)
> If off-site person, name, address, and phone number of person filing a complaint
> 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 monitored on-site or outside the buffer zone (if
applicable)
> Location of elevated air concentration levels
> Description of control measures or emergency procedures followed
> Air monitoring results
ฆ 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, continue operations with respiratory
protection)
ฆ When using a direct read instrument:
Type of sample (e.g., area, breathing zone, structure)
Sample date and time
Handler task/activity (if applicable)
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Handler location or structure location
Air concentration
Sampling method
~~~ Date of sign removal
~~~ Any deviations from the FMP
In addition to recordkeeping requirements from 7 CFR part 110 "Recordkeeping
Requirements for Certified Applicators of Federally 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 and the post-application summary record for 2 years from the date of
application.
Applicators and other stakeholders have the flexibility to use EPA's template, prepare
their own FMPs templates, or use other commercially 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/techlibrary/fum mgmt plan.doc
http://www.agr.state.ne.us/division/bpi/pes/fumigation plan.pdf
http://www.agr.state.ne.us/division/bpi/pes/fumigation plan2.pdf
http://nmdaweb.nmsu.edu/pesticides/Management%20Plans%20Required%20for%20Fu
migations.html
iii. Site Specific Response and Management
EPA believes measures for ensuring preparedness for situations when accidents or
emergencies occur are an important part of the suite 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 response to situations as they arise.
Although EPA believes buffers and other mitigation will prevent many future incidents, it
is likely that some incidents will still occur due to accidents, errors, and/or unforeseen weather
conditions such as diurnal inversions. Early detection and appropriate response to accidental
chemical releases is an effective means of reducing 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 combining 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 mechanisms are in place in the event of a fumigant
exposure incident, EPA is requiring that registrants provide training information, in the context
of their community outreach and education programs to first responders in high-fumigant use
areas and areas with significant interface between communities and fumigated fields. In
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addition, for situations in which people, homes, or other structures are in close proximity to
buffer zones, applicators must either monitor buffer zone perimeters or, alternatively, provide
emergency response information directly to neighbors. Each element 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 and respond to fumigant
exposure incidents. EPA believes this will help ensure, in the case of a fumigant accident or
incident that first responders recognize the exposure as fumigant related and respond
appropriately. Additional details are included in the Community Outreach and Education section
of this document.
Emergency Preparedness and Response 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 response 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, compared to other pesticides, has a
greater potential to move off site and affect people not involved in the application. State
regulators have different views on this requirement. Some support the sharing of information
with neighbors, and some states have notification requirements for fumigations with certain
products or for certain application methods. In addition, some states require notification to
chemically sensitive individuals in proximity to pesticide applications. Others also had concerns
about the enforceability of this type of measure and the possible burden on the states to enforce a
notification requirement.
California currently requires notification of persons within 300 feet of a methyl bromide
buffer zone. California strawberry growers consider 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 planned methyl bromide application, strawberry
growers indicated that they would rather not use methyl bromide because some communities
could mobilize to prevent the fumigation from taking 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 hours 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 user would be required to implement the emergency
response measures specified in the fumigant management plan.
EPA has concluded that bystanders could take steps to protect themselves if they had
basic information about fumigations 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 significantly reduced if people had such information.
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Similarly, having on-site monitoring will enable site managers to take remedial action (i.e.,
activate the control plan in the FMP) to lower emissions sooner, 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.ifas.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 applications. 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 within Vi 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 maintaining the Agency's protection goals.
EPA is not requiring a specific method of providing 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 documentation that would be retained. To address
concerns about enforcement, EPA 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 required applicators to either monitor buffer zone
perimeters or, alternatively, provide emergency response information directly to neighbors. This
measure is intended to ensure protection in places people may be found. Whether measures are
required depends on the size of the buffer zone and how close land, not within 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 RED, it is important to note that site-specific
Emergency Preparedness and Response measures are only required if there are people, homes or
businesses within a specified distance from the edge of the buffer zone.
Some comments were received that questioned the rationale behind scaling the
Emergency Preparedness and Response measures. EPA believes that scaling the size of the
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Emergency Preparedness and Response area will be protective. Generally the larger the buffer
distance the higher the application rate or the size of the treated area translates to a greater total
amount of fumigant being applied and potentially higher exposure in the area surrounding the
application block. The buffer distances for triggering the Emergency Preparedness and
Response requirements are scaled to allow the amount of fumigant used (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 application techniques, will have small
or no areas to monitor or inform, while larger applications will have larger areas to monitor or
inform. In addition, to create additional incentive to achieve the smallest buffer possible, EPA
has included an exception for application blocks with the smallest required buffer (25 feet) which
would not be subject to this requirement, 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 Emergency 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 concern over the potential burden the July 2008 RED
requirements may have on applicators and growers. Specifically, the frequency and cost of
monitoring using sampling devices such as colorimetric tubes were of concern. Several of these
comments noted concerns with the reliability of such devices at low concentration. Stakeholders
felt the inherent warning properties of chloropicrin 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 during 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 available devices are likely to be more reliable
at fumigant concentrations which exceed EPA's action level concentrations. In fact, some of
these action levels are at or near the detection 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., monitoring 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 characteristic 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 for monitoring buffer zones because there are
technological limitations of currently available MITC and chloropicrin monitoring devices such
that these devices are neither practical nor reliable for field use. However, the Agency does
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believe that quantitative air monitoring would enhance safety if the appropriate technology were
available as it is for methyl bromide. Some equipment manufacturers have indicated interest in
developing devices that would be more functional and reliable for field fumigation applications
(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. 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 response instead of using tubes.
