United States Prevention, Pesticides EPA 738-R-06-026
Environmental Protection and Toxic Substances August 2006
Agency (7508C)
Report of Food Quality Protection
Act (FQPA) Tolerance
Reassessment and Risk
Management Decision (TRED) for
Methyl Bromide, and Reregistration
Eligibility Decision (RED) for Methyl
Bromide's Commodity Uses
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Report of Food Quality Protection Act (FQPA) Tolerance Reassessment and
Risk Management Decision (TRED) for Methyl Bromide, and Reregistration
Eligibility Decision (RED) for Methyl Bromide's Commodity Uses
List A
Case No. 0355
Approved by:
Debra Edwards, Ph. D.
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
LOG
LOAEL
MATC
|ig/g
|ig/L
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. EP A' 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
Reregistration 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
Methyl bromide Reregistration Eligibility Decision Team 7
Abstract 8
I. Introduction 9
II. Chemical Overview 10
A. Chemical Identity 10
B. Use and Usage Profile 11
III. Methyl Bromide Risk Assessments 12
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 13
A. Determination of Reregistration Eligibility 13
B. Public Comments and Responses 14
C. Regulatory Position 15
1. Food Quality Protection Act Findings 15
a. "Risk Cup" Determination 15
b. Determination of Safety to U.S. Population 15
2. Endocrine Disrupter Effects 15
3. Cumulative Risks 16
4. Tolerance Reassessment Summary 16
a. Commodity Uses 16
b. Pre-Plant Soil Uses 22
D. Regulatory Rationale 23
1. Dietary (food + drinking water) Risk 23
2. Residential Risks 24
3. Aggregate Risk 26
a. Acute 26
b. Short-, Intermediate-Term, and Chronic Aggregate Risk 26
4. Worker Risks 27
5. Stratospheric Ozone Depletion Risks 27
6. Ecological Risk 27
E. Residential Bystander and Occupational Risk Mitigation 27
1. Site-Specific Fumigation Management Plan (FMP) 27
a. Buffer Zones 29
1) Buffer Zones Based on Agency Look-Up-Tables 30
2) Buffer Zones Based on Alternate Methods 31
3) Minimum Buffer Zones 31
4) Exceptions 31
b. Posting and Notification 32
c. Record Keeping 33
1) Fumigation Sites 33
2) Fumigators 33
2. Respiratory Protection for Fumigation Workers and Other On-site Workers 33
3. Storage Areas 35
4. Minimum Aeration Times 35
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a. Mechanical and Passive Aeration 35
b. Exceptions 35
V. What Registrants Need to Do 36
A. Manufacturing Use Products 36
1. Additional Generic Data Requirements 36
2. Labeling for Manufacturing-Use Products 38
B. End-Use Products 38
1. Additional Product-Specific Data Requirements 38
2. Labeling for End-Use Products 39
C. Conclusions 58
Appendices 58
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Methyl bromide Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Jeff Dawson
Elizabeth Mendez
Toiya Goodlow
Christine Olinger
Michael Metzger
Biological and Economic Analysis Assessment
Bill Chism
Jonathan Becker
Colwell Cook
David Donaldson
Elisa Rim
TJ Wyatt
Istanbul Yusuf
Environmental Fate and Effects Risk Assessment
Faruque Khan
James Felkel
Registration Support
Mary Waller
Risk Management
Steven Weiss
Eric Olson
John Leahy
Robert Mcnally
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Abstract
This document presents EPA's decision regarding the Food Quality Protection Act
(FQPA) tolerance reassessment for methyl bromide (MeBr) and reregistration eligibility of the
commodity uses of the active ingredient methyl bromide. The Agency has conducted human
health and environmental fate and effects risk assessments for methyl bromide and has made
tolerance reassessment decisions for 140 tolerances related to all registered methyl bromide uses.
The Agency has determined that, with label amendments and changes as specified in this
document, there is a reasonable certainty that no harm will result to the general U.S. population,
infants, children, or other population subgroups, from methyl bromide's food commodity uses.
Generally, registered methyl bromide application/fumigation uses fall into four basic
categories that include: (1) pre-plant soil fumigations; (2) structural, industrial, and residential
uses; (3) post-harvest food commodity uses; and (4) other specialized fumigations. This decision
document covers methyl bromide uses that have accompanying food residue tolerances for post-
harvest fumigation of food commodities in chambers at ports or specialized structural
fumigations at food processing facilities. Although some methyl bromide uses such as
fumigation of timber, wood products, and industrial equipment do not require a food residue
tolerance, the Agency has included them in this reregistration decision since they are performed
in similar facilities and were assessed with a similar risk assessment methodology. Hereafter,
these methyl bromide uses will be referred to as "methyl bromide's commodity uses."
EPA is currently assessing risks and will be developing risk management decisions for
five soil fumigant pesticides: chloropicrin, dazomet, metam sodium, methyl bromide, and a new
active ingredient, iodomethane. Risks of a sixth soil fumigant, 1,3-D (Telone), are also being
analyzed along with the 5 soil fumigants for comparative purposes (see website link below); its
risk management decision was completed in 1998. The Agency is evaluating these soil fumigants
concurrently to ensure that human health risk assessment approaches are consistent, and that risk
tradeoffs and economic outcomes can be 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. A decision on the reregistration of methyl bromide's non-commodity uses
that do not have food tolerances (e.g., structural and pre-plant soil uses) is scheduled to be
completed in 2007 with the other soil fumigants. For further details on the reregistration of the
soil fumigants see http://www.epa.gov/oppsrrdl/reregistration/soil_fumigants/.
The completion of the methyl bromide RED for food commodity uses results in the
reassessment of 128 existing tolerances. As of April 26, 2006, the Agency considered the
existing 12 tolerances from soil fumigation reassessed (see April 26, 2006, memo, "Completion
of Tolerance Reassessment for Inorganic Bromides Resulting from Soil Treatment," from D.
Edwards, Special Review and Reregistration Division Director to J. Jones, Office of Pesticides
Program Director). The Agency's reregistration decision on methyl bromide's soil uses will not
impact this RED since soil uses no longer have related food tolerances and have a negligible
contribution to drinking water risks.
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EPA has identified potential human health risks of concern associated with the currently
registered commodity uses of MeBr from acute inhalation exposure to workers and bystanders.
In this document the term "worker" refers to persons involved in applications of methyl bromide.
Since methyl bromide is a restricted-use pesticide (RUP), fumigation workers must be certified
applicators, or be working under the direct supervision of a certified applicator. The term
"bystander" in this document refers to any other person who lives or works in the vicinity of a
fumigation site. To reduce these exposures and to address subsequent risks of concern, EPA is
requiring a number of mitigation measures such as site-specific fumigant management plans
(FMPs), respiratory protection, buffer zones, posting and notification. The focus of the
Agency's mitigation measures is on direct acute exposure to methyl bromide from commodity
uses. However, the Agency has concluded that many of these measures, combined with the
MeBr phase-out mandated by the Montreal Protocol, will further reduce the potential health
effects from ozone depletion that may be attributed to methyl bromide's commodity uses, such
as skin cancer. The Agency has determined that MeBr's commodity uses are eligible for
reregistration provided that the risk mitigation measures outlined in this document are adopted
and label amendments are made to reflect these measures.
The Agency is issuing this decision document for MeBr, as announced in a Notice of
Availability published in the Federal Register. There will be a 60-day public comment period for
this document to allow stakeholders the opportunity to review and provide comments on this
decision.
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 a review of all data submitted to the
Environmental Protection Agency (hereafter referred to as EPA or the Agency). 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 each pesticide chemical. This document presents EPA's assessment and risk
management decisions for methyl bromide's uses in enclosures, chambers and structural food
processing/storage facilities (hereafter referred to as commodity uses) to determine the need for
additional data on health and environmental effects, and to determine whether or not these uses
of the pesticide meet the "no unreasonable adverse effects" criteria of FIFRA and the "reasonable
certainty of no harm" criteria of the Food Quality Protection Act (FQPA). Risks summarized in
this document are those that result only from the commodity uses of methyl bromide. However,
EPA has considered potential dietary (food + drinking water) risks associated with all methyl
bromide uses, including pre-plant soil uses. As a result of this review, the Agency has
determined that all products registered for commodity uses containing the active ingredient
methyl bromide are eligible for reregistration provided that the risk mitigation measures
indicated in this document are adopted.
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The completion of the methyl bromide RED for commodity uses results in the
reassessment of all 140 existing tolerances (i.e., 128 post-harvest uses +12 tolerances from pre-
plant soil applications that were already re-assessed by the Agency). A decision on the
reregistration of methyl bromide's pre-plant soil uses will be completed in 2007 with the other
soil fumigants. For further details on the reregistration of the soil fumigants see
http://www.epa.gov/oppsrrdl/reregistration/soil_fumigants/. The Agency's reregistration
decision on methyl bromide's soil uses will not impact this TRED/RED since soil uses no longer
have related food tolerances and have a negligible contribution to drinking water.
The Food Quality Protection Act (FQPA) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider available information concerning
the cumulative effects of a particular pesticide's residues and other substances that have a
common mechanism of toxicity. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to methyl bromide, and methyl bromide does not
appear to produce a toxic metabolite produced by other substances. Therefore, for the purposes
of reregistration, EPA has not assumed that methyl bromide shares a common mechanism of
toxicity with other compounds. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism of toxicity on EPA's
website at http://www.epa.gov/pesticides/cumulative/.
Unless otherwise noted, all Agency references in this document are available for review
in the methyl bromide docket (EPA-HQ-OPP-2005-0123) at www.Regulations.gov.
II. Chemical Overview
A. Chemical Identity
Chemical Structure: Br
Empirical Formula:
Common Name:
CAS Registry Number:
OPP Chemical Code:
CH3Br
Methyl bromide
74-83-9
053201
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Case Number:
Technical or
Manufacturing-Use
Registrants:
Regulatory History:
0335
Albemarle Corporation, Ameribrom, Inc., Great Lakes Chemical
Corporation (a Chemtura Company), and TriCal
Introduced as pesticide in 1932
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, (2) a quarantine and preshipment exemption, or
(3) an emergency exemption.
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.
A wide range of pests including spiders, mites, fungi, plants, insects,
nematodes, rodents, and snakes.
The most prevalent use pattern is as a soil fumigant; however, it is
also used as a structural fumigant and for post harvest treatment of
commodities.
Pressurized gas (PrG) formulations for commodity fumigation are
marketed under the trade names Meth-O-Gas and Metabrom. 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.
MeBr gas is injected into an enclosure, chamber, structure, or under a
tarp remotely using flexible tubing connected to PrG tanks.
Application rates for commodity fumigations can range from 1 to 20
Ib ai/1000 ft3, but most perishable goods with established food
tolerances under 40 CFR have application rates in the range of 1 to 4
Ib ai/1000 ft3 (e.g., grapes). Likewise, structural fumigation
application rates are in the 1 to 9 Ib ai/1000 ft3 range.
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Annual Usage in the There were a total of 23 million pounds of methyl bromide used in the
U.S.: U.S. in 2004 with 3 million pounds used on commodities, food
processing facilities, and for food quarantine uses, and 20 million
pounds used on all other sites.
Tolerances: There are currently 140 tolerances related to registered methyl
bromide uses in 40 CFR180.123, 180.199, and 180.522.
# of Tolerances Citation
90 180.123(a)(l)
3 180.123(a)(2)(i)(A)
2 180.123(a)(2)(i)(B)
2 180.123(a)(2)(i)(C)
18 180.123(a)(2)(i)(D)
1 180.123(a)(2)(ii)
1 180.123(a)(3)(i)
7 180.123(a)(3)(ii)
1 180.123(c)
12 180.199
1 180.521
2 180.522
Methyl bromide's commodity uses encompass a wide range of enclosure types (tarps,
vacuum chambers, tractor trailers, sea vans, drop-down enclosures, flour mills, etc.), enclosure
volumes (less than 1,000 ft3 to more than 1,000,000 ft3), and locations (urban, rural, and
industrial). Most flour mills and other food processing plants are fumigated no more than once
per year, while other facilities perform fumigations with methyl bromide on a daily basis (e.g.,
for quarantine uses). Additional summary and analysis of methyl bromide's use and usage is
included in the following Agency's memos which are available in the docket:
Qualitative Assessment of the Impact of Changes in the Use of Methyl Bromide for
Quarantine Purposes in Support of the Reregistration Eligibility Decision (August 1,
2006)
Qualitative Assessment of the Impact of Changes in the Use of Methyl Bromide on Non-
Quarantine Commodities in Support of the Reregistration Eligibility Decision (August 1,
2006
Qualitative Assessment of the Impact of Changes in Use of Methyl Bromide on Dry
Cured Pork Product Facilities in Support of the Reregistration Eligibility Decision
(August 1, 2006
Qualitative Assessment of the Impact of Changes in the Use of Methyl Bromide in
Structural Food Processing/Storage Facilities in Support of the Reregistration Eligibility
Decision (August 1, 2006)
III. Methyl Bromide Risk Assessments
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For details on the human health risks associated with methyl bromide's commodity uses,
please refer to Appendices J and K for the following documents:
Methyl Bromide: Phase 5 Health Effects Division (HED) Human Health Risk
Assessment for Commodity Uses. PC Code: 053201, DP Barcode: D304623 (March 10,
2006)
Addendum To Phase 5 Health Effects Division (HED) Human Health Risk Assessment
For Commodity Uses. PC Code: 053201, DP Barcode: D304619 (July 12, 2006)
The Agency does not conduct ecological risk assessments for most indoor uses, such as
an enclosed container or perimeter treated with MeBr. EPA has assessed risks associated with
the outdoor soil uses of MeBr which are expected to result in higher environmental exposures.
