United States Office of Prevention, Pesticides EPA 738-R-94-002
Environmental Protection And Toxic Substances February 1994
Agency (7508W)
v>EPA Reregistration
Eligibility Decision (RED)
Methiocarb 738R94002
Recycled/Recyclable
Printed on paper that contains
at least 50% recycled fiber
SM-X3
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*"* PRO*
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 Methiocarb
which includes the active ingredients 4-methylthio-3,5-xylylmethylcarbamate. The enclosed
Reregistration Eligibility Decision (RED) 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 may also include requirements for additional data (generic) on
the active ingredient(s) 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 are due 90 days from
the date of this letter. Hie second set of required responses are 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.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Karen Jones at 703-308-8047 .
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE TtFttF/lTSTRATION ELIGIBILITY DECISION
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. Complete the
two response forms provided with each DCI letter by following the instructions contained in
each DCI. You must submit the response forms for each product and for each DCI
within 90 days of the date you receive the RED; 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 data waivers must be submitted as part
of the 90-day response. Requests for time extensions should be submitted in the 90-day
response, but certainly no later than the 8-month response date. 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 RttRFaTSTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the RED issuance
date (the cover letter 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 reregistration) separately. You
may delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer 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; 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 (CSF1 for each hasir
each alternate formulation. The labeling and CSF which you submit for each product must
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
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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 Citation of Data. Complete and sign this form
(EPA form 8570-29) for each product. Cite-all is not a valid option for reregistration.
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 ALL PCI RESPONSES (90-DAY) AND APPLICATIONS FOR
REREGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail;
Document Processing Desk (RED-SRRD-0577)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
Bv express;
Document Processing Desk (RED-SRRD-0577)
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 reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY
DECISION DOCUMENT
METfflOCARB
LIST A
CASE 0577
ENmONMENTAL-FROTECTION-AGENCY
OFFICE-OF-FESnCEDE'FROGRAMS
SPECIAL-REVIEW-AND-REREGISTRATION-DIVISION
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TABLE OF CONTENTS
METHIOCARB REREGISTRATION ELIGIBILITY TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 5
D. Regulatory History 5
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 7
c. Chronic toxicity 8
d. Carcinogenicity 9
e. Developmental Toxicity 9
f. Reproductive Toxicity 10
g. Mutagenicity 10
h. Metabolism 11
i. Other Toxic Endpoints 11
j. Other Toxicological Considerations 11
k. Reference Dose 12
2. Exposure Assessment 12
a. Dietary 12
b. Occupational and Residential 13
3. Risk Assessment 16
a. Dietary 16
b. Occupational and Residential 16
C. Environmental Assessment 18
1. Environmental Fate 18
a. Environmental Chemistry, Fate and Transport ...... 18
b. Environmental Fate Assessment 19
2. Ecological Effects 20
a. Ecological Effects Data 20
(1) Terrestrial Data 20
(2) Aquatic Data 21
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(3) Non-Target Insects Data 21
b. Ecological Effects Risk Assessment 21
(1) Risk to Terrestrial Organisms 21
(2) Risk to Aquatic Organisms 23
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 26
A. Determination of Eligibility 26
1. Eligibility Decision 27
2. Eligible and Ineligible Uses 27
B. Regulatory Position 27
1. Tolerance Reassessment 28
2. Restricted Use Classification 28
3. Endangered Species Statement 28
4. Labeling Rationale 29
a. Postapplication/Reentry Requirements 29
b. Personal Protective Equipment (PPE) Requirements ... 30
c. Ecological Effects 31
V. ACTIONS REQUIRED BY REGISTRANTS 31
A. Manufacturing-Use Products 31
1. Additional Generic Data Requirements 31
2. Labeling Requirements for Manufacturing-Use Products 32
B. End-Use Products 32
1. Additional Product-Specific Data Requirements 32
2. Labeling Requirements for End-Use Products 33
a. Compliance with the Worker Protection Standard .... 33
b. Entry Restrictions; Labeling 33
c. Personal Protective Equipment Requirements;
Labeling 35
d. Other Labeling Requirements 37
C. Existing Stocks 39
VI. APPENDICES 41
APPENDIX A. Table of Use Patterns Subject to Reregistration 43
APPENDIX B. Table of the Generic Data Requirements and Studies Used
to Make the Reregistration Decision 51
APPENDIX C. Citations Considered to be Part of the Data Base
Supporting the Reregistration of Methiocarb 65
APPENDIX D. List of Available Related Documents 81
APPENDIX E. PR Notice 91-2 85
APPENDIX F. Combined Generic and Product Specific Data Call-in 91
Attachment 1. Chemical Status Sheet . 113
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions ... 117
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Attachment 3. Generic and Product Specific Requirement Status
and Registrant's Response Forms (Form B inserts)
and Instructions 127
Attachment 4. EPA Grouping of End-Use Products for Meeting
Data Requirements for Reregistration 149
Attachment 5. EPA Acceptance Criteria 153
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice 167
Attachment 7. Confidential Statement of Formula, Cost Share and
Data Compensation Forms 171
APPENDIX G. RED Fact Sheet 181
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METHIOCARB REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
William Gross Biological Analysis Branch
Frank Hernandez Economic Analysis Branch
Steve Jarboe LUIS Staff, Biological Analysis Branch
Environmental Fate and Effects Division
Regina Hirsch Ecological Effects Branch
James Hetrick Environmental Fate and Groundwater Branch
Jean Holmes Science Analysis and Coordination Staff
Health Effects Division
Nguyen Thoa Chemical Coordination Branch
Karen Hammernik Toxicology Branch I
Jeffrey Evans Occupational and Residential Exposure Branch
Registration Division
Marilyn Mautz Insecticide-Rodenticide Branch
Bipin Gandhi Registration Support Branch
Joanne Hayes Registration Support Branch
Special Review and Reregistration Division
Karen Jones Reregistration Branch
Linda Propst Reregistration Branch
Carol Stangel Planning and Reregistration Branch
Policy and Special Projects Staff
Jean Frane
Office of Compliance Monitoring
Beverly Updike Pesticides Enforcement Policy Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GRAS Generally Recognized As Safe as designated by FDA
HDT 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.
LD10 Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
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GLOSSARY OF TERMS AND ABBREVIATIONS
MOE Margin Of Exposure (PAD)
MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*i The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution.
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide methiocarb, 4-methylthio-3,5-xylylmethylcarbamate.
Methiocarb is a carbamate insecticide, acaricide, molluscicide, and avian repellent
produced by Miles, Inc. Methiocarb is used to control slugs, snails, and other pests on
ornamentals, lawns, turf, and ginseng. Ginseng is not considered a food use because current
methiocarb end-use labels bear the 12 months' preharvest interval. The end-use formulations
of methiocarb are granular and pelleted/tableted, wettable powder, and pressurized liquid.
The registered products are applied by broadcast, foliar spray, and soil-incorporation (spot
treatment).
Methiocarb was initially registered as a pesticide in 1972. A Registration Standard
was issued in March 1987 (NTIS# PB87-190898). This Registration Standard summarized
available data supporting the registration of products containing methiocarb used as a bird
repellent in corn fields and fruit orchards and for slug, snail, and other types of pest control
on ornamentals, lawns, turf and ginseng. The Registration Standard also required additional
product chemistry, residue chemistry, ecological effects, environmental fate, toxicology and
occupational/residential exposure data. The residue chemistry data requirements were
waived because of the deletion of the food uses from methiocarb product registration labels
in 1992. The technical producer is no longer supporting commercial turf uses and support
from end-use registrants or amendment of their labels deleting the commercial turf use is
required. However, this document addresses commercial turf uses because such uses are
currently still on labels. The Agency has now completed its review of the methiocarb target
data base including data submitted in response to the 1987 Registration Standard.
The Agency has classified methiocarb as a Group D carcinogen (insufficient
information to evaluate the chemical). The Agency has determined that methiocarb is a
developmental toxicant based on a dermal developmental toxicity study in rabbits. The no
observed effect level (NOEL) for developmental toxicity is 50 mg/kg/day.
There may be a risk to workers tending to plants in greenhouses/nurseries, handlers
(mixer/loader/applicators), commercial turf workers, and homeowners exposed to
methiocarb. The margins of exposure (MOE) for the uses with the greatest potential for
occupational exposure indicate a level of concern. Specifically, for handlers using the
wettable powder.formulation, the MOE's are estimated to be less than 100, the commonly
accepted margin of exposure. In order to achieve an acceptable MOE, the Agency is
imposing additional PPE. The Agency is also concerned about workers entering treated
areas following application of the wettable powder and pressurized liquid formulations. In
order to achieve an acceptable MOE for workers, the Agency is requiring a 25-day restricted
entry interval (REI) following foliar applications with the wettable powder formulation and
treatment of greenhouses with the pressurized liquid. After 10 days workers may enter
treated areas to perform tasks, including hand labor tasks that involve contact with treated
IV
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surfaces provided each worker spends no more than three hours in each 24-hour period
performing such tasks. PPE is not required during the 3 hour work period. The Agency
has determined that the uses of the wettable powder and the pressurized liquid formulations
are eligible for reregistration. Confirmatory data on estimation of dermal and inhalation
exposure to handlers for the wettable powder formulation is required. The Agency is also
requiring an inhalation passive dosimetry study to better define exposure to workers
reentering treated greenhouses following application of the pressurized liquid.
The Agency is requiring that coveralls be added to current Personal Protective
Equipment (PPE) requirements in order to provide handlers of the wettable powder
formulation with adequate MOE's for all uses. This PPE with modifications also applies to
early entry workers entering treated areas. The Agency is also requiring that a dust mask be
worn while mixing/loading the wettable powder formulation because the wettable powder is a
potentially high exposure route with respect to inhalation. In addition, the Agency is
requiring that a respirator be worn by handlers during ventilation activities.
With respect to homeowner uses of methiocarb, the Agency has determined that there
is insufficient exposure data for the use of methiocarb by broadcast application on residential
lawns and turf and a reregistration eligibility decision cannot be made at this time. The
Agency is unable to estimate the risk to homeowners and children from the broadcast
treatment of methiocarb granulars on residential lawns because of the numerous uncertainties
in potential exposure levels. The only registered homeowner use is for the broadcast
application of the 1 % or 2% granular or pellet products on ornamentals and lawns. Data
relating to postapplication reentry will be derived from the turfgrass foliar dislodgeable
dissipation and dermal passive dosimetry studies required at this time to support the
residential lawn uses. Registrants may prohibit use on lawns and commercial turf while
maintaining uses on ornamentals and avoid generation of the foliar dissipation and passive
dosimetry studies. Exposure to homeowners using methiocarb for applications to building
foundations is expected to be low and additional data are not required to support this use.
