United States Prevention, Pesticides EPA 738-R-98-021
Environmental Protection And Toxic Substances December 1998
Agency (7508C)
&EPA Reregistration
Eligibility Decision (RED)
Methomyl
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case methomyl. The
enclosed Reregistration Eligibility Decision (RED), which was approved on September 29, 1998,
contains the Agency's evaluation of the data base of this chemical, its conclusions of the potential
human health and environmental risks of the current product uses, and its decisions and conditions
under which these uses and products will be eligible for reregistration. The RED includes the data
and labeling requirements for products for reregistration. It also includes requirements for
additional data (generic) on the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations
will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.
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If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Bonnie
Adler (703) 308-8523. Address any questions on required generic data to the Special Review and
Reregi strati on Division representative Tom Myers (703) 308-8589.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e Certification With Respect to Data Compensation Requirements Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By Express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
METHOMYL
LIST A
CASE 0028
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
METHOMYL REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY y
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 6
D. Data Requirements 14
E. Regulatory History 14
III. SCIENCE ASSESSMENT 15
A. Physical Chemistry Assessment 1_5
B. Human Health Assessment 15
1. Toxicology Assessment 1_5
a. Acute Toxicity \6_
b. Subchronic Toxicity j/7
c. Chronic Toxicity and Carcinogenicity \9_
d. Developmental and Reproductive Toxicity 20
e. Mutagenicity 22
f. Metabolism 22
2. Dose-Response Assessment 23.
a. Potential Risk to Infants and Children and FQPA Safety
Factor 23
b. Reference Dose 24
c. Carcinogenicity Classification and Risk Quantification . ... 25
d. Toxicological Endpoints 25
3. Exposure Assessment 26
a. Dietary Exposure (food sources) 26
b. Dietary Risk Assessment and Risk Characterization 34
c. Aggregate Exposure 37
d. Drinking Water Assessment 3J5
e. Cumulative Risk 39
4. Occupational and Residential 40
a. Occupational and Residential Exposure 40
b. Occupational Risk Estimates 56
c. Post-Application 5£
d. Post-Application Risks 61
e. Non-Occupational Exposures and Risks 62
C. Environmental Assessment 64
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1. Toxicity to Terrestrial Animals 64
2. Toxicity to Aquatic Animals 67
3. Toxicity to Plants 73
D. Environmental Fate 73_
1. Environmental Fate Assessment 73_
2. Terrestrial Exposure Assessment 75
3. Water Resource Assessment 76
4. Aquatic Exposure Assessment 78
E. Environmental Risk Assessment 80
1. Exposure and Risk to Nontarget Terrestrial Animals 8l_
2. Exposure and Risk to Nontarget Freshwater and Marine Aquatic
Animals 90
3. Exposure and Risk to Endangered Species 95^
4. Environmental Risk Characterization 95^
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 100
A. Determination of Eligibility 100
B. Determination of Eligibility Decision 100
1. Eligibility Decision 100
2. Eligible and Ineligible Uses 100
C. Regulatory Position 101
1. Food Quality Protection Act Findings 101
2. Tolerance Reassessment 103
3. Summary of Risk Management Decisions 114
4. Ecological Risk Mitigation for Methomyl 115
5. Restricted Use Classification 117
6. Endangered Species Statement 117
7. Labeling Rationale 117
8. Spray Drift Advisory 122
V. ACTIONS REQUIRED OF REGISTRANTS 122
A. Manufacturing-Use Products 122
1. Additional Generic Data Requirements 122
2. Labeling Requirements for Manufacturing-Use Products and End-Use
Products 124
B. Existing Stocks 137
VI. APPENDICES 139
A. Table of Use Patterns Subject to Reregistration 140
B. Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision 141
C. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision 157
D. Combined Generic and Product Specific Data Call-In 197
1. Chemical Status Sheets 217
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2. Combined Generic and Product Specific Data Call-In Response
Forms (Insert A) Plus Instructions 219
3. Generic and Product Specific Requirement Status and Registrant's
Response Forms (Insert B) and Instructions 225
4. EPA Batching of End-Use Products for Meeting Data Requirements
for Reregistration 238
5. List of All Registrants Sent This Data Call-In (insert) Notice 243
E. List of Available Related Documents and Electronically Available Forms 244
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METHOMYL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
William Gross
Jihad Alsadek
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Jose Melendez
Nick Federoff
Richard Felthousen
Nelson Thurman
Ann Stavola
Health Effects Risk Assessment
Yung Yang
John Leahy
Brian Steinwand
Cathy Eiden
Registration Support Risk Assessment
Tom Harris
Risk Management
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Toxicology Branch I
Chemistry and Exposure Branch I
Chemistry and Exposure Branch I
Risk Characterization and Analysis Branch
Insecticide-Rodenticide Branch
Tom Myers
Reregi strati on Branch II
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
drinking water) lifetime exposure at which adverse, non-carcinogenic health effects are not
anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EUP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FRSTR Final Registration Standard and Tolerance Reassessment
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 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 substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 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.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
Mg/L Micrograms per liter
mg/L Milligrams Per Liter
MOE Margin of Exposure
MUP Manufacturing-Use Product
MPI Maximum Permissible Intake
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 © of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
Background
This Reregi strati on Eligibility Decision (RED) document addresses the reregi strati on
eligibility of the pesticide methomyl, S-methyl N-((methylcarbamoyl)oxy) thioacetimidate.
Methomyl is a carbamate registered on a wide variety of sites including field, vegetable, and
orchard crops; turf (sod farms only); livestock quarters; commercial premises; and refuse
containers. Methomyl acts as an insecticide against Lepidopterous, suppresses Coleopterous and
some Hemipterous insect pests. Methomyl acts as an ovicide against cotton bollworms and
budworms.
Methomyl was first registered in the United States in October, 1968. All methomyl
products, except the 1% bait formulations, are classified as restricted use pesticides. A
Registration Standard issued in April, 1989 required additional testing, modified tolerances, and
required label modifications related to applicator safety, reentry intervals, and environmental
hazards.
Reregi strati on Eligibility
EPA has completed its reregistration eligibility decision of the pesticide methomyl. This
decision includes a comprehensive reassessment of the required target data and the use patterns of
currently registered products. This decision considered the requirements of the "Food Quality
Protection Act of 1996" (FQPA, Public Law 104-170) that amended the Federal Food Drug and
Cosmetic Act and the Federal Insecticide, Fungicide and Rodenticide Act. These are the two
Federal statutes that provide the framework for pesticide regulation in the United States. FQPA
became effective immediately upon signature. All reregistration eligibility decisions signed after
August 3, 1996 are, accordingly, being evaluated under the new standards imposed by FQPA.
In establishing or reassessing tolerances, FQPA requires the Agency to consider aggregate
exposures to pesticide residues, including all anticipated dietary exposures and other exposures
for which there is reliable information, as well as the potential for cumulative effects from
pesticides and other compounds with a common mechanism of toxicity. The Act further directs
EPA to consider the potential for increased susceptibility of infants and children to the toxic
effects of pesticide residues.
In determining whether to retain, reduce, or remove the lOx FQPA safety factor for
infants and children, EPA uses a weight of evidence approach taking into account the
completeness and adequacy of the toxicity data base, and the nature and severity of the effects
observed in pre- and post-natal studies. Although the data provided no indication of increased
sensitivity of rats or rabbits to in utero and/or postnatal exposure to methomyl, data gaps exists
for the acute and subchronic neurotoxicity studies. These studies would have yielded
cholinesterase inhibition and field observation behavior data, as well as histopathology of the
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central and peripheral nervous system which are not presently available for evaluation. The
Agency determined that the lOx safety factor to account for increased sensitivity of infants and
children should be reduced from lOx to 3x. Regarding aggregate exposure, the Agency only
considered dietary exposure from food and water because there are no homeowner uses of
methomyl.
The Agency has determined that methomyl is a degradate of thiodicarb, which is a
registered pesticide. Therefore, methomyl residues resulting from applications of both thiodicarb
and methomyl have been considered in an aggregate risk assessment and compared to appropriate
toxicological endpoints for methomyl.
The Agency does not have, at this time, available data to determine whether methomyl has
a common mechanism of toxicity with other substances or how to include this pesticide in a
cumulative risk assessment. For the purposes of this assessment, therefore, the Agency has not
assumed that methomyl has a common mechanism of toxicity with other substances.
The Agency has determined that methomyl, labeled and used as specified in this
Reregi strati on Eligibility Decision document, will not cause unreasonable risks to humans or the
environment and that these uses are eligible for reregistration. The Agency is requiring additional
data for toxicology, ecological effects, and residue chemistry that are expected to confirm the risk
assessment.
Health Effects
Methomyl was classified by the HED/RfD/Peer Review Committee as Group E, that is,
not likely to be carcinogenic to humans via relevant routes of exposure.
The RfD for methomyl was calculated to be 0.008 mg/kg/day from a two-year feeding
study in dogs with a NOEL of 2.5 mg/kg/day for males and females. The LOEL was 10
mg/kg/day based on histopathological effects in the kidney. An uncertainty factor (UF) of 100
was applied to account for intraspecies variability and interspecies extrapolation together with a
safety factor of 3x for FQPA, based on the lack of acute and subchronic neurotoxicity studies
(data gaps).
The results of the Monte Carlo acute dietary exposure analyses, for methomyl only,
indicate that there are adequate margins of exposure for the general U.S. population (MOE=958),
children 1 to 6 years of age (MOE=417), and infants (MOE=1117) from the application of
methomyl. For this analysis, percent crop treated information and field trial residue data were
utilized for all commodities.
The results of the acute aggregate exposure analyses for food, for thiodicarb and
methomyl, were compared to the methomyl acute dietary NOEL of 6 mg/kg/day. There are
adequate margins of exposure for the general U.S. population (MOE=912), children 1 to 6 years
VI
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of age (MOE=417) and infants (MOE=756). This analysis used a Monte Carlo simulation which
included anticipated residues and percent crop treated information for all commodities.
The results of the chronic dietary risk evaluation system (DRES) analyses, for methomyl
only, indicate that the anticipated residue contribution for infants occupies 67% of the RfD. For
children 1-6 years old 62.6% of the RfD is occupied and for the general U.S. population, 35% of
the RfD is occupied. For this analysis, anticipated residues were determined for only five of the
approximately 70 commodities and percent crop treated information was used for all
commodities.
Results of the chronic aggregate exposure analyses for food, for thiodicarb and methomyl,
show that the most significantly exposed subpopulation is infants (<1 year old) with 6.5% of the
RfD occupied. For children 1-6 years old 2.7% of the RfD is occupied. For the general U.S.
population, only 1.9% of the RfD is occupied. For this aggregate exposure analysis, anticipated
residues and percent crop treated information were utilized for all of the approximately 70
commodities, which is why the numbers are lower when compared to the analysis for methomyl
alone, where anticipated residues were used for only 5 commodities.
The Agency has calculated drinking water levels of concern for acute exposure to
methomyl in surface and ground water for the U.S. population and children (1-6 yrs.). They are
470 and 56 ppb, for the U.S. population and children, respectively. For chronic (non-cancer)
exposure to methomyl in surface and ground water, the drinking water levels of concern are 275
and 78 ppb for U.S. population and children (1-6 yrs old), respectively.
Estimated maximum (acute exposure) concentrations of methomyl in surface and ground
water are 30 and 20 ppb, respectively. The estimated average (chronic exposure) concentration
of methomyl in surface water is 26 ppb. Average concentrations in ground water are not
expected to be higher than the maximum concentrations. The maximum estimated concentrations
of methomyl in surface and ground water are less than the Agency's levels of concern for
methomyl in drinking water as a contribution to acute aggregate exposure. The estimated average
concentrations of methomyl in surface and ground water are less than the Agency's levels of
concern for methomyl in drinking water as a contribution to chronic aggregate exposure.
Therefore, the Agency concludes that aggregate exposure to all sources of methomyl does
not exceed the Agency's risk concerns.
To minimize the risks of potential systemic toxicity to mixers/loaders the Agency is
requiring the use of personal protective equipment and/or the use of engineering controls.
Environmental Fate and Ecological Effects
Laboratory studies indicate that methomyl is moderately persistent and highly mobile. It is
stable to hydrolysis at lower pH's (neutral to acidic) and degrades slowly in alkaline conditions.
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Methomyl photolyzes quickly in water but more slowly in soils. It is moderately stable to aerobic
soil metabolism but degrades more rapidly under anaerobic conditions. In laboratory studies,
methomyl does not readily adsorb to soil and has the potential to be very mobile. Field studies
show varying dissipation rates of the chemical in soils. Dissipation rates were related primarily to
differences in soil moisture content, which may affect the microbial activity, and rainfall/irrigation,
which could influence leaching.
Methomyl has been detected in ground water in a prospective ground water monitoring
study and in other reported incidences. While it may reach ground water under certain conditions,
methomyl will not likely persist under many conditions. Methomyl can contaminate surface water
as a result of spray drift during application or by runoff from treated sites. Methomyl would not
be expected to persist in clear, shallow waters because of its susceptibility to photolysis.
The major concerns for non-target organisms are chronic risks to non-target mammalian
and freshwater invertebrate organisms. Risks to aquatic invertebrates from exposure to methomyl
are likely to occur wherever methomyl is used. Accumulation of methomyl from repeated
applications contributes to the chronic risks.
Risk to non-target mammalian and freshwater invertebrate organisms have been
addressed by reducing the highest seasonal use rates between 11 to 20 percent on eight crops.
These crops are generally the crops for which most methomyl is sold. The highest single
application rate will be reduced by 50 percent (from 1.8 pounds to 0.9 pounds). No crop will
have a single application rate above 0.9 pounds of methomyl per acre. These measures will result
in less loading of methomyl in the environment. Reductions in risk to non-target aquatic
organisms is also expected from measures that reduce the potential for spray drift during aerial or
ground applications. Risk mitigation through spray drift control requirements and buffer zones
was imposed. In addition, label statements are required to minimize the potential for ground
water and surface water contamination. A statement supporting the use of an Integrated Pest
Management (IPM) plan will also be added to the labels.
Product Reregistration
Before reregistering the products containing methomyl, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry and acute toxicity testing for each registration. After reviewing these data and the
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will be
eligible for reregi strati on only when the other active ingredients are determined to be eligible for
reregi strati on.
Vlll
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C.136 et seq. The FQPA amendments went into effect immediately. As a result,
EPA is embarking on an intensive process, including consultation with registrants, States, and
other interested stakeholders, to make decisions on the new policies and procedures that will be
appropriate as a result of enactment of FQPA. This process will include a more in depth analysis
of the new safety standard and how it should be applied to both food and non-food pesticide
applications. The FQPA did not, however, amend any of the existing reregistration deadlines in
section 4 of FIFRA. The Agency, will therefore, continue its ongoing reregistration program
while it continues to determine how best to implement FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of methomyl. The document consists of six sections. Section I is the introduction.
Section II describes methomyl, its uses, data requirements and regulatory history. Section III
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV presents the reregistration decision for methomyl. Section V discusses the
reregistration requirements for methomyl. Finally, Section VI contains the Appendices which
support this Reregistration Eligibility Decision. Additional details concerning the Agency's review
of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility
Decision:
! Common Name:
Methomyl
! Chemical Name:
! Chemical Family:
S-methyl N-((methylcarbamoyl)oxy) thioacetimidate
Carbamate
! CAS Registry Number: 16752-77-5
! OPP Chemical Code:
090301
Empirical Formula:
C5H10N202S
! Trade and Other Names: Lannate
! Basic Manufacturer:
B. Use Profile
E.I. du Pont de Nemours and Company Inc.
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of methomyl is contained
in Appendix A.
Type of Pesticide: carbamate insecticide and molluscicide
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Use Sites:
TERRESTRIAL FOOD CROP
leafy vegetables, cucumber, cucurbit vegetables, melons, melons (cantaloupe),
melons (water), pumpkin, squash (summer), eggplant, beets, groundcherry
(strawberry tomato/tomatillo), pepper, broccoli, broccoli raab, broccoli (chinese),
brussels sprouts, cabbage, cabbage (chinese), cauliflower, celery, chard (swiss),
chicory, collards, dandelion, endive (escarole), fennel, kale, lettuce, lettuce (head),
lettuce leaf (black seeded simpson, salad bowl, etc.), parsley, spinach, avocado,
pomegranate, asparagus, onions (green and bulb), pecan, pear, artichoke
(Jerusalem), beets (roots and tops), carrot (roots and tops), garlic, horseradish,
radish, sweet potato, blueberry, strawberry, nectarine, peach, grapefruit, lemon,
orange, tangelo, tangerines, mint, peppermint, spearmint, tomato, barley, oats,
rye, wheat, corn (field), corn (pop), corn (sweet), corn (unspecified), cotton
(unspecified), peanuts (unspecified), sorghum (unspecified), soybeans
(unspecified), mustard (greens), turnip (greens), apple, potato (white/Irish), onion,
beans (dried-type), beans (succulent), lentils, peas (field), peas (succulent), peas
(unspecified), grapes, sugar beet.
TERRESTRIAL FEED CROP
bermudagrass, alfalfa, lentils, sugar beets (including tops).
TERRESTRIAL NON-FOOD CROP
commercial/institutional/industrial premises/equipment (outdoor), manure,
cattle/swine feedlots and surrounding areas, recreational areas, refuse/solid waste
sites (outdoor), tobacco, animal kennels/sleeping quarters (commercial), turf sod
farms, tree nuts (non-bearing), deciduous fruit trees (non-bearing).
INDOOR FOOD
agricultural/farm structures/buildings and equipment, dairy farm milk handling
facilities and equipment, livestock, food/meat/dairy/poultry processing plant,
premises/equipment, food/grocery marketing/storage/distribution.
INDOOR NON-FOOD
agricultural/farm structures/buildings and equipment, silos,
commercial/industrial/institutional premises and equipment, commercial
storages/warehouses premises (indoor), eating establishments, egg handling
facilities and equipment, fur and wool bearing animals, fur farm
equipment/premises, rabbits, animal kennels/sleeping quarters (commercial), horses
(show/race/special/ponies), incinerators.
-------
Target Pests:
Invertebrates (insects and related organisms, molluscs, fouling organisms and
miscellaneous invertebrates). Including: alfalfa blotch leafminer, alfalfa caterpillar,
alfalfa looper, alfalfa weevil (larvae), aphids, apple aphid, armyworm and eggs,
asparagus beetle, aster leafhopper, avocado leafroller, avocado looper, bean leaf
beetle, beet armyworm and larvae, beet webworm, black bean aphid, black
cutworm, blueberry budmoth, blueberry leafhopper, blueberry leafroller, blueberry
maggot, bollworm and eggs/larvae, budworms, cabbage looper, cabbageworms,
carrion beetle, catfacing insects, cereal leaf beetle, chaff scale, cherry fruitworm,
citrus cutworm, climbing cutworms, codling moth,corn earworm and larvae/eggs,
corn rootworm beetles (adult), corn rootworms (adult), cotton aphid, cotton
fleahopper, cotton leaf perforator (larvae), cotton leafworm, cranberry fruitworm,
crickets, cucumber beetles, cutworms, darkling ground beetles, diamondback
cabbage moth, diamondback moth, egyptian alfalfa weevil (larvae), european corn
borer and eggs/larvae, fall armyworm and larvae, flea beetles and larvae, forest tent
caterpillar, fruittree leafroller, fruitworms, glover scale, granulate cutworm, grape
berry moth, grape leaffolder, grapeleaf skeletonizer, grasshoppers, green
cloverworm, green fruitworm, green peach aphid, hornworms, house fly, imported
cabbageworm,leafhoppers, lesser appleworm, loopers, lygus bugs (adults and
nymphs), melon aphid, melonworm, mexican bean beetle, mint flea beetle,
obliquebanded leafroller, omnivorous leafroller, omnivorous leaftier, omnivorous
looper, orange tortrix, oriental fruit moth, pea aphid, peach twig borer,
pickleworm, picnic beetle, plant bugs, potato leafhopper, potato tuberworm,
purple scale, redbacked cutworm, redbanded leafroller, rosy apple aphid, saltmarsh
caterpillar, sawflies (larvae), sharpnosed leafhopper, silverspotted skipper, sod
webworms, soft brown scale, sorghum midge, sorghum webworm, southern
armyworm, soybean looper and larvae, spirea aphid, spotted asparagus beetle,
spotted cucumber beetle, spruce budworm (larvae), stink bugs, striped grass
loopers, tarnished plant bug, tentiform leafminers, thrips, tobacco budworm and
eggs/larvae, tomato fruitworm, tomato hornworm, tomato pinworm, tubeworms,
tufted apple bud moth, tussock moths, variegated cutworm, variegated leafroller,
velvetbean caterpillar, weevils, western flower thrips, western tent caterpillar,
western tussock moth, western yellowstriped armyworm, white apple leafhopper,
white cutworm, whiteflies, yellow scale and yellowstriped armyworm.
Types/Formulations Registered:
Manufacturing product, bait/solid, dust, granular, soluble concentrate/liquid and
solid.
Methods and Rates of Application:
Types of Treatment: Bait application; Band treatment; Broadcast; Brush-on; Dust;
Feed lot treatment; Foliar treatment; Ground spray; High volume spray (dilute);
-------
Low volume spray (concentrate); Outdoor premise treatment; Soil band treatment;
Spray; Ultra low volume spray.
Equipment: Aircraft; bait box; brush; cup; duster; glove; granule applicator;
ground; high volume ground sprayer; low volume ground sprayer; package
applicator; scoop; shaker can; shaker jar; sprayer; ultra low volume sprayer
Rates: See Appendix A
Timing: Normally applied when pest pressure is highest on a "When Needed"
basis. With fruit crops during the bloom, petal fall, prebloom and leaf stages. On
corn, can be applied during the whorl/foliar stages. With other crops, application
is during the foliar or leaf stages of the crop.
Use Practice Limitations: (these do not apply to all uses on all products)
Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes).
Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply in residential areas.
Do not apply through any type of irrigation system.
Do not apply to food or feed contact surfaces.
Do not apply where runoff is likely to occur.
Do not contaminate food or feed.
Do not contaminate water, food or feed.
Do not discharge effluent containing this pesticide into sewage systems without
notifying the sewage treatment plant authority (POTW).
Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license restriction).
Do not discharge into lakes, streams, ponds, or publicwater unless in accordance
with NPDES Permit.
Do not make more than applications per crop cycle (10, 3).
Do not place in locations accessible to children, pets or domestic animals.
Do not store or use in or around the home or home garden.
Do not use in homes.
Do not use in milking stalls, milking parlors, or milk houses.
Endangered species restriction.
Keep out of lakes, streams, and ponds.
Keep out of lakes, streams, ponds, tidal marshes, and estuaries.
Preharvest interval not located on the label.
Proper ventilation required
Runoff from treated areas may be hazardous to aquatic organisms in neighboring
areas.
-------
day(s) prefeeding interval (10, 12, 3).
day(s) pregrazing interval (10, 3).
day(s) preharvest interval (1, 10, 14, 15).
Site/Application Limitations: (these apply to specific methods and rates of
application)
Do not make more than applications per crop cycle (6, 10).
day(s) pregrazing interval (3, 5, 7, 10, 14, 30).
Do not graze livestock in treated areas.
_ day(s) prefeeding interval (3, 7, 10, 12, 14, 21, 30).
Do not feed to livestock.
Do not feed or graze animals on treated areas.
Do not feed treated forage to livestock.
Do not feed treated vines to livestock
_ day(s) preharvest interval. (0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 15, 21, 25, 30, 40, 65,
80)
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticidal uses of
methomyl. These estimates are derived from a variety of published and proprietary sources
available to the Agency. The data, reported on an aggregate and site (crop) basis, reflect
annual fluctuations in use patterns as well as the variability that results from using data
from various information sources.
An estimated 2.5 to 3.5 million pounds active ingredient of methomyl are applied
annually in the U.S. Almost 100 percent of lettuce, artichokes, asparagus, okra, oriental
vegetables, and rhubarb are treated. Almost 75 percent of pomegranates are treated.
Between 50 and 60 percent of peppers (sweet), sweet corn and sweet corn (fresh) are
treated. Between 40 to 50 percent of cabbbage, cole crops, eggplants/peppers and
tomatoes (fresh) are treated.
The table on the following pages shows the estimated typical annual usage of
methomyl.
-------
COLUMN HEADINGS
Wtd Avg = Weighted average~the most recent years and more reliable data are weighted more heavily.
Est Max = Estimated maximum, which is estimated from available data.
Average application rates calculated from the weighted averages.
NOTES ON TABLE DATA
Usage data primarily covers 1987 - 1995.
Calculations of the numbers may not appear to agree because they are displayed as rounded:
to the nearest 1000 for acres treated or Ib. a.i. (Therefore 0 = < 500)
to the nearest whole percentage point for % of crop treated. (Therefore 0% = < 0.5%)
0 = Available EPA sources indicate that no usage is observed in the reported data for this site, which implies that
there is little or no usage.
Definition of Crop Groups
Citrus, Other includes kumquats, limes, tangelos, and tangerines.
Cole Crops includes broccoli, Brussels sprouts, cabbage, cauliflower, mustard greens, collards, bok choy, and
chard.
Cucurbits includes cucumber, squash, and pumpkin.
Leafy Vegetables, Other includes celery, kale, parsley, and spinach.
Melons includes cantaloupe, watermelon, honeydew, muskmelon, and winter melon.
Nut Trees, Other includes chestnuts, filberts, hazelnuts, hickory nuts, macadamia nuts, pistachios, lychie nuts, and
palm.
Pome-Like Fruit, Other includes figs, kiwifruit, persimmons, pomegranates, carambolas, and papaya.
Root and Tuber Crops includes red beets, carrots, horseradish, parsnips, radish, rutabagas, sweet potatoes, turnips,
and yams.
Stone-Like Fruit, Other includes apricots, avocados, dates, nectarines, olives, coconuts, mangoes, and feijoa.
Vegetables, Other includes, artichokes, aspargus, okra, oriental vegetables, rhubarb, and truck garden.
Other Crops includes ornamentals, popcorn, rapeseed/canola, and safflower.
SOURCES: EPA data, USD A, and National Center for Food and Agricultural Policy
-------
Table 1 - Estimated Typical Annual Usage of Methotnyl
Site
Alfalfa
Almonds
Apples
Beans, Lima, Fresh
Beans/Peas, Dry
-Beans, Dry
-Peas ,Dry
Beans, Green
Beans, Snap, Fresh
Peas, Green
Berries
-Blueberries
-Raspberries
-Strawberries
Cabbage, Fresh
Cabbage
Cherries
Acres
Grown
(000)
23,949
429
572
6
2,051
1,802
249
304
81
386
121
59
11
51
84
85
128
Acres Treated
(000)
Wtd
Avg
215
0
132
1
13
11
2
57
22
14
37
22
0
15
31
37
1
Est
Max
410
0
245
2
53
45
8
103
40
43
72
43
0
29
54
65
2
% of Crop
Treated
Wtd
Avg
1%
0%
23%
16%
<1%
1%
1%
19%
28%
4%
31%
37%
0%
29%
37%
44%
1%
Est
Max
2%
0%
43%
38%
3%
0.03
0.03
34%
49%
11%
60%
73%
4%
57%
64%
76%
2%
LB AI Applied
(000)
Wtd
Avg
94
0
80
1
6
5
1
25
23
6
66
19
0
47
61
77
1
Est
Max
186
0
150
2
26
20
6
45
41
18
133
39
1
93
106
133
3
Average Application Rate
Ibai/
acre/yr
0.4
1.3
0.6
1.1
0.5
0.5
0.7
0.4406
1.0
0.4
1.8
0.9
1.8
3.2
2.0
2.1
1.4
#appl
/yr
1.0
1.0
1.0
2.3
1.0
1.0
1.0
1.0
2.6
1.0
1.0
2.0
1.0
6.4
3.9
5.5
1.0
Ibai/
A/appl
0.4
1.3
0.6
0.5
0.5
0.5
0.7
0.44065
0.4
0.4
1.8
0.4
1.8
0.5
0.5
0.4
1.4
States of Most Usage
(% of total Ibai used
on this site)
CA AZ NM 83%
CA 100%
MI PA VA NY WV MD 86%
GA 100%
OR CA TX 80%
CA 100%
CA 92%
FL DE CA GA VA 82%
FL 86%
WA CA NY 92%
CA FL NJ LA 86%
MI NJ 99%
OH 100%
FL CA 100%
FL GA TX CA 87%
FL GA TX CA 88%
MI PA 85%
-------
Site
Citrus, Other
Cole Crops
-Broccoli
-Brussels Sprouts
-Cauliflower
-Collards
Corn
Corn Continuous
Cotton
Cucurbits
-Cucumbers
--Cucumbers, Fresh
--Cucumbers, Proc.
-Squash
-Pumpkins
Eggplant
Eggplant/Peppers
Garlic
Acres
Grown
(000)
51
313
114
3
58
11
72,284
27,111
12,689
261
172
55
117
53
36
4
119
25
Acres Treated
(000)
Wtd
Avg
0
151
26
0
13
2
181
65
781
41
27
14
13
12
2
1
59
3
Est
Max
1
238
52
0
26
5
458
198
1,627
77
45
20
25
26
6
3
119
8
% of Crop
Treated
Wtd
Avg
1%
48%
23%
1%
23%
19%
0%
0%
6%
16%
16%
25%
11%
22%
6%
38%
49%
13%
Est
Max
2%
76%
46%
7%
45%
48%
1%
1%
13%
30%
26%
36%
21%
48%
16%
77%
100%
31%
LB AI Applied
(000)
Wtd
Avg
0
81
26
0
25
3
69
21
260
46
37
30
12
18
2
3
30
1
Est
Max
1
131
53
0
50
7
181
55
572
93
81
64
24
40
5
5
56
2
Average Application Rate
Ibai/
acre/yr
1.0
0.5
1.0
0.6
1.9
1.4
0.4
0.3
0.3
1.1
1.4
2.1534
0.9
1.6
0.8
1.9
0.5
0.2
#appl
/yr
1.0
1.0
1.6
1.0
1.8
1.0
1.0
1.0
1.0
1.0
1.0
4.1
2.2
1.0
1.0
4.9
1.0
1.0
Ibai/
A/appl
1.0
0.5
0.6
0.6
1.1
1.4
0.4
0.3
0.3
1.1
1.4
0.52466
0.4
1.6
0.8
0.4
0.5
0.2
States of Most Usage
(% of total Ibai used
on this site)
CA AZ FL 100%
CA FL AZ TX NC LA 76%
CA AZ 94%
CA 100%
CA 82%
AZ GA CA 84%
TX FL SC GA MO NM 67%
FL MA AZ NY LA CA 70%
MS TX AR LA AZ AL 77%
FLTXLA81%
FL GA NC 85%
FL 89%
FL TX 87%
FL 93%
CA 100%
FL 85%
FL CA TX LA NC AL 80%
CA 100%
-------
Site
Grapefruit
Grapes
Grapes, Raisin
Grapes, Table
Greens
Hay, Other
Lemons
Lettuce
Lettuce, Head
Lettuce, Other
Lots/Farmsteads/etc
Cantaloupes
Watermelons
Melons, Honeydew
Mint
Nut Trees
Nut Trees, Other
Oats
Acres
Grown
(000)
194
825
267
76
2
33,427
63
519
212
47
24,815
113
258
27
154
712
100
4,525
Acres Treated
(000)
Wtd
Avg
2
59
5
5
1
17
5
519
157
24
o
5
9
41
3
16
7
0
5
Est
Max
4
139
21
12
2
41
10
519
212
41
6
15
60
5
38
30
4
192
% of Crop
Treated
Wtd
Avg
1%
7%
2%
6%
47%
0%
8%
100%
74%
51%
0%
8%
16%
11%
10%
1%
0%
0%
Est
Max
2%
17%
8%
16%
100%
0%
16%
100%
100%
89%
0%
13%
23%
17%
25%
4%
5%
4%
LB AI Applied
(000)
Wtd
Avg
2
45
o
3
4
2
6
o
3
350
230
25
1
4
33
1
16
3
0
3
Est
Max
3
102
12
11
5
19
5
501
387
44
2
6
66
3
38
11
4
90
Average Application Rate
Ibai/
acre/yr
0.9
0.8
0.6
0.9
1.7
0.3
0.5
0.7
1.5
1.1
0.4
0.4
0.8
0.5
1.0
0.4
1.0
0.5
#appl
/yr
1.0
1.0
1.0
1.0
3.1
1.0
1.0
1.0
2.3
1.7
1.0
1.0
1.0
1.3
1.0
1.0
1.0
1.0
Ibai/
A/appl
0.9
0.8
0.6
0.9
0.6
0.3
0.5
0.7
0.6
0.6
0.4
0.4
0.8
0.4
1.0
0.4
1.0
0.5
States of Most Usage
(% of total Ibai used
on this site)
AZ TX 90%
CA WA 83%
CA 100%
AZ 100%
NC MS FL CA 84%
AZ 94%
AZ CA 96%
CA AZ 97%
CA AZ 99%
NM FL AR GA AL LA 66%
CA 80%
FL GA TX SC CA 82%
CA TX 100%
IN WI 89%
GA 83%
PA 100%
TX NC CA 89%
10
-------
Site
Onions, Dry
Onions, Green
Oranges
Pasture
Peaches
Peanuts
Pears
Pecans
Peppers, Bell
Peppers, Hot
Peppers, Sweet
Plums & Prunes
Pomegranates
Pome-Like Fruit,
Other
Potatoes
Rice
Roots/Tubers
Acres
Grown
(000)
157
14
867
86,960
212
1,610
78
488
55
23
77
140
o
5
29
1,421
2,921
244
Acres Treated
(000)
Wtd
Avg
33
2
18
18
12
145
2
8
27
0
41
3
2
4
39
1
28
Est
Max
60
6
31
36
27
344
4
34
53
2
77
14
3
9
124
5
47
% of Crop
Treated
Wtd
Avg
21%
14%
2%
0%
6%
9%
2%
2%
49%
1%
52%
2%
69%
13%
3%
0%
11%
Est
Max
38%
43%
4%
0%
13%
21%
5%
7%
97%
7%
100%
10%
100%
30%
9%
0%
19%
LB AI Applied
(000)
Wtd
Avg
48
1
14
9
8
65
1
3
57
0
84
3
2
3
18
0
18
Est
Max
87
4
28
18
15
132
2
15
114
1
174
10
5
9
62
2
40
Average Application Rate
Ibai/
acre/yr
1.4
0.6
0.8
0.5
0.7
0.4
0.6
0.4
2.1
0.7
2.1
0.8
0.9
0.9
0.5
0.4
0.7
#appl
/yr
3.4
1.0
1.0
1.0
1.0
1.0
1.0
1.0
5.5
1.0
2.1
1.0
1.0
1.0
1.0
1.0
1.0
Ibai/
A/appl
0.4
0.6
0.8
0.5
0.7
0.4
0.6
0.4
0.38446
0.7
1.0
0.8
0.9
0.9
0.5
0.4
0.7
States of Most Usage
(% of total Ibai used
on this site)
TX CA 93%
CA 100%
CA 82%
NC 92%
PA CA TX NJ AL GA 64%
GA AL FL 82%
CA NY MI PA GA IN 71%
GA AL 93%
FL TX 87%
CA 100%
FL NJ TX 83%
CA AL MI 80%
CA 100%
CA FL 100%
FL CA AL PA 88%
AR CA 100%
FL CA 83%
11
-------
Site
-Beets
-Carrots
-Radishes
-Sweet Potatoes
Sorghum
Soybeans
Spinach, Fresh
Stone-Like Fruit,
other
Nectarines
Sugar Beets
Sugarcane
Summer Fallow
Sunflower
Sweet Corn
Sweet Corn, Fresh
Sweet Corn, Proc.
Tobacco
Acres
Grown
(000)
12
107
37
85
11,280
62,879
19
189
29
1,415
852
29,040
2,745
784
233
544
695
Acres Treated
(000)
Wtd
Avg
1
7
13
0
75
135
4
8
10
62
6
11
8
446
134
18
135
Est
Max
2
15
23
4
211
316
8
23
20
138
13
889
95
784
228
47
228
% of Crop
Treated
Wtd
Avg
6%
7%
34%
1%
1%
0%
22%
4%
36%
4%
1%
0%
0%
57%
58%
3%
19%
Est
Max
14%
14%
61%
5%
2%
1%
43%
12%
69%
10%
2%
3%
3%
100%
98%
9%
33%
LB AI Applied
(000)
Wtd
Avg
0
4
11
0
25
44
o
6
7
10
33
2
5
5
180
380
10
61
Est
Max
1
8
20
4
63
113
7
21
19
74
4
387
57
373
643
25
104
Average Application Rate
Ibai/
acre/yr
0.5
0.5
0.9
0.9
0.3
0.3
0.8
0.9
0.9
0.5
0.3
0.4
0.6
0.4
2.8
0.5
0.5
#appl
/yr
1.0
1.3
1.0
1.0
1.0
1.0
1.5
1.0
1.0
1.0
1.0
1.0
1.0
1.0
8.5
1.8
1.0
Ibai/
A/appl
0.5
0.4
0.9
0.9
0.3
0.3
0.5
0.9
0.9
0.5
0.3
0.4
0.6
0.4
0.3
0.3
0.5
States of Most Usage
(% of total Ibai used
on this site)
CA 100%
CA FL 84%
FL 100%
CA 100%
TX FL AR LA SC GA 78%
MS GA LA TN NC TX 74%
TX CA AZ MD 82%
CA 83%
CA 100%
CA ID 95%
FL 100%
GA 99%
FL 100%
FL GA AR CA WA NJ 71%
FL GA CA 85%
MN WA IL 100%
GA KY NC SC 85%
12
-------
Site
Tomatoes
Tomatoes, Fresh
Vegetables, Bulb
Celery
Parsley
Vegetables, Other
Asparagus
Walnuts
Wheat
Wheat, Winter
Woodland
Acres
Grown
(000)
500
136
198
37
2
286
88
205
62,407
45,854
62,825
Acres Treated
(000)
Wtd
Avg
255
62
42
21
0
286
13
0
94
35
0
Est
Max
445
85
80
29
1
286
25
0
2,680
119
0
% of Crop
Treated
Wtd
Avg
51%
45%
21%
56%
19%
100%
15%
0%
0%
0%
0%
Est
Max
89%
62%
40%
78%
80%
100%
28%
0%
4%
0%
0%
LB AI Applied
(000)
Wtd
Avg
130
110
20
32
0
190
6
0
42
20
0
Est
Max
190
170
37
44
1
355
11
0
1,206
72
0
Average Application Rate
Ibai/
acre/yr
0.5
1.8
0.5
1.5
0.6
0.7
0.5
0.3
0.5
0.6
1.0
#appl
/yr
1.0
3.5
1.0
2.2
1.0
1.0
1.0
1.0
1.0
1.0
1.0
Ibai/
A/appl
0.5
0.5
0.5
0.7
0.6
0.7
0.5
0.3
0.5
0.6
1.0
States of Most Usage
(% of total Ibai used
on this site)
CA FL AL 88%
FL CA 94%
TX NM NY 85%
CA FL MI 89%
CA 100%
AZ CA TX FL NM NJ 77%
CA WA 90%
CA 100%
MD NC VA 88%
AR NC VA MD 82%
FL MI 100%
13
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D. Data Requirements
In addition to data requirements imposed to obtain the original registration of this
active ingredient, data were required in the April 1989 Registration Standard for
methomyl. Data required included studies on ecological effects, environmental fate,
residue chemistry, and mammalian toxicity. Appendix B includes all data requirements
identified by the Agency for currently registered uses.
E. Regulatory History
Methomyl was first registered in the United States in October, 1968 by E. I.
Dupont de Nemours and Co. for use as an insecticide in commercial plantings of
chrysanthemums (use in home planting was specifically prohibited). Cabbage, broccoli,
and cauliflower were added on June 18, 1969. Additional sites and pests have been added
to the labels over the years. Currently, methomyl is registered on a wide variety of sites
including field, vegetable, and orchard crops; turf (sod farms only); livestock quarters;
commercial premises; and refuse containers. All uses are agricultural, industrial, or
commercial. There are no residential uses of methomyl.
In 1978 all methomyl products were classified as restricted use pesticides except
the 90% soluble bag formulations (which became restricted use pesticides in 1989) and
1% bait formulations (which are currently not restricted use products).
The Registration Standard issued in April, 1989 required, in addition to testing,
modifying tolerances, and label modifications related to applicator safely, reentry intervals,
and environmental hazards.
In 1995 as part of a risk mitigation plan, limitations on fly baits were imposed
including restricting use to certain commercial agricultural production areas where
children would not be present, incorporating an embittering agent into the formulation,
using only colors unattractive to children for the final bait formulation, and (for selected
uses only) requiring the use of bait stations instead of scattering the bait.
The ornamental and greenhouse uses were voluntarily cancelled in July 1998.
14
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The following figure shows the chemical structure of methomyl.
3 ^s
J H
H3C ^N^ XVX' ^CH3
O
Empirical Formula: C5H10N2O2S
Molecular Weight: 162.2
CAS Registry No.: 16752-77-5
OPPCodeNo.: 090301
Identification of Active Ingredient
Technical methomyl is a white crystalline solid with a slightly sulfurous odor and
melting point of 78-79 C. Methomyl is soluble in water (5.8 g/100 g) and in most organic
solvents (100 g/100 g methanol; 72 g/100 g acetone; 42 g/100 g ethanol; 22 g/100 g
isopropanol; and 3 g/100 g toluene). Methomyl decomposes slowly in water. The rate of
degradation increases with temperature, alkalinity, aeration, and sunlight.
Manufacturing-Use Products
There are two methomyl manufacturing-use products (MPs) registered under
Shaughnessy No. 090301: the E. I. du Pont de Nemours and Company, Inc. 98%
technical (T; EPA Reg. No. 352-366) and 90% formulation intermediate (FI; EPA Reg.
No. 352-361). Only the du Pont MPs are subject to a reregi strati on eligibility decision.
Product Chemistry Data Requirements
All pertinent data requirements are satisfied for the du Pont 98% T and the 90%
FI; except for Guideline 830.7050 pertaining to UV/visible absorption for the pure active
ingredient. This guideline is required. In addition, the registrant must certify that the
suppliers of the beginning materials and the manufacturing processes for the methomyl
MPs have not changed since the last comprehensive product chemistry review or submit
complete updated product chemistry data packages.
B. Human Health Assessment
1. Toxicology Assessment
15
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The available toxicological database for methomyl is adequate and will support a
reregi strati on eligibility determination. No data are available on the acute and subchronic
neurotoxicity of methomyl. Since methomyl is a carbamate and neurotoxic signs have
been observed in two species (dogs and rabbits) by two different exposure routes (oral and
dermal), acute and subchronic neurotoxicity studies are required.
a. Acute Toxicity
The following table summarizes the results of the acute mammalian toxicity studies
conducted with technical methomyl.
Table 2 - Summary of Methhomyl Acute Mammalian Toxicity Studies.
Route
Oral
Dermal
Inhalation
Eye Irritation3
Skin Irritation3
Dermal Sensitizationa
Delayed Neurotoxicity
Species
Rat
Rabbit
Rat
Rabbit
Rabbit
Guinea Pig
Hen
Results
LD50 (m) = 34 mg/kg
LD.,o (f) = 30 mg/kg
LD50 >2000 mg/kg
LC50 = 0.258, mg/L (male and female)
Corneal opacity
No Irritation
Not a skin sensitizer
Negative
Tox Category
I
III
II
I
IV
N/A
N/A
1 Not required for TGAI, however, presented here for informational purposes.
The oral LD50 values for methomyl based on rat studies, were 34 and 30 mg/kg in
males and females, respectively (Toxicity Category I). Clinical signs observed in all
treatment groups of both sexes included tremors, low posture and salivation. (MRTD
42140101).
The dermal LD50 value for methomyl in rabbits was greater than 2000 mg/kg for
both sexes (Toxicity Category III) (MRID 42074602).
The acute inhalation LC50 for methomyl was 0.258 mg/L in rats for both sexes
(Toxicity Category II), based on a four-hour exposure (nose only) to technical grade
methomyl aerosol. (MRID 42140102).
Methomyl is highly toxic via ocular exposure. In a primary eye irritation study, a
female rabbit treated with 15 mg of technical methomyl (92.4%) died 20 minutes after the
treatment with typical cholinergic symptoms indicative of neurotoxicity. Animals treated
with 10 mg of methomyl exhibited similar clinical signs of neurotoxicity but survived. At
16
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this dose, corneal opacity and iritis were observed at 1 hour after the treatment and
completely reversed by 7 days (MRID 41964001). Another primary eye irritation study in
rabbits using a 30.5% methomyl formulation showed corneal opacity and conjunctivitis
from 7 to 14 days in washed and unwashed eyes, respectively (MRID 00053407). Primary
eye irritation for methomyl is considered to be in Toxicity Category I.
A primary dermal irritation study with technical methomyl in rabbits showed no
erythema or edema (Toxicity Category IV) (MRID 42074603). A dermal sensitization
study in guinea pigs using technical methomyl showed that the compound is not a skin
sensitizer (MRID 42074605).
An acute delayed neurotoxicity study with methomyl in atropine-pretreated hens,
using the LD50 dose (28 mg/kg) as well as higher doses, was negative. No treatment
related effects were observed over the duration of the study (MRID 00008827).
b. Subchronic Toxicity
The following table summarizes the results of the sub-chronic toxicity studies for
methomyl.
Table 3 - Summary of Methomyl Sub-Chronic Toxicity Studies
GLN#
82-la
82-lb
82-2
82-2
Type of Study
90-day feeding - rat
90-day feeding - dog1
21 -day dermal - rabbit
21 -day dermal - rabbit2
NOEL
mg/kg/day
6.25
14.68 males
12.5 females
5
90
LOEL
mg/kg/day
12.5
not
established
50
not
established
Toxic Effects
Inhibited body weight gain in both sexes
and erythroid hyperplasia in the bone
marrow of males.
No apparent treatment-related effects at
highest dose tested.
Brain and plasma ChE inhibitions.
Lack of lexicologically significant plasma,
RBC or brain ChE inhibition at the doses
tested.
1 This study was classified as unacceptable due to deficiencies in the study. However, it is not necessary to repeat
the study because sufficient data from a chronic toxicity study in dogs are available.
2 The NOEL from this study was used as the short term and intermediate term dermal occupational endpoints for
risk assessments.
In a 90-day feeding study in rats, Charles River CD rats (10/sex/group) were fed
methomyl at dietary levels of 0, 0.5, 2.5 or 12.5 mg/kg/day for 13 weeks. An additional
group received 6.25 mg/kg/day of the test material for 6 weeks and 25 mg/kg/day for the
remaining 7 weeks. Treatment did not cause increased mortalities. No inhibition of
17
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cholinesterase activity was observed in any treated group. The NOEL is 6.25 mg/kg/day
and the LOEL is 12.5 mg/kg/day based on inhibited body weight gain in both sexes and
erythroid hyperplasia in the bone marrow of males (MRID 00007190).
In a 90-day feeding study in dogs, beagle dogs (4/sex/group) were fed methomyl at
dietary levels of 0, 1.44, 3.18 or 14.68 mg/kg/day, in males and 0, 1.45, 3.01 and 12.5
mg/kg/day, in females. The examination of body weights, food consumption, hematology,
clinical chemistry, urinalysis and gross examinations in all treated animals as well as
microscopic examinations in control and high-dose dogs did not reveal any apparent
treatment-related effects. The NOEL is 14.68 and 12.5 mg/kg/day, respectively, for males
and females. These are the highest doses tested. This study is unacceptable because the
purity of the test substance and its stability and actual concentration in the diet were not
determined and many tissues were not examined microscopically (MRID 00009010).
However, since sufficient data from a chronic toxicity study are available, an additional
subchronic toxicity study in dogs is not required.
In a 21-day dermal toxicity study, New Zealand White rabbits were dermally
exposed to methomyl (98.35%, a.i.) for 21 days at dose levels of 0, 5, 50 or 500
mg/kg/day. Clinical signs included hyperactivity (increased reaction to stimuli-noise) at
the high-dose in both sexes. At Day 21, mid- and high-dose males and high-dose females
displayed significantly lower plasma cholinesterase (ChE) activity. Mean RBC ChE
activity was also decreased, but only slightly, at the high-dose (both sexes). Brain ChE
activity was significantly decreased at the high-dose (both sexes). At the mid-dose,
although not statistically significant, inhibition of brain ChE activity was indicated (3/5
males and 4/5 females exhibited brain ChE inhibition when compared with controls). The
NOEL for systemic toxicity is 5 mg/kg/day and the LOEL is 50 mg/kg/day based on brain
and plasma ChE inhibitions. No dermal irritation was observed (MRID 41251501).
In another 21-day dermal toxicity study conducted for better characterization of
cholinesterase inhibition, groups of New Zealand White rabbits (6/sex/group) received
repeated dermal applications of methomyl (98.6%) at dose levels of 0, 15, 30, 45, or 90
mg/kg/day, 6 hours/day, 7 days/week for 21 consecutive days. No treatment-related
deaths or clinical signs of toxicity were observed. Body weight and food consumption
were not affected by the treatment. Hematology and clinical chemistry parameters were
not measured. Gross pathological examination did not reveal significant effects from the
treatment. Histopathological examination was not conducted. There were no statistically
or biologically significant differences in plasma or RBC cholinesterase inhibition.
Statistically significant decreases were observed in brain ChE in males at doses of >30
mg/kg/day and in females at 90 mg/kg/day.