For the latest ecological risk assessment of methyl bromide's pre-plant soil fumigant uses, see
the June 6, 2005, document "Environmental Fate and Ecological Risk Assessment for the
Reregistration of Methyl Bromide."
For details on the Agency's assessment of methyl bromide's impact on stratospheric
ozone depletion, as well as the health effects expressed as incremental number of skin cancer
mortality and incidence for U.S. residents that would result under various methyl bromide use
scenarios, please refer to the March 17, 2006, document "Methyl Bromide: Science of Ozone
Depletion and Health Effects Estimates."
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregistration
of products for commodity fumigation containing methyl bromide as an active ingredient. The
Agency has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of products containing methyl bromide registered for
commodity uses provided the label changes detailed below are implemented. Additional data are
required to confirm this determination.
The Agency has completed its review of submitted data and its assessment of the dietary,
residential, and occupational risks associated with the commodity uses of pesticide products
containing the active ingredient methyl bromide. Based on these data, the Agency has sufficient
information on the human health and ecological effects of methyl bromide to make its decision
as part of the reregistration process under FIFRA, as amended by FQPA. The Agency has
determined that products containing methyl bromide registered for commodity fumigation will
be eligible for reregistration provided that (i) required product specific data are submitted, (ii) the
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risk mitigation measures outlined in this document are adopted, and (iii) label amendments are
made to reflect these measures. Needed label changes and language are listed in Section V.
Appendix A is a detailed table listing all methyl bromide uses that are eligible for reregistration.
Appendix B identifies generic data requirements that the Agency reviewed as part of its
determination of the reregistration eligibility of methyl bromide's commodity uses, and lists the
submitted studies the Agency found acceptable. Data gaps are identified as either outstanding
generic data requirements that have not been satisfied with acceptable data or additional data
necessary to confirm the decision presented here.
Based on its evaluation of methyl bromide, the Agency has determined that methyl
bromide products for commodity fumigation, unless labeled and used as specified in this
document, would present risks inconsistent with FIFRA and FFDCA. 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 all current
risks for commodity uses of methyl bromide commodity fumigation will be adequately mitigated
for the purposes of this determination under FIFRA.
B. Public Comments and Responses
Through the Agency's use of a 6-phase public participation process, EPA worked
extensively with stakeholders and the public to reach the regulatory decisions for methyl
bromide's commodity uses. The 6-phase process included two 60-day comment periods.
For the first comment period (Phase 3), the Agency solicited and received comments on
the Agency's methyl bromide risk assessments and supporting documents. The Agency's
response to comments received during this period was included in the Agency's March 21, 2006
document, "Agency Responses to Phase 3 Public Comments Related to Methyl Bromide's Uses
in Enclosures, Chambers, and Structural Food Processing/Storage Facilities."
For the second comment period (Phase 5), the Agency solicited and received comments
on the revised methyl bromide risk assessment and a risk mitigation options document. During
the second public comment period, the Agency received comments from 18 sources: California
Department of Pesticide Regulation; Value Recovery, Inc; Dow AgroSciences, LLC; The Royal
Group; USA Rice Federation; Western Industries-North, Inc; ASOEX; Natural Resources
Defense Council; Fumigation Service & Supply, Inc.; Pet Food Institute; North American
Millers' Association (NAMA); Methyl Bromide Industry Panel (MBIP); National Pest
Management Association (NPMA); Industrial Fumigant Company (IFC); US Department of
Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS);and a citizen. Most of
the comments received were related to feasibility, cost, and impact of risk mitigation options
document.
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The comments in their entirety from both comment periods are available in the public
docket (EPA-HQ-OPP-2005-0123) at http://www.regulations.gov. Detailed response to
comments documents for both comment periods are also available in the public docket.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with methyl bromide's commodity uses. EPA has determined that risk from dietary (food +
drinking water) exposure is within its own "risk cup." EPA considered aggregate risks for
methyl bromide's commodity uses for exposures through dietary and residential sources. In the
case of MeBr, these residential exposures are to any person who lives or works in the vicinity of
a fumigation site. The Agency has determined that the human health risks from these combined
exposures are within acceptable levels provided the mitigation measures outlined in this
document are adopted. In other words, EPA has concluded that the tolerances for methyl
bromide meet FQPA safety standards provided the mitigation measures outlined in this
document are adopted. In reaching this determination, EPA has considered the available
information on the special sensitivity of infants and children, as well as aggregate exposure from
dietary (food + drinking water) and residential sources.
b. Determination of Safety to U.S. Population
The Agency has determined that the 140 established tolerances for methyl bromide, with
amendments and changes as specified in this document, meet the safety standards under the
FQPA amendments to Section 408(b)(2)(D) of the FFDCA, as amended by FQPA, and that there
is a reasonable certainty no harm will result to the general population or any subgroup from the
commodity uses of methyl bromide. In reaching this conclusion, the Agency has considered all
available information on the toxicity, use practices, and the environmental behavior of methyl
bromide. The risks from food, drinking water, and residential exposures related commodity uses
do not exceed the Agency's levels of concern, with the risk mitigation specified in this
document.
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 endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
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system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening for additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
In the available toxicity studies on methyl bromide, there was no evidence of endocrine
disruption effects. When additional appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, methyl bromide may be subjected to
further screening and/or testing to better characterize effects related to endocrine disruption.
3. Cumulative Risks
Unlike other pesticides for which EPA has followed a cumulative risk approach based on
a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding
as to methyl bromide, or its metabolites, and any other substances. For the purposes of this
reregistration decision, therefore, EPA has not assumed that methyl bromide has a common
mechanism of toxicity with any other substances.
4. Tolerance Reassessment Summary
a. Commodity Uses
Table 1 provides a summary of the methyl bromide tolerance reassessment decision for
128 tolerances associated with commodity uses. The other 12 tolerances for soil uses were
reassessed and are discussed below in section b. Further explanation of the tolerance
reassessment decision is provided in Appendix K. There are no established or proposed Codex
maximum residue limits for methyl bromide.
Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/Correct Commodity Definition
Tolerances listed under 40 CFR §180.123 (a)(l):
Alfalfa, hay (POST-H)
Almonds (POST-H)
Apples (POST-H)
50.0
200.0
5.0
Revoke
150.0 a
8.0 a
The MBIP is not supporting this use.
Reassign to crop group tolerance for residues
in/on the Tree Nuts Group. Commodity
fumigation trials support a decreased tolerance
level for methyl bromide.
Reassign to crop group tolerance for residues
in/on the Pome Fruits Group. Commodity
fumigation trials support an increased
tolerance level for methyl bromide.
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Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Apricots (POST-H)
Artichokes, Jerusalem (POST-H)
Asparagus (POST-H)
Avocados (POST-H)
Barley (POST-H)
Beans (POST-H)
Beans, green (POST-H)
Beans, lima (POST-H)
Beans, snap (POST-H)
Beets, garden, roots (POST-H)
Beets, sugar, roots (POST-H)
Blueberries (POST-H)
Brazil nuts (POST-H)
Bush nuts (POST-H)
Butternuts (POST-H)
Cabbage (POST-H)
Cantaloupes (POST-H)
Carrots (POST-H)
Current
Tolerance
(ppm)
20.0
30.0
100.0
75.0
50.0
50.0
50.0
50.0
50.0
30.0
30.0
20.0
200.0
200.0
200.0
50.0
20.0
30.0
Tolerance
Reassessment
(ppm)
5.0 a
3.0 a
0.05
5.0
8.0 a
3.0 a
3.0 a
0.5 a
150.0 a
1.0 a
5.0 a
3.0 a
Comment/Correct Commodity Definition
Reassign to crop group tolerance for residues
in/on the Stone Fruits Group. Commodity
fumigation trials support a decreased tolerance
level for methyl bromide.
Reassign to crop group tolerance for residues
in/on the Root and Tuber Vegetables Group.
Commodity fumigation trials support a
decreased tolerance level for methyl bromide.
Commodity fumigation trials support a
decreased tolerance level for methyl bromide.
No registered use or MBIP is not supporting.
However, APHIS has requested to retain this
tolerance.
Reassign to crop group tolerance for residues
in/on the Cereal Grains Group. Commodity
fumigation trials support a decreased tolerance
level for methyl bromide.
Reassign to crop group tolerance for residues
in/on the Legume Vegetables Group.
Commodity fumigation trials support a
decreased tolerance level for methyl bromide.
See comments under artichokes, Jerusalem.
Reassign to crop group tolerance for residues
in/on Berries Crop Group. Commodity
fumigation trials support a decreased tolerance
level for methyl bromide.
See comment under almonds.
Reassign to crop group tolerance for residues
in/on the Brassica Leafy Vegetables Group.
Commodity fumigation trials support a
decreased tolerance level.
Reassign to crop group tolerance for residues
in/on the Cucurbit Vegetables Group.
Commodity fumigation trials support a
decreased tolerance level.
See comments under artichokes, Jerusalem.
17
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Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Cashews (POST-H)
Cherries (POST-H)
Chestnuts (POST-H)
Cippolini, bulbs (POST-H)
Citrus citron (POST-H)
Cocoa beans (POST-H)
Coffee beans (POST-H)
Copra (POST-H)
Corn (POST-H)
Corn, pop (POST-H)
Corn, sweet (K+CWHR)(POST-H)
Cottonseed (POST-H)
Cucumbers (POST-H)
Cumin, seed (POST-H)
Eggplant (POST-H)
Filberts (Hazelnuts) (POST-H)
Garlic (POST-H)
Ginger, roots (POST-H)
Grapefruit (POST-H)
Grape (POST-H)
Hickory nuts (POST-H)
Honeydew melons (POST-H)
Horseradish (POST-H)
Kumquats (POST-H)
Current
Tolerance
(ppm)
200.0
20.0
200.0
50.0
30.0
50.0
75.0
100.0
50.0
240.0
50.0
200.0
30.0
100.0
20.0
200.0
50.0
100.0
30.0
20.0
200.0
20.0
30.0
30.0
Tolerance
Reassessment
(ppm)
150.0 a
5.0 a
150.0 a
2.0 a
2.0 a
8.0
Revoke
8.0
8.0 a
Revoke
5.0 a
Revoke
7.0 a
150.0 a
2.0 a
3.0 a
2.0 a
4.0
150.0 a
5.0 a
3.0 a
2.0 a
Comment/Correct Commodity Definition
See comments under almonds.
See comments under apricots.
See comments under almonds.
Reassign to crop group tolerance for residues
in/on the Bulb Vegetables Group.
Commodity fumigation trials support a
decreased tolerance level.
Reassign to crop tolerance for residues in/on
Citrus Fruits Group. Commodity fumigation
trials support a decreased tolerance level.
Commodity fumigation trials support a
decreased tolerance level.
The MBIP is not supporting these uses.
The MBIP is not supporting this use.
However, APHIS has requested to retain this
tolerance.
See comments under barley.
The MBIP is not supporting this use.
See comments under cantaloupe.
Covered by tolerance for residues in herbs and
spices.
Reassign to crop group tolerance for residues
in/on the Fruiting Vegetables Group.
Commodity fumigation trials support a
decreased tolerance level.
See comments under almonds.
See comments under Cippolini bulbs.
See comments under artichoke, Jerusalem.
See comments under citrus citron.
Commodity fumigation trials support a
decreased tolerance level.
See comments under almond.
See comments under cantaloupe.
See comments under artichokes, Jerusalem.
See comments under citrus citron.
