US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility Decision (RED)
for Methyl Bromide
July 9, 2008
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United States Prevention, Pesticides EPA 738-R-08-005
Environmental Protection and Toxic Substances July 2008
Agency (7508P)
Reregistration Eligibility Decision
for Methyl Bromide (soil and non-
food structural uses)
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Reregistration Eligibility Decision for Methyl Bromide (soil and non-food structural uses)
List A
Case No. 0335
Approved by:
Steven Bradbury, Director
Special Review and Reregistration Division
Date:
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
BCF
CFR
cPAD
CSF
CSFII
DCI
DEEM
DFR
DNT
EC
EDWC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
GLN
IR
LCso
LD
50
LOC
LOAEL
MATC
mg/kg/day
mg/L
MOE
MRID
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formulation
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Developmental Neurotoxicity
Emulsifiable Concentrate Formulation
Estimated Drinking Water Concentration
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Guideline Number
Index Reservoir
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
Maximum Acceptable Toxicant Concentration
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligram Per Liter
Margin of Exposure
Master Record Identification Number. EPA's system for recording and
tracking studies submitted.
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MUP
NOAEL
OPP
OPPTS
PAD
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
TGAI
USDA
USGS
UF
UV
WPS
Manufacturing-Use Product
No Observed Adverse Effect Level
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides, and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Pre-harvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
Raw Agriculture Commodity
Reregi strati on Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Technical Grade Active Ingredient
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
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Table of Contents
Abstract 8
I. Introduction 9
II. Chemical Overview 10
A. Chemical Identity 10
B. Use and Usage Profile 11
C. Regulatory History 12
III. Fumigant Overview and Agency Documents 12
A. General Overview of Soil Fumigants 12
B. Human Health Risks 12
C. Stratospheric Ozone Depletion 15
D. Environmental Fate and Ecological Risks 18
E. Benefits 21
IV. Risk Management and Reregistration Decision 23
A. Determination of Reregistrati on Eligibility 23
B. Public Comments and Responses 26
C. Regulatory Position 26
1. Regulatory Rationale 26
a. Generic Risk Management 27
1) Use Sites 27
2) Formulations 28
3) Application Methods 28
4) Maximum Application Rates 29
b. Human Health Risk Management 29
1) Bystander Risk Mitigation 31
i. Buffer Zones 31
ii. Posting 48
2) Occupational Risk Mitigation 51
i. Handlers Definition 52
ii. Handler Requirements 52
iii. Respiratory Protection 53
iv. Tarp Perforation and Removal 57
v. Entry Prohibitions 58
3) Other mitigation 61
i. Good Agricultural Practices (GAPs) 61
ii. Fumigant Management Plans (FMPs) 66
iii. Emergency Preparedness and Response 69
iv. Notice to State Lead Agencies 75
v. Soil Fumigation Training for Applicators and Other Handlers 75
vi. Community Outreach and Education Programs 78
c. Environmental Risk Management 79
d. Stratospheric Ozone Depletion Risk Management 80
2. Endocrine Disrupter Effects 81
3. Endangered Species Considerations 82
D. Conclusions 82
V. What Registrants Need to Do 83
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A. Manufacturing Use Products 84
1. Additional Generic Data Requirements 84
2. Labeling for Manufacturing-Use Products 87
B. End-Use Products 87
1. Additional Product-Specific Data Requirements 87
2. Labeling for End-Use Products 88
Appendix A 112
Appendix B 113
Appendix C 114
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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
Steven Weiss, Industrial Hygienist, Chemical Review Manager for Methyl Bromide
Andrea Carone, Chemical Review Manager for Chloropicrin
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) decision regarding the reregi strati on eligibility of the registered soil and
structural (non-food) uses of methyl bromide.
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 Reregi strati on Eligibility
Document (RED) for 1,3-D was completed in 1998. The Agency evaluated these four 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 Reregi strati on Eligibility Decision
(RED) for Methyl Bromide's Commodity Uses was published on August 9, 2006 l (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 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:
1 EPA-HQ-OPP-2005-0123-0231 The of the Food Quality Protection Act (FQPA)
and Risk Management Decision (TRED) for Methyl Bromide and Reregistration Eligibility Decision (RED) for
Methyl Bromide's Commodity Uses
z MRID 47420302, Measurement of Structural and Ambient Methyl Bromide During Fumigation Activities at Food
Processing Facilities: Final Report
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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;
Good agricultural practices (GAPs);
Fumigant management plans (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 RED document has been completed for chloropicrin (see docket number
EPA-HQ-OPP-2007-03 50). 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. Due to the broad scope of the decision
for the soil fumigant group, there will be a 60-day public comment period for this document to
allow stakeholders the opportunity to review and provide comments on issues related to the
implementation of the risk mitigation measures.
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (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.
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This document presents the Agency's reregi strati on 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 reregi strati on. Section II provides a profile of the use and usage of the
chemical. Section III provides a general overview fumigants and summarizes methyl bromide's
human health and ecological risk assessments, as well as benefit assessments. Section IV
presents the Agency's reregi strati on 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 wj^^jegujj^^
II. Chemical Overview
A. Chemical Identity
Chemical Structure: H
I
H-C-Br
Empirical Formula:
Common Name:
CAS Registry Number
OPP Chemical Code: 053201
Case Number:
Technical or
Manufacturing-Use
Registrants:
H
CH3Br
Methyl bromide
74-83-9
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 1, 2008, Ameribron Inc. changed the corporate name to "ICL-IP America Inc."
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B. Use and Usage Profile
Pesticide Type:
Target pests:
Use patterns:
Formulations:
Methods of Application:
Application Rates:
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.
Soil uses: Methyl bromide is injected in to 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.
Soil uses: Common pre-plant agricultural field uses for various crops
have maximum application rates that range from 200 Ib
ai/acre/application up to 430 Ib ai/acre/application (e.g., EPA
registration numbers 5785-4 and 5785-42). Rates as high as 2 Ibs
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
Ib ai/1000 ft3, but most perishable goods with established food
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tolerances under 40 CFR have application rates in the range of 1 to 4
Ib ai/1000 ft3 (e.g., grapes).
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 QPS 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:
httpV/www.epa.gov/ozone/mbr/M eBr_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 quarantine and preshipment
exemption (QPS), or (3) an emergency exemption. For more information about the phase out of
methyl bromide, see htt|r//wwwji|3a^^
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 ability to move off site during and after application. For example,
pesticide spray drift is the physical movement of pesticide parti culate or droplets from the target
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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 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
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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.
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, 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)
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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
EPA-HQ-OPP-2005-0123-0318, Summary Fumigants Group Incident Reports
EPA-HQ-OPP-2005-0123-0319, Summary Fumigants Group Incidents
C. Stratospheric Ozone Depletion
In addition to methyl bromide's direct effects previously described in Section B on page
12, methyl bromide soil fumigant uses pose 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
EPA-HQ-OPP-2005-0123-0166, Human Health Benefits Of Stratospheric Ozone
Protection
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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 EPA 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 US was 23,000,000 Ibs (10,433 metric tons). As required by 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 Ib 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 annually3. 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.
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
4 EPA Science Advisor*7 Board reports. htJlK//H!iSIBi^^
3 National Cancer Institute, "Common Cancer Types," at www.cancer/gov/cancertopics/commoncancers
6 Ries. L,, M.P., Kosary, C.L.. et al. eds. SEER Cancer Statistics Review. 19734999. Vol2003.
(MD): National Cancer Institute; 2002.
; National Cancer Institute, "'Melanomas," at www^cancei/gOT/cancertoDics/tyDes/nielanoma
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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 phaseout. 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 quarantine and preshipment (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 has not promulgated a regulation for the implementation of an
emergency use exemption. An emergency use exemption would offer limited benefits given the
strict Montreal Protocol criteria and limitations placed on its application.
D. Environmental Fate and Ecological Risks
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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
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 (LOG) 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 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 LDso 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 LCso for methyl bromide from the inhalation route is 780 ppm.
Methyl bromide is slightly to moderately toxic to fish by acute exposure (LCso is 3.9
mg/L), and to aquatic invertebrates (LCso 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.
2. Exposure
a. Terrestrial Exposure
The Industrial Source Complex Short Term (ISCST3) model together with historical air
monitoring data was 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
' Data on the toxic of methyl bromide to algae are only available from a single study (Canton et al. 1980).
which appears to be an report and not published in the peer-reviewed literature
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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 Ibs ai/A. A North Carolina tobacco scenario was also
assessed at the maximum rate of 855 Ibs 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.
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
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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 Ib 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 LOG 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 LOG are the acute risk to
endangered or threatened aquatic invertebrates species. The acute aquatic listed species LOG
(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 RQs values below the LOG.
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
application rate of 575 Ib 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 invertebraes. 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
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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
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
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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
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 reregi strati on. The Agency has previously identified and required the submission
of the generic (i.e., active ingredient specific) data required to support reregi strati on 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, etc.). 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.
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;
9 EPA-HQ-OPP-2005-0123-0340. BEAD'S Impact on Agricultural Site with Use
of Soil Fumigants
10 EPA-HQ-OPP-2005-0123-0282, Mitigation Options to Bystander and Occupational Exposures
Soil Fumigant Applications
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Respiratory protection;
Tarp cutting/removal procedures;
Entry-restricted period;
Application method/practice restrictions;
Fumigant management plans (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 has 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 have been placed into two groups:
Group 1 includes 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 critical use exemptions)
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 has determined 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 http://www.epa.gov/ozone/mbr/cueinfo.html). Based
upon those analyses, EPA has 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 has determined 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 this RED are
implemented. Therefore, products containing methyl bromide for these uses are eligible for
reregi strati on as long as they are granted CUE and QPS status under the Montreal Protocol.
Required label changes are described in Section V of this document. The Agency has
determined that any Group 1 uses that no longer qualify for CUE and QPS status should be
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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 has determined that Group 2 uses
are not eligible for reregi strati on. Substantial information currently 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, indicates that these uses do not
have high benefits and/or have economically and technologically feasible alternatives.
The Agency has determined that use sites in Group 2 for which no data is available to
demonstrate high benefits should be canceled following completion of the comment period on
this 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. 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.
Should methyl bromide registrants request voluntary cancellation of some or all of these
uses under Section 6(f) of FIFRA, there will also be a public comment period on that request
before a cancellation order is issued by EPA. If registrants do not request voluntary cancellation
and EPA does not receive data to support continued use on these sites until existing stocks are
depleted, EPA will take additional regulatory action.
EPA believes that eliminating Group 2 uses will reduce the total amount of methyl
bromide applied in the US, and therefore reduce the incidence of skin cancer resulting from
stratospheric ozone depletion. EPA estimates that in 2007 approximately 291 metric tons and in
2006 approximately 1519 metric tons of methyl bromide was applied for uses with low benefits
and/or have feasible alternatives and which do not qualify for exemptions under the Montreal
Protocol. While the Agency acknowledges that limiting use to only Group 1 uses may slow the
drawdown of the pre-2005 stockpile, it is reasonable to expect that new production for exempted
uses will also continue to decline as 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.
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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.
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 bromode 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)
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.
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As detailed in Section III on page 12, 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.
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
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.
Good agricultural practices (GAPs), fumigant management plans (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 Section III, Other Mitigation (page 61).
1) Use Sites
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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:
Given the risks associated with methyl bromide use, this decision preserves uses with
high benefits and no alternatives, and eliminates uses with lower benefits and/or
alternatives;
This decision reconciles inconsistency between phase-out of methyl bromide production
and EPA registered uses;
This decision 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;
This decision restricts the use of stockpiled methyl bromide to uses with high benefits,
critical uses, and other exempted uses; and
Along with other mitigation, this decision contributes 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 on page 80 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
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
The Agency is asking for stakeholders to comment regarding other current uses of 98:2
formulations and whether other formulations can be used effectively.
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
June 2, to April 10.200? 5 Division (HED)
For Soil, Greenhouse, and Residential/Structural (DP Barcode: D350818)
28
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Agency's LOG 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) untarped shank applications for
California orchard replant uses that qualifies for a CUE or QPS exemption and tree-hole
applications with deep (18 inches) 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 Methyl Bromide Industry Panel (MBIP) and other stakeholders have acknowledged
that current methyl bromide use rates are substantially less than the current maximum rates on
registered labels. As a result, the Agency is requiring registrants to reduce the maximum
application rates to rates that are currently used and shown to be efficacious. This will prevent
future applications at rates greater than needed to effectively control target pests.
The Agency has analyzed information from the most recent critical use nominations
(CUNs) and CUEs and is requiring registrants to amend labels to specify maximum label rates
listed in Table 1. Maximum rates for QPS and emergency exemptions uses are not affected by
this decision but must be identified on end use labels.
Table 1. Maximum Application Rates for Pre-plant Soil Methyl Bromide CUEs
Approved critical uses
Eggplant
Cucurbits (including muskmelons,
cantaloupe, watermelon, cucumber,
squash, pumpkin, and gourds)
Forest Nursery Seedlings
Orchard Nursery Seedlings (raspberry,
deciduous trees, roses)
Strawberry Nurseries
Orchard Replant l (walnuts, almonds,
stone fruit, table and raisin grapes, wine
grapes)
Orchard Replant (grapes)
Ornamentals
Pepper, Bell
Strawberry Fruit
Sweet Potato Slips
Tomato (grown for fresh market)
Maximum Broadcast Equivalent Rates (Ib ai/A)
New
170
200
260
200
260
200
250
360
170
200
200
160
Current
400
435
870
435
870
870
870
870
480
870
870
870
handheld equipment is 1.5 Ib ai/100 ft
b. Human Health Risk Management
29
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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
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;
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 training and community outreach and
education programs, which are also implemented by the registrant, will help reduce risk.
Additionally, EPA is interested in working 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 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
30
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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
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 emergency
preparedness and response, notice to state lead agencies, training, and community outreach as
well as labeling changes.
i. Buffer Zones
The human health risk assessment indicates bystanders may be exposed to methyl
bromide air concentrations that exceed the Agency's level of concern. In general, the risk from
inhalation exposures decreases as the distance from the field to where bystanders are located
increases. Because of this relationship, the Agency is requiring that a buffer zone 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 inhalation risks and eliminate
incidents caused by equipment failure, human error, and weather or other events (e.g.,
temperature inversions). 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.
-------
The Agency considered various buffer zone schemes ranging from fixed buffer zones for
every application to site-specific buffer zones. During the most recent comment period, the
Agency received input in favor of a flexible buffer approach that would allow fumigant users to
determine the buffer zone distance based on site conditions and application practices. While the
Agency believes that site-specific buffer zones would provide the most flexibility for users, the
EPA currently does not have sufficient data to support this scheme. As a result, the Agency has
developed a scalable buffer zone system that does provide flexibility by setting buffer zones for
different application methods at various acreages and application rates. These rates have also
been captured in "Look-up Tables" presented below [see Tables 2, 3, 4, 5 and 6 which begin on
page 39].
Version 2.1.4 of the Probabilistic Exposure and Risk model for Fumigants (also called
the PERFUM model) combined with monitoring data and incident data were used to characterize
the risk for specific buffer zone distances corresponding to the range of application scenarios
anticipated. A CD containing all of the PERFUM input/output files and files with the PERFUM
MOE/air concentration analysis that were considered for this decision are available upon request
at the OPP Docket Office. Additional information on the PERFUM inputs and outputs can be
found in the Agency risk assessment12, (EPA-HQ-OPP-2005-0123-0285), in a June 2006 a peer-
reviewed article describing the model (http://www.sciencedirect.com/science/joumal/ 1 35223 1 0),
and/or the PERFUM user's guide which can be download from the internet
(a) General Buffer Zone Requirements
The following describes the general buffer zone requirements for methyl bromide and other
soil fumigants currently going through the reregi strati on process:
"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).
An "application block" is a field or portion of a field treated with a fumigant in any 24-hour
period [see Figures 1 and 2 on page 36 for further explanation].
The "buffer zone period" starts at the moment when any fumigant is delivered/dispensed to
the soil within the application block and lasts for a minimum of 48 hours after the fumigant
has stopped being delivered/dispensed to the soil.
Buffer zone distances
Buffer zone distances must be based on look-up tables on product labels (25 feet is the
smallest distance regardless of site-specific application parameters).
lz EPA-HQ-OPP-2005-0123-0285. 5 Division Risk
Assessment for Soil. Greenhouse, and Residential/Structural Uses
32
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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).
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.
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 (including blocks
fumigated by adjacent property owners, see below for exemptions for areas not under the
control of owner/operator of application block).
No fumigant applications will be permitted within 0.25 miles of schools, state licensed day
care centers, nursing homes, assisted living facilities, elder care facilities, hospitals, in-patient
clinics and prisons if occupied 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 though such
sidewalk or shoulder is used by persons riding bicycles. In the event a highway includes two
or more separated roadways, the term "roadway" shall refer to any such roadway separately.