However, the Agency did not attribute the statistically significant decreases
observed in brain ChEI to treatment, for the following reasons: 1) lack of dose-response in
either sex; 2) the values approached the level of sensitivity of the assay itself; 3) there was
18
-------
concern about inherent variability; 4) lack of convincing evidence in the other two
compartments (RBC and plasma) at this dose; 5) lack of clinical signs in this dermal study
as opposed to the observance of clinical signs in the oral study in the same species; and 6)
lack of toxicity via the dermal route (LD50=2000 mg/kg) when compared to the oral route
(NOEL=16 mg/kg/day) in the developmental rabbit study. Therefore, the NOEL was
established at 90 mg/kg/day (HOT) for plasma, RBC and brain ChE and a LOEL for ChE
was not established in this study (MRID 44436301).
c. Chronic Toxicity and Carcinogenicity
Based on the available chronic toxicity and carcinogenicity studies which
demonstrated no evidence of carcinogenicity, methomyl was classified as a Group E, not
likely to be carcinogenic to humans via relevant routes of exposure (HED/RfD/ Peer
Review Committee document dated October 25, 1996). The following table summarizes
the results of the chronic/carcinogenicity toxicity studies for methomyl.
Table 4 - Summary of Methomyl Chronic/Carcinogenicity Toxicity Studies
GLN#
83-la
and
83 -2a
83-lb1
83 -2b
Type of Study
2-year chronic/
carcinogenicity- rat
2-year chronic -
dog1
mice 104-week
carcinogenicity
NOEL
mg/kg/day
5
2.5
not
established
LOEL
mg/kg/day
20
10
not
established
Toxic Effects
Depressed body weight gain in both male
and females rats. No evidence of
carcinogenicity from the test material.
Histopathological effects in the kidneys.
No evidence of carcinogenicity from the
test material.
1 The NOEL from this study was used to calculate the methomyl reference dose (RfD), multiplied by the
uncertainty factor of 300.
In a combined chronic toxicity and carcinogenicity study, Charles River CD rats
(80/sex/group) were fed diets containing methomyl (99+%) for two years at dose levels of
0, 50, 100 or 400 ppm (0, 2.5, 5.0 or 20.0 mg/kg/day, respectively, based on the standard
conversion ratio). No significant toxicity was observed. The NOEL is 100 ppm (5
mg/kg/day) and the LOEL is 400 ppm (20 mg/kg/day) based on depressed body weight
gain. Methomyl was not considered carcinogenic because there was no evidence that the
test material increased the incidence of any neoplastic lesion. (MRID 00078361).
In a chronic toxicity study, beagle dogs (4/sex/group) were fed diets containing
methomyl (90%) at dose levels of 0, 50, 100, 400 or 1000 ppm (0, 1.25, 2.5, 10, or 25
mg/kg/day, respectively, based on the standard conversion ratio) for 24 months. Two
males at the 1000 ppm group exhibited tremors, salivation, incoordination, and circling
movements during the 13th week of the study. One female in the 1000 ppm group died in
the 9th week of the study. A replacement dog exhibited repeated convulsive seizures after
19
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17 days of dosing and died on day 18. There were no significant differences among
treatment and the control groups for RBC and plasma ChE activities which were
measured at week 9 and week 13 (high dose only) of the study. The NOEL is 100 ppm
(2.5 mg/kg/day) and the LOEL is 400 ppm (10.0 mg/kg/day) based on histopathological
effects in kidneys manifested as swollen/irregular epithelial cells of the proximal
convoluted tubules as well as an increase in the amount of pigment in the cytoplasm of
these cells (MRID 00007091).
In a carcinogen!city study, CD-I mice (80/sex/group) were fed diets containing
methomyl (99+%) initially at levels of 0, 7.5, 15 or 120 mg/kg/day. Due to increased
mortality, the high dose level was decreased to 60 mg/kg/day at week 28; further, the high
and mid dose levels were reduced to 30 and 11.25,mg/kg/day respectively, at week 39 for
the same reason. These levels (7.5, 11.25 and 30 mg/kg/day) were maintained for the
remainder of the 104 week treatment period. The highest dose level tested in this study
was considered to be adequate for carcinogen!city testing based on increased mortality.
The treatment did not alter the spontaneous tumor profile in this strain of mice under the
test conditions (MRID 00078423).
Other Carcinogenic Issues
Methomyl is a metabolite of and is structurally-related to thiodicarb, a pesticide
that was classified as a B2 carcinogen. Although thiodicarb appears to have some
carcinogenic concerns, thiodicarb would not be found as a result of application of
methomyl. There are two animal metabolites acetamide and acetonitrile. Acetamide, a
metabolite of methomyl, has been evaluated by the the Agency and classified as a Group
C, possible human carcinogen. However, after a thorough investigation, the Agency
concluded that the ingestion of methomyl and acetamide in the diet should not represent a
significant carcinogenic hazard to the consuming public based on the following: 1) the
conversion rate of methomyl to acetamide is low, approximately 2-3 percent, therefore,
residue levels of acetamide in edible meat should be low, 2) carcinogenicity studies with
methomyl in two rodent species indicated no increase in any type of tumor under the test
conditions, 3) the product is comprised of 98.7 percent syn-isomer and 0.092 percent anti-
isomer, syn-isomer must be converted to anti-isomer before acetamide is formed, and 4)
acetamide induced liver tumors in rats only when administered at very high dosages, i.e.
more than 1000 mg/kg/day. Ingestion of acetonitrile from application of methomyl would
not represent a significant carcinogenic hazard because it is volatile, residues are small, it
has little or no cancer potential, and since it is a rat metabolite its toxicity was accounted
for in the toxicity studies.
d. Developmental and Reproductive Toxicity
The following table summarizes the results of the developmental and reproductive
toxicity studies for methomyl.
20
-------
Table 5 - Summary of Methotnyl Developmental and Reproductive Toxicity Studies.
GLN#
83 -3 (a)
83-3(b)
83-4
Type of Study
developmental -
rat
developemental -
rabbit
2-generation - rat
NOEL
mg/kg/day
maternal;
9.4
developmental;
33.9 (HOT)
maternal;
6
developmental;
16, (HOT)
offspring;
3.75
parental;
3.75
LOEL
mg/kg/day
maternal
33.9
maternal;
16
offspring;
30
parental;
30
Toxic Effects
Decreased body weight gain and food
consumption during gestation.
Based on mortalities and clinical signs.
Decrease in mean number of live pups
and body weights of offspring
Decreased body weight and food
consumption and altered hematology
parameters.
In a developmental toxicity study in rats, methomyl (99%) was administered in the
diet to 25 presumed pregnant Charles River-CD (ChR-CD) rats per group at
concentrations of 0, 4.9, 9.4 and 33.9 mg/kg/day on gestation days 6 through 16. The
data did not reveal any apparent developmental toxicity. The NOEL for maternal toxicity
is 9.4 mg/kg/day and the LOEL is 33.9 mg/kg/day based on decreased body weight gain
and food consumption during gestation. The NOEL for developmental toxicity is 33.9
mg/kg/day, the highest dose tested (MRID 00008621).
In a developmental toxicity study in rabbits, methomyl (98.7%) was administered
via stomach tube to 20 presumed pregnant New Zealand white (DLLNZW) rabbits per
group (19 in the high-dose group) at dosages of 0, 2, 6 and 16 mg/kg/day on gestation
days 7 through 19. Clinical signs indicated neurotoxic effects in high-dose rabbits. There
was no evidence of developmental toxicity in this study. The NOEL for developmental
toxicity is 16 mg/kg/day. The NOEL for maternal toxicity is 6 mg/kg/day and the LOEL
is 16 mg/kg/day based on mortalities and clinical signs (MRID 00131257).
In a 2-generation reproduction study, Sprague-Dawley rats in the F0 parental
generation were fed methomyl at dose levels of 0, 3.75, 30, or 60 mg/kg/day. The Ft
offspring were treated at the same dosages. There was a dose-related increase in clinical
signs involving the nervous system during the first few weeks of the study and the
incidence of alopecia was increased in the 30 and 60 mg/kg/day group animals. The
NOEL for parental systemic toxicity is 3.75 mg/kg/day and the LOEL is 30 mg/kg/day
based on decreased body weight and food consumption and altered hematology
parameters. The NOEL for offspring toxicity is 3.75 mg/kg/day and the LOEL is 30
21
-------
mg/kg/day based on decreases in both the mean number of live pups and mean body
weights of offspring (MRIDs 43250701, 43769401).
The data provided no indication of increased sensitivity of rats or rabbits to in
utero and/or postnatal exposure to methomyl. In the prenatal developmental toxicity
studies in rats and rabbits and the two-generation reproduction study in rats, effects in the
offspring were observed only at or above treatment levels which resulted in evidence of
parental toxicity. There was no assessment of potential susceptibility in the area of
functional development.
e. Mutagenicity
Sufficient data are available to satisfy data requirements for mutagenicity testing.
Technical methomyl did not induce a genotoxic response in any of the tests listed below.
In a Chinese hamster ovary cells HGPRT forward gene mutation assay, methomyl
was negative up to cytotoxic levels (>40 mM = 6.5 mg/mL -S9; > 150 jiM = 0.24 mg/mL
+S9)(MRID00161887).
In a mouse micronucleus assay, methomyl was negative in ICR mice up to an
overtly toxic dose (12 mg/kg) administered once by oral gavage. There was no evidence
of a cytotoxic effect on the target tissue (MRID 44047703).
An in vivo bone marrow cytogenetic assay indicated that the test was negative in
Sprague Dawley rats up to an overtly toxic level (20 mg/kg) administered once by oral
gavage. Target tissue cytotoxicity was not observed (MRID 00161888).
Methomyl was found to be inactive in a series of USEPA-sponsored mutagenicity
studies which included: Salmonella typhimurium/Escherichia coli reverse gene mutation
assays, DNA damage studies in bacteria, yeast and human lung fibroblasts, and a
Drosophila melanogaster sex-linked recessive lethal assay (MRID 00124901).
f. Metabolism
In a metabolism study, male and female CD rats were given a single oral dose of 5
mg/kg of radiolabelled methomyl. Results indicated that methomyl was rapidly absorbed
(>95%) and metabolized in both sexes. Approximately 53% of the dose was eliminated in
the urine, 22-23% in expired air as 14CO2, 12-13% in expired air as 14C-acetonitrile while
only 2-3% was eliminated in the feces. The levels found in the carcass and tissues were 8-
9% of the dose. The overall elimination half-life was about 5 hours. One major metabolite
found in the urine was mercapturic acid derivative of methomyl (approximately 18% of the
dose). More than 10 additional minor metabolites were also found including acetonitrile
(«2%), acetate (-2%), a sulfate conjugate of methomyl oxime («4%) and acetamide (0.2-
22
-------
0.4%). Three major metabolic pathways were discussed in the study. One involves the
displacement of the S-methyl moiety of methomyl with glutathione which is then
transformed in vivo to the corresponding mercapturic derivative. Another major metabolic
pathway involves cleavage of the carbamate ester to release the oxime portion of the
molecule which may be rapidly metabolized or conjugated. The third pathway involves in
vivo isomerization of methomyl to the anti-methomyl isomer and then a Beckman re-
arrangement and elimination reaction to form acetonitrile which is mostly eliminated in
expired air (MRID 42021301).
Another metabolism study was conducted to determine whether or not methomyl
undergoes biotransformation to acetamide in a species more closely related to humans.
Male cynomolgus monkeys were given a single oral dose (4.8-5.4 mg/kg) of radiolabelled
methomyl. Recovery of radioactivity in 48 hours amounting to 64.52-76.2% of the dose
in urine, volatiles, and tissues indicated appreciable absorption of methomyl from the GI
tract. Approximately 23.5-34.9% of the dose was eliminated in urine and 2.6-4.6% of the
dose was eliminated in feces. Elimination in expired air at 48 hours amounted to 3.6-6.8%
of the dose as acetonitrile and 31.2-38.2% of the dose as CO2. After seven days, total
radioactive residue in tissue was 4.02-5.4% of the dose. Acetamide excretion in 24-hour
urine was 0.3-0.5% of the dose (MRIDs 42379001, 42816701 ).
2. Dose-Response Assessment
a. Potential Risk to Infants and Children and FQPA Safety
Factor
In determining whether to retain, reduce, or remove the lOx FQPA safety factor
for infants and children, EPA uses a weight of evidence approach taking into account the
completeness and adequacy of the toxicity data base, the nature and severity of the effects
observed in pre- and post-natal studies, and other information such as epidemiological
data.
For purposes of assessing the pre- and post-natal toxicity of methomyl, EPA has
evaluated two developmental studies and one reproduction study. Based on current
toxicological data requirements, the data base for methomyl, relative to pre- and post-
natal toxicity is complete. The effects observed in the methomyl developmental and
reproduction studies are summarized in Table 5, section II, B,d.
The data provided no indication of increased sensitivity of rats or rabbits to in
utero and/or postnatal exposure to methomyl. In the prenatal developmental toxicity
studies in rats and rabbits and the two-generation reproduction study in rats, effects in the
offspring were observed only at or above treatment levels which resulted in evidence of
parental toxicity.
23
-------
Although the data provided no indication of increased sensitivity of rats or rabbits
to in utero and/or postnatal exposure to methomyl, data gaps exists for the acute and
subchronic neurotoxicity studies. These studies would have yielded cholinesterase
inhibition and field observation behavior data, as well as histopathology of the central and
peripheral nervous system which are not presently available for evaluation. These studies
are considered data gaps because methomyl has exhibited neurotoxic signs in two species
(dogs and rabbits) by two different routes of exposure (oral and dermal). The Agency has
determined that the need for a developmental neurotoxicity study should be placed in
reserve status pending receipt and review of the acute and subchronic neurotoxicity
studies.
FOPA Safety Factor
The lOx Safety Factor for increased susceptibility to infants and children (as
required by FQPA) was reduced to 3x (FQPA Safety Factor Committee, April 6, 1998).
In determining whether to retain, reduce, or remove the lOx FQPA safety factor
for infants and children, EPA uses a weight of evidence approach taking into account the
completeness and adequacy of the toxicity data base, and the nature and severity of the
effects observed in pre- and post-natal studies. Although the data provided no indication
of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to
methomyl, data gaps exists for the acute and subchronic neurotoxicity studies. These
studies would have yielded cholinesterase inhibition and field observation behavior data, as
well as histopathology of the central and peripheral nervous system which are not
presently available for evaluation. The Agency determined that the lOx safety factor to
account for increased sensitivity of infants and children should be reduced from lOx to 3x.
The FQPA Safety Factor (3x) should be applied for acute and chronic dietary risk
assessments for the General Population including infants and children. Application of the
FQPA Safety Factor is appropriate for these risk assessments because of the lack of data
on the neurotoxic potential of methomyl following single and repeated exposures (i.e.,
acute and subchronic neurotoxicity studies).
b. Reference Dose
An RfD was established based on a two-year feeding study in dogs with a NOEL
of 2.5 mg/kg/day for males and females. The LOEL was 10 mg/kg/day for males and
females, based on histopathological efffects in the kidney (MRTD 00007091). An
uncertainty factor (UF) of 100 was applied to account for intraspecies variability and
interspecies extrapolation together with a safety factor of 3x for the FQPA safety factor
based on the lack of acute and subchronic neurotoxicity studies (data gaps). On this basis,
the RfD was calculated to be 0.008 mg/kg/day.
24
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Methomyl has been reviewed by the FAO/WHO Joint Committee Meeting (1989)
on Pesticide Residues (JMPR) which established an acceptable daily intake (ADI) of 0.03
mg/kg/day.
c. Carcinogenicity Classification and Risk Quantification
The Agency has classified methomyl as a Group E, not likely to be carcinogenic to
humans via relevant routes of exposure based on the results of the chronic toxicity and
carcinogenicity studies conducted with methomyl which showed no evidence of
carcinogenicity (HED/RfD/Peer Review Committee, 1996).
d. Toxicological Endpoints
The following toxicological endpoints were selected for methomyl (Hazard
Identification Assessment Review Committee, March 3, 1998).
Dermal Absorption
A dermal absorption factor is not applicable since a dermal NOEL was selected for
short- and intermediate-term dermal risks assessments. The current use pattern does not
warrant long-term dermal risk assessments.
Acute Dietary (1 day)
The maternal NOEL of 6 mg/kg/day from a developmental toxicity study in the
rabbit is the endpoint used for the risk assessment. This is based on deaths in dams on
days 1-3 after dosing at 16 mg/kg/day (LOEL). An uncertainty factor (UF) of 100 was
applied to account for intraspecies variability and interspecies extrapolation. The FQPA
safety factor of lOx to account for potential increased susceptibility of infants and children
was reduced to 3x. The 3x was due to the lack of acute and subchronic neurotoxicity
studies (MRID 00131257).
Short Term Dermal Occupational or Residential Exposure (1-7 days)
For short-term dermal occupational or residential exposure, the NOEL of 90
mg/kg/day from a rabbit 21-day dermal toxicity study was the endpoint selected to be used
in risk assessments. No treatment-related deaths or clinical signs of toxicity were
observed at the doses tested. Body weight and food consumption were not affected by
the treatment. There were no statistically or biologically significant differences in plasma
or RBC cholinesterase inhibition (ChEI) at the doses tested. Two 21 day dermal toxicity
studies were available for consideration. After review of the results of both studies
together, it was determined that the most recent study provided a better characterization
of cholinesterase inhibition (MRID 44436301).
25
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Intermediate Term Dermal Occupational or Residential Exposure (several days to several
months)
See Short Term exposure (above).
Long-Term Occupational or Residential Exposure (several months to lifetime)
Based on the use patterns there is minimal concern for long-term dermal exposure
or risk.
Inhalation Exposure (any time period)
For short, intermediate, and long term inhalation exposure, mortality and clinical
signs of neurotoxicity at 0.137 mg/L (NOEL) from an acute inhalation study in rats
(MRID# 42140102) was selected as the endpoint. This risk assessment was performed
only for those scenarios where inhalation exposure is greater than 1% of total dermal and
inhalation exposure. The risks due to dermal and inhalation exposure were combined
because of a common endpoint (i.e., clinical signs of neurotoxicity seen following dermal
and inhalation exposures). The combined risk resulting from dermal and inhalation
exposure to methomyl may be calculated by combining MOEs for these routes. The
following equation was used to calculate a total MOE (MOET):
MOET =
MOEjnhalatjon
(John E. Whalan and Hugh M. Pettigrew. Route-Specific vs. Route-To-Route Procedures in Margin of Exposure
(MOE) Calculations for Inhaled Pesticides, and the Combining of MOEs. IDraft Interim Policy. September 16,
1996. Page?.)
3. Exposure Assessment
a. Dietary Exposure (food sources)
The residue chemistry database includes information on the types of pesticide
residues found in plants and animals, the levels of detected pesticide residues, and a
description of the analytical methods used. Residue chemistry data are used by the
Agency to determine the residues of concern and to establish tolerances in food and feed.
Tolerances are pesticide residue levels that should not be exceeded in or on a raw
agricultural commodity in the channels of interstate commerce. Tolerances for residues of
methomyl are currently expressed in terms of methomyl per se, in/on plant raw agricultural
commodities (RACs) [40 CFR §180.253 (a) and (b)]. Tolerances on plant commodities
range from 0.1 ppm to 40 ppm. A food/feed additive tolerance has been established for
26
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methomyl residues in imported dried hops (12 ppm) [40 CFR §185.4100]. Adequate
methods are available for the enforcement of established tolerances, as currently defined.
The Agency has determined that residues of acetamide and acetonitrile resulting
from the application of methomyl are not residues of concern in animals and will not be
regulated (See discussion under B.l.c. "Chronic Toxicity and Carcinogenicity"). The
residue of concern in plants and animals is methomyl. The chemical name and structure of
methomyl is depicted in the following table.
Table 6 - Chemical name and structure of methomyl
Common Name/Chemical Name
Chemical Structure
Methomyl
H3C
^-methyl 7V-[(methylcarbamoyl)oxy]
thioacetimidate
The Agency has updated the Livestock Feeds Table [Table 1 in the Residue
Chemistry Test Guidelines, OPPTS Series 860, August 1996]. Additional residue data are
now required for some commodities as a result of these changes in Table 1; these data
requirements have been incorporated into this document. The need for additional
tolerances and for revisions to exposure/risk assessments will be determined upon receipt
of the required residue chemistry data.
Summary of Science Findings
OPPTS GLN 860.1200 (formerly 171-1V Directions for Use
There are two methomyl end-use products (EPs) with food/feed uses registered to
E. I. du Pont de Nemours & Company, Inc. These EPs are presented below (Reference
Files System, September 23, 1996).
EPA Reg No.
352-342 a
352-384 b
Label Acceptance
Date
9/96
9/96
Formulation
Class
90% SC/S
2.4 Ib/gal SC/L
Product Name
DuPont Lannate® SP Insecticide
DuPont Lannate® LV Insecticide
Includes SLNNos. CA770495, CA780136, CA850052, CA860059, CA880014, CA900034, CA910010,
CA910011, DE800009, FL780004, FL780037, FL780055, FL820014, LA950016, NC820011, NJ940009,
PA930002, TX930022, and WV930003.
Includes SLN Nos. FL880004, IL830019, LA950017, and TX920011.
27
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A review of the above labels and supporting residue data indicate that the
following label amendments are required:
A 14-day preharvest interval (PHI) is specified for beet tops under use directions for
"Beets (Table)" and a 10-day PHI is specified for beet tops under use directions for "Leafy
Green Vegetables." Use directions should be amended to specify a single PHI for beet
tops. The available data support a 10-day PHI.
Label directions for sweet corn should be amended to include a PHI for sweet corn stover,
which is listed as a regulated feed item. The available corn fodder (stover) data support a
21-day PHI.
Label directions for cotton state "Do not graze or feed treated cotton to livestock." This
restriction should be deleted from the labels because cotton gin trash is a regulated
livestock feed item that is not under the grower's control.
Directions for garlic specify a maximum single application rate of 0.45 Ib ai/A and a
maximum of six applications per crop, which would result in a maximum seasonal rate of
2.7 Ib ai/A. However, the currently labeled seasonal rate is 3.6 Ib ai/A/crop. The seasonal
use rate should be amended to be no higher than the total resulting from the maximum
number of applications at the maximum rate.
A 7-day PHI is specified for bermudagrass forage. However, current Agency Guidelines
(Table 1, OPPTS Guideline 860.1000) require 0-day PHIs for grass forages. Concomitant
with developing zero day residue data for bermudagrass forage, the registrant should
amend product labels to list a 0-day PHI for bermudagrass forage.
Since lentil forage and hay are no longer considered to be significant livestock feed items,
PHIs for these commodities can be deleted from the use directions for lentils.
Use directions for peppers list a maximum seasonal use rate of 4.05 Ib ai/A. This rate
appears to be a typographical error. The maximum seasonal rate should be 4.5 Ib
ai/A/crop. The registrant should clarify the maximum seasonal rate for peppers.
For sorghum, the registrant should either specify a 0-day PHI for forage and submit
supporting residue data or amend labels to restrict the use only to grain sorghum.
Label directions for soybeans specify PHIs for forage and hay that depend upon whether
the last application was made at <0.45 Ib ai/A or at 0.45-0.9 Ib ai/A. Because the current
federally registered maximum use rate is 0.45 Ib ai/A, these label directions are confusing.
The use directions should be amended to specify PHIs of 3 and 12 days for forage and
hay, respectively, regardless of the application rate. These PHIs are supported by the
available data.
28
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Use directions for sugar beets should be amended to specify a 21-day PHI for both sugar
beet roots and tops concomitant with establishing the proposed tolerance for sugar beet
tops.
OPPTS GLN 860.1300 (formerly 171-4aV Nature of the Residue in Plants
The qualitative nature of the residue in plants is adequately understood based on
cabbage, corn, and tobacco metabolism studies. The residue of concern in plants is
methomyl.
OPPTS GLN 860.1300 (formerly 171-4K): Nature of the Residue in Livestock
The qualitative nature of the residue in animals is adequately understood based
upon acceptable ruminant and poultry metabolism studies. The Agency has determined
that residues of acetamide and acetonitrile resulting from the application of methomyl to
crops are not residues of concern in animals and will not be regulated. (See discussion
under B.l.c. "Chronic Toxicity and Carcinogen!city"). The residue of concern in animals
is methomyl, per se. The Agency concluded that there is no reasonable expectation of
finite methomyl residues in ruminant and poultry commodities [180.6(a)(3)J. Therefore,
tolerances for methomyl are not required for meat, milk, poultry, and eggs.
OPPTS GLN 860.1340 (formerly 171-4c.dV Residue Analytical Methods
Adequate analytical methodology is available for data collection and enforcing
tolerances of methomyl. Method I in the Pesticide Analytical Manual (PAM), Vol. II, is a
GLC/ sulfur microcoulometric detection method that has undergone a successful EPA
method validation on corn, leafy vegetables, and fruiting vegetables. This method involves
solvent extraction, clean-up by liquid-liquid partitioning, and a base hydrolysis of
methomyl residues to methomyl oxime. Acidified residues of methomyl oxime are then
partitioned into an organic solvent and determined by GLC using a sulfur
microcoulometric detector. The limit of detection is 0.02 ppm for plant commodities.
A HPLC/fluorescence detection method (Method AMR 3015-94) has also been
proposed as an enforcement method. For this method, methomyl residues are extracted
into water:acetone, solvent partitioned, and cleaned up using a Florisil column. Residues
of methomyl are then quantified by HPLC using post-column hydrolysis and derivatization
with o-phthalaldehyde followed by fluorescence detection. This method has recently
undergone a successful EPA method validation using dry pea seeds, sorghum hay, and
sugar beet foliage. The validated limit of quantitation is 0.02 ppm.
Data from analysis of methomyl residues in plants have been collected using
Method I or modifications of Method I, which included modifications to the clean-up
procedures and/or use of a flame photometric detector with a sulfur filter (FPD-S) instead
29
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of the microcoulometric detector. Data have also been collected using variations of the
adequate HPLC/fluorescence detection method.
Data from the recent ruminant feeding study were collected using a modification of
the above HPLC/fluorescence detection method. Methomyl residues were extracted and
purified using solid-phase extraction and liquid-liquid partitioning. Residues were then
quantified by HPLC/fluorescence detection following post-column derivatization. The
reported limit of quantitation was 0.01 ppm in milk and meat commodities. Since
tolerances are not required for animal commodities, an enforcement method for animal
commodities is also not required.
OPPTS GLN 860.1360 (formerly 171-4mV Multiresidue Method Testing
The FDA PESTDATA database indicates that methomyl is completely recovered
using FDA Multiresidue Protocols A and D (PAM I Sections 242.2 and 232.4).
OPPTS GLN 860.1380 (formerly 171-4eV Storage Stability Data
Requirements for storage stability data are satisfied for purposes of reregi strati on,
with the exception of the need for storage stability data on residues of methomyl in potato
tubers, onions, dry bean and pea seeds, pea hay, peanut nutmeats, soybean hay, and
sorghum forage and hay.
The available data indicate that methomyl is stable in apples, broccoli, corn,
oranges (halves) stored at -20 C for up to 24 months; grapes stored at -20 C for up to 27
months; succulent beans stored at -18 C for up to 30 months; beets and beet foliage stored
at -10 C for ~1 year; milk stored at -20 C for up to 22 months; mint hay stored at -10 C
up to 6 months; mint oil stored at -20 C up to 5 months; and tobacco leaves stored at -18
C for up to 83 days.
Data submitted with a ruminant feeding study indicate that methomyl is stable at <-
70 C in liver for 5.4 months and in muscle and milk for 6 months.
Methomyl declined in fortified chopped oranges stored at -20 C by 30% within 6
months, -60% within 12 months, and by >80% within 24 months.
OPPTS GLN 860.1500 (formerly 171-410: Magnitude of the Residue in Crop Plants
For purposes of reregi strati on, requirements for magnitude of the residue in plants
are fulfilled for the following crops/commodities: alfalfa, fennel, apple, asparagus,
avocado, barley, beans (succulent), beet (table), bermudagrass hay, blueberry, broccoli,
Brussels sprouts, cabbage (incl. Chinese cabbage), carrot, cauliflower, celery, chicory
roots, citrus fruits, corn (field, pop, and sweet), cottonseeds, cowpea forage, cucumber,
eggplant, garlic, grape, green onions, lettuce, melons, mint hay, nectarine, peach, oats,
30
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peanut, pear, pea vines, peas (succulent), pecan, peppers, pomegranate, pumpkin, rye,
soybean, spinach, summer squash, strawberry, sugar beet (roots and tops), sweet potato,
tomato, tomatillo, tobacco, and wheat. Adequate field trial data depicting methomyl
residues following applications made according to the maximum or proposed federally
registered use patterns have been submitted for these commodities. Geographical
representation is adequate and a sufficient number of trials reflecting representative
formulation classes were conducted.
Once the registrant provides acceptable storage stability data on methomyl
residues in dry beans and peas, pea hay, onions (dry bulb), potatoes, soybean hay, and
sorghum fodder (stover) and hay, adequate residue data would also be available for these
commodities.
Residue data on dry bulb onions can be translated to support the use on garlic; and
residue data on celery can be translated to support a similar use on anise (fennel). Residue
data on green onions can be translated to support use on leeks. Residue data from
tomatoes will be translated to support use on tomatillos.
Although residue data do not exist or are incomplete for beet tops, collards,
dandelions, kale, mustard, greens, parsley, and Swiss chard, the Agency has previously
determined that residue data on spinach can be translated to support similar uses on these
commodities. Residue data on lettuce can be translated to support use on endive
(escarole).
The available data on carrots, potatoes, sugar beets, and table beets adequately
support a crop group tolerance of 0.2 ppm for the Root Vegetables Crop Group provided
adequate storage stability data are submitted. There is no federally registered use on the
representative commodity radish and no residue data are available on radish. For purposes
of a crop group tolerance, residue data on table beets can be substituted for data on
radishes, as these crops are culturally similar.
In November 1987 the Methomyl Final Registration Standard and Tolerance
Reassessment, (FRSTR) previously concluded that the available residue data on dry beans
would be translated to support the use on lentils. However, label directions for lentils
more closely approximate the proposed use on dried peas. Therefore, residue data on
dried peas will be translated to support the use on lentils once storage stability issues
pertaining to dried bean and pea seeds are resolved.
For purposes of reregi strati on, additional residue data and/or label amendments are
required on chicory tops, radishes, turnips (greens), sorghum forage, bermudagrass
forage, and cotton gin byproducts as explained in detail below.
For chicory tops, data are required from a single test in Region 2 depicting
methomyl residues in/on chicory leaves following multiple applications at the maximum
31
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labeled rate. Leaves should be harvested at the proposed 30-day PHI. Based upon the
residue data, the registrant should propose an appropriate tolerance for chicory tops
(leaves) and amend labels to include a 30-day PHI for chicory leaves.
For radishes, data are required depicting methomyl residues in/on tops (leaves)
harvested 3 days following the last of two foliar applications of methomyl each at 0.9 Ib
ai/A. These data are required to support SLN No. CA770495. As per OPPTS Guideline
860.1500, the registrant can conduct three tests for radish at Ix the maximum rate at three
separate sites in CA (two samples per test), or Ix and 2x tests for radish at two separate
sites in CA (one sample per test). Alternatively, the registrant may elect to cancel this use
on radishes. Residue data from carrots can be translated to cover radish roots.
Turnip greens appears on the current labels under the crop grouping Leafy Green
Vegetables. The registrant must remove turnip greens from the labels. If the registrant
wishes to keep turnip greens on the labels then they would be required to do so under the
new crop groupng "Leaves of Root and Tuber Vegetables". Then the registrant is
required to generate data depicting residues of methomyl in/on turnip tops (leaves) as per
whatever the established maximum application and minimum PHI for turnip greens on the
labels would be. The registrant cannot translate data from existing data on leafy green
vegetables to turnip greens. Turnip greens (tops) are no longer included in the new crop
group for Leafy Green Vegetables (Crop Group 4). Turnip tops are considered a
representative commodity under the crop grouping for Leaves of Root and Tuber
Vegetables (Crop Group 2). If the registrant wishes to keep turnip tops on the labels, they
must submit the required residue data, and then along with existing data on sugar beet
tops, they could propose a crop group tolerance for Leaves of Root and Tuber Vegetables
(Crop Group 2).
In accordance with current Agency guidance (Residue Chemistry Test Guidelines,
OPPTS 860 series), zero-day residue data are required on grass forages. Therefore, zero-
day residue data are required on bermudagrass forage. Data are required depicting
methomyl residues in/on bermudagrass forage harvested the same day as an application at
0.9 Ib ai/A. A total of 12 trials are required in regions of the country in which
bermudagrass is grown for forage. Grass forages include forage sorghums. Therefore,
data are required on methomyl residues in/on sorghum forage harvested the same day as
the last of two applications of methomyl each at 0.45 Ib ai/A (for a toal seasonal
application of 0.9 Ib ai/A). Residue data from the bermuda grass trials can be translated to
support the sorghum forage uses. Alternatively, the registrant may amend their labels to
restrict the use of methomyl to only grain sorghum, in which case the available sorghum
forage data (14-day PHI) are adequate. In addition, if the use is restricted to grain
sorghum, then a tolerance would not be required for sorghum hay.
Data are required depicting methomyl residues in/on cotton gin byproducts ginned
from cotton harvested 15 days after the last of multiple foliar applications of methomyl at
the maximum labeled rate and totaling 1.8 Ib ai/A/season. The cotton must be harvested
32
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by commercial equipment (stripper and mechanical picker) to provide an adequate
representation of plant residue from the ginning process. At least three field trials for each
type of harvesting (stripper and picker) are needed, for a total of six field trials.
OPPTS GLN 860.1520 (formerly 171-40: Magnitude of the Residue in Processed
Food/Feed
The reregi strati on requirements for magnitude of the residue in processed
food/feed commodities are fulfilled for apple, citrus, corn, cottonseed, grape, mint, peanut,
potato, sorghum, soybean, sugar beet, tomato, and wheat. Based on the available
processing studies, a separate tolerance is only required for dried citrus pulp.
Methomyl residues did not concentrate in any processed commodities except
wheat bran (1.9x) and dried citrus pulp (2.9x). The Agency has concluded that separate
tolerances are not required for bran of barley, rye, or wheat. Based upon HAFT residues
of 0.7 ppm for small grain field trials and the 1.9x concentration factor, the maximum
expected residues in bran would be 1.3 ppm, which is not significantly higher than the 1
ppm RAC tolerance.
Based upon HAFT residues of 0.53 ppm for citrus fruits and the observed 2.9x
concentration factor, the maximum expected methomyl residues in dried citrus pulp would
be 1.54 ppm. Because the RAC tolerance for citrus fruits is being reassessed to 1 ppm,
the registrant should propose a tolerance of 2.0 ppm for methomyl residues in dried citrus
pulp.
OPPTS GLN 860.1480 (formerly 171-4H: Magnitude of the Residue in Meat. Milk.
Poultry, and Eggs
No tolerances have been established for methomyl residues in livestock
commodities. The requirement for a poultry feeding study has been waived. The Agency
believes this to be a 180.6(a)(3) situation, that is no reasonable expectation of finite
residues, based upon the results of the poultry metabolism study, which used a 45x feeding
level.
Adequate ruminant metabolism and feeding studies are available. Residues of
methomyl were not detected in milk and meat of livestock. The Agency concluded that
there is no reasonable expectation of finite methomyl residues in ruminant commodities
[180.6(a)(3)J. Therefore, no tolerances will be required for livestock commodities.
OPPTS GLN 860.1850 (formerly 165-1V Confined Accumulation in Rotational Crops
The application rate used in the study was not the appropriate maximum seasonal
rate (IX) for the individual crops tested. This study must be conducted at the IX rate.
Beets, sunflower seeds, and cabbage planted at 30- and 120-days posttreatment contained
33
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total radioactive residues (TRR) ranging from 0.04-2.0 ppm. A 12-month plantback
interval was not included in the study. Although the registrant stated the belief that
residues of methomyl per se were <0.01 ppm, no definitive anlayses for methomyl per se
were conducted. Based on all of the above, a new confined rotational crop study is
required. (See OPPTS Test Guidelines Series 860 Residue Chemistry Section 860.1850).
OPPTS GLN 860.1900 (formerly 165-2): Field Accumulation in Rotational Crops
The Agency reserves the requirement of this study until the results of the confined
rotational crop study are received and reviewed.
b. Dietary Risk Assessment and Risk Characterization
The Agency has determined that methomyl is a degradate of a registered pesticide,
thiodicarb. Therefore, where relevant, methomyl residues resulting from applications of
both thiodicarb and methomyl will be considered in an aggregate risk assessment and
compared to appropriate toxicological endpoints for methomyl.
Chronic (Non-Cancer) Risk - Methomyl Alone (food source only)
Chronic dietary risk from food sources is not a concern. A Dietary Risk
Evaluation System (DRES) chronic exposure analysis for the US Population and 22
subgroups was performed using percent crop treated data for all commodities and
anticipated residue data for only 5 commodities. Tolerance level residues were used for
the other commodities.
Existing tolerances result in an anticipated residue contribution (ARC) which
represents 34.6% of the RfD for the U.S. general population. The highest subgroup, Non-
Nursing Infants (<1 year old) occupies 67% of the RfD and Children (1-6 years old)
occupies 62% of the RfD.
Increasing the rye tolerance from 1 to 10 ppm, and the increase in the lentil
tolerance from 0.1 ppm to 0.2 ppm and the deletion of watercress results in an ARC of
35% of the RfD for the U.S. general population, 67% for Non-Nursing Infants (<1 year
old) and 63% for Children (1-6 years old).
This chronic analysis for methomyl is not a worst case estimate of dietary exposure
with most residues at tolerance level although, some refinements such as percent crop
treated data and anticipated residues for 5 commodities have been incorporated. Based on
the risk estimates calculated in this analysis, it appears that chronic dietary risk from food
sources is not of concern.
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Chronic (Non-Cancer) Risk - Methotnyl and Thiodicarb Combined (food source only)
Chronic exposures to methomyl residues from both thiodicarb and methomyl
applications were combined and compared to the methomyl reference dose. The
aggregated chronic exposure is shown in the table below (MRIDs 44327202, 44360702).
Table 7 - Chronic Aggregate Risk - Methomyl and Thiodicarb Combined
Population Subgroup
U. S. General
Children (1 to 6 years)
Infants
Dietary %RfDa
1.9
2.7
6.5
a Dietary %RfD includes methomyl residues from application of thiodicarb and methomyl
Results of the chronic exposure analysis show that no single subpopulation
exceeded 7% of the RfD. For the subpopulations, infants (<1 year old) and children (1- 6
years old), 6.5% and 2.7% of the RfD is occupied, respectively. For the general U.S.
population, only 1.9% of the RfD was occupied. In this analysis anticipated residue data
were used for all 70 commodities (as opposed to only 5 in the analysis for methomyl
alone). Percent crop treated information was used for all commodities. This refinement
accounts for the lower numbers in this assessment compared to the assessment for
methomyl alone.
Cancer Risk
Methomyl is classified as a Group E. The chemical is not likely to be carcinogenic
to humans via the relevant routes of exposure.
No aggregate cancer risk assessment is required because methomyl is not a
carcinogen.
Acute Dietary Risk - Methomyl Alone (food source only)
To estimate acute dietary exposure to the residues of methomyl, the registrant
conducted Monte Carlo simulations which utilized residues from the application of
methomyl. For this analysis, percent crop treated information and field trial residue data
were used for all commodities (MRIDs 44327201, 44360701).
Acute exposure estimates to methomyl were compared to the methomyl maternal
NOEL of 6 mg/kg/day from a rabbit developmental study based on deaths in dams on days
1-3 after dosing at 16 mg/kg/day. The acute exposure analysis was calculated for the
overall U.S. population, children 1 to 6 years of age, and infants.
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For calculating the Margin of Exposure (MOE) for methomyl, the FQPA safety
factor to account for any special sensitivity to infants and children has been reduced from
lOx to 3x to account for the lack of acute and subchronic neurotoxicity studies.
Therefore, a MOE of at least 300 is considered acceptable.
Table 8 - Acute Exposure MOEs for Methomyl.
Group of Concern
U.S. Population
Children 1 to 6 years
Infants
Exposure
0.006261
0.014399
0.005370
NOEL
6 mg/kg/day
6 mg/kg/day
6 mg/kg/day
MOE1
958
417
1117
1 99.9 percentile
The results of the acute exposure analyses indicate that there are adequate margins
of exposure for the overall U.S. population, children 1 to 6 years of age and infants.
Acute Risk - Methomyl and Thiodicarb Combined (food source only)
The registrant provided and the Agency has found acceptable, an acute dietary
Monte Carlo distributional risk assessment which utilized combined residues of methomyl
from the application of thiodicarb and residues of methomyl from the application of
methomyl. For this analysis, percent crop treated information and field trial residue data
were used for all commodities. The methomyl acute dietary NOEL of 6 mg/kg/day was
used to calculate the MOEs. The estimated MOEs are shown in the table below. Again,
an MOE of at least 300 is considered acceptable (MRTDs 44327202, 44360702).
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Table 9: EPA-calculated Margins of Exposure (MOEs) for Various U.S. Subpopulations Based on
Acute Effects and 24-hour intervals (NOEL = 6 mg/kg BW/day).
Population Group
U.S. Population
95th percentile
99th percentile
99. 9th percentile
Infants
95th percentile
99th percentile
99. 9th percentile
Children 1-6 years
95th percentile
99th percentile
99. 9th percentile
Food
24 hour interval
mg/kg BW/day
0.000349
0.001099
0.006577
0.000215
0.000874
0.007940
0.000482
0.002108
0.014396
MOE
17192
5460
912
27907
6865
756
12448
2846
417
Although refined using percent crop treated data, these estimates are still likely to
be a conservative estimate of the Margin of Exposure. For example, they assume that
residues, when present, are present as a result of application at the maximum permitted
level and observance of the minimum PHI. No reduction as a result of transport time from
farm gate to consumer is assumed to occur. Also, no further reduction of residues
through washing, peeling, or cooking at the producer or consumer level is assumed to
occur. The Agency concludes that sufficient margins of exposure exist at the 99.9th
percentile value.
c. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to take into account
available information concerning exposures from pesticide residues in food and other
exposures for which there is reliable information. These other exposures include drinking
water and non-occupational exposures, e.g., to pesticides used in and around the home.
Risk assessments for aggregate exposure consider both short-term and long-term
(chronic) exposure scenarios considering the toxic effects which would likely be seen for
each exposure duration.
Methomyl is a food use chemical. There are no residential uses of methomyl;
therefore the considerations for aggregate exposure are those from food and drinking
water.
37
-------
d. Drinking Water Assessment
OPP has calculated drinking water levels of concern (DWLOCs) for methomyl in
surface and ground water for the U.S. population and children 1 to 6 years old (Standard
Operating Procedures for Drinking Water Exposure and Risk Assessments, 11/26/97 and
Interim Guidance for Conducting Drinking Water Exposure Estimates, 12/2/97). For
acute exposures, they are 470 and 56 ppb, for the U.S. population and children (1-6 yrs
old), respectively. For chronic (non-cancer) exposure they are 275 and 78 ppb for the
U.S. population and children (1-6 years old ), respectively.
To calculate the DWLOC for acute exposure relative to the acute toxicity
endpoint, the acute dietary food exposure (from the combined thiodicarb and methomyl
Monte Carlo analysis) was subtracted from the ratio of the acute NOEL (used for acute
dietary assessments) to the "acceptable" MOE for aggregate exposure to obtain the
acceptable acute exposure to methomyl in drinking water. To calculate the DWLOC for
chronic (non-cancer) exposure relative to a chronic toxicity endpoint, the chronic dietary
food exposure (from ORES) was subtracted from the RfD to obtain the acceptable
chronic (non-cancer) exposure to methomyl in drinking water. DWLOCs were then
calculated using default body weights and drinking water consumption figures.
Estimated concentrations of methomyl in surface water are from PRZM/Exams
modeling. The estimated maximum (acute exposure) concentration is 30 ppb and the
estimated average (chronic exposure) concentration is 26 ppb. The estimated maximum
concentration of methomyl in ground water is 20 ppb based on the Agency's Pesticides in
Ground Water Database. Average concentrations in ground water are not expected to be
higher than the maximum concentrations. These estimated concentrations of methomyl in
surface and ground water are less than the Agency's levels of concern for methomyl in
drinking water as a contribution to acute and chronic aggregate exposure. Therefore,
taking into account the present uses, the Agency concludes with reasonable certainty that
residues of methomyl in drinking water when considered along with other sources of
exposure for which the Agency has reliable data would not result in levels of aggregate
human health risk that exceed levels of concern.
The estimates of methomyl in surface and ground waters are derived from models
that use conservative assumptions (health-protective) regarding the pesticide transport
from the point of application to surface and ground water. Because the Agency considers
the aggregate risk resulting from multiple exposure pathways associated with a pesticide's
uses, levels of concern in drinking water may vary as those uses change. If new uses are
added in the future, the Agency will reassess the potential impacts of methomyl on
drinking water as a part of the aggregate risk assessment process.
38
-------
Endocrine Disruption
EPA is required to develop a screening program to determine whether certain
substances (including all pesticides and inerts) "may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or such other endocrine
effect...". The Agency is currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research scientists in developing
a screening and testing program and a priority setting scheme to implement this program.
Congress has allowed 3 years from the passage of FQPA (August 3, 1999) to implement
this program. At that time, EPA may require further testing of this active ingredient and
end use products for endocrine disrupter effects.
e. Cumulative Risk
Section 408(b)(2)(D)(v) of the Food Quality Protection Act 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." The Agency
believes that "available information" in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and methodologies for
understanding common mechanisms of toxicity and conducting cumulative risk
assessments. For most pesticides, although the Agency has some information in its files
that may turn out to be helpful in eventually determining whether a pesticide shares a
common mechanism of toxicity with any other substances, EPA does not at this time have
the methodologies to resolve the complex scientific issues concerning common mechanism
of toxicity in a meaningful way. EPA has begun a pilot process to study this issue further
through the examination of particular classes of pesticides. The Agency hopes that the
results of this pilot process will increase the Agency's scientific understanding of this
question such that EPA will be able to develop and apply scientific principles for better
determining which chemicals have a common mechanism of toxicity and evaluating the
cumulative effects of such chemicals. The Agency anticipates, however, that even as its
understanding of the science of common mechanisms increases, decisions on specific
classes of chemicals will be heavily dependent on chemical specific data, much of which
may not be presently available.
Although at present the Agency does not know how to apply the information in its
files concerning common mechanism issues to most risk assessments, there are pesticides
for which the common mechanism issues can be resolved. These pesticides include
pesticides that are lexicologically dissimilar to existing chemical substances (in which case
the Agency can conclude that it is unlikely that a pesticide shares a common mechanism of
activity with other substances) and pesticides that produce a common toxic metabolite (in
which case common mechanism of activity will be assumed).
39
-------
EPA does not have, at this time, available data to determine whether methomyl has
a common mechanism of toxicity with other substances or how to include this pesticide in
a cumulative risk assessment. For the purposes of this tolerance action, therefore, EPA
has not assumed that methomyl has a common mechanism of toxicity with other
substances.
4. Occupational and Residential
a. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is required for an active
ingredient if (1) certain toxicological criteria are triggered and (2) there is potential
exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering
treated sites after application is complete.
Occupational-use products and homeowner-use products
At this time, products containing methomyl are intended primarily for occupational
use only and not for homeowner use. Therefore, no residential risk assessment is
required.
Epidemiological Information
In 1993 EPA issued a Data Call-In for Poison Control Center Data for 28
organophosphate and carbamate insecticides, and identified methomyl as one of five
candidates for immediate action under the Acute Worker Risk Strategy. Use of methomyl
products in California from 1982 - 1989 resulted in the second highest total number of
agricultural worker poisoning incidents, and the highest number of agricultural related
hospitalizations of all the chemicals reviewed.
The Agency has evaluated incident data for methomyl in two recent documents:
"Review of 1982 - 1989 Poison Control Center Data Call In,", dated December 5, 1994;
and "Review of 1990 - 1994 Poisoning Data for Aldicarb, Azinphosmethyl, Carbofuran,
Methamidophos, and Methomyl,"dated June 26, 1996. The second memorandum was an
update of the first, and summarizes the limited available data from the OPP Incident Data
System (IDS) and California data from the Pesticide Illness Surveillance System for five
insecticides ranked among the top six in the 1994 review.
In the 1994 review, methomyl ranked twelth among the 28 pesticides on most
measures of hazard where methomyl was clearly identified as the cause of the incident. It
was ranked fourth out of the five reviewed pesticides based on handler poisoning per
1,000 applications in California. Methomyl is the most widely used chemical in California
of the 28 reviewed. Exposures to methomyl ranked third in terms of percentage of
occupational cases requiring medical treatment among pesticides with a sufficient number
40
-------
of cases reported. For non-occupational cases, it also ranked third for percent life-
threatening cases. Methomyl had the third highest ratio of Poison Control Center (PCC)
poisonings, health care referrals, and hospitalizations per 1,000 pounds reported used in
agriculture. The ratio of childhood exposures and poisonings per 1,000 applications
reported in U.S. homes was ranked third for methomyl.
In the 1996 review, cases reported to the IDS and the California Pesticide Illness
Surveillance System were considered. Most of the cases reported to the IDS occurred in
California. The review concluded that application, mixing/loading, and spray drift
appeared to be roughly equally involved in undue exposures to methomyl. Improper use
of water soluble bags continued to be a problem although it seemed likely that this type of
poisoning would decline as workers become more familiar with this type of container.
Serious cases occurred when backpack sprayers were left unattended and when methomyl
was stored in improper containers. The backback sprayer issue was resolved during the
development of the Acute Worker Risk Strategy which required that methomyl can only
be applied to crops using mechanical ground and aerial application equipment.