The Agency is retaining the 24-hour REI for postapplication activities for the granular
formulation use on commercial or research production of turfgrass. The commercially
grown turfgrass use is eligible for reregistration. Also, the use of the self-contained granular
shakers are eligible for reregistration except for the use on residential lawns and turf.
Applications to ornamentals in residential situations, including application by
commercial applicators, is eligible for reregistration except for products marketed in
packages larger than the 2 Ib. shaker cans (e.g. 20 - 25 Ib. bags) for use by homeowners.
The Agency is requiring data (soil dissipation and dermal exposure) to assess the exposure to
persons entering treated ornamental planting areas. These data are considered confirmatory.
After the Agency reviews exposure data on ornamentals and residential lawns, the Agency
will determine if further marketing in packages other than 2 Ib. shaker containers for use by
homeowners is appropriate.
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The Agency has also determined that the use of methiocarb exceeds levels of concern
for endangered species for birds, mammals, non-target insects, and freshwater invertebrates
for all outdoor uses. Because of these concerns, the Agency is requiring label amendments
and confirmatory data, as well as negotiating with the registrants to maintain a production
cap in an effort to decrease the environmental risk of methiocarb.
In addition, the Agency has classified methiocarb as a restricted use pesticide for all
outdoor uses except homeowner uses.
In summary, the Agency has determined that the following uses and formulations are
eligible for reregistration: 1) granular/pelleted formulations (1-2% a.i.) applied to
commercially grown turfgrass; to residential and commercially grown ornamentals except for
20 - 25 Ib. bag products used by homeowners; in commercial greenhouses and nurseries; and
around building foundations. 2) wettable powder formulation (75 % a.i.) used as a foliar
spray to nursery and greenhouse grown ornamentals. 3) pressurized liquid formulation (1 %
a..i.) applied as a total release spray in commercial greenhouses.
Due to a lack of exposure information, a reregistration eligibility decision on the
granular and pelleted formulations for use on residential.lawns and turf by broadcast methods
cannot be made at this time.
The Agency is requiring that additional generic data be submitted to confirm the risk
assessment done on the uses declared eligible in the reregistration review. These data
include the following:
Estimation of dermal exposure - for wettable powder
formulation use in greenhouses and nurseries
Estimation of inhalation exposure - for wettable powder
formulation use in greenhouses and nurseries
Estimation of dermal exposure and soil dissipation - for granular formulations
used on ornamentals
Inhalation passive dosimetry - for pressurized liquid formulation use in
greenhouses
Aquatic and estuarine organisms - fish/mollusk/shrimp - required for all
lawn and turf uses
Aquatic invertebrate life cycle - required for all lawn and turf uses
Fish early life stage - required for all lawn and turf uses
Fish life cycle - required for all lawn and turf uses
Hydrolysis - required for all outdoor uses
Adsorption/desorption/leaching - required for all outdoor uses
Terrestrial field dissipation - required for all lawn and turf uses
Outdoor usage data - specify pounds used per year by site
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The following data are required to support the use of granular formulations of
methiocarb on residential lawns and turf:
Foliar dislodgeable dissipation
Dermal passive dosimetry
Also, data on acute and subchronic neurotoxicity, which are not part of the target data
base for methiocarb, are required because methiocarb is a carbamate pesticide.
Accordingly, the Agency has determined that only the products containing methiocarb
as the sole active ingredient for the uses declared eligible for reregistration will be
reregistered when acceptable labeling and product specific data are submitted and/or cited.
Before reregistering each product, the Agency is requiring that product specific data (product
chemistry and acute toxicity) be submitted by the registrants within eight months of the
issuance of this document. Additionally, in order to remain in compliance with FIFRA, it is
the Agency's position that revised labeling be submitted by the registrants within that same
time period. After reviewing these data and revised labels, the Agency will determine
whether the conditions and requirements of FIFRA 3(c)(5) have been met for the
reregistration of these products.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to
be completed in nine years. 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 registration" 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.
This document presents the Agency's decision regarding the reregistration eligibility
of the registered uses of methiocarb. The document consists of six sections. Section I is the
introduction. Section II describes methiocarb, 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 methiocarb.
Section V discusses the reregistration requirements for methiocarb. Finally, Section VI is
the Appendices which support this Reregistration Eligibility Decision document. Additional
details concerning the Agency's review of applicable data are available on request.1
'EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: methiocarb
• Chemical Name: 4-methylthio-3,5-xylylmethylcarbamate
• Chemical Family: Carbamate
• CAS Registry Number: 2032-65-7
• OPP Chemical Code: 100501
• Empirical Formula: CnHi5NO2S
Trade and Other Names: Mercaptodimethur, Metmercapturnon,
Mesurol, Methiocarbe, Bay 376344, and
H-321
• Basic Manufacturer: Miles, Inc.
B. Use Profile
The following contains information on the current registered uses of
methiocarb with an overview of use sites and application methods. A detailed table of
these uses of methiocarb is in Appendix A.
For methiocarb:
Type of Pesticide: Molluscicide/Avian Repellent/Insecticide/Acaricide
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Use Sites: Terrestrial Non-Food Crop: ornamental and/or shade trees,
ornamental herbaceous plants, ginseng, ornamental non-
flowering plants, ornamental woody shrubs and vines.
Terrestrial Non-Food/Outdoor Residential: ornamental and/or
shade trees, ornamental herbaceous plants, ornamental lawns
and turf, ornamental non-flowering plants, ornamental woody
shrubs and vines.
Greenhouse Non-Food Crop: ornamental and/or shade trees,
ornamental herbaceous plants, ornamental non-flowering plants,
ornamental woody shrubs and vines.
Outdoor Residential: household/domestic dwellings outdoor
premises
Target Pests: snails, slugs, sowbugs, millipedes, crickets, aphids,
centipedes, fall webworms, scales, spider mites, pillbugs,
moths, and whiteflies.
Formulation Types Registered:
Bait - Granular
(1.0% methiocarb plus other active ingredients, 2.0 % methiocarb)
Bait - Pelleted/Tableted
(2.0% methiocarb)
Wettable Powder
(75.0% methiocarb)
Pressurized Liquid
(1.0% methiocarb)
Technical Grade
(95% methiocarb, soluble concentrate/solid)
Manufacturing Use
(75% methiocarb, form not identified/solid)
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Current Method and Rates of Application:
Granular: Water area to be treated before application. Sprinkle one pound of
product directly from container or with spreader over 1000 square feet (for 2%
product this equals 0.87 Ibs ai/A). Scatter so that granules are hardly visible
in treated area. Special attention should be given to treating areas around
flower beds, under greenhouse benches, and around building foundations. Use
sites include ornamentals, border plantings, flower gardens (ornamental
gardens), shrubs, ornamental greenhouses, ornamental nurseries, lawns, turf,
ornamental ground covers, around the home, around building foundations, and
ginseng gardens.
Pelleted/Tableted: Sprinkle one pound of pellets over 1000 square feet (0.87
Ibs ai/A). For best results lightly water area to be treated before application.
Scatter bait so that it is visible on the ground. Use sites include flower
gardens, ornamental greenhouses, around the home, and around building
foundations.
Wettable Powder: Apply up to two pounds product (1.5 Ibs ai/A) per acre in
50 gallons water using conventional ground spray equipment. Spray plants
and foliage until thoroughly wet. Maximum of four applications per season (8
pounds of product per acre equals 6.0 Ibs ai/A per season). Use sites include
ornamental nurseries and ornamental greenhouses for use on shrubs, flowers,
and trees.
Pressurized Liquid (Total Release Aerosol): For best results, apply in early
evening when foliage is dry and temperatures are between 60-80°F. Shut off
all exhaust fans and close all windows, doors and ventilators. Keep
greenhouse closed 2-4 hours after treatment. Maximum rate is 1 pound per
1500 square feet. Place container on ground or on bench depending on
location where plants are grown. Press tab down to lock position and leave
greenhouse. Entire contents will release automatically. Use site includes
commercial greenhouses.
Current Limitations on Use Practices:
Granular: Do not use on or around plants grown for food. Do not put
granules in piles. Do not enter treated areas for 24 hours unless protective
clothing is worn. This restriction is not applicable to the homeowner use of
granular formulations.
Pelleted/Tableted: Do not use on plants grown for food. Do not put bait in
piles. Toxic to fish and highly toxic to birds.
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Wettable Powder: Do not apply through any type of irrigation system. Do not
apply with oil. Do not enter treated areas for 24 hours without protective
clothing. Do not apply in conjunction with foliar fertilizer applications.
Pressurized Liquid: Do not remain in treated area and ventilate area after
treatment. Container must be at room temperature before use. Test for
phytotoxicity before use. Toxic to fish.
C. Data Requirements
Data requested in the March 1987 Registration Standard for methiocarb
included studies on product chemistry, residue chemistry, ecological effects,
environmental fate, toxicology and occupational/residential exposure. These data
were required to support the uses listed in the Registration Standard. Appendix B
includes all data requirements identified by the Agency for currently registered uses
needed to support reregistration.
D. Regulatory History
A Registration Standard was issued in March 1987 (NTIS #PB87-190898) for
all pesticide products containing the active ingredient, methiocarb. This document
identified the additional generic data required to support the continued registration of
the use of methiocarb as a bird repellent, insecticide, acaricide and molluscicide. The
use patterns registered at that time included terrestrial food and non-food, greenhouse
non-food and domestic outdoor. This document also specified those product-specific
product chemistry and acute toxicity data required for the manufacturing-use products.
Additionally, the Registration Standard restricted all outdoor agricultural and
commercial (non-domestic) uses of methiocarb for use by certified applicators or
workers under their direct supervision on an interim basis pending submittal and
evaluation of the required terrestrial field, avian repellency and aquatic residue
monitoring data. The Registration Standard further specified that no new permanent
tolerances would be granted pending submittal and evaluation of data required to
ascertain and validate an appropriate analytical method for the enforcement of
tolerances for residues of methiocarb and any metabolites deemed to be of
lexicological concern.
Consequently, in 1989, Miles Inc. (technical producer) dropped all terrestrial
food uses of methiocarb and in 1992, the end-use registrants either voluntarily
cancelled their product(s) or amended their label(s) by deleting the food uses.