18
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Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Lemons (POST-H)
Limes (POST-H)
Mangoes (POST-H)
Muskmelons (POST-H)
Nectarines (POST-H)
Oats (POST-H)
Okra (POST-H)
Onions (POST-H)
Oranges (POST-H)
Papayas (POST-H)
Parsnips (POST-H)
Peaches (POST-H)
Peanuts (POST-H)
Pears (POST-H)
Peas (POST-H)
Peas, black-eyed (POST-H)
Pecans (POST-H)
Peppers (POST-H)
Pimentos (POST-H)
Pineapples (POST-H)
Pistachio nuts (POST-H)
Plums (POST-H)
Pomegranates
Potatoes (POST-H)
Pumpkins (POST-H)
Quinces (POST-H)
Radishes (POST-H)
Rice (POST-H)
Rutabagas (POST-H)
Current
Tolerance
(ppm)
30.0
30.0
20.0
20.0
20.0
50.0
30.0
20.0
30.0
20.0
30.0
20.0
200.0
5.0
50.0
50.0
200.0
30.0
30.0
20.0
200.0
20.0
100.0
75.0
20.0
5.0
30.0
50.0
30.0
Tolerance
Reassessment
(ppm)
Revoke
5.0 a
5.0 a
8.0 a
7.0
2.0 a
2.0 a
Revoke
3.0 a
5.0 a
150.0
8.0 a
3.0 a
150.0 a
7.0 a
5.0
150.0 a
5.0 a
Revoke
3.0 a
5.0 a
8.0 a
3.0 a
8.0 a
3.0 a
Comment/Correct Commodity Definition
No registered use or MBIP is not supporting.
See comments under cantaloupe.
See comments under apricot.
See comments under barley.
The MBIP is not supporting this use.
However, APHIS has requested to retain this
tolerance.
See comments under Cippolini bulbs.
See comments under citrus citron.
No registered use or MBIP is not supporting.
See comments under artichoke, Jerusalem.
See comments under apricot.
No registered use or MBIP is not supporting.
However, APHIS has requested to retain this
tolerance.
See comment under apples.
See comments under beans.
See comment under almonds.
See comment under eggplants.
Commodity fumigation trials support a
decreased tolerance level.
See comment under almonds.
See comment under apricots.
No registered use or MBIP is not supporting
See comments under artichokes, Jerusalem.
See comments under cantaloupes.
See comments under apples.
See comments under artichokes, Jerusalem.
See comments under barley.
See comments under artichokes, Jerusalem.
19
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Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Rye (POST-H)
Salsify, roots (POST-H)
Sorghum, grain (POST-H)
Soybeans (POST-H)
Squash, summer (POST-H)
Squash, winter (POST-H)
Squash, zucchini (POST-H)
Strawberries (PRE- and POST-H)
Sweet potatoes (POST-H)
Tangerines (POST-H)
Timothy, hay (POST-H)
Tomatoes (POST-H)
Turnips, roots (POST-H)
Walnuts (POST-H)
Watermelons (POST-H)
Wheat (POST-H)
Current
Tolerance
(ppm)
50.0
30.0
50.0
200.0
20.0
20.0
20.0
60.0
75.0
30.0
50.0
20.0
30.0
200.0
20.0
50.0
Tolerance
Reassessment
(ppm)
8.0 a
3.0 a
8.0 a
3.0 a
5.0 a
0.05
3.0 a
2.0 a
Revoke
7.0 a
3.0 a
150.0 a
5.0 a
8.0 a
Comment/Correct Commodity Definition
See comments under barley.
See comments under artichokes, Jerusalem.
See comments under barley.
See comments under beans.
See comments under cantaloupes.
Commodity fumigation trials support a
decreased tolerance level.
See comments under artichokes, Jerusalem.
See comments under citrus citron.
No registered use or MBIP is not supporting
See comments under eggplants.
See comments under artichokes, Jerusalem.
See comments under almonds.
See comments under cantaloupes.
See comments under barley.
Tolerances listed under 40 CFR §185.123 (a)(2):
Dried eggs
Parmesan cheese
Roquefort cheese
Tomatoes, concentrated products
Figs, dried
b Processed foods, excluding
chocolate, other than those listed
above
Herbs, processed
Spices, processed
Fermented malt beverages
400
325
325
250
250
125
400
400
25
10.0
10.0
35.0
35.0
Revoke
Reassign to "processed foods, excluding
chocolate" under §180.123 (a)(2).
Processed foods, excluding chocolate
Tolerance level can be lowered to cover levels
of methyl bromide detected in processed food
fumigation trials.
This tolerance can be lowered to cover levels
of methyl bromide detected in processed herb
and spice fumigation trials.
No registered use
Tolerances listed under 40 CFR §185.123 (a)(3):
Dog food
Barley, milled fractions
Corn, milled fractions
400
125
125
Revoke
10.0
This is not considered a human food use and
therefore the tolerance is not required.
Reassign to "processed feeds" under §180.123
(a)(3).
20
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Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Sorghum (milo), grain, milled
fractions
Oats, milled fractions
Rice, milled fractions
Rye, milled fractions
Wheat, milled fractions
Current
Tolerance
(ppm)
125
125
125
125
125
Tolerance
Reassessment
(ppm)
Comment/Correct Commodity Definition
Tolerance listed under 40 CFR §180.123 (c):
Ginger, roots (PRE- and POST-H)
100
Revoke
Use will be covered by tolerance for residues
in/on the Root and Tuber Vegetables Group.
Tolerance listed under 40 CFR §180.521(a)(3):
Cereal grain, milled fraction
125
Revoke
Residues for the milled fractions would be no
higher than that of the raw agricultural
commodity and are therefore this tolerance is
not needed.
Tolerance listed under 40 CFR §180.522(a):
Cereal grains
Fermented malt beverages
125
125
Revoke
Revoke
There are no registered fumigation uses of
methyl bromide on these products.
Tolerances needed under 40 CFR §180.123 (a)(l):
Vegetable, root and tuber, group 1
Vegetable, bulb, group 3
Vegetable, leafy, group 4
Vegetable, Brassica leafy, group 5
Vegetable, legume, group 6
Vegetable, fruiting, group 8
Vegetable, cucurbit, group 9
Fruit, citrus, group 10
Fruit, pome, group 1 1
Fruit, stone, group 12
Berry group 13
Nut, tree, group 14
Grain, cereal, group 15
Kiwifruit
None
None
None
None
None
None
None
None
None
None
None
None
None
None
3.0
2.0
0.5
1.0
3.0
7.0
5.0
2.0
8.0
5.0
0.5
150.0
8.0
5.0
Crop group tolerance recommendations are
based on maximum methyl bromide residues
in/on representative commodities of each
group in commodity fumigation trials.
The available data would support a tolerance
of 5.0 ppm if a registrant intends to include a
use on kiwifruit on MeBr labels.
Tolerances needed under 40 CFR §180.123 (a)(2):
21
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Table 1. Revised Tolerance Reassessment Summary for Methyl bromide
Commodity
Chocolate products
Processed foods, excluding
chocolate
Current
Tolerance
(ppm)
None
None
Tolerance
Reassessment
(ppm)
55.0
10.0
Comment/Correct Commodity Definition
The available residue data on processed foods
support a separate tolerance for "chocolate,
products" at 55.0 ppm.
The available residue data on processed foods
support a tolerance for "processed foods,
excluding chocolate" at 10.0 ppm.
Tolerances needed under 40 CFR §180.123 (a)(3):
Processed feeds
None
10.0
The available residue data on processed foods
also supports at 10 ppm tolerance for
"processed feeds".
a Reassessed tolerance for the associated crop group.
b For tolerance reassessment purposes, this one term accounts for 18 reassessments because after the enactment of
FQPA, this term was entered as 18 separate items in the Tolerance Index System (TIS). The 18 items include
barley, flour; biscuit mixes; bread mixes; breading; cake mixes; cookie mixes; flours, cereal and related products;
macaroni products; noodle products; oats, flour; pie mixes; processed food; rice, cracked; rice, flours; rye flour;
sorghum, milo, flours; soya, flour; vegetables, dried.
b. Pre-Plant Soil Uses
There are 12 tolerances currently established for residues of inorganic bromide resulting
from methyl bromide soil fumigation (40 CFR 180.199). However, EPA has classified methyl
bromide as a non-food use pesticide with regard to its soil fumigant uses and has proposed to
revoke tolerances for soil fumigation related inorganic bromide. The Agency stated that although
methyl bromide is used as an agricultural pesticide, it is considered a non-food use chemical for
soil fumigation uses since it is quickly degraded or metabolized in the soil, and subsequently
incorporated into natural plant constituents. Methyl bromide is also emitted to the atmosphere.
Residues of the parent compound are not likely to be found in foods as a result of prior treatment
of fields. While residues of inorganic bromide may be present, these residues are
indistinguishable from background levels of inorganic bromide because of its ubiquity in the
environment. Therefore, tolerances are not required for soil fumigant uses of methyl bromide,
and tolerances currently established for residues of inorganic bromide resulting from methyl
bromide soil fumigation have been proposed for revocation by the Agency. On May 31, 2006,
EPA issued a proposed rule to revoke the twelve tolerances for residues of inorganic bromide
from pre-plant soil uses (71 FR 30845) and accepted comments for 60 days. The Agency
anticipates issuing a final rule that revokes the 12 tolerances in August 2006, after the Agency
has completed its review of any comments received.
The rationale for why tolerances are not needed for pre-plant soil uses is provided in the
Agency's February 8, 2006, memo, "Methyl Bromide: Tolerance Revocation of Inorganic
Bromides. PC Code: 053201, DP Barcode: D304618."
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As of April 26, 2006, the Agency considered the existing 12 tolerances from soil
fumigation reassessed (see April 26, 2006, memo "Completion of Tolerance Reassessment For
Inorganic Bromides Resulting from Soil Treatment" from D. Edwards, Special Review &
Reregistration Division Director to J. Jones, Office of Pesticides Program Director).
D. Regulatory Rationale
1. Dietary (food + drinking water) Risk
The Agency's assessment of dietary risk from food plus drinking water exposure does not
exceed the Agency's level of concern. Based on conservative estimates of exposure through
food and drinking water, dietary risks are below EPA's level of concern for the general
population and all population sub-groups. The following sections describe the details of the
Agency's food and water exposure estimates.
a. Food
For all included commodities, the acute and chronic risks do not exceed the Agency's
level of concern for the general U.S. population and all population subgroups. The acute dietary
food exposure estimate for females 13-49 years old, the population subgroup with the highest
acute risk, is at 2.4% of the aPAD. The chronic dietary food exposure estimate for children (3 to
5 years old), the most highly exposed population subgroup, is 10% of the cPAD. The acute and
chronic exposure estimates are considered to be very conservative since it was assumed that
100% of the crops were treated with methyl bromide. This is likely to be an overestimate of the
percent that is treated. Therefore, no mitigation is necessary to address the risks associated with
food.
b. Drinking Water
The Agency typically does not estimate transport of pesticides from indoor uses such as
methyl bromide's commodity uses to surface or ground water. However estimated drinking
water concentrations (EDWCs) for methyl bromide's soil uses were developed for surface and
ground water and were determined to be below EPA's level of concern.
For pre-plant soil uses, Florida strawberries resulted in the highest modeled surface water
concentration of 357 |ig/L for acute exposure, and 1.0 |ig/L for the chronic exposure. The
surface water EDWCs are considered conservative, upper-bound estimates of potential
concentrations of methyl bromide in drinking water, and EPA believes actual concentrations are
likely to be much lower. This is due to several factors which including:
Methyl bromide is a highly volatile compound and rapid volatilization from soil and
surface water is expected to significantly reduce the potential concentrations of methyl
bromide in drinking water.
23
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Modeled EDWCs represent potential methyl bromide concentrations in raw (i.e.,
untreated) drinking water. EPA expects additional volatilization and degradation to occur
between the reservoir and the point of consumption.
The EDWCs are based on applications to the most sensitive surface water/crop scenario
(Florida strawberries) at the maximum application rate. Further, the assessment assumes
that 87% of a watershed is planted in strawberries, and all strawberries in the watershed
are treated with methyl bromide at the same time.
The PRZM/EXAMS models have limited capability to capture the effect of using tarps to
contain methyl bromide, which is the standard application method for strawberries in
Florida.
The EDWCs are l-in-10 year maximum concentrations.