In 1995, the Agency met with the registrants of methomyl and mitigation measures
were adopted to reduce incidents for the fly bait formulations. For the fly bait products
the use was limited to commercial agriculture production where children would not be
present. In addition, the bait stations are required to be placed four feet above the ground,
an embittering agent was added to all fly bait stations, and the color of the formulations
was limited to earth-tones or other dark unattractive colors.
In 1996, the Agency met with the registrants of methomyl and developed an Acute
Worker Risk Strategy. The measures adopted to reduce worker risks included, but were
not limited to: the addition to the label of generic spray drift language, and label language
prohibiting the application of this product in a way that will contact workers or other
persons, either directly or through drift; an agreement to require closed systems if
warranted by the risk assessments; the use of only mechanical ground or aerial application
equipment when applying methomyl to crops; the use of additional PPE or engineering
controls based on WPS requirements; and chemical resistant apron and footwear for
cleaners and repairers. A pictogram was added to water soluble bag packaging
demonstrating no cutting, ripping or tearing of the bag. A safe use educational program
was initiated and the registrant is required to provide California incident data for
methomyl directly to the Agency as it becomes available.
As each set of mitigation measures were put into effect the number of incidents
reported from the use of methomyl has been decreasing.
41
-------
Handlers
Exposures and Assumptions
EPA has determined that there are potential exposures to mixers, loaders,
applicators, and other handlers as the result of usual use patterns associated with
methomyl. Based on the use patterns, 15 major exposure scenarios were identified for
methomyl: (la) mixing/loading wettable powders for aerial application; (Ib) mixing/
loading wettable powders for groundboom application; (Ic) mixing/loading wettable
powders for airblast application; (2a) mixing/loading liquids for aerial application; (2b)
mixing/loading liquids for groundboom application; (2c) mixing/loading liquids for airblast
application; (3a) loading granulars for tractor-drawn/mechanical spreader application; (3b)
loading granulars for tractor-drawn bait application; (3c) loading granulars for aerial bait
application; (3d) loading granulars for bait station application; (4) applying sprays with a
fixed-wing aircraft; (5) applying sprays with a helicopter; (6) applying sprays with
groundboom equipment; (7a) applying granulars with a tractor-drawn spreader; (7b)
applying baits with a tractor-drawn spreader; (8) applying baits with aerial equipment; (9)
applying baits by hand; (10) applying dust with various dust application equipment;
(11) applying liquids with an airblast sprayer; (12) applying pastes with a paint brush; (13)
loading/applying granular bait with a belly-grinder spreader; (14) flagging aerial bait
applications; and (15) flagging for aerial spray applications.
No data are available for the following scenarios: dust application; mixing pelleted
baits with water for paint brush applications or mixing pastes (which are assumed to be the
same worker as the applicator, however, only applicator data are available); and flagging
for aerial bait applications. Risk estimates will be made by extrapolation from other data.
Short-term and intermediate-term dermal and inhalation exposure estimates
(developed using PHED Version 1.1 surrogate data) are presented in Table 10. No
chemical-specific data were submitted. Where appropriate, multiple application rates are
used to represent crops with differing maximum application rates. The maximum rates for
most crops are (1) 0.45 Ib ai/acre (e.g., barley, garlic); (2) 0.9 Ib ai/acre (e.g., citrus,
melons), or (3) 1.8 Ibs ai/acre (e.g., sod farm turf, peaches). These calculations of
handlers' daily dermal and inhalation exposure to methomyl are used to calculate the daily
doses to those handlers. Table 11 presents the dermal risk assessment for both short-term
and intermediate-term exposures together with risk estimates utilizing PPE and
engineering controls. Table 12 presents the inhalation risk assessment. Table 13 presents
combined dermal and inhalation MOEs for scenarios where inhalation exposure exceeded
1% of the dermal exposure. Table 13 also notes the minimum level of mitigation
considered to achieve MOEs greater than 100. Table 14 summarizes the caveats and
parameters specific to each exposure scenario and corresponding risk assessment.
42
-------
The following assumptions were made:
1) Average body weight of an adult handler is 70 kg; 2) area treated in each scenario: 350
acres for aerial applications (including flaggers supporting aerial applications), 80 acres for
groundboom applications and granular tractor drawn/mechanical spreader applications, 40
acres for airblast sprayer applications, 1 acre for belly-grinder applications, 10 Ibs. of
product for paint brush applications, and 0.25 acres for granular bait station applications
(based on EPA Reg. No. 5871-3, 0.25 Ib product (1 percent ai) per 500 ft2; which
assumes 0.25 acre maximum likely treatment area).
Since inhalation absorption data are not available, 100% inhalation absorption was
assumed.
43
-------
Table 10: Short-term and Intermediate-term Dermal and Inhalation Exposures to Methomyl (Engineering controls are in Table 11)
Exposure Scenario (Scen.#)
Baseline Dermal
Unit Exposure
(mg/lb ai)a
Baseline
Inhalation Unit
Exposure
(Mg/lb ai)b
Application Rate (Ib ai/acre)°
Daily Acres
Treated4
Daily Dermal
Exposure
(mg/day)e
Daily
Inhalation
Exposure
(mg/day)f
Mixer/Loader Exposure
Mixing/Loading Wettable Powder for Aerial Application
(la)
Mixing/Loading Wettable Powder for Groundboom
Application (Ib)
Mixing/Loading Wettable Powder for Airblast Application
(Ic)
Mixing/Loading Liquids for Aerial Application (2a)
Mixing/Loading Liquids for Groundboom Application (2b)
Mixing/Loading Liquids for Airblast Application (2c)
Loading Granulars for Tractor -Drawn/Mechanical Spreader
Application (3 a)
Loading Granulars for Tractor-Drawn Bait Applications
(3b)
Loading Granulars for Aerial Bait Applications (3c)
Loading Granulars for Bait Station Application (3d)
3.8
2.9
0.0076
43.4
1.2
1.7
(1)0.45
(2) 0.9
(3) 1.8
(1)0.45
(2) 0.9
(3) 1.8
(1)NA
(2) 0.9
(3) 1.8
(1)0.45
(2) 0.9
(3) 1.8
(1)0.45
(2) 0.9
(3) 1.8
(1)NA
(2) 0.9
(3) 1.8
0.15
0.9
0.9
0.2175
350
80
40
350
80
40
80
80
350
0.25 (44 bait
stations)
599
1,197
2,394
137
274
547
NA
137
274
457
914
1827
104
209
418
NA
104
209
0.091
0.547
2.394
0.0004
6.84
13.67
27.34
1.56
3.12
6.25
NA
1.56
3.12
0.19
0.38
0.76
0.043
0.086
0.17
NA
0.043
0.086
0.02
0.122
0.536
0.000092
44
-------
Table 10: Short-term and Intermediate-term Dermal and Inhalation Exposures to Methomyl [Engineering controls are in Table 11 ] (continued)
Exposure Scenario (Scen.#)
Baseline Dermal
Unit Exposure
(mg/lb ai)a
Baseline
Inhalation Unit
Exposure
(Mg/lb ai)b
Application Rate (Ib ai/acre)°
Daily Acres
Treated4
Daily Dermal
Exposure
(mg/day)e
Daily
Inhalation
Exposure
(mg/day)f
Applicator Exposure
Applying Sprays with a Fixed- Wing Aircraft (4)
Applying Sprays with a Helicopter (5)
Applying Sprays with a Groundboom Sprayer (6)
Applying Granulars with a Broadcast Spreader (Tractor)
(7a)
Applying Baits with Tractor-Drawn Spreader (7b)
Applying Baits with Aerial Equipment (8)
Applying Baits by Hand (9)
Applying Dust with Dust Application Equipment (10)
Applying Liquids with an Airblast Sprayer (11)
Applying Paste with a Brush (12)
(Note: No mixer/loader data available, though likely to be
same worker. No information available about area covered
by paste.)
See Engineering
Controls
See Engineering
Controls
0.015
0.01
See Eng.
Controls
No data— See
PPE
No data
0.36
182
See Engineering
Controls
See Engineering
Controls
0.7
1.2
See Eng. Controls
468
No data
4.5
284
(1)0.45
(2) 0.9
(3) 1.8
(1)0.45
(2) 0.9
(3) 1.8
(1)0.45
(2) 0.9
(3) 1.8
0.15
0.9
0.9
0.2175
1.0
(1)NA
(2) 0.9
(3) 1.8
O.Ollbai/lb product,
0.25 Ibs product/4 oz H20
350
350
80
80
80
350
0.25
No data
40
10 Ibs product
See
Engineering
Controls
See
Engineering
Controls
0.54
1.08
2.16
0.12
0.72
See Eng.
Controls
See PPE
No data
NA
12.96
25.92
18.2
See
Engineering
Controls
See
Engineering
Controls
0.025
0.05
0.1
0.014
0.086
See Eng.
Controls
0.025
No data
NA
0.16
0.32
0.028
Mixer/Loader/Applicator Exposure
Loading/Applying Granular Bait with a Belly Grinder (13)
10.4
61.8
0.2175
1
2.26
0.013
45
-------
Exposure Scenario (Scen.#)
Flagging Aerial Bait (granular) Applications (14)
Flagging Aerial Spray Applications (15)
Baseline Dermal
Unit Exposure
(mg/lb ai)a
No data
0.01
Baseline
Inhalation Unit
Exposure
(Mg/lb ai)b
Flagger Exposure
No data
0.28
Application Rate (Ib ai/acre)°
0.9
(1)0.45
(2) 0.9
1.8
Daily Acres
Treated4
350
350
Daily Dermal
Exposure
(mg/day)e
No data
1.58
3.15
6.3
Daily
Inhalation
Exposure
(mg/day)f
No data
0.044
0.088
0.18
Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/loading, open cab tractor. Baseline data are not available for
aerial application or applying baits by hand.
Baseline inhalation exposure represents no respirator.
Application rates are maximum values found in the Methomyl labels. In some scenarios, a range of maximum application rates were used as follows: (1) low
rate (e.g., barley, garlic), (2) medium rate (e.g., citrus, melons), (3) high rate (e.g., peaches, sod farm turf).
Daily acres treated values are estimates of acreage that could be treated in a single day for each exposure scenario of concern. For Scenario 12, no information
is available to estimate area treated with pastes mixed from bait pellets. EPA estimates that 10 Ibs of product could be handled per day (yielding roughly 2
gallons of paste). Note that no mixer/loader data are available from which to estimate exposure, and that the mixer/loader would likely apply the paste, too.
Thus, resulting MOEs would be somewhat lower than are estimated in Tables 11 - 13.
Daily dermal dose (mg/day) = Exposure (mg/lb ai) * Appl. rate (Ib ai/acre) * Acres treated.
Daily inhalation exposure (mg/day) = Exposure (ug/lb ai) * (lmg/1000^g) conversion * Appl. Rate (Ib ai/A) * Acres Treated.
46
-------
Table 11: Short-term and Intermediate-term Dermal Risks of Methotnyl
Exposure Scenario (Seen #)
Baseline
Dermal Dose
(mg/kg/day)"
Baseline Dermal
MOEb
Risk Mitigation Measures
Additional PPE1
PPE Dermal Unit
Exp. (mg/lb ai)
PPE
Daily Dermal
Dose (mg/kg/day)a
PPE Dermal
MOEb
Engineering Controls'1
Eng. Controls Dermal
Unit Exposure
(mg/lb ai)
Eng. Controls
Dermal Daily Dose
(mg/kg/day)"
Eng. Controls
Dermal MOEb
Mxer/Loader Risk
Mixing/Loading Wettable Powder for Aerial
Application (la)
Mxing/Loading Wettable Powder for Groundboom
Application (Ib)
Mixing/Loading Wettable Powder for Airblast
Application (Ic)
Mixing/Loading Liquids for Aerial Application (2a)
Mxing/Loading Liquids for Groundboom Application
(2b)
Mixing/Loading Liquids for Airblast Application (2c)
Loading Granulars for Tractor-Drawn/Mechanical
Spreader Application (3a)
Loading Granulars for Tractor-Drawn Bait
Applications (3b)
Loading Granulars for Aerial Bait Applications (3c)
Loading Granulars for Bait Station Application (3d)
(JAM
(2) 17.1
(3) 34.2
I1) 2.0
(2).3,9
(3) 7.8
(1)NA
(2) 2.0
(3) 3.9
(1)6.5
(2) 13.1
(3)26.1
(1)1.5
(2) 3.0
(3) 6.0
(1)NA
(2) 1.5
(3) 3.0
0.0013
0.0078
0.0342
5.7 x 10'6
10
5
3
45
23
12
NA
45
23
14
7
3
60
30
15
NA
60
30
69,000
12,000
2,600
1.5X107
0.13
0.16
0.043
0.043
NA
NA
NA
NA
0.29
0.59
1.17.
0.08
0.16
0.33
NA
0.08
0.16
0.10
0.20
0.39
0.02
0.04
0.09
NA
0.02
0.04
NA
NA
NA
NA
310
150
77
1100
560
270
NA
1100
560
900
450
230
4,500
2,300
1,000
NA
4,500
2,300
NA
NA
NA
NA
0.02
NA
NA
NA
NA
NA
NA
NA
0.18
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
500
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Applicator Risk
Applying Sprays with a Fixed- Wing Aircraft (4)
Applying Sprays with a Helicopter (5)
Applying Sprays with a Groundboom Sprayer (6)
Applying Granulars with a Broadcast Spreader
(Tractor) (7a)
Armlvina Baits with Tractor-Drawn Snreader db)
See
Engineering
Controls
See
Engineering
Controls
(_!) 0.008
(2) 0.015
(3) 0.03
0.0017
0.010
See Engineering
Controls
See Engineering
Controls
11,000
6,000
3,000
53,000
9.000
See Engineering
Controls
See Engineering
Controls
NA
NA
NA
See Engineering
Controls
See Engineering
Controls
NA
NA
NA
See
Engineering
Controls
See
Engineering
Controls
NA
NA
NA
0.005
0.0021
NA
NA
NA
0.011
0.023
0.045
0.005
0.009
0.019
NA
NA
NA
8,200
3,900
2,000
18,000
10,000
4,700
NA
NA
NA
47
-------
Exposure Scenario (Seen #)
Applying Baits with Aerial Equipment (8)
Applying Baits by Hand (9)
Applying Dust with Dust Application Equipment (10)
Applying Liquids with an Airblast Sprayer (11)
Applying Paste with a Brush (12)
Note: No mixer loader data available.
Baseline
Dermal Dose
(mg/kg/day)"
See
Engineering
Controls
No data— See
PPE
No data
(1)NA
(2)0.19
(3) 0.37
0.26
Baseline Dermal
MOEb
See Engineering
Controls
No data- See
PPE
No data
NA
470
240
350
Risk Mitigation Measures
Additional PPE1
PPE Dermal Unit
Exp. (mg/lb ai)
See Engineering
Controls
71.3
No data
NA
NA
PPE
Daily Dermal
Dose (mg/kg/day)a
See Engineering
Controls
0.06
No data
NA
NA
NA
NA
PPE Dermal
MOEb
See
Engineering
Controls
1,500
No data
NA
NA
NA
NA
Engineering Controls'1
Eng. Controls Dermal
Unit Exposure
(mg/lb ai)
0.0016
NA
No data
NA
NA
Eng. Controls
Dermal Daily Dose
(mg/kg/day)"
0.007
NA
No data
NA
NA
NA
NA
Eng. Controls
Dermal MOEb
13,000
NA
No data
NA
NA
NA
NA
Mxer/Loader/Applicator Risk
Loading/ Applying Granular Bait with a Belly Grinder
(13)
0.032
2,800
NA
NA
NA
NA
NA
NA
Flagger Risk
Flagging Aerial Bait (granular) Applications (14)
Flagging Aerial Spray Applications (15)
No data
(1) 0.023
(2) 0.045
(3) 0.09
No data
3,900
2,000
1,000
No data
NA
No data
NA
NA
NA
No data
NA
NA
NA
No data
NA
No data
NA
NA
NA
No data
NA
NA
NA
Note: Application rates are maximum values found in the Methomyl labels. In some scenarios, a range of maximum application rates were used as follows: (1) low rate (e.g., barley,
garlic), (2) medium rate (e.g., citrus, melons), (3) high rate (e.g., peaches, sod farm turf).
a Dermal Dose (mg/kg/day) = Dermal Exposure (mg/day) / Body weight (70 kg).
b Dermal MOE = NOEL (90 mg/kg/day) / Daily Dermal Dose (mg/kg/day). Values are rounded to 2 significant figures. PPE daily doses rounded to nearest hundredth.
c Additional PPE:
Double layer of clothing and chemical resistant gloves.
Single layer of clothing and chemical resistant gloves.
Single layer of clothing and chemical resistant gloves.
Single layer of clothing and chemical resistant gloves (no data for no gloves scenario).
Scenarios la:
Scenarios Ib, Ic
Scenarios 2a, 2b, 2c:
Scenario 9:
d Engineering Controls:
Scenario la:
Scenario 4:
Scenario 5:
Scenario 8:
Water soluble packets, single layer of clothing, no gloves.
Enclosed cockpit, single layer of clothing, no gloves (no data for open cockpit scenario).
Enclosed cockpit, single layer of clothing, no gloves (no data for open cockpit scenario).
Enclosed cockpit, single layer of clothing, no gloves (no data for open cockpit scenario).
48
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Table 12: Inhalation Risks of Methotnyl (any duration)
Exposure Scenario (Seen #)
Baseline Inhalation
Dose (mg/kg/day)"
Baseline
Inhalation MOEb
Risk Mitigation Measures
Additional PPE1
PPE Inhalation
Unit Exp.
Og/lb ai)
PPE
Daily Inhalation Dose
(mg/kg/day)"
PPE Inhalation
MOEb
Engineering Controls'1
Eng. Controls Inhalation
Unit Exposure
C^g/lb ai)
Eng. Controls Inhalation
Daily Dose (mg/kg/day)a
Eng. Controls
Inhalation MOEb
Mixer/Loader Risk
Mixing/Loading Wettable Powder for Aerial
Application (la)
Mixing/Loading Wettable Powder for
Groundboom Application (Ib)
Mixing/Loading Wettable Powder for Airblast
Application (Ic)
Mixing/Loading Liquids for Aerial Application
(2a)
Mixing/Loading Liquids for Groundboom
Application (2b)
Mixing/Loading Liquids for Airblast
Application (2c)
Loading Granulars for Tractor Drawn/
Mechanical Spreader Application (3a)
Loading Granulars for Tractor-Drawn Bait
Applications (3b)
Loading Granulars for Aerial Bait Applications
(3c)
Loading Granulars for Bait Station Application
(3d)
(1) 0.098
(2) 0.20
(3) 0.39
(1) 0.022
(2) 0.045
(3) 0.089
(1)NA
(2) 0.022
(3) 0.045
<1 percent of dermal
dose
(1) 0.0006
(2) 0.0012
(3) 0.0024
<1 percent of dermal
dose
<1 percent of dermal
dose
0.002
0.008
<1 percent of dermal
dose
380
190
95
1,700
820
420
NA
1,700
820
NA
62,000
31,000
15,000
NA
NA
19,000
4,600
NA
8.68 (dust/mist
respirator)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0.039
0.078
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
950
470
NA
NA
NA
NA
NA
NA
NA
NA
NA
0.24
NA
0.08
NA
NA
NA
NA
NA
NA
NA
0.002
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
18,500
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Applicator Risk
Applying Sprays with a Fixed- Wing Aircraft
(4)
Applying Sprays with a Helicopter (5)
Applying Sprays with a Groundboom Sprayer
(6)
Applying Granulars with a Tractor Drawn
Spreader Rate = 0.15 Ibs ai/A) (7a)
See Engineering
Controls
See Engineering
Controls
(1) 0.0004
(2) 0.0007
(3) 0.0014
0.0002
See Engineering
Controls
See Engineering
Controls
93,000
53,000
26,000
190,000
See Engineering
Controls
See Engineering
Controls
NA
NA
See Engineering Controls
See Engineering Controls
NA
NA
See Engineering
Controls
See Engineering
Controls
NA
NA
0.068
<1 percent of dermal
dose
NA
NA
0.0002
0.0003
0.0006
NA
NA
NA
190,000
120,000
61,000
NA
NA
NA
49
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Exposure Scenario (Seen #)
Applying Baits with a Tractor-Drawn Spreader
(7b)
Applying Baits with Aerial Equipment (8)
Applying Baits by Hand (9)
Applying Dust with Dust Application
Equipment (10)
Applying Liquids with an Airblast Sprayer (11)
Applying Paste with a Brush (12)
Baseline Inhalation
Dose (mg/kg/day)"
0.001
See Eng. Controls
0.0004
No data
(1)NA
(2) 0.0023
(3) 0.0046
< 1 percent of dermal
dose
Baseline
Inhalation MOEb
37,000
See Eng.
Controls
93,000
No data
NA
16,000
8,000
NA
Risk Mitigation Measures
Additional PPE1
PPE Inhalation
Unit Exp.
O^g/lb ai)
NA
See Eng. Controls
NA
No data
NA
NA
PPE
Daily Inhalation Dose
(mg/kg/day)"
NA
See Eng. Controls
NA
No data
NA
NA
PPE Inhalation
MOEb
NA
See Eng.
Controls
NA
No data
NA
NA
Engineering Controls'1
Eng. Controls Inhalation
Unit Exposure
(Aig/lb ai)
NA
1..32
NA
No data
0.4
NA
Eng. Controls Inhalation
Daily Dose (mg/kg/day)a
NA
0.006
NA
No data
NA
0.0002
0.0004
NA
Eng. Controls
Inhalation MOEb
NA
6,200
NA
No data
NA
190,000
93,000
NA
Mxer/Loader/ Application Risk
Loading/ Applying Granular Bait with a Belly
Grinder (13)
<1 percent of dermal
dose
NA
NA
NA
NA
NA
NA
NA
Flagger Risk
Flagging Aerial Bait (granular) Applications
(14)
Flagging Aerial Spray Applications (15)
No data
(1) 0.0006
(2) 0.0013
(3) 0.0026
No data
62,000
28,000
14,000
No data
NA
No data
NA
No data
NA
No data
0.0056
No data
NA
NA
0.00005
No data
NA
NA
740,000
Note: Application rates are maximum values found in the Methomyl labels. In some scenarios, a range of maximum application rates were used as follows: (1) low rate (e.g., barley, garlic), (2) medium
rate (e.g., citrus, melons), (3) high rate (e.g., peaches, sod farm turf).
a Inhalation dose (mg/kg/day) = Inhalation Exposure (mg/day) / Body Weight (70 kg)
b Inhalation MOE = NOEL (mg/kg/day) / Inhalation Dose (mg/kg/day), where NOEL = 0.137 mg/L; route-to-route extrapolation = [(0.0048 mg/L/day * 1 * 8.46 L/hr * 6 hr * 1) / (0.190 kg)] =
NOEL of 37 mg/kg/day.
Additional PPE:
(la) Dust/mist respirator (5 fold protection factor)
d Engineering Controls:
(la) Water soluble packets
(4) Enclosed cockpit
(5) Enclosed cockpit
(8) Enclosed cockpit
Note: For Scenario la, PPE and Engineering Controls inhalation MOEs were calculated at the 0.9 and 1.8 Ib ai/acre rates (although inhalation MOEs were acceptable at baseline and PPE respectively) so
that the dermal and inhalation MOEs could be combined in Table 11.
50
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Table 13: Combined Short-term and Intermediate-term Dermal and Inhalation Risks of Methotnyl
Exposure Scenario (Seen #)
Mixing/Loading Wettable Powder for Aerial Application
(la)
Mixing/Loading Wettable Powder for Groundboom
Application (Ib)
Mixing/Loading Wettable Powder for Airblast
Application (Ic)
Mixing/Loading Liquids for Aerial Application (2a)
Mixing/Loading Liquids for Groundboom Application
(2b)
Mixing/Loading Liquids for Airblast Application (2c)
Loading Granulars for Tractor Drawn/Mechanical
Spreader Application (3a)
Loading Granulars for Tractor-Drawn Bait Applications
(3b)
Loading Granulars for Aerial Bait Applications (3c)
Loading Granulars for Bait Station Application (3d)
Applying Sprays with a Fixed- Wing Aircraft (4)
Dermal MOEa
Mixer/Loader Risk
(1) 310 PPE
(2) 150 PPE
(3) 500 PPE
(1) 1100 PPE
(2) 560 PPE
(3) 270 PPE
(1) NA (0.45 Ib ai/A rate not
used)
(2) 1,100 PPE
(3) 560 PPE
(1) 900 PPE
(2) 450 PPE
(3) 230 PPE
(1) 4500 PPE
(2) 2300 PPE
(3) 1000 PPE
(1) NA (0.45 Ib ai/A rate not
used)
(2) 4500 PPE
(3) 2300 PPE
69,000 Baseline
12,000 Baseline
2600 Baseline
880,000 Baseline
Applicator Risk
(1) 8200 Eng. Cntrls.
(2) 3900 Eng. Cntrls.
(3) 2000 Eng. Cntrls.
Inhalation MOEb
380 Baseline
950 PPE
< 1 percent of dermal dose
1,700 Baseline
820 Baseline
420 Baseline
NA
1,700 Baseline
820 Baseline
<1 percent of dermal dose
62,000 Baseline
31,000 Baseline
15,000 Baseline
<1 percent of dermal dose
<1 percent of dermal dose
19,000 Baseline
4600 Baseline
<1 percent of dermal dose
190,000 Eng. Cntrls.
120,000 Eng. Cntrls.
61,000 Eng. Cntrls.
Combined Dermal and Inhalation MOEC
170 PPE (double layers, gloves, no
respirator)
130 PPE (double layers, gloves, dust/mist
respirator)
500 Eng. Controls (water soluble packets,
single layer, no gloves or respirator)
670 PPE (single layer, gloves)
330 PPE (single layer, gloves)
160 PPE (single layer, gloves)
NA (0.45 Ib ai/A rate not used)
660 PPE (single layer, gloves)
330 PPE (single layer, gloves)
900 PPE (single layer, gloves)
450 PPE (single layer, gloves)
230 PPE (single layer, gloves)
4200 PPE (single layer, gloves)
2100 PPE (single layer, gloves)
930 PPE (single layer, gloves)
NA (0.45 Ib ai/A rate not used)
4500 PPE (single layer, gloves)
2300 PPE (single layer, gloves)
69,000 Baseline
7,400 Baseline
1,700 Baseline
880,000 Baseline
7,900 Eng. Cntrls. (Closed cockpit)
3,800 Eng. Cntrls. (Closed cockpit)
1,900 Eng. Cntrls. (Closed cockpit)
51
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Exposure Scenario (Seen #)
Applying Sprays with a Helicopter (5)
Applying Sprays with a Groundboom Sprayer (6)
Applying Granulars with a Broadcast Spreader (Tractor)
(7a)
Applying Baits with Tractor-Drawn Spreader (7b)
Applying Baits with Aerial Equipment (8)
Applying Baits by Hand (9)
Applying Dust with Dust Application Equipment (10)
Applying Liquids with an Airblast Sprayer (11)
Applying Paste with a Brush (12)
Mixing/Loading/Applying Granular Bait for Belly
Grinder Application (13)
Flagging Aerial Bait Applications (14)
Flagging Aerial Spray Applications (15)
Dermal MOEa
(1) 18,000 Eng. Cntrls.
(2) 10,000 Eng. Cntrls.
(3) 4700 Eng. Cntrls.
(1) 1100 Baseline
(2) 6000 Baseline
(3) 3000 Baseline
53,000 Baseline
9000 Baseline
13,000 Eng. Controls
1500 PPE
No data
(1) NA (0.45 Ib ai/acre rate not
used)
(2) 470 Baseline
(3) 240 Baseline
350 Baseline
Mixer/Loader/Application Risi
2800 Baseline
Flagger Risk
No data
(1) 3900 Baseline
(2) 2000 Baseline
(3) 1000 Baseline
Inhalation MOEb
<1 percent of dermal dose
93,000 Baseline
53,000 Baseline
26,000 Baseline
190,000 Baseline
37,000 Baseline
6,200 Eng Cntrls.
93,000 Baseline
No data
NA
16,000 Baseline
8,000 Baseline
<1 percent of dermal dose
<1 percent of dermal dose
No data
62,000 Baseline
28,000 Baseline
14,000 Baseline
Combined Dermal and Inhalation MOEC
18,000 Eng. Cntrls. (Closed cockpit)
10,000 Eng. Cntrls. (Closed cockpit)
4,700 Eng. Cntrls. (Closed cockpit)
9,800 Baseline
5,400 Baseline
2,700 Baseline
42,000 Baseline
7,200 Baseline
4,200 Eng. Cntrls. (Closed cockpit)
1,500 PPE (single layer, gloves)
No data
NA
460 Baseline
230 Baseline
350 Baseline
2,800 Baseline
No data
3,700 Baseline
1,900 Baseline
930 Baseline
Note: Application rates are maximum values found in the Methomyl labels. In some scenarios, a range of maximum application rates were used as follows: (1) low rate (e.
barley, garlic), (2) medium rate (e.g., citrus, melons), (3) high rate (e.g., peaches, sod farm turf).
a Dermal MOEs and levels of PPE and Eng. Cntrl. descriptions are listed in Table 11.
b Inhalation MOEs are listed in Table 12.
Combined MOE (formula from Methomyl Hazard ID, dated 3/3/98) = 1
1 + 1
MOED
MOE,
52
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Table 14: Exposure Scenario Descriptions for the Use of Methotnyl
Exposure Scenario (Number)
Data
Source
Standard Assumptions
(8-hr work day)
Comments
Mixer/Loader Descriptors
Mixing/Loading Wettable Powder
Formulations (la, Ib and Ic)
PHED
VI.1
350 acres for aerial, 80
acres for groundboom, 40
acres for airblast.
Baseline: "Best Available" grades: Hands= all grades, dermal = acceptable grades,
inhalation = ABC grades. Hands 28 replicates; dermal = 7 to 24 replicates; inhalation = 44
replicates. Low confidence in dermal data; medium confidence for inhalation data.
PPE: "Best Available" grades: Hands, dermal, and inhalation = ABC grades. Hands 24
replicates; dermal = 22 to 45 replicates; inhalation = 44 replicates. Medium confidence in
hands, dermal and inhalation data.
Engineering Controls: "Best Available" grades: Dermal acceptable grades; hands and
inhalation = all grades. Hands 5 replicates; dermal = 6 to 15 replicates; inhalation = 15
replicates. Low confidence in dermal and inhalation data.
PHED data used for baseline no Protection Factors (PFs) were necessary. A 50% PF was
used for PPE to represent double layer of clothing (dermal exposure excluding head and
hands). A 5-fold PF was used for the PPE scenario for the addition of a dust/mist respirator.
Mixing/Loading Liquid Formulations
(2a, 2b and 2c)
PHED
VI.1
350 acres for aerial, 80
acres for groundboom, 40
acres for airblast.
Baseline: "Best Available" grades: Hands, dermal, and inhalation acceptable grades. Hands
= 53 replicates; Dermal = 25 to 122 replicates; Inhalation = 85 replicates. High Confidence
in dermal and inhalation data.
PPE: "Best Available" grades: Hands and dermal acceptable grades, hands = 59 replicates:
Dermal = 25 to 122 replicates. High confidence in dermal data.
PHED data used for baseline no PFs were necessary.
Loading Granular Formulations (3 a,
3b, 3c, and 3d)
PHED
VI.1
350 acres for aerial, 80
acres for row planters and
tractor-drawn spreaders.
0.25 acres for bait stations
(equivalent to 44 bait
stations).
Baseline: "Best Available" grades: Hands = all grades; dermal and inhalation acceptable
grades. Hands = 10 replicates; dermal = 29 to 36 replicates; inhalation = 58 replicates. Low
confidence in dermal data; high confidence for inhalation data.
PHED data used for baseline, no PFs were necessary.
53
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Exposure Scenario (Number)
Data
Source
Standard Assumptions
(8-hr work day)
Comments
Applicator Descriptors
Applying Sprays with a Fixed-wing
Aircraft (4)
Applying Sprays with a Helicopter (5)
Applying Sprays with a Groundboom
Sprayer (6)
Applying Granulars and Pelleted
Baits with a Tractor-Drawn Spreader
(7a and 7b)
Applying Baits with Aerial
Equipment (8)
Applying Baits by Hand (9)
Applying Dust with Dust Applicator
Equipment (10)
Applying Liquids with an Airblast
Sprayer (11)
PHED
VI. 1
PHED
VI. 1
PHED
VI. 1
PHED
VI. 1
PHED
VI. 1
PHED
VI. 1
No data
PHED
VI. 1
350 acres.
350 acres.
80 acres.
80 acres.
350 acres.
0.25 acres.
No data.
40 acres.
Engineering Controls: "Best Available" grades: Hands = acceptable grades; dermal, and
inhalation ABC grades. Hands = 34 replicates; dermal = 24 to 48 replicates; inhalation = 23
replicates. Medium Confidence in dermal and inhalation data.
PHED data used no PFs were necessary.
Engineering Controls: "Best Available" grades: Hands, dermal and inhalation acceptable
grades. Hands = 2 replicates; dermal = 3 replicates; inhalation = 3 replicates. Low
confidence in dermal and inhalation data.
PHED data used no PFs were necessary.
Baseline: "Best Available" grades: Hands, dermal, and inhalation acceptable grades. Hands
= 16 replicates; dermal = 16 to 18 replicates; inhalation = 18 replicates. High confidence in
dermal and inhalation data.
PHED data used no PFs were necessary.
Baseline: "Best Available" grades: Hands, dermal, and inhalation = acceptable grades.
Hands = 5 replicates; dermal = 1 to 5 replicates; inhalation = 5 replicates. Low confidence in
dermal and inhalation replicates.
PHED data used no PFs were necessary.
Engineering Controls: "Best Available" grades: Hands, dermal, and inhalation all grades.
Hands = 4 replicates, dermal and inhalation =13 replicates. Low confidence in dermal and
inhalation data.
PHED data used no PFs were necessary.
PPE: "Best Available" grades: Hands, dermal, and inhalation = acceptable grades ABC.
Hands = 15 replicates; dermal and inhalation = 16 replicates. Medium confidence in dermal
and inhalation data. (Baseline data not available.)
PHED data used no PFs were necessary.
No data
Baseline: "Best Available" grades: Hands, dermal, and inhalation = acceptable grades.
Hands = 22 replicates; dermal = 32 to 49 replicates; inhalation = 47 replicates. High
confidence in dermal and inhalation data.
PHED used for baseline data, no PFs necessary.
54
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Exposure Scenario (Number)
Applying Paste with a Brush (12)
Data
Source
PHED
VI. 1
Standard Assumptions
(8-hr work day)
10 Ibs. End-use product, or
about 2 gallons of paste.
Comments
Baseline: "Best Available" grades: Hands and dermal = ABC grades, inhalation = C grade.
Hands, dermal, and inhalation =15 replicates. Medium confidence in dermal data and
inhalation data.
PHED data used for baseline, no PFs were necessary.
Mixer/Loader/ Applicator Descriptors
Mixing/Loading/Applying Granular
Bait with a Belly-Grinder (13)
PHED
VI. 1
1 acre.
Baseline: "Best Available" grades: Hands and dermal = ABC grades, inhalation = acceptable
grades. Hands = 23 replicates, dermal = 29 to 45 replicates, inhalation = 40 replicates.
Medium confidence in dermal data, high confidence for inhalation data.
PHED data used for baseline, no PFs were necessary.
Flagger Descriptors
Flagging Aerial Bait (Granular)
Applications (14)
Flagging Aerial Spray Applications
(15)
No data
PHED
VI. 1
350 acres.
350 acres.
No data
Baseline: "Best Available" grades: Hands, dermal, and inhalation acceptable grades. Hands
= 16 replicates: dermal = 16 to 18 replicates; inhalation = 18 replicates. High confidence in
dermal and inhalation data.
PHED data used for baseline, no PFs were necessary.
Standard Assumptions based on an 8-hour work day. BEAD data were not available.
"Best Available" grades are defined by OREB SOP for meeting Subdivision U Guidelines. Best available grades are assigned as follows: matrices with grades A and B
data and a minimum of 15 replicates; if not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the
quality and number of replicates. Data confidence are assigned as follows:
High
Medium
Low
= grades A and B and 15 or more replicates per body part
= grades A, B, and C and 15 or more replicates per body part
= grades A, B, C, D and E or any combination of grades with less than 15 replicates
55
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b. Occupational Risk Estimates
Estimates of exposure and risk indicate that, for several scenarios, measures to reduce
handlers exposures should be considered. Table 13 shows the levels of mitigation needed to
attain MOEs greater than 100, while Table 14 describes the data quality and confidence level for
each scenario. Options to reduce handlers' exposures and risk range from personal protective
equipment (double layer of clothing and chemical resistant gloves) to engineering controls (water
soluble packets).
Combined Dermal and Inhalation Risk from Occupational Handler Exposure
The calculations of combined dermal and inhalation risk indicate that the MOEs are
acceptable (100 or greater) at baseline (long pants, long sleeved shirt) for the following scenarios:
(3a thru 3d) loading granulars for ground, air, and bait applications;
• (6) applying sprays with groundboom sprayers;
(7a and 7b) applying granulars and baits with tractor-drawn broadcast spreaders;
• (11) applying liquids with an airblast sprayer;
(12) applying pastes with a brush;
• (13) mixing/loading/applying granular baits for belly grinder applications; and
(15) flagging aerial spray applications.
The calculations of combined dermal and inhalation risk indicate that the MOEs are
acceptable (100 or greater) with the noted additional PPE for the following scenarios:
• (la) Mixing/loading wettable powders for aerial applications at the 0.45 Ib. a.i./A rate
requires double layer of clothing and chemical resistant gloves. At the 0.9 Ib. a.i./A
rate double layer of clothing, chemical resistant gloves, and a dust/mist respirator are
required. At the 1.8 Ib. a.i./A rate water soluble bags and single layer of clothing are
required. However, if water soluble packaging is used for all rates for wettable
powders then only a single layer of clothing (long-sleeved shirt, long pants, and
shoes plus socks) is required;
(Ib) Mixing/loading wettable powders for groundboom applications requires single layer
of clothing and chemical resistant gloves;
(Ic) Mixing/loading wettable powders for airblast applications requires single layer of
clothing and chemical resistant gloves; and
(2a, 2b, and 2c) Mixing/loading liquids for aerial, groundboom and airblast applications
requires single layer of clothing and chemical resistant gloves;
(9) applying baits by hand requires single layer of clothing and chemical resistant gloves.
In the regulatory section this information has been integrated with other considerations
based on epidemiological information and handler incident data to determine the final PPE
requirements.
56
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The calculations of combined dermal and inhalation risk indicate that the MOEs are
acceptable (100 or greater) with the noted engineering controls for the following scenarios:
• (la) mixing/loading wettable powders for aerial application at the 1.8 Ib rate requires
water soluble bags;
• (4) applying sprays with fixed-wing aircraft (baseline and PPE not available) requires an
enclosed cockpit;
• (5) applying sprays with a helicopter (baseline and PPE not available) requires an
enclosed cockpit; and
• (8) applying baits with aerial equipment (baseline and PPE not available) requires an
enclosed cockpit.
However, when estimated MOEs for closed-cockpit exposure scenarios are an order of
magnitude larger than the uncertainty factor (i.e., the acceptable MOE), then this scenario would
also be acceptable using an open-cockpit plane. For methomyl, an occupational MOE of 100 or
higher is required to be above the Agency's level of concern. The combined dermal and
inhalation MOEs for enclosed cockpits range from 1900 to 18000. Therefore, an enclosed
cockpit is not required for scenarios 4, 5, and 8 above.
The combined dermal and inhalation risks for the following scenarios were not calculated
because the inhalation dose was less than 1 percent of the dermal dose:
(2a) mixing/loading liquids for aerial application;
• (2c) mixing/loading liquids for airblast application;
(3a and 3d) mixing/loading granulars for tractor drawn spreaders;
• (5) applying sprays with a helicopter;
(12) applying paste with a brush; and
• (13) mixing/loading/applying granular bait for belly grinder application.
There are data gaps for the following scenarios:
• (10) applying dust with dust application equipment; and
(14) flagging aerial bait applications
There are no data that can be used to assess the risk associated with the use of dust
formulations. Therefore, a maximum level of PPE is required until appropriate exposure data are
developed for risk assessment and the assessment justifies removal of PPE. Mixers and loaders
are required to wear long-sleeve shirt, long pants, chemical resistant apron, chemical resistant
gloves, chemical resistant footwear plus socks, and a respirator. Applicators are required to wear
coveralls over long-sleeve shirt, long pants, chemical resistant gloves, chemical resistant footwear
plus socks, chemical resistant headgear for overhead exposure, and a respirator.
57
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There are no data that can be used to assess the risk associated with flagging for aerial bait
applications. Therefore, the PPE requirements are the same as those for flagging for aerial spray
applications and consist of long-sleeve shirt, long pants, and shoes plus socks.
There are no data that can be used to assess the risk associated with mixing pelleted baits
or pastes for paint brush applications. Therefore, the minimum PPE requirements are long-sleeve
shirt, long pants, chemical resistant apron, chemical resistant gloves and a respirator.
c. Post-Application
Exposure & Assumptions
Dermal
Grapes Reentry Exposure Study (app. Rate 0.9 Ib a.i./A)
Among the postapplication data developed for methomyl, the Agency has selected a study
which monitored residues resulting from applications to grapes as the best available for assessing
potential exposure to reentry workers. The Agency has used the data from this study to estimate
exposure and risk for workers following methomyl applications in a variety of scenarios. Also,
the Agency has excluded data developed for canceled sites (e.g., greenhouse, ornamentals). In
the grape study both foliage and soil dislodgeable residues as well as worker reentry exposure
were measured. Grapes were treated with a single application of methomyl at a rate of 0.9 Ib
ai/acre using an airblast sprayer. Dislodgeable foliar residue (DFR) measurements were
conducted before treatment, and on days after treatment (DAT) 1, 2, 3, 5, 7, 10, and 14.
Replicate soil samples were collected on the day of reentry. Workers reentered seven sites treated
with methomyl between DAT 7 and 11 (MRID 41032301).
The Best Fit DFR data in the following table were derived by averaging the DFRs from six
study sites. The seventh site, Del Rey, CA, was not used because of insufficient data points. The
transfer coefficient used in the following table (27,021 cm2/hr) was obtained by averaging the
transfer coefficients obtained from three sites where reentry to perform grape girdling took place.
(The three site-specific transfer coefficients for girdling were 9,757 cm2/hr; 13,192 cm2/hr; and
58,114 cm2/hr.) The table below presents the dose, exposure, and MOEs for workers girdling
grapes.
58
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Table 15: Worker (Girdling) Reentry Exposure to Methomyl Residues Following Application to Grapes
Days
After
Treatment
0
1
2
1
Best Fit DFR
(Mg/cm2)a
0.5432
0.4361
0.3516
0 9845
Tc
(cm2/hr)b
27,021
27,021
27,021
97 091
Exposure
(mg/day)c
117.42
94.27
76.00
61 50
Dose
(mg/kg/day)d
1.68
1.35
1.09
088
MOEe
54
67
83
100
a The average foliar dislodgeable residues from the grape study at an application rate of 0.9 Ib a.i./A (MRID
41032301). DFR (ag/cm2) was derived by converting the measured DFR data into lognormal then
running a linear regression equation to estimate the dissipation over time.
b Transfer coefficients calculated by averaging three girdling activity study sites.
Exposure (mg/day) = [(Best Fit DFR x Transfer Coefficient (27,021 cmVhr)) /1,000 Mg/mg] x 8 hrs/day]
d Dose (mg/kg/day) = Exposure (mg/day) / 70 kg (assumed weight of worker).
e MOE = NOEL (90 mg/kg/day) / Dose (mg/kg/day). MOEs are rounded to 2 significant figures.
Other Crops with Similar Maximum Application Rates
For other crops with similar maximum rates, the Agency has used the grape DFR data
combined with a range of estimated transfer coefficients to assess potential postapplication dermal
exposure to workers. The Agency has estimated 1,000 cm2/hr to represent the transfer coefficient
for crops with potentially low dermal transfer during routine postapplication activities ("low
exposure crops"), and 10,000 cm2/hr to represent the transfer coefficient for crops with
potentially high dermal transfer during routine postapplication activities ("high exposure crops").
The Agency believes these transfer coefficients are reasonable estimates for these crop types.
Low Exposure Crops: Alfalfa, fennel, asparagus, barley, beans (lima, snap), beets, broccoli,
Brussels sprouts, cabbage, carrot, cauliflower, celery, chard, chicory, collards, cucumber, cucurbit
vegetables, dandelion, eggplant, endive, garlic, groundcherry, horseradish, kale, lentils, lettuce,
melons, mint, mustard, oats, onion, parsley, peanuts, pea, pecan, pepper, peppermint, potato,
pumpkin, radish, rye, sorghum, spinach, squash, sugar beet, sweet potato, turnip, and wheat.
High Exposure Crops: Apple, artichoke, avocado, blueberry, cotton, corn, grapes (activities
other than girdling), grapefruit, lemon, nectarine, orange, peach, pear, pomegranate, tangelo,
tangerine, tobacco, tomato, tree nuts, sod farm turf (cutting/rolling).
Using the DFR data from the grape study and estimated transfer coefficients, the table
below presents the dermal exposure, dose, and MOEs for the low and high exposure crops.
59
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Table 16: Worker Reentry Exposure to Methomyl Residues for Low and High Exposure Crops
Days
After
Treatment
0
1
9
Best Fit DFR
(Mg/cm2)a
0.5432
0.4361
03516
Tc
(cm2/hr)b
1,000 (Low)
10,000 (High)
1,000 (Low)
10,000 (High)
10000
Exposure
(mg/day)c
4.35
43.46
3.49
34.89
98 13
Dose
(mg/kg/day)d
0.062
0.62
0.05
0.50
040
MOEe
1500
150
NA
NA
NA
a The average foliar dislodgeable residues from the grape study at an application rate of 0.9 Ib a.i./A (MRID
41032301). DFR (ag/cm2) was derived by converting the measured DFR data into lognormal then
running a linear regression equation to estimate the dissipation over time. The application rate in the
study was 0.9 Ibs. active ingredient per acre.
b Transfer coefficients: 10,000 cm2/hr for crops with potentially high dermal transfer; and 1,000 cm2/hr for
crops with potentially low dermal transfer.
Exposure (mg/day) = [(Best Fit DFR x Transfer Coefficient (cmVhr)) /1,000 Mg/mg] x 8 hrs/day
d Dose (mg/kg/day) = Exposure (mg/day) / 70 kg (assumed weight of worker).
e MOE = NOEL (90 mg/kg/day) / Dose (mg/kg/day). MOEs are rounded to 2 significant figures.
Crops with Other Maximum Application Rates
Lower Rates: Several crops/sites have application rates lower than that used in the grape
study. For these crops, the values reflected in the table above are assumed to represent the high-
end of potential exposures. Actual exposures are likely to be lower due to lower application rates
and lower resulting DFRs.
Higher Rates: Peaches and sod farm turf have application rates which exceed the 0.9 Ibs
ai/acre that was used in the grape study. For these crops, the DFRs resulting from applications
made at higher rates would likely result in higher exposures than those reflected in the last table.
Both peaches and turf are in the "high exposure crop" category. If the DFRs were assumed to be
twice as high for turf and peaches based on the application rate being double that used in the
grape study (i.e., 1.8 Ibs ai/acre versus 0.9 Ibs ai/acre), MOEs would still exceed 100 on DAT 2.
The table below presents these estimates.
60
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Table 17: Estimated Worker Reentry Exposure to Methomyl Residues Following Application to Peaches and Turf
Days
After
Treatment
0
1
9
Estimated DFR
(Mg/cm2)a
1.0864
0.8722
0 7039
Tc
(cm2/hr)b
10,000
10,000
10000
Exposure
(mg/day)c
86.91
69.78
5696
Dose
(mg/kg/day)d
1.24
1.00
080
MOEe
73
90
110
a The average foliar dislodgeable residues from the grape study MRID 41032301; DFR (ag/cm2) was
derived by converting the measured DFR data into lognormal then running a linear regression equation to
estimate the dissipation over time. The values in this table are double those derived from the grape data
based on the maximum application rate for peaches and turf being double the rate used in the study.
b Transfer coefficient estimated to be: 10,000 cmVhr for crops with potentially high dermal transfer.
Exposure (mg/day) = [(Best Fit DFR x Transfer Coefficient (10,000 cmVhr)) /1,000 Mg/mg] x 8 hrs/day]
d Dose (mg/kg/day) = Exposure (mg/day) / 70 kg (assumed weight of worker).
e MOE = NOEL (90 mg/kg/day) / Dose (mg/kg/day). MOEs are rounded to 2 significant figures.
Baits, Dusts, and Pastes
There are currently no data from which to estimate postapplication exposure following
application of dusts, baits, and pastes using aerial and ground equipment, and paint brushes. Risk
estimates were made by extrapolation from other data.
Inhalation
Although methomyl has an inhalation endpoint of 37 mg/kg/day, no postapplication
inhalation risk assessment has been completed. The postapplication risk assessment quantified
only dermal exposures. This is because of the relatively high vapor pressure of methomyl (1 x 10"
5 mM Hg), historical data which indicate that dermal expsoure is the predominant exposure route
and the low inhalation risk estimates for applicators.
d.
Post-Application Risks
The calculations of postapplication exposure and risk in Tables 15, 16, and 17 indicate
that for certain crops, restricted-entry intervals (REIs) based on the short and intermediate term
dermal toxicological endpoint should be considered. MOEs for grape girdlers do not reach 100
until the third day after application, indicating at least a 3-day REI. Estimates of exposure and
risk for peach and commercial sod harvesters indicate that MOEs exceed 100 on the second day
after application, indicating at least a 2-day REI. For other crops and sites, no additional
postapplication mitigation is indicated based on the short and intermediate term dermal endpoint.