Therefore, no residue chemistry data requirements remain for methiocarb. The
technical producer also dropped their support of all commercial turf and field grown
ornamental uses. However, these uses remain on end-use product labels. A
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Reregistration Eligibility Decision document reflects a reassessment of all data which
were submitted in response to the Registration Standard.
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The physical and chemical characteristics of methiocarb are described below:
TGAI Methiocarb
Molecular weight 225.3
Color White
Physical State Crystalline solid
Odor Slightly mercaptan
Melting Point 121°C
Boiling Point N/A
Bulk Density 35-40 Ib/cu. ft (0.56 - 0.64 g/cc)
Solubility 27 mg/1 in water, 80 g/1 in 2-propanol, 70 g/1 in toluene and 2
g/1 in n-hexane
Vapor Pressure 8.8 x 10'7 mbar at 25°C (6.6 x 10'7 torr)
Dissoc. Constant N/A
Oct./Water Part. Coeff. 2200 at 20°C
pH N/A
Stability Half life at 22°C is > 1 year at pH 4
There are no further Product Chemistry data requirements for methiocarb technical.
B. Human Health Assessment
1. Toxicology Assessment
Adequate animal lexicological data on methiocarb are available and will
support reregistration eligibility as a terrestrial non-food use pesticide. The
data are reported below.
a. Acute Toxicity
Acute toxicity data for methiocarb technical are listed in the
table below.
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Acute Toxicity
Test
Oral LD50 (rat)1-2
Dermal LD50 (rabbit)3
Inhalation LCSO (rat)4
Eye Irritation5
Dermal Irritation6
Delayed Neurotoxicity7'0
Result
30 mg/kg (both sexes)*
14 mg/kg (males)b
16 mg/kg (females)*
> 2000 mg/kg
0.585 mg/1 (males)
0.433 mg/1 (females)
Not an irritant
Not an irritant
Negative
Category
I
m
II
IV
IV
N/A
1-7 MRID numbers are 00036477, 00083437, 00036478, 4040420, 00055163, 00055163, and 00083438.
a Test material in ethanol and propylene glycol vehicle.
b Test material in polyethylene glycol 400 (Lutrol) vehicle.
c Study available but not required for carbamates.
N/A Not applicable
b. Subchronic Toxicity
Four dermal toxicity studies in rabbits are available. The first
two, a six-day initial range-finding study and a 21-day repeated dermal
toxicity study (interrupted at day 14), were performed by the same
laboratory . In the range-finding study, doses of 0 (saline vehicle),
15.7, 31.3, 62.5, 125, 250, 500, 1000, or 2000 mg/kg/day of
methiocarb technical were administered. Death occurred in one out of
two females per group at doses of 250, 500, and 1000 mg/kg/day and
in both of the high dose females. One out of two males per group died
at doses of 1000 mg/kg/day and above. All deaths were ascribed to
treatment since no other explanation was provided in the study report.
Other clear-cut clinical signs of toxicity were noted at the two highest
doses. The interrupted 21-day study, in which doses of 0 (saline
vehicle), 60, 150, or 375 mg/kg/day of methiocarb technical were
being administered, was stopped due to three accidental deaths at the
high dose. No treatment-related effects were observed by day 14 at the
lower doses.
The third and fourth dermal studies were 21-day studies which
were performed at later dates by a different laboratory. The respective
doses of methiocarb technical used in the two studies were 0 (saline
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vehicle), 60, 150, or 375 mg/kg/day and, 0 (saline vehicle) or 500
mg/kg/day. No clear adverse findings were observed and a lowest
observed effect level (LOEL) could not be established (MRIDs
40922301 and 41771701).
Although inconsistencies were noted in the data from the two
laboratories and the quality of the data from the two completed 21-day
dermal studies exceeded that of the earlier studies, the deaths in the
dose ranging study cannot be ignored. Therefore, based on all of the
available information, a no observed effect level (NOEL) for
subchronic dermal toxicity could be established at 150 mg/kg/day (the
next lower dose tested from amongst the studies in which no treatment-
related effects were noted). The LOEL was 250 mg/kg/day based on
mortality in females at doses of 250 mg/kg/day and above. (MRIDs
40922301 and 41771701).
Since a subchronic NOEL could be established from the above
studies, the requirements for subchronic toxicity studies in rodents and
non-rodents are formally satisfied by the availability of acceptable
chronic feeding studies (MRIDs 00115226, 00128939, and 00149362).
c. Chronic toxicity
In a chronic feeding study in rodents, groups of rats (60/
sex/group) were fed diets containing 0, 67, 200, or 600 ppm of
methiocarb technical for two years. The systemic NOEL was
determined to be 600 ppm (30 mg/kg/day). At this dose, in both sexes,
body weight decreases, relative to controls, were observed which were
considered to be a secondary effect of cholinesterase inhibition. Both
erythrocyte and plasma cholinesterase inhibition occurred at the high
dose. The LOEL for cholinesterase inhibition was judged to be 200
ppm (10 mg/kg/day), at which dose transitory erythrocyte
cholinesterase inhibition was observed. The NOEL for cholinesterase
inhibition was set at 67 ppm (3.35 mg/kg/day). Brain cholinesterase
was not affected (MRID 00115226 and 00128723)
In a chronic feeding study in the non-rodent, groups of six-
month old pure bred beagle dogs (4/sex/group) were fed diets
containing 0, 5 (reduced from 15 ppm at study week three), 60, or 240
ppm of methiocarb technical in the diet for two years. Effects which
appeared to be treatment-related were sporadic incidences of hind limb
weakness and tremor in the high dose group animals fed 240 ppm (6
mg/kg/day) of test material and plasma cholinesterase inhibition of 30%
or greater, with respect to controls, at dose levels of 15 ppm (0.375
8
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mg/kg/day) and above. The NOEL for systemic effects was
determined to be 60 ppm (1.5 mg/kg/day) and the NOEL for plasma
cholinesterase inhibition was determined to be 5 ppm (0.125
mg/kg/day). RBC and brain cholinesterase were not affected (MRIDs
00128939 and 00149362).
d. Carcinogenicity
Methiocarb technical was not found to be carcinogenic in a two-
year rat feeding/carcinogenicity study in which the highest dose tested
was 600 ppm (30 mg/kg/day) (MRID 00115226 and 00128723).
The data presented in a two-year mouse carcinogenicity study
were not sufficient to fully evaluate the carcinogenic potential of the
test material in the mouse. An acceptable mouse carcinogenicity study
is no longer required since the registrant dropped food-uses for the
chemical (MRIDs 00128723, 00133477, and 00133480)
e. Developmental Toxicity
In a developmental toxicity study in rats, daily oral doses of
vehicle, 1, 3, or 10 mg/kg/day of methiocarb technical, were
administered to groups of 19 or 20 fertilized female FB-30 rats from
the sixth to the fifteenth day of pregnancy inclusive. Although a
decrease in weight gain was noted in the high dose group compared to
controls, there was no evidence of developmental toxicity in the study.
The LOEL and NOEL for maternal toxicity were 10 mg/kg/day and 3
mg/kg/day, respectively. The NOEL for developmental effects was
greater than 10 mg/kg/day (MRID 00124617).
In an oral developmental toxicity study in rabbits, groups of 17
New Zealand White rabbits were dosed orally with vehicle, 1, 3 or 10
mg/kg/day of methiocarb technical from day 6 to 18 inclusive of
gestation. The maternal toxicity NOEL was 3 mg/kg/day and the
LOEL was 10 mg/kg/day based on cholinergic signs and body weight
loss. There was no evidence of developmental toxicity in the study.
The NOEL for developmental toxicity was greater than 10 mg/kg/day
(MRID 00143213).
In a dermal developmental toxicity study in rabbits, methiocarb
technical was administered by the dermal route to 16 Chinchilla rabbits
(CHbb:CH, hybrids, SPF quality) per group during gestational days 6
through 18 at doses of 0 (1 % Cremophor vehicle), 10, 50, or 250
mg/kg/day. The NOEL for developmental toxicity is 50 mg/kg/day.
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The LEL for developmental toxicity is judged to be 250 mg/kg/day
based on a statistically significant increase in embryonic resorptions as
a percentage of implantation sites and incompletely ossified hind limb
phalanx at multiple sites. The maternal NOEL/LEL was judged to be
50/250 mg/kg/day based on a slight body weight decrement in the main
study, confirmed by a definitive body weight decrement in the range-
finding study (MRIDs 42496401, 42931901).
f. Reproductive Toxicity
An acceptable reproduction study is not available. There is no
requirement for a reproductive study since the registrant dropped food-
uses for the chemical.
g. Mutagenicity
The 1987 Methiocarb Registration Standard listed data gaps for
three categories of mutagenicity studies based on the 1982 Pesticide
Assessment Guidelines: I. Gene Mutation; n. Structural Chromosomal
Aberration; and HI. Other Genotoxic Effects. Three studies, the results
of which are summarized below, were submitted by the registrant to fill
the data gaps:
Gene Mutation - Methiocarb was not mutagenic in the presence
or absence of metabolic activation in the Salmonella
typhimurium/mammalian microsome mutagenicity assay (MRID
40508101).
Structural Chromosomal Aberration - In a sister chromatid
exchange assay in Chinese hamster ovary (CHO) cells,
methiocarb was not genotoxic. The guidance given under the
1982 guidelines for mutagenicity was that a sister chromatid
exchange assay could be used to satisfy the requirement for a
study in either Mutagenicity Study Category II or HI (MRID
40508102).
Other Genotoxic Effects - In an in vitro unscheduled DNA
synthesis assay in primary rat hepatocytes, methiocarb was not
genotoxic up to and including cytotoxic concentrations (MRID
40700801).
The current mutagenicity guideline requirements (starting from
1991) for mutagenicity testing include an Ames assay, a mammalian
cell gene mutation assay, and an in vivo cytogenetics assay. According
10
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to this guidance, there would be two data gaps for methiocarb
mutagenicity testing. However, since the submitted studies are
acceptable and negative, and since food uses for methiocarb have been
withdrawn, no additional mutagenicity testing will be required at this
time.
h. Metabolism
A metabolism study was performed in rats. More than 80% of
the 14C-carbonyl label was eliminated in 48 hours. Radioactivity was
distributed in expired CO2, urine, feces, and body tissues. The study
was considered to be inadequate due to a number of deficiencies (only
one dose level was tested, an insufficient number of animals was used,
and a number of metabolites was not clearly identified). There is no
requirement for a metabolism study since the registrant dropped food-
uses for the chemical.
i. Other Toxic Endpoints
Neurotoxicity Testing
Both an acute and a subchronic (90-day) neurotoxicity study in
rodents must be performed with methiocarb technical. These studies
are now required for all carbamate pesticides. They are not part of the
target data set for this reregistration review, but are required for the
continued registration of methiocarb.