Monitoring tubes are still required for measuring products that contain 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 effectiveness of the option to provide information to
neighbors. EPA agrees with the importance of users 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 receive, 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 emergency 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 300 feet
overlap
Then either monitoring of the buffer zone perimeter 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 applicable. Also, if all of the land within 300
feet of the edge of the buffer zone is under the control of the property operator, then no site
monitoring or informing neighbors would be required regardless of the size of the buffer zone.
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Fumigation Site Monitoring
EPA has determined that monitoring of the buffer zone perimeter for fumigants moving
beyond buffers is an effective approach to protecting 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 level, 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 day following applications, and the greatest
potential for concentrations outside 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 night and during the day, to ensure 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 applicator or someone under his/her supervision.
Monitoring for air concentrations above the action level for the fumigant, as determined by
sensory irritation, must take place in areas between the buffer zone perimeter and residences
or other occupied areas that trigger this requirement. Air concentrations of methyl bromide
must be measured using a direct-read instrument if the methyl bromide product applied
contains less than 20% chloropicrin.
The persons monitoring for perceptible levels must start monitoring approximately 1 hour
before sunset of the day the application begins 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 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 FMP.
While protective, this site monitoring might be burdensome for users fumigating in areas
with few people. Therefore, EPA is allowing users the alternative option of providing
emergency response information directly to neighbors.
Response Information for Neighbors
As an alternative to on-site monitoring, the certified applicator supervising the fumigation
(or someone under his/her direct supervision) would need to ensure that residences, businesses,
or other sites that meet the criteria outlined below have been provided the required information at
least one week prior to the fumigant application in a specified field. 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,
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o Fumigant(s) applied including the active ingredient, name of the fumigant
products(s), and the EPA Registration number,
o Contact information for the applicator 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 information about fumigants.
The method for distributing information to neighbors 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 and 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 must monitor the area between 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 minimum of 25 feet, neither site monitoring nor
providing information to neighbors is required.
Figure G. Example Site Map for Informing Neighbors
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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 mitigation package since these requirements are
designed to mitigate risks of concern for bystanders, handlers, and workers. Knowledge of the
location and timing of fumigant applications allows enforcement officials to focus their
compliance assistance and inspection efforts around periods when, and places where,
fumigations are expected to occur. Therefore, in the July 2008 RED, the Agency required
written notification of the appropriate 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 enhance their ability to
provide technical assistance and assure compliance. However, the Agency also received
comments from states that were concerned about the notification requirement largely due to
resource constraints. Some states also indicated 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 notice 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 than providing notice directly to states,
fumigators could enter application information into a registrant-developed and maintained
database. They suggested this would be an appropriate mechanism because it would standardize
and streamline the process for applicators to provide the required information, 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 critical component of the soil fumigant mitigation. EPA agrees that
some states already have mechanisms in place to provide them with information needed to assist
and assure compliance with new fumigant requirements, but other states are in need of additional
information to accomplish this objective. The Agency also believes that all states in which
fumigants are used will need to modify their 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 all state and tribal lead agencies on efficient
ways to obtain the information needed to plan and implement compliance assistance and
assurance activities, the Agency is currently retaining the notification requirement only for state
and tribal lead agencies that choose 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 application block(s)
o Name of fumigant(s) products(s) applied including EPA Registration number
o Time period in which fumigation may occur
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The Agency will work with all states to amend their cooperative agreements to include
strategies for compliance assistance and assurance, which will be particularly important over the
next several years as the new mitigation measures are implemented. For states that do not
choose to be notified of fumigant applications, modification of their cooperative agreements
must include the methods these agencies will use 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 specialized equipment and
application techniques. Additionally, the mitigation 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 fumigant 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 errors on the part of fumigant applicators.
Although states have certification programs, some of which include a specific category or
subcategory for soil fumigation, there currently is not a consistent standard across states and
regions where soil fumigation is done. Additionally, the federal certification 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 federal certification program and worker safety
regulations to include a soil fumigation category are not anticipated in the near future.
EPA believes that training is an effective way to increase applicators' skill and
knowledge so they are better prepared to effectively 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 labeling. Therefore, EPA determined that training
designed to establish a national baseline for safe fumigant use, 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 management options, stakeholders were broadly
supportive of additional training for applicators and handlers. During the Phase 5 and post-RED
comment periods, the majority of stakeholders, including growers, community groups, farm
workers, states, and registrants expressed strong support for increased training for applicators
and other handlers. Several comments noted that fumigant incidents 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 and
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noncompliance. EPA believes fumigant-specific training for applicators and additional training
information for handlers also will help reduce the magnitude and frequency of exposure
incidents and, coupled with the other mitigation measures described in this decision, will address
risks of unreasonable adverse effects from the use of soil fumigants.
It is important to note that training developed and provided by registrants as required by
this RED is separate and distinct from state certification 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 complement state programs. However, the training
programs required as part of this decision are intended 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 registrants on these activities, but are not required to
do so. It is important to note that some fumigant 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-quality certification programs for fumigators
that include exams to test the competency of fumigators. EPA recognized that for applicators to
become certified in those states, they must acquire the knowledge and skill necessary to pass the
exam. But several stakeholders commented that training opportunities are varied across the
country, and the scope and detail of information provided in available training is not consistent.
EPA is also concerned that information in existing programs will need to be substantially
updated as a result of new requirements associated with this decision and the label changes
which will implement it. Although EPA is considering 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 materials to best develop and deliver training in the
interim.
EPA stresses that registrant training 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 and training experts to explore opportunities for the
registrant programs to supplement any existing state programs to provide additional training
resources for fumigators working in those states. EPA will also work with state lead agencies
and extension programs to review training program proposals, the content for the programs and
materials, and proposed vehicles for delivery.