Groundwater concentrations were not estimated for methyl bromide because the model
used for estimating groundwater concentration, SCIGROW, has limited capability to model
vapor phase transport of methyl bromide to groundwater. Therefore, EPA used monitoring data
to estimate potential exposure to MeBr in ground water. Based on a database of pesticides in
groundwater, two wells in California (out of 20,429 wells monitored in Florida, California, and
Hawaii) had detections of methyl bromide at levels from 2.5 - 6.4 |ig/L. Given the
concentrations detected, that two of the three states monitored account for the vast majority of
MeBr use in the U.S., and the number high of samples with non-detects, the Agency has
concluded that the potential exposure to methyl bromide in ground water is negligible.
The Agency has determined that the drinking water risk from methyl bromide from
commodity uses is much lower than for soil uses and the potential for MeBr exposure through
drinking water is negligible since essentially all of the methyl bromide applied during
commodity fumigation is emitted to the atmosphere and does not readily transport to drinking
water sources. For further details on the Agency's drinking water exposure analysis, see the
June 6, 2005, document "Environmental Fate and Ecological Risk Assessment for the
Reregistration of Methyl Bromide."
2. Residential Risks
The human health risk assessment indicates that acute inhalation exposures to methyl
bromide concentrations of 1 ppm or greater for an 8-hour time weighted average (TWA) pose
risks of concern for residential bystanders. The 1 ppm 8-hour TWA is based on the 8-hour TWA
human equivalent concentration (FIEC) of 30 ppm from a developmental rabbit inhalation study
where the fetal effects are presumed to occur after one exposure and an uncertainty factor (UF)
of 30 with a 3x for interspecies extrapolation and lOx for intraspecies variation (i.e. 30 ppm/30
UF = 1 ppm). For further details on the HEC and UF, see the Agency's March 10, 2006, memo,
"Methyl Bromide: Phase 5 Health Effects Division (HED) Human Health Risk Assessment for
Commodity Uses. PC Code: 053201, DP Barcode: D304623." In the case of MeBr, these
residential bystander exposures are to any person who lives or works in the vicinity of a
fumigation site. The mitigation measures described below are expected to ensure that acute
exposures do not exceed this level. The Agency has concluded that measures to ensure that
24
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acute risks are below EPA's level of concern will also mitigate risks for other exposure durations
(i.e. short-term, intermediate-term, and chronic) to levels below EPA's level of concern. In
addition, many of the mitigation measures are expected to indirectly reduce the amount of
methyl bromide used or emitted into the atmosphere and therefore will reduce the potential risks
associated with stratospheric ozone depletion resulting from methyl bromide commodity uses.
The Agency believes that a comprehensive approach that requires mitigation measures
such as fumigation management plans (FMPs), buffer zones, air monitoring, posting and
notification, and record keeping, will ensure that acute risks from inhalation exposure to both
workers involved in the fumigation process and bystanders in areas around enclosures do not
exceed EPA's level of concern. California established permit conditions for methyl bromide
commodity fumigations in 1994 that included the use of buffer zones and other measures that are
similar to what EPA is now requiring. A recent analysis conducted by the California Department
of Pesticide Regulation (CDPR) indicates a major reduction of injury and illnesses associated
with methyl bromide commodity fumigations since permits were required. CDPR attributes this
reduction in large part to the conditions under which permits are granted. Further details
regarding California's permit conditions for MeBr commodity fumigations are available on
CDPR's website (http://www.cdpr.ca.gov/docs/enfcmpli/penfltrs/penf2001/2001048.htm).
Quarantine fumigations supervised by USDA's Animal and Plant Health Inspection
Service (APHIS) account for a large percentage of the total commodity fumigations performed in
the US. The EPA has worked closely with APHIS in the development of the Agency's risk
assessment and mitigation measures. Many of the fundamental elements (e.g., FMPs, buffer
zones, air monitoring, record keeping, etc.) of the mitigation measures that are being required by
this decision document for commodity fumigations are already required and enforced by on-site
APHIS Plant Protection and Quarantine Officers (PPQOs).
The mitigation measures detailed below will require the applicator/fumigator to develop a
fumigation management plan (FMP), or ensure one exists for each specific site that will be
fumigated with methyl bromide. Required elements of the FMP are listed below in Section E.
In developing this plan, the fumigator will determine the distance, called a buffer zone, which
will protect workers and bystanders from exposure to methyl bromide that could exceed the
Agency's level of concern. The Agency will provide guidance in the form of buffer zone look-
up tables to enable fumigators to protect workers and bystanders. These tables will be available
on the Agency internet website along with an Agency methyl bromide commodity fumigation
reference manual. If, based on the current site conditions (e.g., local exhaust ventilation systems,
enclosure/chamber/structure retention rates, size of treatment area, etc.), the size of the buffer
zone listed in the Agency's look-up-tables is not feasible due to encroachment of occupied
areas/structures, the fumigator can opt to modify the fumigation parameters or alter the site
conditions so that a smaller buffer zone can be used. Examples of alternative approaches include
but are not limited to:
Reducing application rates
25
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Extending treatment time and allowing methyl bromide concentrations to slowly decline
before starting active aeration (e.g., in California, large mills are extending treatment time
from 24 to 48 hours to attain smaller buffer zones)
Subdividing treatment areas
Installing or modifying local exhaust ventilation systems (e.g., location/height of exhaust
outlet)
Improving the tightness or retention capacity of the enclosure/chamber/structure
Empirically deriving retention or loss rates of the enclosure/chamber/structure (e.g.,
CDPR uses a one-time procedure where the low rate of 1 Ib ai/1000 ft3 rate is used with
an empty chamber to determine loss rate)
Installing capture recovery or destructive systems (e.g., scrubbers)
If these options do not result in feasible buffer zones for the site, there are additional
alternatives detailed below that will give fumigators more flexibility but still ensure that methyl
bromide levels do not exceed the Agency's level of concern (e.g., buffers based on site-specific
modeling and air monitoring, with limited exceptions for traffic and other areas provided certain
conditions are met). Although the Agency believes the approach outlined here offers substantial
flexibility for site-specific solutions that are protective of workers and bystanders, it also
recognizes that there will likely be some commodity fumigation sites where MeBr will no longer
be practical to use. The mitigation measures that the Agency is requiring to protect bystanders
are described further in Section E below.
3. Aggregate Risk
a. Acute
For methyl bromide, acute dietary risks are well below EPA's level of concern for the
general U.S. population and all population subgroups based on conservative data and
assumptions as described above in the dietary risk section of this document.
Because the acute dietary and acute inhalation endpoints for methyl bromide are based on
a common effect, it would be appropriate to aggregate dietary exposures (using average, or
"chronic", dietary exposure values) with acute inhalation exposures. However, because the
dietary contribution to acute aggregate risk is negligible, EPA has determined that the mitigation
measures EPA is requiring to protect residential bystanders will ensure that acute aggregate risks
do not exceed EPA's level of concern. Therefore no additional mitigation is necessary to address
acute aggregate risk.
b. Short-, Intermediate-Term, and Chronic Aggregate Risk
EPA did not aggregate short-, intermediate-term, or chronic dietary and inhalation
exposures to methyl bromide because endpoints for dietary and inhalation exposures for these
durations are not based on common toxicological effects.
26
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4. Worker Risks
The human health risk assessment indicates that acute inhalation exposures to methyl
bromide concentrations of 1 ppm or greater for an 8-hour time weighted average (TWA) pose
risks of concern for workers. The mitigation measures described below in Section E are
designed to ensure that acute exposures for workers do not exceed this level. These measures
include requiring respiratory protection for methyl bromide air concentration levels of greater
than 1 ppm for an 8-hr TWA and establishing procedures for determining when the use of
respiratory protection may be discontinued. The mitigation measures also specify air monitoring
requirements to document the measurement of worker's potential methyl bromide inhalation
exposure throughout the fumigation process. The Agency is also requiring that fumigators
ensure that site-specific management plans that include the elements described in detail in
Section E below are in place before initiating fumigation. EPA has determined that these
requirements will protect fumigation workers as well as other onsite workers (e.g., forklift
operators and other occupational bystanders).
5. Stratospheric Ozone Depletion Risks
The focus of the Agency's mitigation measures as specified in section E below is to
ensure protection from direct acute exposure to methyl bromide from commodity uses. The
Agency concludes that many of these measures (e.g., those that reduce the total amount used or
use MeBr capture/destruction systems) combined with the methyl bromide phase-out under the
Montreal Protocol (i.e. all commodity uses except for pre-shipment and quarantine uses which
are exempt) will further reduce the potential health effects from ozone depletion, such as skin
cancer, which may result from methyl bromide's commodity uses.
6. Ecological Risk
The Agency does not perform ecological risk assessments for most indoor uses, such as
an enclosed container or perimeter treated with MeBr. Ecological risks from outdoor soil
fumigation uses of MeBr will be addressed in the reregistration decisions for those uses in 2007.
E. Residential Bystander and Occupational Risk Mitigation
The following describes the rationale for the risk management decisions for bystander
and worker risks associated with methyl bromide's commodity uses. Public comments and input
from key stakeholders were considered in making these decisions. Where labeling revisions are
warranted, specific language is set forth in summary tables of Section V of this document. It is
the Agency's goal to ensure exposures are below the Agency's level of concern but allow
flexibility for local, site-specific approaches, where feasible.
1. Site-Specific Fumigation Management Plan (FMP)
27
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Prior to fumigating commodities, a site-specific FMP must be developed and followed.
The purpose of the FMP is to ensure the safety of the fumigators, other on-site employees, the
surrounding community, and the environment. It is also designed to ensure an effective
fumigation that complies with label requirements. The responsible party (i.e., the person
supervising the fumigation) is responsible for ensuring FMPs are up-to-date and accurately
reflect the site and current circumstances for fumigation before it takes place, and that the FMPs
are followed. The Agency will provide detailed guidance for FMPs including a list of minimum
elements that site-specific plans must address. This guidance will be incorporated in a methyl
bromide commodity fumigation reference manual that will be available on the Agency's internet
website. Product labels will require FMPs be developed based on the Agency manual. Elements
that are not applicable to a given site may be so noted in the site-specific plans. The following
are elements that must be included in all FMPs unless not relevant to a specific site:
»»» General site information (site address, site operator/owner, phone number)
> Type of fumigation (e.g., quarantine, structural, mill, ship)
> Description of enclosure/chamber/structure (map or sketch of the facility, volume of
treatment area, enclosure materials, commodities fumigated, maximum rates and dosage
times, local exhaust ventilation systems, MeBr destruction/capture systems, proximity to
other structures and common walls)
> Estimate of loss/retention rate (methods for evaluating and documenting)
> Descriptions and locations of control rooms, storage areas, restricted areas, other work
areas, and sensitive surrounding sites (such as homes, schools, hospitals, employee
housing centers)
»»» Fumigator/applicator information (license #, address, phone, contact information for person
supervising the fumigation, i.e., the responsible party)
»»» Treatment and aeration procedures
> Maximum rates and dosage for each commodity
> Location of gas introduction site (including map and description)
> Leak testing procedures
> Interior and perimeter air monitoring of treated areas (methods, procedures, and
equipment)
*»* Buffer zones (see below for method to calculate treatment and aeration buffer zones based on
Agency look-up tables or alternate methods)
*»* Authorized on-site personnel
> Fumigators (fumigation workers must be certified applicators, or be working under the
direct supervision of a certified applicator)
> Other on-site workers
Personal protective equipment (selection, fit-testing, maintenance, storage procedures)
Posting and notification (plans, procedures, record of notifications)
Record keeping
Emergency procedures (evacuation routes, emergency utility shut-offs, locations of
telephones, emergency company, local/state/federal contacts, key personnel and emergency
responsibilities in case of an incident, equipment failure, or other emergency).
Site security
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»«» Hazard communication (product labels, material safety data sheets, etc.)
»»» Name, address, contact information, credentials, and signature of certifying party
The use of a comprehensive FMP will result in careful planning of all aspects of the
fumigation process. While FMPs alone will not eliminate risk, they constitute a written record
that provides specific logistical, performance, and contact information to help characterize the
site and the fumigation process.
The responsible party (i.e. the person supervising the fumigation) must certify in writing
that he/she has reviewed the FMP and that it addresses all elements required by product labels
and the Agency methyl bromide commodity fumigation reference manual, and that all decisions
on the treatment/aeration processes, buffer zones, and PPE are appropriate and protective. States
or local governments may opt to require third-party certification (e.g., county agricultural
commissioners, state pesticide enforcement officials, certified industrial hygienists, or certified
safety professionals). In that case, where fumigations are supervised by a federal authority such
as APHIS, the federal agency may certify the FMP. The responsible party must contact the
applicable State lead agency to determine the certification requirements for that state.