Ocular Toxicity Testing
Ocular toxicity testing is not currently required for the
carbamate class of pesticides.
Dermal Absorption
A dermal absorption study is not required at this time.
Domestic Animal Safety
A domestic animal safety study is not required at this time.
j. Other Toxicological Considerations
When food uses existed for methiocarb, an amendment to the
1987 Methiocarb Registration Standard Toxicology Chapter required
11
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that a 30-day dog feeding study (including measurement of
cholinesterase activities) be performed using methiocarb sulfoxide, a
cholinesterase-inhibiting metabolite of methiocarb (Mesurol®).
Methiocarb sulfoxide had been shown in some studies to be more
acutely toxic than methiocarb and to comprise a much larger portion of
certain post-application, non-removable residues than the parent
compound. The 30-day dog study was no longer required when food
uses were dropped for methiocarb.
k. Reference Dose
On February 25, 1993, the OPP RfD/Peer Review Committee
recommended that the RfD for methiocarb (Mesurol®) be established at
0.005 mg/kg/day. This value was based on a NOEL of 1.5 mg/kg/day
for tremors and muscle weakness observed at 6 mg/kg/day in a long-
term feeding study in dogs using an uncertainty factor (UF) of 100 to
account for inter-species extrapolation and intra-species variability.
Even though a reproduction study is not required, the RfD Committee
recommended that an additional UF of 3 be added to compensate for
the lack of adequate reproduction data. Since methiocarb was shown to
be a developmental toxicant in rabbits, when administered by the
dermal route, the Committee also expressed a concern for acute risk
from exposure to methiocarb.
On November 18, 1993, the OPP RfD/Peer Review Committee
reconsidered the NOEL/LOEL in light of the additional information
submitted by the registrant on the dermal developmental toxicity study.
The OPP RfD/Peer Review Committee reevaluated and changed the
NOEL/LOEL from 10/50 mg/kg/day to 50/250 mg/kg/day for the
dermal toxicity study with methiocarb.
2. Exposure Assessment
a. Dietary
No dietary exposure is expected from use of methiocarb since
there are no remaining food uses. Ginseng is not considered a food use
since current methiocarb end-use labels bear a 12 month-preharvest
interval.
Since all food uses for methiocarb have been cancelled, there
are no Residue Chemistry data requirements and no Codex
harmonization issues to be resolved. The Agency accordingly intends
to revoke all tolerances for methiocarb (40 CFR 180.320).
12
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b. Occupational and Residential
Post-application/reentry data and mixer/loader/applicator data
are required by the Agency when both toxicity and exposure criteria are
met. Methiocarb is a N-methyl carbamate pesticide used to control
snails, slugs and other pests on ornamental plants and turfgrass.
Methiocarb was previously used on agricultural food crops, primarily
as a bird repellent. The registrants however, are not supporting the
food uses and these uses have been deleted from all labels.
Methiocarb end-use products are formulated as granulars/pellets
(1 - 2% a.i.), wettable powder (75% a.L), and pressurized liquids (1%
a.i.). The granular/pelleted formulations are applied to residential and
commercially grown turfgrass; to residential and commercially grown
ornamentals; in commercial greenhouses; and around building
foundations. A 75% wettable powder formulation is used as a foliar
spray to nursery and greenhouse grown ornamentals. A pressurized
liquid formulation is applied as a total release spray in commercial
greenhouses.
In the Methiocarb Registration Standard, the Agency imposed an
interim 24-hour, reentry interval. The reentry interval was imposed for
labels containing directions for applications to the then registered
agricultural food crops, commercially grown turfgrass, commercially
grown ornamentals, and greenhouses. The reentry interval was
required until postapplication/reentry data were submitted and reviewed
by the Agency.
The Worker Protection Standard (WPS) for Agricultural
Pesticides ~ 40 CFR Parts 156 and 170 -- converted the 24-hour
reentry interval (where reentry with protective clothing is allowed) to a
24-hour restricted-entry interval (where entry is prohibited except under
the limited circumstances allowed under the Worker Protection
Standards such as exception for activities with no contact, 40 CFR
170.112 [b], short term activities, 40 CFR 170.112[c], exceptions for
agricultural emergencies, 40 CFR 170.112[d], and exceptions for
requiring Agency approval, 40 CFR 170.112[e]).
Personal protective equipment (PPE) were required while
applying end use products containing 20 to 75% methiocarb. These
PPE consisted of a long sleeve shirt, long pants, shoes, socks, and
chemical-resistant gloves. There are no current PPE requirements or
reentry intervals for the homeowner products. However, there are
certain labels containing directions for applications to greenhouses as
13
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well as residential turfgrass and building foundations that display the
reentry and PPE statements regardless of percent methiocarb.
On March 2, 1993, the OPP's Toxicology Branch determined
that methiocarb is a developmental toxicant based on a dermal toxicity
study using rabbits. The data, which were submitted to the Agency
under 6(a)(2), indicate a no observed effect level (NOEL) of 50
mg/kg/day. Because methiocarb is a developmental toxicant, it meets
the Agency's toxicity criteria for requiring postapplication/reentry and
mixer/loader/applicator exposure data. In addition, methiocarb, a
cholinesterase inhibitor (reversible), is in Toxicity Category I for acute
oral toxicity (MRID 42496401).
Mixer/Loader/Applicator Exposure (Handlers)
There is a potential for exposure to methiocarb sprays and dusts
via the dermal and inhalation route, particularly during foliar applications
using low pressure, hand sprayers. Applicator exposure regarding the
total release aerosol applications, .and self-contained granular shakers is
expected to be lower.
There are no chemical-specific mixer/loader/applicator exposure
data available for methiocarb. In the absence of these data, the Agency
has reviewed the Pesticide Handlers Exposure Database (PHED) for
application scenarios similar to those used to apply methiocarb. The one
identified by PHED with the greatest potential for exposure is the
application of wettable powder formulations using a low pressure hand
sprayer.
Based on the available data in PHED, the exposure estimate for an
individual mixing/loading and applying methiocarb (while wearing the
currently labeled PPE) is as follows:
A mixer/loader/applicator applying a wettable powder (open bag)
with a low pressure hand wand, is exposed to 8.6 mg/lb ai
(dermal). Inhalation exposure is estimated to be 1 mg/lb ai per
acre. The Agency assumes a mixer/loader/applicator treating 6
acres per day (based on previous backpack sprayer assessment for
maleic hydrazide).
6 acres x 0.75 Ib ai/acre x 8.6 mg/lb. ai handled (dermal)
6 acres x 0.75 Ib ai/acre x 1 mg/lb. ai handled (inhalation)
14
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Thus, the respective dermal and inhalation exposure estimates are 38.7
mg/day and 4.5 mg/day for the wettable powder formulation.
The mixer/loader/applicator exposure assessment was estimated
using surrogate data and conservative exposure assumptions. The Agency
is requiring mixer/loader/applicator exposure data to support reregistration
of methiocarb for the following commercial uses:
233 and 234 - For commercial application of wettable powder
formulations to greenhouse/nursery grown ornamentals.
These data will be considered confirmatory for scenarios where
margins of exposure (MOE) are estimated to be greater than 100 with
appropriate personal protective equipment (PPE) (coveralls) and
appropriate restricted entry intervals.
Postappiication/Reentry Exposure (Worker and Residential)
There is a potential for postapplication exposure following most of
the methiocarb applications. These include dermal exposure to residues
on treated lawns and turf, thatch and soil following the granular
applications; and to the foliage of commercially grown ornamentals treated
with the wettable powder and pressurized liquid formulations. There is
also a potential for inhalation exposure following the application of the
total release aerosols.
Postapplication exposure is expected to be low following the
application of granular formulations beneath greenhouse benches, around
building foundations, and in residential ornamental plantings other than
lawns and turf.
Postapplication inhalation monitoring data are required to support
the reregistration of the pressurized liquid formulation. These data are
considered confirmatory:
Inhalation passive dosimetry for entry into greenhouses following
an application using the pressurized liquid formulation (133-4).
Postapplication/reentry data are required to support the
reregistration of the granular formulations used on ornamentals. These
data are considered confirmatory:
Soil residue dissipation (132-lb)
Dermal passive dosimetry exposure (133-3)
15
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The following postapplication/reentry data are required to support
homeowner lawn use:
Foliar dislodgeable dissipation, lawns and turf (132-la), and
Dermal passive dosimetry, lawns and turf (133-3)
These studies must be conducted concurrently.
3. Risk Assessment
The data available on the lexicological effects of methiocarb are sufficient
for assessing human risks.
In acute toxicity studies in laboratory animals, methiocarb is highly toxic
by the oral route (Toxicity Category I), moderately toxic by the inhalation route
(Toxicity Category II), slightly toxic by the dermal route (Toxicity Category III),
but is not a dermal or eye irritant. In long-term studies, administration of
methiocarb have been observed to inhibit RBC and/or plasma cholinesterase but
not brain cholinesterase in both the rat and dog. In the latter species the enzyme
inhibition was associated with signs of muscular weakness and/or tremors at the
high dose. Methiocarb is not carcinogenic in rats and does not appear to have
any mutagenicity potential. Methiocarb administered by the dermal route is
associated with developmental toxicity in rabbits. Administered by the oral route,
it is associated only with maternal toxicity in both rats and rabbits.
The OPP RfD/Peer Review Committee considered the carcinogenicity
study in rats to be acceptable and the doses used to be adequate for
carcinogenicity testing. There was no other carcinogenicity study available on
methiocarb. On this basis the OPP RfD/Peer Review Committee classified
methiocarb as a Group D carcinogen (insufficient information to evaluate
chemical).
The toxicology endpoint of concern is developmental toxicity. Based on
the developmental study with the most sensitive species (rabbits) and the
appropriate developmental NOEL (NOEL = 50 mg/kg/day), there may be a
potential for adverse developmental effects in exposed humans.
a. Dietary
Dietary risk from exposure is not expected since there are no
remaining food uses for methiocarb.
b. Occupational and Residential
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Workers and homeowners may be at risk for developmental effects
from exposure to methiocarb. The Agency has no chemical-specific data
for assessing potential exposure from the use of methiocarb. The margin
of exposure (MOE) may be estimated by the following equation:
MOE = NOEL fmg/kg/day)
Exposure (mg/kg/day)
where the NOEL = 50 mg/kg/day based on the dermal developmental
study in rabbits. The MOE from use of the granular formulations cannot
be estimated at this time because we do not have actual or surrogate
exposure data. The MOEs from the use of the wettable powder
formulations are presented in the table below.