During the post-RED comment period, the Agency received comments from several
states asking that the applicator training requirements be coordinated with existing state
certification and training programs. The Agency agrees that for states that have existing soil
fumigation certification programs 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 state certification program in lieu of completing the
registrant soil fumigation training. For the state soil fumigation certification program to qualify,
both EPA and the state must agree that the program satisfies the applicator training elements
required in the RED.
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Pesticide labels will state that "Before applying the product, the certified applicator
supervising that application 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 registrant-provided training
program or state certification was completed. This requirement for registrant-provided
applicator training does not supersede or fulfill state requirements, unless the state has expressly
acknowledged that the registrant training 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 broadly supportive of additional training for
fumigators, but concerns were raised with regard to implementation of the training. The Agency
also received comments from state representatives and pesticide applicator training
organizations, such as the Association of American Pesticide Control Operators, Association of
American Pesticide Safety Educators, and Certification & Training Assessment Group,
expressing concern over EPA's decision to implement the training via labeling and raising
questions over compliance and state enforcement of such a requirement and the potential for
conflict or redundancy with state certification and training programs. Various stakeholders
recommended that, rather than a label-mandated training requirement, the Agency, instead,
should require registrants to develop and implement training for soil fumigant applicators as a
condition of registration.
The Agency's goal in requiring soil fumigation training for applicators is to ensure that
all applicators in charge of soil fumigations understand the safe use of soil fumigants and in how
to apply products in compliance with new product labeling, including provision required by the
RED. Given the unique properties of soil fumigants and their application and safety procedures
compared with other agricultural and non-agricultural pest control practices, the inherent
complexities involved in soil fumigant applications, 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 needed. 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 important means of ensuring that such training is
ultimately developed and implemented. However, it would not ensure that all individuals in
charge of soil fumigant applications avail themselves of the training. The Agency believes that
making successful completion of the training a condition of use is also important to achieve this
goal. Therefore, EPA has decided that development and delivery of training will be included in
the DCI that accompanies this RED and successful 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 will
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accompany this RED. EPA will review each program and determine whether it adequately
addresses the requirements specified in the DCI. The proposal must address, among other
elements, both the content and the format for delivering training. The Agency acknowledges the
value of hands-on training in the field, 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 evaluation of the registrant training proposals and materials that are
submitted.
The training programs must address, at a minimum, the following elements: (1) how to
correctly apply the fumigant, including how to comply 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 application summary; (5) how to determine when
weather and other site-specific factors are not favorable 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 the post-RED comment period, the Agency is
adding a seventh training elementtraining programs must also include information on how to
develop and implement emergency response plansto ensure that applicators are prepared in the
event that a problem develops during or shortly after the fumigant application. EPA is also
requiring registrants to incorporate 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 requirements, 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 documentation shall include the applicator's name,
address, license number, and the date of completion. Applicators must 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 required 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 substance and content of
training would not change significantly from year to year, and that an annual training
requirement for applicators would be excessive 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 enforcement 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.
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Based on questions received during the post-RED comment period, the Agency is
clarifying that the applicator training requirements are active ingredient-specific rather than
product-specific. That is, applicators who apply more than one of the soil fumigant active
ingredients (i.e., methyl bromide, chloropicrin, 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 ingredient(s). Further, EPA encourages the soil
fumigant registrants to jointly 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 information common to all could be generic and
each fumigator would participate in those modules, while separate modules addressing active
ingredient-specific content could be provided to those fumigators supervising applications with
those active ingredients only. Documentation provided to trainees could indicate the active
ingredient modules completed. While EPA sees efficiencies in such an approach, 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., those 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 will 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 application and handling of soil fumigants, (3) air
monitoring and respiratory protection requirements for handlers, (4) early signs and symptoms of
exposure, (5) appropriate steps to take to mitigate exposures, (6) what to do in case of an
emergency, and (7) how to report incidents. Registrants must provide this training information
through channels open to the public (e.g., via a website). Pesticide labels will require that
applicators supervising fumigations provide this training information to handlers under their
supervision before 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.
Applicators supervising fumigations must ensure the FMP includes how and when the required
training information was provided to the handlers under their supervision.
"The certified applicator must provide fumigant safe handling information to each
handler involved in the application in a manner that they can understand prior to
performing any fumigant handling task or confirm that each handler participating in
the application has received fumigant safe handling information in the past 12
months."
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During the post-RED comment period, no substantive comments were received that
resulted in changes to the RED requirements for training 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 indicating that there was some confusion about
whether fumigant handlers working under the supervision of the certified applicator would be
required to be trained, i.e., participate in a training program developed by the soil fumigant
registrant(s), or whether handlers 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 supervising a soil fumigation will
be required to provide the registrant-developed, EPA-approved training information to handlers
in a manner that they can understand prior to performing any fumigant handling task, or
applicators must ensure that the 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 community 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 risk. Community outreach
will address the risk of acute bystander exposure by informing community members in high-use
areas about buffer zones and their characteristics and purpose, the meaning of posted warning
signs, the importance of not entering buffer zones, how to recognize early signs of fumigant
exposure, and how to respond appropriately in case of an incident.