(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 on page 48 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 on page 48 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,
0 The buffer zone period has ended, and
33
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0 Two consecutive air samples for methyl bromide have been taken in the structure at
least 1 hour apart must indicate less than 1 ppm methyl bromide, and
0 Two consecutive air samples for chloropicrin have been taken in the structure at least
1 hour apart must indicate than less than 0.15 ppm chloropicrin is present.
Buffer zones may not include agricultural areas owned/operated by persons other than the
owner/operator of the application block, UNLESS,
1. The owner/operator of the application block can ensure that the buffer zone will not
overlap with a buffer zone from any adjacent property owners, and
2. The owner/operator of the areas that are not under the control of the application 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.
Buffer zones may not include publicly owned and/or operated areas (e.g., parks, rights of
way, side walks, walking paths, playgrounds, athletic fields, etc), 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.
See the Posting Section on page 48 for additional requirements that may apply.
(b) PERFUM Model Inputs
The major input parameters for the modeling are: application rates, application block
sizes, application method emission profiles, weather conditions, and the target air concentration
(based on acute inhalation endpoint and uncertainty factors). The following summarizes the key
points for each of these input parameters.
Rates
The Agency modeled up to 430 Ib ai/acre for broadcast applications and 250 Ibs ai/acre
effective broadcast rate for bedded applications. 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 Ib 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 (Ib 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 field in Figure 2 is fumigated, the rate
34
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per treated acre is 400 Ibs ai/A for both Figure 1 and 2. The broadcast rate for Figure 1 is 400
Ib ai/A but the effective broadcast equivalent rate for Figure 2 is 200 Ibs ai/A.
Labels may express rates as Ibs 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.]
35
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Figure 1. Broadcast Application Figure 2. Bedded Application
Block Sizes
The Agency has 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.
Emission Profiles
The Agency's risk assessment includes 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.
The Agency has 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)
Weather
The largest methyl bromide use in the US occurs in Florida and California followed by
Michigan. Based on these high-use areas, five weather data sets were modeled (Ventura, CA;
36
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Bakersfield, CA; Bradenton, FL; Tallahassee, FL; and Flint, MI). 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., 1825 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, MI data resulted in significantly smaller buffers
compared to the other four locations.
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 99th percentile air
concentration from PERFUM outputs.
(c) 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
37
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incidents were valuable in determining buffer distances to manage potential risks from methyl
bromide use when coupled with other mitigation measures.
(d) Buffer Zone Distances
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 at high percentiles of the of the PERFUM model outputs. 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.
The Agency has developed required buffer zone distances based on application method,
application rate, and application block size. These distances are summarized in Tables 2, 3, 4, 5
and 6.
For each of the outdoor pre-plant soil emission profiles, 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 Ib 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 adequate
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 "greenhouse" industry sector is extremely varied because of the breadth 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". Certainly, in common "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-transluscent 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 2, 3, and 5).
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
38
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bromide, while the formulations with higher concentrations of chloropicrin will have buffers
zone distances based on chloropicrin.
Minimum and Maximum Distances
A minimum buffer zone of 25 feet will be required 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, but the Agency believes that a 25 foot minimum buffer is a good agricultural
practice (GAP). While modeling may support no buffer in some cases, a minimum buffer is
being required because of variability in the emission rates over a field and other factors not
accounted for in the modeling. Application scenarios requiring buffer zone distances of more
than l/2 mile (2,640 feet) are prohibited. EPA believes that for areas where methyl bromide is
used, buffers greater than /^ mile are not practical and difficult to enforce.
Maximum Application Block Sizes
The maximum application block sizes allowed for methyl bromide applications are:
100 acres for tarped bedded and broadcast applications,
40 acres for untarped deep applications (i.e., California orchard replant),
10 acres for outdoor hot gas applications, and
45,000 square feet for greenhouse hot gas applications.
Table 2. Tarped Bedded Buffer Zone Distances (feet)
Block
Size
(acres)
1
5
10
20
30
40
60
80
100
Broadcast Equivalent Application Rate (Ib ai/acre)
25
25
25
25
25
25
25
25
25
25
44
25
25
25
25
25
50
75
100
150
63
25
25
25
25
25
75
125
175
200
79
25
45
70
110
135
190
275
350
400
94
25
65
115
190
240
300
425
525
600
110
25
85
160
270
345
425
375
700
790
125
25
100
200
350
450
525
725
875
985
141
25
140
260
425
550
645
865
1045
1190
157
25
175
315
500
650
765
1005
1215
1390
172
45
215
370
575
750
885
1145
1385
1590
188
50
250
425
650
850
1000
1285
1550
1790
204
70
290
470
720
940
1115
1435
1725
2010
219
90
325
515
790
1025
1215
1580
1900
2215
235
110
365
560
960
1115
1320
1730
2075
2430
250
125
400
600
925
1200
1425
1875
2250
2640
39
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Table 3. Tarped Broadcast Buffer Zone Distances (feet)
Block
Size
(acres)
1
5
10
20
30
40
60
80
100
Broadcast Equivalent Application Rate (Ib ai/acre)
43
25
25
25
25
25
25
25
25
25
75
25
25
25
25
38
75
115
165
200
108
25
25
25
25
50
125
200
300
375
134
25
60
95
145
210
310
425
565
690
161
25
90
165
265
365
490
650
825
1000
188
25
120
235
385
520
770
875
1090
1315
215
25
150
300
500
675
850
1100
1350
1625
242
25
210
385
625
835
1035
1350
1660
1985
269
25
265
465
750
980
1215
1595
1965
2340
296
25
320
545
875
1145
1395
1840
2270
2695
323
25
375
625
1000
1300
1575
2085
2575
3050
350
50
450
700
1115
1440
1760
2330
2865
3375
377
75
525
775
1225
1575
1940
2570
3150
3700
403
100
600
850
1340
1115
2120
2810
3440
4025
430
125
675
925
1450
1850
2300
3050
3725
4350
Table 4. Deep Untarped Buffer Zone Distances (feet)
Block
Size
(acres)
1
5
10
20
30
40
Broadcast Equivalent Application Rate (Ib ai/acre)
43
25
25
25
25
25
25
75
25
25
25
88
125
163
108
25
25
25
150
225
300
134
25
85
135
295
410
515
161
25
140
240
440
590
725
188
25
195
345
585
770
940
215
25
250
450
725
950
1150
242
45
315
545
865
1125
1365
269
65
375
640
1000
1300
1575
296
85
440
735
1140
1475
1790
323
100
500
825
1275
1650
2000
350
135
560
910
1410
1825
2215
377
165
615
990
1540
2000
2425
403
200
770
1070
1670
2175
2640
430
225
725
1150
1800
2350
2850
Table 5. Outdoor Tarped Hot Gas Buffer Zone Distances (feet)
Block
Size
(acres)
1
5
10
Broadcast Equivalent Application Rate (Ib ai/acre)
43
25
25
50
75
25
150
250
108
25
275
450
134
85
385
610
161
140
490
765
188
195
595
920
215
250
700
1075
242
285
790
960
269
325
875
840
296
345
965
720
323
375
1050
600
350
415
1140
985
377
450
1225
1365
403
490
1315
1745
430
525
1400
2125
Table 6. Greenhouse Hot Gas Buffer Zone Distances
Broadcast
Equivalent
Application Rate
fib ail
100
0,25
0.5
0,75
1
Block Size
25
25
50
100
25
50
125
200
25
100
175
250
25
125
225
300
25
150
250
350
25
175
300
400
50
200
350
450
50
225
375
475
75
250
400
500
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
40
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approach to set the buffers which included consideration of the 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 Model13). 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, this goal was achieved and the determined
buffer zone distances are also believed to be manageable using existing cultural practices. The
following characterizes the risks associated with the buffer zone distances summarized in Tables
2, 3, 4, 5 and 6:
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).
For some of the weather stations modeled, the distances result in MOEs much higher than 30
at the 99th percentile on the maximum distance distribution.
The PERFUM model was modified since the Agency last released its risk assessment for
public comment. Version 2.1.4 now 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.
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 (see pages 61 and 66, respectively, for GAP and
FMP Sections).
Table 7 summarizes the required buffer zone distances and corresponding PERFUM
modeling results for the pre-plant soil uses that qualify for critical use exemptions with current
typical application rates (based on information identified in the Agency's benefits assessments).
Focusing on tomatoes as an example (last row of Table 7), the buffer zone for a 10 acre
application block in the Southeast at a rate of 120 Ibs ai/A is 200 feet. At 200 feet, the PERFUM
ijffiv/soramD(yyd^
41
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model to 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, FL). 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 200 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, FL)
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 (see page
44) 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.
42
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Table 7.
Projected Buffers Zones for Methyl Bromide Critical Use Exemptions Based on Current Typical
Application Rates
Crop
Cucurbits
Eggplant
Forest Seedlings
Nursery, Fruit, Nut
&Rose
Stone Fruit, Tree
Nut Orchard
Replant, Grape
Vineyards
Ornamentals
Pepper, Bell
Strawberry Fruit
Strawberry Nursery
Tomato, Fresh
Region
MI
Southeast
Southeast
Southeast
National
CA
CA
FL
MI
Southeast
CA
FL
CA
NC
Southeast
Application
Method
Tarped Shank
Bedded
Tarped Shank
Bedded
Tarped Shank
Bedded
Tarped Shank
Broadcast
Tarped Shank
Broadcast
Tarped Shank
Broadcast
Tarped Shank
Broadcast
Tarped Shank
Broadcast
Tarped Shank
Bedded
Tarped Shank
Bedded
Tarped Shank
Broadcast
Tarped Shank
Bedded
Tarped Shank
Broadcast
Tarped Shank
Bedded
Tarped Shank
Broadcast
Tarped Shank
Bedded
Broadcast
Equivalent
Rate (Ib
ai/A)
200
120
120
236
350
180
182
235
390
200
120
175
120
235
235
235
120
Block
Size
(acres)
10
20
10
20
10
20
10
20
10
20
10
40
10
40
10
20
10
20
10
20
10
20
10
20
10
20
10
20
10
20
10
20
10
20
Buffer
Zones
without
credits
(ft)
470
720
200
350
200
350
385
625
700
1115
235
775
235
670
385
625
850
1340
470
720
200
350
235
285
200
350
385
625
560
856
380
625
200
350
Maximum
Distribution
Percentile where
MOEreaches302
Bradenton
>95
>95
>95
>95
>95
>95
>99
>99
>97
>99
>99
>99
>99
>99
>99
>99
>99
>99
>95
>95
>95
>95
>99
>99
>95
>95
>99
>99
>95
>95
>99
>99
>95
>95
Ventura
>95
>97
>97
>97
>97
>97
>99.9
>97
>99
>97
>99.9
>99.9
>99.9
>99.9
>97
>97
>97
>95
>97
>97
>97
>99.9
>99,9
>97
>97
>99.9
>97
>97
>97
>99.9
>97
>97
>97
MO E for
Pe ree n ti 1 e Ai r
Conceal tratioii from
PERFUM2 output
Bradenton
>4()
>40
>40
>35
>40
>35
>45
>45
>5()
>50
>45
>45
>45
>45
>45
>45
>55
>55
>4()
>40
>40
>35
>45
>45
>40
>3S
>45
>45
>35
>35
>45
>45
>40
>35
Ventura
>45
>45
>45
>40
>45
>40
>5()
>50
>6()
>60
>50
>so
>50
>50
>50
>so
>60
>60
>45
>45
>40
>5()
>50
>45
>40
>50
>50
>40
>35
>5()
>50
>45
>40
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
43
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The Agency believes that the buffer zone distances described above, combined with other
risk mitigations described herein, will provide protection against any unreasonable adverse
effects.
(e) Buffer Zone Reduction Credits
The Agency has undertaken a significant effort to evaluate available empirical data,
modeling, and 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,"14 in the methyl bromide docket. The Agency has also
coordinated and led forums to discuss this issue at the 2006 and 2007 Methyl Bromide
Alternatives Outreach (MB AO) Conferences with leading researchers and other stakeholders. A
general description of the MBAO sessions can be found at httrj^/mbao.org.
Based on the Agency's analysis of the current data, the Agency has developed methyl
bromide buffer zone reduction credits for: high barrier tarps, soils with high organic matter, and
for soils with high clay content. To take advantage of the credit for high barrier tarps, users can
modify their current application practices. Organic matter and clay content are difficult to
change and these credits may only be applicable for areas where these characteristics already
exist. Changing current practices or site conditions to utilize these credits may be a challenge,
but the Agency believes that in addition to reducing bystander risk and the size of buffer zones,
the credit for high barrier tarps has the potential to decrease application rates, increase efficacy,
and reduce depletion of stratospheric ozone. None of the buffer zone credits apply to hot gas
applications.
Methyl bromide buffer zone credits are additive but can 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).
High Barrier Tarps
EPA has determined that 25% buffer credit for methyl bromide is appropriate for the
following high barrier tarps: Bromostopฎ (1.38 mil), IPM Clear VIF (1.38 mil), and Eval/Mitsui
(1.38 mil). The credits are based primarily on laboratory studies performed by Dr. Husein
Ajwa15 from the University California-Davis as described in the Agency's emission factors
analysis14. There have been no methyl bromide empirical field studies on emission or
permeability for modern high barrier tarps submitted to EPA. The Agency believes that the
actual reduction for tarps could be higher for certain conditions but that a 25% credit is
appropriate based on uncertainties in the available data. Other high barrier tarps could qualify
for credits if supporting data are provided to the Agency.
14 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor
Approach. June 9. 2008. DP 306857
13 Ajwa, H., A. 2007. Testing Film Permeability to Fumigants Under Laboratory1 and Field Conditions. 2007 Methyl
Alternatives Outreach Conference. http://mbao.org/2007/PDF/Preplant/PP3/Ajwa(16).pdf
44
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The use of high barrier tarps may not be feasible or applicable to all situations where
methyl bromide is currently used. For example, growers using broadcast applications have
reported that high barrier tarps are difficult to use because of problems with gluing or bonding
the edges of the tarps together. Researchers and other stakeholders are reportedly exploring
alternate methods to accomplish this task (e.g., using heat to weld the tarps together). Also,
California currently prohibits the three high barrier tarps listed above and other virtually
impermeable films (VIFs) for methyl bromide applications based on risk concerns for handlers
when tarps are being cut. The EPA believes these handler risks will be adequately addressed
with mitigation required by this decision (e.g., new requirements for tarp perforation, respirators,
air monitoring, application rates, tarp removal plans, etc.)
Tarp emission reduction data reviewed by EPA show that tarps have varying degrees of
effectiveness. There is no current standard to evaluate tarps performance under field conditions,
and in the absence of a standard, EPA has established conservative buffer reduction factors based
on available data. EPA requested assistance from USDA's Agricultural Research Service (ARS)
in this effort to identify those tarps that have demonstrated low permeability and reduced
emissions under field conditions16. USDA's research includes a hybrid field-lab performance
test where tarps are stretched out over beds, subjected to atmospheric and soil conditions, and
then tested in the lab. The Agency believes that this approach to evaluating the permeability of
agricultural tarps could simulate more realistic field conditions especially if conducted with
concurrent field measurements, and EPA requested the results of tarp permeability testing
currently being conducted in support of USDA's Area-wide Pest Management Projects for both
the Pacific Region and the South Atlantic Regions.
In a response to EPA's request, USDA indicated that at least several months are needed
for data review, and that it was not able to provide the data in a timeframe for EPA's current
decisions17. USDA did offer to provide samples of tarp taken from its ARS experiments for
testing in EPA laboratories. EPA is evaluating the feasibility of this option.
EPA plans to work with USDA, registrants, and other stakeholders to develop a protocol
for measuring the performance of tarp materials (e.g., using the mass transfer coefficient for each
fumigant) and performance criteria that could be used to evaluate additional tarps to derive
emission credits. Although there are several protocols being evaluated, there is no consensus on
a method. The Agency's factors analysis discusses methods that could be employed 14.
Guidelines for conducting flux studies in the field to use as point of comparison to performance
testing are already well established.
EPA (through OPP's Environmental Stewardship Branch) has proposed to co-fund a
grant with USD A-ARS for several flux studies in the southeastern U.S. These studies would
provide (1) field data on the emission reduction potential of certain low permeability barrier
films to support possible, additional, buffer reduction credits as well as to (2) help develop an
affordable and reliable hybrid field/lab test to evaluate the many barrier films available to
growers. EPA has also prepared a document to describe possible research and study designs to
'' EPA-HQ-OPP-2005-0123-0459, USDA's Film Testing
1EPA-HQ-OPP-2005-0123-0460. USDA Letter to Caulkins on Agricultural Film Testing
45
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reduce uncertainties in understanding emission factors in the context of different films and seals,
agricultural practices, and environmental conditions18. During the 60-day comment period the
Agency anticipates learning more about ongoing and planned research from the scientific
community that will address these uncertainties to help the Agency identify potential studies that
would help refine the current risk-based mitigation decisions. The EPA will defer decisions
regarding calling-in any data to address uncertainties identified with regard to these and other
factors until comments provided during the 60-day comment period have been reviewed.