For these other crops and sites the REI should be based on the acute toxicity of methomyl. Since
methomyl is in acute toxicity category 1 for primary eye irritation, a 48 hour REI is indicated. In
61
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the regulatory section this information has been integrated with other considerations based on
epidemiological information and incident data to determine the required REIs.
For early entry into treated areas (i.e., during the REI) that is permitted under the Worker
Protection Standard and that involves contact with anything that has been treated, reentry
workers should wear the clothing and PPE consistent with the acute toxicity categories of the
active ingredient (i.e., long sleeved shirt, long pants, shoes and socks, chemical resistent gloves,
and protective eyewear).
No data are available for estimating worker's dermal exposures to methomyl following
applications of baits. However, EPA recognizes that dermal exposures to methomyl following
application of baits are likely to be significantly lower than would result from workers' contact
with treated foliage. Therefore, EPA believes that dermal risk from bait applications would not
exceed the risks estimated above for foliar contact in "low exposure" crops.
Postapplication risk assessments were not completed for dusts, pastes, and paintbrush
applications of methomyl. Dust use scenarios were not addressed due to lack of appropriate data
and the similarity with other postapplication agricultural scenarios (i.e., a postapplication
exposure assessment for sprays on various crops may be used to crudely assess risks from dusts
given the uncertainty associated with the extrapolation). Pastes and paintbrush postapplication
exposure assessments were not completed because of a lack of data and because these scenarios
are believed to have a low potential for exposure (i.e., dermal contact with treated surfaces is
likely minimal or nonexistent given the use pattern).
e. Non-Occupational Exposures and Risks
Non-Occupational Exposure
Dermal: Based on current labels and information provided by the registrants, EPA
believes that the following three scenarios represent potential non-occupational postapplication
exposure for methomyl:
1. Non-Occupational dermal exposure to methomyl-treated "U-Pick" peaches.
This is believed to be a worst-case scenario for non-occupational postapplication exposure
to methomyl. DFR data from the grape study were used in combination with the SOPs for
Residential Exposure Assessments (draft, December 18, 1997) to estimate non-occupational
postapplication exposure.
The following scenario was used for children. A youth, 10-12 years of age, is assumed
to have 2 hours of exposure, a transfer coefficient of 5,000 cm2/hr, and weigh 39.1 kg. Because
the pre-harvest interval for peaches treated with methomyl is 4 days, the best fit DFR values (from
Table 12) for DAT 4 were used, and doubled to represent the maximum rate of 1.8 Ibs ai/acre for
62
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peaches. A child's exposure picking peaches is thus estimated as: DFR (0.4628//g/cm2) x Tc
(5,000 cm2/hr) x Duration (2 hrs) x Conversion //g/mg (1/1,000) = 4.6 mg/day. Daily dose is
estimated by dividing the exposure by the body weight: 4.6 mg per day / 39.1 kg = 0.12
mg/kg/day.
The resulting MOE is calculated using the 90 mg/kg/day dermal NOEL as: 90 (NOEL) /
0.12 (Dose) = 750.
The following scenario was used for adults picking peaches: an adult is assumed to have 4
hours of exposure, a transfer coefficient of 10,000 cm2/hr, with a body weight of 71.8 kg. The
adult exposure is estimated to be 18.5 mg/day, with a daily dose of 0.26 mg/kg/day.
The resulting MOE is calculated as, 90 (NOEL) / 0.26 (Dose) =350.
To further limit exposure, a statement has been added to the agricultural labels prohibiting
the use of methomyl in home plantings and on any commercial crop that is turned into a "U-Pick",
"Pick Your Own" or similar operation.
2. Incidental dermal exposure following application of bait pellets in public access areas
(such as trash disposal areas associated with commercial establishments).
No data are available to quantify potential exposures and risks. However, based on the
above estimates for occupational and residential exposures to treated peach foliage, which would
be expected to be much higher than for incidental dermal exposures to baits, EPA believes that
potential non-occupational dermal exposures to baits is below that which would present a risk
concern.
3. Ingestion of bait pellets by children mistaking them for food or candy.
No data are available for quantifying such potential exposures. However, the issue of
accidental ingestion by children was addressed through mitigation agreed upon between the
registrants and the Agency in 1995 for the fly bait formulations. For the fly bait products, the use
was limited to commercial agriculture production where children would not be present. The bait
stations are required to be placed four feet above the ground. An embittering agent has been
added to all fly bait stations and the color of the formulations are limited to earth-tones or other
dark, unattractive colors. The Agency believes that when baits are applied according to label
instructions, potential for children's accidental oral exposure would not present a significant risk.
Summary of Non-Occupational Risk
Estimates of dermal exposure and risk, presented above, indicate that MOEs exceed 100
for both adults and children for the scenario considered to represent a worst case, harvesting
treated peaches at a U-Pick farm. The adult MOE at day 4 is 350, and the MOE for children is
63
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750. Methomyl-specific DFR data from the grape study were used with the SOPs for Residential
Exposure Assessment, to derive these results. Because the pre-harvest interval (PHI) for peaches
is 4 days, DAT 4 DFR values were selected. EPA believes these estimates are conservative and
represent the high end of potential non-occupational dermal exposures. Since the U-Pick scenario
has been prohibited on the label and because the bait pellets are not a significant use of methomyl
these uses will not be added to the aggregate risk assessment.
Additional Occupational/Residential Exposure Studies
Handler Studies
Based on the risk assessment of the current uses of methomyl, additional handler exposure
studies are not required at this time.
Post-Application Studies
Based on the risk assessment of the current uses of methomyl, additional post-application
exposure studies are not required at this time.
C. Environmental Assessment
The Agency has adequate data to assess the hazard of methomyl to nontarget terrestrial
organisms. However, an estuarine/marine fish early life-cycle study (72-4a), and an
estuarine/marine invertebrate life-cycle study (72-4b) are required as confirmatory information.
1. Toxicity to Terrestrial Animals
a. Birds, Acute and Subacute
An acute oral toxicity study using the technical grade of the active ingredient (TGAI) is
required to establish the toxicity of methomyl to birds. The preferred test species is either mallard
duck (a waterfowl) or bobwhite quail (an upland gamebird). Results of the tests are tabulated
below.
64
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Table 18: Avian Acute Oral Toxicity
Species
Northern bobwhite quail
(Colinus virginianus)
Mallard duck
(Anas platyrhynchos)
Ring-necked Pheasant
(Phasianus colchicus)
%ai
98.7
90
90
LD50
(mg/kg)
24.2
15.9
15.4
Toxicity Category
highly toxic
highly toxic
highly toxic
MRID No.
Author/Year
00161886
Beavers, 1983
00160000
Tucker, 1970
00160000
Tucker, 1970
Study
Classification1
core
core
core
1 Core (study satisfies guideline).
The LD50 for methomyl falls in the 10-50 mg/kg range, which is considered highly toxic to
avian species on an acute oral basis. The guideline (71-1) is fulfilled (MRID 00161886,
00160000).
Two subacute dietary studies using the TGAI are required to establish the toxicity of
methomyl to birds. The preferred test species are mallard duck and bobwhite quail. Results of
these tests are tabulated below.
Table 19 - Avian Subacute Dietary Toxicity
Species
Northern bobwhite quail
(Colinus virginianus)
Mallard duck
(Anas platyrhynchos)
Ring-necked pheasant
(Phasianus colchicus)
%ai
>95
>95
>95
5-Day LC50
(ppm)
1100
2883
1975
Toxicity
Category
slightly toxic
slightly toxic
slightly toxic
MRID No.
Author/Year
#22923
Hilletal.,1975
#22923
Hilletal, 1975
#22923
Hilletal.,1975
Study
Classification
core
core
core
The LC50 for methomyl falls in the 1001-5000 ppm range, which is considered slightly
toxic to avian species on a subacute dietary basis. The guideline (71-2) is fulfilled. (MRTD#
22923).
b.
Birds, Chronic
Avian reproduction studies using the TGAI are required for methomyl because birds may
be subject to repeated or continuous exposure to the pesticide, especially preceding or during the
breeding season. The preferred test species are mallard duck and bobwhite quail. Results of these
tests are tabulated below.
65
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Table 20 - Avian Reproduction
Species/
Study Duration
Northern bobwhite quail
(Colinus virginianus)
Mallard duck
(Anas platyrhynchos)
%ai
98.35
98.35
NOEC1
(ppm)
150
150
LOEC
Endpoints
fewer eggs laid and
eggs set
female weight change
(loss)
MRID No.
Author/Year
41898602
Beavers etal., 1990
41898601
Beavers etal., 1990
Study
Classification
core
core
'NOEC = No Observed Effect Concentration
The results indicate that methomyl does not affect avian reproduction at 150 ppm. The
guideline (71-4) is fulfilled. (MRID 41898602, 41898601).
c.
Mammals, Acute and Chronic
Wild mammal testing is required on a case-by-case basis, depending on the results of
lower tier laboratory mammalian studies, intended use pattern and pertinent environmental fate
characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health
Effects Division (HED) substitute for wild mammal testing. Results of these tests are tabulated
below.
Table 21: Mammalian Toxicity
Species
laboratory rat (Rattus rattus)
Laboratory rat (Rattusrattus)
Laboratory rat (Rattusrattus)
Laboratory rat (Rattusrattus)
Mule deer (Odocoileus
hemionus)
%ai
90
98.35
98
97.5
90
Test Type
LD50
LD50
Repro.
Repro.
LD50
Toxicity Value
mg/kg
17-24mg/kg
30-34 mg/kg
NOEC 75 ppm
LOEC 600 ppm
NOEC 100 ppm
LOEC >100 ppm
11.0-22.0
Affected
Endpoints
mortality
mortality
body weight
no effects
mortality
MRID No.
00009227
421401-01
432507-01
MRO-00007093
Tucker, 1970
00160000
The results indicate that methomyl is very highly toxic to mammals on an acute oral basis.
There is no guideline requirement.
d.
Insects
Honey bee acute contact and toxicity of residues on foliage studies using the TGAI are
required for methomyl because its use will result in honey bee exposure. Results of this test are
tabulated below.
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Table 22: Nontarget Insect Acute Contact Toxicity
Species
Honey bee
(Apis mellifera)
%ai
90
LD50 fag/bee)
<0.5
Toxicity Category
highly toxic
MRID. No. /Year
00014715/1971
Study Classification
Supplemental
An analysis of the results indicates that methomyl is categorized as highly toxic to bees on
an acute contact basis. Although the study (MRID 00014715) is supplemental and does not fulfill
the guideline (141-1) requirements, a new study is not required.
2. Toxicity to Aquatic Animals
a. Freshwater Fish, Acute
Two freshwater fish toxicity studies using the TGAI are required to establish the toxicity
of methomyl to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill
sunfish (a warmwater fish). Results of these tests are tabulated below.
67
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Table 23 - Freshwater Fish Acute Toxicity
Species/ (Flow-through
or Static)
Rainbow trout
(Oncorhynchus mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Brook Trout
(Salvelinus fontinalis)
Cutthroat trout
(Salmo clarki)
Channel catfish
(Ictalurus punctatus)
Largemouth bass
(Micropterus
salmoides)
Atlantic salmon
(Salmo salar)
Fathead minnow
(Pimephales promelas)
Channel catfish
(Ictalurus punctatus)
Bluegill sunfish
(Lepomis macrochirus)
Rainbow Trout
(Onchoryhncus mykiss)
Fathead minnow
(Pimephales promelas)
Rainbow trout
(Onchoryhncus mykiss)
Atlantic salmon
(Salmo salar)
Brook trout
(Salvilinus fontinalis)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
%ai
95-98
95-98
95-98
95-98
95-98
95-98
95-98
95-98
29
29
29
29
24
24
24
24
degradate
96-hr LC50
(ppm) (mea./
nominal)
1.6
1.05
1.5
6.8
0.53
1.25
1.12
2.8
0.32
0.67
1.2
1.5
1.2
1.4
2.2
0.7
462
Toxicity
Category
moderately
toxic
moderately
toxic
moderately
toxic
moderately
toxic
highly toxic
moderately
toxic
moderately
toxic
moderately
toxic
highly toxic
highly toxic
moderately
toxic
moderately
toxic
moderately
toxic
moderately
toxic
moderately
toxic
highly toxic
practically
non-toxic
MRID No.
Author/Year
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Johnson, 1980
40094602
Schneider, 1976
00009061
Study
Classification
core
core
core
core
core
core
core
core
core
core
core
core
core
core
core
core
core
68
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Because the 96-hour LC50 for the technical grade material falls in the range of 0.5 ppm to 6.8
ppm, methomyl is considered to be moderately to highly toxic to freshwater fish on an acute basis.
The guideline (72-1) is fulfilled (MRID 40094602). Since the 96-hour LC50 falls between 0.32 and
2.2, the formulated products of methomyl are also considered to be moderately toxic to highly toxic
to freshwater fish on an acute basis. (MRID 40094602). The toxicity of the degradate
thiolacetohydroxamic acid, 5-methyl ester, was found to be 462 ppm. This degradate is considered
to be practically non-toxic to freshwater fish (MRID 00009061).
b.
Freshwater Fish, Chronic
A freshwater fish early life-stage test using the TGAI is required for methomyl because the
end-use product may be transported to water from the intended use site, and the following
conditions are met: (1) methomyl is intended for use such that its presence in water is likely to be
continuous or recurrent, (2) it has aquatic acute LC50s or EC50s of less than 1 mg/1, and (3) the EEC
in water is equal to or greater than 1 percent of an acute LC50 or EC50 value. The preferred test
species is rainbow trout. Results of this test are tabulated below.
Table 24: Freshwater Fish Early Life-Stage Toxicity Under Flow-through Conditions
Species/
Study Duration
Fathead Minnow
(Pimephales
promelus)
%ai
>99
NOEC
(ppb)
57
MATC/
LOEC1
(ppb)
82/117
Endpoints
Affected
larvae
survival
MRID No.
Author/Year
00131255
Driscoll, 1982
Study
Classification
core
1 MATC = Maximum Allowed Toxic Concentration, defined as the geometric mean of the NOEC and LOEC.
The data indicate that methomyl significantly reduced larvae survival at concentrations
greater than 117 ppb. The guideline (72-4) is fulfilled.(Acc. # 00118512).
A freshwater fish life-cycle test using the TGAI is required for methomyl because the end-use
product may be transported to water from the intended use site and the EEC is equal to or greater
than one-tenth of the NOEL in the fish early life-stage and invertebrate life-cycle tests. The
preferred test species is fathead minnow. Results of this test are tabulated below.
Table 25: Freshwater Fish Life-Cycle Toxicity Under Flow-through Conditions
Species
Fathead minnow
(Pimephales
promelas)
%ai
98.4
NOEC/LOEC
(ppm)
0.076/0.142
MATC1
(ppm)
0.104
Endpoints
Affected
growth
MRID
43072101
Study
Classification
Core
1 Defined as the geometric mean of the NOEC and LOEC.
The data indicate that methomyl affected the growth of fathead minnows at concentrations of
0.142 ppm. The guideline (72-5) is fulfilled (MRID 43072101).
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c.
Freshwater Invertebrates, Acute
A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the
toxicity of methomyl to aquatic invertebrates. The preferred test species is Daphnia magna. Results
of these tests are tabulated below.
Table 26 - Freshwater Invertebrate Acute Toxicity
Species
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Waterflea (Daphnia
magna)
Scuds (Gammams
pseudolimnaeus)
Skwala
Pteronarcella
%ai
>99
95-98
24
>99
24
24
24
48-hour LC50/
EC50 (ppb)
31.7
8.8 EC50
7.6
28.7
1,050
343
69
Toxicity
Category
very highly
toxic
very highly
toxic
very highly
toxic
very highly
toxic
highly toxic
very highly
toxic
very highly
toxic
MRID No.
Author/Year
00019977
Goodman, 1978
Johnson & Finney,
1980; 40094602
Johnson & Finney,
1980; 40094602
00131254
Mayer, 1986
40098001
Johnson & Finney,
1980; 40094602
Johnson & Finney,
1980; 40094602
Johnson & Finney,
1980; 40094602
Study
Classification
core
core
core
core
core
core
core
Because the LC50/EC50 of the TGAI falls in the range of 8.8 to 31.7 ppb, methomyl is
considered to be highly to very highly toxic to aquatic invertebrates on an acute basis. The guideline
(72-2) is fulfilled (MRID# 00019977, 40094602). The LC50/EC50 for the 24% formulated product
ranges from 7.6 to 1,050 ppb (MRID# 40098001, 40094602) . Therefore, the formulated product is
also considered to range from highly to very highly toxic to aquatic invertebrates.
d.
Freshwater Invertebrates, Chronic
A freshwater aquatic invertebrate life-cycle test using the TGAI is required for methomyl
because the end-use product may be transported to water from the intended use site, and the
following conditions are met: (1) methomyl is intended for use such that its presence in water is
likely to be continuous or recurrent, (2) it has aquatic acute LC50s or EC50s of less than 1 mg/1, and
(3) the EEC in water is equal to or greater than 1 percent of an acute LC50 or EC50 value. The
preferred test species is Daphnia magna. Results of this test are tabulated below.
70
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Table 27: Freshwater Aquatic Invertebrate Life-Cycle Toxicity
Species
Waterflea
(Daphnia magna)
%ai
>99
21-dayNOEC
(ppb)
>0.4
MATC1
(ppb)
0.6
Endpoints
Affected
number of
young /adult
MRID No.
Author/Year
00118512
Britelli, 1982
Study
Classification
core
Maximum Allowed Toxic Concentration, defined as the geometric mean of the NOEC and LOEC.
The data indicate that methomyl significantly reduced the number of young produced at
concentrations greater than 0.4 ppb. The guideline (72-4) is fulfilled. (Acc# 00118512).
e.
Estuarine and Marine Fish, Acute
Acute toxicity testing with estuarine/marine fish using the TGAI is required for methomyl
because the active ingredient is expected to reach this environment due to its use in coastal counties.
The preferred test species is sheepshead minnow. Results of this test are tabulated below.
Table 28 - Estuarine/Marine Fish Acute Toxicity
Species
Sheepshead minnow
(Cyprinodon variegatus)
%ai
98.35
96-hour LC50 (ppb)
(measured/
nominal)
1,160
Toxicity
Category
moderately
toxic
MRID No.
Author/Year
41441202
Study
Classification
core
Since the LC50 falls in the range of >1-10 ppm, methomyl is considered to be moderately
toxic to estuarine/marine fish on an acute basis. The guideline (72-3a) is fulfilled (MRTD#
41441202).
f.
Estuarine and Marine Fish, Chronic
An estuarine/marine fish early life-stage toxicity test using the TGAI is required for methomyl
because the end-use product may be transported to estuarine/marine waters from the intended use
site and the following conditions are met: (1) methomyl is intended for use such that its presence in
water is likely to be continuous or recurrent, and (2) the EEC in water is equal to or greater than 1
percent of an acute LC50 or EC50 value. The preferred test species is sheepshead minnow. This
guideline (72-4a) is not fulfilled.
An estuarine/marine fish life-cycle test using the TGAI may be required for methomyl
because the end-use product is expected to reach this environment due to its use in coastal counties
and the following conditions are met: (1) the EEC is equal to or greater than one-tenth of the NOEC
in the fish early life-stage or invertebrate life-cycle test, or, (2) studies of other organisms indicate
the reproductive physiology offish may be affected. The preferred test species is sheepshead
minnow. The requirement for this study is deferred until a valid estuarine fish early life-stage study is
submitted and reviewed.
71
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g-
Estuarine and Marine Invertebrates, Acute
Acute toxicity testing with estuarine/marine invertebrates using the TGAI is required for
methomyl because the end-use product may reach this environment because of its use in coastal
counties. The preferred test species are mysid shrimp and eastern oyster. Results of these tests are
tabulated below.
Table 29 - Estuarine/Marine Invertebrate Acute Toxicity
Species
Eastern oyster
(shell deposition)
(Crassostrea virginica)
Mysid
(Mysidopsis bahia)
Grass
(Palaemonetes
vulgaris)
Fiddler crab
(Uce pugilator)
Grass shrimp
(Palaemonetes
vulgaris)
Pink Shrimp
(Penaeus duorarum)
Mud crab
(Neopanope texand)
%ai.
98.35
98.35
24
24
90
90
90
96-hr LC50/EC50
(ppm) (me a/nominal)
EC50>140
0.23
0.13
2.38 (TL50)
0.049 (TL50)
0.019 (TL50)
0.410 (TL50)
Toxicity
Category
practically non-
toxic
highly toxic
highly toxic
moderately toxic
very highly toxic
very highly toxic
highly toxic
MRID No.
Author/Year
42074601
Ward, 1991
41441201
Ward, 1989
00009230
Bentley,1973
00009230
Bentley,1973
Sleight, 1973
00009134
Sleight, 1973
00009134
Sleight, 1973
00009134
Study
Classification
core
core
supplemental
supplemental
core
core
supplemental
An LC50 in the range of 0.019 to 0.23 ppm suggests that methomyl has the potential to be
very highly toxic to marine shrimp species (TGAI and formulation). A study used to evaluate oyster
shell deposition (short term growth) produced an EC50 of greater than 140 ppm, which suggests
practically no toxicity to adult oysters. The guideline (72-3b and 72-3c) is fulfilled (MRID#s
41441201, 42074601). The LC50 for the 24% formulation ranges from 0.13 to 2.38 (TL50)
indicating that this product is moderately to highly toxic to estuarine invertebrates.
h.
Estuarine and Marine Invertebrates, Chronic
An estuarine/marine invertebrate life-cycle toxicity test using the TGAI is required for
methomyl because the end-use product may be transported to the estuarine/marine environment from
the intended use site, and the following conditions are met: (1) the pesticide is intended for use such
that its presence in water is likely to be continuous or recurrent regardless of toxicity, (2) it has an
aquatic acute LC50 or EC50 of less than 1 mg/1, and (3) the EEC in water is equal to or greater than 1
72
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percent of an acute LC50 or EC50 value. The preferred test species is mysid shrimp. This Guideline
(72-4b) is not fulfilled.
3. Toxicity to Plants
a. Terrestrial
Currently, terrestrial plant testing is not required for pesticides, other than herbicides, except
on a case-by-case basis. It is not required for methomyl.
b. Aquatic
Currently, aquatic plant testing is not required for pesticides, other than herbicides and
fungicides, except on a case-by-case basis. It is not required for methomyl.
D. Environmental Fate
1. Environmental Fate Assessment
Laboratory studies indicate that methomyl is moderately persistent and highly mobile. It is
stable to hydrolysis at lower pH's (neutral to acidic) and degrades slowly in alkaline conditions.
Methomyl photolyzes quickly in water but more slowly in soils. It is moderately stable to aerobic
soil metabolism but degrades more rapidly under anaerobic conditions. In laboratory studies,
methomyl does not readily adsorb to soil and has the potential to be very mobile. Field studies show
varying dissipation rates of the chemical in soils. Dissipation rates were related primarily to
differences in soil moisture content, which may affect the microbial activity; and rainfall/irrigation,
which could influence leaching.
Degradation and Metabolism
Methomyl is stable to hydrolysis at pH 5 and 7 and slowly degrades in pH 9 buffered
solutions (half-life, t1/2«30 days). The major hydrolysis degradate is S-methyl-N-
hydroxythioacetimidate (41-44% of the applied after 30 days) (MRTD 00131249). Methomyl
photodegrades quickly in water (t1/2 of 1 day), but more slowly on soils (t1/2 of 34 days). The major
photolysis degradate, acetonitrile, peaked at 66% of the applied after 15 days in water and 40% of
the applied after 30 days on soil (MRTD 00161885).
Methomyl degraded with a half-life of 30-45 days in an aerobic silt loam soil and 10.5 days in
an aerobic loam soil. The major degradate was 14CO2 (22.5% of the applied after 45 days in the silt
loam soil, and 75% of the applied at 3 months in the loam soil). Nonextractable residues peaked at
26% of the applied after 45 days in the silt loam soil and 25% of the applied in the loam soil. A
minor degradate, S-methyl-N-hydroxythioacetimidate, accounted for <2% of the applied (MRTD
00008568).
73
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Under anaerobic conditions, methomyl degraded with a half-life of 14 days in static
conditions (nitrogen atmosphere) and <7 days in dynamic conditions (flowing nitrogen atmosphere)
on a loam soil following 14 days of aerobic incubation. In the dynamic system, the major degradate
was 14CO2, which comprised 30% of the applied during the 14 days of aerobic incubation, and an
additional 23% after 60 days of anaerobic incubation. Unextracted residues peaked at 36% of the
applied after 7 days of anaerobic incubation. More rapid degradation under anaerobic conditions
may be catalyzed by the presence of dissolved (ferrous) iron (MRID 43708806; open literature).
In a supplemental aquatic metabolism study, methomyl degraded with estimated half-lives of
4-5 days from two water-sediment systems that were not completely aerobic or anaerobic.
Acetonitrile averaged a maximum of 17% of the applied at 7 days, and acetamide accounted for up
to 14% of the applied at day 7. After 102 days, volatilized acetonitrile totaled up to 27% of the
applied and 14CO2 was up to 46% of the applied (MRID 43325402).
The only nonvolatile degradate found in the laboratory studies was S-methyl-N-
hydroxythioacetimidate. It was present at high concentrations in the alkaline hydrolysis study but
was only a minor degradate in the aerobic soil metabolism, anaerobic soil metabolism, and photolysis
in water studies (<3% of the applied at all test intervals) (MRID 43325403).
Mobility
Methomyl and its degradate S-methyl-N-hydroxythioacetimidate are very mobile in soils, as
demonstrated by soil TLC (Rf values 0.46-0.82 and 0.86-0.93, respectively). Results of the batch
equilibrium studies show methomyl has a low affinity to bind to soil (Kads 0.23-1.4, Koc 19-34; Kdes
0.5-2.8, Koc(des) 37-48), further indicating that the chemical will be mobile. Methomyl is a highly
soluble chemical (5.47 g/100 g water). Its vapor pressure (5x10"5 mm Hg) and Henry's Law
Constant (l.SxlO"10 atm nrVmol) suggest a low potential to volatilize from water (MRIDs 00044306
and 00161884).
Bioaccumulation
The low octanol/water partition coefficient (1.29 to 1.33) suggests that the chemical will
have a low tendency to accumulate in fish.
Field Dissipation
Five terrestrial field dissipation studies are available on methomyl (MRIDs 00008844,
00009324, 00009326, 41623901, and 41623902). Although the studies were found acceptable,
some have deficiencies that increase the level of uncertainly in the results. Dissipation half-lives from
the surface soil ranged from 4 to 52 days. Such variations can be expected in the terrestrial field
dissipation studies because of the large number of processes that occur simultaneously and the large
number of variables present in the field.
74
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The moderate persistence of methomyl appears to be tied to the soil conditions. In a muck
soil (52% organic matter content), no methomyl was detected 7 days after treatment. A quick
dissipation in a soil with such a high organic matter content may be related to microbial activity or
rapid permeability. Two other studies conducted in sand and silt loam soils show extensive
dissipation (>82% of the applied) after 1-3 months, with the remaining radioactivity recovered in the
upper 8-15 inches of soil. No dissipation half-lives could be calculated in these studies because only
a few sampling intervals are available.
In two recent studies conducted in cropped cabbage fields, the dissipation half-life from the
surface ranged from 4-6 days in Mississippi to 54 days in California. Two factors may explain the
differences in dissipation between the two sites. Soil moisture content, which may affect the level of
biological activity, varied between the two sites (moisture contents ranged from 2.5 to 17% in the
CA soils and averaged 16% over the first 15 days in the MS soils). The MS site received more
rainfall, which may have led to more leaching out of the surface. In both studies the majority of the
methomyl residues were found in the upper 30 cm of soil.
Spray Drift
No methomyl-specific studies were reviewed. Droplet size spectrum (201-1) and drift field
evaluation (202-1) studies were required since the products may be applied aerially and the concern
exists for potential risk to nontarget aquatic organisms. To satisfy these requirements the registrant
is part of the Spray Drift Task Force (SDTF). The SDTF has completed and submitted to the
Agency its series of studies which are intended to characterize spray droplet drift potential due to
various factors, including application methods, application equipment, meteorological conditions,
crop geometry, and droplet characteristics. After its review of the new studies the Agency will
determine whether a reassessment is warranted of the potential risks from the application of
methomyl to nontarget organisms.
2. Terrestrial Exposure Assessment
The terrestrial exposure assessment is based on the methods of Hoerger and Kenaga (1972)1
as modified by Fletcher et al. (1994)2. Terrestrial estimated environmental concentrations (EECs)
were derived from maximum application rates. For multiple applications they incorporate dissipation
rates for methomyl. The Agency used a foliar dissipation rate of 4 days, which was the maximum
rate reported in the field residue monitoring studies submitted by the registrant. Uncertainties in the
terrestrial EECs are primarily associated with a lack of data on interception by and subsequent
Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative
data as a basis for estimation of their magnitude in the environment. In F. Coulston, F. Korte, eds., Environmental
Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme Publ, Stuttgart, W. Ger., pp. 9-28.
2 Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the
EPA food-chain (Kenaga) nomogram, an instrument forestimating pesticide residues on plants. Environ. Tox.
Chem. 13:1383-1391.
75
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dissipation from foliar surfaces. The estimated EECs in this table are the basis for the exposure
estimates for birds and mammals in the terrestrial risk assessments.
Table 30: Estimated Environmental Concentrations (EECs) on Avian and Mammalian Food Items for Selected
Uses, Based on Hoerger and Kenaga (1972), Modified by Fletcher et al (1994).
Site / Use
Baseline
Corn
Cotton
Lettuce
Peaches
Citrus
Application Rate (Ib ai/ac)
x No. of Apps. /Interval (da)
= Max. Seasonal Rate (Ib
ai/ac)
Single App, 1 Ib/A
0.45 x 16/1 = 7.2
0.6x3/3 = 1.8
0.9 x 10/2 = 9.0
1.8x3/5 = 5.4
0.9x3/5 = 2.7
Short grass
Tall grass
Broadleaf
plants, small
insects
Fruits, pods,
seeds, large
insects
Maximum /Mean EECs (ppm)
240 / 85
636 / 225
281/99
714/253
690 / 244
345 / 122
110/36
292 / 95
129 / 42
327 / 107
316/104
158/52
135/45
358/119
158/53
402 / 134
388/129
194/65
15/7
40/19
18/8
45/21
43/20
22/10
1 For multiple applications, a foliar dissipation half-life of 4 days, based on field residue monitoring studies, was
incorporated.
3. Water Resource Assessment
Ground Water Assessment
Available data suggest that methomyl is moderately persistent in soils, highly soluble in
water, and very mobile in soils. Such properties are characteristic of chemicals that are known to
leach to ground water. A prospective ground water monitoring study conducted in a vulnerable area
in Georgia (1992-1994) detected methomyl in ground water at concentrations ranging from 0.110 to
0.428 ppb. The monitoring study was conducted with a total application rate of 11.25 Ib ai/ac,
approximately 1.5 times the maximum label rate for corn. Although sampling continued for 27
months after application, no methomyl was detected after approximately 4 months. In addition, the
Pesticides in Ground Water Database indicates that methomyl has been detected in three other states
(Missouri, New York, and New Jersey) at concentrations up to 20 ppb.
The available information shows that in some of its use area, methomyl has the potential to
leach to ground water. However, as illustrated by the prospective study conducted in Georgia, this
degradation of ground-water quality will probably be short-lived.
Surface Water Assessment
Methomyl can contaminate surface water as a result of spray drift during application or
runoff from treated sites. Substantial fractions of methomyl may be available for runoff for several
days to weeks after application. Most of the methomyl reaching surface waters will be dissolved in
76
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the runoff water rather than adsorbed to eroding soil. The rapid direct aqueous photolysis of
methomyl should greatly limit its persistence in clear shallow waters. Its susceptibility to
biodegradation should also limit the persistence of methomyl in waters with microbiological activity.
Due to its resistance to abiotic hydrolysis, it will be more persistent in deeper and/or unclear waters
with low microbiological populations and long hydrologic residence time.
The low soil/water partitioning coefficient of methomyl indicates that it will readily move into
the water body. Dissolved concentrations of methomyl in sediment pore water and the water body
will be comparable to concentrations adsorbed to sediment. The low octanol/water coefficient of
methomyl indicates that its bioaccumulation potential is probably low.
The South Florida Water Management District (SFWMD) collected samples every two to
three months from 27 surface water sites within the SFWMD from November 1988 through
November 1993 and analyzed them for multiple pesticides. Methomyl was detected (detection limits
ranging from 1.9 to 20 //g/L) in one sample at a concentration of 1.9 //g/L. In 1994, Washington
state collected surface water samples in April, June, and October from 8 sites (24 total samples) and
analyzed them for multiple pesticides including methomyl. Methomyl was not detected in any of the
samples above an approximate quantification limit of 0.04 ug/L. However, methomyl was detected at
a concentration of 0.088 ug/L in a 1993 sample collected from a site (Salmon Creek) not resampled
in 1994. Neither study indicated whether the samples were taken in major methomyl use areas and
whether detections are related to actual methomyl usage.
A search of STORET for methomyl in surface water revealed 9 detections in 3849 samples
collected over 37 states. Detections were reported in California (5 detects ranging from 0.13 to 0.67
ug/L), Texas (3 detects ranging from 0.12 to 1 ug/L), Pennsylvania (0.19 ug/L), and Washington
(0.9 ug/L). Most of the detection limits were below 1 ug/L.
The reported monitoring data provide supplemental information on methomyl concentrations
in surface water. However, these data were not used for determining ecological risks or drinking
water concentrations because of uncertainties in sample collection and location (particularly the
association with actual use areas), methods of analysis, limits of detection, and quality control.
The relatively low soil/water partitioning of methomyl indicates that it will probably not be
effectively removed by the primary sediment removal treatment processes employed by many surface
water supply systems. Methomyl is not regulated under the Safe Drinking Water Act (SDWA) and
has no established MCL. However, the Office of Drinking Water has established one- and ten-day
Health Advisory Levels (HALs) of 300 ug/L and a lifetime HAL of 200 ug/L for methomyl. The
annual mean concentrations of high use pesticides with fate characteristics comparable to methomyl,
such as atrazine and metolachlor, rarely exceed several ug/L. Consequently, it is unlikely annual
mean methomyl concentrations will exceed the lifetime HAL of 200 ug/L. However, peak
concentrations of high use pesticides with similar fate characteristics do occasionally exceed 100
ug/L. Therefore, the possibility exists for peak methomyl concentrations to occasionally fall within
range of the 300 ug/L 1-day and ten-day HALs.
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4. Aquatic Exposure Assessment
Preliminary aquatic EECs are estimated using GENEEC, a screening model that provides an
upper-bound estimate of EECs on a high exposure site. The GENEEC program uses basic
environmental fate values (adsorption to soil, degradation in soil before runoff and in water) and
pesticide label information (rates, intervals, incorporation, method of application) to estimate the
EECs in a one-hectare, two-meter deep pond following the treatment of a 10 ha field. The runoff
event occurs two days after the last application. The model accounts for direct deposition of spray
drift onto the water body (assuming 5% of the application rate for aerial spray applications and 1%
for ground spray applications). When risk quotients (RQs) for aquatic organisms are exceeded,
refined aquatic EECs are calculated using PRZM/EXAMS.
Table 31: Environmental fate parameters used to predict methomyl EECs.
Parameter
water solubility (ppm)
Koc (avg):
aerobic soil metabolism, tl/2
hydrolysis tl/2, pH 7
aerobic aquatic metabolism, tl/2
aqueous photolysis tl/2
Methomyl
58,000
24 - 421
45 da2
stable
n/a
Ida
1 The Koc value for methomyl is 42. The value used in the calculations was 24 (corrected for organic
matter). Given the variability inherent in the parameters and the level of sensitivity of the existing models,
the new value will not change the assessment or the bottom line substantially.
2 The 90% upper confidence interval for the three reported half-lives of 10.5, 30, and 45 days (mean
of 28.5; standard deviation of 14.1) is 44 days.
The Pesticide Root Zone Model (PRZM2.3) simulates pesticides in field runoff on daily time
steps, incorporating runoff, infiltration, erosion, and evapotranspiration. The model calculates foliar
dissipation and runoff, pesticide uptake by plants, microbial transformation, volatilization, and soil
dispersion and retardation. The Exposure Analysis Modeling System (EXAMS II) simulates
pesticide fate and transport in an aquatic environment (one hectare body of water, two meters deep).
The modeled scenarios were selected on the basis of major uses (cotton, corn, lettuce), high
application rates (peaches), and variations in label rates (lettuce). The Table below shows the EECs
calculated from each method.
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Table 32: Estimated Environmental Concentrations (EECs) For Aquatic Exposure from Aerial Application on
Selected Uses Using GENEEC and PRZM2.
Site
Application
Rate x No/
Interval (da)
Peak
EEC
(ppb)
21-day
avg. EEC
(ppb)
56-day
avg. EEC
(ppb)
90-day
avg. EEC
(ppb)
90% Upper
EEC (ppb)
GENEEC
Peaches
Lettuce
Corn (Sweet)
Lettuce
1.81b/Ax3/5
0.9 Ib/A x 10/2
0.45 Ib/A x 16/1
0.225 Ib/A x 15/2
260
409
334
143
246
386
315
135
223
350
286
122
PRZM2/EXAM II
Corn
Cotton
Lettuce
Lettuce
Peaches
0.45 Ib/A x 16/1
0.6 Ib/A x 3/3
0.225 Ib/A x 15/2
0.9 Ib/A x 10/2
1.81b/Ax3/5
60
55
30
88
99
59
52
28
84
95
54
47
26
81
85
50
43
24
76
79
18
10
8
24
23
Monitoring Studies for Methomyl
Aquatic residue monitoring studies for various use patterns were conducted on sweet corn in
Illinois and Georgia, apples in Michigan, lettuce and tomatoes in Florida, and cantaloupe in
California.
The dissipation half-life from the soil surface ranged from 4 days (FL lettuce) to 26 days (MI
apple orchard during a dry period). In at least one study, the dissipation rate increased greatly after
rainfall events, suggesting that leaching may be a major route of dissipation. Foliar dissipation half-
lives ranged from a few hours (on corn) to 4 days (on apples). Peak concentrations in adjacent
water bodies ranged from 2 to 175 ppb. Such variations would be expected because of differences in
site characteristics, weather conditions, and cropping practices. At least under the conditions of the
monitoring studies, spray drift appeared to be the primary source of methomyl residues reaching the
surface waters. Runoff may be more of a contributing factor under site, soil, and weather
characteristics that favor runoff.
Except for the Georgia sweet corn study, peak methomyl concentrations in adjacent water
bodies were similar to or lower than those estimated by the Agency in Table 32. However, scenarios
used in the models differed from the actual field conditions, so direct comparisons should be
interpreted with caution. Predicted and measured concentrations were generally similar in magnitude
79
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and pattern of dissipation for those sites that were both modeled and monitored. This supports the
use of PRZM/EXAMS to provide a reasonable estimate of methomyl concentrations in adjacent
surface waters. For risk assessment purposes, the modeled data, which incorporates 36 years of
weather data and provides a 90% upper bound estimate based on variations in weather patterns, was
used. Under actual use conditions, a chemical such as methomyl, which is moderately persistent but
highly mobile, is likely to be susceptible to variations in rainfall amounts and patterns (MRIDs
43569301, 43599801, 43708807).
E. Environmental Risk Assessment
The results of exposure and ecotoxicity data are integrated using the quotient method. For
this method, risk quotients (RQs) are calculated by dividing exposure estimates by ecotoxicity
values, for both acute and chronic effects.
RQ= EXPOSURE/TOXICITY
RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteria used by
OPP to indicate potential risk to nontarget organisms and the need to consider regulatory action.
The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on
nontarget organisms. LOCs currently address the following risk presumption categories: (1) acute
high - potential for acute risk is high, regulatory action may be warranted in addition to restricted use
classification, (2) acute restricted use - the potential for acute risk is high, but this may be mitigated
through restricted use classification, (3) acute endangered species - the potential for acute risk to
endangered species is high, regulatory action may be warranted, and (4) chronic risk - the potential
for chronic risk is high, regulatory action may be warranted. Currently, the Agency does not
perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic
risk to mammalian or avian species from granular/bait formulations.
The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk
quotients are derived from the results of required studies. Examples of ecotoxicity values derived
from the results of short-term laboratory studies that assess acute effects are: (1) LC50 (fish and
birds), (2) LD50 (birds and mammals, (3) EC50 (aquatic plants and aquatic invertebrates), and (4)
EC25 (terrestrial plants). Examples of toxicity test effect levels derived from the results of long-term
laboratory studies that assess chronic effects are: (1) LOEC (birds, fish, and aquatic invertebrates),
(2) NOEC (birds, fish and aquatic invertebrates) and (3) MATC (fish and aquatic invertebrates). For
birds and mammals, the NOEC value is used as the ecotoxicity test value in assessing chronic effects.
Other values may be used when justified. Generally, the MATC (defined as the geometric mean of
the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic effects to fish and
aquatic invertebrates. However, the NOEC is used if the effect is production of offspring or
survival.
Risk presumptions, along with the corresponding RQs and LOCs are tabulated below.
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Table 33 - Risk Presumptions for Terrestrial Animals
Risk Presumption
RQ
LOC
Birds
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC'/LCSO orLD50/sqft2 orLD50/day3
EEC/LC50 or LD50/sqft2 or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft2 or LD50/day
EEC/NOEC
0.5
0.2
0.1
1.0
Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC/LC50 or LD50/sqft2 or LD50/day
EEC/LC50 or LD50/sqft2 or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft2 or LD50/day
EEC/NOEC
0.5
0.2
0.1
1.0
1 Abbreviation for Estimated
2 mg/ft2
LD50 * wt. of bird
Environmental Concentration (ppm) on avian/mammalian food items
3 mg of toxicant consumed/day
LD50 * wt. of bird
Table 34 - Risk Presumptions for Aquatic Animals
Risk Presumption
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RQ
EECVLC50orEC50
EEC/LC50 or EC50
EEC/LC50orEC50
EEC/MATC or NOEC
LOC
0.5
0.1
0.05
1.0
1 EEC = (ppm or ppb) in water
1. Exposure and Risk to Nontarget Terrestrial Animals
Birds
For pesticides applied as a nongranular product (e.g., liquid, dust), the estimated
environmental concentrations (EECs) on food items following product application are compared to
LC50 values to assess risk. The predicted 0-day maximum and mean residues of a pesticide that may
be expected to occur on selected avian or mammalian food items can be found in the following
Tables. The tables also show the risk quotients for avian species.
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Non-granular Products
The acute risk quotients for broadcast applications of nongranular products are tabulated
below.
Table 35: Avian Acute Dietary Risk Quotients for a Range of Single Application Rates for
Nongranular Products (Broadcast) Based on a bobwhite quail LC50 of 1 100 ppm.
Single App.
Rate
(Ibs ai/A)
0.225
0.45
0.9
1.8
Food Items
Short Grass
Tall grass
Broadleaf plants/Insects
Seeds
Short Grass
Tall grass
Broadleaf plants/Insects
Seeds
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Maximum EEC
(ppm)
54
25
30
3
108
50
61
7
216
99
122
14
432
198
243
27
LC50 (ppm)
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
1100
Acute RQ
(EEC/LC50)
0.05
0.02
0.03
<0.01
0.10*
0.05
0.06
0.01
0.20**
0.09
0.11*
0.01
0.39**
0.18*
0.22**
0.02
* exceeds acute endangered species LOCs.
** exceeds acute restricted and acute endangered species LOCs.
The acute restricted use LOG (0.2) is exceeded for all use patterns with application rates
greater than or equal to 0.9 Ibs. a.i./acre. The endangered species LOG (0.1) is exceeded for all use
patterns with application rates greater than or equal to 0.45 Ibs. a.i./acre. There are no reported field
incidents involving methomyl and any avian species.
Chronic risk quotients were calculated using the peak (maximum) and average residues on
food items. Average residues are calculated from multiple pesticide applications degrading over time
from the first to after the last application. The following Table presents avian chronic risk quotients
based on both peak and average residues for multiple, broadcast applications of non-granular
products.
82
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Table 36: Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular
Products Based on a mallard duck NOEC of 150 ppm .
Site/App. Method
Rate (Ib ai/A) x #
ofApps.
Interval (days)
Corn / Aerial
0.45 x 16 (1 da)
7.2 Ib/ac max
Citrus / Aerial
0.9x3 (5)
2.7 Ib/ac max.
Lettuce, Cole Crops /
Aerial
0.9 x 10 (2 da)
9.0 Ib/ac max.
Cotton / Aerial
0.6 x 3 (3 da)
1.8 Ib/ac max
Peaches / ground
1.8x3 (5 da)
5.4 Ib/ac max
Food Items
Short grass
Tall Grass
Broadleaf
plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf
plants/Insects
Seeds
Short Grass
Tall Grass
Broadleaf
plant/Insect
Seeds
Short Grass
Tall Grass
Broadleaf
plant/Insect
Seeds
Short grass
Tall grass
Broadleaf
plants/Insects
Seeds
EEC1 (ppm)
Maximum
636
292
358
40
345
158
194
22
714
327
402
45
281
129
158
18
690
316
388
43
Average
225
95
119
19
122
52
65
10
253
107
134
21
99
42
53
8
244
104
129
20
NOEC
(ppm)
150
150
150
150
150
Chronic RQ (EEC/
NOEC)
Maximum
4.24 +
1.94 +
2.38 +
0.26
2.30 +
1.05 +
1.30 +
0.14
4.76 +
2.18 +
2.68 +
0.30
1.87 +
0.86
1.05 +
0.12
4.60 +
2.10 +
2.58 +
0.28
Average
1.50 +
0.63
0.79
0.12
0.81
0.34
0.43
0.06
1.68 +
0.71
0.89
0.14
0.66
0.28
0.35
0.05
1.62 +
0.69
0.86
0.13
1 Assumes dissipation using the FATE program and foliar dissipation data from the residue monitoring studies
(half-life = 4 days).
+ exceeds chronic risk LOG for reproductive effects.
83
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For multiple broadcast applications of nongranular products the avian chronic level of
concern, for maximum residue concentrations, is exceeded at a multiple total rate equal to or above
0.45 Ibs. a.i./A. For average residue concentrations, chronic LOCs are exceeded at rates greater than
1.0 Ibs. a.i./A applied at least 3, times or lower rates applied more than 3 times.
Granular Products (Sweet Corn in Georgia and Florida)
Birds may ingest granular pesticide formulations when foraging for food or grit. They also
may be exposed by other routes, such as walking on exposed granules or drinking water
contaminated by granules. The number of lethal doses (LD50s) that are available within one square
foot immediately after application (LD50s/ft2) is used as the acute risk quotient for granular/bait
products. Risk quotients are calculated for three separate weight classes of birds: 1000 g (e.g.,
waterfowl), 180 g (e.g., upland gamebird) and 20 g (e.g., songbird). The results are tabulated in the
following table.
Table 37: Avian risk quotients for granular products broadcast on corn and not incorporated,
based on a ring-necked pheasant LD50 of 15.4 mg/kg.
Site/ Application Method/
Rate in Ibs ai/A
0.15
0.15
0.15
% Pesticide
Left on Surface
5
5
5
Body Weight (g)
20
180
1000
LD50 (mg/kg)
15.4
15.4
15.4
Acute RQ1 (LD50/ft2)
0.26**
0.03
0.51
1 RO = 0.05 * App. Rate (Ibs ai/A) * (453.590 mg/lbs/43.560 ftVAl
LD50 mg/kg * Weight of Animal (g) /1000 g/kg
** exceeds endangered species
and restricted use LOCs
For broadcast applications of granular products, levels of concern are exceeded only for
songbird species or small birds (e.g., juveniles). However, mitigating factors may greatly reduce the
potential for hazard even to these species. For example, the methomyl 5G granule is not only
extremely small (0.08 mg compared to an average of 0.34 mg for granules) but also is shaped more
like a flake than a typical grit. In addition, application directions specify that the product is to be
applied directly to the whorls of the corn plant rather than broadcast over the crop. This greatly
reduces the amount of product likely to be applied to the ground. These factors make the selection
of such granules very unlikely by avian species, greatly reducing the hazard. Therefore, no avian
acute levels of concern are exceeded at any registered application rates for broadcast applications of
granular products. There are no banded or in-furrow applications for any of the granular
registrations. Currently, the Agency does not have a standard procedure for assessing chronic risk
to avian species for granular products.
84
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Mammals
The estimated potential for adverse effects to wild mammals is based on the Agency's draft
1995 SOP for mammalian risk assessments and the methods of Hoerger and Kenaga (1972) as
modified by Fletcher et al. (1994). The concentration of methomyl in the diet that is expected to be
acutely lethal to 50% of the test population (LC50) is determined by dividing the LD50 value (usually
rat LD50) by the % (decimal of) body weight consumed. A risk quotient is then determined by
dividing the EEC by the derived LC50 value. Risk quotients are calculated for three separate weight
classes of mammals (15, 35, and 1000 g), each presumed to consume four different kinds of food
(grass, forage, insects, and seeds).
Non-granular Products
The following table presents the acute risk quotients for herbivores/insectivores from single
broadcast applications of nongranular products of methomyl.
85
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Table 38: Mammalian (Herbivore/Insectivore) Acute Risk Quotients for a Range of Single
Application Rates for Nongranular Products (Broadcast) Based on a rat LD50 of 32 mg/kg.
Appl.
Method/
Rate in
Ibs ai/A
aerial/
.225
aerial/ .45
aerial/ 0.9
ground/
1.8
Body
Wt.