For emergency fumigations that must be performed with limited advance notice, (e.g.,
quarantine fumigation of a ship or other container) generic plans that are not-site specific may be
developed, completed, and certified as needed.
a. Buffer Zones
This decision requires that fumigators establish a buffer zone during the treatment and
aeration periods which the responsible party has determined will protect bystanders and workers
from risks posed by MeBr. EPA is preparing guidance to assist fumigators in making these
decisions. Only persons supervising or performing fumigation activities are permitted within the
buffer zones. All other people including workers, nearby residents, and other bystanders must be
excluded from this zone except for as provided below. The buffer zone established for the
treatment period must be maintained from the time MeBr is introduced until the aeration period
begins. An aeration buffer zone must then be established and maintained until the methyl
bromide concentration being exhausted from the enclosure is less than 5 ppm (see below for
minimum aeration times). This 5 ppm level for aeration is currently required by the product
label. It should be noted that the buffer zone during the aeration period in most fumigations will
last only a portion of the aeration period (e.g., the air being exhausted from the treated area is
less than 5 ppm but aeration is still being done until air concentration within commodity reaches
5 ppm or less).
The Agency's risk assessment provides modeled distances for treatment and aeration
periods for a wide range of sites at which acute exposures have the potential to exceed the
Agency's level of concern of 1 ppm for an 8-hour TWA if bystanders are present. The Agency
modeled potential acute bystander exposure to methyl bromide with a distributional approach
using PERFUM. The PERFUM model (V2.1.2) is available at
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http://www.sciences.com/perfutn/index.httnl and will eventually be placed on the Agency's
website at http://www.epa.gov/opphed01/models/fumigant/. The PERFUM modeling framework
was subjected to a Scientific Advisory Panel (SAP) review in 2004. Please refer to the SAP
background documents and the SAP report (http://www.epa.gov/scipoly/sap/2004/index.htm).
Additional characterization of the Agency's use of PERFUM in estimating acute bystander
exposure to methyl bromide is also included in section 6.2 of the Agency risk assessment
document.
The PERFUM model provides two types of results that include the maximum buffer
distance and the whole field buffer distance. Each is reported as a distribution of distances. The
whole field distance outputs represent the entire range of potential exposures, whereas maximum
buffer distance outputs represent a subset of the highest daily exposure levels that were
calculated. This approach provides more resolution at the highest levels of exposures. In other
words, a given percentile of the whole field distance results is essentially equivalent to a
corresponding percentile of maximum buffer distance results (i.e., 'x' percentile whole field
distance results = 'y' percentile maximum buffer distance results). The Agency considered
which PERFUM output results would adequately ensure bystander's acute exposures do not
exceed 1 ppm for an 8-hour TWA.
The Agency is basing its buffer zone distances for MeBr's commodity uses on 99th
percentile whole field distance outputs from PERFUM model results. These results represent the
distances within which all bystanders must be excluded to ensure that their acute exposure to
methyl bromide does not exceed the Agency's level of concern. EPA believes that requiring
buffers at these distances combined with other mitigation measures described in this document
will ensure that exposures will not exceed the Agency's level of concern. Furthermore, an
analysis by the Agency has determined that the distances for scenarios modeled using the 99th
percentile whole field distance outputs are in many cases is similar to the distances currently
required by California's permit conditions for MeBr commodity fumigations. As previously
noted above, the EPA believes that establishing buffers zones along with other elements of
California's permitting system have been very effective in reducing methyl bromide exposures.
It should be noted that the Agency has modeled ground level local exhaust ventilation
(i.e., the PPQ method), while CDPR prohibits this practice. The Agency will allow the use of this
method in states that do not prohibit it provided all mitigation measures described in this
document and on product labels are followed. The discharge location of the ground level
exhaust ventilation must be at least 25 feet from the enclosure (and any building that houses the
enclosure).
1) Buffer Zones Based on Agency Look-Up-Tables
The Agency will provide information in the form of look-up tables for commodity
fumigators to follow to ensure that workers and bystanders are protected. These tables will be
available on the Agency's internet website along with a methyl bromide commodity fumigation
reference manual for a full range of application rates, loss rates, local ventilation systems, and
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enclosure/chamber/structure volumes which can be determined and which must be established
for each site. Distinct buffer zones will be required during the treatment and aeration periods and
once the aeration period is completed the buffer zones may be discontinued. The Agency has
determined that establishment of these buffers will ensure that bystander exposure to methyl
bromide will not exceed the Agency's level of concern. Only authorized persons with
respiratory protection (as specified in respiratory protection section below) may be permitted
within the buffer zones.
2) Buffer Zones Based on Alternate Methods
Buffer zones that are more or less than those listed in the Agency's look-up tables may be
established based on site-specific modeling (using site-specific data such as weather, flux rates,
empirically derived or measured retention rates, etc.). The Agency recognizes that it is not
practical or feasible to capture every possible site scenario in look-up tables. Therefore buffer
zones based on site-specific enclosure/chamber/structural volumes or local exhaust ventilation
(LEV) system parameters may also be modeled for individual sites. Only models specified in the
Agency's methyl bromide commodity fumigation reference manual may be used to determine
buffer zones.
Since the number of samples needed to adequately measure maximum downwind
concentration is possible but impractical, air-monitoring data alone will likely not be sufficient to
reduce required buffer zones. However, the Agency will allow buffer zone distances to be
determined based on site-specific air monitoring that is done in accordance with criteria that will
be specified in the Agency methyl bromide commodity fumigation manual.
Air monitoring and modeling for methyl bromide destruction or capturing devices such as
scrubbers may also be used to determine the use of smaller buffer zones than those listed in the
Agency's look-up tables. While this mitigation method may not yet be currently economically
feasible for larger sites, it is one of the few options that directly reduce the total methyl bromide
released and potential ozone depletion.
3) Minimum Buffer Zones
While modeling results predict no risk concern for locations immediately adjacent to the
discharge location for some scenarios, the Agency believes that best management practices
warrant a minimum buffer for all sites. Therefore, the responsible party must determine an
appropriate minimum buffer zone based on site-specific conditions. For example, APHIS may
decide to maintain their currently required buffers of 30 ft and 200 ft buffers for treatment and
aeration periods, respectively, as a minimum buffer zone. However, EPA believes the minimum
buffers during treatment and aeration periods should never be less than 10 feet during treatment
and aeration periods. These minimum distances are based on the current requirements used by
California for commodity fumigation.
4) Exceptions
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Occupied Structures
Exceptions from buffer zones for occupied structures that are within the buffer zones may
be made in a FMP if air monitoring of methyl bromide concentrations within the occupied
structure and around the perimeter of the fumigated enclosure during treatment and aeration
periods are less than a ceiling limit of 5 ppm or an 8-hour TWA of 1 ppm. The Agency's methyl
bromide commodity fumigation reference manual will provide guidance regarding air monitoring
methods for these exceptions. Exemptions may not be used for sensitive sites (such as homes,
schools, hospitals, employee housing centers) or buildings that share a wall with an enclosure
being fumigated. FMPs must establish emergency procedures to be followed in the event air
concentrations exceed a ceiling limit of 5 ppm or an 8-hour TWA of 1 ppm at these locations
(e.g., immediate evacuation or use of respirators for workers). The specified buffer zone will be
required for all other areas. Prior to conducting fumigations, the responsible party must obtain
written acknowledgement from occupants of any structures that are exempted from buffer zones
that the occupants have received information on the hazards of methyl bromide and understand
the emergency procedures specified in the FMP.
Non-Occupied Structures
Exceptions from buffer zones for structures that have been evacuated that are within the
buffer zone may be made in the FMP. Steps must be specified that will ensure that occupants do
not reenter the structure until treatment and aeration periods are completed and that air
concentrations within the structure do not exceed 1 ppm for an 8-hour TWA when occupants
reenter the structure.
Transit
Limited transit (e.g., use of roads) for brief durations within the buffer zone may occur be
if unavoidable.
b. Posting and Notification
Workers who handle treated commodities after they are transported from fumigation sites
have a right-to-know the potential risks related to the handling of the treated commodities. This
is especially a concern for workers who handle treated commodities from which the methyl
bromide desorption rate is slow (e.g., walnuts and timber). The fumigator must provide these
workers access to the material safety data sheet (MSDS) for the methyl bromide end-use product
before workers come in contact with the treated commodities. In addition, the exterior of
containers/packaging of all treated commodities must be clearly identified as having been
fumigated with methyl bromide and aerated in accordance with EPA labels before leaving
fumigation facilities. Fumigators must also comply with applicable Department of
Transportation and any other federal, state, and local requirements for placarding vehicles
leaving fumigation sites.
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The community living or working in close proximity to commodity fumigation sites must
have accesses to information on the nature of applications taking place and potential hazrads that
nearby fumigations may pose. Specifically, fumigators must ensure that all residents and
businesses that own or occupy properties adjacent to sites where commodity fumigations with
MeBr are taking place (and those located adjacent to buffer zones specified in the FMP) have
been notified and provided with information on how the community can access FMPs for that
site. Once an initial notification is completed, notification must occur annually, or within 30
days after a change in the FMP. Notification may done via mail, newspaper, radio, television,
posting at public sites (e.g., library, court house, post office) or other methods which the
responsible party has determined is likely to ensure adjacent residents and businesses have
access to the required information.
The posting and notification requirements for the community and workers will help
ensure compliance with mitigation measures required by this decision and the product label.
Furthermore, EPA believes that when workers and members of the community are well
informed, compliance with mitigation measures is more likely to be successful and protective.
c. Record Keeping
1) Fumigation Sites
All monitoring results, application dates, and current FMPs must be kept on-site and be
made readily available to local/state/federal enforcement personnel and all workers, and be
provided upon request to any interested party in the community. FMPs must be kept and be
available for at least 2 years from the date of fumigations. Mobile or non-fixed sites (e.g., ship
holds or sites with no fixed buildings or structures after fumigation is completed) are required to
keep records on-site only during the entire fumigation process (i.e., pre-treatment, treatment, and
aeration periods). Site records may be maintained and made available to the public using the
Internet or other methods. On-sites records will be used by local, state, and federal enforcement
staff to verify compliance with EPA labels.
2) Fumigators
Responsible parties supervising fumigations must also maintain records of monitoring
results and application dates for all sites where they have conducted fumigations for at least two
years from the date of fumigations. In addition, they must also maintain FMPs for each site
fumigated for at least two years from the date of fumigations. Fumigators must also comply with
any local or State record keeping requirements.
2. Respiratory Protection for Fumigation Workers and Other On-site Workers
Respiratory protection will be required for anyone entering any area where methyl
bromide concentrations are greater than 1 ppm for an 8-hour TWA. The Mine Safety and Health
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Administration-National Institute for Occupational Safety and Health (MSHA-NIOSH)
certification for cartridges used with air purifying respirators has not been given for any
cartridges currently on the market that are specifically designed for protection against methyl
bromide. The 3M 60928 is a NIOSH-approved combination organic vapor/acid gas chemical
cartridge/Pi00 particulate filter. While NIOSH does not have a test procedure to certify air
purifying filters for protection against methyl bromide, this combination cartridge is
recommended by 3M for use against radioiodine or methyl bromide at ambient concentrations up
to 5 ppm and for not more than one shift. For further details on the 3M's recommendations, see
February 2001 "3M Technical Data Bulletin #146 Use Recommendations for 3M 60928
Cartridge/Filter" (link to 3M website:
http://multimedia.mmm.com/mws/mediawebserver.dvn76666660Zjcf61Vs6EVs666BraCOrrrrO- ). 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 (and any MSHA-NIOSH certified cartridge for MeBr that
becomes available). 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. CDPR currently allows the use of the 3M 60928 Cartridge/Filter for
methyl bromide concentrations up to 5 ppm for commodity fumigations. The current
requirement that aeration of all treated commodities continue until methyl bromide
concentrations (within the treated commodity) are 5 ppm or less will not be changed. For methyl
bromide air concentrations greater than 5 ppm, supplied air (SA) respirators or self contained
breathing apparatus (SCBA) must be worn by all fumigation workers and other on-site
personnel.
Manufacturers of direct-read instruments commonly used during fumigations specify a
limit of detection as low as 0.2 ppm (e.g., Drager Methyl Bromide Tube, Model # 0.2/a
8103391). However, fumigators and other industry stakeholders report that direct-read
instruments allow reliable measurement only as low as 2 ppm. The Agency has determined that
the use of respiratory protection can be discontinued within buffer zones specified above based
on either of the following two procedures:
Procedure 1: Daily exposure to MeBr without a respirator is less than 240
minutes. If four consecutive air samples are taken at least 15 minutes apart within
the treated area using direct read devices show that air concentrations of 2 ppm or
less, then use of respiratory protection may be discontinued. At least two
additional samples must then be taken at least 30 minutes apart. If either of these
samples is greater than 2 ppm, the use of respiratory protection must be resumed,
and can only be discontinued again if two sample readings taken at least 15
minutes apart are less than 2 ppm.