Soil Conditions
Like high barrier tarps, inherent soil conditions (e.g. organic matter and soil type) do
have an impact on fumigant emissions. However, soil conditions differ from the high barrier
tarp credits because soil conditions are factors that are 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. EPA acknowledges that some variability in soil
characteristics within a given field is likely. If users are unsure whether the fields they intend to
treat meet the criteria for a credit, they may consult with their local agriculture extension office
or soil conservation district for assistance in determining soil characteristics.
The Agency's factors document not only reviews available literature regarding soil
conditions, but also describes modeling exercises that estimate the impact of organic matter and
soil type using the Chain_2D model14. Chain_2D is a first principles model that takes into
consideration factors such as boundary layers or moisture that could impact fumigant emissions.
The Agency used Chain_2D as modified by Dow AgroSciences' Steve Cryer and Ian van
Wesenbeek in the sensitivity analysis19. Cryer and van Wesenbeek modified the original source
code to create a more usable graphical user interface, this included incorporating a new air/soil
boundary condition proposed by Wang in 199820 See the Agency's factors analysis for further
details about the Chain_2D model .
Based on the review of available literature and modeling with the CHAIN_2D model,
EPA believes 10 percent buffer zone credits are 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.
The Agency's Chain_2D sensitivity analysis suggests that organic matter can have a
small impact on emissions. There is generally a high correlation between the organic matter
content of the soils and the dissociation constant (K d) value. Increasing K d value by 10 or 25
percent generally reduced emissions by 10 or 20 percent. Decreasing the Kd value by 10 or 25
percent increased emissions by 10 or 20 percent (see figures 157-159 of the factors analysis for
further details).
18 Health Effects Division Recommendation for Fumigant Data Requirements. Dawson and Smith. June 2008
19 Cryer. S.A. (200?) Air/Soil Boundary Conditions For Coupling Soil Physics and Air Dispersion Modeling.
Unpublished report of Dow AgroSciences LLC (Report # DN241493)
20
Wang. D; Yates, S.R.; Jury. W.A. (1998) Temperature Effect on Methyl Bromide Volatilization: Permeability of
Plastic Cover Films. I Environ. Qua! 27, 821-827.
46
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Generally, clay loam and sandy clay loam soils tended to show significantly lower
emissions than other soil types, sometimes showing 50 percent lower reductions. Conversely,
loamy sand and loam soils tended to show higher emissions than other soil types (see figures
176-179 of the factors analysis for further details).
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 Ibs 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 25 percent. The resulting buffer zone distance for this case is 150 feet. If the organic
matter in the application block is greater than 3 percent and Bromostopฎ (1.38 mil) high barrier
tarp is used, the resulting buffer zone distance would be 130 feet.
Other Buffer Zone Credits Considered
Other factors such as soil moisture content, field preparation, water sealing, and
application injection depth could not be used to justify credits based on the available data.
However, EPA has established mandatory good agricultural practices (GAPs) for these
conditions. See the GAP Section (page 61) 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, and will
consider such data in future decisions if new data becomes available. Such data may also
support the Agency's decisions on additional emission credits in the future.
(f) Buffer Zone Impacts
EPA acknowledges 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. As part of the most recent public comment period on fumigant risk
assessments and proposed mitigation, several stakeholders submitted analyses estimating the
impact of buffer zones around fumigated agricultural fields. The Agency's review of these
studies and discussion of an EPA contracted study using the same approach for Kern County,
California is included in the docket21. While buffers may restrict certain application practices,
this decision allows growers the flexibility to modify their practices to achieve smaller buffers;
for example treat smaller application blocks, or switch to a lower emission application method.
Available data indicate that for some crops and regions, 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. Some growers in
the Southeast are commonly using high barrier tarps and lower rates at present.
z 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# 353940)
47
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The Agency has also looked at how buffer zones have impacted California practices 21.
California currently requires buffer zones for pre-plant soil fumigations with methyl bromide.
California's buffers are based on local conditions and use practices, while the buffers EPA is
establishing in this decision are based on conditions and practices nation wide. The CDPR has
indicated that their buffer zone distances will not be reduced in cases where buffer zones
required by EPA are less. In cases where EPA buffers are larger, however, California would
increase their buffers to be consistent with EPA's buffers.
Table 8 shows a comparison of current CDPR buffers to EPA buffers for applicable
CUEs using the same typical application rates and block sizes included in Table 7. In California
methyl bromide is predominantly applied using the broadcast method.
Table 8. EPA Methyl bromide buffers vs. Current CDPR Buffer Zones for CUEs in CA
Crop1
Orchard
Replant
Orchard
Replant
Ornamentals
Strawberry
Fruit
Strawberry
Nursery
Application
Method
Tarped Shank
Broadcast
Deep Untarped
Shank Broadcast
Tarped Shank
Broadcast
Tarped Shank
Broadcast
Tarped Shank
Broadcast
Broadcast
Equivalent
Rate (Ib ai/A)
182
182
235
175
235
Block
Size
(acres)
10
40
10
40
10
20
10
20
10
20
EPA Buffer
Zones without
credits 2
(ft)
235
670
345
940
385
625
235
285
385
625
California
Buffer
Zones3
(ft)
160 - 1000
370 - 2200
370
810
240 - 1300
360 - 1900
120 - 930
240 - 2000
240 - 1300
360 - 1900
1 CUE crops are generally applied using the broadcast method in California
2 EPA buffer zone period ends 48 hours after application ends
3 For above scenarios, California's buffer zone period ends 36 hours after application ends. Longer buffer zone
periods (up to 84 hrs) are required depending on rate and block size. California buffer distances vary depending on
application equipment used (See page 33 of http://www.cdpr.ca.gov/docs/coiint}'/training/iiiethbroni/iTiebriiiaii.pdf
for further details)
ii. Posting
Posting is recognized as an effective means of informing workers and others 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 to ensure they do not enter
areas designated as part of the buffer zone.
(a) Posting Requirements
48
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In addition to alerting bystanders, posting a buffer zone will help handlers determine
where and when they are required to use PPE. As described below, handlers working in 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 buffers for
bystanders and handlers, the perimeter of the fumigant buffer zones must be posted as described
below and in the example that follows.
Posting of a buffer zone is required except when one of the following conditions exist:
(1) a physical barrier that is reasonably likely to prevent bystander access to the buffer
zone (e.g., a fence or wall) separates the edge of the buffer zone from bystander access.
OR
(2) the area within 300 feet of the edge of the buffer zone is controlled by the application
block owner/operator. That is, if land under someone else's control is within 300 feet
from the edge of the buffer zone, the buffer zone must be posted.
A buffer within 300 feet of an area that includes worker housing must be posted even if
the area is under the control of the land owner/operator.
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 When there are no usual points of entry, be posted in the corners of the buffer zone,
between the corners of the buffer zone, and along sides so that one sign can be
viewed (not read) from the previous one. Some examples of points of entry include,
but are not limited to, roadways, sidewalks, paths, and bike trails.
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.
Exception: If multiple contiguous blocks are fumigated within a 14-day period, the entire
periphery of the contiguous blocks' buffer zones may be posted. The signs must remain posted
until the last buffer zone period expires and signs may remain posted until 3-days after the buffer
zone period for the last block has expired.
Additional requirements for treated area posting:
The treated area posted signs must remain posted for no less than the duration of the entry
restricted period after treatment.
49
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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
(40CFRง170.120).
Contents of Signs
The treated area sign (currently required for
fumigants) must state the following:
~ Skull and crossbones symbol
The buffer zone sign must include the
following:
Do not walk sign
- "DANGER/PELIGRO,"
~ "Area under fumigation, DO NOT
ENTER/NO ENTRE,"
~ "[Name offumigant] 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.
sJL
- "DO NOT ENTER/NO ENTRE,"
~ "[Name offumigant] Fumigant BUFFER
ZONE,"
~ the date and time of fumigation,
~ the date and time buffer zone restrictions are
lifted (i.e., buffer zone period expires)
~ Name and EPA registration number of the
product applied, and
~ name, address, and telephone number of the
certified applicator in charge of the fumigation
(b) Posting Example
To clarify the posting requirements, the following example has been included.
50
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Figure 3. Posting Example
Property
Operator's
Residence
Red Houses = Structure within 300 feet of the buffer zone edge. Yellow dots = posted signs
The structures in red are (1) within 300 feet of the edge of the buffer zone, and (2) there
is no physical barrier between the two structures and the buffer zone, and (3) the land
operator does not control these structures.
Although the property operator's building (striped building) is within 100 feet of the
edge of the buffer zone, since it is controlled by the property operator, no posting of the
buffer zone is necessary here.
There is a road within 100 feet of the edge of the buffer zone. Since there is a possibility
of people from the road entering the buffer zone area, the buffer zone needs to be posted
in the northwest corner.
(c) Buffer zone posting considerations
The Agency received comments on the burden for applicators to post the entire perimeter
of a buffer zone due to the large distance it covers. In an effort to reduce the burden on growers,
but retain the posting requirement for situations where people are most likely to enter a buffer
zone, EPA believes posting area where people are most likely to enter buffers will be protective.
USDA also noted that as growers break their fields into smaller application blocks to result in
smaller buffer zones, the posting requirements would be burdensome in that users would need to
put up and take down signs for multiple adjacent, sequential applications. To address this
concern, EPA is allowing signs for contiguous application blocks to be placed on the edge of the
buffer zone area for all blocks treated within a 14-day period. EPA believes this will be
protective and potentially less burdensome.
2) Occupational Risk Mitigation
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i. Handlers Definition
Based on stakeholder comments, a clarification of EPA's definition of handler activities,
as currently defined in the WPS and fumigant labels, is needed. Persons engaged in any of the
following activities will be defined as handlers on product labels.
Persons participating in the application as supervisors, drivers, co-pilots, shovelers, or as
other direct application participants;
Persons taking air samples to monitor fumigant air concentrations;
Persons cleaning up fumigant spills;
Persons handling or disposing of fumigant containers;
Persons cleaning, handling, adjusting, or repairing the parts of fumigation equipment that
may contain fumigant residues;
Persons installing, repairing, operating irrigation equipment in the fumigant application block
or surrounding buffer zone during the buffer zone period;
Persons entering the application site or surrounding buffer zone during the buffer zone period
to perform scouting or crop advising tasks;
Persons installing, perforating (cutting, punching, slicing, poking), removing, repairing, or
monitoring tarps - until
o After tarps are perforated and removed if tarp removal is completed less than 14 days
after application; or
o 14 days after application is complete if tarps are not perforated and removed during
those 14 days, or
o 48 hours after tarps are perforated if they will not be removed prior to planting.
ii. Handler Requirements
Currently 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 onsite trained
personnel will help to reduce these risks. Therefore, a certified applicator must maintain visual
contact with any fumigant handler while the fumigant is being incorporated into the soil. The
person monitoring other handlers may also be engaged in fumigant handling tasks during the
monitoring period and two qualified monitors may monitor one another simultaneously.
Before applying this product the certified applicator supervising that application must
have, within the preceding 12 months, successfully completed a methyl bromide training
program, made available by the registrant (see page 77). The FMP described on page 66 of
Section IV must document when and where the training program was completed.
For cases when the certified applicator leaves the site after the application portion of the
fumigation process is complete and other parties will be performing handler tasks (e.g., tarp
perforating/removal, water application, etc.), the certified applicator must communicate in
writing to the site owner/operator and other handlers key information needed to comply with
label requirements (e.g. PPE requirements, location of buffers, when buffer zone ends, reentry
restrictions, minimum times for perforating tarps, etc.).
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When handlers are fixing tarps, moving irrigation equipment or performing other
handling tasks as defined above, the Agency is requiring at least two WPS trained handlers be
present for all activities. Due to the volatile nature of the fumigants there is a possibility that
handlers could be overcome with the vapors and have difficulty leaving the area while they are
performing handling tasks. Therefore, EPA is requiring at least two WPS trained handlers be on
site during all post-fumigation handling activities.
iii. Respiratory Protection
The Agency's risk assessment indicates that there is an inhalation risk concern for
handlers without respirator protection for a majority of handler tasks. The addendum to the April
10, 2007 risk assessment (D350818) 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.
During the most recent public comment period, the Agency received comments from
applicators that respirators are not necessary because (1) chloropicrin's warning properties are
sufficient to alert handlers if there has been an unsafe exposure, (2) respirators inhibit
communication which could cause an accident; and (3) in warm weather respirators can cause
heat stress and other ailments. On the other hand, some stakeholders are in favor of mandatory
respiratory protection because they believe if fumigants are continued to be used that respirators
are the only effective means to protect workers from chloropicrin exposures. These stakeholders
have also stated that handlers will not be given access to respirators and other PPE unless it is
required on the label.
Current product 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.
(a) Air monitoring
Air monitoring requirements herein will ensure that acute, short-, and intermediate-term
risks are not exceeded and will ensure that 5 ppm upper working limit of the respirator cartridge
has not been exceeded.
There are several commercial systems for monitoring methyl bromide and chloropicrin
air concentrations. Methyl bromide colorimetric tubes (pn 10-131-10) from RaeSystems have a
working range of (1-18 ppm methyl bromide) or an extended range of (0.5-36 ppm methyl
bromide). The Ultra Rae (pn 012-3024-005) sensitivity is 0.2 ppm but this piece of equipment is
more expensive and difficult to use. Chloropicrin colorimetric tubes are available from varied
manufacturers including: Matheson/Kitagawa # 172, sensitivity 0.1 ppm; Sensidyne #134,
sensitivity 1-60 ppm; Draeger, #l-a, sensitivity 1-15 ppm.
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(b) Respiratory requirements
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.
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 if 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.
Formulations with 80% or less methyl bromide
The use of air purifying respirators is mandated in this approach only when warranted by
monitoring air concentrations during applications. If certain triggers are met then respirators are
required. The following air monitoring procedures must be followed for all formulations with 80
percent or less methyl bromide to determine whether respiratory protection is required for any
person performing a fumigant handling task:
Air monitoring samples for methyl bromide and chloropicrin 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) methyl bromide concentrations are greater than or equal to 1 ppm or (2)
chloropicrin concentrations are greater than or equal to 0.15 ppm or (3) any handler
experiences sensory irritation, then a air-purifying respirators must be worn by all handlers at
the handling site.
If two consecutive breathing zone air samples taken at least 30 minutes apart, show levels
have decreased to less than 1 ppm for methyl bromide and less than 0.15 ppm for
chloropicrin, then handlers may remove the respirators.
If at any time (1) a handler experiences any sensory irritation when wearing a respirator, or
(2) any air sample is greater than or equal to 5 ppm for methyl bromide, or (3) any air sample
is greater than or equal to 1.5 ppm for chloropicrin, then all handler activities must cease and
handlers must be removed from the application block and surrounding buffer zone until
corrective action has been taken.
During the corrective actions if methyl bromide air concentrations are greater than or equal to
5 ppm or if chloropicrin air concentrations are greater than or equal to 1.5 ppm, a SCBA
must be worn.
In order to resume work activities:
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0 Two consecutive air samples for methyl bromide and chloropicrin taken at the handling
site at least 30 minutes apart must be less than 5 ppm for methyl bromide and less than
1.5 ppm for chloropicrin.
0 During the collection of air samples, an air purifying respirator must be worn by the
handler taking air samples.
0 If methyl bromide concentrations are greater than or equal to 1 ppm or if chloropicrin
concentrations are greater than or equal to 0.15 ppm, then handlers resuming their
handler activities must wear air-purifying respirators
Formulations with more than 80 % methyl bromide
If the fumigant applied contains greater than 80 percent methyl bromide (e.g., 98:2
formulations), air purifying respirators must be worn during all handler tasks and the following
air monitoring procedures must be followed to ensure that the upper protection limit of the
respirator plus respirator 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.
During the corrective actions if methyl bromide air concentrations are greater than or equal to
5 ppm or if chloropicrin air concentrations are greater than or equal to 1.5 ppm, then a
SCBA must be worn.
In order to resume work activities:
0 Two consecutive air samples for methyl bromide and chloropicrin taken in the treatment
area at least 30 minutes apart must be less than 5 ppm for methyl bromide and less than
1.5 ppm for chloropicrin.
0 During the collection of samples an air purifying respirator must be worn by the handler
taking air samples.
Hot gas tarped applications
During hot gas applications in greenhouses, the fumigant must be introduced from
outside of the greenhouse. For outdoor hot gas applications, the fumigant must be introduced
from outside of the application block. Once the fumigation has started, if entry into the
greenhouse enclosure or the 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.
Deep probe injection
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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.
Tarp Repair
An air purifying respirator must be worn by handlers performing tarp repair operations
before the entry prohibitions have ended. The Agency is requiring respiratory protection during
tarp repair since the duration of the activity is likely to be short and because methyl bromide
concentrations are unknown, but could be high, especially if the tarp repair occurs shortly after
the fumigation is completed.