Margin of Exposure
Wettable
Powder
Formulation
With current PPE
With coveralls
Exposure Rate
(mg/day)
Dermal Inhalation
38.70 4.50
7.74 2.25
Exposure Kate
(mg/kg/day)
Dermal Inhalation
0.645 0.072
0.129 0.072
MOE*
Dermal +
Inhalation
70
250
A ssurnpuons:
(1) A handler weighs 60 kg,
(2) Currently labeled-PPE are used, and
(3) maximum efficiencies achieved for coverall (80%).
The MOE is less than 100 for handlers (with PPE) of wettable powder
formulations. With risk mitigation steps such as coveralls, the margins of
exposure are expected to be greater than 100 with a maximum efficiency of 80%
for coveralls.
Restricted Entry Intervals (REIs)
The registrant submitted a foliar dissipation study measuring
dislodgeable residues after a wettable powder formulation of methiocarb had
been foliarly applied to grapes. The dislodgeable residues declined in a linear
fashion with residue decay equation having an intercept of 2.95 and a slope of
-0.064. These data are considered supplementary and have been used to
calculate a reentry interval for ornamental crops foliarly treated with
methiocarb. These data are not appropriate to calculate a reentry interval
following the application of granular formulations to turfgrass due to the
differences in formulation type and method of application (MRID 40465901).
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Based on the data from MRID 40465901, an REI of 25 days is imposed
following foliar applications of the wettable powder and the pressurized liquid
(total release aerosol) formulations to ornamental plants. After 10 days
workers may enter treated areas to perform tasks, including hand labor tasks
that involve contact with treated surfaces provided each worker spends no
more than 3 hours in each 24-hour period performing such tasks. PPE is not
required during the 3 hour work period.
Personal Protective Equipment (PPE)
Occupational Uses: Although methiocarb has been classified as a
Toxicity Category HI chemical for acute dermal toxicity and skin irritation
potential, the Agency is requiring personal protective equipment (PPE) for
applicators and other handlers as well as early entry workers consistent with the
PPE level (as established by 40 CFR Part 156, the Worker Protection Standard)
required for pesticides classified as Toxicity Category II for acute dermal toxicity.
In addition, the Agency is requiring that a respirator be worn by handlers during
ventilation activities. The Agency is also requiring that a dust mask be worn
while mixing/loading the wettable powder formulation because this is a potentially
high exposure route with respect to inhalation. These PPE requirements are due
to the known lexicological concerns for methiocarb, including its identification
as a developmental toxicant.
Homeowner Uses: The Agency has determined that, at this time, the
personal protective equipment discussed in this section need not apply to
homeowner users of methiocarb. The predicted frequency, duration, and degree
of exposure by homeowners should not warrant the risk mitigation measures being
required for occupationally exposed users. No data are available to support
homeowner use by broadcast method.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
Based on incomplete, supplemental and acceptable
environmental fate data, methiocarb appears to be moderately persistent
and relatively immobile in soil. Methiocarb degradation appears to be
dependent on microbial-mediated (aerobic soil metabolism - half-life =
17 to 111 days); anaerobic soil metabolism (half-life = 64 days); and
abiotic processes (photodegradation metabolism in water and on soil
(half-life = 88 days). These data indicate that methiocarb degrades in
mineral soils and anaerobic soil environments, and should photodegrade
18
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slowly in soil and slightly acidic aqueous environments. The major
degradates are methiocarb sulfoxide, methiocarb sulfoxide phenol,
methiocarb phenol, and methiocarb sulfone. Supplemental field
dissipation studies suggest methiocarb residues (e.g., methiocarb,
methiocarb sulfone, and methiocarb sulfoxide) are moderately persistent
(half-life < 92 days) in surface soil (30 cm). Methiocarb was also
detected in a single well in a New York well survey of 21,000 wells.
b. Environmental Fate Assessment
Methiocarb appears to be relatively immobile (K,, = 12.5) in
loam textured soil, but methiocarb degradates as well as parent
methiocarb were found to be mobile in "aged" soil column leaching
studies. The mobility of methiocarb and its degradates could not be
confirmed in field dissipation studies because of inadequate soil
sampling and/or nonspecific analytical methodologies. Although
compounds similar to methiocarb (e.g., aldicarb) are mobile in soil and
have been found in groundwater, the weight of evidence from
supplemental field dissipation data suggest that methiocarb, methiocarb
sulfoxide, and methiocarb sulfone are retained in the surface soil(0-30
cm). The results of the screening model PATRIOT (Pesticides
Assessment Tool for Rating Investigations of Transport), performed
over a range of soil textures for methiocarb reinforced the conclusion
that methiocarb per se is not likely to contaminate groundwater.
However, a full assessment will only be possible when the following
confirmatory data are provided.
These studies are required for all outdoor uses:
161-1 Hydrolysis
163-1 Adsorption-Desorption/Leaching
This study is required to support the lawns and turf uses of
methiocarb:
164-1 Terrestrial Field Dissipation
The additional confirmatory data will help to define the rates
and routes of methiocarb dissipation under typical use conditions. The
additional hydrolysis data would provide information on abiotic
degradation of methiocarb in soil and aquatic environments. Although
the unaged portion of the adsorption-desorption/leaching (GL 163-1)
study was previously fulfilled using a single soil type, additional batch
equilibrium data on parent methiocarb would provide a more reliable
19
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mobility classification in coarse textured soils (e.g., sand and loamy
sands) with low organic matter. Fine textured soil, which was used in
the study, tends to decrease estimates of mobility. In addition, parent
methiocarb was detected in the leachate of aged-residue soil column
studies and hence may be mobile in coarse textured soils. The
additional terrestrial field dissipation data are necessary with greater
sampling depths and appropriate soil sampling increments to assess
leaching of methiocarb below 30 cm.
The Fish Accumulation (165-4) study is waived because
methiocarb and its degradates in aquatic systems are likely to kill fish
before the residues could accumulate to levels of concern in fish
tissues.
2. Ecological Effects
a. Ecological Effects Data
There are enough ecotoxicological data submitted to characterize
the toxicity of methiocarb to nontarget terrestrial and aquatic
organisms when used primarily on ornamentals and in greenhouses.
The toxicity evaluation of methiocarb for lawns and turf use is based on
limited available data.
(1) Terrestrial Data
Available data indicate that methiocarb is toxic to
terrestrial mammals (acute oral LD50 range from 14 to 30
mg/kg) for males and females rats, respectively.
The avian toxicity of methiocarb was evaluated from
thirty-four studies. The data indicate that the technical grade
(TGAI) of methiocarb is very highly toxic to birds on an acute
oral basis. The LD50 s to passerine species tested ranged as low
as 2.47 mg/kg, and the LD50 values to mallards (waterfowl)
were determined to be 12.8 mg/kg. The subacute dietary data
using the TGAI indicate that methiocarb is practically non-toxic
to upland game birds, LC50 of > 5000 ppm for ring-necked
pheasants and slightly toxic to waterfowl with an LC50 of 1071
ppm for mallard ducks. Because no feed consumption data were
provided, it can not be determined if the low dietary toxicity is
attributable to reduced feed consumption. Also, pen studies
with 2% bait and 4% bait suggest that these formulations may
produce a repellent effect in bobwhite quail and pheasants,
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respectively. Avian reproduction studies indicate that no
reproductive impairment is caused in the mallard duck at a
dietary dose level of 100 ppm TGAI methiocarb or in bobwhite
quail at a dietary dose level of 50 ppm. Pen studies with 2%
bait suggest that this formulation may produce a repellency
effect in the bobwhite quail (MRIDs 00036482, 00036491,
00128119, and GS0577006).
(2) Aquatic Data
The available data indicate that the TGAI of methiocarb
is highly toxic to coldwater (rainbow trout LC50 =0.436 ppm)
and warmwater (bluegill LC50 = 0.734 ppm) fish. The
freshwater fish acute toxicity data on formulated products
indicate that the 75 % wettable powder formulation of
methiocarb is moderately toxic to coldwater (rainbow trout LC50
= 1.4 ppm) and warmwater (bluegill LC50 =1.9 ppm) fish.
Data from a fish early life stage study using rainbow trout
suggest that methiocarb is highly toxic (the MATC of technical
methiocarb to this species is 50 to 100 ppb). The data indicate
that methiocarb is very highly toxic to freshwater aquatic
invertebrates (48-hour EC50 for Daphnia magna was 0.019
ppm); (48-hour EC50 for mayflies was 0.007 ppm). Data from
an aquatic invertebrate life cycle test further support the very
high toxicity of methiocarb to aquatic invertebrates (test using
Daphnia magna suggest that the MATC of technical methiocarb
to this species is 0.10-0.17 ppb). There are no estuarine data
available on methiocarb. (MRIDs 0036484, 00127638,
00150383, 00150628, 155967).
(3) Non-Target Insects Data
There are sufficient data to characterize technical
methiocarb as very highly toxic to honey bees (LD50 for honey
bees is 0.375 ug/bee) (MRIDs 00001999, 00036935).
b. Ecological Effects Risk Assessment
(1) Risk to Terrestrial Organisms
Granular
The level of concern to mammalian and avian species,
1/2 the LC50, is exceeded for all formulations of methiocarb for
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all outdoor uses of methiocarb. The acute toxicity data of
methiocarb to rats indicate that a rat weighing 0.4 kg could
obtain an LDJO (14 to 30 mg/kg for male and females rats,
respectively) eating less than 10 of the 1% ( 0.6mg a.i./granule)
bait formulation granules. Less than one granule of the 2% (1-2
mg per granule) bait formulation or 1 % bait formulation could
contain the LD50 for blackbirds (3.2 mg/kg). Therefore, all of
the granular uses represent a hazard to blackbirds or other birds
of similar size and sensitivity to the toxicant. After ingesting 10
to 20 granules of the 2% and 1% granular formulations,
respectively, the mallard duck would reach the LD50 (12.8
mg/kg). Repellency data demonstrated that it is not clear that
medium to large sized birds may be repelled from treated
granules; therefore, granular formulations could present a
hazard to medium and larger birds.