Procedure 2: Daily exposure to MeBr without a respirator is less than 160
minutes. If four consecutive air samples are taken at least 15 minutes apart within
the treated area using direct read devices show air concentrations of 3 ppm or less,
then use of respiratory protection may be discontinued. At least two additional
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samples must then be taken at least 30 minutes apart. If either of these samples is
greater than 3 ppm, the use of respiratory protection must be resumed, and can
only be discontinued again if two sample readings taken at least 15 minutes apart
are less than 3 ppm.
Under both procedures, air samples must be collected at least hourly throughout the
workday (if workers are present) after respiratory protection is discontinued to ensure
concentrations do not exceed 1 ppm for an 8 hour TWA. Records of sampling must be kept (see
record keeping requirements above). The Agency has determined that these measures will
ensure that worker exposures will not exceed 1 ppm for an 8-hour TWA.
3. Storage Areas
The Agency has concerns for when commodities are treated, aerated to 5 ppm and then
moved to storage areas where air exchange rates may not be sufficient to allow for adequate
dissipation of methyl bromide. This is especially a concern for commodities for which the
desorption rate of methyl bromide is slow (e.g., walnuts, timber, etc.). Air monitoring of all
storage areas where fumigated commodities are located must be conducted before workers
without respiratory protection are allowed to enter. The procedures described in the previous
section must be followed to determine when worker respiratory protection use is required and
when its use may be discontinued.
4. Minimum Aeration Times
a. Mechanical and Passive Aeration
Enclosures (i.e., areas fumigated) must be aerated for a minimum of 4 hours if
mechanically ventilated using fans, or 12 hours if passively ventilated. At the end of the aeration
process, the concentration within the treated commodity (or space for structural fumigations)
must be no greater than 5 ppm. The commodity may not be moved from the enclosure during
the aeration period, except where noted below. For some commodities and enclosure types,
aeration times of longer than 12 hours may be needed to achieve concentrations of 5 ppm or less.
b. Exceptions
Exceptions for these minimum aeration times are allowed under the following conditions:
Vacuum Chambers - Vacuum chambers that provide at least 4 air changes per
hour.
Aeration Outside of Fumigation Enclosure - Fumigated commodity may be
removed from the fumigation enclosure as soon as the concentration of methyl
bromide in the air spaces between the stacked commodities is less than 5 ppm and
at least ten air changes have been completed. However, the minimum aeration
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time (4 or 12 hours) must be provided before anyone is permitted to handle
(process, package) the treated commodity. In other words, the minimum aeration
time must be provided before people can handle the treated commodity. The
aeration can occur within the enclosure, a storage area, or some other holding
area. The length of time for which aeration is required can be prorated between
the time inside the enclosure and outside the enclosure if the method of aeration is
changed. For example, if two hours of mechanical aeration are completed before
the commodity is removed from the enclosure, one-half of the required aeration
has been achieved. Therefore, six hours of passive aeration outside of the
enclosure is still required (the second half of the required aeration).
Air Monitoring - Various types of monitoring may indicate that the minimum
aeration times can be reduced. This may involve testing the rate of desorption for
a specific commodity or monitoring workers with charcoal tubes, Summa
canisters, long-path infrared spectrometer, or some other sensitive method. This
type of monitoring cannot be done with colorimetric detector tubes. Air
monitoring must be done with devices that have a limit of detection (LOD) of 0.5
ppm or lower. Additional guidance regarding monitoring requirements will be
provided in the Agency methyl bromide commodity fumigation reference manual.
The facts that support using any of these exceptions must be clearly explained in the
site'sFMP.
V. What Registrants Need to Do
The Agency has determined that with the mitigation measures identified in this
document, use of methyl bromide to fumigate commodities is eligible for reregistration;
however, additional data are required to confirm this decision. In the near future, the Agency
intends to issue Data Call-In Notices (DCIs) requiring product specific data and generic
(technical grade) confirmatory data. Generally, registrants will have 90 days from receipt of a
DCI to complete and submit response forms or request time extension and/or waiver requests
with a full written justification. For product specific data, the registrant will have 8 months to
submit data and amended labels. For generic data, due dates can vary depending on the specific
studies being required. Below are additional confirmatory generic data that the Agency intends
to require for methyl bromide's commodity uses.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of methyl bromide for the above
eligible uses has been reviewed and determined to be substantially complete. However, the data
listed below are necessary to confirm the reregistration eligibility decision documented in this
RED.
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Most pertinent product chemistry requirements data have been satisfied for the
Ameribrom 100% and Albemarle 99.8% T/TGAIs, and for the Albemarle 98% FI; however,
additional data are required for:
OPPTS Guideline 830.6314 and 7050 - T/TGAIs concerning oxidation/reduction
and UV/vis absorption
OPPTS 830.6314 - Albemarle 98% FI concerning oxidation/reduction
For further details regarding product chemistry please refer to "Reregistration of Methyl
bromide: Product and Residue Chemistry Chapters to the Reregistration Eligibility Document
(D271583, C. Olinger, 2/22/02)." This document is included in the methyl bromide docket
(EPA-HQ-OPP-2005-0123).
The assessment of occupational and residential risks associated with the use of methyl
bromide is complex. There was a significant amount of data available but additional data are
still required to confirm the findings of this document. These include both occupational
monitoring of various workers in different industry sectors and data to better assess exposures to
the general population. The types of data, guideline citations, and examples of the scenarios
which need to be addressed are presented below. Final selection of the scenarios must be
approved by the Agency. Development of data described below may fall under the Agency's
final rule for protection of human subjects (40 CFR Part 26); any such studies must comply with
the requirements of this rule.
OPPTS Guideline 875.1400 - Inhalation exposure for applicators (indoors)
Commodity - (e.g., fumigators, material handlers, aerators)
Industrial - (e.g., fumigators, material handlers, aerators)
OPPTS Guideline 875.2500 - Inhalation exposure for postapplication workers
Commodity - (e.g., forklift drivers, sorters, packagers)
Industrial - (e.g., line workers, forklift drivers)
Requirements for special studies -
Meteorological data for probabilistic modeling purposes product use information
by major use region, frequency, application
Parameters (e.g., rate, amounts treated, data, application equipment and emission
control technologies used)
Measurements of indoor methyl bromide air concentrations for residences in
proximity to treated facilities
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Measurement of ambient methyl bromide air concentrations in representative
high-use areas of the U.S.
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling must be
revised to comply with all current EPA regulations, PR Notices, and applicable policies.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
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. For questions regarding the PDCI, contact Karen Jones from
OPP/SRRD's Product Reregistration Branch at (703)308-8047 or by e-mail at
Jones. Karen@epa. gov.
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2. Labeling for End-Use Products
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
following table describes how language on the labels should be amended.
The
Table 2. Summary of Labeling Changes for Methyl Bromide Commodity Fumigation
Description
Amended Labeling Language
Placement on Label
For all Manufacturing
Use Products
Methyl bromide cannot be formulated into end-use products containing directions for use for fumigation
of commodities in chambers at ports or specialized structural fumigations at food processing
facilities unless the end-use product labeling includes requirements for site-specific fumigant
management plans, buffer zones, air concentration monitoring, aeration periods, respiratory protection
requirements and contains a reference to following all of the requirements in EPA's methyl bromide
commodity fumigation manual.
"Methyl bromide cannot be formulated into end-use products labeled for commodity use on alfalfa hay,
coffee beans, cottonseed, mangoes, papayas, pomegranates, timothy hay. End-use product labels must
be revised to delete all references to and use directions for these commodities."
Directions for Use
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 product is toxic to birds, fish, and aquatic invertebrates. 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 Pollution 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
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End Use Products Intended for Occupational Use
Identify as a fumigant any
methyl bromide end-use
product containing
directions for use for
commodity fumigation
Prominently identify the end-use product as a "Fumigant''
Insert the word
"fumigant" as part of
the product name or
close to the product
name, either as part of
the product-type
identification or as a
separate word or
sentence
Add precautionary
language in Spanish on
any methyl bromide end-
use product containing
directions for use for
commodity fumigation
Add the following Spanish signal word and statement:
"PELIGRO
Si Usted no entiende la etiqueta, busque a alquien para que se la explique a Usted en detalle. (If you do
not understand the label, find someone to explain it to you in detail.)"
On front panel of the
label near the signal
word DANGER.
Add acceptable air
concentration language to
any methyl bromide end-
use product containing
directions for use for
commodity fumigation
"AIR CONCENTRATION LEVEL
The acceptable air concentration level for persons exposed to methyl bromide from commodity uses is 1
ppm for an 8-hour time weighted average (TWA) (4 mg/m3). The air concentration level must be
measured by a direct reading detection device, such as a Matheson-Kitagawa, Draeger, or Sensidyne and
air monitoring must be conducted as specified in the "Monitoring Air Concentrations Section of this
labeling."
In the Hazards to
Humans and Domestic
Animals section of the
labeling immediately
following the
precautionary
statements.
PPE Requirements
Established by the RED
for methyl bromide end-
use products containing
directions for use for
commodity fumigation
"PERSONAL PROTECTIVE EQUIPMENT
Applicators and other handlers must wear:
~ Loose-fitting long-sleeved shirt and long pants
~ Shoes and socks
~ Protective eyewear when handling liquid.
~ In addition, when a respirator is required, protect the eyes from the vapors by wearing a full-face
respirator or face-sealing goggles with a half-face respirator.
Immediately
following^elow
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Respirator Requirements: Once methyl bromide has been introduced into an enclosure, a person
located within the treatment area, treatment buffer zone, aeration buffer zone, post-treatment commodity
storage areas, and tank storage areas may only be present without a respirator when air monitoring
procedures in the "Monitoring Air Concentration Levels" are followed. The certified applicator
supervising the fumigation must make sure that all persons in the treatment buffer zone and the aeration
buffer zone have appropriate respiratory protection or are removed from the exposure area.
Air Concentrations Greater than 5 ppm: If the methyl bromide air concentration level is measured to
be 5 ppm or greater at anytime, each person in the exposure area must wear either
~ a supplied-air respirator (MSHA/NIOSH approval number prefix TC-19C), or
~ a self-contained breathing apparatus (SCBA) (MSHA/NIOSH approval number prefix TC-13F)."
Air Concentrations of 5 ppm or less: If the methyl bromide air concentration level is measured to be
5 ppm or less, each person in the exposure area must wear one of the following types of respirator:
~ a supplied-air respirator (MSHA/NIOSH approval number prefix TC-19C), or
~ a self-contained breathing apparatus (SCBA) (MSHA/NIOSH approval number prefix TC-13F), or
~ 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. The
manufacturer must provide EPA, in writing, certification of the effectiveness of the cartridge or canister
against exposures to methyl bromide and specify the length of time (such as one 8-hour work shift) that
the cartridge or canister will remain effective. EPA will provide a list all certified cartridges and
canisters in the Agency's Methyl Bromide Commodity Fumigation Reference Manual
Air Concentrations Less than 1 ppm for an 8-hour TWA No respirator is required if the air
concentration level of methyl bromide in the working area is measured to be less than 1 ppm for an 8-
hour time weighted average (TWA).
Transit Exception: If roads or other vehicle passageways are located within the treatment buffer zone
or the aeration buffer zone, occupants of vehicles are permitted to travel through the buffer zone without
respiratory protection, provided the transit period is brief and the need for the transit is unavoidable.
User Safety Requirements
for all methyl bromide
end-use products
containing directions for
use for commodity
fumigation
"USER SAFETY REQUIREMENTS
- Respirator Requirements: When a respirator is required for use with this product, the certified
applicator supervising the fumigation must make sure that:
a) Respirators must be fit tested and fit checked using a program that conforms with OSHA's
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following Personal
Protective Equipment
-------
requirements (described in 29 CFR Part 1910.134;
b) Respirator users must be trained using a program that conforms with OSHA's requirements
(described in 29 CFR Part 1910.134;
c) Respirator users must be examined by a qualified medical practitioner to ensure the physical
ability to safely wear the style of respirator to be worn;
d) Respirators must be maintained according to a program that conforms with OSHA's requirements
(described in 29 CFR Part 1910.134.
~ Do not wear jewelry, gloves, tight clothing, rubber protective clothing, or rubber boots when handling.