Respirator fit testing, medical qualification, and training
The respirator protection factors described above are based on the following assumptions:
1) the respirator is fit-tested, 2) proper respirator training occurs, and 3) an annual medical
evaluation and clearance is done. Without these requirements, it is unclear whether the reduction
in inhalation exposure that is assumed by the protection factor will be achieved. In order to
ensure that the respiratory protection EPA is assuming is being achieved in the field, respiratory
requirements will include fit testing, respirator training, and annual medical evaluation. The
following language must be added to product labels:
"Employers must also ensure that all handlers are:
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. It does not need
to be repeated unless the health status or respirator 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/Pi00 particulate filter, this combination
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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"22. The EPA has decided that the use of 3M air purifying
respirators (APRs) equipped with 3M Model 60928 Organic Vapor/Acid Gas/Pi00 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).
Respirator availability
The handler employer must confirm and document in the fumigant management plan that
the following are immediately available:
at least one air rescue device (e.g., SCBA) on-site in case of an emergency, and
air-purifying respirators and cartridges for each handler.
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, particularly when
high barrier tarps are used. In addition to respiratory protection requirements described above,
the Agency is requiring the following to mitigate risks from inhalation exposure:
Tarps cannot be perforated until a minimum of 5 days (120 hours) have elapsed after the
fumigant injection into the soil is complete (e.g., after shank injection of the fumigant
product and tarps (if used) have been laid or after drip lines have been purged and tarps
have been laid, unless an adverse weather condition exists for broadcast applications.
If tarps will be removed after perforation, tarp removal cannot begin until at least 24
hours after tarp perforation is complete.
If tarps will not be removed after perforation, planting or transplanting cannot begin until
at least 48 hours after tarp perforation is complete.
If tarps are left intact for at least 14 days after fumigation injection into the soil is
complete, planting or transplanting may occur while the tarps are being perforated.
Adverse Weather Conditions Exemption for Broadcast Applications Only (See Figure 8):
Tarps may be removed before the required 5 days (120 hours) if adverse conditions will
compromise the integrity of the tarp, provided that:
o At least 48 hours have passed after the fumigant injection is complete,
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o The buffer zone period is extended until 24 hours after tarp removal is complete,
and
o Subsequent fumigations of untreated areas within the application block do not
occur for at least 24 hours after tarp removal is complete.
To reduce exposure to handlers perforating tarps
o Tarps used for fumigations must be perforated only by mechanical methods.
o Perforation by hand or with hand-held tools is prohibited.
Each tarp panel used for broadcast fumigations must be perforated using a lengthwise cut.
This measure is to reduce the likelihood of the tarp blowing away prior to tarp 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 LOG for
workers entering fields at this time period. However the risk assessments indicates that
extending this period decreases the risk. In addition, stakeholder comments indicate that non-
handler entry to perform postapplication (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, the
Agency is prohibiting entry into the treated area or buffer zone by anyone other than a protected
handler. The prohibition differs from a Restricted Entry Interval (REI) that are currently
required for most convention pesticides which contains exceptions for workers doing certain
tasks before the REI has expired (e.g., scouting). Workers permitted entry under the REI, will
now be prohibited for soil fumigants.
EPA believes that risks will not exceed the Agency's LOG 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, or
After tarps are perforated and removed if tarp removal is completed less than 14 days
after application, or
48 hours after tarps are perforated if they will not be removed prior to planting, or
5 days (120 hours) after application is complete if tarps are not perforated and removed
14 days after the application is complete.
Figures 4, 5, 6, 7, and 8 provide a graphical depiction of mitigation required to mitigate worker
risk in various methyl bromide fumigant application scenarios.
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Figure 4. Untarped Applications (only for CA Orchard Replant)
5 (120
Figure 5. Tarps removed before planting
Tarp Perforation
Begins
Tatp
Imp. RffBDval
Beans
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Tap Sfiiamfsl
Ends
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Figure 6. Tarps NOT Removed Before Planting
Figure 7. Tarps NOT Removed Before Planting and NOT punched until 14 days after the
application
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Figure 8. Adverse Weather Conditions Exemption (Broadcast tarp applications ONLY)
5davsfl20hours)
3) Other mitigation
Below are requirements for FMPs, GAPs, emergency preparedness and response, notice
to 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 the handlers have direct impact on
the amount of fumigant applied and emitted, the Agency believes that labeling should describe
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 the best mitigation measure to reduce the amount of fumigants applied and emitted.
The following GAPs must be followed during all fumigant applications. The registrants
have the option to develop additional optional GAPs to be listed on product labels. All
measurements and other documentation planned to ensure that the mandatory GAPs are achieved
must be recorded in the FMP and/or the post-application summary report.
Tarps (for all applications except for deep shank CA orchard replant 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 that includes:
o schedule and procedures for checking tarps for damage, tears, and other problems
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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 when tarp repair will be conducted:
schedule, equipment, and methods used to perforate tarps
aeration plans and procedures following perforation of tarp, but prior to tarp removal
or planting/transplanting
schedule, equipment, and procedures for tarp removal
The written tarp plan must be included in the site specific FMP as described in the FMP section
below.
Weather Conditions
Prior to fumigation the weather forecast for the day of the application and the 48-hour period
following the fumigant application must be checked.
Do not apply fumigant if ground-level winds are less than 2 mph.
Applications must not occur during a temperature inversion or when temperature inversions
are forecasted to persist for more than 6 consecutive hours for the 36-hour period after
application.
o Visual features that could indicate an inversion is occurring are misty conditions
during day or night, and clear night skies.
Detailed local forecasts for sky conditions, weather conditions, wind speed, and forecasted
temperature inversions may be obtained on-line at
For further guidance, contact the local National Weather Service Forecasting Office.
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 for more than three hours in any of the
three days prior to application, then soil temperature shall be measured and recorded in
the FMP.
Soil Moisture
The soil must be moist two to six inches below the surface. The amount of moisture needed
in this zone will vary according to soil type and shall be determined using standard feel
testing methods (see below). Surface soil generally dries rapidly and must not be considered
in this determination.
If there is insufficient moisture two to six inches below the surface, the soil moisture must be
adjusted. If irrigation is not available and there is adequate soil moisture below six inches,
soil moisture can be brought to the surface by discing or plowing before or injection. To
conserve existing soil moisture, pretreatment or treatment tillage should be done as close to
the time of application as possible.
Soil moisture determination
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The soil shall contain at the time of application enough moisture two to six inches below the
surface to meet the following criteria as appropriate for the soil texture.
For fine textured soils (clay loam, silty clay loam, sandy clay, silty clay, sandy clay loam
and clay) there must be enough moisture so that the soil is pliable, not crumbly, but does not
form a ribbon when squeezed between the thumb and forefinger.
For coarse soils (sand and loamy sand) there must be enough moisture to allow formation of
a weak ball when compressed in the hand. Due to soil texture, this ball is easily broken with
little disturbance.
For medium textured soils (coarse sandy loam, sandy loam, and fine sandy loam) there
must be enough moisture to allow formation of a ball which holds together with moderate
disturbance, but does not stick between the 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
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, local extension service or soil conservation
service specialist or pest control advisor (ag consultant) should be consulted for assistance.
Soil Preparation
Soil shall be properly prepared and at the surface generally be free of clods that are golf ball
size or larger. The area to be fumigated shall be tilled to a depth of 5 to 8 inches.
Field trash must be properly managed. Residue from a previous crop must be worked into the
soil to allow for decomposition prior to fumigation. Little or no crop residue shall be present
on the soil surface. Crop residue that is present must not interfere with the soil seal.
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: Performed beds shall be sealed by disruption of the chisel trace
using press sealers, bed shapers, cultipackers, or by re-shaping (relisting, lifting and
replacing, etc.) 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 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 or allow fumigant to drain onto the soil surface. For each injection line either
have a check valve located as close as possible to the final injection point, or drain/purge the
line of any remaining fumigant prior to lifting injection shanks from the ground.
Do not lift injection shanks from the soil until the shut-off valve has been closed and the
fumigant has been depressurized (passively drained) or purged (actively forced out via air
compressor) from the system.
Calibration, Set-up, Repair, and Maintenance for Application Rigs
Brass, carbon steel or stainless steel fittings must be used throughout. Polyethylene
tubing, polypropylene tubing, 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
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}
o Ensure that application rigs are equipped with properly functioning check valves
between the compressed gas cylinder or compressed air system and the fumigant
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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:
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.
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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)
The Agency is requiring FMPs to be completed before a fumigant application occurs.
FMPs will reduce risks by requiring that applicators develop a series of performance criteria for
their given application situation that are intended to minimize risks according to the Agency's
guidance provided below, then review those criteria before a fumigation occurs. Fumigant
management plans (FMPs) will reduce potential risks to bystanders as well for handlers. The
FMPs will also require that applicators verify compliance with the criteria 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. As an additional
benefit, the Agency believes FMPs will ensure directions on the product labels have been
followed and that the conditions for the fumigation are documented.
FMPs may should aide in the proper response of the applicator or others involved in the
application should an incident occur. A proper and prompt response will 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).
There is information from various sources 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 these plans 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 Association23 (i.e., through "Administrative" and
"Workplace" controls). The Centers for Disease Control provides guidance for developing
health and safety plans in agricultural settings.24 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
z" Ignacio and Bullock (2006) A Strategy For Assessing and Managing Occupational Exposures (Third Edition).
American Hygiene Association. AIHA Press 2700 Prosperity Avenue, Suite 250 Fairfax VA 22031 (ISBN
1-931504-69-5)
z 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/d00150i-
dOO 1571/dOO 1571
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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
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.25
According to stakeholder comments, most of the information required for the site-specific
FMP is already being documented by users. Most industry stakeholders support mandatory
FMPs provided they are not too restrictive and do not result in an excessive administrative
burden.
Each site-specific FMP must contain the following elements:
*ป* General site information
> Site address or description of location
> Site operator/owner's name, address, and, phone number
> Map, aerial photo, or detailed sketch showing field location, dimensions, buffer zones,
property lines, public roads, bus stops, water bodies, wells, rights-of-ways inside buffers,
nearby application blocks, surrounding structures (occupied and non-occupied), locations
of posted signs for buffers, and sites requiring 1A mile buffer zones (e.g., prisons, schools,
hospitals, state licensed day care centers) with distances from the application site labeled
*ป* Applicator information (license #, address, phone, contact information for person supervising
the fumigation with location and date for completing registrant methyl bromide training
program)
*ป* Authorized on-site personnel (Names of all handlers and the tasks they are authorized and
trained to perform)
ปปป Application procedures
> Fumigation window (target application date, earliest and latest possible date of
fumigation)
> Product information (brand name, registration number)
> Type of fumigation (e.g., shank, broadcast, drip, raised bed, strip, etc.)
> Target application rate and application block size
*ป* Good Agricultural Practices (GAPs)
> Description of applicable mandatory GAPs (registrants may also include optional GAPs)
> Measurements and other documentation planned to ensure GAPs are achieved (e.g.
measurement of soil and other site conditions; tarp repair/perforating/removal plans; etc.)
*ป* Buffer zones
> Calculations and rationale for buffer zones distances (e.g. specify table from label that
distances based on, rate and block size, applicable credits applied)
> Start and stop times for buffer zones
z3 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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*ป* Respirators and other personal protective equipment (PPE) for handlers (respirator type,
respirator cartridge, and other PPE selection; verification that respirator training/fit-
testing/medical exams is current; and maintenance/storage procedures)
ปซป Air monitoring
> Type of samples that will be collected (e.g., occupational, in occupied structures, outside
buffer zone area if site monitoring is conducted, etc.)
> When and where samples will be collected
> Duration of samples
> Sampling methods and equipment
> Name, address, and, phone number of person taking samples
ปปป Posting (names of persons who will post signs, location of posting signs, procedures for
posting and sign removal)
*ป* Site-specific response and management
> Fumigant site monitoring
Description of who, when, where, and procedures for monitoring buffer zone
perimeter
> Response information for neighbors
List of residences and businesses informed (neighboring property owners)
Method of sharing information
ปปป State and tribal lead agency notification
> Include the information that is sent to the lead agency
ปปป Plan describing how communication will take place between applicator, land owner/operator,
and other on-site handlers (tarp cutters/removers, irrigators, etc.)
ปปป Record keeping procedures
ปปป 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, odor
complaints or elevated air concentration levels outside buffer zone suggesting potential
problems, or other emergencies).
ปปป Hazard communication (product labels, material safety data sheets, etc.)
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, etc.) 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 and owner/operator of the application
block must provide a copy of the FMP to handlers involved in the fumigation, workers in
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adjacent areas to the application block, and federal/state/local enforcement personnel, upon
request.
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 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. The
summary must include the actual date of the application, application rate, and size of application
block fumigated.
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 must 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 prepare FMPs templates or use
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/fumigationjlan2.pdf
http://nmdaweb.nmsu.edu/pesticides/Management%20Plans%20Required%20for%20Fu
migations.html
iii. Emergency Preparedness and Response
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
education for first responders, and information for specific sites to ensure early detection and
quick 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. 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 and information, in the
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context of their community outreach and education programs (see page 78) to first responders in
high-fumigant use areas and areas with significant interface between communities and fumigated
fields. In addition, applicators must provide on-site monitoring of buffer zone perimeters in
areas where residences and other occupied structures are present. As an alternative to on-site
monitoring, applicators may provide emergency response information directly to neighbors.
Each element is discussed in more detail below.
(a) First Responder Education
EPA is requiring registrants through their community outreach and education programs
(see page 78) 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. The information/training to be provided
to first responders will include: how to recognize the early signs and symptoms of fumigant
exposure, how to treat fumigant exposures, how fumigant exposure differs from other pesticide
exposure, plus the material safety data sheet(s) (MSDS) for the fumigant(s) applied.
The Agency is interested in comments from state and/or local officials about the extent to
which first responders are currently receiving information on soil fumigants, for example can
they recognize fumigant exposures, and are they aware of the appropriate steps to take to
mitigate the exposures and address the source of the exposure. In California, for example, where
soil fumigation is common in many areas, the state administers training and outreach for first
responders to help raise awareness and improve skills in responding to incidents. If registrants
can document that effective state programs are already in place, additional training may not be
required. However, registrants must 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.
(b) Site Specific Response and Management
Fumigation Site Monitoring
EPA has determined that monitoring of the buffer zone perimeter would be an effective
approach to protect bystanders. Under this approach, if measured concentrations anywhere along
the buffer perimeter reach a level of concern specified on product labels, or if the person
monitoring the air concentrations experiences eye irritation, an early sign of exposure to
concentrations that exceed the Agency's LOG, then the emergency response plan stated in the
FMP Section (see page 66) 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, EPA decided
that this monitoring must be done for the full buffer zone period to ensure concentrations do not
exceed the action level which will be specified on product labels.
Specific requirements include:
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Monitoring must take place from the beginning of the fumigant application until the
buffer zone period expires.
Monitoring must be conducted by a certified applicator or someone under his/her
supervision.
Monitoring of air concentration levels of the fumigant must take place in the area
between the buffer zone and the residences or other occupied areas.
The person monitoring the air concentration levels must take readings starting
approximately 30 minutes from the start of application and at least once each hour during
the entire application and buffer zone period.
A direct reading detection device, such as a Draeger device with a sensitivity of at least 1
1 ppm for methyl bromide and 0.15 ppm for chloropicrin must be used to monitor the air
concentration levels of chloropicrin.
If at any time (1) methyl bromide air concentrations are greater than or equal to 1 ppm,
OR (2) chloropicrin air concentrations are greater than or equal to 0.15 ppm, OR (3) the
person monitoring the air concentrations experiences sensory irritation, then the
emergency response plan stated in the FMP must be immediately implemented by the
person monitoring the air concentrations.
If other problems occur, such as a tarp coming loose, then the appropriate control plan
must be activated.
The results of the air concentration monitoring must be recorded in the FMP.
EPA is interested in comments from fumigant users, researchers, and equipment
manufacturers about the extent to which mechanical devices are available or are under
development that can both monitor air concentrations and also notify the person responsible for
the fumigation when air concentrations approach levels of concern. Such devices are routinely
used to monitor environmental conditions in laboratories, and could represent an effective
alternative to posting a person on site. EPA also requests input from stakeholders who have
experience conducting air monitoring and use of devices on whether more effective, efficient, or
practical alternative approaches exist. For example, with specific application methods,
fumigants, and/or regional weather conditions, what frequency and duration of sampling would
be equally as effective as what is specified in the mitigation?
While protective, this site monitoring might be burdensome for users fumigating in areas
with few or no 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 and
businesses that meet the criteria outlined below have been provided the information below at
least 48 hours prior to fumigant application in a specified field. If after 2 weeks, the fumigation
has not yet taken place, the information must be delivered again.
Information that must be provided includes:
o Location of the application block
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o Name of fumigant products(s) applied including EPA Registration number
o Applicator and property owner/operator contact information
o Location of buffer zones
o Time period in which the fumigation is planned to take place and the
duration of buffer zone period
o Early signs and symptoms of exposure to the fumigant(s) applied, what to
do, and who to call if you believe you are being exposed (911 in most
cases).