In the July 2008 RED, the Agency required registrants to develop and implement
community outreach and education programs to address 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 effectiveness of these programs. Few details on how
the programs would be implemented were provided 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 community members in high-use areas. The Agency
encouraged the registrants to work with existing 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 registrants develop and implement a community outreach
and education program is unnecessary and likely to needlessly raise heath and safety concerns
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among community members, and such a requirement could draw scarce resources from other
registrant stewardship efforts. As noted previously, 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 mitigation measures to address bystander risk. EPA's
community outreach requirements do not preclude other voluntary stewardship programs or
activities targeted to community members or the applicator/grower community, but rather are
meant to help ensure that community members in high fumigant usage areas are informed about
soil fumigant safety and better able to respond appropriately 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 Agency is identifying minimum requirements that
each registrant must fulfill when developing its 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 registrants have suggested that programs
focusing on specific target audiences, such as staff and managers of migrant health care and day
care facilities, prison officials, and school nurses and principals, may be more effective in
providing useful information in a meaningful way than broadcast messages to entire
communities. Registrants have indicated that they will provide proposals for such programs in
late May 2009. EPA looks forward to these proposals and will consider the extent to which they
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 newspapers in high-use fumigant areas during the
fumigation season(s) in those areas. As per the requirements included 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 they work, (2) what buffer zones are, (3) early
signs and symptoms of exposure to methyl bromide, (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 the 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 the needed information about the importance of
staying out of buffer zones and treated areas.
The Agency is requiring registrants to implement their outreach programs in communities
located in areas where there is high soil fumigant 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 areas in the subsection following the section on
information for first responders. However, the Agency is willing to consider alternative
proposals for identifying high soil fumigant-use areas, based on additional data sources and
alternate approaches identified by the registrant(s) and other stakeholders.
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Information for First Responders
In the July 2008 RED, the Agency required registrants to ensure that first responders in
areas with high fumigant usage have the training and information that they need to effectively
identify and respond to fumigant exposure incidents. Specifically, the registrants were required
to provide information and/or training to first responders, which at a minimum, included the
following elements: (1) how to recognize the early signs and symptoms of fumigant exposure,
(2) how to treat fumigant exposures, and (3) how fumigant exposure differs from other pesticide
exposure. In addition, the registrants were required to provide material safety data sheets to first
responders for the fumigant applied. Few details on how the education programs would be
implemented were provided 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 first responders in high-use areas. The Agency encouraged the registrants to
work with state and local emergency response coordinators to identify needs and opportunities to
supplement any information already included in state and local training for first responders about
soil fumigants specifically.
During the post-RED comment period, the Agency received comments from several
registrants indicating that rather than requiring registrants to implement face-to-face training
programs, the Agency should consider allowing the required first responder training information
to be conveyed via written materials to state and local emergency response agencies, which
would provide these agencies the ability to incorporate this information into their existing
training programs. Other comments indicated that even if training programs were developed, it
would be difficult to ensure participation of first responders. The Agency's goal for the first
responder training program is to ensure that first 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 respond appropriately. The Agency agrees 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 first 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 responder entities the ability to incorporate this information into
their existing first responder training programs as they best see fit. This recommendation has
been incorporated into the RED amendments 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 the program requirements described below. At a
minimum, registrants will be required to develop 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 fumigant-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 soil fumigant-use areas to
which they will disseminate the training materials, and (2) provide materials to the first
responders in these areas. Additionally registrants must provide draft copies of the training
materials for EPA review and approval. As per the requirements included in the July 2008 RED,
at a minimum, the materials must convey the following information to first responders: (1) how
to recognize the early signs and symptoms of methyl bromide fumigant exposure, (2) how to
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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 compound generated, if applicable. Training materials
can take a number of forms (e.g., brochures, fact sheets, CDs, videos, web-based training
materials) as long as these materials incorporate, at a minimum, 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-use areas. For the purposes of the RED, high-
use areas are considered at the county level. To identify these areas, the Agency is proposing the
following process. However, the Agency is willing to consider alternative proposals in the
registrants' response to the DCIs for identifying and targeting high-use soil fumigant areas, based
on additional data sources and alternate approaches identified by the registrant(s).
Process for Identifying High-Use Fumigant Areas:
Identifying high-use areas for methyl bromide is a two-step process because reliable
fumigant use data is not available at the county level from either publicly available data sources
or EPA proprietary data sources. First, the states with high use 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 responsibility, using the process defined below.
Step 1: Identifying States with 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 lbs 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 Economic 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 bromide and chloropicrin are Washington,
Oregon, Idaho, South Carolina, Georgia, North 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, the registrants will be required to identify the
counties where use of methyl bromide may be high. Because county-level fumigant
usage data is not publicly available and EPA proprietary data are not appropriate for this
level of specificity, crop acreage should be used as a surrogate indicator for fumigant
usage. Crop acreage can be obtained for major use sites of methyl bromide from the
publicly available 2007 USD A Census of Agriculture. 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.
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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 identified for methyl bromide 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 identifying 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 with High Use of Metam Sodium:
o Based on its analysis of proprietary data, the Agency has identified the following
high-use states for metam sodium: California, Washington, Idaho, Oregon,
Wisconsin, Michigan, Florida, Minnesota, North Carolina, Virginia, Arizona,
Nevada, Georgia, Colorado, and North Dakota. 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 California 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 Agriculture, registrants will need to obtain
harvested crop acreage data for each of the 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 the 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 atEPA-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 California and then select all the counties
that make up at least the top 90% of acreage in the county. [An example of this
analysis is also provided as a supporting document to the 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.]
As with the training for fumigant applicators and handlers and the community outreach
program that the Agency is requiring, the first responder training requirements are intended to be
part of the registrants' long-term product stewardship. The Agency encourages registrants to
work with appropriate state emergency response entities in these areas to ensure that the
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appropriate first responder entities 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 concerns 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 although 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 and individual treatment areas which 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 environments is predominately dependent on
volatilization and to a lesser extent on leaching and 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 importance of adequate soil moisture as described in
the GAP section and the knowledge that volatilization is methyl bromide's most important route
of dissipation, EPA required the following language 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 soil), volatilization is this chemical's most important route of
dissipation."