Methyl bromide is heavier than air and can be trapped inside clothing or objects and cause skin injury.
~ If liquid fumigant splashes or spills on clothing, remove them at once and place them outdoors in an
isolated place to aerate, because fumes will be an intolerable source of irritation.
~ Immediately after application remove outer clothing, shoes, and socks. Do not reuse contaminated
clothing or shoes until cleaned. Keep and wash the clothing and shoes separately from other laundry.
~ Discard clothing and other absorbent materials that have been drenched or heavily contaminated with
this product. Do not reuse them.
- Follow manufacturer's instructions for cleaning/maintaining protective eyewear and respirators."
Requirements
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. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
User Safety
Requirements
(Must be placed in a
box.)
Site-Specific Fumigation
Management Plans for all
methyl bromide end-use
products containing
directions for use for
"SITE-SPECIFIC FUMIGATION MANAGEMENT PLAN (FMP)
Prior to fumigating commodities, a site-specific fumigation management plan (FMP) must be developed.
The certified applicator supervising the fumigation must ensure that the FMP is up-to-date and
applicable to the fumigation before it takes place. The minimum elements that FMP site-specific plans
In the Directions for
Use for Commodity
Fumigation under the
heading "Site-Specific
Fumigation
-------
commodity fumigation
must address, details about how to develop the FMP, and a methyl bromide commodity fumigant
reference manual are available through EPA's publication office (EPA # XXXX or at EPA's website
(www.epa.gov/XXXXX)
For emergency fumigations that must be performed with limited advance notice, (e.g., quarantine
fumigation of a ship or other container) generic (non-site-specific) plans may be developed, completed,
and certified as needed.
During the two year period following a fumigation, the site-specific FMP must be made readily
available to all fumigation workers and other on-site workers, and must be made available upon request
to any local, state, tribal, or federal pesticide enforcement personnel, and to any interested individuals in
the community.
Before the start of any commodity fumigation, the certified applicator supervising the fumigation must
certify in writing that he/she has reviewed the FMP and that it addresses all elements identified on this
labeling and in EPA's Methyl Bromide Commodity Fumigation Reference Manual. In addition, he/she
must certify in writing that the elements in the FMP related to the treatment and aeration processes,
appropriate buffer zones, and personal protective equipment are appropriate to that fumigation and that
they will be implemented according to the FMP. The signed certification must be kept for at least two
years with the FMP and application records as specified in this labeling."
Management Plan
(FMP)"
Restrictions During
Fumigation and Aeration
"BUFFER ZONES
The certified applicator supervising the fumigation must determine the buffer zone (the appropriate
distance from the fumigation site) that must be maintained during fumigation and the buffer zone that
must be maintained until the air concentration exhausted from the treatment area is 5 ppm or less. The
treatment buffer zone and the aeration buffer zone must be included in the site-specific fumigation
management plan. The appropriate buffer zones may be determined through one of the following
methods:
~ EPA's Methyl Bromide Commodity Fumigation Buffer Zone Tables located in EPA's Methyl
Bromide Commodity Fumigation Reference Manual, which is available through EPA's publication
office (EPA # XXXX or at EPA's website (www.epa.gov/XXXXX): or
~ buffer zones less than those listed in EPA's Buffer Zone Tables can be established based on site-
specific modeling using only models meeting the criteria described in EPA's Methyl Bromide
Commodity Fumigation Reference Manual. The site data needed for such models includes weather, flux
rates, measured or empirically derived retention rates, exhaust methods, and other site-specific
information. Note that air monitoring and modeling for methyl bromide destruction or capturing
devices, such as scrubbers, may be used to establish buffer zones less than those listed in EPA's Buffer
Directions for Use for
Commodity
Fumigation under the
heading "BUFFER
ZONES"
-------
Zone Tables provided that it complies with criteria described in EPA Methyl Bromide Commodity
Fumigation Reference Manual.
Minimum Buffer Zones: Regardless of the method use to establish appropriate treatment buffer zone
and aeration buffer zone, the minimum treatment or aeration buffer zone is 10 feet."
Buffer Zone Entry
Restrictions
"BUFFER ZONE ENTRY RESTRICTIONS
Entry by any person, except the certified applicator supervising the fumigation, or persons under his/her
direct supervision, is prohibited in the treatment buffer zone and in the aeration buffer zone. Authorized
persons who enter the treatment or aeration buffer zones must be wearing all of the personal protective
equipment specified for handlers on this labeling. If a structure within the treatment buffer zone or the
aeration buffer zone is not occupied (due to deliberate evacuation or other reasons), steps must be taken
to ensure that persons do not enter the structure until the treatment and aeration periods are completed
and until the air concentrations within the structure do not exceed 1 ppm for an 8-hour TWA when any
persons are permitted to re-occupy the structure..
Exceptions to Buffer Zone Entry Restrictions: Two exceptions are permitted to treatment buffer
zones and aeration buffer zones
1. Occupied Structure Exception: Occupants of a structure that is within the treatment and/or
aeration buffer zone may remain in the structure, provided continuous real-time monitoring
indicates that methyl bromide concentrations are 5 ppm or less within the occupied structure.
This exception only applies to structures occupied by occupational workers. It does not apply
to homes, apartment buildings, schools, hospitals, nursing homes, employee housing centers, or
other sensitive sites. To use this exception, the FMP must state the distance of the occupied
structure to the fumigation site, the method of conducting the real time monitoring for methyl
bromide during treatment and aeration, and specific procedures for immediate intervention,
such as cessation of aeration, evacuation of building, or supplying all occupants with
appropriate respirators if the concentration of methyl bromide exceeds 5 ppm at any time.
2. Transit Exception: If roads or other vehicle passageways are located within the treatment
buffer zone or the aeration buffer zone, occupants of vehicles are permitted to travel through
the buffer zone without respiratory protection, provided the transit period is brief and the need
for the transit is unavoidable. To use this exception, the FMP must state the distance from the
fumigation site to the vehicle passageway, the estimated length of time vehicles will be in the
buffer zone, and the rationale why occupants of the vehicle will not be adversely affected by
the exposure methyl bromide while in transit through the buffer zone."
Directions for Use for
Commodity
Fumigation under the
heading "BUFFER
ZONE ENTRY
RESTRICTIONS"
-------
Monitoring Air
Concentration Levels
"MONITORING AIR CONCENTRATION LEVELS
Monitoring Air Concentrations in Treatment Buffer Zones, Aeration Buffer Zones, and
Commodity Storage Areas: Air concentration levels must be monitored using a direct reading
detection device, such as a Matheson-Kitagawa, Draeger, or Sensidyne device. If colorimetric tubes are
used for air monitoring, measurements of 2 ppm or less should be considered and recorded as 2 ppm.
Respiratory protection must be used by all personnel who enter and remain in a treatment buffer zone, in
an aeration buffer zone, or in a commodity storage area until one of the following air concentration
monitoring procedures has been completed:
~ Procedure 1: Provided that exposure to methyl bromide by any worker who is not wearing respiratory
protection is limited to a maximum of 240 minutes (4 hours) per day, respirator protection may be
discontinued in the treatment buffer zone, the aeration buffer zone, and/or the commodity storage area,
provided four consecutive air concentration samples taken at least 15 minutes apart indicate methyl
bromide air concentration levels of 2 ppm or less and two additional air concentration samples taken at
least 30 minutes apart also indicate methyl bromide air concentration levels of 2 ppm or less. If either of
the two samples taken at least 30 minutes apart indicates a methyl bromide air concentration level
greater than 2 ppm, then respiratory protection must continue until two additional air concentration
samples taken at least 15 minutes apart indicate that methyl bromide air concentration levels are 2 ppm
or less.
~ Procedure 2: Provided that exposure to methyl bromide by any worker who is not wearing respiratory
protection is limited to a maximum of 160 minutes (2 hours and 40 minutes) per day, respirator
protection may be discontinued in the treatment buffer zone, the aeration buffer zone or the commodity
storage area, provided, provided four consecutive air concentration samples taken at least 15 minutes
apart indicate methyl bromide air concentration levels of 3 ppm or less and two additional air
concentration samples taken at least 30 minutes apart also indicate methyl bromide air concentration
levels of 3 ppm or less. If either of the two samples taken at least 30 minutes apart indicates a methyl
bromide air concentration level greater than 2 ppm, then respiratory protection must continue until two
additional air concentration samples taken at least 15 minutes apart indicate that methyl bromide air
concentration levels are 3 ppm or less.
Continued Air Monitoring: After respiratory protection is discontinued on the day of fumigation, the
certified applicator supervising the fumigation or someone under his/her supervision must continue to
monitor air concentration levels of methyl bromide in the treatment buffer zone, in the aeration buffer
zone, and in any area where the treated commodity is stored at least hourly throughout the remainder of
Directions for Use for
Commodity
Fumigation under the
heading
"MONITORING AIR
CONCENTRATION
LEVELS"
-------
the workday (when any workers are present). If at any time, methyl bromide air concentration levels
exceed 2 ppm or 3 ppm corresponding to for Procedures 1 and 2, respectively as described above , then
respiratory protection must be resumed for all personnel in the exposure area.
Recordkeeping: Records must be kept of all methyl bromide air monitoring (see recordkeeping
requirements elsewhere on this labeling)."
Aeration Period
"AERATION PERIOD
Aeration period is the time from the end of the treatment period until the concentration within the treated
commodity or space for structural fumigations is no greater than 5 ppm. The certified applicator
supervising the fumigation must determine the aeration time that is appropriate for the fumigation that
will take place. The time of the aeration period must be included in the site-specific fumigation
management plan.
Except as provided below, enclosures where methyl bromide fumigation took place must be aerated for
a minimum of:
~ 4 hours if mechanically ventilated using fans, or
12 hours if passively ventilated using windows or doors only.
The minimum aeration time is measured starting at the end of the fumigation period and the beginning
of aeration through mechanical or passive means. At the end of the aeration period, the methyl bromide
air concentration level within the treated commodity or within the space for structural fumigation must
be measured. Until the air concentration level is measured to be 5 ppm or less, the commodity cannot be
moved from the fumigation enclosure.
Exceptions to minimum aeration times: Enclosures where methyl bromide fumigation took place need
not be aerated for the minimum aeration times listed here, provided:
a vacuum chamber is used that provides at least 4 air exchanges per hour. The minimum aeration time
for such a vacuum chamber is the time from the start of aeration until 10 air exchanges have been
completed. If this exception to the minimum aeration period is used, the site-specific fumigant
management plan must explain the basis for exception, such as documentation on the designation that
the enclosure is a vacuum chamber and about the number of air exchanges per hour for the fumigation
enclosure. Criteria for vacuum chambers may found in the EPA's Methyl Bromide Commodity
Fumigation Reference Manual, which is available through EPA's publication office (EPA # XXXX or at
EPA's website (www.epa.gov/XXXXX):
various types of air monitoring indicate that the minimum aeration times can be reduced. This may
Directions for Use for
Commodity
Fumigation under the
heading "AERATION
PERIOD"
-------
involve testing the rate of desorption for a specific commodity or monitoring workers with charcoal
tubes, Summa canisters, long-path infrared spectrometer, or some other sensitive method. This type of
air monitoring cannot be done with colorimetric detector tubes. Air monitoring must be done with
devices that have a limit of detection (LOD) of 0.5 ppm or lower. Additional guidance regarding
monitoring requirements will be provided in the EPA Methyl Bromide Commodity Fumigation
Reference Manual. If this exception to the minimum aeration period is used, the site-specific fumigant
management plan must explain the basis for exception."
Moving Fumigated
Commodities from the
Fumigation Enclosure
"MOVING FUMIGATED COMMODITIES TO SEPARATE STORAGE AREAS
Fumigated commodities may be moved from the fumigation enclosure to storage areas, provided
the concentration of methyl bromide in the air spaces among the stacked commodities is measured to
be 5 ppm or less, and
at least ten air exchanges have been completed in the fumigation enclosure.
However, the minimum aeration time must be completed in the storage area before workers are
permitted to process, package, or otherwise handle the treated commodity. The total aeration time is
measured from the start of aeration in the fumigation enclosure and includes aeration time in the
fumigation enclosure plus any aeration that occurs in a holding area and aeration that occurs in the
storage area. If a combination of aeration techniques are used, the effective aeration time can be
prorated to reflect the techniques used. For example, if two hours of mechanical ventilation occur in the
fumigation enclosure before the commodity is moved to a storage area, then that constitutes one-half of
the required minimum aeration time (2 hours out of 4 hours for mechanical ventilation). If the storage
area uses passive ventilation, then the storage area would have to be passively ventilated for at least 6
hours (one half of the 12 hours for passive ventilation) before workers would be permitted to handle the
treated commodity."