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 residences and businesses within the required
distance from the edge of the buffer zone.
Who Needs to be Informed?:
If the buffer zone is People within this distance
less than or equal to: from the edge of the buffer zone
must be informed:
Buffer< 100 feet 50 feet
100 feet < Buffer < 200 feet 100 feet
200 feet < Buffer < 3 00 feet 200 feet
Buffer > 3 00 feet 3 00 feet
To clarify this option, the following example is provided:
IF the buffer zone is 125 feet, people within 100 feet of the buffer zone must be provided
emergency response information. So the red houses would need to be informed, but the
house would not.
This requirement does not impact the roadway or the property operator's residence (striped).
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Figure 9. Example Site Map for Informing Neighbors
Roadway
100ft
45ft
Buffer
zone V 125ft
Treated field
/K
75ft
i
50ft
288ft
Property
Operator's
Residence
If there are no residences or other occupied structures within 300 feet of the edge of the
buffer zone, no site monitoring or advising of neighbors will be required.
(c) Emergency Preparedness and Response Considerations
EPA received comments from many stakeholders about the Agency's Phase 5 proposal
for notification. 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 state 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
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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.
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.edo/pi004
and http://www.legis.state.wi.us/rsb/code/atcp/atcp029.pdf). 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 1A 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.
If users opt, based on their site conditions, to provide emergency response information to
neighbors rather than monitor, EPA believes that scaling the size of the informed area will be
protective and helps address concerns expressed by some fumigant users. When the informed
area is scaled to the size of the buffer, small buffers which generally result from applications to
small areas, at low application rates, and/or using low-emission application techniques, will have
small or no areas to inform, while larger applications will have larger areas to inform.
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.
EPA is interested in input on the importance and usefulness of information specifying the
location of the application block and buffer. EPA recognizes that such information may be
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difficult to convey clearly and concisely, especially if there are no easily recognizable land
marks nearby. While such information may be helpful, it may not be critical to ensuring an
appropriate response to early signs and symptoms of exposure.
iv. Notice to State Lead Agencies
EPA believes that when state, tribal and local enforcement officials have information
about when and where applications take place they are better able to plan and execute
compliance assistance and assurance activities. Therefore, EPA is requiring notification of the
appropriate state or tribal lead agency before an application begins to assist enforcement
agencies in compliance monitoring.
The information that must be provided includes the following:
o Applicator contact information (name, telephone number, and applicator license
number)
o Property owner/operator contact information
o Location of the application block
o Name of fumigant(s) products(s) applied including EPA Registration number
o Time period in which the fumigation is planned to take place and the duration of
buffer zone period
Assuring compliance with new label requirements is an important component of the
fumigant risk mitigation package. Notice to enforcement officials allows them to target
inspections around periods when fumigations are expected to occur to ensure label requirements
designed to mitigate risks of concern for bystanders, handlers, and workers, have been followed
and that the conditions for the fumigation have been documented in the FMP. In states such as
California, where permitting processes are already in place, additional notice to state and tribal
lead agencies will not be required.
v. Soil Fumigation Training for Applicators and 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, workers nearby, and other bystanders. Incident data show that a
number of fumigant incidents are the result of misapplications, failure to follow label
requirements and safe use procedures, and other errors on the part of fumigant applicators.
Although states have certification programs, some of which include a specific category for soil
fumigation, there currently is not a consistent standard across states and regions where soil
fumigation is done, and the federal certification program currently has no category for soil
fumigation. Proposed changes in the federal certification program and worker safety regulations
to include a soil fumigation category are not, however, anticipated in the near future.
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EPA believes that training is an effective way to increase applicators' skill and
knowledge so they are better prepared to effectively manage soil fumigation and are able to
understand and comply with revised labeling. 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.
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 will 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 product-specific
training that will serve as a good basis for this expanded effort.
(a) Training for Applicators Supervising Fumigations
Registrants will be required to develop and implement training programs for applicators
in charge of soil fumigations on the proper use and GAPs for soil fumigants. EPA is requiring
registrants to submit proposals for these programs as data requirements in the Data Call-In that
will accompany this RED. 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 12
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).
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Product labels will state that before applying the product, the certified applicator
supervising the application must have successfully completed, within the preceding 12 months, a
chloropicrin training program made available by the registrant, and that the FMP must document
when and where the training program was completed.
EPA encourages registrants to include in their proposals additional stewardship elements
such as technical support information and resources for certified applicators and/or handlers
(e.g., hotlines to answer technical questions from applicators about product use and provide
emergency preparedness and response), and equipment verification programs to assist
applicators with calibration and testing of soil fumigation equipment. The Agency is soliciting
input during the post-RED comment period from states, user groups, registrants, and other
stakeholders on content and how best to implement training programs and other stewardship
elements.
(b) 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. EPA is requiring registrants to submit
proposals for these materials as data requirements in the Data Call-Ins that will accompany this
RED. 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. Below is the language
that must appear on the label.
"The certified applicator must provide fumigant safe handling information 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. "
(c) Soil Fumigation Training Considerations
In comments on fumigant risk management options, stakeholders were broadly
supportive of additional training for applicators and handlers. During the most recent comment
period, the vast 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.
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The Agency agrees that additional training and technical support for fumigant applicators
and handlers will help educate and inform these workers, thus decreasing the likelihood of both
incidents and noncompliance. EPA believes fumigant-specific training for applicators and
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.
As noted above, several states have high-quality certification programs for fumigators
which 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 updated as a result
of new requirements associated with this decision and the label changes which will result.
Although the federal program will be revised eventually and will establish a consistent standard,
EPA believes that registrants must play a central role in developing and delivering 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 state programs to provide additional training opportunities for
fumigators. EPA will work with registrants in reviewing training program proposals and in
developing the content for the programs and materials. EPA will also work with states to
identify ways in which registrant training programs can be tailored to complement existing state
programs. EPA's goal in requiring registrant training is to add to training resources. EPA is
aware of the need to coordinate carefully with states to ensure that new training does not become
a burden on state agencies. EPA specifically requests comments from states on the best
implementation approaches to meet these goals, and plans to meet with states during and after
the public comment period to discuss options.
The Agency also expects that FMPs will serve as tools with which fumigant users can
maintain records of their compliance with training requirements in addition to the other measures
described in this document. Thus, FMPs would serve as an additional tool for verification state
enforcement personnel to verify compliance.
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 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
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outreach and education to communities where soil fumigation occurs is an important component
of the overall package of measures to address bystander risk. This outreach and education will
address the risk of acute bystander exposure by educating community members in high-use areas
about buffer zones and their characteristics and purpose; the importance of not entering these
zones; how to recognize early signs of fumigant exposure, and how to respond appropriately in
case of an incident. The first responder education discussed on page 70 is a significant part of
this program.
Therefore, the Agency is requiring registrants to develop and implement community
outreach programs, including programs for first responders, to address these needs. EPA
encourages registrants' proposals to work with existing community resources, such as
community health networks, for dissemination of information and implementation of their
programs. Registrants' proposals must also include criteria and a plan for identifying and
selecting the communities that will be receive outreach programs.
Community outreach and education 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, and (6) how to report an incident.
EPA expects registrants' proposals for the first responder programs described above (see
page 70) will also be designed to integrate with existing local first-response and emergency
preparedness networks.
The community outreach and education proposal and supporting materials for
communities and first responders, as well as a plan for evaluating the effectiveness of the
programs, will be included as data requirements in the Data Call-In that will accompany this
RED.
As with the training for fumigant applicators and handlers, the community outreach and
education program that the Agency is requiring is intended to be part of the registrants' long term
product stewardship. State governments are not required to participate in the program, but have
the option of working with EPA and registrants to develop and track this and any other
stewardship components which the registrants may include in their proposals.
c. Environmental Risk Management
For details on the methyl bromide ecological fate and effects risk assessment, please refer
to the ecological risk assessment and other related documents for methyl bromide. These
documents are 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.
As mentioned in Section HID, the Agency is concerned about both aquatic and terrestrial
risks. The Agency believes that mitigation measures detailed in the Human Health Risk
Mitigation Section will also reduce ecological risks. Although buffer zones and GAPs do not
directly reduce the potential risk to ecological organisms, they do provide an incentive to reduce
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fumigant application rates and individual treatment areas which in turn will contribute to lower
exposure and risks for non-target organisms.
The Agency still has concerns regarding methyl bromide's potential to leach into
groundwater and surface water, and therefore is requiring the following language for both tarped
and untarped methyl bromide applications, "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 recognizes that managing soil
moisture is an important factor that may be used to reduce peak emissions, and the requirements
related to soil moisture described in the GAP section will not result in the leaching of methyl
bromide into ground or surface water.
In addition to the language above, to reduce the potential for methyl bromide to leach into
groundwater when tarps are used in broadcast applications, tarps must be perforated and/or
removed before noon and only when rainfall is not expected within 12 hours. Falling
temperatures typically found in the late afternoon and evening will 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 ground water. 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.
When methyl bromide applications are not tarped, the Agency has concerns about methyl
bromide's potential to leach into both groundwater and surface water if a rainfall event occurs
shortly after 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.
Leaching and runoff of this product will be reduced by avoiding applications when heavy rainfall
is forecasted to occur within 24 hours.
The Agency also 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 on
those 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:
Required Mitigation Rationale for expecting a reduction of
Measure Stratospheric Ozone Depletion
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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
EPA estimates that in 2007 approximately 1,213
metric tons of methyl bromide were applied for
uses with low benefits and/or have feasible
alternatives which do not qualify for exemptions
under the Montreal Protocol. While the Agency
acknowledges that limiting use to only Group 1
uses may slow the drawdown of the pre-2005
stockpile, it is reasonable to expect that new
production for exempted uses will also continue to
decline as 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.
In order to achieve manageable buffer zones
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 Disrupter 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 Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
Buffer zones
Good agricultural practices
(GAPs) and Fumigant
management plans (FMPs)
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the program, androgen and thyroid hormone systems, in addition to the estrogen hormone
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, dazomet may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
3. Endangered Species Considerations
The Endangered Species Act requires federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. The Agency
has developed the Endangered Species Protection Program to identify pesticides whose use may
cause adverse impacts on threatened and endangered species, and to implement mitigation
measures that address these impacts. To analyze the potential of registered pesticide uses that
may affect any particular species, the Agency uses basic toxicity and exposure data developed
for the REDs and then considers ecological parameters, pesticide use information, geographic
relationship between specific pesticide uses and species locations, and biological requirements
and behavioral aspects of the particular species. When conducted, this species-specific analysis
will also consider the risk mitigation measures that are being implemented as a result of this
RED.
Following this future species-specific analysis, a determination that there is a likelihood
of potential effects to a listed species may result in limitations on use of the pesticide, other
measures to mitigate any potential effects, or consultations with the Fish and Wildlife Service
and/or the National Marine Fisheries as appropriate. If the Agency determines use of methyl
bromide "may affect" listed species or their designated critical habitat, the Agency will employ
the provisions in the Services' regulations (50 CFR Part 402). Until the species-specific analysis
is completed, the risk mitigation measures being implemented through this RED will reduce the
likelihood that endangered and threatened species may be exposed to methyl bromide at levels of
concern. The Agency is not requiring specific methyl bromide label language at the present time
relative to threatened and endangered species. If, in the future, specific measures are necessary
for the protection of listed species, the Agency will implement them through the Endangered
Species Program.
D. Conclusions
In this document, the Agency has described a package of mitigation measures with
elements that are designed to work together to reduce risk to human health and the environment.
Due to methyl bromide's volatility, the Agency believes that all of the mitigation measures
required by this decision will mitigate risks so that methyl Bromide use will result in no
unreasonable adverse effects.
Stakeholder comments and Agency analyses indicate that mitigation may impact the
benefits of fumigant use. One analysis the Agency completed quantifies the potential impact of
buffer zones21. The Agency believes that some impact will occur in order to protect human
health and the environment from unreasonable adverse effects. EPA believes that impacts have
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been minimized because the mitigation package incorporates flexibility which allows users to
make choices that minimize potential impacts. For example a current application practice might
require a large buffer that a user is not able to implement. However, instead of setting a fixed
buffer for all applications regardless of application-specific parameters, this decision allows
growers the flexibility to modify their practices to achieve smaller buffers; for example treat
smaller application blocks, or switch to a lower emission application method. Also, the buffer
zone reduction credits allow users to take advantage of site conditions (e.g., soil conditions) or
other emission reduction factors such as high barrier tarps to lessen the impact. In addition the
Agency believes that flexibility decreases the impacts associated with respiratory protection
mitigation. Instead of requiring respirators for all handling tasks, the monitoring scheme
indicates when respiratory protection is needed. This mitigation is protective of handlers while
not increasing the burden to users by mandating respirators that may hinder communication or
could potentially cause heat stress.
Taking into consideration the risk and benefit assessments and stakeholder comments, the
Agency believes the mitigation required by this document will be protective and minimize
impacts.
V. What Registrants Need to Do
The Agency has determined that the products containing methyl bromide are eligible for
reregi strati on provided that the mitigation measures and label changes identified in this RED are
implemented. EPA recognizes that the extent and complexity of the mitigation needed for
methyl bromide will require continued coordination among state regulatory agencies, the EPA,
registrants, growers and other stakeholders. This is necessary 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. EPA also acknowledges
that certain provisions of the RED, such as the worker training program and community
education, will take time to develop in terms of both the content of the program as well as a
strategy for implementation.
EPA envisions the following approximate schedule for implementation of the methyl bromide
RED:
June 2008 Methyl Bromide RED issued
Fall 2008 Comment period closes
Early 2009 EPA responds to comments, amends RED if appropriate
Mid 2009 EPA issues product and generic DCIs
Mid 2009 Registrants submit revised labels to EPA
Late 2009 EPA reviews/approves new labeling
During 2009 Registrants develop worker and community training and outreach
plans and submit to EPA; approved plans implemented
Early 2010 Products bearing new labels enter the market; training and
outreach programs expand
2009-2012 Registrants develop data per DCI
2013 EPA begins Registration Review for methyl bromide and other fumigants
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The Agency is issuing this decision document for methyl bromide, as announced in a
Notice of Availability published in the Federal Register. Due to the broad scope of the decision
for the soil fumigant group, there will be a 60-day public comment period for this document to
allow stakeholders the opportunity to review and provide comments on issues related to the
implementation of the risk mitigation measures. After considering public comment, the Agency
will issue a public determination as to whether modifications to this decision are appropriate.
Labeling
Registrants will need to amend their product labeling to incorporate the label statements set
forth in Table 9. The Agency will consider post-RED comments prior to finalizing labeling. The
Agency anticipates that label amendments will need to be submitted approximately 1 year from
the issuance of the RED.
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
OPPTS Guideline 835.8100
Data Requirement
Field volatility from soil
Study type
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
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.
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b. Environmental fate and ecological risk
Environmental fate: none
Ecological effects:
OPPTS Guideline Number
Special
850.1075
850.1075
850.1025
850.1035
850.4225
850.4250
850.4400
850.3020
Data Requirement
Avian acute inhalation
Acute Fish Toxicity - bluegill trout
Acute Marine/Estuarine Fish
Acute Marine/Estuarine Mollusk
Acute Marine/Estuarine Shrimp
Seedling Emergence - Tier II
Vegetative Vigor - Tier II
Aquatic Plant Growth - Tier II
Honeybee Acute Contact
Study type
ECO
ECO
ECO
ECO
ECO
ECO
ECO
ECO
ECO
The following data are needed on methyl bromide (and the bromide ion, where indicated) for
ecological risk assessment26'
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 LOG. 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.
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.
26 EPA-HQ-OPP-2005-0123-0038, Reregistration Environmental Risk Assessment for Methyl Bromide, June i
2004, DP Barcode 304641
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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
Special
Special
Special
Data Requirement
Community Outreach and Education Program
Training for Applicators Supervising
Fumigations
Training Materials for Handlers
Study type
Special
Special
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, and (6)
how to report an incident. 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
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
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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 12 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.
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. The following table
describes how language on the labels should be amended.
B. End-Use Products
1. Additional Product-Specific Data Requirements
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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
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. The following table describes how language on the
labels should be amended.
Table 9: Summary of Labeling Changes for Methyl Bromide Pre-plant Soil Fumigation
Description
Amended Labeling Language
Placement on
Label
For all
Manufacturing
Use Products
"Only for formulation into a pre-plant soil fumigant for the following use-sites:
Uses, users, and locations that qualify for exemptions under the Montreal Protocol
(e.g., critical use exemption or Quarantine and preshipment exemption uses). All
end use products that contain directions for use as for crops/use sites that do not
qualify for exemptions under the Montreal Protocol must be changed to remove
those crops/use sites. All structural/space uses have been cancelled."
"Methyl bromide formulated into end-use products containing 98% methyl
bromide must contain directions for use only for the following uses: orchard
replant, ornamentals (hot gas method only), forest seedlings, and quarantine uses.
All other use sites and use patterns are prohibited and must be removed from the
end-use product labeling."