The Agency still believes that a deviation from the recommended language in the Label
Review Manual is necessary due to the importance of soil moisture and methyl bromide's
volatility. While the Agency believes that volatilization is this chemical's most important route
of dissipation, it is being removed from the groundwater statement because volatilization is
addressed in other areas of the mitigation package. The new language will state, "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
soil)."
EPA also discussed, in the July 2008 RED, the potential for methyl bromide to leach into
groundwater when tarps are used in broadcast applications: falling temperatures typically found
in the late afternoon and evening would not promote 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 applications, 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, EPA required that tarps for broadcast 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.
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The July 2008 RED also discussed the potential for methyl bromide to leach into
groundwater and surface water if a rainfall event occurs 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 commenters 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 effort 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 fumigation." This is more likely in areas with poor
draining soils. The revised statement is based on information presented in a 2007 article by
Zhang and Wang.19
In addition to the changes above, EPA is requiring several ecological fate and effect
studies to address data gaps identified in the ecological risk assessment. See Section V of this
document for details for revised label language and the studies.
d. Stratospheric Ozone Depletion Risk Management
While a quantitative reduction of methyl bromide'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. Emission, distribution, and leaching of methyl isothiocyanate and chloropicrin
under different surface containments. Chemosphere, 2007 Jun; 68(3): 445-454.
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Required Mitigation
Measure
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)
Reducing maximum application
rates;
Limiting use of 98:2
formulations to essential crops
Buffer zones
GAPs and FMPs
Rationale for expecting a reduction of
Stratospheric Ozone Depletion
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 there will be more pre-2005
stockpile material available for critical uses. The
Agency believes that that this measure could
contribute to the reduction of methyl bromide
applied annually.
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.
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.
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, using alternatives, etc.
Overall, these changes will result in lower
application rates and less methyl bromide
volatilizing into the atmosphere.
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 amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects 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 systems, in addition to the estrogen hormone
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system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and vetted, methyl bromide may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption.
3. Endangered Species Considerations
The Agency has not conducted a risk assessment that supports a complete endangered
species determination. The ecological risk assessment 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 species (listed species) or their designated critical
habitats. When an assessment concludes that a pesticide's use "may affect" a listed species or its
designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service
and/or National Marine Fisheries Services (the Services), as appropriate.
D. Conclusions
The Agency has determined that Group 1 uses of methyl bromide are eligible for
reregi strati on as long as they have CUE or QPS status under the Montreal Protocol, and provided
the risk mitigation measures outlined above are adopted and label amendments are made to
reflect these measures. Where labeling revisions are warranted, specific 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 reregi strati on.
V. What Registrants Need to Do
EPA recognizes that the extent of the mitigation needed for methyl bromide and the other
soil fumigants will require continued coordination 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 evaluated expeditiously, and that bystander and worker
protection measures are implemented as soon as practicable.
When the soil fumigant REDs were issued in July, 2008, EPA specifically requested
comment on the mechanisms and timing of implementing the provisions of the REDs. After
considering stakeholder comments largely focused on the challenges of implementing many new
measures simultaneously, EPA has developed the following schedule:
July 2008
October 2008
May 2009
Mid 2009
September 1, 2009
Methyl Bromide RED issued
Comment period closed
EPA responds to comments, amends RED as appropriate
EPA issues product and generic DCIs
Registrants must submit revised labels to EPA, reflecting phase one of
the mitigation measures as outlined in Table 2: restricted use, GAPs, rate
reductions, limitations on use sites, new handler protection measures, tarp
cutting and removal restrictions, extended worker re-entry restrictions,
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December, 2009
During 2009-10
September 1, 2010
2009-2012
2013
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 approved 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 reregi strati on of methyl bromide's preplant soil uses
has been reviewed and determined to be substantially complete. However, the data listed below
are necessary to confirm the reregi strati on eligibility decision documented in this RED.
a. Human health risk
Toxicity: none
Dietary Exposure: none
Occupational and Residential Exposure (ORE):
OPPTS Guideline Number
Data Requirement
Study type
OPPTS Guideline 835.8100
Field volatility from soil
Field Emissions
The following data are needed on methyl bromide for human health risk assessment:
Field Emissions/Volatility: The current estimates of emissions which are critical in the
calculation of modeling estimates used to define buffer zones are limited only to California
and are not based on the most current cultural practices. These data will enable a more
training information for workers, and relevant portions of the FMP
requirements.
EPA reviews/approves new labeling for 2010 use season.
EPA works with registrants, states and stakeholders to develop and begin
implementation of first responder and community outreach, applicator
training, and compliance assistance and assurance measures.
Registrants must submit revised labels to EPA reflecting all remaining
mitigation measures outlined in Table 2 including:
applicator training, restrictions on applications near sensitive sites, buffer
zones, buffer credits, buffer zone posting and buffer overlap prohibitions
and exceptions, and the full FMP requirements.
Registrants develop data per DCIs.
EPA begins Registration Review for methyl bromide and other fumigants.
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refined inhalation risk assessment to be completed for buffer zone determinations that will
allow evaluations to be completed in all of the major use regions of the country and that are
reflective of the most current cultural practices. It is believed that application practices have
rapidly evolved over the last few years to account 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:
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
ECO
The following data are needed on methyl bromide (and the bromide ion, where indicated) for
ecological risk assessment20'
Avian acute inhalation. The current estimate of avian risk is based largely on the mammal
assessment. This study will enable an inhalation 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 Supplemental study for rainbow trout and various
general literature toxicity values for other species.