Directions for Use for
Commodity
Fumigation under the
heading "MOVING
FUMIGATED
COMMODITIES TO
SEPARATE
STORAGE AREAS"
-------
Onsite Notification for all
methyl bromide end-use
products containing
directions for use for
commodity fumigation
"PLACARDING OF FUMIGATED AREAS
The certified applicator in charge of the fumigation (or someone under his/her supervision) must placard
all entrances to the fumigated area with signs bearing:
~ skull and crossbones symbol
- "DANGER/PELIGRO,"
- "Area under fumigation, DO NOT ENTER/NO ENTRE,"
~ "Methyl Bromide Fumigant in use,"
~ the date and time of fumigation, and
~ name, address, and telephone number of the certified applicator in charge of the fumigation."
"Do not enter or allow entry by unprotected persons into the fumigated area until the signs are removed.
Such signs must only be removed when aeration has occurred and when the air concentration level of
methyl bromide is monitored as described in this labeling and indicates that workers can enter without
respiratory protection. Signs must remain legible during entire posting period."
"The warning signs at entrances to fumigated structures may only be removed by the certified applicator
in charge of the fumigation (or someone under his/her supervision)."
"Vehicles leaving the fumigation site must be placarded with applicable U.S. Department of
Transportation warning signs."
In the Directions for
Use for Commodity
Fumigation under the
heading
"PLACARDING
FUMIGATED
AREAS"
Treated Commodity
Notification
TREATED COMMODITY NOTIFICATION
"The certified applicator supervising the fumigation or someone under his/her supervision must affix a
tag or label to the exterior of every container or package containing fumigated commodities that states:
'The contents of this container have been fumigated with methyl bromide fumigant and have been
aerated in accordance with EPA approved methyl bromide product labels."
The certified applicator supervising the fumigation (or someone under his/her direct supervision) must
make the Material Safety Data Sheet (MSDS) for this methyl bromide product available to workers
before they handle methyl bromide fumigated commodities.
In the Directions for
Use for Commodity
Fumigation under
"Treated Commodity
Notification"
immediately following
"Placarding of
Fumigated Areas:"
Community Notification
"COMMUNITY NOTIFICATION
The certified applicator supervising the fumigation (or someone under his/her direct supervision) must
ensure that residents and owners/operators of businesses within and immediately adjacent to the
treatment and aeration buffer zones for the facility have been notified that commodities are being
In the Directions for
Use for Commodity
Fumigation under
"NCOMMUNITY
OTIFICATION'
-------
fumigated with methyl bromide at the facility and how they can access the Fumigant Management
Plan(s) for the facility. The notification must state that in case of an accident:
~ people in the immediate area may be exposed to methyl bromide,
~ exposure to methyl bromide may result in irritation to the skin, eyes, and respiratory tract, and
~ persons who experience such symptoms should seek fresh air immediately.
The notification must take place before the first fumigation begins after the FMP is completed and must
be repeated annually or within 30 days of a change in the FMP, which ever occurs first.
The notification method must be included in the FMP and may be accomplished through mail,
newspaper, radio, television, posting at public sites, such as local library, court house, post office), or
through another method that effectively notifies persons within or immediately adjacent to the treatment
and aeration buffer zones for the fumigation facility."
immediately following
"Treated Commodity
Notification"
Recordkeeping
"RECORDKEEPING
The certified applicator supervising the fumigation or persons under his/her direct supervision must
maintain records which include the dates fumigation took place and the results of air monitoring.
During the two-year period following a fumigation, these records must be made readily available to all
fumigation workers and other on-site workers, and must be made available upon request to any local,
state, tribal, or federal pesticide enforcement personnel, and to any interested individuals in the
community. The records may be provided to the public using the Internet."
Directions for Use for
Commodity
Fumigation under the
heading
"RECORDKEEPING"
Environmental
Hazards Statements
"ENVIRONMENTAL HAZARDS
This product is toxic to wildlife. 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
Pollution 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 under
Environmental Hazards
Storage and Disposal
language of for all methyl
bromide end-use products
containing directions for
use for commodity
fumigation
"Persons moving, handling, or opening containers must wear the personal protective equipment
(including prescribed respirators when necessary) specified in the Human Hazards section of this
labeling. Store containers in a well-ventilated area."
Storage and Disposal
section of the label
Spill and Leak
Procedures of for all
methyl bromide end-use
"SPILL AND LEAK PROCEDURES
Evacuate everyone from the immediate area of the spill or leak. No person may enter into the spill or
leak area without wearing the appropriate personal protective equipment, including prescribed
In the labeling section
titled "Storage and
Disposal" or by
-------
products containing
directions for use for
commodity fumigation
respiratory protection, (see the Hazards to Humans section of this labeling),until one of the air
concentration monitoring procedures has been completed (see the Monitoring Air Concentrations
section of this labeling).
Only certified applicators or persons under their direct supervision are permitted to perform such
cleanup. Move leaking or damaged containers outdoors or to an isolated location. Observe strict safety
precautions. Work upwind, if possible. Allow spilled fumigant to evaporate.
Contaminated soil, water, and other cleanup debris is a toxic hazardous waste. Report spill to the
National Response Center (800-424-8802) if the reportable quantity of 1000 Ibs. is exceeded."
themselves under the
heading "Spill and
Leak Procedures"
General Application
Restrictions
"DIRECTIONS FOR USE
It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.
Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application. For any
requirements specific to your State or Tribe, consult the agency responsible for pesticide
regulation."
Place in the Direction
for Use directly below
the heading "Directions
for Use"
Commodity-Specific
Application Restrictions
(The product label must
list the specified
application rates in
pounds or gallons of
formulated products in
place of pounds of active
ingredient.)
End-Use Products with directions for use for commodity fumigations must have the following maximum
application rates and maximum exposure periods:
Almonds: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Apples: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Apricots: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Artichokes, Jerusalem: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period
is 4 hours.
Asparagus: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Avocados: APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period
is 4 hours. Users other than APHIS: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum
-------
exposure period is 3 hours
Barley: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Beans (succulent): maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 2
hours.
Beans (dried): maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 24
hours.
Beets (roots) : maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4
hours.
Blackberries: APHIS only: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure
period is 4 hours. Users other than APHIS: maximum application rate is 4.0 Ib ai/1000 ft3 and
maximum exposure period is 4 hours.
Blueberries: maximum application rate is 2.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Brazil nuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Broccoli: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Bushnuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Butternuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Cabbage: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Cantaloupes: APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours. Users other than APHIS: maximum application rate is 2.5 Ib ai/1000 ft3 and
maximum exposure period is 2 hours.
-------
Carrots: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Cashews: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Cauliflower: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Cherries: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Chestnuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Chestnuts: use limited to vacuum chambers only, maximum application rate is 6.0 Ib ai/1000 ft3
and maximum exposure period is 6 hours.
Cippolini bulbs: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 6
hours.
Citron Citrus Fruit: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2
hours.
Cocoa beans: maximum application rate is 1.5 Ib ai/1000 ft3 and maximum exposure period is 24
hours. Maximum number of fumigations is two with a 12-day retreatment interval.
Cocoa beans: when used in a vacuum chamber, the maximum application rate is 1.5 Ib ai/1000 ft3 and
maximum exposure period is 12 hours.
Copra: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Corn: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Corn, pop: use limited to vacuum chambers only, maximum application rate is 4.0 Ib ai/1000 ft3 and
maximum exposure period is 24 hours.
-------
Corn, sweet: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Cucumbers: APHIS only: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure
period is 4 hours. Users other than APHIS: maximum application rate is 2.0 Ib ai/1000 ft3 and
maximum exposure period is 4 hours.
Eggplant: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Filberts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Garlic: APHIS only: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4
3
hours. Users other than APHIS: maximum application rate is 2.5 Ib ai/1000 ft and maximum exposure
period is 4 hours.
Grapefruit: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Grapes: APHIS only: maximum application rate is 2.0 Ib ai/1000 ft3 and maximum exposure period is 4
hours. Users other than APHIS: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours.
Hickory nuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24
hours.
Honeydew melons: APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours. Users other than APHIS: maximum application rate is 2.5 Ib ai/1000 ft3 and maximum
exposure period is 2 hours
Horseradish: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Kiwi fruit: APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period
is 4 hours. Users other than APHIS: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum
-------
exposure period is 3 hours
Kumquats: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Leafy vegetables: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 2
hours.
Lemons: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Limes: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Macadamia nuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24
hours.
Muskmelons: APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours. Users other than APHIS: maximum application rate is 2.5 Ib ai/1000 ft3 and
maximum exposure period is 2 hours
Nectarines: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Oats: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Okra: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Onions: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 6 hours.
Oranges: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Parsnips: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Peaches: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
-------
Peanuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Pears: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Peas (with pods): maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2
hours.
Peas (dried): maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Pecans: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Peppers: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Pimentos: maximum application rate is 2.5 Ib ai/1000 ft3 and maximum exposure period is 3 hours.
Pineapples: APHIS only: maximum application rate is 2.0 Ib ai/1000 ft3 and maximum exposure period
is 6 hours. Users other than APHIS: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum
exposure period is 2 hours
Pistachios: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Plums: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Potatoes: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 6 hours.
Pumpkins: maximum application rate is 2.5 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Quinces: maximum application rate is 5.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Radishes: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
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Rice: APHIS only: when using a tarp, the maximum application rate is 9.0 Ib ai/1000 ft3 and
maximum exposure period is 12 hours. APHIS only when using a vacuum chamber, the maximum
application rate is 12 Ib ai/1000 ft3 and maximum exposure period is 12 hours. Users other than APHIS:
maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours
Rutabagas: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 6 hours.
Rye: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Salsify roots: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 3 hours.
Sorghum (grain): maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 24
hours.
Squash (summer): APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours. Users other than APHIS: maximum application rate is 3.0 Ib ai/1000 ft3 and
maximum exposure period is 2 hours
Squash (winter): APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours. Users other than APHIS: maximum application rate is 2.5 Ib ai/1000 ft3 and
maximum exposure period is 2 hours
Squash, zucchini: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2
hours.
Strawberries: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4
hours.
Sugar beets (roots): maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2
hours.
Sweet potatoes: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 4
hours.
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Tangelos: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Tangerines: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 2 hours.
Tomatoes: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
Turnips (roots) : maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 4
hours.
Walnuts: maximum application rate is 3.5 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Watermelons: APHIS only: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure
period is 2 hours. Users other than APHIS: maximum application rate is 2.5 Ib ai/1000 ft3 and maximum
exposure period is 2 hours
Wheat: maximum application rate is 3.0 Ib ai/1000 ft3 and maximum exposure period is 24 hours.
Yams: maximum application rate is 4.0 Ib ai/1000 ft3 and maximum exposure period is 4 hours.
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C. Conclusions
The Agency is issuing this Reregistration Eligibility Decision (RED) document for
commodity fumigation uses of methyl bromide, as announced in a Notice of Availability
published in the Federal Register. This RED document includes guidance and time frames for
complying with any required label changes for products containing methyl bromide. The
Agency has determined that all currently registered commodity fumigation uses of methyl
bromide are eligible for reregistration provided that the mitigation measures are adopted on
product labels.
The Agency has also determined that all methyl bromide tolerances are reassessed, as
detailed in this document. There will be a 60-day public comment period for this document to
allow stakeholders the opportunity to review and provide comments on this document.
Appendices
Appendix A: Methyl Bromide Use Patterns Eligible For Reregistration
Appendix B: Table of Generic Data Requirements and Studies Used to Make the Reregistration
Decision for Methyl Bromide
Appendix C: Technical Support Documents
Appendix D: Bibliography
Appendix E: Generic Data Call-in
Appendix F: Product Specific Data Call-In
Appendix G: EPA's Batching of Methyl Bromide Products for Meeting Acute Toxicity Data
Requirements for Reregistration
Appendix H: List of Registrants Sent Data Call-Ins
Appendix I: List of Available Related Documents and Electronically Available Forms
Appendix J: Methyl Bromide: Phase 5 Health Effects Division (HED) Human Health Risk
Assessment for Commodity Uses. PC Code: 053201, DP Barcode: D304623," (March 10, 2006)
Appendix K: Addendum To Phase 5 Health Effects Division (HED) Human Health Risk
Assessment For Commodity Uses. PC Code: 053201, DP Barcode: D304619 (July 12, 2006)
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