"Methyl bromide cannot be formulated into end-use products labeled for pre-plant
uses without the use of tarps with the exception of California orchard replant for
CUE use using the deep broadcast application method."
"Methyl bromide cannot be formulated into end-use products labeled for pre-plant
or pre-transplant uses unless the registrant makes available to certified applicators
who purchase or apply the end-use product a training program approved by EPA
that provides information on how to correctly apply the fumigant including how
to protect themselves, other handlers and bystanders, how to determine buffer
zone distances, how to develop a Fumigant Management Plan, and how to
determine when weather and other site-specific factors are not favorable for
fumigant application. The training program must be made available to the
certified applicators at least annually and the registrant must be able to provide,
upon request, the names, addresses, and certified applicator license number of
persons who successfully complete the training program."
"Methyl bromide cannot be formulated into end-use products labeled for pre-plant
Directions for Use
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or pre-transplant uses unless the registrant assures warning signs suitable for
posting buffer zones are available to end-use product users at the point of sale.:
"The buffer zone sign must meet the following standards:
o Signs must remain legible during entire posting period.
o The size and type of the buffer zone signs must follow the
requirements in the Worker Protection Standard for Agricultural
Pesticides for treated area posting."
Contents of Sign
- "DO NOT ENTER/NO ENTRE,"
- "[Name offumigant] Fumigant BUFFER ZONE,"
~ a space for the date and time of fumigation,
~ a space for the date and time buffer zone restrictions are lifted
(i.e., buffer zone period expires)
~ brand name of this product, and
~ a space for the name, address, and telephone number of the
certified applicator in charge of the fumigation
One of these
statements may
be added to a
label to allow
reformulation
of the product
for a specific
use or all
additional uses
supported by a
formulator or
user
"This product may be used to formulate products for specific use(s) not listed on
the MP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not
listed on the MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding support of such use(s)."
Directions for Use
Environmental
Hazards
Statements
Required by the
RED and
Agency Label
Policies
"This pesticide is toxic to mammals and birds. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or other
waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authority has
been notified in writing prior to discharge. Do not discharge effluent containing
this product to sewer systems without previously notifying the local sewage
treatment plant authority. For guidance, contact your State Water Board or
Regional Office of the EPA."
Precautionary
Statements
End Use Products Intended for Occupational Use
Restricted Use
Requirement for
all products that
contain soil use
"Restricted Use Pesticide due to acute inhalation toxicity to humans. For retail
sale to and use by certified applicators or persons under their direct
supervision and only for those uses covered by the certified applicator's
certification."
Top of the front
panel
Certified
applicator must
complete annual
training program
"The certified applicator supervising that application must successfully
complete a methyl bromide training program made available by the registrant
within the last 12 months. The Fumigant Management Plan (see details
elsewhere on this label) must document when and where the training program
was completed."
Directions for Use
Under the section
"protection for
handlers"
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Fumigation
Handlers
Persons engaged in any of the following activities are defined as fumigant
handlers:
Persons participating in the application as supervisors, loaders, drivers,
co-pilots, shovelers, or as other direct application participants (application
starts when the fumigant is first introduced into the soil and ends after the
fumigant has stopped being delivered/dispensed to the soil);
Persons taking air samples to monitor fumigant air concentrations;
Persons cleaning up fumigant spills;
Persons handling or disposing of fumigant containers;
Persons cleaning, handling, adjusting, or repairing the parts of fumigation
equipment that may contain fumigant residues;
Persons installing, repairing, operating irrigation equipment in the
fumigant application block or surrounding buffer zone during the buffer
zone period;
Persons entering the application site or surrounding buffer zone during the
buffer zone period to perform scouting or crop advising tasks;
Persons installing, perforating (cutting, punching, slicing, poking),
removing, repairing, or monitoring tarps:
> until 14 days after application is complete if tarps are not
perforated and removed during those 14 days, or
> until tarp removal is complete if tarps are both perforated and
removed-less than 14 days after application; or
> until 48 hours after tarp perforation is complete, if they will not
be removed within 14 days of application
NOTE: see Tarp Perforation and Removal section on this labeling for
requirements about when tarps are allowed to be perforated.
Directions for Use
Under the section
"protection for
handlers"
For pre-plant soil
use.
Supervision of
Handlers
"The certified applicator supervising the application must be at the fumigant
application site and able to maintain visual contact with every handler
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.
The certified applicator must provide fumigant safe handling information 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 other fumigant handling tasks (as defined on this label), at least two
WPS-trained handlers must be present to monitor one another."
Directions for Use
Under the section
"protection for
handlers"
Exclusion of Non
Handlers from
Application Block
and Buffer Zone
The certified applicator supervising the application and the owner/operator of
the establishment where the fumigation is taking place must make sure that all
persons who are not trained and PPE-equipped and who are not performing
one of the handling tasks defined in this labeling are:
excluded from application block during the entry prohibition period, and
excluded from the buffer zone during the buffer zone period.
Directions for Use
Under the section
"protection for
handlers"
Providing,
cleaning, and
maintaining PPE
The employer of the fumigant handlers must make sure that all handlers in the
application block and the surrounding buffer zone are provided and correctly
wear the required PPE. The PPE must be cleaned and maintained as required
by the Worker Protection Standard for Agricultural Pesticides.
Directions for Use
Under the section
"protection for
handlers"
90
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Respirator "In case of emergency or the need for immediate respiratory protection, the
Availability fumigation handler employer must make sure that the following PPE are
immediately available to all persons performing fumigant handling activities:
at least one air rescue device (e.g., SCBA) must be on-site in case of
an emergency, and
unless an air-purifying respirator is being worn by each person
performing a handling task at the site, enough air-purifying
respirators and face-sealing goggles (if the respirator is a half-face
style) of the type specified in the PPE section of this labeling must be
immediately available at the site for each handler.
Directions for Use
Under the section
"protection for
handlers"
PPE Requirements
Established by the
RED for all
Formulations with
80% or less methyl
bromide
"All fumigant handlers must wear:
Loose-fitting long-sleeved shirt and long pants
Shoes and socks, and
Loose fitting protective eyewear. (a full face shield or safety glasses with
brow, temple, and side protection), except when a respirator is required.
In addition, when air monitoring indicates a respirator is required OR when
repairing an unperforated tarp within 14 days after the end of application,
fumigant handlers must wear:
a NIOSH-approved half-face, full-face, or hood-style respirator with a
cartridge or canister certified by the manufacturer for protection from
exposure to methyl bromide at concentrations up to 5 ppm (e.g., a 3M air-
purifying respirator equipped with 3M Model 60928 Organic Vapor/Acid
Gas/PlOO cartridges)
face-sealing goggles when a half-face respirator is worn.
IMPORTANT: an air-supplying respirator [i.e., a respirator connected directly
to a clean air source or a serf-contained breathing apparatus (SCBA)] is not
permitted for routine fumigant handler tasks. Such respirators are only
permitted in emergencies such as a spill or leak or when corrective action is
needed to reduce air levels to acceptable levels."
Immediately
following/below
Precautionary
Statements:
Hazards to
Humans and
Domestic Animals
Fumigant Air
Monitoring for all
Formulations with
80% or less methyl
bromide
Fumigant Air Monitoring: The following air monitoring procedures must be
followed to determine whether respiratory protection is required for any
person performing a fumigant handling task as defined in this labeling.
* Air monitoring samples for methyl bromide and chloropicrin must be
collected in the breathing zone of a handler performing a representative
handling task starting approximately 30 minutes from the handler's initial
exposure and at least once every 2 hours thereafter
To monitor air concentration levels, a direct reading detection device,
such as a Matheson-Kitagawa, Draeger, or Sensidyne device must be
used. The devices must have sensitivity of at least 1 ppm for methyl
bromide and 0.15 ppm for chloropicrin.
If at any time: (1) methyl bromide concentrations are greater than or equal
to 1 ppm or (2) chloropicrin concentrations are greater than or equal to
0.15 ppm or (3) any handler experiences sensory irritation, then an air-
purifying respirator as specified in the PPE section of this label must be
worn by all handlers.
If two consecutive breathing zone air samples taken at least 30 minutes
apart show levels have decreased to less than 1 ppm for methyl bromide
and less than 0.15 ppm for chloropicrin, then handlers may remove the
respirators.
If at any time (1) a handler experiences any sensory irritation when
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
Directions for Use
91
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handlers must be removed from the application block and surrounding
buffer zone until corrective action has been taken.
During the corrective actions if methyl bromide air concentrations are
greater than or equal to 5 ppm or if chloropicrin air concentrations are
greater than or equal to 1.5 ppm, then a serf-contained breathing apparatus
(SCB A) must be worn.
In order to resume work activities:
> Two consecutive air samples for methyl bromide and chloropicrin
taken at the handling site at least 30 minutes apart must be less than 5
ppm for methyl bromide and less than 1.5 ppm for chloropicrin.
> During the collection of air samples, an air purifying respirator must
be worn by the handler taking air samples.
> If methyl bromide concentrations are greater than or equal to 1 ppm
or if chloropicrin concentrations are greater than or equal to 0.15
ppm, then handlers resuming their handler activities must wear air-
purifying respirators and face-sealing goggles (if the respirator is a
half-face style) of the type specified in the PPE section of this
labeling.
PPE Requirements
Established by the
RED1
For Formulations
with > 80%
Methyl Bromide
(i.e., 98:2)
(This is different
from the
formulations with
80% or less MEBr
because handlers
must wear air-
purifying
respirators when
performing
handling tasks and
the monitoring
requirements are
different.)
"All handlers must wear:
Loose-fitting long-sleeved shirt and long pants
Shoes and socks
NIOSH-approved half-face, full-face, or hood-style respirator with a
cartridge or canister certified by the manufacturer for protection from
exposure to methyl bromide at concentrations up to 5 ppm (e.g., a 3M air-
purifying respirator equipped with 3M Model 60928 Organic Vapor/Acid
Gas/PlOO cartridges), and
face-sealing goggles when a half-face respirator is worn
IMPORTANT: an air-supplying respirator (i.e., a respirator connected directly
to a clean air source or a self-contained breathing apparatus (SCB A) is not
permitted for routine fumigant handler tasks. Such respirators are only
permitted in emergencies such as a spill or leak or when corrective action is
needed to reduce air levels to acceptable levels.
Immediately
following^elow
Precautionary
Statements:
Hazards to
Humans and
Domestic Animals
92
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Fumigant Air
Monitoring for all
Formulations with
> 80% methyl
bromide
(i.e., 98:2)
"Fumigant Air Monitoring Requirements: The following air monitoring
procedures must be followed to ensure that the upper protection limit of the
respirator plus respirator cartridge or canister is not exceeded (i.e., 5 ppm for
methyl 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.
To monitor air concentration levels, a direct reading detection device,
such as a Matheson-Kitagawa, Draeger, or Sensidyne device must be
used. The devices must have sensitivity of at least 5 ppm for methyl
bromide and 1.5 ppm for chloropicrin
If at any time (1) a handler experiences any sensory irritation while
wearing a respirator, or (2) any air sample is greater than or equal to 5
ppm for methyl bromide, or (3) any air sample is greater than or equal to
1.5 ppm for chloropicrin, then all handler activities must cease and
handlers must be removed from the application block and surrounding
buffer zone until corrective action has been taken.
During the corrective actions if methyl bromide air concentrations are
greater than or equal to 5 ppm or if chloropicrin air concentrations are
greater than or equal to 1.5 ppm, then a serf-contained breathing
apparatus (SCB A) must be worn.
In order to resume work activities:
> Two consecutive air samples for methyl bromide and chloropicrin
taken in the treatment area at least 30 minutes apart, must be less than
5 ppm for methyl bromide and less than 1.5 ppm for chloropicrin.
> During the collection of samples an air purifying respirator must be
worn by the handler taking air samples.
Immediately
following^elow
Precautionary
Statements:
Hazards to
Humans and
Domestic Animals
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco,
or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product. As soon as
possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to
Humans and
Domestic Animals
immediately
following
Engineering
Controls
(Must be placed in
a box.)
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables exist, use detergent and hot water. Keep and wash
PPE separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched or
heavily contaminated with this product's concentrate. Do not reuse them."
Precautionary
Statements:
Hazards to
Humans and
Domestic Animals
immediately
following the PPE
requirements
PPE Requirements
Established by the
RED1
For all
Formulations
"Respirator fit testing, medical qualification, and training
Employers must ensure that all fumigant handlers are:
Fit-tested and fit-checked using a program that conforms to OSHA's
requirements (see 29CFRPart 1910.134)
Trained using a program that confirms to OSHA's requirements (see
29CFR Part 1910.134)
Examined by a qualified medical practitioner to ensure physical ability to
safely wear the style of respirator to be worn. A qualified medical
Directions for Use
Under the section
"Protection for
Handlers"
93
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practitioner is a physician or other licensed health care professional 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 if their health statue or respirator style or use-
conditions change.
Application
Requirements,
when tarps are
used: Tarp
Perforation and/or
/Removal
"Tarp Perforation and/or Removal
IMPORTANT: Persons perforating, repairing, removing, and/or monitoring
tarps are defined, within certain time limitations, as fumigant handlers (see
definition of fumigant handlers in this labeling) and must be provided the PPE
and other protections for handlers as required on this labeling and in the
Worker Protection Standard for Agricultural Pesticides.
Tarps used for fumigations must be perforated (cut, punched, poked, or sliced)
only by mechanical methods. Perforation by hand or with hand-held tools is
prohibited.
Each tarp panel used for broadcast fumigation must be perforated using a
lengthwise cut.
Tarps cannot be perforated until a minimum of 5 days (120 hours) have
elapsed after the fumigant injection into the soil is complete (e.g., after shank
injection of the fumigant product and tarps (if used) have been laid or after
drip lines have been purged, unless an adverse weather condition exists for
broadcast applications. See below.
If tarps will be removed after perforation, tarp removal cannot begin until at
least 24 hours after tarp perforation is complete.
If tarps will NOT be removed after perforation, planting or transplanting
cannot 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.
Adverse Weather Conditions Exception for broadcast applications only:
Tarps may be removed before the required 5 days (120 hours) if adverse
conditions will compromise the integrity of the tarp, provided that:
At least 48 hours have passed after the fumigant injection into the soil is
complete,
The buffer zone period is extended until 24 hours after tarp removal is
complete,
Subsequent fumigations of untreated areas within the application block do
not occur for at least 24-hours after tarp removal is complete, and
Appropriate PPE, respiratory protection, air monitoring and other
requirements for the protection of handlers are met."
Direction For Use
Monitoring Air "MONITORING AIR CONCENTRATION LEVELS
Concentration Monitoring Air Concentrations in the Buffer Zone Areas: When air
Levels concentration levels must be monitored (i.e., as specified in the general buffer
zone requirements section), use a direct reading detection device, such as a
Directions for Use
under the heading
"General Buffer
Zone
94
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Matheson-Kitagawa, Draeger, or Sensidyne device. The devices must have
sensitivity of at least 1 ppm for methyl bromide and 0.15 ppm for
chloropicrin."
Requirements'
Agriculture Use
Requirements box
Agricultural Use Requirements
After the standard paragraphs for the Agricultural Use Requirements box,
substitute the following text for the standard restricted-entry interval and
double notification requirements:
"For entry prohibition and notification requirements, see the 'Application
Block Entry Prohibition and Notification' section of this labeling."
Agricultural Use
Requirements box
Entry Prohibitions
"Entry Prohibitions
Entry (including early entry that would otherwise be permitted under the WPS)
by any person - other than a correctly trained and PPE-equipped handler who
is performing a handling task listed on this labeling - is PROHIBITED -from
the start of the application until:
5 days (120 hours) after application has ended for untarped applications.
5 days (120 hours) after application is complete if tarps are not perforated
and removed for at least 14 days following application, or
48 hours after tarp perforation is complete if they will not be removed for
at least 14 days following application, or
after tarps are removed if tarps are both perforated and removed less than
14 days after application.
NOTE: see Tarp Perforation and Removal section on this labeling for
requirements about when tarps are allowed to be perforated.
Directions for Use
under the heading
"heading
"Application
Block Entry
Prohibition and
Notification"
Notification
Requirement for
the treated area
NOTIFICATION: Notify workers of the application by warning them orally
and by posting fumigant warning signs. The signs must bear the skill and
crossbones symbol and state:
- "DANGER/PELIGRO,"
- "Area under fumigation, DO NOT ENTER/NO ENTRE,"
"[Name offumigant] Fumigant in USE,"
~ the date and time of fumigation,
~ the date and time the entry prohibition period is over
~ Name of this product, and
~ name, address, and telephone number of the certified applicator in charge of
the fumigation.
Post the fumigant warning sign instead of the WPS sign for this application but
follow all WPS requirements pertaining to location, legibility, size, and timing
of posting and removal.