(g)
15
35
1000
15
35
1000
15
35
1000
15
35
1000
%Body
Weight
Consumed
95
66
15
95
66
15
95
66
15
95
66
15
Rat
LD50
(mg/
kg)
32
32
32
32
EEC
(ppm)
Short
Grass
54
108
216
432
EEC
(ppm)
Forage/
Insects
30
61
122
243
EEC
(ppm)
Large
Insects
3
7
14
27
Acute
RQ1
Short
Grass
1.60***
I jj***
0.25**
3.21***
2.23***
0.51***
6.40***
4 45***
1.01***
12 83***
897***
2.03***
Acute RQ
Forage
& Small
Insects
0.89***
0.62***
0.14*
1.81***
I 26***
0.29**
3.63***
2 52***
0.57***
7 21***
5.01***
1 14***
Acute
RQ
Large
Insects
0.12*
0.06
0.01
0.21**
0.14*
0.03
0.42**
0.29**
0.07
0.80**
*
0.56**
*
0.13*
1 RQ =
EEC (mm)
* exceeds endangered species LOG
LD50 (mg/kg)/ % Body Weight Consumed ** exceeds endangered species and restricted use LOG
*** exceeds endangered species, restricted use and acute high risk LOCs
Single broadcast applications at rates equal to or greater than 0.225 Ibs. a.i./A exceed
endangered species, acute restricted use and high acute risk LOCs for herbivores and insectivores.
The following table presents the acute risk quotients for granivores from single broadcast
applications of nongranular products of methomyl.
86
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Table 39: Mammalian (Granivore) Acute Risk Quotients for Single Application of Nongranular
Products (Broadcast) Based on a rat LD50 of 32 mg/kg.
Site/ Applic.
Me th/ Rate
Lettuce/aerial
.45 Ib ai/ac
Citrus/aerial
0.9 Ib ai/ac
Peaches/ground
1.8 Ib ai/ac
Body
Weight (g)
15
35
1000
15
35
1000
15
35
1000
% Body Weight
Consumed
21
15
3
21
15
3
21
15
3
RatLDSO
(mg/kg)
32
32
32
EEC (ppm)
Seeds
7
14
27
Acute RQ1
Seeds
0.05
0.03
0.01
0.09
0.06
0.01
0.17*
0.12*
0.02
RQ =
EEC (ppm)
* exceeds endangered species LOG
LD50 (mg/kg)/ % Body Weight Consumed
Single broadcast applications at maximum application rates greater than 0.9 Ibs. a.i./A exceed
the endangered species LOG for granivores.
The following table presents the acute risk quotients for herbivores/insectivores from multiple
broadcast applications of nongranular products of methomyl.
Table 40: Mammalian (Herbivore/Insectivore) Acute Risk Quotients for Multiple Applications of Nongranular
Products (Broadcast). Based on a rat LD50 of 32 mg/kg.
Site/ ' App. Method/
Rate in Ibs ai/A (No.
ofApps.) (Interval)
Cotton/aerial
0.6x3(3)
1.81b./Amax.
Corn / aerial
0.45x16(1)
7.2 Ib./A max.
Lettuce / aerial
0.9 x 10 (2 da)
9.01b./Amax.
Body
Weight
(g)
15
35
1000
15
35
1000
15
35
1000
%Body
Weight
Consumed
95
66
15
95
66
15
95
66
15
Rat
LD50
(mg/kg)
32
32
32
EEC
(ppm)
Short
Grass
281
636
714
EEC
(ppm)
Forage/
Insects
158
358
402
EEC
(ppm)
Large
Insect
18
40
45
Acute RQ'
Short
Grass
8.34***
5.80***
1.32***
18.88***
13.12***
2.98***
21.20***
14.73 ***
3.35***
Acute RQ
Forage
& Small
Insects
4.69 ***
3.26***
0.74***
10.63 ***
7.38***
1.68***
11.93***
8.29***
1.88***
Acute RQ
Large
Insects
0.53***
0.37**
0.08
1.19***
0.83 ***
0.19*
1.34***
0.93 ***
0.21 **
87
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Table 40: Mammalian (Herbivore/Insectivore) Acute Risk Quotients for Multiple Applications of Nongranular
Products (Broadcast). Based on a rat LD50 of 32 mg/kg.
Site/App. Method/
Rate in Ibs ai/A (No.
ofApps.) (Interval)
Citrus/aerial
0.9x3(10)
2.7 Ib./A max.
Peaches/aerial
1.8x3(5)
5.4 Ib./A max.
Body
Weight
(g)
15
35
1000
15
35
1000
%Body
Weight
Consumed
95
66
15
95
66
15
Rat
LD50
(mg/kg)
32
32
EEC
(ppm)
Short
Grass
345
690
EEC
(ppm)
Forage/
Insects
194
388
EEC
(ppm)
Large
Insect
22
43
Acute RQ'
Short
Grass
10.24***
7.12***
1.62***
20.48 ***
14.23 ***
3.23***
Acute RQ
Forage
& Small
Insects
5.76***
4.00 ***
0.91 ***
11.52***
8.00***
1.82***
Acute RQ
Large
Insects
0.65 ***
0.45 **
0.10*
1.28***
0.89***
0.20**
1 RQ = .
EEC (ppm)
LD50 (mg/kg)/ % Body Weight Consumed
! exceeds endangered species LOG.
! exceeds acute restricted use and endangered species LOG.
*** exceeds endangered species, acute restricted use and acute high risk LOG.
Multiple broadcast applications at all rates and intervals of application exceed the endangered
species, acute restricted use and acute high risk LOCs for herbivores and insectivores.
The following table presents the acute risk quotients for granivores from multiple broadcast
applications of nongranular products of methomyl.
Table 41: Mammalian (Granivore) Acute Risk Quotients for Multiple Applications of Nongranular Products
(Broadcast) Based on a rat LD50 of 32 mg/kg.
Use/App. Meth./Rate
Ibs ai/A (# apps)
Cotton / aerial
0.6 x 3 (3 da)
1.81b./Amax.
Com / aerial
0.45 x 16 (1 da)
7.2 Ib./A max.
Citrus /aerial
0.9 x 3 (5 da).
2.7 Ib. A max.
Lettuce / aerial
0.9 x 10 (2 da)
9.0 Ib./A max.
Peaches/aerial/
1.8x3 (5 da)
5.4 Ib./A max.
Body Wt.
(g)
15
35
1000
15
35
1000
15
35
1000
15
35
1000
15
35
1000
% Body Weight
Consumed
21
15
3
21
15
3
21
15
3
21
15
3
21
15
3
RatLDSO
(mg/kg)
32
32
32
32
32
EEC (ppm)
Seeds
18
40
22
45
43
Acute RQ'
Seeds
0.12*
0.08
0.02
0.26**
0.19*
0.04
0.14*
0.10*
0.02
0.30**
0.21**
0.04
0.28**
0.20**
0.04
RQ = .
EEC (ppm)
LD50 (mg/kg)/ % Body Weight Consumed
* exceeds endangered species LOG
** exceeds endangered species and restricted use LOCs
88
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Multiple broadcast applications of nongranular products at application rates equal to or
greater than 5.4 Ibs a.i./A exceed the endangered species and acute restricted use LOG for granivores.
At multiple total application rates less than 5.4 Ibs. a.i./A, only the LOG for endangered species is
exceeded.
Chronic mammalian RQs were based on multiple broadcast applications of nongranular
products. Results are tabulated below.
Table 42: Mammalian Chronic Risk Quotients for Multiple Applications of Nongranular Products (Broadcast)
Based on a laboratory rat NOEC of 75 ppm in a reproductive study.
Site/App. Method
Rate (Ib ai/A) x No ofApps.
Interval (days)
Corn / Aerial
0.45 x 16 (Ida)
7.2 Ib/acmax
Citrus / Aerial
0.9x3(5)
2.7 Ib/ac max.
Lettuce, Cole Crops / Aerial
0.9 x 10 (2 da)
9.0 Ib/ac max.
Cotton / Aerial
0.6 x 3 (3 da)
1.8 Ib/ac max
Peaches / ground
1.8x3 (5 da)
5. 4 Ib/ac max
Food Items
Short grass
Tall Grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Seeds
Short Grass
Tall Grass
Broadleaf plant/Insect
Seeds
Seeds
Short Grass
Tall Grass
Broadleaf plant/Insect
Seeds
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
EEC1 (ppm)
Maximum
636
292
358
40
345
158
194
22
714
327
402
45
2ii
129
158
18
690
316
388
43
Average
225
95
119
19
122
52
65
10
253
107
134
21
99*
42
53
8
244
104
129
20
NOEC
(ppm)
75
75
75
75
75
Chronic RQ (EEC/ NOEC)
Maximum
8.48 +
3.89 +
4.77 +
0.53
4.60 +
2.10 +
2.58 +
0.29
9.52 +
4.36 +
5.36 +
0.60
3.74 +
1.72 +
2.10 +
0.24
9.20 +
4.21 +
5.17 +
0.57
Average
3.00 +
1.26 +
1.58 +
0.25
1.62 +
0.69
0.01
0.13
3.37 +
1.42 +
1.78 +
0.28
1.32 +
0.56
0.70
0.10
3.25 +
1.38 +
1.72 +
0.26
1 Assumes dissipation using FATE program and foliar dissipation data from the aquatic residue monitoring studies (half-life = 4 days).
+ exceeds chronic risk LOG for reproductive effects.
For multiple broadcast applications of nongranular products, the mammalian chronic LOG is
exceeded at all rates and intervals of applications for both maximum and average residues.
Granular Products (Sweet Corn in Georgia and Florida)
Mammalian species may be exposed to granular/bait pesticides by ingesting granules. They
also may be exposed by other routes, such as by walking on exposed granules and drinking water
contaminated by granules. The number of lethal doses (LDSO's) that are available within one square
foot immediately after application can be used as a risk quotient (LD50's/ft2)for the various types of
89
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exposure to bait pesticides. Risk quotients are calculated for three separate weight classes of mammals:
15 g, 35 g and 1000 g. Results are tabulated below.
Table 43: Mammalian Acute Risk Quotients for Granular Products (Broadcast and Unincorporated on Corn)
Based on a Rat LD50 of 32 mk/kg.
Site/ Application Method/
Rate in Ibs ai/A
0.15
0.15
0.15
Fraction of pesticide
Left on the Surface
5
5
5
Body Weight (g)
15
35
1000
RatLDSO
(mg/kg)
32
32
32
Acute RQ1 (LDSO/ft2)
0.16*
0.07
<0.01
1 RQ = 0.05 * App. Rate (Ibs ai/A) * (453,590 mg/lbs/43,560 ft2/A)
LD50 mg/kg * Weight of Animal (g) / 1000 g/kg
: exceeds endangered species LOG
For broadcast granular products, mammalian acute high risk LOCs are not exceeded.
Although the endangered species level of concern is exceeded at a registered maximum application rate
equal to or greater than 0.15 Ibs. a.i./A, other factors greatly reduce the potential for hazard even to
these species. For example, the methomyl 5G granule is an extremely small granule (0.08 mg as
compared to an average size granule that weighs 0.34 mg). In addition, the shape of the methomyl 5G
granule is quite different than the typical grit. The methomyl 5G granule is shaped more like a flake
rather than the typical granular structure. These factors greatly reduce the likelihood of exposure to
non-target organisms. Therefore, for broadcast applications of granular products, no mammalian acute
levels of concern are exceeded at any registered application rates. There are no banded or in-furrow
applications for any of the granular registrations. Currently, EPA does not have a standard procedure
for assessing chronic risk to mammalian species from granular products.
Insects
Currently, EPA does not assess risk to nontarget insects. Results of the honey bee acute
contact study have used for recommending appropriate label precautions.
2. Exposure and Risk to Nontarget Freshwater and Marine Aquatic Animals
Acute risk assessments are based on the maximum (peak) EEC values (see Aquatic Exposure
Assessment). For chronic risk, 21-day EECs are used for invertebrates and 60-day EECs are used for
fish. The EPA believes that, because of their proximity to aquatic environments, citrus uses will result
in the direct application of methomyl to aquatic environments. For citrus use patterns, EPA assumes
simple dilution of the amount applied to a surface acre of water 6 inches deep.
Freshwater Fish
Preliminary RQs calculated using EECs from the GENEEC model all exceeded aquatic
endangered species, acute restricted use, and chronic risk LOCs. Therefore, refined EECs, generated
by PRZM/EXAMS, were used to calculate the RQs in the Table below.
90
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Table 44: Risk Quotients for Freshwater Fish based on a channel catfish LC50 of 500 ppb and a fathead
minnow NOEC of 57 ppb of methomyl.
Site/ Application
Method/ Rate in Ibs ai/A
(No. ofApps.)
LC50
(ppb)
NOEC/
MATC
(ppb)
EEC
Initial/
Peak (ppb)
EEC
21-Day
Ave. (ppb)
Acute RQ
(EEC/LC50)
Chronic RQ
(EEC/NOEC
or MATC)
Refined EECs based on PRZM/EXAMS Modeling
Peaches/aerial /1. 8 (3)
Lettuce/aerial 70.9(10)
Com/aerial 70.45 (16)
Lettuce/aerial / 0.225 (15)
500
500
500
500
57
57
57
57
99
88
60
30
95
84
59
28
0.20 **
0.18**
0.12**
0.06*
1.67 +
1.47 +
1.04
0.49
EECs based on Direct Application to a 6" layer of water
Citrus/aerial 70.9(3)
500
57
130
111
0.26**
1.95 +
+ Exceeds chronic risk LOG
* Exceeds endangered species LOG
** Exceeds endangered species and acute restricted use LOG
Based on refined EECs for peaches, lettuce, and corn, acute aquatic endangered species
LOCs are exceeded for freshwater fish at application rates equal to or greater than 0.225 Ibs. a.i./A.
Endangered species, and acute restricted use LOCs are exceeded at application rates equal to or greater
than 0.45 Ibs.a.i./A. Chronic risk LOCs for freshwater fish are exceeded at multiple application rates
greater than 0.45 Ibs. a.i./A. For citrus use, direct application of methomyl to water at an application
rate equal to or greater than 0.9 Ibs. a.i./acre exceeds LOCs for endangered species and acute restricted
use and the chronic risk LOG for freshwater fish.
Freshwater Invertebrates
The acute and chronic risk quotients are tabulated below.
91
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Table 45: Risk Quotients for Freshwater Invertebrates. Based on a Daphnia LC50 of 8.8 ppb and a Daphnia
NOEC/MATC of 0.6 ppb.
Site/ Applic. Method/
Rate in Ibs ai/A (No. of
Apps.)
LC50
(ppb)
NOEC/
MATC
(ppb)
EEC (ppb)
Peak
EEC (ppb)
21-DayAvg
Acute RQ
(EEC/LC50)
Chronic RQ
(EEC/NOEC or
MATC)
Refined EECs based on PRZM/EXAMS Modeling
Peaches /aerial /1. 8 (3)
Lettuce /aerial 70.9(10)
Com /aerial 70.45 (16)
Lettuce / aerial / 0.225
(15)
8.8
8.8
8.8
8.8
0.6
0.6
0.6
0.6
99
88
60
30
95
84
59
28
11.25***
10.00***
6.82***
3.41***
158.3 +
140 +
98 +
46.6 +
EECs based on Direct Application to a 6" layer of water
Citrus /aerial/ 0.9 (3)
8.8
0.6
130
123
14.77***
205 +
+ Exceeds the chronic LOG.
*** Exceeds the acute high risk, acute restricted use and endangered species LOCs.
Results using refined EECs for peaches, lettuce, and corn indicate aquatic acute high risk,
restricted use, and endangered species levels of concern are exceeded for freshwater invertebrates at
application rates equal to or above 0.225 Ibs. a.i./A. Multiple applications at rates greater than or equal
to 0.225 Ibs a.i./acre result in chronic hazard to freshwater invertebrates.
For citrus uses, acute high risk, acute restricted use, endangered species, and chronic risk
LOCs are exceeded for freshwater invertebrates from the direct application of methomyl to a 6 inch
layer of water at the maximum application rate of 0.9 Ibs. a.i./acre. Based on these results, mitigation
agreed to in 1993 between the Agency and the registrants, limited the citrus use to Arizona and
California only. Methomyl is no longer allowed on Florida citrus. However, application to shallow
bodies of water such as irrigation ditches and canals in California is possible for this use pattern.
Estuarine and Marine Animals
Estuarine Fish
The following table shows the risk quotients for estuarine/marine fish.
92
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Table 46: Risk Quotients for Estuarine/Marine Fish Based on a Sheepshead minnow LC50 of 1,160 ppb.
Based on refined EECs using PRZM/EXAMS.
Site/ Applic. Method/
Rate in Ibs ai/A (No. ofApps.)
Peaches /aerial /1. 8 (3)
Lettuce /aerial 70.9(10)
Com /aerial 70.45 (16)
Lettuce / aerial / 0.225 (15)
LC50
(ppb)
1160
1160
1160
1160
EEC Initial/
Peak (ppm)
99
88
60
30
Acute RQ
(EEC/LC50)
0.09*
0.08*
0.05*
0.03
* exceeds acute endangered species LOG
Acute endangered species levels of concern are exceeded for estuarine fish at maximum
application rates above 0.225 Ibs. a.i./A.
Estuarine Aquatic Invertebrates
The following table shows the risk quotients for estuarine/marine invertebrates.
Table 47: Risk Quotients for Estuarine/Marine Aquatic Invertebrates Based on a pink shrimp species) TL50
of 49 ppb. Based on refined EECs using PRZM/EXAMS.
Site/ Application Method
Rate in Ibs ai/A (No. ofApps.)
Peaches /aerial /1. 8 (3)
Lettuce /aerial/ 0.9 (10)
Com /aerial/ 0.45 (16)
Lettuce / aerial / 0.225 (15)
LC50
(ppb)
19
19
19
19
EEC Initial/ Peak
(ppb)
99
88
60
30
Acute RQ
(EEC/LC50)
5.21*
4.63*
3.15*
1.58*
*exceeds acute endangered species, restricted use and acute high risk LOG.
Acute high risk, restricted use, and endangered species levels of concern are exceeded for
estuarine invertebrates at maximum application rates equal to or above 0.225 Ibs. a.i./A.
Exposure and Risk to Aquatic Organisms Based on Residue Monitoring Data
The following tables summarize the residue monitoring data collected from the aquatic field
studies and uses these results for the EECs. The tables include either the peak, median or maximum
reported residues that occurred in ponds and the drainage/irrigation canals that were located either
within or adjacent to the treated fields.
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Freshwater Fish
The following table shows the risk quotients for freshwater fish using monitoring estimates
for EECs.
Table 48: Risk Quotients for Freshwater Fish based on a channel catfish LC50 of 500 ppb and a fathead
minnow NOEC of 57 ppb of methomyl. EECs derived from residue monitoring data.
Site/ Application Method/
Rate in Ibs ai/A (No. of
Apps.)
Apples/air blast / 1.35 (5)
Com/aerial / 0.45 (28)
Com/aerial 70.3-0.5(29)
Lettuce/aerial / 0.225 (15)
Cantaloupe/aerial / 0.9 (6)
LC50
(ppb)
500
500
500
500
500
NOEC/
MATC
(ppb)
57
57
57
57
57
Initial
Peak/Max
Res. (ppb)
13.3
15.75
7.0
65.5
96
21-DayAve.
Res. (ppb)
7.6
5.8
4.2
38.3
9
Acute RQ
(EEC/LC50)
0.03
0.03
0.01
0.13*
0.19*
Chronic RQ
(EEC/NOEC or
MATC)
0.13
0.10
0.07
0.67
0.16
*exceeds endangered species LOG.
1 Application rates and number of applications are from the actual monitoring studies and may not necessarily coincide with maximum
label applications.
The use of methomyl, at least for certain use patterns, exceeds the endangered species acute
LOCs for freshwater fish. The chronic LOG was not exceeded for any of the use patterns.
Freshwater Invertebrates
The following table shows the risk quotients for invertebrates using monitoring estimates for
EECs.
Table 49: Risk Quotients for Freshwater Invertebrates (based on a Daphnia LC50 of 8.8 ppb and a NOEC of
0.4 ppb of methomyl). EEC derived from residue monitoring data.
Site/ Application Method/
Rate, Ibs ai/A (# of Apps.)1
Apples/air blast / 1.35 (5)
Com/aerial / 0.45 (28)
Corn/aerial 70.3-0.5(29)
Lettuce/aerial / 0.225 (15)
Cantaloupe/aerial / 0.9 (6)
LC50
(Ppb)
8.8
8.8
8.8
8.8
8.8
NOEC/
MATC
(ppb)
0.4
0.4
0.4
0.4
0.4
Initial
Peak/Max
Res. (ppb)
13.3
15.75
7.0
65.5
96
21-DayAve.
Res.
(ppb)
7.6
5.8
4.2
38.3
9
Acute RQ
(EEC/LC50)
1.51***
1.79***
0.80***
744***
10.91***
Chronic RQ
(EEC/NOEC
or MATC)
19.00 +
14.50 +
10.50 +
95.75 +
22.50 +
1 Application rates and number of applications are from the actual monitoring studies and may not necessarily coincide with maximum
label applications.
+ Exceeds chronic LOG for aquatic invertebrates
*** Exceeds acute endangered species, acute restricted use and acute high risk LOCs.
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The use of methomyl in all of the field-tested use patterns exceeded the acute endangered
species, acute restricted use and acute high risk LOCs for freshwater invertebrates. Chronic LOCs for
freshwater invertebrates were also exceeded for all of the use patterns tested.
3. Exposure and Risk to Endangered Species
The Endangered Species Protection Program is expected to become final in the future.
Limitations in the use of methomyl may be required to protect endangered and threatened species, but
these limitations have not been defined and may be formulation specific. EPA anticipates that a
consultation with the Fish and Wildlife Service may be conducted in accordance with the species-based
priority approach described in the Program. After completion of consultation, registrants will be
informed if any required label modifications are necessary. Such modifications would most likely
consist of the generic label statement referring pesticide users to use limitations contained in county
bulletins.
4. Environmental Risk Characterization
Fate and Exposure
Methomyl appears to be moderately persistent and highly mobile. The dominant routes of
dissipation appear to be metabolism (biologically-mediated degradation), leaching, and photolysis in
clear waters. Site-specific factors affecting the persistence of methomyl include aerobicity, organic
matter and soil moisture content, exposure to sunlight, pH, climate (especially rainfall) and crop
management factors that influence leaching and runoff.
Methomyl photolyzes quickly in water but slowly in soils. It is moderately stable to aerobic
soil metabolism but degrades more rapidly under anaerobic conditions. While methomyl becomes more
susceptible to hydrolysis as the pH increases above neutral, this is not expected to be a major route of
dissipation under most circumstances. Laboratory studies show that methomyl does not readily adsorb
to soil and has the potential to be very mobile. Dissipation from the soil surface occurs by a
combination of chemical breakdown and movement. Field studies show that the varying dissipation
rates for methomyl were related primarily to differences in soil moisture content, which may affect the
microbial activity, and rainfall/irrigation, which could influence leaching. The major degradate in most
metabolism studies was CO2. Another degradate, S-methyl-N-hydroxythioacetamidate, primarily
appears to be a product of alkaline hydrolysis.
Ground Water Assessment: Methomyl has been detected in ground water in a prospective ground water
monitoring study and in other reported incidences. The potential for ground water contamination is
greatest with highly permeable soils, shallow depths to ground water, and an excess of water (from
precipitation and/or irrigation) moving through the soil to carry the chemical with it. While it may
reach ground water under certain conditions, methomyl will not likely persist under many conditions.
Surface Water Assessment: Methomyl can contaminate surface water as a result of spray drift during
application or by runoff from treated sites. Methomyl would not be expected to persist in clear,
shallow waters because of its susceptibility to photolysis. However, it may persist longer in waters
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where sunlight penetration is limited (such as in deeper waters or waters with a significant sediment
load or population of organisms such as algae). Monitoring studies suggest that spray drift is likely to
be a major source of methomyl in surface waters. Under certain conditions, runoff may be a source of
methomyl contamination. Runoff vulnerability is likely to be greater in high rainfall areas (eastern and
southeastern U.S.) than in semi-arid to arid areas (in large areas of the southwest and western U.S.).
Other avenues of methomyl movement include irrigation and drainage ditches/channels/lines and lateral
subsurface flow.
Inferences From Field Monitoring Studies
The dissipation half-lives of methomyl from the soil surface in monitoring studies conducted
in California, Illinois, Michigan, Georgia, and Florida were similar in range to those measured in the
terrestrial field dissipation studies. In at least one study, the dissipation rate increased greatly after
rainfall events, suggesting that leaching may be a major route of dissipation. Foliar dissipation half-lives
ranged from a few hours (on corn) to 4 days (on apples). These data were similar to foliar half-lives
reported for cotton leaves.
Predicted (using PRZM/EXAMS) and measured concentrations of methomyl in water were
generally similar in magnitude and pattern of dissipation for those sites that were both modeled and
monitored. This provides supporting evidence that PRZM/EXAMS can provide a reasonable estimate
of methomyl concentrations in adjacent surface waters under the tested conditions. For risk assessment
and screening purposes, EPA used the modeled data, which incorporates 36 years of weather data and
generally provides a 90% upper bound estimate based on variations in weather patterns. A chemical
such as methomyl, which is moderately persistent but highly mobile, is likely to be susceptible to
variations in rainfall amounts and patterns.
Environmental Risk
Non-target Terrestrial Organisms
Because of its versatility in controlling a wide variety of insects, methomyl can be, and is,
used throughout the U.S. As such, the potential for exposure to numerous non-target birds, mammals,
and beneficial insects that directly utilize these crops for nesting, feeding, cover, and other activities is
likely. In addition, indirect exposure from drift is likely to contaminate a wide variety of ecosystems
and possibly adversely affect non-target organisms utilizing these habitats.
Laboratory studies show that methomyl is highly toxic and very highly toxic to avian and
mammalian species, respectively, on an acute oral basis but only slightly toxic to avian species on a
subacute dietary basis. However, avian acute dietary risk quotients (RQs) indicate that acute restricted
and acute endangered species Levels of Concern (LOG) are exceeded only from exposure to short grass
and large insects. Since short grass or similar vegetative material does not constitute a major portion of
many avian diets, most birds are not expected to be at risk on a subacute dietary basis. However, other
species (e.g, ducks, geese and swans) that tend to graze on short grass are at greater risk. Risks to
birds that eat mainly insects are expected to occur within the acute restricted use LOG range, at the
highest application rate of 1.8 Ibs. a.i./A.
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Avian chronic LOCs (based on avian reproductive toxicity data) are exceeded for both
average and maximum EECs from multiple applications even at the lowest application rate of 0.225 Ibs.
a.i./A. RQs suggest that seed eating birds are at less risk than insectivores or birds that feed on short
grass or other herbaceous material. Seed-eaters are not at risk from multiple applications at the highest
application rate of 1.8 Ibs. a.i./A on peaches.
Mammalian acute dietary RQs are considerably greater than avian RQs and exceed the LOCs
for endangered species, acute restricted use and acute high risk for herbivores and insectivores for all
application rates. This is especially the case for multiple applications. However, for granivores (seed
eaters) only acute RQs at the highest single application rate exceed the endangered species LOCs.
Multiple applications only exceed the acute endangered species and acute ristricted use LOCs at
application rates equal to or greater than 0.45 pounds a.i./A. Unlike avian species, many small rodents
and other mammals consume copious amounts of grass and herbaceous material. As such, the
likelihood that mammals, especially herbivores and insectivores, will be adversely affected is
considerably greater than for birds.
Mammalian chronic RQs based on reproductive toxicity data suggest that even from a single
application, the chronic LOG is exceeded at registered maximum application rates equal to or greater
than 0.45 Ibs. a.i./A for herbivores (based on residues for short grass). However, chronic LOCs for
insectivores are only exceeded at application rates greater than or equal to 0.90 Ibs. a.i./A. Chronic
LOCs are not exceeded for seed-eaters at any application rate for either single or multiple applications.
Based strictly on the RQs derived from laboratory toxicity data and EECs it can be
concluded that methomyl poses acute and chronic risks to numerous non-target wildlife species,
including threatened and endangered species. However, "real world" factors, both biotic and abiotic,
reduce the potential for this risk. Data suggest that physical abrasion, rainfall, and spray irrigation
remove most of the product from the plant surface which reduces the risk to non-targets that may feed
on either the treated crops and/or other contaminated vegetation in adjacent habitats.
Non-target Aquatic Organisms
Laboratory toxicity data show that methomyl and its formulated products are moderately to
highly toxic to freshwater fish and moderately toxic to estuarine fish on an acute basis. However,
results from a chronic early life-stage study show that methomyl significantly reduced fish larvae
survival under flow through conditions.
Methomyl and its formulated products are highly to very highly toxic to freshwater
invertebrates on an acute basis. Acute toxicity studies on estuarine/marine invertebrates show very high
toxicity to several shrimp species while short-term oyster shell growth appeared to be practically
unaffected from methomyl exposure. Chronic toxicity from exposure to methomyl at concentrations
greater than 0.4 ppb can reduce the number of young freshwater invertebrates produced. In general,
the toxicity data suggest that aquatic invertebrates are much more sensitive to methomyl contamination
than either fresh or salt water fish species.
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RQs generated by PRZM/EXAMS indicate that acute endangered species LOCs are
exceeded for freshwater fish at application rates equal to or greater than 0.225 Ibs a.i./A and for
estuarine fish at application rates equal to or greater than 0.45 Ibs. a.i./A. Acute restricted use LOCs
for freshwater fish are only exceeded at maximum application rates equal to or greater than 0.45 Ibs
a.i./A. Chronic risk LOCs for freshwater fish (based on a fathead minnow early life stage study) are
exceeded at multiple application rates greater than 0.45 Ibs. a.i./A.
Finally, the direct application of methomyl to a 6 inch layer of water (as is likely to occur
from spraying citrus groves) at an application rate equal to or greater than 0.9 Ibs. a.i./acre will result in
chronic hazard to freshwater fish as well as exceeding the LOCs for acute endangered species and acute
restricted use.
RQs generated by PRZM/EXAMS indicate that acute endangered species, acute restricted
use and acute high risk LOCs are exceeded for freshwater and estuarine invertebrates at application
rates equal to or greater than 0.225 Ibs. a.i./A. Chronic risk LOCs (based on a daphnia life-cycle study)
for freshwater invertebrates are exceeded at multiple application rates greater than 0.225 Ibs. a.i./A.
These chronic RQs range from 46.6 (multiple applications of 0.225 Ibs.a.i./A for lettuce) to 158.3
(multiple applications of 1.8 Ibs. a.i./A for peaches).
Finally, the direct application of methomyl to a 6 inch layer of water (as is likely to occur
from spraying citrus groves) at an application rate equal to or greater than 0.9 Ibs. a.i./acre exceeds the
acute endangered species, acute restricted use and acute high risk LOCs as well as the chronic LOG for
freshwater invertebrates.
RQs for freshwater fish, based on actual field monitoring data, indicate that only the
endangered species LOCs are exceeded even at application rates equal to 1.35 Ibs. a.i./acre. Results
from these studies also indicate that chronic LOCs for aquatic invertebrates are not exceeded at any
application rate.
Therefore, based strictly on the risk quotients derived from laboratory toxicity data and
model-generated EECs, methomyl poses acute and chronic risk to numerous non-target aquatic
organisms, especially aquatic invertebrates, including threatened and endangered species. The refined
EECs generated using PRZM/EXAMS are based on high runoff potential sites in actual crop use areas.
The values used are based on 1 in 10 year runoff events, which are dependent on the amount and timing
of precipitation (typically generated from 24 to 36 years of actual precipitation data). On sites which
are less prone to runoff and in years in which weather patterns do not favor high runoff, the actual
aquatic environmental concentrations are likely to be less than those predicted and used for this risk
assessment.
The results of the field monitoring studies conducted in various crops at different
geographical locations provide snap shots of the potential toxicity of methomyl to aquatic organisms
under actual use conditions. Since modeled concentrations based on individual site and weather data
were similar to measured concentrations, the EPA concludes that PRZM/EXAMS provides a
reasonable estimate of methomyl concentrations in water. Results of the monitoring studies illustrate
the range in methomyl concentrations in water that may occur under a variety of site conditions and
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weather patterns. It is most likely that actual risks are somewhere between those predicted with
PRZM/EXAMS and those found in the monitoring studies.
Using these measured residue concentrations, freshwater fish RQs showed that, even at the
highest application rates, only the endangered species LOCs were exceeded. Chronic LOCs were not
exceeded for any of the use patterns. However, endangered species, acute restricted use and acute high
risk LOCs were exceeded for aquatic invertebrates even at the lowest application rates. These results
clearly show that the greatest hazard to non-target aquatic organisms is to aquatic invertebrates.
An outdoor microcosm study was conducted to evaluate the fate of methomyl in tank water
and hydrosoil and the effects on populations of zooplankton, phytoplankton, macroinvertebrates and
bluegill sunfish from exposure to methomyl. Results of the study show no apparent methomyl-related
treatment effects to either bluegill sunfish or phytoplankton populations. Decreases in abundance in the
Cladocera zooplankton populations occurred; however, other zooplankton populations (Copepoda and
Rotifera) actually increased in abundance (probably as a result of decreased competition with reduced
populations of Cladocera) during the study. Macroinvertebrate (Ephemeroptera) abundance clearly
decreased in the two highest treatment groups. In addition, results also show a decrease in abundance
for Chironomidae; however, these decreases were very short-lived, were not dose related, and could
not be solely attributable to treatment. This study summary is based on a cursory review of the study
and is not the result of a critical analysis of the study design, data, or interpretations of results (MRID
43744402).
Results of an apple orchard monitoring study conducted in Michigan showed that nearly 44
percent of the application rate never reached the ground because of the wind conditions. Drift cards
placed in an adjacent pond indicated that 2 to 44 percent of the application rate may have drifted into
the pond. The data from this and other monitoring studies indicate that the broad scale use of
methomyl on sites adjacent to or near aquatic habitats may result in methomyl reaching aquatic
environments on an annual basis.
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregi strati on. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing methomyl active ingredients. The Agency has
completed its review of these generic data, and has determined that the data are sufficient to
support reregistration of all products containing methomyl. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of methomyl, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of methomyl and to determine that methomyl can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing methomyl as the active ingredient, labeled and used as specified
in this Reregistration Eligibility Decision document, are eligible for reregistration. The
reregistration of particular products is addressed in Section V. of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found that all uses of methomyl, labeled and used as specified in
this Reregistration Eligibility Decision document, are eligible for reregistration, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing methomyl, if
new information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient methomyl, the
Agency has sufficient information on the health effects of methomyl and on its potential
for causing adverse effects in fish and wildlife and the environment. The Agency has
determined that methomyl products, labeled and used as specified in this Reregistration
Eligibility Decision, will not pose unreasonable risks or adverse effects to humans or
the environment. Therefore, the Agency concludes that products containing methomyl
for all uses, labeled and used as specified in this Reregistration Eligibility Decision
document, are eligible for reregistration.
2. Eligible and Ineligible Uses
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The Agency has determined that all uses of methomyl, labeled and used as
specified in this Reregi strati on Eligibility Decision document, are eligible for
reregi strati on.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for methomyl.
Where labeling revisions are imposed, specific language is set forth in Section V. of this
document.
1. Food Quality Protection Act Findings
Determination of Safety for U.S. Population
The Agency has determined that established tolerances with amendments and changes
as specified in this document for methomyl meet the safety standards under the FQPA
amendments to section 408(b)(2)(D) for the general population. In reaching this
determination the Agency has considered the available information on aggregate exposures,
both acute and chronic, from food and water as well as the possibility of aggregate effects
from methomyl and thiodicarb since thiodicarb degrades rapidly to methomyl.
Since there are no residential or lawn uses of methomyl, no dermal or inhalation
exposure is expected in and around the home.
The results of the acute aggregate exposure analyses for food, for thiodicarb and
methomyl, demonstrate that there are adequate margins of exposure for the general U.S.
population (MOE=912). Estimated acute water exposures do not exceed the drinking water
level of concern.
Results of the chronic aggregate exposure analyses for food, for thiodicarb and
methomyl, show that for the general U.S. population, only 1.9% of the RfD is occupied.
Estimated chronic water exposures do not exceed the drinking water level of concern.
Determination of Safety for Infants and Children
The Agency has determined that established tolerances with amendments and changes
as specified in this document for methomyl meet the safety standards under the FQPA
amendments to section 408(b)(2)(D) for infants and children. In reaching this determination
the Agency has considered the available information on the aggregate exposures, both acute
and chronic, from food and water as well as the possibility of aggregate exposure from
methomyl and thiodicarb since thiodicarb degrades rapidly to methomyl.
In determining whether to retain, reduce, or remove the lOx FQPA safety factor for
infants and children, EPA uses a weight of evidence approach taking into account the
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completeness and adequacy of the toxicity data base, the nature and severity of the effects
observed in pre- and post-natal studies, and information on exposure.
For purposes of assessing the pre- and post-natal toxicity of methomyl, EPA has
evaluated two developmental studies and one reproduction study. Based on current
toxicological data requirements, the data base for methomyl, relative to pre- and post-natal
toxicity is complete. The data provided no indication of increased sensitivity of rats or
rabbits to in utero and/or postnatal exposure to methomyl. In the prenatal developmental
toxicity studies in rats and rabbits and the two-generation reproduction study in rats, effects
in the offspring were observed only at or above treatment levels which resulted in evidence of
parental toxicity. There was no assessment of potential susceptibility in the area of functional
development.
There are however, data gaps for acute and subchronic neurotoxicity studies in rats.
These studies are considered data gaps because methomyl has exhibited neurotoxic signs in
two species (dogs and rabbits) by two different routes of exposure (oral and dermal). The
Agency has determined that the need for a developmental neurotoxicity study should be
placed in reserve status pending receipt and review of the acute and subchronic neurotoxicity
studies.
Based on these considerations, the lOx Safety Factor for increased susceptibility to
infants and children (as required by FQPA) was reduced to 3x.
The results of the acute aggregate exposure analyses for food, for thiodicarb and
methomyl, demonstrate that there are adequate margins of exposure for children 1 to 6 years
of age (MOE=417) and infants (MOE=756). Estimated acute water exposures do not
exceed the drinking water level of concern.
Results of the chronic aggregate exposure analyses for food, for thiodicarb and
methomyl, show that the most significantly exposed subpopulation is infants (<1 year old)
with 6.5% of the RfD occupied. For children 1-6 years old, 2.7% of the RfD is occupied.
Estimated chronic water exposures do not exceed the drinking water level of concern.
In deciding to continue to make reregi strati on determinations during FQPA
implementation, the Agency recognizes that it will be necessary to make decisions relating to
FQPA before the implementation process is complete. In making these case-by-case
decisions, the Agency does not intend broad precedents for the application of FQPA to its
regulatory determinations. Rather, these first decisions will be made on a case-by-case basis
and will not bind the Agency as it proceeds with further policy development and rulemaking
that may be required.
If the Agency determines, as a result of this later implementation process, that any
determinations described in this RED are no longer appropiate, the Agency will consider
itself free to pursue whatever action may be appropiate, including but not limited to,
reconsideration of any portion of this RED.
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Endocrine Disruption
The Agency is required to develop a screening program to determine whether certain
substances (including all pesticides and inerts) "may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen, or such other endocrine effect...". The
Agency is currently working with interested stakeholders, including other government
agencies, public interest groups, industry and research scientists in developing a screening
and testing program and a priority setting scheme to implement this program. Congress has
allowed 3 years from the passage of FQPA (August 3, 1999) to implement this program. At
that time, the Agency may require further testing of this active ingredient and end use
products for endocrine disrupter effects.
Cumulative Risk
Although at present the Agency does not know how to apply the information in its files
concerning common mechanism issues to most risk assessments, there are pesticides for
which the common mechanism issues can be resolved. These pesticides include pesticides
that are lexicologically dissimilar to existing chemical substances (in which case the Agency
can conclude that it is unlikely that a pesticide shares a common mechanism of activity with
other substances) and pesticides that produce a common toxic metabolite (in which case
common mechanism of activity will be assumed).
The Agency does not have, at this time, available data to determine whether methomyl
has a common mechanism of toxicity with other substances or how to include this pesticide in
a cumulative risk assessment. For the purposes of this tolerance action, therefore, The
Agency has not assumed that methomyl has a common mechanism of toxicity with other
substances.
2. Tolerance Reassessment
Tolerance Reassessment Summary
As a result of FQPA, pesticide residues are no longer regulated under section 409 of
FFDCA. Consequently, all tolerances will eventually be placed in 40 CFR section 180.
However, because methomyl tolerances still exist under sections 185 and 186, references to
these sections are still used in this document. The Agency will issue a Federal Register
Notice moving all methomyl tolerances listed under sections 185 and 186 to 40 CFR
§180.253.
Tolerances for residues of methomyl in/on plant RACs are currently expressed in terms
of methomyl [40 CFR §180.253 (a) and (b)]. A food/feed additive tolerance has been
established for residues of methomyl in dried hops [40 CFR §185.4100].
A summary of the methomyl tolerance reassessment and recommended modifications in
commodity definitions are presented in Table 50.
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Tolerances Listed Under 40 CFR S180.253(aV
Sufficient data are available to ascertain the adequacy of the established tolerances on
all listed commodities except for dry beans, bermudagrass forage, lentils, sorghum forage,
and turnips (greens).
Additional residue data and/or label amendments are required before the adequacy of
tolerances can be determined on bermudagrass forage, sorghum forage, radishes, and turnips
(greens); and supporting storage stability data are required before tolerances can be
reassessed on dry beans and lentils. Because the use on lentils is similar to the proposed use
on dry peas, data on dried pea seeds will be translated to support the tolerance on lentils.
Provided acceptable storage stability data are submitted, residue data on dry peas indicate
that the tolerance on lentils should be increased to 0.2 ppm.
Tolerances on barley forage, bean forage, peanut hulls, and rye hay will be revoked
because the Agency no longer considers these commodities to be significant livestock feed
items due to revisions in Table 2. (Table 1 in OPPTS Guideline 860.1000).
In accordance with 40 CFR §180.1 (h), the tolerance on green onions covers leeks and
the tolerance on peaches covers nectarines. Therefore, individual tolerances on leeks and
nectarines will be revoked.
Tolerances will also be revoked for the outdated listings on leafy vegetables (exc. beet
tops, broccoli, . . . etc.) and root crop vegetables. Tolerances either already exist for
individual members of these outdated crop groups or sufficient data are available to establish
new tolerances. In addition, the tolerance on Brassica (cole) leafy vegetables should be
revoked because individual tolerances ranging from 2 to 6 ppm have been established on all
brassica vegetables having registered uses.
Individual tolerances have been established on peppers (2 ppm) and tomatoes (1 ppm),
and the available data support a 0.2 ppm tolerance in/on eggplants. Concomitant with
establishing a tolerance on eggplant, the tolerance on fruiting vegetables must be revoked.
The available residue data on oranges, grapefruits, tangerines, and lemons adequately
support a crop group tolerance for citrus fruits. Methomyl residues were <0.02-0.53 ppm
in/on citrus fruits harvested 1 day following application(s) of methomyl at < Ix the maximum
labeled rate. Therefore, a 1 ppm tolerance must be established on the citrus fruits crop
group. Concomitant with establishing the crop group tolerance, individual tolerances for
grapefruit, lemon, orange, and tangerines should be revoked.
Since there are no registered uses on watercress, the tolerance on watercress should be
revoked.
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Tolerances Listed Under 40 CFR §180.253 (b\.
Sufficient data are available to ascertain the adequacy of the established 4 ppm
tolerance with a regional registration on pears.
Tolerances Listed Under 40 CFR §185.4100:
Sufficient data are available to ascertain the adequacy of the established 12.0 ppm
tolerance on imported dried hops. In accordance with PR Notice 93-12 (12/93), dried hops
are now regulated as a RAC. A permanent tolerance will be established on dried hops cones,
and the food additive tolerance will be revoked.
New Tolerances Needed Under 40 CFR §186.253 (a):
Sufficient data are available to determine appropriate tolerances for aspirated grain
fractions (grain dust), the citrus fruits crop group, dried citrus pulp, cowpea forage, eggplant,
dried hops cones, and sugar beet tops. Grain dust data generated using treated wheat and
sorghum indicate that a 25 ppm tolerance is needed for methomyl residues in/on aspirated
grain fractions. The available residue data support methomyl tolerances of 1 ppm in/on citrus
fruits, 10 ppm in/on cowpea forage, 0.2 ppm in/on eggplants, 10 ppm in/on dried hops cones,
and 2 ppm in/on sugar beet tops.
Before tolerances can be established on cowpea hay, bulb onions, pea seeds, field pea
seeds and hay, root and tuber vegetables, sorghum stover and hay, and soybean hay, storage
stability data are required to support the available residue data.
Provided the registrant submits acceptable storage stability data, the available residue
data also support methomyl tolerances of 0.2 ppm on the root and tuber vegetables crop
group, 0.2 ppm in/on onion bulbs, 0.2 ppm in/on pea seeds and field pea seeds, 2 ppm in/on
field pea hay, 10 ppm in/on cowpea hay, 0.2 ppm in/on soybean hay, 4 ppm in/on sorghum
stover, and 1 ppm in/on sorghum hay.
Tolerances are required for methomyl residues in/on chicory tops, radish tops, and
cotton gin byproducts. Appropriate tolerances will be determined once residue data are
submitted.
The following table provides a tolerance reassessment summary for methomyl.
105
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Table 50 - Tolerance Reassessment Summary for Methomyl.
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR §180.253 (a):
Alfalfa
Apples
Asparagus
Avocados
Barley, forage
Barley, grain
Barley, hay
Barley, straw
Beans, dry
Beans, forage
Beans, succulent
Beets, tops
Blueberries
Brassica (cole) leafy
vegetables
Broccoli
Brussels sprouts
Cabbage
Cabbage, Chinese
Cauliflower
Celery
Citrus Fruits Crop Group
Collards
Corn, fodder
Corn, forage
Corn, fresh (inc. sweet)
(K+CWHR)
Corn, grain (inc. pop)
Cottonseed
Cucurbits
Dandelions
Endive (escarole)
10
1
2
2
10
1
10
10
0.1 (N)
10
2
6
6
6
3
2
5
5
2
3
None
6
10
10
0.1 (N)
0.1 (N)
0.1 (N)
0.2 (N)
6
5
10
1
2
2
Revoke
1
10
10
0.1 a
Revoke
2
6
6
Revoke
o
J
2
5
5
2
o
3
1
6
10
10
0.1
0.1
0.1
0.2
6
5
Separate tolerances each at 10 ppm
should be established for alfalfa,
forage and alfalfa, hay.
Apple
Avocado
No longer considered to be a
significant feed item.
Storage stability data are required to
support the reassessed tolerance.
Bean, seed
No longer a regulated feed item.
Bean, succulent
Beets, tops (leaves)
Blueberry
Individual tolerances ranging from
2 to 6 ppm have been established for
brassica vegetables with registered
uses.
The available data support a 1 ppm
tolerance for the Citrus Fruits Crop
Group
Com, sweet (K+CWHR)
Corn, grain
Cotton, seed, undelinted
Cucurbit Vegetables Crop Group
106
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Table 50 (continued).
Commodity
Grapefruit
Grapes
Grasses, Bermuda
Grasses, Bermuda, hay (dry,
dehydrated)
Kale
Leeks
Lemons
Lentils
Lettuce
Mint, hay
Mustard, greens
Nectarines
Oats, forage
Oats, grain
Oats, hay
Oats, straw
Onion, green
Oranges
Parsley
Peaches
Current Tolerance
(ppm)
2
5
10
40
6
3
2
0.1
5
2
6
5
10
1
10
10
3
2
6
5
Tolerance
Reassessment (ppm)
Revoke
5
TBDb
40
6
Revoke
Revoke
0.2 a
5
2
6
Revoke
10
1
10
10
3
Revoke
6
5
Comment/Correct Commodity
Definition
Tolerance should be revoked once a
1 ppm tolerance is established for
the Citrus Fruits Crop Group.
Grape
Additional data are required. Grass,
Bermuda, forage
Grass, Bermuda, hay
In accordance with 40 CFR
§180.1 (h), residues in/on leeks are
covered by the tolerance on green
onions.
Tolerance should be revoked once a
1 ppm tolerance is established for
the Citrus Fruits Crop Group.
Once supporting storage stability
data are provided for dried legume
seeds, data on dry pea seed, which
will be translated to support the use
on lentils. These data indicate that
the tolerance should be increased to
0.2 ppm. Lentil, seed.
Separate tolerances each at 2 ppm
should be established for
peppermint, tops and spearmint,
tops.
In accordance with 40 CFR
§180.1 (h), residues in/on nectarines
are covered by the tolerance on
peaches.
Tolerance should be revoked once a
1 ppm tolerance is established for
the Citrus Fruits Crop Group.
Peach
107
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Table 50 (continued).
Commodity
Peanuts
Peanuts, hulls
Peas
Peas, vines
Pecans
Peppers
Pomegranates
Rye, forage
Rye, grain
Rye, hay
Rye, straw
Sorghum, forage
Sorghum, grain
Soybeans
Soybean, forage
Spinach
Strawberries
Swiss chard
Tangerines
Tomatoes
Turnips, greens, tops
Vegetables, fruiting
Current Tolerance
(ppm)
0.1 (N)
0.1 (N)
5
10
0.1
2
0.2 (N)
10
1
10
10
1
0.2 (N)
0.2 (N)
10
6
2
6
2
1
6
0.2 (N)
Tolerance
Reassessment (ppm)
0.1
Revoke
5
10
0.1
2
0.2
10
1
Revoke
10
TBD
0.2
0.2
10
6
2
6
Revoke
1
TBD
Revoke
Comment/Correct Commodity
Definition
Peanut, nutmeat
No longer a regulated feed item.