Wettable Powder
Methiocarb 75% wettable powder is applied indirectly to
avian food items as an insecticide. The chemical is applied as a
spray. Therefore, residues are expected to be available to birds
on a variety of food and forage items. A model, explained in
the following paragraph, was used to estimate the maximum
residues expected after application on several different exposed
substrates, for example, leaves, long grass, short grass, and
soil. For all application rates, except the lowest, residues on
short grass exceeded endangered species concern levels (1/10
LC50 for mallard duck, 107 ppm) from 1 to 3.5 times and
exceed the restricted use criteria (1/5 LC50 for mallard duck 214
ppm) by 1.5 times on short grass at the highest application rate.
Calculation of Exposure Levels
The majority of the labels for methiocarb do not indicate
a maximum amount of active ingredient to be applied per season
nor time intervals between applications. Therefore, the Agency
Fate Model for Accumulated Pesticide Residues for Multiple
Applications was run for a number of different scenarios. The
model looked at various application intervals (7, 20, 30 days)
and initial concentrations based on vegetative residue data
determined from a nomograph developed by Hoerger and
Kenega.
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The results indicate that the lowest level of active
ingredient applied per application to short grass would trigger
the endangered species concern (1/10 LC50 for mallard duck,
107 ppm) by 1.5 times by the second application no matter if
the interval was 7, 20, or 30 days. In addition, by the third
application on short grass at either 7, 20, or 30 days the trigger
for restricted use concern would be exceeded (1/5 LC50 for
mallard duck 214 ppm) by < 1.5 times.
Models for long grass residue indicate that at the 0.5 Ibs
a.i./A application rate triggers for both endangered species and
restricted use would be exceeded by the 2nd and 3rd
applications, respectively, at all interval times (7, 20, and 30
days).
The last set of models looked at the residue on leaves
and leafy plants with the lowest amount of active ingredient per
application. These results indicate that both endangered species
and restricted use triggers would be exceeded by the 3rd and 5th
application, respectively, at 7 and 20 day intervals. At the 30
day interval endangered species and restricted use triggers were
exceeded at the 3rd and 8th application, respectively. Special
Review trigger levels were exceeded for small mammals (1 to 3
times the LD50) at the two highest application rates for short
grass. These models were run on the lowest amount of active
ingredient per application; therefore, it is likely that the level of
concern would be exceeded for endangered species and
nontarget terrestrial organisms earlier for all other active
ingredient application levels. In addition, the predicted EEC
values exceed the NOEC levels for avian species with respect to
chronic effects for short grass. Therefore, the use of
methiocarb 75% wettable powder may be expected to result in
hazard to exposed avian species both acutely and chronically.
(2) Risk to Aquatic Organisms
The level of concern for chronic fish and acute and
chronic aquatic invertebrate exposures is exceeded for all
formulations of methiocarb. Refined EEC's were modeled for
two methiocarb formulations, Mesurol® 2% Bait and Mesurol®
75% Wettable Powder for 1, 2, and 4 applications per year.
One application per year with an occasional second application
is the typical use pattern for methiocarb. The 75% Wettable
Powder may be applied up to four times a year. There are no
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restrictions on the number of applications of the 2% bait, but 4
applications were modeled as the maximum number of uses for
this formulation also. A New York turf farm was used for both
formulations, as it is a reasonable surrogate for scenarios with
significant turf coverage such as ornamentals and shade trees.
(Spagnoli, 1993).
Results from the refined model on methiocarb in
Mesurol® Bait 2% indicated that fish endangered species
concern levels, 1/20 LC50, were exceeded by 2 to 7 times and
after 90 days the value was exceeded by 1 time, and restricted
use levels, 1/10 LC50> were exceeded by 1 to 4 times but after
90 days was not exceeded. Aquatic invertebrate endangered
species concern levels, 1/20 LC50) were exceeded by 50 to 168
times from the first to the fourth application and after 90 days
with just one application the 1/20 LC50 value was still exceeded
by 27 times. In addition, restricted use concerns were exceeded
by 26 to 84 times and after 90 days the value was exceeded by
13 times, and special review concerns, 1/5 LC50, were exceeded
by 5 to 17 times and after 90 days the value was exceeded by 3
times.
Results from the refined model on methiocarb in
Mesurol® 75% Wettable Powder, indicated that fish endangered
species concern levels were exceeded by 3 to 8 times and after
90 days by 2 times, and restricted use levels were exceeded 1 to
4 times but not exceeded after 90 days. Aquatic invertebrate
endangered species concern level were exceeded by 57 to 185
times from the first to the fourth application and after 90 days
with just one application the endangered species concern level
was still exceeded by 29 times. In addition, restricted use
concerns were exceeded by 29 to 93 times and after 90 days
1/10 LC50 value exceeded by 15 times.
Conclusions
The ecological effects risk assessment for methiocarb
indicates that for all the formulations used on all outdoor sites,
the acute and chronic levels of concern are exceeded for avian
species, and the acute level of concern is exceeded for
mammalian species and aquatic invertebrates. The toxicity data
used in the risk assessment suggest that the chronic level of
concern also is exceeded for aquatic organisms.
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Some of the factors considered in further evaluation of
the risk of methiocarb to nontarget organisms include: 1) refined
aquatic EEC's using typical number of applications, 2)
methiocarb production volume, and 3) the estimate of the
amount of methiocarb used for the use sites.
When the aquatic EEC's were refined using maximum as
well as typical number of applications the level of concern was
still exceeded (ex. the level of concern for aquatic invertebrates
is exceeded by about nine times the typical number of
applications). However, the typical number of applications
decreased the risk by about a factor of two. The labels for
methiocarb should reflect the typical number of applications as
the maximum application rate. (2 Ibs 75% a.i. wettable powder
per 50 gallons of water applied up to 2, not 4, times a year, bait
formulations should not be applied more than twice a year).
The environmental fate and ecological risk assessments
are based on the estimate that 90% of methiocarb is used in
nursery and greenhouses and the other 10% of methiocarb use
includes homeowner ornamentals, as well as turf and lawn uses.
Methiocarb outdoor use is likely to have adverse effects
on aquatic and terrestrial species. Although the total volume of
methiocarb used is low relative to other pesticides, it still could
have major impacts in localized areas if there is concentrated
outdoor use. At present the Agency is unable to estimate how
much of the use is outdoors.
If the lawn and turf use of methiocarb continues to be
supported, the following studies are required on a confirmatory
basis:
72-3 (a) Acute LC50 Estuarine/Marine Tox Fish
72-3 (b) Acute LC50 Estuarine/Marine Tox Mollusk
72-3 (c) Acute LC50 Estuarine/Marine Tox Shrimp
72-4 (a) Fish Early Life Stage
(Data describing water temperatures in each test
tank are required to ensure that no significant
variance of temperature occurred in any of these
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tanks. If this data is submitted the currently
available study may be upgradable.)
72-4 (b) Aquatic Invertebrate Life-Cycle.
(Study was submitted, however it was deemed
supplemental because raw data were not
available.)
72-5 Fish Life-Cycle
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 ingredient are eligible for reregistration. The Agency has
previously identified and required the submission, of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing methiocarb
active ingredient. The Agency has completed its review of these generic data, and
has determined that the data are sufficient to support reregistration of products
containing methiocarb except for those products which are used on residential lawns
and turf. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility of methiocarb, 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 methiocarb and to determine that methiocarb can be used
without resulting in unreasonable adverse effects to humans and the environment only
for greenhouses, homeowner use around building foundations and ornamentals,
commercially grown turfgrass, and ginseng uses. The Agency, therefore, finds that
products containing methiocarb as the active ingredient used on ornamentals,
greenhouses, homeowner use around building foundations, commercially grown
turfgrass, and ginseng are eligible for reregistration. The reregistration of these
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 and the data identified in Appendix B.
Although the Agency has found that the greenhouse, homeowner use around building
foundations and ornamentals, commercially grown turfgrass, and ginseng uses of
methiocarb are eligible for reregistration, it should be understood that the Agency
may take appropriate regulatory action, and/or require the submission of additional
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data to support the registration of products containing methiocarb, if new information
comes to the Agency's attention or if the data requirements for reregistxation (or the
guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
methiocarb, the Agency has sufficient information on the health effects of
methiocarb and on its potential for causing adverse effects in fish and wildlife
and the environment to make a reregistration eligibility decision. The Agency
has determined that granular and pelleted products containing methiocarb for
use on ornamentals in greenhouses, homeowner use around building
foundations and ornamentals, commercially grown turfgrass, ginseng, as well
as the wettable powder and pressurized liquid products for use on ornamentals
in greenhouses and nurseries are eligible for reregistration.
The Agency has determined that methiocarb granular, pelleted, wettable
powder, and pressurized liquid products, labeled and used as specified in this
Reregistration Eligibility Decision document, will not pose unreasonable risks
or adverse effects to humans or the environment.
There is insufficient exposure data for the use of methiocarb by
broadcast application on residential lawn and turf and a reregistration
eligibility decision for this use cannot be made until appropriate postapplication
reentry exposure, ecological effects and environmental fate data are submitted
and evaluated.
2. Eligible and Ineligible Uses
The Agency has determined that methiocarb use on ornamentals in
greenhouses, homeowner use around building foundations, ornamentals,
commercially grown turfgrass, and ginseng are eligible for reregistration.
The Agency has also determined that a reregistration eligibility decision
for residential lawn and turf uses cannot be made at this time.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
methiocarb. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
Since methiocarb is considered to be an important tool for control of slugs in
nurseries and greenhouses and the total use volume is relatively low, the Agency is
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declaring eligible for reregistration the nursery and greenhouse ornamental uses of
granular/pellet and pressurized liquid formulations. However, in order to prevent the
use volume and hence the risk of impact on aquatic and terrestrial species from
increasing, the Agency is negotiating with the registrants to maintain a production
cap.
1. Tolerance Reassessment
Since all food uses for methiocarb are cancelled, the Agency has
determined that all existing tolerances for methiocarb will be revoked.
2. Restricted Use Classification
Based on the ecological effects risk assessment for methiocarb, a
restricted use classification should be placed on all outdoor uses except
homeowner uses.
3. Endangered Species Statement
Methiocarb (a molluscicide, insecticide and avian repellent) may pose a
hazard to many listed birds, mammals, insects, and aquatic organisms. To
date the Agency has one recorded incident, a wild bird kill, from the use of
methiocarb. (Dec. 1983, Lima, Ohio - waterfowl (NWHR 1980- 1990). The
Agency requested consultation with the U.S. Fish and Wildlife Service
(USFWS) in 1986 on, 1) blueberries and cherries, and 2) golf courses,
cemeteries, parkways, roadways, and industrial sites for certain birds, reptiles,
fish, mussels, and insects. The consultation was rejected because of lack of
information.