Acute Marine/Estuarine Fish. Given the use patterns of methyl bromide, marine/estuarine
species could be exposed. This study will 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. This study will enable a risk assessment specific
for marine/estuarine species exposure. It will also improve certainty with the endangered
species risk assessment, as this test species 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
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Acute Marine/Estuarine Shrimp. Given the use patterns of methyl bromide, marine/estuarine
species could be exposed. This study will 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 application site, and a wide range of open literature and other non-
guideline studies indicate the potential for plant damage. This study will enable the
assessment of risk to nontarget terrestrial plants off-site.
Vegetative Vigor - Tier II. Methyl bromide is used in part due to its phytotoxicity at the
application site, and a wide range of open literature and other non-guideline studies indicate
the potential for plant damage. This study will enable the assessment 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 range of open literature and other non-guideline studies indicate
the potential for plant damage. This study will enable the assessment of risk to non-target
aquatic plants off-site. The current assessment used a non-guideline open literature toxicity
value.
Honeybee Acute contact - This basic study is now being requested for virtually all outdoor
uses, and will help determine the need for, and specifics of, bee hazard labeling.
c. Other data requirements
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
Special
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. EPA 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.
Special Study - Training for Applicators Supervising Fumigations
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EPA has determined that training, developed and implemented by registrants to foster
product stewardship, will help reduce potential risks 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 that will help handlers protect themselves from
risks of exposure.
Registrants are required to develop 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 programs. The training programs must address, at
minimum, the following elements: how to correctly apply the fumigant; how to protect handlers
and bystanders; how to determine buffer zone distances; how to develop a FMP and complete the
post fumigation application summary; how to determine when weather and other site-specific
factors are not favorable for fumigant application; how to comply with required GAPs and
document compliance in the FMP. The training program 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, license number, and the date of completion. The registrant must be
able to provide to federal, state, or local enforcement 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. Applicators supervising fumigations must
have successfully completed the program within the preceding 36 months and must document
when and where the training program was completed in the FMP. The registrants will be
required to (1) develop a database 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 addition, the applicator must provide to Federal, State, or local
enforcement personnel, upon request, documentation that 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 materials must address, at minimum,
the following elements: (1) what fumigants are and how they work, (2) safe application and
handling of soil fumigants, (3) air monitoring and respiratory protection requirements for
handlers, (4) early signs and symptoms of exposure, (5) appropriate steps to take to mitigate
exposures, (6) what to do in case of an emergency, and (7) how to report incidents. Registrants
must provide this training information through channels open to the public (e.g., via a website).
Pesticide labels will require that applicators supervising fumigations provide this training
information to handlers under their supervision before 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. Applicators supervising fumigations must ensure the
FMP includes how and when the required training information was provided to the handlers
under their supervision.
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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 general standards outlined in the WPS for text size
and legibility (see 40 CFR ง170.120). The requirements 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 information above, excluding the contact information
for the certified applicator in charge of fumigating. However, registrants must provide
appropriate space on the sign, and the sign must be made of material appropriate for applicators
to write in this information on the buffer zone posting signs. Registrants 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 strategy for development and dissemination of the
buffer zone posting signs.
2. Labeling for Manufacturing-Use Products
In order to be eligible for reregi strati on, amend 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.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
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must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant 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 reregi strati on, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV.
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APPENDIX A
Methyl Bromide PC Code 053201 Pre-plant Soil Uses Eligible for Reregistration
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Appendix A. Methy
Bromide PC Code 053201 Pre-plant Soil Uses Eligible for Reregi strati on
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
See applicable
GAPs from
label table
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 ft2
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 USD A-APHIS quarantine
program.
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APPENDIX B
PERFUM Model Inputs and Outputs
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Appendix B. PERFUM Model Inputs and Outputs
Inputs for PERFUM Model
The major input parameters for the fumigant emission and dispersion modeling were:
application rates, application block sizes, application method emission profiles, weather
conditions, and the target air concentration (based on acute inhalation endpoint and uncertainty
factors).
ฆ 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 bromide rates used. According to EPA proprietary
data for 2004-2005, approximately 95% of methyl bromide was applied at a rate of 250 lb ai/acre
or less. This is illustrated in the Agency's benefits assessments by crop and region that include a
more detailed analysis of use rates. These assessments 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 nominations (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 minimum buffer zone distance. In Figures 1 and 2
(shown below), 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 that both fields are 10 acres, and only 50% of the 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.
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 effective broadcast equivalent
rates. [Note: In the risk assessment, a 60 percent value of field treated was used in the
calculations.]
Figure 1. Broadcast Application Figure 2. Bedded Application
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ฆ Block sizes
The Agency had limited information available on the size of application blocks typically
treated in a given day, but estimates that each crew or application rig treats less than 40 acres for
most treatment methods. However, several commercial applicators have indicated they
sometimes use multiple rigs and crews to treat blocks of more than 80 acres per day.
The application block size pertains to size of the field and not 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.
ฆ Emission profiles
The Agency's risk assessment for the July 2008 RED included modeling of 5 outdoor
pre-plant soil application methods: (1) tarped broadcast, (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 California from 1992 to 1999. Buffer
zone distances for other application 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 not reflect the performance of today's high barrier
tarps. The profiles also may not be representative of some methods/equipment used outside
California. In the U.S., tarped bedded and tarped broadcast are the most common methods, hot
gas and deep untarped use is somewhat limited, while shallow untarped application is reportedly
no longer used. Note that only tarped uses will be allowed henceforth except in limited
circumstances as described in the Generic Risk Management sections above.
In the July 2008 RED, the Agency modeled greenhouse pre-plant 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 Division (HED) Human Health Risk Assessment For
Soil, Greenhouse, and Residential/Structural in the methyl bromide docket).