Pea, succulent
Vines of pea cultivars used for
human food are no longer
considered to be a significant feed
item; only vines of field pea
cultivars grown for livestock feeding
are regulated. The current tolerance
should be changed to Pea, field,
vines.
Pecan
Pepper, bell and non-bell
No longer considered to be a
significant feed item.
A label amendment or additional
data are required.
Soybean, seed
Strawberry
Tolerance should be revoked once a
1 ppm tolerance is established for
the Citrus fruits Crop Group.
Tomato
Additional data are required unless
the registrnat removes turnip
greens, tops from the federal labels.
Tolerance should be revoked once a
0.2 ppm tolerance is established for
Eggplants. Separate tolerances are
already established on tomatoes and
peppers.
108
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Table 50 (continued).
Commodity
Vegetables, leafy (exc.
beets(tops), broccoli,
Brussels sprouts, cabbage,
cauliflower, celery, Chinese
cabbage, collards,
dandelions, endive
(escarole), kale, lettuce,
mustard greens, parsley,
spinach, Swiss chard, turnip
greens (tops), and
watercress)
Vegetables, root crop
Watercress
Wheat, forage
Wheat, grain
Wheat, hay
Wheat, straw
Current Tolerance
(ppm)
0.2 (N)
0.2 (N)
6
10
1
10
10
Tolerance
Reassessment (ppm)
Revoke
Revoke
Revoke
10
1
10
10
Comment/Correct Commodity
Definition
The outdated tolerance for leafy
vegetables should be revoked
because separate tolerances have
been established for leafy vegetables
commodities with registered uses.
The outdated tolerance for root crop
vegetables should be revoked once a
tolerance is established for the Root
and Tuber Vegetables Crop Group
There are no registered uses on
watercress.
Tolerances with A Regional Registration listed under 40 CFR §180.253 (b):
Pears
4
4
Pear
Food Additive Tolerances listed under 40 CFR §185.4100 :
Hops, dried
12
Revoke
In accordance with PR Notice 93-12
(12/93), dried hops are now
regulated as a RAC. A section 408
tolerance should be established on
Hops cones, dried.
Tolerances needed under 40 CFR §186.253 (a):
Aspirated grain fractions
Chicory, tops (leaves)
Citrus, pulp, dried
Cotton gin byproducts
None
None
None
None
25
TBD
2
TBD
The available data indicate that a 25
ppm tolerance should be proposed
for Aspirated grain fractions.
Additional data are required.
The available data indicate that the
registrant should propose a 2 ppm
tolerance for Citrus pulp, dried.
Data are required.
109
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Table 50 (continued).
Commodity
Cowpea, forage
Cowpea, hay
Eggplant
Onions, bulb
Pea, seed
Pea, field, hay
Pea, field, seed
Hops cones, dried
Radish, tops (leaves)
Root and Tuber Vegetables
Crop Group
Sorghum, stover
Sorghum, hay
Current Tolerance
(ppm)
None
None
0.2 c
0.2 d
None
None
None
None
None
None
None
None
Tolerance
Reassessment (ppm)
10
10 a
0.2
0.2 a
0.2 a
2a
0.2 a
10
TBD
0.2 a
4a
1 a
Comment/Correct Commodity
Definition
Cowpea is the only bean foliage
crop the Agency considers to be a
significant livestock feed item.
The available bean forage and hay
data support equivalent tolerances
on cowpea forage and hay.
Tolerances should be proposed for
Cowpea, forage and Cowpea, hay.
The registrant should propose a 0.2
ppm tolerance for Eggplant.
Once acceptable storage stability
data are available, the registrant
should propose a 0.2 ppm for
Onions, bulb.
Once acceptable storage stability
data are available, the available data
support the proposed tolerances.
Once acceptable storage stability
data are available, the registrant
should propose tolerances for Pea,
field, seed and Pea, field, hay,
which are supported by the available
dry pea data.
As per PR Notice 93-12 (12/93), a
section 408 RAC tolerance should
be established for Hops cones,
dried. In addition, a review of the
available residue data indicate that
the import tolerance can be lowered
to 10 ppm to achieve compatibility
with the Codex MRL.
Data are required.
Once supporting storage stability
data are available for potato,
adequate data will be available to
support a crop group tolerance for
the Root and Tuber Vegetables Crop
Group
Storage stability data are required to
support the proposed tolerances.
110
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Table 50 (continued).
Commodity
Soybean, hay
Sugar beet, tops
Current Tolerance
(ppm)
None
0.2 e
Tolerance
Reassessment (ppm)
0.2 a
2
Comment/Correct Commodity
Definition
Based upon the proposed 12-day
PHI, the available residue data
support a 0.2 ppm tolerance. Once
supporting storage stability data are
available the registrant should
propose a revised tolerance on
Soybean, hay.
The available data indicate that the
tolerance should be increased to
2 ppm. Beets, sugar, tops (leaves) .
a Reassessed tolerance is tentative pending submission of supporting storage stability data.
b TBD = To be determined. Tolerance cannot be determined at this time because additional data are required.
0 Tolerance as part of the outdated fruiting vegetables crop group.
d Tolerance as part of the outdated root crop vegetables group.
e Tolerance as part of the outdated leafy vegetables crop group.
Codex Harmonization
The Codex Alimentarius Commission has established maximum residue limits (MRLs) for
methomyl residues in/on various plant and animal commodities (see Guide to Codex Maximum Limits
For Pesticide Residues, Part A.I, 1995). Codex has combined MRLs for thiodicarb and methomyl into
a single listing. Codex MRLs and U.S. tolerances are not presently compatible because the U.S.
tolerance expression currently includes only methomyl, whereas the Codex MRL residue definition
includes methomyl and methomyl oxime (methyl hydroxythioacetimidate).
A comparison of the Codex MRLs and the corresponding U.S. tolerances is presented in
Table 51.
The following conclusions can be made regarding efforts to harmonize the U.S. tolerances
with the Codex MRLs:
" If the Codex MRL residue definition for methomyl is amended to include only
methomyl, U.S. tolerances and Codex MRLs would be compatible for the following
crops/commodities: alfalfa, asparagus, beans (dry and succulent), cabbage, cauliflower,
citrus fruits, cucumbers, eggplants, grapes, hops, lettuce (head), melons, mint hay,
onions (bulb), pea vines, peaches/nectarines, peanuts, peas (succulent), sorghum,
soybeans, soybean forage, summer squashes, tomatoes, and watermelons. In addition,
the MRL and tolerance for sorghum forage would be compatible if the registrant
chooses to restrict the U.S. use to only grain sorghum.
" Based upon the use patterns registered in the U.S. and the available residue data,
compatibility of U.S. tolerances and Codex MRLs is not possible for the following
111
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crops/commodities: celery, cottonseeds, kale, maize (field corn), oats, welsh onion,
peppers, pome fruits, potato, spinach, sugar beet, sweet corn, and wheat.
Table 51 - Codex MRLs for methomyl and applicable U.S. tolerances.
Codex
Commodity
(As Defined)
Alfalfa forage (green)
Asparagus
Barley
Barley straw and
fodder, dry
Beans (dry)
Cabbages, head
Cauliflower
Celery
Citrus fruits
Common bean (pods
and/or immature seeds)
Cotton seed a
Cucumber
Egg plant
Grapes
Hops, dry
Kale
Lettuce, head
Maize a
Maize fodder a
Maize forage a
Meat (from mammals
other than marine
mammals)
MRL
(mg/kg)
10
2
0.5
5
0.1
5
2
2
1
2
0.5
0.2
0.2
5
10
5
5
0.05 * b
50
fresh wt.
50
fresh wt.
0.02*
Step
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
Reassessed U.S.
Tolerance (ppm)
10
2
1
10
0.1
5
2
3
1
2
0.1
0.2
0.2
5
10
6
5
0.1
10
10
None
Recommendation and Comments
U.S. residue data indicate that higher
tolerances are required.
U.S. residue data indicate that the higher
tolerance is required.
U.S. residue data indicate that a lower
tolerance is acceptable.
Covered by U.S. tolerance for the Cucurbit
Vegetables Crop Group.
U.S. residue data indicate that the higher
tolerance is required.
U.S. residue data indicate that the higher
tolerance is required.
U.S. residue data indicate that a lower
tolerance is acceptable.
The Agency has determined that residues in
meat represent a 40 CFR §180.6(a)(3)
situation; therefore U.S. tolerances are not
required.
112
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Table 51 (continued).
Codex
Commodity
(As Defined)
Melons, except
watermelon
Milks
Mint hay
Nectarine
Oat straw and fodder,
dry
Oats
Onion, bulb
Onion, Welsh
Pea vines (green)
Peach
Peanut
Peanut forage (green)
Peas (pods and
succulent=immature
seeds)
Peas, shelled
(succulent)
Peppers
Pineapple
Pome fruits
Potato
Sorghum
MRL
(mg/kg)
0.2
0.02*
2
5
5
0.5
0.2
0.5
10
5
0.1
5
5
0.5
1
0.2
2
0.1
0.2
Step
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
Reassessed U.S.
Tolerance (ppm)
0.2
None
2
None
10
1
0.2
o
5
10
5
0.1
None
5
2
None
None
0.2
0.2
Recommendation and Comments
Covered by U.S. tolerance for the Cucurbit
Vegetables Crop Group
The Agency has determined that residues in
milk represent a 40 CFR §180.6(a)(3)
situation; therefore a U.S. tolerance is not
required.
Covered by 5.0 ppm U.S. tolerance on
peaches.
U.S. residue data indicate that the higher
tolerance is required.
U.S. residue data indicate that the higher
tolerance is required.
Covered by U.S. tolerance for green onions;
U.S. residue data indicate that a higher
tolerance is required.
U.S. label directions prohibit feeding of
treated peanut vines to livestock.
Succulent podded and shelled peas are covered
by a single U.S. tolerance.
U.S. residue data indicate that a higher
tolerance is required.
Not registered for this use in the U.S.
Separate U.S. tolerances have been established
for apples at 1.0 ppm and pears at 4.0 ppm
Cover by U.S. tolerance for the Root and
Tuber Vegetables Crop Group; U.S. residue
data indicate that a higher tolerance is
required.
113
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Table 51 (continued).
Codex
Commodity
(As Defined)
Sorghum forage (green)
Soya bean (dry) a
Soya bean (immature
bean)
Soya bean forage
(green)
Spinach
Squash, summer
Sugar beet
Sweet corn (corn-on-
the-cob) a
Tomato a
Watermelon
Wheat
Wheat straw and
fodder, dry
MRL
(rag/kg)
1
0.2
0.1
10
5
0.2
0.1
2
1
0.2
0.5
5
Step
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
Reassessed U.S.
Tolerance (ppm)
TBDC
0.2
10
6
0.2
0.2
0.1
1
0.2
1
10
Recommendation and Comments
Additional residue data are required to support
the U.S. tolerance, or the current 1.0 ppm
tolerance could be compatible if the registrant
restricts the use to only grain sorghum.
U.S. tolerance for soybeans does not
distinguish between immature and mature
seeds.
U.S. residue data indicate that a higher
tolerance is required.
Covered by U.S. tolerance for the Cucurbit
Vegetables Crop Group.
Covered by U.S. tolerance for the Root and
Tuber Vegetables Crop Group; U.S. residue
data indicate that a higher tolerance is
required.
U.S. residue data indicate that a lower
tolerance is acceptable.
Covered by U.S. tolerance for the Cucurbit
Vegetables Crop Group
U.S. residue data indicate that a higher
tolerance is required.
a MRL is based upon thiodicarb use.
b An asterisk (*) signifies that the MRL was established at or about the limit of detection.
0 To be determined; additional residue data are required.
3. Summary of Risk Management Decisions
Human Health
The Agency concludes that there are no acute dietary concerns associated with
potential residues of methomyl from application of thiodicarb and methomyl in food. Based
on Monte Carlo analysis with the level of concern being an MOE of 300, sufficient margins
of exposure exist [U.S. population (MOE=912), children 1 to 6 years of age (MOE=417) and
114
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infants (MOE=756)] at the high-end percentile exposure level of interest (99.9th percentile
value).
Results of the chronic exposure analysis show that no single subpopulation exceeded
7% of the RfD. For the subpopulations, non-nursing infants (<1 year old) and children (ages
1- 6 years old), 6.5% and 2.7% of the RfD is occupied, respectively. For the general U.S.
population, only 1.9% of the RfD was occupied.
Estimated concentrations of methomyl in surface and ground water are less than the
Agency's levels of concern for methomyl in drinking water as a contribution to acute and
chronic aggregate exposure. Therefore, the Agency concludes that aggregate exposure to all
sources of methomyl does not exceed the Agency's risk concerns.
To minimize the risks of potential systemic toxicity to mixers/loaders the Agency is
requiring the use of personal protective equipment and/or the use of engineering controls
(water soluble bags).
Environmental Fate and Effects
Laboratory studies indicate that methomyl is moderately persistent and highly mobile.
It is stable to hydrolysis at lower pH's (neutral to acidic) and degrades slowly in alkaline
conditions. Methomyl photolyzes quickly in water but more slowly in soils. It is moderately
stable to aerobic soil metabolism but degrades more rapidly under anaerobic conditions. In
laboratory studies, methomyl does not readily adsorb to soil and has the potential to be very
mobile. Field studies show varying dissipation rates of the chemical in soils. Dissipation
rates were related primarily to differences in soil moisture content, which may affect the
microbial activity, and rainfall/irrigation, which could influence leaching.
Methomyl has been detected in ground water in a prospective ground water monitoring
study and in other reported incidences. While it may reach ground water under certain
conditions, methomyl will not likely persist under many conditions. Methomyl can
contaminate surface water as a result of spray drift during application or by runoff from
treated sites. Methomyl would not be expected to persist in clear, shallow waters because of
its susceptibility to photolysis.
The major concerns for non-target organisms are the chronic risks posed by the use of
methomyl to non-target mammalian and freshwater invertebrate organisms. Risks to aquatic
invertebrates from exposure to methomyl are likely to occur wherever methomyl is used.
Accumulation of methomyl from repeated applications contributes to the chronic risks.
4. Ecological Risk Mitigation for Methomyl
To lessen ecological and potential water risks posed by methomyl, EPA is requiring the
following mitigation from registrants of methomyl containing products.
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1) The registrant will revise end use product labels to reduce the maximum seasonal use
rates as noted in the table below;
Table 52 Revised Maximum Seasonal Use Rates
Crop
Broccoli
Cabbage
Cauliflower
Celery
Chinese cabbage
Corn, sweet
Lettuce, head
Tomato
From Present Season Rate
(Ibai)
7.2
9.0
9.0
9.0
8.1
7.2
9.0
7.2
To New Season Rate
(Ibai)
6.3
7.2
7.2
7.2
7.2
6.3
7.2
6.3
Percent
Decrease
12.5
20
20
20
11.1
12.5
20
12.5
These measures will result in less loading of methomyl in the environment.
2) The registrant will reduce the single maximum per acre application rate of methomyl by
50% from 1.8 pounds to 0.9 pounds on peaches and commercial sod farms. No
methomyl crop use will exceed a single application rate of 0.9 pounds of methomyl per
acre.
3) The following statement supporting the use of an Integrated Pest Management (IPM)
plan must be added to the labels.
"This product should be used as part of an Integrated Pest Management (IPM)
program which can include biological, cultural, and genetic practices aimed at
preventing economic pest damage. Application of this product should be based on
IPM principles and practices including field scouting or other detection methods,
correct target pest identification, population monitoring and treating when target pest
populations reach locally determined action thresholds. Consult your state cooperative
extension service, professional consultant or other qualified authorities to determine
appropriate action threshold levels for treating specific pest/crop systems in your area."
4) Based on the environmental risk assessment for methomyl, the following advisories are
required to be on the label for methomyl: a labeling statement for potential ground
water contamination, a labeling statement to minimize the potential for surface water
contamination and labeling statements are required on manufacturing use products and
end use products based on the toxicity to nontarget organisms. A bee hazard statement
is also required.
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5) The following spray drift label requirement for products with aerial applications is
required to be on the label for methomyl: "Do not apply by ground equipment within
25 feet, or by air within 100 feet of lakes, reservoirs, rivers, estuaries, commercial fish
ponds and natural, permanent streams, marshes or natural, permanent ponds. Increase
the buffer zone to 450 feet from the above aquatic areas when ultra low volume
application is made."
5. Restricted Use Classification
Based on its acute toxicity and use patterns, the Agency is maintaining Restricted Use
classification for all methomyl products that are currently so classified.
6. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures to address the adverse impacts.
The program would require use restrictions to protect endangered and threatened species at
the county level. Consultations with the Fish and Wildlife Service may be necessary to assess
risks to newly listed species or from proposed new uses. In the future, the Agency plans to
publish a description of the Endangered Species Program in the Federal Register and have
available voluntary county-specific bulletins. Because the Agency is taking this approach for
protecting endangered and threatened species, it is not imposing label modifications at this
time through the RED. Rather, any requirements for product use modifications will occur in
the future under the Endangered Species Protection Program.
7. Labeling Rationale
At this time, all products containing methomyl are intended primarily for occupational
use (e.g. mixed, loaded, and applied by occupational applicators only; generally not available
to homeowners). No registered use is likely to involve applications at residential sites.
The Worker Protection Standard (WPS)
The Agency has issued the Worker Protection Standard for Agricultural Pesticides
(WPS) affecting all pesticide products whose labeling reasonably permits use in the
commercial or research production of agricultural plants on any farm, forest, nursery, or
greenhouse. In general, WPS products had to bear WPS-complying labeling when sold or
distributed after April 21, 1994. The WPS labeling requirements pertaining to personal
protective equipment (PPE), restricted entry intervals (REI), and notification were interim.
These requirements are to be reviewed and revised, as appropriate, during reregi strati on and
other Agency review processes.
At this time some of the registered uses of methomyl are within the scope of the WPS
and some uses are outside the WPS scope.
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Requirements for Handlers
For each end-use product, personal protective equipment and engineering control
requirements for pesticide handlers are set during reregi strati on as follows:
! Based on risks posed to handlers by the active ingredient, EPA may establish active-
ingredient-specific ("a.i. specific") handler requirements for end-use products
containing that active ingredient. If the risks to handlers posed by the active ingredient
are minimal, EPA may establish no a.i. specific handler requirements.
! Based on the acute toxicity characteristics of the end-use product, EPA usually
establishes handler PPE requirements for each end-use product.
! If a.i. specific requirements have been established, they must be compared to the end-
use-product-specific PPE and the more stringent choice for each type of PPE (i.e.,
bodywear, hand protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product. Engineering controls are more stringent than PPE requirements.
Occupational-Use Products
EPA is establishing a.i. specific requirements for some occupational handlers of
methomyl. In determining the a.i. specific requirements for handlers of methomyl, the
Agency considered the exposure and risk assessment for occupational handlers and the
available epidemiological information about methomyl.
The MOE's for combined dermal and inhalation exposure were less than 100 for some
occupational mixers and loaders handling wettable powder and liquid formulations. The
MOEs were greater than 100 for persons mixing and loading wettable powder to support
aerial applications only when engineering controls (i.e., water soluble packaging) are
employed for the 1.8 Ib a.i./A. However, the registrant has agreed to reduce this rate to 0.9
Ib a.i./A for the remaining uses of peaches and commercial sod farms. No methomyl crop use
will exceed a single application rate of 0.9 Ib a.i./A. At the 0.45 Ib a.i./A rate, double
layering of clothing, and chemical resistent gloves are required. At the 0.9 Ib a.i./A rate,
double layering of clothing, chemical resistant gloves and a respirator are required.
However, if water soluble packaging is used for the 0.45 and 0.9 Ib a.i./A rates for wettable
powders then only a single layer of clothing (long-sleeved shirt, long pants, and shoes plus
socks) is required. The MOEs are greater than 100 for (1) handlers mixing/loading wettable
powder formulations to support ground applications and (2) handlers mixing/loading liquid
formulations to support aerial, chemigation, and ground applications only when personal
protective equipment (i.e., chemical-resistant gloves) is worn. Due to lack of data for
baseline scenarios, MOEs are greater than 100 for applications of baits by hand only when
chemical resistent gloves are worn. The Agency is requiring active-ingredient-based
protection for handlers of methomyl in this exposure situation.
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In 1993 EPA issued a Data Call-In for Poison Control Center Data for 28
organophosphate and carbamate insecticides and identified methomyl as one of five
candidates for immediate action under the Acute Worker Risk Strategy. Use of methomyl
products in California from 1982 - 1989 resulted in the second highest total number of
agricultural worker poisoning incidents, and the highest number of agricultural related
hospitalizations of all the chemicals reviewed.
In 1995, the Agency met with the registrants of methomyl and mitigation measures
were adopted to reduce incidents for the fly bait formulations. For the fly bait products the
use was limited to commercial agriculture production where children would not be present.
The bait stations are required to be placed four feet above the ground. Also, an embittering
agent is required to be added to all fly bait stations and the color of the formulations are
limited to earth-tones or other dark unattractive colors.
In 1996, the Agency and the registrants of methomyl adopted measures to reduce
handler poisoning incidents. These measures included (1) the use of only mechanical ground
or aerial application equipment when applying methomyl to crops, and (2) the use of
chemical resistant apron and footwear for cleaners and repairers of equipment. In addition,
wettable powder formulations must be formulated in water soluble packaging that has a
pictogram depicting that the bags should not be cut, ripped, or torn.
As each set of mitigation measures were put into effect the number of handler incidents
from the use of methomyl has been decreasing. Therefore, EPA has determined to retain the
risk reduction measures already in place. In addition, based on the exposure and risk
assessment and concerns about handler incidents, EPA is imposing additional personal
protective equipment requirements as identified in Section V, Actions Required by
Registrants, Table 53, Summary of Required Label Changes for Methomyl Products.
There are no data that can be used to assess the risk associated with the use of dust
formulations. Therefore, a maximum level of PPE is required until appropriate exposure data
are developed for risk assessment and the assessment justifies removal of PPE. Mixers and
loaders are required to wear long-sleeve shirt, long pants, chemical resistant apron, chemical
resistant gloves, chemical resistant footwear plus socks, and a respirator. Applicators are
required to wear coveralls over long-sleeve shirt, long pants, chemical resistant gloves,
chemical resistant footwear plus socks, chemical resistant headgear for overhead exposure,
and a respirator.
There are no data that can be used to assess the risk associated with flagging for aerial
bait applications. Therefore, the PPE requirements are the same as those for flagging for
aerial spray applications and consist of long-sleeve shirt, long pants, and shoes plus socks.
There are no data that can be used to assess the risk associated with mixing pelleted
baits or pastes for paint brush applications. Therefore, the minimum PPE requirements are
long-sleeve shirt, long pants, chemical resistant apron, chemical resistant gloves and a
respirator.
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For applicators using fixed- and rotary-wing aircraft to apply methomyl, the risks are
acceptable (i.e., ranging from 1900 to 18,000) when enclosed cockpits are assumed. Since
the Pesticide Handlers Exposure Database does not contain sufficient data to estimate
exposure to applicators using aircraft with open cockpits, only exposure for aerial applicators
using engineering controls, (i.e., enclosed cockpits) was estimated. However, an enclosed
cockpit is not required for methomyl if estimated MOEs for enclosed cockpit exposure are an
order of magnitude larger than the uncertainty factor (i.e., the acceptable MOE). For
methomyl, an occupational MOE of 100 or higher is required to be above the Agency's level
of concern. The enclosed cockpit MOEs range from 1900 up to 18000. Therefore, the
Agency does not have concerns for handlers who may apply methomyl using aircraft with
open cockpits.
WPS and NonWPS Uses:
Since potential handler exposure is similar for WPS and nonWPS uses, the a.i. specific
handler requirements (specified in Section V) are the same for WPS and nonWPS
occupational uses of methomyl end-use products.
Post-Application/Entry Restrictions
Occupational-Use Products (WPS Uses)
Restricted-Entry Intervals, Early-Entry PPE, and "Double" Notification:
The interim Worker Protection Standard (WPS) restricted-entry intervals (REIs) for
agricultural workers are based solely on the acute dermal toxicity and skin and eye irritation
potential of the active ingredient. In addition, the WPS retains two types of REI's established
by the Agency prior to the promulgation of the WPS: (1) product-specific REI's established
on the basis of adequate data, and (2) interim REI's that are longer than those that would be
established under the WPS. The WPS prohibits routine entry to perform hand labor tasks
during the REI and requires PPE to be worn for other early-entry tasks that require contact
with treated surfaces. "Double" notification is the statement on the labels of some WPS
pesticide products requiring employers to notify workers about pesticide-treated areas orally
as well as by posting of the treated areas. The interim WPS "double" notification
requirement was imposed if the active ingredient is classified as toxicity category I for acute
dermal toxicity or skin irritation potential.
During the reregi strati on process, EPA establishes REIs, early-entry PPE, and double
notification requirements based on consideration of all available relevant information about
the active ingredient, including acute toxicity, other adverse effects, epidemiological
information, and post-application data.
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In determining the post-application requirements for methomyl, EPA considered the
exposure and risk assessment for post-application workers and the available post-application
epidemiological information about methomyl.
Estimates of postapplication exposure and risk indicate that for certain crops,
restricted-entry intervals (REIs) based on the short and intermediate term dermal
toxicological endpoint are necessary. MOEs for grape girdlers do not reach 100 until the
third day after application, requiring at least a 3-day REI. Estimates of dermal exposure and
risk for peach and commercial sod harvesters indicate that MOEs exceed 100 on the second
day after application, requiring at least a 48 hour REI. For other crops and sites, estimates of
dermal exposure and risk indicate that MOEs exceed 100 on the day of application after
sprays have dried (i.e., 12 hours following application). However, since methomyl is in acute
toxicity category 1 for primary eye irritation, a 48 hour REI is required.
Based on the epidemiological information analyzed for the Acute Worker Risk Strategy
and on previous post-application risk assessments of methomyl, the Agency has established
crop-specific restricted-entry intervals for methomyl for the following crops: apple, cotton,
grapefruit, lemon, nectarine, oranges, tangelo, tangerine (3 days), peaches (4 days), grapes (7
days). The Agency has determined that these crop-specific REIs should be retained.
For early entry into treated areas (i.e., during the REI) that is permitted under the
Worker Protection Standard and that involves contact with anything that has been treated,
early-entry workers should wear the clothing and PPE consistent with the toxicity of the
active ingredient and with the incidents associated with post-application exposures. The
Agency has determined that the appropriate early-entry attire for dermal protection is
coveralls, shoes plus socks, and chemical-resistant gloves. In addition, protective eyewear
must be worn, since methomyl is classified as category I for eye irritation potential.
Since the restricted-entry interval for grapes is 7 days, the Agency is requiring double
notification for uses of methomyl on grapes.
Occupational-Use Products (NonWPS Uses)
At this time, EPA is not establishing entry restrictions of a specific length for nonWPS
occupational uses of methomyl end-use products, since the anticipated frequency, duration,
and degree of exposure following nonWPS occupational applications do not warrant special
risk mitigation measures. However, EPA will prohibit entry into treated areas (such as
rights-of-way, hedgerows, fencerows, and drainage areas) until sprays have dried, due to
concerns about dermal and inhalation exposures immediately after application and as a
prudent safety practice.
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Other Labeling Requirements
The Agency is also requiring other use and safety information to be placed on the
labeling of all end-use products containing methomyl. For the specific labeling statements,
refer to Section V. of this document.
8. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices
and State Lead Agencies for pesticide regulation to develop the best spray drift management
practices. The Agency is now requiring interim measures that must be placed on product
labels/labeling as specified in Section V. Once the Agency completes its evaluation of the
new data base submitted by the Spray Drift Task Force, a membership of U.S. pesticide
registrants, the Agency may impose further refinements in spray drift management practices
to further reduce off-target drift and risks associated with this drift.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration of
both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of methomyl for the above
eligible uses has been reviewed and determined to be substantially complete. The
following studies are required for methomyl.
81-8 Acute neurotoxicity - rat
82-7 Subchronic neurotoxicity - rat
72-4(a) Estuarine/marine fish early life stage test
72-4(b) Estuarine/marine invertebrate life-cycle test
830.7050 UV/visible absorption spectrum
860.1380 Storage Stability Data (formerly 171-4e)
860.1500 Magnitude of the Residue in Crop Plants (formerly 171-4k)
860.1850 Confined Accumulation in Rotational Crop (formerly 165-1)
Additional Residue Chemistry Data
For those crops with reduced application rates, new residue data must be submitted in
support of lower tolerances. The Agency is willing to discuss ways to reduce the number of
field trials necessary to support appropriate tolerances.
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Additional storage stability data are required to depict the stability of methomyl
residues in frozen storage in/on dry beans and peas, bean and pea hay, onions (dry bulb),
potatoes, soybean hay, and sorghum fodder (stover) and hay.
Additional residue data and/or label amendments are required on chicory tops, radishes,
turnips (greens), sorghum forage, bermudagrass forage, and cotton gin byproducts.
For chicory tops, data are required from a single test in Region 2 depicting methomyl
residues in/on chicory leaves following multiple applications at the maximum labeled rate.
Leaves should be harvested at the proposed 30-day PHI. Based upon the residue data, the
registrant should propose an appropriate tolerance for chicory tops (leaves) and amend labels
to include a 30-day PHI for chicory leaves.
For radishes, data are required depicting methomyl residues in/on tops (leaves)
harvested 3 days following the last of two foliar applications of methomyl each at 0.9 Ib ai/A.
These data are required to support SLN No. CA770495. As per OPPTS Guideline
860.1500, the registrant can conduct three tests for radish at Ix the maximum rate at three
separate sites in CA (two samples per test), or Ix and 2x tests for radish at two separate sites
in CA (one sample per test). Alternatively, the registrant may elect to cancel this use on
radishes. Residue data from carrots can be translated to cover radish roots.
Turnip greens appear on the current labels under the crop grouping Leafy Green
Vegetables. The registrant must remove turnip greens from the labels. If the registrant
wishes to keep turnip greens on the labels then they would be required to do so under the
new crop grouping Leaves of Root and Tuber Vegetables. In that case the registrant is
required to generate data depicting residues of methomyl in/on turnip tops (leaves) as per
whatever the established maximum application and minimum PHI for turnip greens on the
labels would be. The registrant cannot translate data from existing data on leafy green
vegetables to turnip greens. Turnip greens (tops) are no longer included in the new crop
group for Leafy Green Vegetables (Crop Group 4). Turnip tops are considered a
representative commodity under the crop grouping for Leaves of Root and Tuber Vegetables
(Crop Group 2). If the registrant wishes to keep turnip tops on the labels, they must submit
the required residue data, and then along with existing data on sugar beet tops, they could
propose a crop group tolerance for Leaves of Root and Tuber Vegetables (Crop Group 2).
In accordance with current Agency guidance (Residue Chemistry Test Guidelines,
OPPTS 860 series), zero-day residue data are required on grass forages. Therefore, zero-day
residue data are required on bermudagrass forage. Data are required depicting methomyl
residues in/on bermudagrass forage harvested the same day as an application at 0.9 Ib ai/A.
A total of 12 trials are required in regions of the country in which bermudagrass is grown for
forage. Grass forages include forage sorghums. Therefore, data are required on methomyl
residues in/on sorghum forage harvested the same day as the last of two applications of
methomyl each at 0.45 Ib ai/A (for a total seasonal application of 0.9 Ib ai/A). Residue data
from the bermuda grass trials can be translated to support the sorgum forage uses.
Alternatively, the registrant may amend their labels to restrict the use of methomyl to only
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grain sorghum, in which case the available sorghum forage data (14-day PHI) are adequate.
In addition, if the use is restricted to grain sorghum, then no tolerance would be required for
sorghum hay.
Data are required depicting methomyl residues in/on cotton gin byproducts ginned
from cotton harvested 15 days after the last of multiple foliar applications of methomyl at the
maximum labeled rate and totaling 1.8 Ib ai/A/season. The cotton must be harvested by
commercial equipment (stripper and mechanical picker) to provide an adequate
representation of plant residue from the ginning process. At least three field trials for each
type of harvesting (stripper and picker) are needed, for a total of six trials.
2. Labeling Requirements for Manufacturing-Use Products and End-Use
Products
To remain in complaince with FIFRA, manufacturing use product (MUP) and end
use product (EUP) labeling must be revised to comply with all current EPA
regulations, PR Notices and applicable policies as noted in the following table.
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Table 53 Summary of Required Labeling Changes for Methomyl Products
Description
Required Labeling
Placement
Manufacturing Use Products
One of these statements may be added to allow
reformulation of the product for a specific use
or all additional uses supported by a
formulator or user group
Environmental Hazards Statement
"Only for formulation into an [fill blank with Insecticide, Herbicide or the applicable term
which describes the type of pesticide use(s)] for the following use(s) [fill blank only with those
uses that are being supported by the MP registrant]."
"This product may be used to formulate product for specific use(s) not listed on the MP label if
the formulator, user group, or grower has complied with the U.S. EPA submission
requirements regarding support of such use(s)."
"This product may be used to formulate product for any additional use(s) not listed on the MP
label if the formulator, user group, or grower has complied with the U.S. EPA submission
requirements regarding support of such use(s)."
"This pesticide is toxic to fish, aquatic invertebrates, and mammals. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans or other waters unless in
accordance with the requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing prior to discharge.
Do not discharge effluent containing this product to sewer systems without previously notifying
the local sewage treatment plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."
Directions for Use
Precautionary Statements
Environmental Hazards
End Use Products Intended for Occupational Use (WPS and non-WPS)
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Table 53 Summary of Required Labeling Changes for Methomyl Products
Worker Protection Requirements for Products
Subject to WPS
Any product whose labeling reasonably permits use in the production of an agricultural plant
on any farm, forest, nursery, or greenhouse must comply with the labeling requirements of PR
Notice 93-7, "Labeling Revisions Required by the Worker Protection Standard (WPS)", and PR
Notice 93-11, "Supplemental Guidance for PR Notice 93-7", which reflect the requirements of
EPA' s labeling regulations for worker protection statements (40 CFR part 156, subpart K).
These labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance with, and
within the deadlines specified in, PR Notices 93-7 and 93-11. Unless otherwise specifically
directed in this RED, all statements required by PR Notices 93-7 and 93-11 are to be on the
product label exactly as instructed in those notices.
PPE Requirements
Default PPE is established on the basis of acute toxicity category of the end-use products in
accordance with PR Notice 93-7.
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
PPE Requirements for wettable powder
formulations
Mixers, loaders, others exposed to the concentrate, and cleaners/repairers of equipment must
wear:
--coveralls over long-sleeve shirt and long pants,
--chemical-resistant gloves*,
--chemical-resistant footwear plus socks,
--chemical-resistant apron,
~a respirator dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).
Applicators, flaggers, and others exposed to the dilute must wear:
--long-sleeve shirt and long pants, and
--shoes plus socks.
*For the glove statement, use the statement established for methomyl through the instructions
in Supplement Three of PR Notice 93-7.
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
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Table 53 Summary of Required Labeling Changes for Methomyl Products
PPE Requirements for liquid formulations
Mixers, loaders, others exposed to the concentrate, and cleaners/repairers of equipment must
wear:
--long-sleeve shirt and long pants,
--shoes plus socks,
--chemical-resistant gloves*,
--chemical-resistant apron.
Applicators, flaggers, and others exposed to the dilute must wear:
--long-sleeve shirt and long pants,
--shoes plus socks.
*For the glove statement, use the statement established for methomyl through the instructions
in Supplement Three of PR Notice 93-7.
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
PPE Requirements for bait formulations that
include directions for application by hand-held
equipment
Mixers, loaders, applicators, and other handlers must wear:
--long-sleeved shirt and long pants,
--chemical resistant gloves*,
--shoes plus socks.
Flaggers, and others exposed to the bait must wear:
--long-sleeve shirt and long pants,
--shoes plus socks.
*For the glove statement, use the statement established for methomyl through the instructions
in Supplement Three of PR Notice 93-7.
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
PPE Requirements for mixers of pelleted baits
or pastes for paint brush applications
Mixers of pelleted baits or pastes for paint brush applications must wear:
--long-sleeved shirt and long pants,
--chemical resistant gloves*,
--chemical resistant apron,
--shoes plus socks,
~a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).
*For the glove statement, use the statement established for methomyl through the instructions
in Supplement Three of PR Notice 93-7.
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
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Table 53 Summary of Required Labeling Changes for Methomyl Products
PPE Requirements for dust formulations
Mixers, loaders, others exposed to the dust, and cleaners/repairers of equipment must wear:
--long-sleeve shirt and long pants,
--chemical-resistant gloves*,
--chemical-resistant apron,
--chemical resistant footwear plus socks,
~a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).
Applicators, and others exposed to the dust must wear:
--coveralls over long-sleeve shirt and long pants,
--chemical-resistant gloves*,
--chemical resistant footwear plus socks,
~a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C),
--chemical resistant headgear for overhead exposure.
*For the glove statement, use the statement established for methomyl through the instructions
in Supplement Three of PR Notice 93-7.
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables, use detergent and hot water. Keep and wash PPE separately from other laundry."
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals, Following PPE
User Safety Requirements for all products that
specify coveralls in the PPE
"Discard clothing or other materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them."
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals, Following PPE
Engineering Controls
"Engineering Controls"
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides
(40CFR 170.240(d)(4-6), the handler PPE requirements may be reduced or modified as
specified in the WPS."
Precautionary Statements Under
Hazards to Humans and Domestic
Animals, Following Use Safety
Requirements
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Table 53 Summary of Required Labeling Changes for Methomyl Products
Engineering Controls For Wettable Powder
Formulatiuons
The following Engineering Controls are required in addition to those specified above:
All wettable powder products must be formulated in water-soluble packaging, the outside of
which contains a pictogram depicting that users should not cut, rip, or tear the bag.
"Water-soluble packets when used correctly qualify as a closed loading system under the WPS.
Handlers handling this product while it is enclosed in intact water-soluble packets are
permitted to wear long-sleeved shirt, long pants, shoes plus socks, chemical-resistant gloves,
and chemical-resistant apron, provided the other required PPE is immediately available in case
the bag is opened."
Precautionary Statements Under
Hazards to Humans and Domestic
Animals, Following Use Safety
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 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 Labeling Under
Hazards to Humans and Domestic
Animals, Following Engineering
Controls
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Table 53 Summary of Required Labeling Changes for Methomyl Products
Environmental Hazards, Ground and Surface
Water Statements
"This pesticide is toxic to fish, aquatic invertebrates, and mammals. Do not apply directly to
water or to areas where surface water is present or to intertidal areas below the mean high-
water mark. Drift and runoff may be hazardous to aquatic organisms in neighboring areas. Do
not contaminate water when disposing of equipment washwater or rinsate."
"This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds.
Do not apply this product or allow it to drift to blooming crops or weeds while bees are actively
visiting the treatment area."
"This chemical is known to leach through soil into ground water under certain conditions as a
result of label use. Use of this chemical in areas where soils are permeable, particularly where
the water table is shallow, may result in ground-water contamination."
"This chemical can contaminate surface water through spray drift. Under some conditions, it
may also have a high potential for runoff into surface water for several days to weeks after
application. These include poorly draining or wet soils with readily visible slopes toward
adjacent surface waters, frequently flooded areas, areas overlaying extremely shallow ground
water, areas with in-field canals or ditches that drain to surface water, areas not separated from
adjacent surface waters with vegetated filter strips, and areas over-laying tile drainage systems
that drain to surface water."
Precautionary Statements
Environmental Hazards
Restricted Entry Interval for WPS Uses
The restricted-entry intervals are:
apple, cotton, grapefruit, lemon, nectarine, oranges, tangelo, tangerine ~3 days,
peaches ~ 4 days,
grapes ~ 7 days,
all other WPS uses ~ 48 hours.
Directions for Use
Agricultural Use Requirements
Box and associated with each
crop/use as specified by
Supplement Three of PR Notice
93-7.
Early-Entry PPE for WPS Uses
The PPE required for early entry is:
--coveralls,
--chemical-resistant gloves*,
--shoes plus socks,
--protective eyewear.
*For the glove statement, use the statement established for methomyl through the instructions
in Supplement Three of PR Notice 93-7.
Directions for Use
Agricultural Use Requirements
Box as specified by Supplement
Three of PR Notice 93-7.
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Table 53 Summary of Required Labeling Changes for Methomyl Products
Double Notification for labels with directions
for use on grapes
The following statement must be added to all end-use product labeling that contains directions
for use on grapes:
"Notify workers of the application to grapes by warning them orally and by posting warning
signs at entrances to treated areas."
Directions for Use
Agricultural Use Requirements
Box as specified by Supplement
Three of PR Notice 93-7.
Entry restrictions for non-WPS uses that are
applied as sprays
"Do not enter or allow others to enter the treated area until sprays have dried.'
If no WPS uses are on the label •
- Place the Non WPS entry
restrictions in the Directions for
Use, under the heading "Entry
Restrictions."
If WPS uses are also on label —
Follow the instructions in PR
Notice 93-7 for establishing a
Non-Agricultural Use
Requirements box, and place the
appropriate Non WPS entry
restrictions in that box.
General Application Restrictions
"Do not apply by ground equipment within 25 feet, or by air within 100 feet of lakes,
reservoirs, rivers, estuaries, commercial fish ponds and natural, permanent streams, marshes or
natural, permanent ponds. Increase the buffer zone to 450 feet from the above aquatic areas
when ultra low volume application is made."
"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."
"Use only in commercial and farm plantings. Not for use in home plantings nor on any
commercial crop that is turned into a "U-Pick", "Pick Your Own" or similar operation."
General Precautions and
Restrictions section in Directions
for Use.
Application Restrictions for products with
directions for applications to crops
"Hand-held equipment is prohibited for applications to crops. This product must be applied to
crops only with mechanical ground or aerial application equipment."
General Precautions and
Restrictions section in Directions
for Use.
Application rate restrictions for products with
directions for application on Brocolli
Directions for application to brocolli must be amended to specify a maximun seasonal
application rate of 6.3 Ibs ai/acre.
Directions For Application section
in Directions for Use
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Table 53 Summary of Required Labeling Changes for Methomyl Products
Application rate restrictions for products with
directions for application on Cabbage
Application rate restrictions for products with
directions for application on Cauliflower
Application rate restrictions for products with
directions for application on Celery
Application rate restrictions for products with
directions for application on Chinese Cabbage
Application rate restrictions for products with
directions for application on Sweet Corn
Application rate restrictions for products with
directions for application on Head Lettuce
Application rate restrictions for products with
directions for application on Tomatoes
Application rate restrictions for products with
directions for application on peaches
Application rate restrictions for products with
directions for application on commercial sod
farms
Preharvest intervals (PHI) for products with
directions for application on beet tops.
Preharvest intervals (PHI) for products with
directions for application on Sweet Corn
Grazing restrictions for products with
directions for application on Cotton
Directions for application to cabbage must be amended to specify a maximun seasonal
application rate of 7.2 Ibs ai/acre.
Directions for application to cauliflower must be amended to specify a maximun seasonal
application rate of 7.2 Ibs ai/acre.
Directions for application to celery must be amended to specify a maximun seasonal
application rate of 7.2 Ibs ai/acre.
Directions for application to Chinese cabbage must be amended to specify a maximun seasonal
application rate of 7.2 Ibs ai/acre.
Directions for application to sweet corn must be amended to specify a maximun seasonal
application rate of 6.3 Ibs ai/acre.
Directions for application to head lettuce must be amended to specify a maximun seasonal
application rate of 7.2 Ibs ai/acre.
Directions for application to tomatoes must be amended to specify a maximun seasonal
application rate of 6.3 Ibs ai/acre.
Directions for application to peaches must be amended to specify a single maximun per acre
application rate of 0.9 Ibs ai/acre.
Directions for application to commercial sod farms must be amended to specify a single
maximun per acre application rate of 0.9 Ibs ai/acre.
Directions for application to beet tops must be amended to specify a preharvest interval (PHI) of
10 days.
Directions for application to sweet corn must be amended to specify a preharvest interval (PHI)
of 21 days for sweet corn stover.
Label directions for cotton state "Do not graze or feed treated cotton to livestock." This
restriction should be deleted from the labels because cotton gin trash is a regulated livestock
feed item that is not under the grower's control.
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
132
-------
Table 53 Summary of Required Labeling Changes for Methomyl Products
Application rate restrictions for products with
directions for application on Garlic
Preharvest interval (PHI) for products with
directions for application on Bermudagrass
Forage
Preharvest interval for products with
directions for application on lentil forage and
hay
Application rate restrictions for products with
directions for application on peppers
Preharvest interval for products with
directions for application on soybeans forage
and hay
Preharvest interval for products with
directions for application on sorghum
Preharvest interval for products with
directions for application on sugar beets
Directions for garlic specify a maximum single application rate of 0.45 Ib ai/A and a maximum
of six applications per crop, which would result in a maximum seasonal rate of 2.7 Ib ai/A.
However, the currently labeled seasonal rate is 3.6 Ib ai/A/crop. The seasonal use rate should
be amended to be no higher than the total resulting from the maximum number of applications
at the maximum rate.
A 7-day PHI is specified for bermudagrass forage. However, current Agency Guidelines (Table
1, OPPTS Guideline 860. 1000) require 0-day PHIs for grass forages. Concomitant with
developing zero day residue data for bermudagrass forage, the registrant should amend product
labels to list a 0-day PHI for bermudagrass forage.
Since lentil forage and hay are no longer considered to be significant livestock feed items, PHIs
for these commodities can be deleted from the use directions for lentils.
Use directions for peppers list a maximum seasonal use rate of 4.05 Ib ai/A. This rate appears
to be a typographical error. The maximum seasonal rate should be 4.5 Ib ai/A/crop. The
registrant should clarify the maximum seasonal rate for peppers.
Label directions for soybeans specify PHIs for forage and hay that depend upon whether the last
application was made at <0.45 Ib ai/A or at 0.45-0.9 Ib ai/A. Because the current registered
maximum use rate is 0.45 Ib ai/A, these label directions are confusing. The use directions
should be amended to specify PHIs of 3 and 12 days for forage and hay, respectively, regardless
of the application rate. These PHIs are supported by the available data.
For sorghum, either specify a 0-day PHI for forage and submit supporting residue data or
amend labels to restrict the use only to grain sorghum.
Use directions for sugar beets should be amended to specify a 21 -day PHI for both sugar beet
roots and tops concomitant with establishing the proposed tolerance for sugar beet tops.
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
Directions For Application section
in Directions for Use
133
-------
Table 53 Summary of Required Labeling Changes for Methomyl Products
The following statement supporting the use of
an Integrated Pest Management (IPM) plan
must be added.
"This product should be used as part of an Integrated Pest Management (IPM) program which
can include biological, cultural, and genetic practices aimed at preventing economic pest
damage. Application of this product should be based on IPM principles and practices including
field scouting or other detection methods, correct target pest identification, population
monitoring and treating when target pest populations reach locally determined action
thresholds. Consult your state cooperative extension service, professional consultant or other
qualified authorities to determine appropriate action threshold levels for treating specific
pest/crop systems in your area."
Spray Drift Label Requirements for Product
with Aerial Applications
Avoiding spray drift at the application site is the responsibility of the applicator. The
interaction of many equipment-and-weather-related factors determine the potential for spray
drift. The applicator and the grower are responsible for considering all these factors when
making decisions.
The following drift management requirements must be followed to avoid off-target drift
movement from aerial applications to agricultural field crops. These requirements do not apply
to forestry applications, public health uses or to applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not exceed 3/4 the length of the
wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never be pointed
downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the
Aerial Drift Reduction Advisory Information.
Aerial Drift Reduction Advisory Information.
(This section is advisory in nature and does
not supersede the mandatory label
requirements.)
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The best drift
management strategy is to apply the largest droplets that provide sufficient coverage and
control. Applying larger droplets reduces drift potential, but will not prevent drift if
applications are made improperly, or under unfavorable environmental conditions (see Wind,
Temperature and Humidity, and Temperature Inversions below).
134
-------
Table 53 Summary of Required Labeling Changes for Methomyl Products
CONTROLLING DROPLET SIZE
! Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles
with higher rated flows produce larger droplets.
! Pressure - Do not exceed the nozzle manufacturer's recommended pressures. For many
nozzle types lower pressure produces larger droplets. When higher flow rates are needed, use
higher flow rate nozzles instead of increasing pressure.
! Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.
! Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the airstream
produces larger droplets than other orientations and is the recommended practice. Significant
deflection from horizontal will reduce droplet size and increase drift potential.
! Nozzle Type - Use a nozzle type that is designed for the intended application. With most
nozzle types, narrower spray angles produce larger droplets. Consider using low-drift nozzles.
Solid stream nozzles oriented straight back produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or
rotor length may further reduce drift without reducing swath width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top of the largest
plants unless a greater height is required for aircraft safety. Making applications at the lowest
height that is safe reduces exposure of droplets to evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be displaced downward.
Therefore, on the up and downwind edges of the field, the applicator must compensate for this
displacement by adjusting the path of the aircraft upwind. Swath adjustment distance should
increase, with increasing drift potential (higher wind, smaller drops, etc.)
135
-------
Table 53 Summary of Required Labeling Changes for Methomyl Products
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many factors, including
droplet size and equipment type determine drift potential at any given speed. Application
should be avoided below 2 mph due to variable wind direction and high inversion potential.
NOTE: Local terrain can influence wind patterns. Every applicator should be familiar with
local wind patterns and how they affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to produce larger
droplets to compensate for evaporation. Droplet evaporation is most severe when conditions
are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because drift potential is high.