The use of methiocarb exceeds triggers for endangered species for
selected avian species, mammals, non-target insects, and freshwater organisms.
These proposed outdoor uses cover the whole United States and are not
restricted by boundaries. Therefore to properly identify endangered species
which may utilize these areas, the U.S. Fish and Wildlife Service (USFWS)
will be consulted. After identifying the endangered species inhabiting these
areas a formal Section 7 consultation with the USFWS may be requested.
Based on current information, a generic label statement may be required when
the Agency's Endangered Species Protection program is implemented.
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4. Labeling Rationale
a. Postapplication/Reentry Requirements
The Worker Protection Standard (WPS) for Agricultural Pesticides -
40 CFR Parts 156 and 170 — converted the 24-hour reentry interval (where
reentry with protective clothing is allowed) to a 24-hour restricted-entry
interval (where entry is prohibited except under the limited circumstances
allowed under the Worker Protection Standards such as exception for activities
with no contact, 40 CFR 170.112 [b], short term activities, 40 CFR
170.112[c], exceptions for agricultural emergencies, 40 CFR 170.112[d], and
exceptions for requiring Agency approval, 40 CFR 170.112[e]).
All methiocarb end-use products within the scope of the Worker
Protection Standard for Agricultural Pesticides (see PR Notice 93-7) — must,
within the timeframes listed in PR Notice 93-7 and 93-11, revise their labeling
to be consistent with the WPS, as directed in those notices and the
requirements of this RED. The restricted-entry interval for methiocarb end-
use products are discussed below.
(1) For Wettable Powder:
For ornamental crops (nurseries and greenhouses) following foliar
application, the Agency is requiring a 25-day restricted-entry interval (REI).
After 10 days workers may enter treated areas to perform tasks, including
hand labor tasks that involve contact with treated surfaces provided each
worker spends no more than three hours in each 24-hour period performing
such tasks. PPE is not required during the 3 hour work period. This REI
is supported by the foliar residue dissipation data presented in MRID
40465901. These restricted entry intervals provide margins of exposure of
approximately 100. The Agency generally considers 100 an acceptable margin
of exposure. Mixer/loader/applicator exposure data (studies on estimation of
dermal exposure at indoor sites and estimation of inhalation exposure at indoor
sites) are required to support reregistration of the wettable powder formulation
(these data are considered confirmatory).
(2) For Granular Formulations:
The Agency has determined that the use of methiocarb on non-
residential turfgrass (including turf grown for sod, turf grown to produce seed,
or turf grown for research purposes) is eligible for reregistration. The Agency
is retaining the 24-hour restricted entry interval for postapplication activities
because of the known lexicological concerns for methiocarb.
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For turfgrass in residential situations, including application by
commercial applicators, the Agency determined that a reregistration eligibility
decision cannot be made until postapplication exposure data (foliar
dislodgeable dissipation and dermal passive dosimetry data) are submitted and
reviewed.
Applications to ornamentals in residential situations, including
application by commercial applicators, is eligible for reregistration except for
products marketed in packages larger than the 2 Ib. shaker cans (e.g. 20 -
25 Ib. bags) for use by homeowners. The Agency is requiring data (soil
dissipation and dermal exposure) to assess the exposure to persons entering
treated ornamental planting areas. These data are considered confirmatory.
After the Agency reviews exposure data on ornamentals and residential lawns,
the Agency will determine if further marketing in packages other than 2 Ib.
shaker containers for use by homeowners is appropriate.
The Agency has determined that, at this time, the entry restrictions
discussed in this section do NOT apply to homeowner uses.
(3) For the Pressurized Liquid Formulation:
For ornamental crops in greenhouses, the Agency is requiring a 25-day
restricted-entry interval (REI). After 10 days workers may enter treated areas
to perform tasks, including hand labor tasks that involve contact with treated
surfaces provided each worker spends no more than three hours in each 24-
hour period performing such tasks. PPE is not required during the 3 hour
work period. This REI is supported by the foliar residue dissipation data
presented in MRID 40465901. These restricted entry intervals provide
margins of exposure of approximately 100. The Agency generally considers
100 an acceptable margin of exposure.
Postapplication inhalation monitoring data are required to assess
inhalation exposure to workers following the use of the pressurized
formulation (these data are considered confirmatory).
b. Personal Protective Equipment (PPE) Requirements
Occupational Uses: Although methiocarb has been classified as a
Toxicity Category III chemical for acute dermal toxicity and skin irritation
potential, the Agency is requiring personal protective equipment (PPE) for
applicators and other handlers as well as early entry workers consistent with
the PPE level (as established by 40 CFR Part 156, the Worker Protection
Standard) required for pesticides classified as Toxicity Category II for acute
dermal toxicity. In addition, the Agency is requiring that a respirator be worn
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by handlers during ventilation activities. The Agency is also requiring that a
dust mask be worn while mixing/loading the wettable powder formulation
because this is a potentially high exposure route with respect to inhalation.
These PPE requirements are being imposed due to the known lexicological
concerns for methiocarb, including its identification as a developmental
toxicant.
Homeowner Uses: The Agency has determined that, at this time, the
personal protective equipment discussed in this section need not apply to
homeowner users of methiocarb.
c. Ecological Effects
The acute and chronic levels of concern are exceeded for avian species,
the acute level of concern is exceeded for mammalian species and aquatic
invertebrates, and the chronic level of concern is exceeded for aquatic
organisms for all formulations of methiocarb. One means to further decrease
the potential risk to the environment from the use of this toxic chemical would
be to remove the turf and lawn site uses. The Agency is requiring label
amendments and confirmatory data, as well as negotiating with registrants to
maintain a production cap in an effort to decrease the environmental risk.
V. ACTIONS REQUIRED BY 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 methiocarb for
the above eligible uses has been reviewed and determined to be substantially
complete. However, additional confirmatory data are needed to fulfill
requirements for the studies listed below:
Estimation of dermal exposure - for wettable powder formulation use in
greenhouses and nurseries
Estimation of inhalation exposure - for wettable powder formulation use
in greenhouses and nurseries
Inhalation passive dosimetry - for pressurized liquid formulation use in
greenhouses
Estimation of dermal exposure and soil dissipation - for granular
formulations used on ornamentals
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Aquatic and estuarine organisms - fish/mollusk/shrimp - required for all
lawn and turf uses
Aquatic invertebrate life cycle - required for all lawn and turf uses
Fish early life stage - required for all lawn and turf uses
Fish life cycle - required for all lawn and turf uses
Hydrolysis - required for all outdoor uses
Adsorption/desorption/leaching - required for all outdoor uses
Terrestrial field dissipation - required for all lawn and turf uses
Outdoor usage data - specify pounds used per year by site
The following data are required to support the use of granular
formulations of methiocarb on residential lawns and turf:
Foliar dislodgeable dissipation
Dermal passive dosimetry
Also, data on acute and subchronic neurotoxicity, which are not part of
the reregistration target data base for methiocarb, are required.
2. Labeling Requirements for Manufacturing-Use Products
The Agency has determined that the current label precautions
are still applicable and are required for product reregistration if the
product is to remain in compliance with FIFRA.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.
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2. Labeling Requirements for End-Use Products
a. Compliance with the Worker Protection Standard
In order to remain in compliance with FIFRA, it is the
Agency's position that any product whose labeling reasonably permits
use in the production of an agricultural plant on any agricultural
establishment (farm, forest, nursery, or greenhouse) must comply with
the labeling 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 the deadlines specified in the WPS, unless official
EPA guidance specifies otherwise. EPA has issued 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 contain specific instructions to registrants about how to
complete the required WPS labeling changes and offer guidance and
deadline-options for making those changes. Unless otherwise
specifically directed in this RED, all statements required by the WPS
(and reflected in PR Notices 93-7 and 93-11) are to be on the product
labeling.
-In order to remain in compliance with FIFRA, after April 21, 1994,
except as otherwise provided in PR Notices 93-7 and 93-11, or other
EPA guidance, all products within the scope of those notices must bear
WPS PR-Notice-complying labeling when they are distributed or sold
by the registrant or any supplementally registered distributor, or any
repackager under the Agency's Bulk Repackaging Policy.
-In order to remain in compliance with FIFRA, after October 23,
1995, except as otherwise provided in PR Notices 93-7 and 93-11 or
other EPA guidance, all products within the scope of those notices must
bear WPS PR-Notice-complying labeling when they are distributed or
sold by any person.
b. Entry Restrictions; Labeling
• Products NOT Primarily Intended for Home Use
-Uses Within the Scope of the WPS:
(1) Wettable Powder Formulations: In order to remain in
compliance with FIFRA, a 25-day restricted entry interval (REI) as
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follows is required on all methiocarb end-use products formulated as a
wettable powder.
Do not enter or allow worker entry in treated areas
during the restricted entry interval (REI) of 25 days,
except, after 10 days, workers may enter treated areas to
perform tasks including hand labor tasks that involve
contact with treated surfaces provided each worker
spends no more than 3 hours in each 24 hour period
performing such tasks.
This REI should be inserted into the standardized REI statement
required by PR Notice 93-7.
In order to remain in compliance with FTFRA, labels of sole-
active-ingredient end-use products that contain methiocarb must be
revised to adopt the entry restrictions set forth in this section. Any
conflicting entry restrictions on current labeling must be removed.
(2) Granular Formulations: In order to remain in compliance with
FIFRA, a 24-hour restricted entry interval (REI) is required for all uses
within the scope of the WPS (see PR Notice 93-7) on all methiocarb
end-use products formulated as a granular, except those products
intended primarily for home use (see tests in PR Notice 93-7 and 93-
11). This REI should be inserted into the standardized REI statement
required by PR Notice 93-7.
In order to remain in compliance with FIFRA, labels of sole-
active-ingredient end-use products that contain methiocarb must be
revised to adopt the entry restrictions set forth in this section. Any
granular homewoner product that currently has a 24 hour REI must
retain that REI as specified on current labeling. Any conflicting entry
restrictions on current labeling must be removed.
In order to remain in compliance with FIFRA, labels of
multiple-active-ingredient end-use products that contain methiocarb
must compare the entry restrictions set forth in this section to the entry
restrictions on their current labeling and retain the more protective. A
specific time-period in hours or days is considered more protective than
"sprays have dried" or "dusts have settled."
(3) Pressurized Liquid Formulations: In order to remain in
compliance with FIFRA, a 25-day restricted entry interval (REI) as
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follows is required on all methiocarb end-use products formulated as a
pressurized liquid.