ฆ Weather
The largest methyl bromide use in the U.S. occurs in Florida and California followed by
Michigan. Based on these high-use areas, five weather data sets were modeled in the 2008 RED
(Ventura, California; Bakersfield, California; Bradenton, Florida; Tallahassee, Florida; and Flint,
Michigan). The California and Florida locations are intended to represent inland and coastal
weather conditions. Each modeling run used five years of weather Data (e.g., 1,825 potential
application days) for each weather location. Generally, Ventura, and Bradenton weather data
result in the largest buffer zone distances, followed 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.
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ฆ Target air concentration
As described in Section III, a non-reversible acute inhalation endpoint was selected from
a developmental rabbit study with a LOAEL based on agenesis of the gall bladder and fused
sternebrae. The human equivalent concentration is 10 ppm for a 24-hour TWA with uncertainty
factor of 30 (i.e., target MOE of 30 and a target air concentration of 0.33 ppm). Based on several
factors including the severity, irreversibility of the effect, and the quality of the hazard database,
the buffer zone distances chosen focused on achieving an MOE of 30 at upper percentiles of both
whole field and maximum distance distributions (these terms are described below) from
PERFUM modeling outputs, as well as achieving an MOE of 30 or greater at the 99th 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 also provides outputs as distributions of air
concentrations from which margins of exposure (MOEs) can be estimated. The following
summarizes the key points for each of these output parameters.
The maximum distance distribution is a compilation of the farthest predicted distances
(i.e., the farthest downwind points) over 5 years of weather. The 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 whole field results and that maximum 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 concentrations at various distances around treated fields. These air
concentrations and MOEs were also considered 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 and whole-field results,
which are predictions of the distances where a target 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-field buffers at predetermined buffer distances,
was employed. Air concentration data 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 information from monitoring studies and
incidents were valuable in determining buffer distances to manage potential risks from methyl
bromide use when coupled with other mitigation measures.
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APPENDIX C
FMP Template for Methyl Bromide Soil Applications
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FUMIGANT MANAGEMENT PLAN
Certified Applicator Supervising 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
EPA Registration Number:
Tarps (check here if section is not applicable ~ )
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 size of damage that will be repaired:
Other factors used to determine when tarp repair will be conducted:
Equipment/methods used to cut tarps:
Schedule and target dates for removing tarps:
Soil Conditions
Description of method used to determine soil moisture level:
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Weather Conditions
Summary of the weather forecast for the day of the application and the 48-hour period following the fumigant application (may attach a copy
of printed forecast to FMP):
Buffer Zones
Application method:
~ Bedded
~ Broadcast
~ Hot gas - outdoor
~ Hot gas - greenhouse
~ Hand held probes
Block size
from lookup
table on label
(acres):
Buffer zone
distance:
ft
List and describe areas in the buffer zone that are not under 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, equipment/tarp/seal failure, complaints or elevated air concentration 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:
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Site Specific Response and Management
D 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
~ Neighbors within 100 ft of buffer zone ~ No neighbors within 100 ft of buffer zone
~ Neighbors within 200 ft of buffer zone ~ No neighbors within 200 ft of buffer zone
~ Neighbors within 300 ft of buffer zone ~ No neighbors within 300 ft of buffer zone
~ Neighbors within 300 ft of buffer zone ~ No neighbors within 300 ft of buffer zone
If buffer zone is 100-200 ft:
If buffer zone is 200-300 ft:
If buffer zone is > 300 ft:
If buffer zones overlap
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
Date notified:
Communication Between Applicator, Land Owner/Operator, and Other On-site Handlers
Plan for communicating to the land owner/operator and all on-site handlers (e.g., tarp cutters/removers, irrigators) requirements 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:
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Location of application block:
Site Map
Map Legend
Application block
[~B~| D _ |WB
Bus stop
n
Inpatient clinic
Buffer zone
Water body
I p I
* * Prison
Property lines
DC
Daycare facility
ฎ Well
S
Roads
School
Nursing home
|NAB j
ED
Right-of-way
Nearby application block
Walkway, sidewalk, path
Assisted living facility
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Handler Information
Handler Name, Address, and Phone
Number
Employer Name, Address, and Phone
Number
Tasks They are Trained and
Authorized to Perform
Date of PPE
Training
Date of
Mcdieal
Qualification to
Wear a
Respirator
Date of Fit
Testing for
Respirator
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Air Monitoring Plan
For Buffer Zone Monitoring: (check here if seetion 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.
Monitoring equipment:
For Handlers with Respiratory Protection: (check here if section is not applicable ~ )
Representative Handler Tasks to be Monitored
Monitoring Equipment
Timing
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Air Monitoring Plan for Methyl Bromide Formulation with < 20% Chloropicrin
For Buffer Zone Monitoring: (cheek 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
Timing
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Methyl Bromide FMP Check List
General Site Information
A map, aerial photo, or detailed sketch is attached to this FMP that shows each of the following with distances from the application site
labeled: field location, application block dimensions, buffer zones, property lines, roads, bus stops, water bodies, wells, rights-of-ways,
nearby application blocks, surrounding structures, and sites requiring Vs and lA mile buffer zones.
~
Supervision of Handlers
An on site certified applicator will directly supervise 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/operator 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 not forecast to persist for more than 18 consecutive hours during the 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 measured 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 decomposition prior
to fumigation, little or no crop residue is present on the soil surface, and crop residue that is present does not interfere with the soil seal).
~
The soil temperature at the depth of injection S 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 covered with tarp or soil before making the turn for the next pass.
~
Shank Applieations (check here if section is not applicable ~ )
For tarped-broadcast and -bedded applications, injection points will be at least 8 inches from the nearest final soil/air interface.
~
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 elimination of the chisel trace, the soil surface will be compacted with a
cultipacker, ring roller, and roller in combination with tillage equipment.