Post the fumigant warning signs at all entrances to the application block.( i.e.,
the greenhouse or field or portion of a field treated with a fumigant in any 24-
hour period))
Direction for Use
under the heading
"Application
Block Entry
Prohibition and
Notification"
Mandatory Good
Agricultural
Practices for all
formulations
"Mandatory Good Agricultural Practices (GAPs)
The following GAPs must be followed during all fumigant applications. All
measurements and other documentation planned to ensure that the mandatory
GAPs are achieved must be recorded in the FMP and/or the postapplication
summary report.
Tarps (for all applications except for deep shank CA orchard replant and hand
held tree-hole applications)
Directions for Use
95
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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 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 when tarp repair will be conducted:
schedule, equipment, and methods used to perforate tarps
aeration plans and procedures following perforation of tarp, but
prior to tarp removal or planting/transplanting
schedule, equipment, and procedures for tarp removal
Weather Conditions
Prior to fumigation the weather forecast for the day of the application and
the 48-hour period following the fumigant application must be checked.
Do not apply fumigant if ground-level winds are less than 2 mph.
Applications must not occur during a temperature inversion or when
temperature inversions are forecasted to persist for more than 6
consecutive hours for the 36-hour period after application.
o Visual features that could indicate an inversion is occurring are
misty conditions during day or night, and clear night skies.
Detailed local forecasts for sky conditions, weather conditions, wind
speed, and forecasted temperature inversions may be obtained on-line at
htt|)i//www.nws.jioaa._gov.
For further guidance, contact the local National Weather Service
Forecasting Office.
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 for more than three
hours in any of the three days prior to application, then soil
temperature shall be measured and recorded in the FMP.
Soil Moisture
The soil must be moist two to six inches below the surface. The amount
of moisture needed in this zone will vary according to soil type and shall
be determined using standard feel testing methods (see below). Surface
soil generally dries rapidly and must not be considered in this
determination.
If there is insufficient moisture two to six inches below the surface, the
soil moisture must be adjusted. If irrigation is not available and there is
adequate soil moisture below six inches, soil moisture can be brought to
the surface by discing or plowing before or-injection. To conserve existing
soil moisture, pretreatment or treatment tillage should be done as close to
the time of application as possible.
Soil moisture determination
Feel Method: The soil shall contain at the time of application enough
moisture two to six inches below the surface to meet the following criteria as
96
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appropriate for the soil texture.
For fine textured soils (clay loam, silty clay loam, sandy clay, silty clay,
sandy clay loam and clay) there must be enough moisture so that the soil
is pliable, not crumbly, but does not form a ribbon when squeezed
between the thumb and forefinger.
For coarse soils (sand and loamy sand) there must be enough moisture to
allow formation of a weak ball when compressed in the hand. Due to soil
texture, this ball is easily broken with little disturbance.
For medium textured soils (coarse sandy loam, sandy loam, and fine
sandy loam) there must be enough moisture to allow formation of a ball
which holds together with moderate disturbance, but does not stick
between the 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 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 you do not know how to determine
the soil moisture content of the area to be treated, consult your local
extension service or soil conservation service specialist or pest control
advisor (ag consultant) for assistance.
Soil Preparation
Soil shall be properly prepared and at the surface generally 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.
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'. Performed beds shall be sealed by disruption
the chisel trace using press sealers, bed shapers, cultipackers, or by re-
shaping (relisting, lifting and replacing, etc.) the beds immediately
following injection. Beds formed at the time of application shall be sealed
by disrupting the chisel trace using press sealers, or bed shapers.
5*0/7 Sealing for Tarped Applications'. The use of a tarp does not eliminate
the need to minimize chisel traces prior to application of the tarp, such as
by using a nobel plow or other injection shank that disrupts the chisel
traces.
Bedded and Broadcast Shank Applications: Additional Mandatory GAPs
In addition to the GAPs required for all soil fumigation applications, the
following GAPs apply for injection applications:
97
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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-Bedded Applications: The injection point shall be a
minimum of 12 inches from the nearest final soil/air interface.
For Untarped-Broadcast Applications (CA orchard replant only): The
injection point shall be a minimum of 18 inches from the nearest final
soil/air interface.
Prevention of End Row Spillage
Do not apply or allow fumigant to drain onto the soil surface. For each
injection line either have a check valve located as close as possible to the
final injection point, or drain/purge the line of any remaining fumigant
prior to lifting injection shanks from the ground.
Do not lift injection shanks from the soil until the shut-off valve has been
closed and the fumigant has been depressurized (passively drained) or
purged (actively forced out via air compressor) from the system.
Calibration, Set-up, Repair, and Maintenance for Application Rigs
Brass, carbon steel or stainless steel fittings must be used throughout.
Polyethylene tubing, polypropylene tubing, 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 If a compressed gas cylinder is used, make sure that positive
pressure is maintained in the cylinder at not less than 200 psi
during the entire time it is connected to the application rig.
(This is not required for a compressed air system that is part
of the application rig because if the compressor system fails
the application rig will not be operable)
o Ensure that application rigs are equipped with properly
functioning check valves between the 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
98
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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.
Tree Replant Application: Mandatory GAPs
In addition to the GAPs required for all soil fumigation applications, the
following GAPs apply for tree replant applications. This application method is
used when methyl bromide is applied to individual tree sites in an existing
orchard where shank application are not possible:
Site Preparation
Each individual tree-site must remove the tree stump and primary
root system with a back-hoe or other similar equipment, for example
an auger.
The hole must be backfilled with soil before application.
Application Depth
The fumigant must be injected at least 18 inches into the soil.
System Flush
Before removing the application wand from the soil the wand must be
cleared using nitrogen or compressed air.
Soil Sealing
99
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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.
Mandatory Good
Agricultural
Practices for Hot
Gas Applications
(98:2 formulations
only)
"Hot Gas Applications
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."
Directions for Use
Site-Specific
Fumigation
Management Plans
for all methyl
bromide end-use
products
containing
directions for use
for pre-plant soil
fumigation
"Site-Specific Fumigation Management Plan (FMP)
Prior to the start of fumigation, the certified applicator supervising the
application must verify that a site-specific fumigation management plan (FMP)
exists for each application block (i.e., a greenhouse or field or portion of a
field treated with a fumigant in any 24-hour period). The FMP may be
prepared by the certified applicator, the site owner/operator, registrant, or other
party. The certified applicator must verify in writing the site-specific FMPs
reflects current site conditions before the start of fumigation.
General site information
o Site address or description of location,
o Site operator/owner's name, address, and, phone number
o Map, aerial photo, or detailed sketch showing field location,
dimensions, buffer zones, property lines, public roads, bus stops,
water bodies, wells, rights-of-ways inside buffers, nearby
application blocks, surrounding structures (occupied and non-
occupied), locations of posted signs for buffers, and sites
requiring 1A mile buffer zones (e.g., prisons, schools, hospitals,
state licensed day care centers) with distances from the
application site labeled
Applicator information (license number, address, phone number, contact
information for person supervising the fumigation with location and date
for completing the registrant's chloropicrin training program)
Authorized on-site personnel (Names of all handlers and the tasks they are
authorized and trained to perform)
Application procedures
o Fumigation window (target application date, earliest and latest
possible date of fumigation)
o Product information (brand name, registration number)
o Type of fumigation (e.g., shank, broadcast, drip, raised bed, strip,
etc.)
o Target application rate and application block size
Good Agricultural Practices (GAPs)
o Description of applicable mandatory GAPs (registrants may also
include optional GAPs)
o Measurements and other documentation planned to ensure GAPs
are achieved (e.g. measurement of soil and other site conditions,
tarp repair/perforation/removal plans, etc.)
Buffer zones
o Calculations and rationale for buffer zones distances (e.g. specify
table from label that distances are based on, rate and block size,
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading "Site-
Specific
Fumigation
Management Plan
(FMP)"
100
-------
applicable credits applied)
o Start and stop times for buffer zones
Respirators and other personal protective equipment (PPE) for handlers
(respirator type, respirator cartridge, and other PPE selection; verification
that respirator training/fit-testing/medical exams is current; and
maintenance/storage procedures)
Air monitoring
o Type of samples that will be collected (e.g., occupational, in
occupied structures, outside buffer zone area if site monitoring is
conducted, etc.)
o When and where samples will be collected
o Duration of samples
o Sampling methods and equipment
o Name, address, and, phone number of person taking samples
Posting (names of persons who will post signs, location of posting signs,
procedures for posting and sign removal)
Site-Specific response and management
o Fumigant site monitoring
Description of who, when, where, and procedures for
monitoring buffer zone perimeter
o Response information for neighbors
List of residences and businesses informed (neighboring
property owners)
Method of sharing information
o State and tribal lead agency notification
Include the information that is sent to the lead agency
Plan describing how communication will take place between applicator,
land owner/operator, and other on-site handlers (tarp cutters/removers,
irrigators, etc.)
Record keeping procedures
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, odor complaints or elevated air
concentration levels outside buffer zone suggesting potential problems, or
other emergencies).
Hazard communication (product labels, material safety data sheets, etc.)
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, etc.)
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; and
Recordkeeping requirements are followed for the entire FMP
(including elements that do not change)
The employer of fumigant handlers must make the FMP available to each of
their handler employees involved in the fumigation and workers in adjacent
fields, upon request.
The certified applicator supervising the fumigation and the owner/operator of
101
-------
General Buffer
Zones
requirements for
all formulations
the agricultural establishment where the fumigation is taking place must, upon
request, make the FMP available to any federal, state, tribal, or local
enforcement personnel, upon request.
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 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. The summary
must include the actual date of the application, application rate, and size of
application block fumigated."
The certified applicator who supervised the fumigation and the owner/operator
of the agricultural establishment where the fumigation took place must keep a
signed copy of the site-specific FMPs and the post-application summary
record for at least 2 years following the application and must make them
available, upon request, to Federal, state, tribal, and/or local enforcement
personnel.
Information "When the certified applicator supervising the application leaves the
Exchange application site after the application portion of the fumigation process is
complete and other persons will be performing handler tasks (see the handling
activities listed elsewhere in this labeling), the certified applicator must
communicate in writing all of the requirements on this labeling with respect to
the fumigation process and protection of handlers to the owner/operator of the
agricultural establishment where the fumigation is taking place.
IMPORTANT: this requirement does not override the requirements in the
Worker Protection Standard for Agricultural Pesticides for information
exchange between owners/operators of agricultural establishments and
commercial pesticide applicators."
"General Buffer Zone Requirements
A "buffer zone" must be established for every fumigant application The
following describes the general buffer zone requirements:
"Buffer zone" is an area established around the perimeter of each
application block or greenhouse where a soil fumigant is applied. The
buffer zone must extend from the edge of the application block perimeter
equally in all directions.
All non-handlers including field workers, nearby residents, pedestrians,
and other bystanders, must be excluded from the buffer zone during the
buffer zone period except for certain persons in transit (see exemptions
section).
An "application block" is a greenhouse or field or portion of a field
treated with a fumigant in any 24-hour period (see Figures 1 and 2 above
for further explanation).
The "buffer zone period" starts at the moment when any fumigant is
delivered/dispensed to the soil within the application block and lasts for a
minimum of 48 hours after the fumigant has stopped being
delivered/dispensed to the soil.
Buffer zone distances
Buffer zone distances must be based on look-up tables on product labels
(25 feet is the smallest distance regardless of site-specific application
parameters).
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading
"General Buffer
Zone
Requirements"
102
-------
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).
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.
Buffer zone proximity
Methyl bromide buffer zones from multiple application blocks may not
overlap (including blocks fumigated by adjacent property owners; see
below for exemptions for areas not under the control of owner/operator of
application block).
No fumigant applications will be permitted within 0.25 miles of schools,
state licensed day care centers, nursing homes, assisted living facilities,
elder care facilities, hospitals, in-patient clinics and prisons if occupied
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 though such sidewalk or
shoulder is used by persons riding bicycles. In the event a highway
includes two or more separated roadways, the term "roadway" shall refer
to any such roadway separately.
Bus stops or other locations where persons wait for public transit are not
permitted within the buffer zone.
See Posting Section for additional requirements that may apply.
Structures under the control of owner/operator of the application block
Buffer zones may not include buildings used for storage such as sheds,
barns, garages, etc., UNLESS,
1. The storage buildings are not occupied during the buffer zone period,
and
2. The storage buildings do not share a common wall with an occupied
structure.
See Posting Section for additional requirements that may apply.
Areas not under the control of owner/operator of the application block
Buffer zones may not include residential areas (including employee
housing, private property, buildings, commercial, industrial, and other
areas that people may occupy or outdoor residential areas, such as lawns,
gardens, or play areas) UNLESS,
1. The occupants provide written agreement that they will voluntarily
vacate the buffer zone during the entire buffer zone period, and
2. Reentry by occupants and other non-handlers must not occur until,
0 The buffer zone period has ended, and
0 Two consecutive air samples for methyl bromide have been
taken in the structure at least 1 hour apart must indicate less than
1 ppm methyl bromide, and
0 Two consecutive air samples for chloropicrin have been taken in
the structure at least 1 hour apart must indicate than less than
103
-------
0.15 ppm chloropicrin is present.
Buffer zones may not include agricultural areas owned/operated by
persons other than the owner/operator of the application block, UNLESS,
1. The owner/operator of the application block can ensure that the buffer
zone will not overlap with a buffer zone from any adjacent property
owner, and
2. The owner/operator of the areas that are not under the control of the
application provides written agreement to the certified applicator
supervising the fumigant application that they, their employees, and
other persons will stay out of the buffer zone during the entire buffer
zone period.
Buffer zones may not include publicly owned and/or operated areas (e.g.,
parks, rights of way, side walks, walking paths, playgrounds, athletic
fields, etc), 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.
Maximum
Application Block
Sizes for all
formulations
"Maximum Application Block Sizes
The maximum application block sizes allowed for methyl bromide
applications are:
100 acres for tarped bedded and broadcast applications
40 acres for untarped deep applications (i.e., California orchard replant)"
Directions for Use
(see next row for
98:2 formulations)
Maximum
Application Block
Sizes for Hot Gas
Applications (98:2
formulations only)
"The maximum application block sizes allowed for methyl bromide hot gas
applications are:
10 acres for outdoor hot gas applications
45,000 square feet for greenhouse hot gas applications"
Directions for Use
immediately after
above row
Pre-plant
Application
Restrictions for all
formulations
"Maximum Application Rates for Critical Use Exemptions (CUEs) under the
Montreal Protocol
Maximum Application Rates for Pre-plant Soil Methyl Bromide CUEs
Crop
Eggplant
Cucurbits (including muskmelons,
cantaloupe, watermelon, cucumber, squash,
pumpkin, and gourds)
Forest Nursery Seedlings
Orchard Nursery Seedlings (raspberry,
deciduous trees, roses)
Strawberry Nurseries
Orchard Replant1 (walnuts, almonds, stone
fruit, table and raisin grapes, wine grapes)
Orchard Replant (grapes)
Ornamentals
Pepper, Bell
Strawberry Fruit
Sweet Potato Slips
Maximum Broadcast
Equivalent Rates (Ib ai/A)
170
200
260
200
260
200
250
360
170
200
200
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading
"Maximum
Application Rates
for Critical Use
Exemptions under
the Montreal
Protocol" within
its own box
(see below row for
98:2 formulations)
104
-------
Tomato (grown for fresh market)
160
1 The maximum application rate when applying methyl bromide to individual
tree holes using handheld equipment is 1.5 Ib ai/100 ft2
The maximum application rate for greenhouse hot gas applications is 1 Ib
ai/100 ft2 and the application block may not exceed 45,000 ft2."
Pre-plant
Application
Restrictions for
98:2 formulations
"The maximum application rate when applying methyl bromide to individual
tree holes using handheld equipment is 1.5 Ib ai/100 ft2"
"The maximum application rate for greenhouse hot gas applications is 1 Ib
ai/100 ft2 and the application block may not exceed 45,000 ft2"
Directions for Use
immediately after
above row
Pre-plant
Application
Restrictions
"Quarantine Uses
This product may be used as a soil fumigant as part of a quarantine program
established by the United States Department of Agriculture-Animal and Plant
Heath Inspection Service (USDA-APHIS) under the Plant Protection Act (7
U.S.C. 7701 et seq.). Limitations including but not limited to application rates
and methods and crops and cropping practices shall be in accordance with
those established by the USD A-APHIS quarantine program."
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading
"Maximum
Application Rates
for Quarantine
Uses
" within its own
box
Buffer Zone
Distances for all
formulations
"Buffer Zone Distances
Buffer zone distances must be calculated using the application rate and the size
of the application block.
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading "
Buffer Zone
Distances"
Figure 1. Broadcast Application
Figure 2. Bedded Application
In Figures 1 and 2, the dashed line represents the perimeter of the field, the
shaded area is the portion of the field that is treated, and the un-shaded area is
the area of the field that is untreated. Assuming that both fields are 10 acres,
and only 50% of field in figure 2 is fumigated, the rate per treated acre is 400
Ibs ai/A for both Figure 1 and 2. The broadcast rate for figure 1 is 400 Ib ai/A
but the effective broadcast equivalent rate for Figure 2 is 200 Ibs ai/A."