Temperature inversions restrict vertical air mixing, which causes small suspended droplets to
remain in a concentrated cloud. This cloud can move in unpredictable directions due to the
light variable winds common during inversions. Temperature inversions are characterized by
increasing temperatures with altitude and are common on nights with limited cloud cover and
light to no wind. They begin to form as the sun sets and often continue into the morning.
Their presence can be indicated by ground fog; however, if fog is not present, inversions can
also be identified by the movement of smoke from a ground source or an aircraft smoke
generator. Smoke that layers and moves laterally in a concentrated cloud (under low wind
conditions) indicates an inversion, while smoke that moves upward and rapidly dissipates
indicates good vertical air mixing.
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adjacent sensitive areas (e.;
residential areas, bodies of water, known habitat for threatened or endangered species, non-
target crops) is minimal (e.g. when wind is blowing away from the sensitive areas).
136
-------
B. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision (RED). Persons
other than the registrant may generally distribute or sell such products for 50 months from the
date of the issuance of this RED. However, existing stocks time frames will be established on a
case-by-case basis, depending on the number of products involved, the number of label changes,
and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell methomyl products
bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons other
than the registrant may distribute or sell such products for 50 months from the date of the
issuance of this RED. Registrants and persons other than registrants remain obligated to meet
pre-existing Agency imposed label changes and existing stocks requirements applicable to
products they sell or distribute.
137
-------
138
-------
VI. APPENDICES
139
-------
APPENDIX A - TABLE OF USE PATTERNS SUBJECT TO THIS RED
Appendix A is 72 pages long and is not being included in this RED. Copies of Appendix A are
available upon request per instructions in Appendix E.
140
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case methomyl covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to methomyl in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols
set in the Pesticide Assessment Guidelines, which are available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
141
-------
142
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
Product Identity and Disclosure of
Ingredients
830.1550 (formerly 61-1)
830.1600 (formerly 61-2a)
830-1670 (formerly 61-2b) Discussion of Formation of Impurities
Starting Materials and Manufacturing
Process
830.1700 (formerly 62-1)
830.1750 (formerly 62-2)
830.1800 (formerly 62-3)
830.6302
830.6303
830.6304
830.6313
830.7000
830.7050
830.7200
830.7300
(formerly 63-2)
(formerly 63-3)
(formerly 63-4)
(formerly 63-13)
(formerly 63-12)
(formerly 63-5)
(formerly 63-7)
Preliminary Analysis
Certification of Ingredient Limits
Analytical Methods to Verify the Certified
Limits
Color
Physical State
Odor
Stability
pH
UV/Visible Absorption
Melting Point/Melting Range
Density/Relative Density
/Bulk Density
830.7370 (formerly 63-10) Dissociation Constant in Water
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41402104, 41402105, 41505201,
42003802, 42476801
41402104, 41402105, 42003801,
42003802
41402104, 41402105, 42003801,
42003802
41505201, 42476801, 42671401
41402105, 41505201, 42003802,
42476801
41505201, 42476801, 42671401
41402103, 41402106, 42003803
41402103
41402103
41402103
41402103
Data Gap
41402103
41402103
41402103
143
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
830.7550 (formerly
830.7840 (formerly
830.7950 (formerly
ECOLOGICAI
71-la
71-2a
71-2b
71-4a
71-4b
72- la
72- Ic
72-2a
72-3a
72-3b
72-3c
72-4a
72-4a
72-4b
72-4b
72-5
141-1
63-1 1) Partition Coefficient Octanol/Water
63-8) Water Solubility
63-9) Vapor Pressure
, EFFECTS
Acute Avian Oral
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Early Life Stage Fish - Freshwater
Early Life Stage Fish - Estuarine/Marine
Life Cycle Invertebrate - Freshwater
Life Cycle Invertebrate - Estuarine/Marine
Fish Life Cycle
Honey Bee Acute Contact
144
USE PATTERN
All
All
All
A,B,C,I,J
A,B,C,I,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,I,J
A,B,C,I,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
A,B,C,J
CITATION(S)
41402102, 41402103
41402103
41402103
00160000, 00161886
22923
22923
41898602
41898601
00009061, 40094602
40094602
00131254, 00019977, 40094602,
40098001
41441202
42074601
41441201, 00009230, 00009134
00131255
Data Gap
00118512
Data Gap
43072101
00014715
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
81-8
82-la
82-lb
82-2
82-7
83-la
83-lb
83-2a
83-2b
83-3a
83-3b
83-4
84-2a
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -Rabbit
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
Acute Neurotoxicity - Rat
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit
Sub chronic Neurotoxicity - Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
All 42140101
All 42074602
All 42140102
All 00053407,41964001
All 42074603
All 42074605
A,B,C,I,J 00008827
A,B,C,I,J Data Gap
A,B,C,I,J 00007190
A,B,C,I,J 00009010
41251501,44436301
A,B,C,I,J Data Gap
A,B,C,I,J 00078361
A,B,C,I,J 0007091
A,B,C,I,J 00078361
A,B,C,I,J 00078423
A,B,C,I,J 00008621
A,B,C,I,J 00131257
A,B,C,I,J 43250701
All 00124901
145
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
84-2b
84-4
85-1
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
USE PATTERN
All
All
A,B,C,I,J
CITATION(S)
00161887
00161888, 44047703
42021301, 42379001
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-la
133-3
133-4
ENVIRONMENTAL
160-5
161-1
161-2
161-3
162-1
162-2
162-3
163-1
Foliar Residue Dissipation
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
FATE
Chemical Identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/ Adsorption/
A,B,C,I,J
A,B,C,I,J
A,B,C,I,J
All
A,B,C,I,J
A,B,C,J
A,B,C,J
A,B,C,I,J
A,B,C
A,B,C,J
A,B,C,I,J
00009185, 41032301, 42271701
(in review)
Ag. Reentry Task Force
Waived
41402104
00131249
00161885,43823305
00163745
00008586, 43217901
00073214, 43217902
43325401, 43325402, 43325403,
43708806
00044306, 00161884
164-1
Desorption
Terrestrial Field Dissipation
A,B,C
00009324, 00009326, 00008844,
41623901, 41623902, 42288001,
43217903, 42345601
146
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
164-2
166-1
Aquatic Field Dissipation
A Small Scale Prospective Groundwater
Monitoring Study with Methomyl
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
RESIDUE CHEMISTRY
860.1300 (formerly 171-4a) Nature of the Residue - Plants
860.1300 (formerly 171 -4b) Nature of the Residue - Livestock
860.1340 (formerly 171 -4c,d) Residue Analytical Method
A,B,C
A,B,C
A,B,C,J
A,B,C,J
A,B
A,B
A,B
43708801, 43708802, 43708803,
43708804, 43708805, 43708806,
43744401, 43744402, 43823302,
43823303, 43823304
43568301, 43599801, 43708807,
Spray Drift Task Force
Spray Drift Task Force
860.1360 (formerly 171-4m) Multiresidue method
A,B
00044069,
05008206
00063418,
41903001,
43741801
00007132,
00009074,
41048301,
41801201,
41402107
00135794, 00158689,
41048301,41513001,
42421401,43144601,
00008837, 00009009,
00085367, 41040401,
41402107, 41721502,
43432002, 43432003
147
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
860.1380 (formerly 171-4e) Storage Stability
A,B
860.1480 (formerly 171-4J)
Magnitude of the Residue in
Meat,Milk,Poultry, and Eggs
A,B
00007071, 00007044, 00007948,
00063421, 00073259, 00144617,
00126579, 05008453, 41801201,
42827201, 42827202, 43081601,
43081602, 43157801, 43188101,
43188102, 43188103, 43188104,
43188105, 43188106, 43334401,
43833301, and Data Gap for other
crops
00008832, 00009365, 41801201,
42291005, 43833301
860.1500 (formerly 171-4k)
Magnitude of the Residue Crop Field
Trials
A,B
148
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
Root and Tuber Vegetables Group:
- Beets, garden
- Carrots
- Chicory
- Horseradish
- Potatoes
- Radishes
- Sugar beets
- Sweet potatoes
- turnips
Leaves of Root and Tuber Vegetables
Group:
- Beet, tops
- Chicory, tops (leaves)
- Radish, tops (leaves)
- Turnip, greens (tops)
- Sugar beet, tops
Bulb Vegetables (Allium spp.) Group:
- Garlic
- Leeks
- Onions, dry bulb
- Onions, green
00073259
00007837
00009063
carrot data
00006997, 00007801, 00008295,
00008862
Data Gap
00007004, 00007161, 00008044,
00008863
42118205
Data Gap
00073259
41853201, Data Gap
Data Gap
00008362, Data Gap
00007004, 00008044, 41701302,
42291004, 43346801
dry bulb onion data
00144617
00007192, 41693503, 42291003
00007192, 00073261
149
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
Leafy Vegetables (Except Brassica
Vegetables)Group:
- Celery
- Dandelions
- Endive (escarole)
- Lettuce
- Parsley
- Spinach
- Swiss chard
Brassica (Cole) Leafy Vegetables Group:
- Broccoli
Brussels sprouts
Cabbage
Cabbage, Chinese
Cauliflower
Collards
Kale
Mustard greens
00007136, 00008061, 00008679,
00008803, 00055457, 42118209
spinach data
lettuce data
00007039, 00007168, 00007175,
00007715, 00008679, 00008803,
00007992, 00008264, 00008964,
42118208
spinach data
00007001, 00007002, 00007003,
00007185, 00007862, 00055457
spinach data
00007604, 00008043, 00008789,
00055457,42118207
00008043, 00008061, 00055457
00007039, 00007168, 00007715,
00007928, 00008679, 00008964,
42118206
cabbage data
00007605, 00008043, 00008789,
00055457, 42118207, 43415201
00008359, 00008535
00008360
00008361
150
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
Legume Vegetables (Succulent or Dried)
Group:
- Beans, dry
- Beans, succulent
- Lentils
- Peas, dry
- Peas, succulent
- Soybeans
- Cowpea, forage
- Peas, vines
- Soybeans, hay
Fruiting Vegetables (Except Cucurbits)
Group:
- Eggplant
- Peppers
- Tomatoes
- Tomatillos
00007134, 00009154, 42118201
00007134, 00007135, 00007168,
00008264, 00008436, 00009154,
42118202
dried peas data
42118204,43432001
00007683, 00007999, 00008154,
00009079
00007008, 00008264, 00008411,
00008602, 00008998, 00009083,
00142925
00007134, 00007168, 00008264,
00009154, 42118201, 42118202,
42514301
00007683, 00007999, 00008154,
00009079, 42118204, 42514301,
43432001
00007008, 00008264, 00008411,
00008602, 00008998, 00009084,
00142925, 42514301, 43358901
00007094, 00009000
00006995, 00006996, 00007094,
00007626, 00144827
00007007, 00007039, 00007094,
00007626, 00008742, 00156940,
05009890
tomato data
151
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
Cucurbit Vegetables Group:
- Cucumbers
- Melons
- Squash
Citrus Fruits Group:
- Grapefruit
- Lemons
- Oranges
- Tangerines
00007970, 00009076, 00009291
00007970, 00009291, 00144827
00007970, 00144827
00007137, 00009070, 44047701
00007138, 00009070, 44047701
00007139, 00009070, 44047701
00007140, 00009070, 44047701
Pome Fruits Group:
- Apples
- Pears
Stone Fruits Group:
- Nectarines
- Peaches
Berries Group:
- Blueberries
Tree Nuts Group:
- Pecans
00007077, 00007610, 00008182,
00009803, 41701301, 42867601
00063419, 00063421, 41693501,
42291001
00007672, 00007832, 44047702
00007832, 00038316, 00144827,
00156939, 44047702
00008334
00008919
152
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
Cereal Grains Group:
- Barley, grain
- Corn, (inc. Sweet)(K+CWHR)
- Corn, grain (inc. pop)
- Oats, grain
- Rye, grain
- Sorghum, grain
- Wheat, grain
Forage. Fodder, and Straw of Cereal
Grains Group:
- Barley forage, hay, straw
- Corn forage and fodder
- Oats forage, hay, straw
- Rye forage, hay, straw
- Sorghum forage
- Wheat forage, hay, straw
Grass Forage. Fodder, and Hay Group:
- Grasses, Bermuda
- Grasses, Bermuda, hay
Nongrass Animal Feeds (Forage. Fodder.
Straw, and Hay) Group:
- Alfalfa
00007612
00007142,42118203
00007039, 00007659, 00008838,
42118203
00007612
00007612
00008233, 00009366, 00006998
00007612, 00156941
00007612
00007039, 00007142, 00008838,
00073260,42118203
00007612
00007612
00008233, 00009366, 41721501,
42324901, 42918201, 43807401,
44073001 and data gap
00007612, 00156941
00019996, 00050461, 00050462,
00050463, 00078359, and data
gap
00019996, 00050461, 00050462,
00050463, 00078359
00007133, 00007159, 00008039,
00008984, 43756601
153
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
Herb and Spices Group:
- fennel (anise)
Miscellaneous Commodities:
- Asparagus
- Aspirated grain fractions
- Avocados
- Cottonseed
- Grapes
- Hops, dried
- Mint, hay
- Peanuts
- Peanuts, hulls
- Pomegranates
- Strawberries
- Tobacco
00019983
00008938
43359401,
00161144
00007690,
00009135,
00007634,
00156937,
40056901,
00007043,
00007081,
00007998,
00028735,
00007081,
00007998,
00028735,
00009002,
00008847,
00007005,
05008453,
43359402
00007989, 00009075,
00009378 and data gap
00007991, 00144827,
41693502, 42291002
41040401,41313101
00007044, 00007996
00007713, 00007997,
00008666, 00009078,
00028736
00007713, 00007997,
00008666, 00009078,
00028736
00009003
00009004
00008964, 00157373,
05013872, 42142701
154
-------
Data Supporting Guideline Requirements for the Reregistration of Methomyl
REQUIREMENT
USE PATTERN
CITATION(S)
860.1520 (formerly 171-41)
860.1850 (formerly 165-1)
860.1900 (formerly 165-2)
Special Studies
Magnitude of the Residues in Processed
Food/Feed
- Apple
- Citrus
- Corn
- Cottonseed
- Grape
-Mint
- Peanut
- Potato
- Sorghum
- Soybean
- Tomato
- Wheat
Confined Accumulation in Rotational
Crop
Field Accumulation in Rotational Crop
Chronic and Acute Dietary Exposure
Assessment
A,B
A,B,C
A,B,C
A,B,C
00007070
00009070, 41898608
41898606
00007925, 41898604
00007657
00007043, 00007044, 00007996
41898603
41898609
41914801
41902901
41898607
00007601, 41898605
00019947 and Data Gap
Data Gap
44327201, 44327202, 44360701,
44360702
155
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156
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregistration Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources including the published literature,
in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRID number". This number is unique to the citation,
and should be used whenever a specific reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify volumes of submitted studies
(see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also
to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (19??),
the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
157
-------
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the earliest
known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL," which stands for "Company Data
Library." This accession number is in turn followed by an alphabetic suffix
which shows the relative position of the study within the volume.
158
-------
BIBLIOGRAPHY
MRID CITATION
Drinking Water Regulations and Health Advisories. Office of Water. EPA.
Published in February, 1996.
Fletcher, J.S., I.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and
evaluation of the EPA food-chain (Kenaga) nomogram, an instrument for
estimating pesticide residues on plants. Environ. Tox. Chem. 13:1383-1391.
Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of
representative data as a basis for estimation of their magnitude in the environment.
In F. Coulston and F. Korte, eds., Environmental Quality and Safety: Chemistry,
Toxicology, and Technology, Georg Thieme Publ, Stuttgart, West Germany, pp.
9-28.
Jones, R.L., Hunt, T.W., Norris, F.A. and C.F. Harden. 1988. Field Research
Studies on the Movement and Degradation of Thiodicarb and Its Metabolite
Methomyl, Rhone-Poulenc Ag. Company, Research Triangle Park, NC.
Lyman, W. I, W.F. Reehl, and D.H. Rosenblatt. 1990. Handbook of Chemical
Property Estimation Methods. Chapter 5: Bioconcentration Factor in Aquatic
organisms. American Chemical Society.
Louis, J.B. and E. Vowinkel. 1989. Pesticides in Terrestrial and Aquatic
Environments, Proceedings of a National Research Conference May 11-12, 1989,
Effect of Agricultural Chemicals on Ground-Water Quality in the New Jersey
Coastal Plain.
Mesko, T.O. and G.M. Carlson. 1988. Occurrence of Pesticides, Nitrates,
Organic Compounds, and Trace Elements in Ground Water and Streams,
Southeastern Missouri, 1986-87, U.S. Geological Survey Open-File Report 88-
495.
Miles, C. J. and R. J. Pfeuffer. 1994. Pesticide Residue Monitoring in Sediment
and Surface Waters. Technical Publication-December, 1994. South Florida Water
Management District.
Moran, D. 1991. Pesticide Monitoring in Suffolk County, New York,
Department of Health Services, Bureau of Drinking Water, Hauppauge, New
York.
Pesticides in Ground Water Database: A Compilation of Monitoring Studies:
1971-1991 National Summary .Published in September 1992. EPA 734-12-92-001.
159
-------
BIBLIOGRAPHY
MRID
CITATION
U.S. EPAWhalan, J. E. and Pettigrew, H. M. (1996) Draft Interim Policy:
Route-Specific vs. Route-To-Route Procedures in Margin of Exposure (MOE)
Calculations for Inhaled Pesticides, and the Combining of MOEs. Page 7.
00006995 Shell Chemical Company (1976) 1975-Residue Data for Nudrin® Insecticide in
Bell Peppers Resulting from the Application of Nudrin, a California Study:
TIR-24-240-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-A)
00006996 Shell Chemical Company (1976) 1975-Residue Data for Nudrin® Insecticide in
Green Peppers Resulting from the Application of Nudrin, an Iowa Study:
TIR-24-268-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-B)
00006997 Shell Chemical Company (1968?) Residue Data: Methomyl in Potatoes.
(Unpublished study received Jun 29, 1976 under 201-347; CDL:232402-C)
00006998 Shell Chemical Company (1976) 1975-Residue Data for Nudrin® Insecticide in
Grain Sorghum Resulting from the Application of Nudrin, a Texas Study:
TIR-24-350-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-D)
00007001 Shell Chemical Company (1976) 1975-Residue Data for Nudrin® Insecticide in
Spinach Resulting from the Application of Nudrin from Modesto, California:
TIR-24-137-75. (Unpublished study including TTR-24-280-75, received Jun 29,
1976 under 201-347; CDL:232402-I)
00007002 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Spinach Following Application of Nudrin from Yakima, Washington:
TIR-24-147-74. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-J)
00007003 Shell Chemical Company (1976) 1975-Residue Data for Nudrin® Insecticide in
Spinach Resulting from the Application of Nudrin, a Tennessee Study:
TIR-24-363-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-K)
00007004 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Sugar Beets Following Application of Nudrin from Williams, California:
TIR-24-177-74. (Unpublished study including TIR-24-184-74 and
TIR-24-247-74, received Jun 29, 1976 under 201-347; CDL:232402-L)
160
-------
BIBLIOGRAPHY
MRID
CITATION
00007005 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Tobacco Leaves Resulting from the Application of Nudrin from Rocky Mtn.,
North Carolina: TIR-24-217-75. (Unpublished study received Jun 29, 1976 under
201-347; CDL:232402-M)
00007007 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Tomatoes Resulting from the Application of Nudrin from Homestead, Florida:
TIR-24-118-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-O)
00007008 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Soybeans Resulting from the Application of Nudrin from Tallasee, Alabama:
TIR-24-103-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232402-P)
00007039 E.I. du Pont de Nemours & Company (1972) Residue Data. (Unpublished study
received Jan 22, 1973 under 352-370; CDL:101340-A)
00007043 Wellman, D.; Kiigemagi, U.; Terriere, L.C. (1971) Residues of Methomyl in
Peppermint Hay and Oil. (Unpublished study received Jun 13, 1972 under
3E1303; prepared by Oregon State Univ., Dept. of Agricultural Chemistry,
submitted by Interregional Research Project No. 4, New Brunswick, NJ;
CDL:092205-C)
00007044 Wellman, D.; Cooley, E.J.; Kiigemagi, U.; Terriere, L.C. (1972) Residues of
Methomyl in Mint Hay and Oil. (Unpublished study received Jun 13, 1972 under
3E1303; prepared by Oregon State Univ., Dept. of Agricultural Chemistry,
submitted by Interregional Research Project No. 4, New Brunswick, NJ;
CDL:092205-D)
00007070 E.I. du Pont de Nemours and Company (1972) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Mar 5, 1974 under 3F1308; CDL:092222-AO)
00007071 Holt, R.F. (1971) Lannate® Residue Cooking Studies. (Unpublished study
received Mar 5, 1974 under 3F1308; submitted by E.I. du Pont de Nemours &
Co., Inc., Wilmington, DE; CDL:092222-AQ)
00007077 E.I. du Pont de Nemours & Company (1971) Residue Data: Methomyl- Apples.
(Unpublished study received Mar 5, 1974 under 3F1308; CDL:092222-AW)
161
-------
BIBLIOGRAPHY
MRID
CITATION
00007081 E.I. du Pont de Nemours and Company (1971) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl] (Unpublished study received
Apr 26, 1971 under 1F1158; CDL:090951-F)
00007091 Busey, W.M. (1968) Final Report: Two-year Dietary Administration-Dogs:
Project No. 201-165. (Unpublished study including addendum, received Jun 5,
1969 under 9F0814; prepared by Hazleton Laboratories, Inc., submitted by E.I. du
Pont de Nemours & Co.,Inc., Wilmington, Del.; CDL:091405-A)
00007094 E.I. du Pont de Nemours & Company (1969) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Jun 5, 1969 under 9F0814; CDL:091405-D)
00007132 Shell Development Company (1975) Residue Determination of Nudrin®
Insecticide in Crops: GLC-Flame Photometric Detector Method: Modesto Method
Series. Method MMS-R-427-1 dated May 1975. (Unpublished study received Jun
29, 1976 under 201-347;CDL:232400-C)
00007133 Shell Chemical Company (1976) 1974-Residue Data for Nudrin® Insecticide in
Alfalfa Resulting from the Application of Nudrin, a Colorado Study:
TIR-24-199-74. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232400-E)
00007134 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Snap Beans Following Application of Nudrin from Modesto, California:
TIR-24-151-74. (Unpublished study including TIR-24-163-74, TIR-24-213-74,
TIR-24-271-74 and TIR-24-117-75, received Jun 29, 1976 under 201-347;
CDL:232400-G)
00007135 Shell Chemical Company (1976) 1974-Residue Data for Nudrin® Insecticide in
Pinto Beans Resulting from the Application of Nudrin, a Colorado Study:
TIR-24-200-74. (Unpublished study including TIR-24-265-75, received June 29,
1976 under 201-347; CDL:232400-I)
00007136 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Celery Resulting from the Application of Nudrin from Lake Harbour, Florida:
TIR-24-128-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232400-M)
00007137 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Grapefruit Resulting from the Application of Nudrin from Weslaco, Texas:
162
-------
BIBLIOGRAPHY
MRID
CITATION
TIR-24-155-75. (Unpublished study including TIR-24-159-75 and
TIR-24-161-75, received Jun 29, 1976 under 201-347; CDL:232400-O)
00007138 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Lemons from Fort Pierce, Florida: TIR-24-268-74. (Unpublished study including
TIR-24-157-75, received Jun 29, 1976 under 201-347; CDL:232400-P)
00007139 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Oranges Following Application of Nudrin from Modesto, California:
TIR-24-115-75. (Unpublished study including TIR-24-158-75, received June 29,
1976 under 201-347; CDL:232400-R)
00007140 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Tangerines Following Application of Nudrin from Modesto, California:
TIR-24-114-75. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232400-T)
00007142 Shell Chemical Company (1976) 1974-Residue Data for Nudrin® Insecticide in
Sweet Corn Resulting from the Application of Nudrin, an Illinois Study:
TIR-24-181-74. (Unpublished study including TIR-24-186-75, TIR-24-311-75
and TIR-24-329-75, received Jun 29, 1976 under 201-347; CDL:232400-AA)
00007159 E.I. du Pont de Nemours and Company (1973) Methomyl Residues-Alfalfa.
(Unpublished study received May 11, 1973 under 352-342; CDL:008508-A)
00007161 E.I. du Pont de Nemours and Company (1973) Supplemental Data Supporting the
Use of Lannate® Methomyl Insecticide on Sugar Beets. Summary of studies
008509-B through 008509-G. (Unpublished study received May 15, 1973 under
352-342; CDL:008509-A)
00007168 E.I. du Pont de Nemours and Company (1973) Data Supporting the Aerial Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide.
(Unpublished study received May 24, 1973 under 352-342; CDL:008511-A)
00007175 E.I. du Pont de Nemours & Company (1971) Methomyl Residue Data: Lettuce.
(Unpublished study received Jan 12, 1971 under 352-342; CDL:106655-E)
00007185 E.I. du Pont de Nemours and Company (1971) Data Supporting the Use of
Lannate® on Spinach. Summary of studies 003029-B through 003029-D,
003029-F through 003029-1, and 003029-K through 003029-Q. (Unpublished
study received Nov 16, 1971 under 352-342; CDL:003029-A)
163
-------
BIBLIOGRAPHY
MRID
CITATION
00007190 Paynter, O.E. (1966) Final Report: Three-Month Dietary Administration-Rats:
Project No. 201-151. (Unpublished study including supplement, received Feb 20,
1966 under 352-342; prepared by Hazleton Laboratories, Inc., submitted by E.I.
du Pont de Nemours & Co., Wilmington, Del.; CDL:050428-A)
00007192 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on Onions.
Summary of studies 026715-B through 026715-D, 026715-G through 026715-N.
(Unpublished study received Jul 30, 1974 under 352-370; CDL:026715-A)
00007604 Shell Chemical Company (1976) 1976-Residue Data for Nudrin® Pesticide in
Broccoli Resulting from the Application of Nudrin, a California Study:
TIR-24-100-76. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232400-U)
00007605 Shell Chemical Company (1976) 1976-Residue Data for Nudrin® Insecticide in
Cauliflower Resulting from the Application of Nudrin, a California Study:
TIR-24-105-76. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232400-V)
00007610 E.I. du Pont de Nemours & Company (1974) Supplemental Data Supporting the
Use of Lannate® Methomyl Insecticide and Lannate® WP Methomyl Insecticide
on Apples. (Unpublished study received Mar 5, 1974 under 352-342;
CDL:023300-Y)
00007612 E.I. du Pont de Nemours & Company (1975) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Apr 8, 1975 under 5F1615; CDL:094495-B)
00007626 E.I. du Pont de Nemours & Company (1974) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Apr 8, 1975 under 5F1616; CDL:094496-B)
00007634 E.I. du Pont de Nemours and Company (1973) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
on unknown date under 4F1437; CDL:093831-A)
00007657 E.I. du Pont de Nemours & Company (1972?) Results of Tests on the published
study received on unknown date under 4F1437; CDL:093830-C)
164
-------
BIBLIOGRAPHY
MRID
CITATION
00007659 E.I. du Pont de Nemours and Company (1967) Results of Tests on the Amount of
Residue Remaining on Treated Crop: [Methomyl]. (Unpublished study received
Dec 28, 1968 under 8F0677; CDL:091184-A)
00007672 E.I. du Pont de Nemours and Company (1972) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Sep 1, 1972 under 2F1246; CDL:091770-A)
00007683 E.I. du Pont de Nemours and Company (1972) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Lannate]. (Unpublished study received
Sep 2, 1972 under 2F1247; CDL:091771-A)
00007690 E.I. du Pont de Nemours and Company (1973) Data Supporting the Use of
Lannate® Methomyl Insecticide on Cotton. Summary of studies 003043-B
through 003043-U. (Unpublished study received Mar 1, 1973 under 352-342;
CDL:003043-A)
00007713 E.I. du Pont de Nemours & Company, Incorporated (1970) Peanut Residue
Data-Methomyl: Table 2. (Unpublished study received Apr 5, 1973 under
201-347; submitted by Shell Chemical Co., Washington, D.C.; CDL:001053-D)
00007715 WARF Institute, Incorporated (1973) Residue Summary-WARF Data.
(Unpublished study including WARF Institute nos. 3020936-69 and
3020936-0952, received Apr 5, 1973 under 201-347; submitted by Shell Chemical
Co., Washington, D.C.; CDL:001053-G)
00007801 E.I. du Pont de Nemours & Company (1972) Date [sic] Supporting the Use of
Lannate® Methomyl Insecticide on Potatoes. Summary of studies 003033-B,
003033-D through 003033-K. (Unpublished study received Feb 28, 1972 under
352-342; CDL:003033-A)
00007832 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate® and Lannate® L Methomyl Insecticide on Nectarines. Summary of
studies 009832-B through 009832-E. (Unpublished study received Mar 4, 1974
under 352-342; CDL:009832-A)
00007837 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Carrots. Summary of studies 028450-B through 028450-G. (Unpublished study
received Dec 20, 1974 under 352-342; CDL:028450-A)
165
-------
BIBLIOGRAPHY
MRID
CITATION
00007862 E.I. du Pont de Nemours & Company (1970) Recovery Studies: Methomyl on
Spinach. Summary of studies 123355-L, 123355-N and 123355-O. (Unpublished
study received Feb 16, 1971 under 352-EX-72; CDL:123355-H)
00007925 E.I. du Pont de Nemours and Company (1971) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Mar 4, 1971 under 1G1144; CDL:093461-F)
00007928 E.I. du Pont de Nemours and Company (1967) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Feb 3, 1968 under 8F0681; CDL:091188-A)
00007948 Niven, C.F., Jr.; Thornburg, W. (1971) Thermal Destruction of Lannate in Spinach
Processing. (Unpublished study received Sep 1, 1972 under 2F1245; prepared by
Del Monte Corp.; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
DE; CDL:091769-F)
00007970 E.I. du Pont de Nemours & Company (1972) Results of the Tests on the Amount
of Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study
received Feb 22, 1972 under 2F1245; CDL:095111-E; 091769)
00007989 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Cottonseed from Portland, Arkansas: TIR-24-254-74. (Unpublished study
including TIR-24-119-75, received Jun 29, 1976 under 201-347; CDL:232401-A)
00007991 Shell Chemical Company (1975) 1974 - Residue Data for Nudrin® Insecticide in
Grapes from Modesto, California: TIR-24-161-74. (Unpublished study received
Jun 29, 1976 under 201-347; CDL:232401-I)
00007992 Shell Chemical Company (1975) 1975-Residue Data for Nudrin® Insecticide in
Lettuce Resulting from the Application of Nudrin from Arvin, California:
TIR-24-214-74. (Unpublished study received Jun 29, 1976 under 201-347;
CDL:232401-J)
00007996 Kiigemagi, U.; Bottom, S.L.; Deinzer, M.L. (1976) Analysis of Mint Hay and Oil
for Methomyl. (Unpublished study received Jun 29, 1976 under 201-347;
prepared by Oregon State Univ., Dept. of Agricultural Chemistry, submitted by
Shell Chemical Co., Washington, D.C.; CDL:232401-O)
166
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BIBLIOGRAPHY
MRID
CITATION
00007997 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Peanuts from Pontotox, Texas: TIR-24-241-74. (Unpublished Study received Jun
29, 1976 under 201-347; CDL:232401-Q)
00007998 E.I. du Pont de Nemours & Company (1970?) [Residue Study Summary
-Peanuts]. (Unpublished study received Jun 29, 1976 under 201-347; submitted by
Shell Chemical Co., Washington, D.C.; CDL:232401-T)
00007999 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Peas Following Application of Nudrin from Modes to, California: TIR-24-126-74.
(Unpublished study including TIR-24-154-75 and TIR-24-165-75, received Jun
29, 1976 under 201-347; CDL:232401-U)
00008039 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Alfalfa Following Application of Nudrin from Reno, Nevada: TIR-24-142-74.
(Unpublished study including TIR-24-153-74, TIR-24-166-74, TIR-24-167-74,
TIR-24-175-74 and TIR-24-803-74, received Mar 31, 1975 under 201-347;
CDL:115269-AP)
00008043 E.I. du Pont de Nemours & Company (1968) Recovery Studies: Methomyl-Leafy
Vegetables. (Unpublished study received Mar 31, 1975 under 201-347; submitted
by Shell Chemical Co., Washington, D.C.; CDL:115269-AY)
00008044 E.I. du Pont de Nemours and Company (1972) Data Supporting the Use of
Lannate® Methomyl Insecticide on Sugar Beets. Summary of studies 003036-B
through 003036-1, 003036-K through 003036-P, and 003 03 6-R through
003036-T. (Unpublished study received Mar 6, 1972 under 352-342;
CDL:003036-A)
00008061 E.I. du Pont de Nemours & Company (1970) Data Supporting Use of Lannate on
Celery and Brussels Sprouts. Summary of studies 003011-B through 003011-L.
(Unpublished study received Feb 3, 1970 under 352-342; CDL:003011-A)
00008154 E.I. du Pont de Nemours & Company (1974) Supplemental Data Supporting the
Use of Lannate® and Lannate® L Methomyl Insecticides on Peas. Summary of
studies 023301-B through 023301-G and 023301-1 through 023301-L.
(Unpublished study received Mar 5, 1974 under 352-342; CDL:023301-A)
00008182 E.I. du Pont de Nemours & Company (1973) Supplemental Data Supporting the
Use of Lannate® Methomyl Insecticide and Lannate® WP Methomyl Insecticide
167
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BIBLIOGRAPHY
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CITATION
on Apples. (Unpublished study received Mar 4, 1974 under 352-362;
CDL:026710-AB)
00008233 E.I. du Pont de Nemours & Company (1974) [Summary of Residues on Sorghum
and Lannate Methomyl Insecticide for Control of South Western Corn Borer and
Corn Earworm on Grain Sorghum]. Summary of studies 009653-B, 009653-D
through 009653-F, 009653-1 through 009653-K, 009653-M, and 009653-O
through 009653-Q. (Unpublished study received Dec 20, 1974 under 352-342;
CDL:009653-A)
00008264 E.I. du Pont de Nemours & Company (1971) Supplemental Information:
[Methomyl]. (Unpublished study received Jun 16, 1971 under IF 1021;
CDL:091071-A)
00008295 E.I. du Pont de Nemours and Company (1969) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Jan 21, 1970 under OF0886; CDL:091530-L)
00008334 E.I. du Pont de Nemours & Company (1976) Methomyl Residue Data—Summary:
Blueberry: Table 1. (Unpublished study received Mar 15, 1978 under 352-342;
CDL:096959-D)
00008359 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Collard Greens:
IR-4-PR #43. (Unpublished study received Dec 8, 1977 under 8E2030; prepared
by Virginia Truck and Ornamentals Research Station in cooperation with Virginia
Polytechnic Institute and State Univ., and U.S. Dept. of Agriculture, Vegetable
Insect Laboratory, submitted by Interregional Research Project No. 4, New
Brunswick, NJ; CDL:097378-F)
00008360 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Kale Greens: IR-4-PR
#43. (Unpublished study received Dec 8, 1977 under 8E2030; prepared by
Virginia Truck and Ornamentals Research Station in cooperation with Virginia
Polytechnic Institute and State Univ., and U.S. Dept. of Agriculture, Vegetable
Insect Laboratory, submitted by Interregional Research Project No. 4, New
Brunswick, NJ; CDL:097378-G)
00008361 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Mustard: IR-4-PR #43.
(Unpublished study received Dec 8, 1977 under 8E2030; prepared by Virginia
Truck and Ornamentals Research Station in cooperation with Virginia Polytechnic
Institute and State Univ., and U.S. Dept. of Agriculture, Vegetable Insect
168
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BIBLIOGRAPHY
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CITATION
Laboratory, submitted by Interregional Research Project No. 4,New Brunswick,
NJ; CDL:097378-H)
00008362 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Turnip No. 4, New
Brunswick, NJ; CDL:097378-1)
00008411 E.I. du Pont de Nemours and Company (1974) Supplemental Data Supporting the
Use of Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Soybeans. Summary of studies 023303-B through 023303-Q, 023303-T through
023 3 03-V, 023 3 03-Y, 023 3 03-AA and 023 3 03-AC through 023 3 03-AH.
(Unpublished study received Mar 4, 1974 under 352-342; CDL:023303-A)
00008436 E.I. du Pont de Nemours and Company (1974) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Succulent Beans. Summary of studies 009841-C through 009841-G and 009841-1
through 009841-AE. (Unpublished study received Mar 4, 1974 under 352-342;
CDL:009841-A)
00008535 E.I. du Pont de Nemours and Company (1976) Data Supporting the Use of
Lannate® Methomyl Insecticide for Control of Insects on Collards. Summary of
studies 227024-B through 227024-E, 227024-G through 227024-K and
227024-M through 227024-R. (Unpublished study received Jun 24, 1976 under
352-342; CDL:227024-A)
00008586 E.I. du Pont de Nemours and Company (1977) Data Supporting Use of Lannate
(R) Methomyl Insecticide and Lannate (R) L Methomyl Insecticide on Citrus.
Summary of studies 230238-B through 230238-G. (Unpublished study received
May 23, 1977 under 352- 342; CDL:230238-A)
00008602 E.I. du Pont de Nemours & Company (1976) Residue Data: Methomyl Soybeans.
(Unpublished study received Jun 15, 1977 under 352-342; CDL:230630-M)
00008621 Rogers, A.S.; Culik, R.; Wood, R.A.; et al. (1978) Oral Teratogenic Study in Rats
with Lannate(AR4) (INX-1179): Haskell Laboratory Report No. 498-78.
(Unpublished study received Oct 18, 1978 under 352-342; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:097449-A)
00008666 E.I. du Pont de Nemours and Company (1972) Peanut Residue Data - Methomyl.
(Unpublished study received Jun 7, 1972 under 352-342; CDL:003041-A)
169
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BIBLIOGRAPHY
MRID
CITATION
00008679 E.I. du Pont de Nemours and Company (1972) Residue Data: Methomyl - Aerial
Application. (Unpublished study received Apr 5, 1972 under 352-342;
CDL:023289-A)
00008742 E.I. du Pont de Nemours & Company (1971) Data Supporting Registration of
Lannate Methomyl Insecticide for Use on Tomatoes. (Unpublished study received
May 26, 1971 under 352-342; CDL:003025-A)
00008789 E.I. du Pont de Nemours & Company (1970) Data Supporting the Use of Higher
Rates of Lannate on Cabbage, Broccoli, Cauliflower and Lettuce. (Unpublished
study received Feb 3, 1970 under 352-342; CDL:003012-A)
00008803 E.I. du Pont de Nemours & Company (1969) Lannate Methomyl
Residues—Celery. (Unpublished study received Jul 22, 1970 under 352-342;
CDL:003020-A)
00008827 Krauss, W.C.; Stula, E.F. (1967) Oral LD50 and Delayed Paralysis Tests (Hens):
Haskell Laboratory Report No. 161-67. (Unpublished study received Dec 12, 1967
under 352-342; submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:050420-B)
00008832 E.I. du Pont de Nemours and Company (1967) Methomyl Livestock Feeding
Studies: Milk and Meat. (Unpublished study received Dec 28, 1968 under
8F0671;CDL:091179-B)
00008837 Pease, H.L. (1968) Selectivity of Methomyl Residue Procedure. (Unpublished
study received Dec 28, 1968 under 8F0671; submitted by E.I. du Pont de Nemours
& Co., Inc., Wilmington, DE; CDL:091179-G)
00008838 E.I. du Pont de Nemours & Company (1968) Residue Data: Methomyl - Leafy
Vegetables. (Unpublished study received Dec 28, 1968 under 8F0671;
CDL:091179-H)
00008844 Harvey, J. (1964?) Exposure of S-Methyl N-(methylcarbamoyl)oxy-
thioacetimidate in Sunlight, Water, and Soil. (Unpublished study received Dec 28,
1968 under 8F0671; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.; CDL:091179-V)
00008847 E.I. du Pont de Nemours and Company (1974) Residue Studies: [Methomyl].
Summary of studies 096079-C through 096079-G. (Unpublished study received
Apr 19, 1977 under 352-342; CDL:096079-B)
170
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BIBLIOGRAPHY
MRID
CITATION
00008862 E.I. du Pont de Nemours and Company (1976) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Potatoes. (Unpublished study received Apr 15, 1976 under 352-342;
CDL:224068-A)
00008863 E.I. du Pont de Nemours and Company (1976) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on Sugar
Beets. (Unpublished study received Apr 5, 1976 under 352-342; CDL:224069-A)
00008919 E.I. du Pont de Nemours and Company (1976) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Sep 21, 1976 under 352-342; CDL:095289-B)
00008938 E.I. du Pont de Nemours & Company (1975) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. Summary of studies
094852-G and 094852-L. (Unpublished study received Jul 10, 1975 under
6F1654; CDL:094852-B)
00008964 E.I. du Pont de Nemours & Company (1971) Residue Data. (Unpublished study
received Jan 31, 1972 under 352-361; CDL:003094-D)
00008984 E.I. du Pont de Nemours & Company (1970) [Methomyl on Alfalfa]. (Unpublished
study received Apr 27, 1971 under 1F1159; CDL:090952-A)
00008998 E.I. du Pont de Nemours and Company (1979) Residue Data. (Unpublished study
received Apr 10, 1979 under 352-342; CDL:238156-A)
00009000 E.I. du Pont de Nemours & Company (1969) Residue Analyses: Eggplant.
(Unpublished study received Mar 26, 1979 under 352-342; CDL:237887-B)
00009002 LaRue J; Dibble, J. (1975) Lannate® Methomyl Insecticide: Pomegranates.
(Unpublished study including letter dated Sep 18, 1975 from J.H. Stoner to Alvin
Barbar, received Mar 26, 1979 under 352-342; prepared by Univ. of California,
Agricultural Experiment Station in cooperation with Stoner Laboratories, Inc.,
submitted by E.I. du Pont de Nemours & Co.; Wilmington, DE; CDL:237887-D)
00009003 E.I. du Pont de Nemours & Company (1975) Methomyl Residue
Analyses—Pomegranate. (Unpublished study received Mar 26, 1979 under
352-342; CDL:237887-E)
171
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BIBLIOGRAPHY
MRID
CITATION
00009004 E.I. du Pont de Nemours and Company (1979) Residue Data. (Unpublished study
received Apr 10, 1979 under 352-342; CDL:098215-A)
00009009 Pease, H.L.; Kirkland, JJ. (19??) Determination of Methomyl Residues Using
Microcoulometric Gas Chromatography. Undated method. (Unpublished study
received Dec 11, 1967 under 8F0671; submitted by E.I. du Pont de Nemours &
Co., Inc., Wilmington, DE; CDL:092971-C)
00009010 Sherman, H. (1967) Three-Month Feeding Study on Dogs with S-Methyl N-
[(methylcarbamoyl)oxy] thioacetimidate [LannateA(R)4 Methomyl Insecticide;
INX-1179]: Haskell Laboratory Report No. 168-67. Unpublished study received
Dec 28, 1968 under 8F0671; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.; CDL:091178-B)
00009061 Schneider, P.W., Jr. (1976) 96-Hour LC50 to Bluegill Sunfish: Haskell Laboratory
Report No. 710-76. (Unpublished study received Jun 21, 1979 under 352-342;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:238781-A)
00009063 E.I. du Pont de Nemours & Company (1977) Residue Data. (Unpublished study
received May 16, 1979 under 352-342; CDL:238519-B)
00009070 E.I. du Pont de Nemours and Company (1972) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Mar 24, 1972 under 2F1254; CDL:095333-C)
00009074 Pease, H.L. (1969) Modification of the Published Gas Chromatographic Method
for Determination of Methomyl Residues: Use of a Flame Photometric Detector.
Method dated Jul 17, 1969. (Unpublished study received Jan 21, 1970 under
OF0886; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE;
CDL:091530-N)
00009075 Shell Chemical Company (1976) 1975-Residue Data for Nudrin® Insecticide in
Cottonseed Resulting from the Application of Nudrin to Cotton Plants, a Texas
Study: TIR-24-207-75. (Unpublished study including TIR-24-208-75, received
Jun 29, 1976 under 201-347; CDL:232401-B)
00009076 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Cucumbers Following Application of Nudrin from Modesto, California:
TIR-24-150-74. (Unpublished study including TIR-24-244-74, received Jun 29,
1976 under 201-347; CDL:132401-D)
172
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BIBLIOGRAPHY
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CITATION
00009078 Shell Chemical Company (1976) 1975 - Residue Data for Nudrin® Insecticide in
Peanuts Resulting from the Application of Nudrin, a Georgia Study:
TIR-24-261-75. (Unpublished study including TIR-24-308-75, received Jun 29,
1976 under 201-347; CDL:232401-R)
00009079 Shell Chemical Company (1976) 1975 - Residue Data for Nudrin® Insecticide in
Dry Peas Resulting from the Application of Nudrin, a Washington Study:
TIR-24-197-75. (Unpublished study including TIR-24-219-75 and
TIR-24-264-75, received Jun 29, 1976 under 201-347; CDL:232401-X)
00009083 Shell Chemical Company (1975) 1974 - Residue Data for Nudrin® Insecticide in
Soybeans Following Application of Nudrin from Painter, Virginia: TIR-24-269-74.
(Unpublished study received Mar 31, 1975 under 201-347; CDL:115269-AT)
00009084 Shell Chemical Company (1975) 1974-Residue Data for Nudrin® Insecticide in
Soybean Forage and Straw Following Application of Nudrin from Pickens,
Arkansas: TIR-24-253-74. (Unpublished study received Mar 31, 1975 under
201-347; CDL:115269-BA)
00009134 Sleight, B.H., III (1973) Bioassay Report Submitted to E.I. DuPont de Nemours
& Company, Newark, Delaware: Acute Toxicity of H- 7946, MR-581 to Grass
Shrimp (Palaemenetes vulgaris), Pink Shrimp (Penaeus duorarum) and Mud Crab
(Neopanope texana). (Unpublished study received May 6, 1976 under 352- 342;
prepared by Bionomics, Inc., submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:224073-AI)
00009135 E.I. du Pont de Nemours and Company (1974) Supplemental Data Supporting the
Use of Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Cotton. Summary of studies 023305-C through 023305-O and 023305-Q through
023305-R. (Unpublished study received Mar 5, 1974 under 352-342;
CDL:023305-A)
00009154 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on Dry
Beans. Summary of studies 023304-D through 023304-H, 023304-J through
023304-M, 023304-O through 023304-AB. (Unpublished study received Jul 16,
1974 under 352-342; CDL:023304-A)
00009185 E.I. du Pont de Nemours & Company (1975?) Reentry of Workers., Summary of
studies 224800-L through 224800-U. (Unpublished study received Jul 29, 1976
under 352-342; CDL:224800-J)
173
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BIBLIOGRAPHY
MRID
CITATION
00009230 Bentley, R.E. (1973) Acute Toxicity of H-8385 to Grass Shrimp (Palaemonetes
vulgaris) and Fiddler Crab (Uca pugilator). (Unpublished study received May 5,
1977 under 352- 342; prepared by Bionomics, Inc., submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:229718-A)
00009291 E.I. du Pont de Nemours and Company (1976) Data Supporting Use of Lannate®
Methomyl Insecticide and Lannate® L Methomyl Insecticide on Cucurbits.
Summary of studies 227340-B through 227340-S. (Unpublished study received
Jun 29, 1976 under 352-342; CDL:227340-A)
00009324 Harvey, 1, Jr.; Pease, H.L. (1971?) Decomposition of Methomyl in Soil.
(Unpublished study received May 5, 1977 under 352-342; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:229711-D)
00009326 E.I. du Pont de Nemours & Company (1971) Methomyl Decomposition in Muck
Soil-A Field Study. (Unpublished study received May 5, 1977 under 352-342;
CDL:229711-F)
00009365 Sherman, H. (1972) Chicken and Egg Study: Haskell Laboratory Report
No. 55-72. (Unpublished study received Sep 7, 1972 under 3F1307; submitted by
E.I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL:092221-C)
00009366 E.I. du Pont de Nemours & Company (1971) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Methomyl]. (Unpublished study received
Sep 7, 1972 under 3F1307; CDL:092221-D)
00009378 E.I. du Pont de Nemours and Company (1976) Data Supporting Use of Lannate®
D Methomyl Insecticide and Lannate® 5-D Methomyl Insecticide on Cotton.
Summary of studies 226190-B through 226190-W. (Unpublished study received
Sep 28, 1976 under 352-380; CDL:226190-A)
00009803 E.I. du Pont de Nemours and Company (1976) Data Supporting the Use of
Lannate, Lannate WP & Lannate L Methomyl Insecticides for Control of Insects
on Apples. Summary of studies 224500-B through 224500-G, 224500-1,
224500-K through 224500-R, and 224500-T through 224500-W. (Unpublished
study received Apr 12, 1976 under 352-342; CDL:224500-A)
00014715 Sakamoto, S.S.; Johansen, C.A. (1971) Toxicity of Orthene to Honey Bees (Apis
mellifera); Alfalfa Leaf Cutter Bees (Megachile rotundata); Alkali Bees (Nomia
melanderi); Bumble Bees (Bombus auricomus). (Unpublished study received June
21, 1972 under 239-EX-61; prepared in cooperation with Washington State Univ.,
174
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BIBLIOGRAPHY
MRID
CITATION
Entomology Dept, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:223505-AT)
00019947 Harvey, I, Jr. (1977?) Crop Rotation Study with 14C-Methomyl in the
Greenhouse. (Unpublished study received Jan 19, 1978 under 352-342; submitted
by E.I. du Pont de Nemours & Co., Wilmington, DE; CDL:232720-A)
00019977 Goodman, N.C. (1978) 48-Hour LC50 to Daphnia magna: Haskell Laboratory
Report No. 165-78. (Unpublished study received May 22, 1978 under 352-342;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:233993-B)
00019983 University of Arizona, Department of Entomology (1978) Lannate® Methomyl
Residue on Fennel: Final Report. (Unpublished study received Mar 29, 1978
under 352-342; submitted by E.I. du Pont de Nemours & Co., Wilmington, DE;
CDL:234044-A)
00019996 Campbell, W.V. (1975) 1975 Fall Armyworm Tests on Coastal Bermuda grass.
(Unpublished study received Aug 1, 1978 under 352-342; prepared by North
Carolina State Univ., submitted by E.I. du Pont de Nemours & Co., Wilmington,
DE; CDL:234573-C)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
Environmental Pollutants to Birds: Special Scientific Report—Wildlife No. 191.