~
For performed bed applications, the soil will be sealed by disruption of the chisel trace using press sealers, bed shapers, cultipackers, 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 trace using press sealers, or bed shapers.
~
For shanked bedded and broadcast applications, tarps will be installed 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 closed and the
fumigant has been depressurized (passively drained) or purged (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, Teflonฎ tubing or Teflonฎ -lined steel braided tubing have been used for all low pressure
lines, drain lines, and compressed gas or air pressure lines and is all other tubing Teflonฎ -lined steel braided.
~
Application equipment been inspected to ensure that application rigs do not contain galvanized, PVC, nylon, or aluminum pipe fittings.
~
All rigs 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.
~
All rigs include a flowmeter or a constant pressure system with orifice plates to insure the proper amount of fumigant is applied.
~
Applicators have been trained and instructed to 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 gas cylinder is used. (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).
~
Application rigs are equipped with properly functioning check valves between the compressed gas cylinder or compressed air system 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.
~
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Before using a fumigation rig for the first time, or when preparing it for use after storage, applicators have been trained and instructed to:
ฐ Check the filter, and clean or replace the filter element as required.
ฐ Check all tubes and chisels to make sure they are free of debris and obstructions.
ฐ Check and clean the orifice plates and screen checks, if installed.
ฐ Pressurize the system with compressed gas or compressed air, and check all fittings, valves, and connections for leaks using soap
solution.
~
Applicators have been trained and instructed to:
ฐ 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.
ฐ 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.
ฐ 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 leaks 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 system have been removed and the tree hole has been backfilled with 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 removed
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 lA (or V$) miles of the application block that will be occupied during the buffer zone period.
~
There are no bus stops or other locations where persons wait for public transit within the buffer zone.
~
There are no buildings used for storage such as sheds, barns, garages, 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 been
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 they, 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 1st application ends until the 2nd application begins.
~
If a structure exists within 300 feet of the buffer zone, appropriate emergency preparedness and response procedures are followed.
~
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 maintained as required by the WPS for Agricultural Pesticides.
~
Ha/ard 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.
~
Record keeping
The owner/operator of the application block has been informed that he/she as well as the certified applicator must keep a signed copy of
the site-specific FMPs and the post-application summary 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 Date
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Post-Application Summary
General Application Information
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 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:
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Description of Incidents (check here if section is not applicable ~ )
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:
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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 application summary reflects the actual site conditions during the fumigation and an accurate
description of deviations from the FMP (if applicable).
Signature of certified applicator supervising the fumigation Date
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APPENDIX D
Technical Support Documents
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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 (South Building), 2777 S. Crystal Drive, Arlington,
VA 22202. It is open Monday through Friday, excluding 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 Internet 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, Greenhouse, and Residential/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 Fumigant Emissions - Evaluation for Use in
Soil Fumigant Buffer Zone Credit Factor Approach (DP Barcode: 306857).
4. EPA-HQ-OPP-2005-0123-0317, Review of Fumigants Group Incident Reports.
5. EPA-HQ-OPP-2005-0123-0318, Summary Fumigants Group Incident Reports.
6. EPA-HQ-OPP-2005-0123-0319, Summary Fumigants Group Incidents.
Stratospheric Ozone Depletion
7. EPA-HQ-OPP-2005-0123-0165, Methyl Bromide: Science of Ozone Depletion and Health
Effects Estimates.
8. EPA-HQ-OPP-2005-0123-0166, Human Health Benefits Of Stratospheric Ozone Protection.
9. EPA-HQ-OPP-2005-0123-0167, Regulatory 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 Impact 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 Review of 30-Day Error Correction Comments.
13. EPA-HQ-OPP-2005-0123-0038, Reregi strati on 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 Methyl Bromide in Eggplant Production.
15. EPA-HQ-OPP-2005-0123-0322, Assessment of the Benefits Soil Fumigants (Methyl
Bromide, Chloropicrin, Metam-Sodium, Dazomet) Used by Forest Tree Seedling Nurseries.
16. 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
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Raspberry Nurseries, Fruit and Nut Deciduous Tree 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 Benefits of Soil Fumigation with Methyl
Bromide, Chloropicrin and Metam-sodium In Grape Production.
19. EPA-HQ-OPP-2005-0123-0326, Assessment of the Benefits 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 Bromide In Pome Fruit Production.
21. EPA-HQ-OPP-2005-0123-0328, Assessment of the Benefits 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 Metam-Sodium in Bell Pepper Production.
23. EPA-HQ-OPP-2005-0123-0330, Assessment of the Benefits of Soil Fumigation with Metam-
sodium in Potato Production.
24. EPA-HQ-OPP-2005-0123-0331, Assessment of the Benefits of Soil Fumigation with
Chloropicrin, Methyl Bromide, and Metam-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 Metam-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 Benefits of Soil Fumigation with Metam
Sodium in Carrot Production.
30. EPA-HQ-OPP-2005-0123-0337, Assessment of the Benefits 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 Sodium 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 Mitigation 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 Forest Seedling Nursery (DP#363546). May 13, 2009.
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37. Process for Defining High-Use Fumigation Areas at the State and County Levels
(DP#3 64647) May 14, 2009.
38. 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 Practices and Associated 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 Comments Received on the Reregi strati on of
Chloropicrin, Dazomet, Metam Potassium, Metam Sodium, and Methyl Bromide. June 25,
2008. (DP Barcode 353940).
42. SRRD's Response to Phase 5 Public Comments 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, Chloropicrin, Dazomet, Metam Sodium/Potassium,
MITC: Health Effects Division (HED) Component of Agency Response To Comments On
2008 Reregi strati on 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 Reregi strati on Eligibility
Decision for Chloropicrin, Dazomet, Metam 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).
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