NOTE TO REGISTRANTS: Labels may express rates as Ibs per treated
acre under the application instructions but they must identify buffer zone
distances based on the broadcast or effective broadcast equivalent rates.
"For selective replant fumigation in an orchard using hand-held application
methods (e.g., deep injection auger probes), the minimum buffer zone will be
25 feet measured from the center of each injection site (i.e., tree hole). For all
other applications, the following tables must be used to determine the
minimum buffer distances. Round-up to the nearest rate and block size, where
applicable."
"Buffer Zone Look-up Table for Shank Bedded with Tarps"
[See driver table below for each formulation. If methyl bromide is the driver
insert Table 2 from Methyl Bromide RED. If chloropicrin is the driver insert
appropriate chloropicrin look-up table for shank bedded with tarps from
105
-------
chloropicrin RED]
"Buffer Zone Look-up Table for Shank Broadcast with Tarps"
[See driver table below for each formulation. If methyl bromide is the driver
insert Table 3 from Methyl Bromide RED. If chloropicrin is the driver insert
appropriate chloropicrin look-up table for shank broadcast with tarps from
chloropicrin RED]
"Shank Broadcast without Tarps (CA orchard replant only)"
[See driver table below for each formulation. If methyl bromide is the driver
insert Table 4 from Methyl Bromide RED. If chloropicrin is the driver insert
appropriate chloropicrin look-up table for shank deep broadcast with tarps
from chloropicrin RED]
Buffer Zone
Distances for Hot
Gas Applications
(98:2 formulations
only)
"Outdoor Hot Gas with Tarps"
[insert from Table 5 from Methyl Bromide RED]
"Greenhouse Hot Gas with Tarps"
[insert from Table 6 from Methyl Bromide RED]
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading
"Buffer Zone
Distances"
Buffer Zone
Credits
"Buffer Zone Credits
The buffer zone distances for bedded and broadcast applications may be
reduced by the percentages listed below. The credits may not be used for hot
gas applications. Credits may be added, but the minimum buffer zone distance
is 25 feet regardless of buffer zone credits available.
25% reduction in buffer zone distance, IF using Bromostop (1.38 mil),
IPM Clear VIF (1.38 mil), or Eval/Mitsui (1.38 mil) tarps. Record the
tarp brand name, manufacturer, lot number, batch number, part number,
and thickness must be recorded in the FMP.
10% reduction in buffer zone distance, IF the organic content of soil in the
application block is greater than 3%. Record the measurements taken to
verify the organic content in the FMP
10% reduction in buffer zone distance, IF the clay content of the soil in
the application block is greater than 27%. Record the measurements taken
to verify the clay content in the FMP
Example of how to calculate credit: Assuming a tarped bedded application,
broadcast equivalent rate of 125 Ibs ai/A, 20 acre application block, using
Bromostop (1.38 mil) with a 25% credit, and 3.1% organic soil with a 10%
credit, the buffer zone would be 130 ft (25% + 10% = 35%; 100% - 35% =
65%; 65% x 200 ft (from the lookup table) = 130 ft)"
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading
"Buffer Zone
Credits"
Posting
"Posting Fumigant Buffer Zones
Posting all entrances to the application block (i.e., the greenhouse or field
or portion of a field treated with a fumigant in any 24-hour period) is
required for all soil fumigants and use sites. The posting requirements for
the application block are listed elsewhere in this labeling.
Posting of the fumigation buffer zone is required, except when one of the
following conditions exist:
(1) if there is a physical barrier that prevents access into the buffer zone,
such as a fence or wall, that separates the edge of the buffer zone
from workers or bystanders, or
(2) if the area within 300 feet of the edge of the buffer zone is entirely
controlled by owner/operator of the application block (i.e., the
greenhouse or field or portion of a field treated with a fumigant in any
24-hour period); however this exception does not apply to any area
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading
"Posting Fumigant
Buffer Zones"
106
-------
under the control of the owner/operator that may be used as housing
for workers or other employees. IMPORTANT: if there is public
land or any land under someone else's control within 300 feet from
the edge of the buffer zone, the buffer zone must be posted.
If the buffer zone must be posted, signs must be placed at all usual points
of entry and along likely routes of approach from areas where people not
under the control of the application block's owner/operator 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 When there are no usual points of entry, signs must be posted in
the corners of the buffer zone, between the corners of the buffer
zone, and along sides so that one sign can be viewed (not read)
from the previous one.
o The buffer zone posting signs must remain posted at least until
the end of the buffer zone period and must be removed within 3
days after the end of the buffer zone period.
Contiguous Application Blocks Exception: If multiple contiguous
application blocks are fumigated within a 14-day period, a buffer zone
may be established starting from the outer edge of the contiguous
application blocks. This buffer zone is in effect from the beginning of the
first application until the buffer zone period for the last application block
has expired. The periphery of the buffer zone must be posted during this
entire period. Signs may remain posted until 3days after the buffer zone
period for the last application block has expired.
The buffer zone posting should meet the following standards:
o The printed side of the sign must face away from the buffer zone.
o Signs must remain legible during entire posting period.
o The signs at entrances to buffer zones must be removed by the
certified applicator in charge of the fumigation (or someone
under his/her supervision).
o The general standards for size and type of signs for the buffer
zone signs must follow the requirements in the Worker
Protection Standard for Agricultural Pesticides for treated area
posting.
o The signs must remain visible and legible during the time they
are posted."
Contents of Signs
107
-------
The treated area sign must state the
following:
- Skull and crossbones symbol
- "DANGER/PELIGRO,"
- "Area under fumigation, DO NOT
ENTER/NO ENTRE,"
"[Name offumigant] Fumigant in
USE,"
- the date and time of fumigation,
- the date and time entry prohibition
is lifted
- brand name of this product, and
~ name, address, and telephone
number of the certified applicator in
charge of the fumigation.
The buffer zone sign must state the
following:
- Do not walk sign
- "DO NOT ENTER/NO ENTRE,"
~ " [Name offumigant] Fumigant
BUFFER ZONE,"
- the date and time of fumigation,
- the date and time buffer zone
restrictions are lifted (i.e., buffer
zone period expires)
- brand name of this product, and
~ name, address, and telephone
number of the certified applicator in
charge of the fumigation
Site specific
response and
management
"Site Specific Response and Management
The certified applicator must either follow the directions under the "fumigant
site monitoring" section or follow the directions under the "response
information for neighbors" section.
Fumigation Site Monitoring
From the beginning of the fumigant application until the buffer zone period
expires, a certified applicator or someone under his/her supervision must
monitor the air concentration levels of the fumigant in the area between the
buffer zone and any residences or businesses that trigger the 'response
information for neighbors' requirement.
The person monitoring the air concentration levels must take readings
starting approximately 30 minutes from the start of application and at least
once each hour during the entire application and buffer zone period.
A direct reading detection device, such as a Draeger device with a
sensitivity of at least 1 ppm for methyl bromide and 0.15 ppm for
chloropicrin must be used to monitor the air concentration levels of
methyl bromide and chloropicrin.
If at any time (1) methyl bromide air concentrations are greater than or
equal to 01 ppm, OR (2) chloropicrin air concentrations are greater than
or equal to 0.15 ppm, OR (3) the person monitoring the air concentrations
experiences sensory irritation, then the emergency response plan stated in
the FMP must be immediately implemented by the person monitoring the
air concentrations
If other problems occur, such as a tarp coming loose, then the appropriate
control plan must be activated.
The results of the air concentration monitoring must be recorded in the
FMP.
Informing the appropriate federal, state or tribal lead agencies is still
required.
In the Directions
for Use for Pre-
plant soil
fumigation under
the heading "Site
specific response
and management"
108
-------
Response Information for Neighbors
The certified applicator (or someone under his/her supervision) supervising the
fumigation must ensure that residences and owners/operators of businesses
that meet the criteria below have been provided the emergency response
information at least 48 hours before fumigation occurs. The information
provided may include application dates that range for no more than 2 weeks.
After 2 weeks, the information must be delivered again.
Criteria for providing response information for neighbors:
If the buffer zone is less than or equal to 100 feet, then residences and
businesses within 50 feet from the edge of the buffer zone must be
informed.
If the buffer zone is greater than 100 feet but less than or equal to 200
feet, then residences and businesses within 100 feet from the edge of the
buffer zone must be informed.
If the buffer zone is greater than 200 feet but less than or equal to 300
feet, then residences and businesses within 200 feet from the edge of the
buffer zone must be informed.
If the buffer zone is greater than 300 feet, then residences and businesses
within 300 feet from the edge of the buffer zone must be informed.
Information that must be included:
Location of the application block and surrounding buffer zone
Fumigant(s) applied including EPA Registration #
Applicator and property owner/operator contact information
Time period that fumigation may occur (must not range more than 2
weeks)
Duration of buffer zone
The information must also include:
o information on what is being applied,
o signs and symptoms of exposure to the fumigant,
o what to do and who to call if you believe you are being exposed
(911 in most cases).
The method used to share the response information for neighbors must be
described in the FMP and may be accomplished through mail, door
hangers, or through other methods that will effectively inform people in
residences and businesses within the required distance from the edge of
the buffer zone."
Notice to State and
Tribal Lead
Agencies
"Notice to State and Tribal Lead Agencies
The state and tribal lead agency information must be provided to the
appropriate state or tribal lead agency in a written format prior to the
application.
The information that must be provided to state and tribal lead agencies
includes the following:
Location of the application block and surrounding buffer zone,
Fumigant(s) applied including EPA Registration #,
Applicator and property owner/operator contact information,
Time period that fumigation may occur (must not range more than 2
weeks),
Directions for Use
under "Notice to
State and Tribal
Lead Agencies"
109
-------
Duration of buffer zone."
Environmental "This pesticide is toxic to mammals and birds. Do not apply directly to water,
Hazards or to areas where surface water is present or to intertidal areas below the mean
high water mark. Do not contaminate water when disposing of equipment
washwaters or rinsate."
Precautionary
Statements
immediately
following the User
Safety
Recommendations
Surface and "This pesticide is toxic to mammals and birds. Do not apply directly to water,
Ground Water or to areas where surface water is present or to intertidal areas below the mean
Requirements high water mark. Do not contaminate water when disposing of equipment
washwaters or rinsate."
Precautionary
Statements
immediately
following the User
Safety
Recommendations
General "Do not apply this product in a way that will contact workers or other persons,
Application either directly or through drift. Only protected handlers may be in the area
Restrictions during application.
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.
To reduce the potential for leaching to groundwater, especially in soils with
shallow groundwater, for broadcast tarped applications, the tarps must be
perforated (cut, punched, etc.) before noon and only when rainfall is not
expected within 12 hours. For bedded tarped applications, rainfall is not a
factor since planting occurs with the tarp in place.
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."
Place in the
Direction for Use
directly above the
Agricultural Use
Box.
110
-------
Methyl Bromide:Chloropicrin Drivers
Standard Tarp (no credits)
Application
Method
Broadcast1
Bedded2
Formulation
98:2
Methyl
Bromide
Methyl
Bromide
80:20
Methyl
Bromide
Methyl
Bromide
75:25
Methyl
Bromide
Methyl
Bromide
67:33
Methyl
Bromide
Methyl
Bromide
57:43
Chloropicrin
Methyl
Bromide
50:50
Chloropicrin
Chloropicrin
45:55
Chloropicrin
Chloropicrin
33:67
Chloropicrin
Chloropicrin
High Barrier Tarps:
Bromostop (1.38 mil), IPM Clear VIF (1.38 mil), and Eval/Mitsui (1.38 mil) with credits of 25% for Methyl Bromide and 40% for
Chloropicrin
Application
Method
Broadcast1
Bedded2
Bedded*3
Formulation
98:2
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
80:20
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
75:25
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
67:33
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
57:43
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
50:50
Chloropicrin
Methyl
Bromide
Chloropicrin
45:55
Chloropicrin
Chloropicrin
Chloropicrin
33:67
Chloropicrin
Chloropicrin
Chloropicrin
High Barrier Tarps:
Hytiblock 7 black, Hytibar, and Black Blockade with no credit for Methyl Bromide and 40% credit for Chloropicrin
Application
Method
Broadcast1
Bedded2
Bedded*3
Formulation
98:2
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
80:20
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
75:25
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
67:33
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
57:43
Methyl
Bromide
Methyl
Bromide
Methyl
Bromide
50:50
Chloropicrin
Methyl
Bromide
Methyl
Bromide
45:55
Chloropicrin
Methyl
Bromide
Chloropicrin
33:67
Chloropicrin
Chloropicrin
Chloropicrin
Deep (> 18 inches) Untarped
Application
Method
Broadcast4
Formulation
98:2
Methyl
Bromide
80:20
Methyl
Bromide
75:25
67:33 57:43
Chloropicrin Chloropicrin Chloropicrin
50:50
Chloropicrin
45:55
Chloropicrin
33:67
Chloropicrin
* When applications occur between 1 hour before sunset and 1 hour after sunrise.
1 Where Methyl Bromide is listed for the appropriate buffer zone, see Table 3 in Methyl Bromide RED. Where
Chloropicrin is listed, see Table 2 in the Chloropicrin RED.
2Where Methyl Bromide is listed, see Table 2 in Methyl Bromide RED. Where Chloropicrin is listed, see Table 2 in
the Chloropicrin RED.
3Where Methyl Bromide is listed, see Table 2 in Methyl Bromide RED. Where Chloropicrin is listed, see Table 3 in
the Chloropicrin RED.
4Where Methyl Bromide is listed, see Table 4 in Methyl Bromide RED. Where Chloropicrin is listed, see Table 6 in
the Chloropicrin RED.
Ill
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Appendix A
Methyl Bromide PC Code 053201 Pre-plant Soil Uses Eligible for Reregi strati on
Use Site
Eggplant
Cucurbits (including
muskmelons,
cantaloupe,
watermelon, cucumber,
squash, pumpkin, and
gourds)
Forest Nursery
Seedlings
Orchard Nursery
Seedlings (raspberry,
deciduous trees, roses)
Strawberry Nurseries
Orchard Replant
(walnuts, almonds,
stone fruit, table and
raisin grapes, wine
grapes)
Orchard Replant
(grapes)
Orchard Replant
(individual tree holes
using)
Ornamentals
Ornamentals
Pepper, Bell
Strawberry Fruit
Sweet Potato Slips
Tomato (grown for
fresh market)
Quarantine uses
Formulation
Pressurized gas with 80% or less
methyl bromide
Pressurized gas with 80% or less
methyl bromide
Pressurized gas
(all methyl bromide: chloropicrin
ratios including 98:2)
Pressurized gas with 80% or less
methyl bromide
Pressurized gas with 80% or less
methyl bromide
Pressurized gas (all methyl bromide:
chloropicrin ratios including 98:2)
Pressurized gas (all methyl bromide:
chloropicrin ratios including 98:2)
Pressurized gas (all methyl bromide:
chloropicrin ratios including 98:2)
Pressurized gas with 80% or less
methyl bromide
Pressurized gas with 98% methyl
bromide
Pressurized gas with 80% or less
methyl bromide
Pressurized gas with 80% or less
methyl bromide
Pressurized gas with 80% or less
methyl bromide
Pressurized gas with 80% or less
methyl bromide
Pressurized gas (all methyl bromide:
chloropicrin ratios including 98:2)
Method of
Application
Shank
Injected
Shank
Injected
Shank
Injected
Shank
Injected
Shank
Injected
Shank
Injected
Shank
Injected
handheld
equipment
Shank
Injected
Hot Gas
Shank
Injected
Shank
Injected
Shank
Injected
Shank
Injected
Maximum
Application Rate
170 Ib ai/A
200 Ib ai/A
260 Ib ai/A
200 Ib ai/A
260 Ib ai/A
200 Ib ai/A
250 Ib ai/A
l.Slbai/
100 ft2
360 Ib ai/A
360 Ib ai/A
170 Ib ai/A
200 Ib ai/A
200 Ib ai/A
160 Ib ai/A
Use sites defined as part of a
quarantine program established by
the United States Department of
Agriculture-Animal and Plant Heath
Inspection Service (USDA-APHIS)
under the Plant Protection Act (7
U.S.C. 7701 et seq.). Limitations
including but not limited to
application rates and methods and
crops and cropping practices shall be
in accordance with those established
by the USDA-APHIS quarantine
program.
Use
Limitations
See applicable
GAPs from
Table 9 of
RED
112
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Appendix B
This section is currently not available.
113
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Appendix C
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: htt^//www.reguiationsฑgov. 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
114
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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
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.
115
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Response to Comments
36. HED Component of Response To Comments Document On Methyl Bromide Phase 5
Fumigant Risk Assessment (DP Barcode 353907)
37. 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)
38. Response to Phase 5 BEAD Related Public Comments Received on the Reregistration of
Chloropicrin, Dazomet, Metam Potassium, Metam Sodium, and Methyl Bromide. June 25,
2008. (DP Barcode 353940)
39. SRRD's Response to Phase 5 Public Comments for the Soil Fumigants (July 2008)
116
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