(U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife Research
Center; unpublished report)
00028735 E.I. du Pont de Nemours & Company (1974) Peanut Residue Data - Methomyl.
(Unpublished study received Jul 16, 1979 under 352-342; CDL:098398-B)
00028736 E.I. du Pont de Nemours & Company (1974) Summary Peanuts—Forage (F) and
Hay (H) Residue Analysis. (Unpublished study received Jul 16, 1979 under
352-342; CDL:098398-D)
00038316 E.I. du Pont de Nemours & Company (1973) Residue Data: Methomyl - Peaches.
(Unpublished study received Jun 24, 1976 under 352-342; CDL:226818-C)
00044069 Feung, C.S.; Chancey, E.L.; Holsing, E.L. (1977) Metabolism of UC 45650 in
Cotton Plant: File No. 23484. (Unpublished study received Sep 10, 1980 under
264-341; submitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
CDL:099600-G)
175
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00044306 Khasawinah, A.M.; Holsing, G.C. (1976) UC 51762 Pesticide: Mobility on Soil
Thin-Layer Chromatograms: File No. 22754. (Unpublished study received Sep 10,
1980 under 264-341; submitted by Union Carbide Agricultural Products Co.,
Ambler, Pa.; CDL: 099602-J)
00050461 E.I. du Pont de Nemours and Company (1976) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Grasses. (Unpublished study received Mar 9, 1977 under 7E1933; submitted by
Interregional Research Project No. 4, New Brunswick, NJ; CDL:097262-D)
00050462 E.I. du Pont de Nemours and Company (1976) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L Methomyl Insecticide on
Grasses. (Unpublished study received Mar 9, 1977 under 7E1933; submitted by
Interregional Research Project No. 4, New Brunswick, NJ; CDL:097262-E)
00050463 Sheets, T.J. (1976) Letter sent to R.T. Guest dated Oct 18, 1976 [Methomyl for
control of fall armyworm in coastal Bermuda grass]. (Unpublished study received
Mar 9, 1977 under 7E1933; prepared by North Carolina State Univ., Dept. of
Entomology, Pesticide Residue Research Laboratory, submitted by Interregional
Research Project No. 4, New Brunswick, NJ; CDL:097262-F)
00053407 Baker, R.G. (1974) Report to E.I. du Pont de Nemours & Company: Eye Irritation
Tests with H-8385 in Albino Rabbits: IBT No. 601-04479. (Unpublished study
received Mar 9, 1977 under 352-384 prepared by Industrial Bio-Test Laboratories,
Inc., submitted by E. I du Pont de Nemours & Co., Wilmington, Del.;
CDL:228667-G)
00055457
00063418
E.I. du Pont de Nemours and Company, Incorporated (1973) Results of Tests on
the Amount of Residue Remaining on Treated Crops. (Unpublished study received
Apr 16, 1974 under 4F1448; CDL:093860-A; 093859)
Harvey, J., Jr. (1976?) Metabolism of [14]C-Methomyl in the Lactating Goat:
Document No. AMR-22-80. (Unpublished study received Mar 18, 1981 under
352-342; submitted by E.I. du Pont de Nemours & Co., Wilmington, DE;
CDL:099952-A)
00063419 Interregional Research Project Number 4 (1979) Summary of Residue Chemistry
Data. (Unpublished study received Jan 15, 1981 under 1E2465; CDL:099885-A)
00063421 Leeper, J.R. (1980) Letter sent to Mark E. Burt dated Sep 16, 1980 [Methomyl
residue tests on pears]. (Unpublished study, including PR no. 1563, received Jan
176
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BIBLIOGRAPHY
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CITATION
15, 1981 under 1E2465; prepared by Cornell Univ., New York State Agricultural
Experiment Station, Dept. of Entomology, Entomology-Plant Pathology
Laboratory, submitted by Interregional Research Project No. 4, New Brunswick,
NJ; CDL:099885-C)
00073214 Harvey, 1, Jr. (1977) Decomposition of 14C-Methomyl in Flooded Anaerobic
Soils. (Unpublished study received Mar 27, 1979 under 352-342; submitted by
E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:237906-A)
00073259 Kiigemagi, U.; Cheng, J.C.; Deinzer, M.L. (1977) Analysis of Table Beets and
Beet Foliage for Methomyl. (Unpublished study received May 15, 1979 under
352-342; prepared by Oregon State Univ., Dept. of Agricultural Chemistry,
submitted by E.I. du Pont de Nemours & Co., Wilmington, DE; CDL:238518-A)
00073260 E.I. du Pont de Nemours & Company (1978) Data Supporting Registration of
Lannate LV Insecticide on Crops. (Compilation; unpublished study received Nov
29, 1978 under 352-EX-95; CDL:236560-A)
00073261 E.I. du Pont de Nemours & Company (1976) Data Supporting the Use of
Lannate® Methomyl Insecticide and Lannate® L methomyl Insecticide on Onions.
(Unpublished study received Jan 12, 1979 under 9E2164; submitted by
Interregional Research Project No. 4, New Brunswick, NJ; CDL:097756-A)
00078359 Interregional Research Project Number 4 (1979) Summary of Residue Data for
Methomyl in or on Forage Grasses and Forage Legumes. (Unpublished study
received Oct 1, 1979 under OE2276; CDL:099025-A)
00078361 Kaplan, A.M.; Hosteller, K.H.; Dilworth, T.; et al. (1981) Long term Feeding
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Methomyl in Male Cynomolgus Monkeys: Lab Project Number: DPT 258/920494:
AMR 1902-90. Unpublished study prepared by Huntingdon Research Centre Ltd.
80p.
42421401 Ryan, D. (1992) Methomyl [carbon 14] in Cow Metabolism Study [Supplement to
MRID 41903001]: Lab Project Number: AMR 1675-90. Unpublished study
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188
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42476801 Djanegara, T. (1992) Technical Grade Methomyl: Analysis and Certification of
Product Ingredients: Lab Project Number: AMR 2267-91. Unpublished study
prepared by E. I. du Pont de Nemours & Co. 82 p.
42514301 Marxmiller, R. (1991) Magnitude of Residues of Lannate L Insecticide in Dry
Beans: Lab Project Number: AMR 1602-90. Unpublished study prepared by E.I.
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73 p.
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Lab Project Number: AMR 1768-90:ML90-0181-DUP. Unpublished study
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42827202 Kennedy, C.; Tomic, D. (1993) Freezer Storage Stability of Methomyl in Grapes:
Lab Project Number: AMR 1769-90:ML90-0180-DUP. Unpublished study
prepared by E.I. du Pont de Nemours and Co. and Morse Labs. 33 p.
42867601 Hausmann, S.; Devine, P. (1993) Magnitude of Residues of Methomyl in Apple
Fruit Following Application of Lannate L Insecticide when Applied at the
Maximum Proposed Use Pattern and Sampled Over Time: Lab Project Number:
AMR 2291-92:ML92-0336-DUP.
42918201 Hausmann, S.; Devine, P. (1993) Magnitude of Residues of Methomyl in Sorghum
Forage and Hay Following Multiple Applications of Lannate L Insecticide: Lab
Project Number: AMR 2343-92. Unpublished study prepared by E.I. du Pont de
Nemours & Co., Dupont Agricultural Products; McKenzie Labs., Inc. 100 p.
43072101 Strawn, T.; Rhodes, J.; Leak, T. (1993) Full Life-Cycle Toxicity of
DPX-X1179-394 (Methomyl) to the Fathead Minnow (Pimephales promelas)
Under Flow-Through Conditions: Final Report: Lab Project Number: 39293: HLO
47-93. Unpublished study prepared by ABC Laboratories, Inc. 3582 p.
43081601 Kennedy, C.; Devine, P. (1993) Freezer Storage Stability of Methomyl in Broccoli:
Lab Project Number: AMR/1765/90:ML90/0184/DUP. Unpublished study
prepared by Du Pont Agricultural Products, Experimental Station and Morse Labs,
Inc. 40 p.
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43081602 Kennedy, C.; Devine, P. (1993) Freezer Storage Stability of Methomyl in Oranges:
Lab Project Number: AMR/1767/90:ML90/0185/DUP. Unpublished study
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Project Number: AMR/2217/91: SC910218. Unpublished study prepared by E.I.
Du Pont Experimental Station and Battelle. 217 p.
43157801 Kennedy, C.; Devine, P. (1993) Freezer Storage Stability of Methomyl in Lettuce:
Lab Project Number: AMR 1764-90:ML90-0183-DUP. Unpublished study
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43188101 Kennedy, C.; Devine, P. (1994) Freezer Storage Stability of Methomyl in
Potatoes: Lab Project Number: AMR 1762-90. Unpublished study prepared by
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43188102 Kennedy, C.; Devine, P. (1994) Freezer Storage Stability of Methomyl in Dry Bulb
Onions: Lab Project Number: AMR 1763-90. Unpublished study prepared by E.I.
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43188103 Ruhl, J.; Devine, P. (1994) Freezer Storage Stability of Methomyl in Corn: Lab
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43188104 Kennedy, C.; Devine, P. (1994) Freezer Storage Stability of Methomyl in Sorghum
Forage: Lab Project Number: AMR 1771-90. and McKenzie Labs., Inc. 46 p.
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Madera, California Soil: Final Report: Lab Project Number: SC890027:
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Supplement: Lab Project Number: AMR/1921/91: ML91/02420DUP: 9100135.
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43325403 Bromilow, R.; Briggs, G.; Williams, M. et al. (1986) The role of ferrous ions in the
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43346801 Ruehl, J.; Devine, P. (1994) Magnitude of the Residues of Methomyl in Sugarbeet
Foliage Following Application of Lannate LV Insecticide: Lab Project Number:
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43358901 Ruhl, J.; Devine, P. (1994) Magnitude of Residues of Methomyl in Soybean Hay
following Application of Lannate Insecticide at Maximum Label Rates: Lab
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43359401 Kennedy, C.; Devine, P. (1994) Magnitude of Residues of Methomyl in Dust
Derived from Wheat Grain Treated with Lannate Insecticide: Lab Project Number:
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AMR 2350-92: ML94-0451-DUP. Unpublished study prepared by E. I. du Pont
de Nemours and Co.; Texas A&M University.; Morse Labs Inc.; USD A. 88 p.
43359402 Kennedy, C.; Devine, P. (1994) Magnitude of Residues of Methomyl in Sorghum
Grain Dust following Application of Lannate Insecticide to a Sorghum Crop: Lab
Project Number: AMR 2652-93: ML94-0452-DUP. Unpublished study prepared
by E. I. du Pont de Nemours and Co.; Texas A&M University.; Morse Labs, Inc.;
USDA. 89 p.
43415201 Kennedy, C.; Devine, P. (1994) Magnitude of Residues of Methomyl Insecticide in
Broccoli and Cauliflower: Supplement No. 1: Lab Project Number: AMR
1600-90: ML90-0196-DUP. Unpublished study prepared by DuPont Agricultural
Products and Morse Labs, Inc. 51 p.
43432001 Tomic, D. (1994) Magnitude of Residues of Methomyl in Field Peas Following
Application of Lannate Insecticide at Maximum Label Rates: Lab Project Number:
ML94-0461-DUP: AMR 2566-93. Unpublished study prepared by E.I. du Pont de
Nemours and Co.; Morse Labs. Inc. 64 p.
43432002 Ruehl, J.; Clark, S. (1994) Enforcement Method for the Determination of
Methomyl in Dry Pea Seed and Hay, Sorghum Forage and Hay, Soybean Hay, and
Sugar Beet Foliage: Lab Project Number: AMR 3015-94. Unpublished study
prepared by Morse Labs, Inc. 68 p.
43432003 Grigor, A. (1994) Independent Laboratory Validation of a Proposed Enforcement
Analytical Method for the Determination of Methomyl in Dry Pea Seed and Hay,
Sorghum Forage and Hay and Sugar Beet Foliage by HPLC with Post-Column
Derivatization and Fluorescence Detection: Revision No. 1: Lab Project Number:
941101 :AMR 3077-94. Unpublished study prepared by ChemAnalysis, Inc. 121 p.
43568301 Russell, M.; Hiscock, A.; DeMartinis,; J. et al. (1995) A Small-Scale Prospective
Groundwater Monitoring Study for Methomyl: Final Report: Lab Project Number:
AMR/2311/92: ML92/0335/DUP: 423/04. Unpublished study prepared by
Blasland, Bouck & Lee, Inc. and other facilities. 619 p.
43599801 Russell, M.; Bergstrom, L. (1995) Modeling of the Results from a Small-Scale
Prospective Groundwater Study for Methomyl: Lab Project Number: 423.13:
AMR 3405-95. Unpublished study prepared by Blasland, Bouck & Lee, Inc. and
DuPont Agricultural Products. 136 p.
192
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43708801 Naylor, M.; Palmer, D.; Krueger, H. (1994) An Aquatic Residue Monitoring Study
of Methomyl in and Around Apple Orchards in Michigan: Lab Project Numbers:
112-292: AMR 2278-92: 91-4-3722. Unpublished study prepared by DuPont
Agricultural Products; Morse Labs.; and Wildlife Int'l. Ltd. 555 p.
43708802 Leva, S. (1995) An Aquatic Residue Monitoring Study of Lannate L Insecticide in
and Around Sweet Corn Fields in Illinois. Unpublished study prepared by DuPont
Agricultural Products; Morse Labs.; and Wildlife Int'l. Ltd. 584 p.
43708803 Armbrust, K. (1995) An Aquatic Residue Monitoring Study of Methomyl in and
Around Cucurbit Fields in California: Lab Project Numbers: AMR 2469-92:
92195: ML93-0445-DUP. Unpublished study prepared by DuPont Agricultural
Products; Morse Labs.; and ABC Labs., Inc. 432 p.
43708804 Leva, S.; McKelvey, S. (1995) An Aquatic Residue Monitoring Study of
Methomyl in and Around Lettuce Fields in Florida: Lab Project Numbers: AMR
2512-92: ML93-0423-DUP: 112-333. Unpublished study prepared by DuPont
Agricultural Products; Morse Labs.; and Wildlife Int'l, Inc. 475 p.
43708805 Ruehl, J. (1995) Dissipation of Methomyl on Plastic Ground Cover Following
Multiple Applications of Lannate L Insecticide to Tomato: Lab Project Number:
AMR 2346-92. Unpublished study prepared by DuPont Agricultural Products.
189 p.
43708806 Ryan, D. (1995) Behavior of Methomyl in Stream, Canal, Ditch, and Pond
Sediments: Lab Project Number: AMR 3381-95. Unpublished study prepared by
DuPont Agricultural Products. 67 p.
43708807 Ruehl, J.; Devine, P. (1994) Storage Stability of Methomyl in Soil and Water: Lab
Project Number: AMR 2204-91: ML91-0272-DUP: 91-4-3722. Unpublished
study prepared by DuPont Agricultural Products and Morse Labs., Inc. 98 p.
43741801 Dietrich, R.; Charlton, R.; Ryan, D.; et al. (1995) The Metabolism of (carbon
14)-Methomyl in the Lactating Goat: Lab Project Number: AMR 2701-93:
SC930210. Unpublished study prepared by DuPont Agricultural Products and
Battelle. 366 p.
43744401 Leva, S.; McKelvey, S. (1995) An Aquatic Residue Monitoring Study of
Methomyl in and Around a Sweet Corn Field in Georgia: Lab Project Number:
AMR 2513-92: ML93-0424: 112-335. Unpublished study prepared by Morse Labs
and Wildlife International Ltd. 395 p.
193
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43744402 Samel, A. (1995) An Evaluation of the Effects and Fate of Methomyl Insecticide
Exposure in Outdoor Microcosms: Lab Project Number: AMR 2389-92:
ML93-0445-DUP: 112-299. Unpublished study prepared by Morse Labs and
Wildlife International, Ltd. 877 p.
43756601 Kennedy, C.; Orescan, D. (1995) Magnitude of Residues of Methomyl Insecticide
in Alfalfa Forage and Hay: Lab Project Number: AMR 2137-92. Unpublished
study prepared by DuPont Agricultural Products and McKenzie Labs, Inc. 317 p.
43807401 Ruehl, J. (1995) Magnitude of Residues of Methomyl in Sorghum Forage and Hay
Following Multiple Applications of Lannate L Insecticide: Supplement No. 1: Lab
Project Number: AMR 2343-92: ML94-0494-DUP: 2343-92. Unpublished study
prepared by Morse Labs, Inc.; McKenzie Labs, Inc.; and DuPont Agricultural
Products. 58 p.
43823302 Williams, W.; Ritter, A.; Cheplick, J.; et al. (1995) Probabilistic Modeling of
Methomyl Exposure to Aquatic Nontarget Organisms Associated with Lannate
Use on Sweet Corn: Lab Project Number: WEI 387.07: AMR 3573-95.
Unpublished study prepared by Waterborne Environmental, Inc. 334 p.
43823303 Williams, W.; Ritter, A.; Cheplick, J.; et al. (1995) Probabilistic Modeling of
Methomyl Exposure to Aquatic Nontarget Organisms Associated with Lannate
Use on Apples: Lab Project Number: WEI 387.06: AMR 3574-95. Unpublished
study prepared by Waterborne Environmental, Inc. 177 p.
43823304 Layton, R. (1995) Modeling of Methomyl Exposure to Aquatic Non-Target
Organisms Associated with Lannate Use on Irrigated Cantaloupe: Lab Project
Number: AMR 3648-95: 94-200. Unpublished study prepared by DuPont
Agricultural Products. 82 p.
43823305 Armbrust, K.; Reilly, D. (1995) Indirect Photodegredation of Methomyl in
Aqueous Solutions: Lab Project Number: AMR 2975-94. Unpublished study
prepared by DuPont Agricultural Products. 103 p.
43833301 Daun, R. (1995) Magnitude of the Residues of Methomyl in Edible Tissues and
Milk of Lactating Dairy Cows: Final Report: Lab Project Number: HWI 6129-187:
AMR 2964-94: 6129-187. Unpublished study prepared by Hazleton Wisconsin,
Inc. 313 p.
44047701 Hausmann, S.; Devine, P. (1993) Magnitude of Residues of Methomyl Insecticide
in Citrus Fruit When Applied at the Maximum Proposed Use Pattern and Sampled
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Over Time: Lab Project Number: AMR 1967-91: ML91-0229-DUP. Unpublished
study prepared by E.I. du Pont de Nemours and Co. and Morse Laboratories, Inc.
104 p.
44047702 Kennedy, C.; Tomic, D. (1994) Magnitude of Residues of Methomyl Insecticide in
Peach and Nectarine When Applied at the Maximum Proposed Use Pattern and
Sampled Over Time: Lab Project Number: AMR 1968-91: 1968-91:
LAN-1968-91. Unpublished study prepared by E.I. du Pont de Nemours and Co.
and McKenzie Laboratories,Inc. 182 p.
44047703 Bentley, K. (1995) Mouse Bone Marrow Micronuclues Assay of DPX-X1179-
394: Lab Project Number: 10210-001: 413-95: HLR 413-95. Unpublished study
prepared by E.I. du Pont de Nemours and Co. 22p.
44073001 Kennedy, C. (1996) Magnitude of Residues of Methomyl in Grain Sorghum
Fodder Following Application of Lannate LV Insecticide at Maximum Label
Rates: Lab Project Number: AMR 3298-95: ML95-0578-DUP. Unpublished
study prepared by Dupont Ag Products and Morse Labs., Inc. 143 p.
44327201 Kidwell, J.; Barraj, L. (1997) Chronic and Acute Dietary Exposure Assessment:
Methomyl: Lab Project Number: METHOMYL 97-01. Unpublished study
prepared by Novigen Sciences, Inc. 221 p.
44327202 Kidwell, J.; Barraj, L. (1997) Chronic and Acute Dietary Exposure Assessment:
Combined Thiodicarb and Methomyl Residues: Lab Project Number:
THIODICARB/METHOMYL 97-01. Unpublishedstudy prepared by Novigen
Sciences, Inc. 79 p.
44360701 Kidwell, J. (1997) Supplemental Report: Chronic and Acute Dietary Exposure
Assessment: Methomyl: Lab Project Number: METHOMYL
97-01-SUPPLEMENTAL REPORT. Unpublished study prepared by Novigen
Sciences, Inc. 93 p.
44360702 Kidwell, J. (1997) Supplemental Report: Chronic and Acute Dietary Exposure
Assessment: Thiodicarb and Methomyl Combined Residues: Lab Project Number:
THIODICARB/METHOMYL 97-01 A- SUPPLEMENTAL REPORT.
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Study in Rabbits: Lab Project Number: 11586: HL-1997-00913: 11586-001.
Unpublished study prepared by Haskell Laboratory. 145 p.
195
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
? WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must respond as
set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2. All products are listed on both the generic
and product specific Data Call-In Response Forms. Also included is a list of all registrants who
were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Formsflnsert A)
with Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status and
Registrant's Response Forms (Insert B) with Instructions
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - List of Registrants Receiving This Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safely of the continued use of
products containing this active ingredient(s). You have been sent this Notice because you have
product(s) containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms (Insert B) (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in the Requirements Status and Registrant's Response Forms (Insert B) within
the time frames provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161
(Telephone number: 703-605-6000).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR § 158. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c}(2}(B} NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(s). or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their
affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is specified
in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
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III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this
Notice. Failure to adequately respond to this Notice within 90 days of your receipt will be
a basis for issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and
other bases for issuance of NOIS due to failure to comply with this Notice are presented
in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to
satisfy the generic data requirements imposed by this Notice or (e) request a data
waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the generic data requirements of
this Notice is contained in Section III-C. A discussion of options relating to requests for
data waivers is contained in Section III-D.
Two forms apply to generic data requirements, one or both of which must be used
in responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Formdnsert A), and the Requirements Status and Registrant's
Response Formfdnsert B).
The Data Call-In Response Formsdnsert A) must be submitted as part of every response
to this Notice. The Requirements Status and Registrant's Response Formsdnsert B) also must be
submitted if you do not qualify for a Generic Data Exemption or are not requesting voluntary
cancellation of your registration(s). Please note that the company's authorized representative is
required to sign the first page of both Data Call-In Response Formsdnsert A) and the
Requirements Status and Registrant's Response Formsdnsert B) and initial any subsequent pages.
The forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed Generic and Product Specific Data
Call-In Response Formsdnsert A), indicating your election of this option. Voluntary cancellation
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is item number 5 on both Data Call-In Response Form(s). If you choose this option, these are the
only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product to
which the requirements apply. If you wish to amend your registration to delete uses, you must
submit the Requirements Status and Registrant's Response Form (Insert B), a completed
application for amendment, a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option number 7 under item 9 in the
instructions for the Requirements Status and Registrant's Response Forms (Insert B). You must
also complete a Data Call-In Response Formdnsert A) by signing the certification, item number 8.
Application forms for amending registrations may be obtained from the Registration Support
Branch, Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date of
your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exempt
from the requirement to submit or cite generic data concerning an active ingredient if the active
ingredient in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not suspend the registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your product
subject to this DCI must be in compliance with the requirements of this Notice and must
remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement of
Formula" for each of your products to which this Notice applies.
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To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Formflnsert A), Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-In Response Formflnsert A). If you claim a generic
data exemption you are not required to complete the Requirements Status and Registrant's
Response Form (Insert A). Generic Data Exemption cannot be selected as an option for
responding to product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(s) who have committed to generate
and submit the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Data Call-In Notice, the Agency will consider that both they and you are
not compliance and will normally initiate proceedings to suspend the registrations of both your
and their product(s), unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this Notice.
These options are discussed in Section III-C.l. of this Notice and comprise options 1 through 6 of
item 9 in the instructions for the Requirements Status and Registrant's Response Formflnsert B)
and item 6b on the Data Call-In Response Form (Insert A). If you choose item 6b (agree to
satisfy the generic data requirements), you must submit the Data Call-In Response Formflnsert A)
and the Requirements Status and Registrant's Response Form (Insert B) as well as any other
information/data pertaining to the option chosen to address the data requirement. Your response
must be on the forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are covered
by options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
Response Formflnsert B). If you choose one of these options, you must submit both forms as well
as any other information/data pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice or
(c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.2. A discussion of options relating
to requests for data waivers is contained in Section III-D.2.
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Two forms apply to the product specific data requirements one or both of which must be
used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Formdnsert A), and the Requirements Status and Registrant's Response
Formdnsert B), for product specific data. The Data Call-In Response Form (Insert A) must be
submitted as part of every response to this Notice. In addition, one copy of the Requirements
Status and Registrant's Response Formdnsert B) also must be submitted for each product listed
on the Data Call-In Response Formdnsert A) unless the voluntary cancellation option is selected.
Please note that the company's authorized representative is required to sign the first page of the
Data Call-In Response Formdnsert A) and Requirements Status and Registrant's Response Form
(Insert B) (if this form is required) and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the printed material. If you have
questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data Call-In Response Formdnsert
A), indicating your election of this option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Formsdnsert B). If you choose this option,
you must complete both Data Call-In response forms. These are the only forms that you are
required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of this
Notice. These options are discussed in Section III-C. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Formdnsert B) and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data Call-In
Response Formdnsert A). Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements. Deletion of
a use(s) and the low volume/minor use option are not valid options for fulfilling product specific
data requirements. It is important to ensure that you are using the correct forms and instructions
when completing your response to the Reregistration Eligibility Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
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Response Formdnsert B). If you choose this option, you must submit the Data Call-In Response
Form (Insert A) and the Requirements Status and Registrant's Response Form (Insert B) as well as
any other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Formdnsert A) that you agree
to satisfy the generic data requirements (i.e. you select item number 6b), then you must select one
of the six options on the Generic Requirements Status and Registrant's Response Formdnsert B)
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for completing the Requirements Status
and Registrant's Response Form. These six options are listed immediately below with information
in parentheses to guide you to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
guidelines and with other Agency requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be in
conformance with the requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which a protocol must
be submitted have been identified in the Requirements Status and Registrant's Response
Formdnsert B) and/or footnotes to the form. If you wish to use a protocol which differs from the
options discussed in Section II-C of this Notice, you must submit a detailed description of the
proposed protocol and your reason for wishing to use it. The Agency may choose to reject a
protocol not specified in Section II-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will not be a basis
for extending the deadline for submission of data.
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A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study requirement,
such as making an offer to cost share or agreeing to share in the cost of developing that study.
This 90-day progress report must include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name and address of the
laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other information
specified in the preceding paragraph, at a minimum, a brief description of current activity on and
the status of the study must be included as well as a full description of any problems encountered
since the last progress report.
The time frames in the Requirements Status and Registrant's Response Formflnsert B) are
the time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant. If
the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your request,
the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions will
not be given in submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension request be considered
if it is submitted at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant who
will be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an agreement and
the other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you may
request EPA (by selecting this option) to exercise its discretion not to suspend your
regi strati on(s), although you did not comply with the data submission requirements of this Notice.
EPA has determined that as a general policy, absent other relevant considerations, it will not
suspend the registration of a product of a registrant who has in good faith sought and continues to
seek to enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept the offer. To qualify for this option, you must submit
documentation to the Agency proving that you have made an offer to another registrant (who has
an obligation to submit data) to share in the burden of developing that data. You must also submit
to the Agency a completed Certification with Respect to Citations of Data (in PR Notice 98-5)
(EPA Form 8570-34) . In addition, you must demonstrate that the other registrant to whom the
offer was made has not accepted your offer to enter into a cost-sharing agreement by including a
copy of your offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of producing
the data upon terms to be agreed to or, failing agreement, to be bound by binding arbitration as
provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant
must also inform EPA of its election of an option to develop and submit the data required by this
Notice by submitting a Data Call-In Response Formflnsert A) and a Requirements Status and
Registrant's Response Formflnsert B) committing to develop and submit the data required by this
Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burden of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant normally will be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit, the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must determine
that the study satisfies the requirements imposed by this Notice. You may only submit a study that
has not been previously submitted to the Agency or previously cited by anyone. Existing studies
are studies which predate issuance of this Notice. Do not use this option if you are submitting
data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
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To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3, Raw data means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3, means "any material derived
from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all
GLP-required quality assurance and quality control information pursuant to the
requirements of 40 CFR Part 160. Registrants also must certify at the time of
submission of the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregi strati on Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
documents available from NTIS). A study not conducted according to the PAG
may be submitted to the Agency for consideration if the registrant believes that the
study clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
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If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such a study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5 entitled "Standard Format for Data Submitted
under FIFRA".
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit data
to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still be
required to submit new data normally without any time extension. Deficient, but upgradeable
studies will normally be classified as supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the contact person
listed in Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply
information to correct all deficiencies in the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with PR Notice 86-5
entitled "Standard Format for Data Submitted under FIFRA."
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally, your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria, as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable, or it must be a study which has not yet been
reviewed by the Agency. Acceptable toxicology studies generally will have been classified as
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"core-guideline" or "core-minimum." For ecological effects studies, the classification generally
would be a rating of "core." For all other disciplines the classification would be "acceptable." With
respect to any studies for which you wish to select this option, you must provide the MRID
number of the study you are citing and, if the study has been reviewed by the Agency, you must
provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form No. 8570-34, Certification with Respect to Citations of Data.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In Response Formflnsert A) that
you agree to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then
you must select one of the six options on the Requirements Status and Registrant's Response
Form (Insert B) related to data production for each data requirement. Your option selection
should be entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form (Insert B). These six options are listed
immediately below with information in parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data - The requirements for developing product specific data are the same
as those described for generic data (see Section III.C.l, Option 1) except that normally no
protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost share,
the same requirements apply to product specific data as to generic data (see Section III.C.l,
Option 2). However, registrants may only choose this option for acute toxicity data and certain
efficacy data and only if EPA has indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group. The registration number of the
product for which data will be submitted must be noted in the agreement to cost share by the
registrant selecting this option.
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Option 3. Offer to Share in the Cost of Data Development —The same requirements for generic
data (Section III.C.L, Option 3) apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study - The same requirements described for generic data (see
Section III.C.l., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
III.C.l., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C.l., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Formflnsert A) and the
Requirements Status and Registrant's Response Form (Insert B), and in the generic data
requirements section (III.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Formdnsert B). Section 3(c)(2)(A) of FIFRA requires EPA to consider the
appropriateness of requiring data for low volume/minor use pesticides. In implementing
this provision, EPA considers low volume pesticides to be only those active ingredients
whose total production volume for all pesticide registrants is small. In determining
whether to grant a low volume, minor use waiver, the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the testing, the importance
of the pesticide, and the exposure and risk from use of the pesticide. If an active ingredient
is used for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient are low volume and the combined volumes for
all uses are also low, then an exemption may be granted, depending on review of other
information outlined below. An exemption will not be granted if any registrant of the
active ingredient elects to conduct the testing. Any registrant receiving a low
volume/minor use waiver must remain within the sales figures in their forecast supporting
the waiver request in order to remain qualified for such waiver. If granted a waiver, a
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registrant will be required, as a condition of the waiver, to submit annual sales reports.
The Agency will respond to requests for waivers in writing.
To apply for a low volume/minor use waiver, you must submit the following information,
as applicable to your product(s), as part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign sales
for those products that are not registered in this country but are applied to sugar (cane or
beet), coffee, bananas, cocoa, and other such crops. Present the above information by year
for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient
for each major use site. Present the above information by year for each of the past five
years.
(iii) Total direct production cost of product(s) containing the active ingredient by
year for the past five years. Include information on raw material cost, direct labor cost,
advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past five
years. Exclude all non-recurring costs that were directly related to the active ingredient,
such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the type
of waiver sought and the estimated cost to you (listed separately for each data requirement
and associated test) of conducting the testing needed to fulfill each of these data
requirements.
(vi) A list of each data requirement for which you are not seeking any waiver and
the estimated cost to you (listed separately for each data requirement and associated test)
of conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the parameters
in item 3 above), and costs of data development pertaining to the active ingredient.
(viii) A description of the importance and unique benefits of the active ingredient
to users. Discuss the use patterns and the effectiveness of the active ingredient relative to
registered alternative chemicals and non-chemical control strategies. Focus on benefits
unique to the active ingredient, providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then present the
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reasoning used to derive your estimates. To assist the Agency in determining the degree of
importance of the active ingredient in terms of its benefits, you should provide information
on any of the following factors, as applicable to your product(s): (a) documentation of the
usefulness of the active ingredient in Integrated Pest Management, (b) description of the
beneficial impacts on the environment of use of the active ingredient, as opposed to its
registered alternatives, (c) information on the breakdown of the active ingredient after use
and on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request
for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should not
apply because the requirement is inappropriate. You must submit a rationale explaining
why you believe the data requirements should not apply. You also must submit the current
label(s) of your product(s) and, if a current copy of your Confidential Statement of
Formula is not already on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice are not appropriate to your product(s), you will
not be required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that
the data are required for your product(s). you must choose a method of meeting the
requirements of this Notice within the time frame provided by this Notice. Within 30 days
of your receipt of the Agency's written decision, you must submit a revised Requirements
Status and Registrant's Response Form indicating the option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note:
any supplemental data must be submitted in the format required by PR Notice 86-5). This
will be the only opportunity to state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not be required to supply
the data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver
request, you must choose an option for meeting the data requirements of this Notice
within 30 days of the receipt of the Agency's decision. You must indicate and submit the
option chosen on the product specific Requirements Status and Registrant's Response
Form (Insert B). Product specific data requirements for product chemistry, acute toxicity
and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that
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submitting a waiver request will not automatically extend the due date for the study in
question. Waiver requests submitted without adequate supporting rationale will be denied
and the original due date will remain in force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. Inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-In Response Formflnsert A) and a Requirements Status and
Registrant's Response Formflnsert B).
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b. Fulfill the commitment to develop and submit the data as required by this
Notice; or
c. Otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified time
frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment Guidelines,
Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the
design, conduct, and reporting of required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures, selection of species, number of
animals, sex and distribution of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this Notice
or contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
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clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You also must explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden, the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily
cancelled products containing an active ingredient for which the Agency has particular risk
concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due, unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3-year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice must include completed Data Call-In Response Forms (Insert
A)and completed Requirements Status and Registrant's Response Forms (Insert B), for both
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(generic and product specific data) and any other documents required by this Notice, and should
be submitted to the contact person(s) identified in Attachment 1. If the voluntary cancellation or
generic data exemption option is chosen, only the Generic and Product Specific Data Call-In
Response Formsflnsert A) need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status and
Registrant's Response Forms with Instructions
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - List of Registrants Receiving This Notice
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METHOMYL DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing methomyl.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of methomyl.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2)
the Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements Status and
Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), and (5) a list of registrants receiving this DCI
(Attachment 5).
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for methomyl are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on methomyl are needed for specific products. These data are required to be submitted
to the Agency within the time frame listed. These data are needed to fully complete the reregistration
of all eligible methomyl products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Bonnie Adler at (703) 308-8523.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Bonnie Adler
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Methomyl
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METHOMYL DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s) containing
methomyl.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required by
this notice, and point of contact for inquiries pertaining to the reregi strati on of methomyl. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data
Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
(Attachment 3), and (4) a list of registrants receiving this DCI (Attachment 5).
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for methomyl are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional product chemistry data on methomyl are needed. These data are needed
to fully complete the reregi strati on of all eligible methomyl products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Tom Myers at (703) 308-8589.
All responsades to this Notice for the generic data requirements should be submitted to:
Tom Myers, Chemical Review Manager
Reregi strati on Branch II
Special Review and Registration Division (7508C)
Office of Pesticiafde Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Methomyl
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Generic and PDCI sample Part A form page number 1 in the actual Printed version of the Red
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Generic and PDCI sample Part A form page number 2 in the actual Printed version of the Red
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
(Insert A) and are to be used by registrants to respond to generic and product specific Data
Call-Ins as part of EPA's Reregi strati on Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI letter
as part of a RED document you have been sent just the product specific "Data Call-In Response
Forms."(Insert A) Only registrants responsible for generic data have been sent the generic data
response form. The type of Data Call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out the
forms.
EPA has developed these forms individually for each registrant, and has preprinted these forms
with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by the
registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to Chief, Information Policy Branch,
Mail Code 2137, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C.
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
INSERT A
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
ItemS. ON BOTH FORMS: This item identifies the type of Data Call-In. The date of
issuance is date stamped.
Item 4. ON BOTH FORMS: This item identifies the EPA product registrations relevant
to the data call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be covered
by this Data Call-In but that is not listed by the Agency in Item 4. You must bring
any such apparent omission to the Agency's attention within the period required
for submission of this response form.
Item 5. ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of that
request. Since this Data Call-In requires both generic and product specific data,
you must complete item 5 on both Data Call-In response forms. You do not need
to complete any item on the Requirements Status and Registrant's Response Forms
(Insert B)
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data
Exemption for the chemical listed in Item 2 and used in the subject product. By
electing this exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you use
in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and any other outstanding Data Call-In Notice), and incorporate that product
into all your products, you may complete this item for all products listed on this
form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
INSERT A
Generic and Product Specific Data Call-In
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic
data requirements of this Data Call-In. Attach the Requirements Status and
Registrant's Response Formflnsert B) that indicates how you will satisfy those
requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if
your product is identical to another product and you qualify for a data exemption.
You must provide the EPA registration numbers of your source(s); do not
complete the Requirements Status and Registrant's Response form. Examples of
such products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you must
respond with option 7 (Waiver Request) for each study for which you are
requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
INSERT A CONTINUED
Generic and Product Specific Data Call-In
ItemS. ON BOTH FORMS: This certification statement must be signed by an
authorized representative of your company and the person signing must include
his/her title. Additional pages used in your response must be initialed and dated in
the space provided for the certification.
Item 9. ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does notfrtonthisform in asignedletterthataccompaniesyour response. For example,
you may wish to reportthatyourproduct has already been transferred to another company orthat you have already voluntarily canceled
this product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.
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Generic and PDCI sample Part B form page number 1 in the actual Printed version of the Red
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Generic and PDCI sample Part B form page number 2 in the actual Printed version of the Red
document
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Generic and PDCI sample Part B form page number 3 in the actual Printed version of the Red
document
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This page has been inserted as a place marker and is replaced by an electronically generated
Generic and PDCI sample Part B form page number 4 in the actual Printed version of the Red
document
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This page has been inserted as a place marker and is replaced by an electronically generated
Generic and PDCI sample Part B form page number 5 in the actual Printed version of the Red
document
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This page has been inserted as a place marker and is replaced by an electronically generated Generic
and PDCI sample Part B form page number 6 in the actual Printed version of the Red document
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Instructions For Completing The "Requirements Status and Registrant's Response
Forms" (Insert B) For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and product
specific Data Call-in's as part of EPA's reregi strati on program under the Federal Insecticide,
Fungicide, and Rodenticide Act. If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms." Only registrants responsible for generic
data have been sent the generic data response forms. The type of Data Call-in (generic or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use
waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms to include certain information unique to this chemical. DO NOT use these forms for any
other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, Mail Code 2137, U.S. Environmental Protection Agency, 401 M St., S.W., Washington,
D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Project
2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS" (Insert B)
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number, case
name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the case
number, case name, and the EPA Registration Number of the product for which
the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
of Data Call-In. The date of issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This ID number must be used in
the transmittal document for any data submissions in response to this Data Call-In
Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in the
Data Call-In Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section III of the Data Call-In Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Formdnsert B).
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS" (Insert B) continued
Generic and Product Specific Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use sites
and/or pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance that
must be used for testing. A brief description of each code follows:
EUP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Indredient or Pute Active
Ingredient Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product
TEP % Typical End-Use Product, Percent Active Ingredient
Specified
TEP/MET Typical End-Use Product and Metabolites
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TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI/TEP Technical Grade Active Ingredient or Typical End-Use
Product
MET Metabolites
IMP Impurities
DEGR Degradates
* See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of your
receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for submission
of product specific studies begins from the date stamped on the letter transmitting
the Reregistration Eligibility Decision document, and not from the date of receipt.
However, your response to the Data Call-In itself is due 90 days from the date of
receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of each
code follow. The Data Call-In Notice contains a fuller description of each of these
options.
Option 1. ON BOTH FORMS: (Developing Data^) I will conduct a new study and
submit it within the time frames specified in item 8 above. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-In Notice and that I will provide the protocols and
progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Shared I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with all
the requirements pertaining to sharing in the cost of developing data as
outlined in the Data Call-In Notice.
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However, for Product Specific Data, I understand that this option
is available for acute toxicity or certain efficacy data ONLY if the Agency
indicates in an attachment to this notice that my product is similar enough
to another product to qualify for this option. I certify that another party in
the agreement is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to
suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Shared I have made an offer to enter
into an agreement with one or more registrants to develop data jointly. I
am also submitting a completed "Certification of offer to Cost Share in the
Development of Data" form. I am submitting evidence that I have made an
offer to another registrant (who has an obligation to submit data) to share
in the cost of that data. I am including a copy of my offer and proof of the
other registrant's receipt of that offer. I am identifying the party which is
committing to submit or provide the required data; if the required study is
not submitted on time, my product may be subject to suspension. I
understand that other terms under Option 3 in the Data Call-In Notice
apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and only if
the Agency indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date that has never before been
submitted to EPA. By indicating that I have chosen this option, I certify
that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data Call-In Notice and I have
attached the needed supporting information along with this response.
Options. ON BOTH FORMS: (Upgrading a Studv^) I will submit by the specified
due date, or will cite data to upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable. By indicating that I have
chosen this option, I certify that I have met all the requirements pertaining
to the conditions for submitting or citing existing data to upgrade a study
described in the Data Call-In Notice. I am indicating on attached
correspondence the Master Record Identification Number (MRID) that
EPA has assigned to the data that I am citing as well as the MRID of the
study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Studv^) I am citing an existing study that
has been previously classified by EPA as acceptable, core, core minimum,
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or a study that has not yet been reviewed by the Agency. If reviewed, I am
providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand that this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
conducted on my product, an identical product or a product which the
Agency has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my
own data. In either case, I will provide the MRID or Accession number (s).
If I cite another registrant's data, I will submit a completed "Certification
With Respect To Data Compensation Requirements" form.
FOR THE GENERIC DATA FORM ONLY: The following three options (Numbers
7, 8, and 9) are responses that apply only to the "Requirements Status and
Registrant's Response Form" (Insert B) for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I am
attaching a detailed justification to support this waiver request including,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching a
rationale explaining why I believe the data requirements do not apply. I am
also submitting a copy of my current labels. (You must also submit a copy
of your Confidential Statement of Formula if not already on file with EPA).
I understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a response
that applies to the "Requirements Status and Registrant's Response Form" (Insert
B) for product specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate for my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data must
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be submitted in the format required by P.R. Notice 86-5]. I understand that
this is my only opportunity to state the reasons or provide information in
support of my request. If the Agency approves my waiver request, I will
not be required to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method
of meeting the data requirements of this Notice by the due date stated by
this Notice. In this case, I must, within 30 days-of my receipt of the
Agency's written decision, submit a revised "Requirements Status" form
specifying the option chosen. I also understand that the deadline for
submission of data as specified by the original Data Call-In notice will not
change.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative of
your company. The person signing must include his/her title, and must initial and
date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that doesnotfitonthisform in asignedletterthataccompaniesthisyour response. For example, you may wishto report
that yourproduct has already been transferred to another company orthat you have already voluntarily cancelled this product. Forthese cases, please supply all
relevant details so that the Agency can ensure that its records are correct.
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ERA'S BATCHING OF PRODUCTS CONTAINING METHOMYL AS THE
ACTIVE INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS
FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing the active ingredient S-Methyl
N-((methylcarbamoyl) oxy) thioacetimidate, the Agency has batched products which can be
considered similar in terms of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition and biological activity), product
form (liquid, paste, solid, etc.), and labeling (e.g., signal word, precautionary labeling, etc.).
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch.
Registrants have the option of participating with all or some other registrants of products in their
product's batch, to deal only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he or she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he or she may do so provided that the
data base is complete and valid by today's standards (see the attached acceptance criteria), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Registrants may
not support their product using data conducted on a product from a different batch. EPA must
approve any new or canceled formulations (that were presented to the Agency after the publication
of the RED) before data derived from them can be used to cover other products in a batch.
Regardless of whether new data is generated or existing data is referenced, registrants must clearly
identify the test material by EPA Registration Number. If more than one confidential statement of
formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by
identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days
of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A registrant who wishes to participate in a batch must decide whether he or she will provide the data
or depend on someone else to do so. If a registrant supplies the data to support a batch of products,
he or she must select one of the following options: Developing Data (Option 1), Submitting an
Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study
(Option 6). If a registrant depends on another's data, he or she must choose among: Cost Sharing
(Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant
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does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant
should know that choosing not to participate in a batch does not preclude other registrants in the
batch from citing his or her studies and offering to cost share (Option 3) those studies.
Table 1 displays the batches for the active ingredient methomyl.
Table 1.
Batch
1
Registration
Number
352-342
352-361
352-366
CA77030800
CA77049500
CA78013600
CAS 1000700
CAS 1000701
CAS 1000702
CA85005200
CA86005900
CA88001400
CA90003400
CA9 100 1000
CA91001100
DE80000900
FL78003700
Percent Active Ingredient
methomyl ... 90%
methomyl ... 90%
methomyl ... 98.7%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
Form
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
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Batch
Registration
Number
FL78005500
FL82001400
LA95001600
NJ94000900
OR78000400
PA93 000200
TX93 002200
WV93000300
Percent Active Ingredient
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
methomyl ... 90%
Form
solid
solid
solid
solid
solid
solid
solid
solid
2
352-384
FL88000400
IL83001900
LA95001700
TX92001100
methomyl ... 29%
methomyl ... 29%
methomyl ... 29%
methomyl ... 29%
methomyl ... 29%
liquid
liquid
liquid
liquid
liquid
3
270-255
1203-69
2724-274
7319-6
53871-3
67517-25
methomyl ... 1.000%
methomyl ... 1.225%
methomyl ... 1.000%
methomyl ... 1.000%
methomyl ... 1.000%
methomyl 1.000%
solid
solid
solid
solid
solid
solid
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Batch
4
Registration
Number
34704-301
45735-15
Percent Active Ingredient
methomyl ... 2.000%
methomyl ... 2.00%
Form
solid
solid
5
9779-331
57242-2
methomyl ... 5%
methomyl ... 5%
solid
solid
Table 2 lists the products in the "No Batch" group. These products can not be batched because they
were not considered to be similar to other the products in terms of acute toxicity. The registrant of
this product is responsible for meeting the acute toxicity data requirements for it individually. These
products may not cite acute toxicity/ irritation data derived from any other products in this RED. The
registrant may cite pre-existing data conducted on their individual product (or data cited in this RED
for the technical product) if it exists and it meets current Agency standards.
Table 2.
Registration
Number
352-270
5481-2802
*5905-487
10163-218
Percent Active Ingredient
methomyl
methomyl
methomyl
methomyl
... 24%
... 2%
... 2%
... 1.5%
Product Type
liquid
solid
solid
solid
*Reg. no. 5905-487 was placed into the "No Batch" group because of a lack of information
concerning the inert ingredient portion of this product. EPA encourages the registrant to submit
information on the inerts of this product to determine if this product can be placed into a batch with
other products.
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This page has been inserted as a place marker and is replaced by an electronically generated PDCI
List of Registrants page number 1 in the actual Printed version of the Red document
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LIST OF AVAILABLE RELATED DOCUMENTS AND ELECTRONICALLY
AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO I/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information'
or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
Forms Required for Responding to the RED:
8570-1
8570-4
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Certification of Attempt to Enter into an
Agreement with other Restraints for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-32.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR_Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
Other Pesticide Registration Forms:
8570-5
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
http://www.epa.gov/opprd001/forms/8570-5.pdf.
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8570-17
8570-25
8570-27
8570-28
8570-30
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
http://www.epa. gov/opprdOO l/forms/8570- 1 7.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
http://www.epa.gov/opprd001/forms/8570-27.pdf.
http://www.epa.gov/opprd001/forms/8570-28.pdf.
http://www.epa.gov/opprd001/forms/8570-30.pdf.
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is
in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat
reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources
of information.
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These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service (NTIS)
the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
at 1-800-858-7378 or through their Web site.
The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:
Date of receipt
EPA identifying number
the Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of receipt
to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying
File Symbol or petition number for the new submission. The identifying number should be used
whenever you contact the Agency concerning an application for registration, experimental use permit,
or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
experimental codes, and other names which identify the chemical (including "blind" codes used when
a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number
if one has been assigned.
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Documents Associated with this RED
The following is a list of available documents for Methomyl that may further assist you
in responding to this Reregi strati on Eligibility Decision document. These documents may be obtained
by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader.
Electronic copies are available on our website at www.epa.gov/REDs, or contact
Tom Myers at (703) 308-8589.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Methomyl.
The following documents are part of the Administrative Record for Methomyl and may be
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the Chemical Status
Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
3. Appendix A - Table of Use Patterns Subject to Reregi strati on
The following Agency reference documents are not available electronically, but may be obtained
by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria.
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