Do not enter or allow worker entry in treated areas
during the restricted entry interval (REI) of 25 days,
except, after 10 days, workers may enter treated areas to
perform tasks including hand labor tasks that involve
contact with treated surfaces provided each worker
spends no more than 3 hours in each 24 hour period
performing such tasks.
These restrictions should be inserted into the labeling section pertaining
to REI's as required by PR Notice 93-7. Early entry by handlers and
ventilation procedures must be in accordance with the WPS for
greenhouse workers, 40 CFR 170.110(c) and this RED.
c. Personal Protective Equipment Requirements; Labeling
(1) Handlers:
• Products NOT Primarily Intended for Home Use: The
minimum personal protective equipment (PPE) requirement for
pesticide handlers on all methiocarb end-use products, except products
intended primarily for home use (see tests in PR Notices 93-7 and 93-
11), is:
"Applicators and other handlers must wear:
-Coveralls over short-sleeved shirt and short pants
--Chemical-resistant or waterproof gloves (see * below)
—Chemical-resistant footwear plus socks
-Chemical-resistant headgear for overhead exposure
-Chemical-resistant apron when cleaning equipment, mixing,
or loading (see ** below)
In addition to the above, handlers must wear a respirator with
an organic vapor cartridge TC-23C during early entry to greenhouses
following treatment with the pressurized liquid for those tasks
associated with ventilating the greenhouse.
A dust mask must be worn while mixing/loading the wettable
powder formulation.
35
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* The glove statement for methiocarb is the statement
established through the instructions in Supplement Three of PR Notice
93-7.
** The words "mixing or loading" are not necessary for the
granular and aerosol formulations.
Producers of end-use products that contain methiocarb must
compare the personal protective equipment requirements set forth in
this section to the personal protective equipment requirements, if any,
on their current labeling and retain the more protective. For guidance
in choosing which requirement is more protective, see Supplement
Three of PR Notice 93-7.
• Products Primarily Intended for Home Use: For products
primarily intended for home use (see tests in PR Notice 93-7 and 93-
11), do not add any additional personal protective equipment for such
products, however, any personal protective equipment requirements on
the current product labeling must be retained.
(2) PPE for Entry During the Restricted Period; Labeling
(i) Wettable Powder Formulations. The personal protective
equipment for early entry is the PPE required for applicators of
methiocarb, except the applicator requirement for an apron is waived.
A dust mask must be worn while mixing/loading the wettable powder
formulation. This PPE should be inserted into the standardized early
entry PPE statement required by PR Notice 93-7.
(ii) Granulars Formulations. The personal protective equipment
for early entry is the PPE required for applicators of methiocarb. This
PPE should be inserted into the standardized early entry PPE statement
required by PR Notice 93-7.
(iii) Pressurized Liquid Formulations. The personal protective
equipment for early entry by workers is the PPE required for
applicators of methiocarb. This PPE should be inserted into the
standardized early entry PPE statement required by PR Notice
93-7.
The personal protective equipment for early entry by handlers
should be the PPE required for applicators of methiocarb. Label
language for reentry to perform ventilation tasks is as follows.
36
-------
Handlers entering a treated greenhouse must wear
a respirator with an organic vapor cartridge TC-
23C during early entry to a greenhouse following
treatment with the pressurized liquid for those
tasks associated with ventilating the greenhouse.
This respirator requirement language must be included with the
standardized early entry PPE statement required by PR Notice 93-7.
(iv) Uses Not Within the Scope of the WPS:
Do not add any additional entry restrictions for uses not within
the scope of the WPS; however, any entry restrictions on the
current product labeling for those uses must be retained.
• Products Primarily Intended for Home Use: For products
primarily intended for home use (see tests in PR Notice 93-7 and 93-
11), do not add any additional entry restrictions for such products;
however, any entry restrictions on the current product labeling must be
retained.
d. Other Labeling Requirements
(1) Labeling for Lawn and Turf Uses.
If a registrant chooses to support lawn and turf uses, he must
submit the data required in this Reregistration Eligibility Decision
document associated with the lawn and turf uses of methiocarb. If a
registrant chooses to support the residential lawn uses only, he must
add the following exclusionary statement to his labels in order to
remove the use site from the scope of the WPS in accordance with PR
Notice 93-11.
Exclusionary Statement: All granular end-use products that contain
methiocarb must carry the following statement located (1) on the front
panel of the label in association with the product name or (2) near the
beginning of the Directions For Use section:
"Not for use on turf being grown for sale
or other commercial use as sod, or for
commercial seed production, or for
research purposes."
37
-------
If registrant does not support the residential lawn uses, the
following statement must appear on his labels located (1) on the front
panel of the label in association with the product name or (2) near the
beginning of the Directions For Use section:
"Do not use on turfgrass around residences
or dwellings."
Also, if any lawn and turf uses are not being supported, the registrant
must amend his labels by deleting the lawn and turf uses in accordance
with the procedures in PR Notice 91-1.
The labels and labeling of all products must comply with EPA's
current regulations and requirements as specified in 40 CFR §156.10.
(2) Restricted Use Labeling.
The following statement must appear on all end-use labels for all
outdoor uses, except those products intended for homeowner uses. If
your product is intended for use on sites that have been classified as
restricted use as well as sites which have not been restricted as such,
you must separate the restricted use from the other uses by splitting the
one product label into two products and applying for a new registration
number for one or the other product. Each of the labels must further
clarify the intended site of use.
Restricted Use Pesticide
Due to Toxicity to Fish, Birds, and Aquatic Organisms
For retail sale to and use only by certified
applicators or persons under their direct
supervision and only for those uses covered by
the certified applicator's certification.
(3) Changes Relating to Label Rates and Number of
Applications.
The following typical number of applications must appear as the
maximum application rate on labels in the Directions for Use section
for the specified uses of methiocarb in order to decrease the aquatic
risks.
38
-------
75% Wettable Powder
2 Ibs 75% wettable powder per 50
gallons of water applied up to 2
times a year.
Granular or Pelletized Bait
Should not be applied more than twice a year.
(4) Labeling for Fish and Wildlife Hazard.
The following statements must appear on labeling for the following
specified uses:
End Use — Granular or Pelletized Bait for Molluscicide Use
This pesticide is toxic to fish and very highly toxic to
birds and mammals. Do not apply directly to water,
wetlands (swamps, bogs, marshes, and potholes).
Runoff from treated area may be hazardous to aquatic
organisms in adjacent aquatic sites. Do not contaminate
water when disposing of equipment washwaters and
rinsates.
End Use - 75% Wettable Powder
This pesticide is toxic to fish and very highly toxic to
birds and mammals. Do not apply directly to water, or
to areas below the mean high water mark. Runoff from
treated area may be hazardous to aquatic organisms in
adjacent aquatic sites. Do not contaminate water when
disposing of equipment washwaters and rinsates.
This product is very highly toxic to honey bees exposed
to direct treatment or residues on blooming shrubs,
flowers, weeds and trees. Do not apply this product or
allow it to drift to blooming shrubs, flowers, weeds, or
trees if bees are visiting the treatment area.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration
39
-------
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 case-by-case, 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 methiocarb
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.
40
-------
VI. APPENDICES
41
-------
-------
APPENDIX A. Table of Use Patterns Subject to
Reregistration
43
-------
-------
The following table includes uses eligible/ineligible (or reregistration. It also includes changes (maximum number of applications and REIs) that result from the RED review.
APPENDIX A Case 0577, [Methiocarb] Chemical 100501
S)T£ Application Typ*. Application Timing. A(.pjication Equipment
Fo.m
USES ELIGIBLE FOR REREGISTRATION
Minimum Application
Ret*
Maximum
Application Ral«
Max. «
Apo..
Max. i
Appa @
Max. R>u
Min. Intetval
Bdtwean Appe. @
Max. Rau
(O.y.l
Realiicled
Enl,V
Inlefval
(Daya)
Geogtaphtc
Li mint ion*
Allowed
DiMllowed
U»« Limitations
NONFOOD/NONFEED USES
Ornamental Herbaceous Plants Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
Bait Application, Foliar Stage, Spreader
B/S
B/S
B/S
na
na
na
.02 Ib Al per
1,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
Vr.
2 per
yr.
2 per
y.
2 per
yr.
2 per
Vr-
2 per
yr.
not spec
not spec
not spec
24 hr.
24 hr.
24hr.
Ornamental Herbaceous Plants Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
B/S
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1.5lb Alper
Acre
2 per
vr-
2 per
Vr.
2 per
Vr.
2 per
yr.
not spec
not spec
24 hr.
•" See
REIat
end
Ornamental Herbaceous Plants Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
Spray, Foliar Stage, Ground
B/S
B/S
or G
PRL
WP
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
1 .5 Ib Al per
Acre
2 per
Vr.
2 per
vr.
not
spec
2 per
V-
2 per
yr.
2 per
yr.
not
spec
2 per
vr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
"« See
REIat
end
»" See
REIat
end
•See
Limitation
at end
45
-------
APPENDIX A Case 0577, [Methiocarb] Chemical 100501
SITE Application Type, Application Timing, Aitplicnrion Equipment
Rale
Application Rate
Max. f
Appe
Max. *
Appa @
Max Rale
Min. tnleival
Between Appa. p
Max Rate
(Dayal
Rtntiicled
Entiy
httnval
lOeye)
Ornamental Lawns and Turf Use Groups; Terrestrial Non-Food Crop
Bait Application, Foliar Stage, Granule
Applicator
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
Bait Application, Foliar Stage, Spreader
B/S
BIS
B/S
B/S
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
24 hr.
24 hr.
Geogfaphic
Ltmilationa
Allowed
Oieellowed
Uae limitationa
Ornamental arid/or Shade Trees Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
B/S
B/S
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1,000 sq.ft.
2 per
yr.
2 per
yr.
2 per
yr-
2 per
vr.
not spec
not spec
24 hr.
24 hr.
Ornamental and/or Shade Trees Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
B/S
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1 .5 Ib Al per
Acre
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
••See
REIat
end
Ornamental and/or Shade Trees Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
B/S
B/S
or G
PRL
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
2 per
yr.
2 per
yr.
not
spec
2 per
yr.
2 per
yr-
not
spec
not spec
not spec
not spec
24 hr.
24 hr.
•• See
REIat
end
•See
Limitation
at end
46
-------
APPENDIX A- Case 0577, [Methiocarb] Chemical 100501
SITE Application lype. Application liming, Application Equipment
Spray, Foliar Stage, Ground
WP
Minimum Application
Rate
na
Application Rate
1 .5 Ib Al per
Acre
Ma*. >
Apps.
2 per
Vr.
Max. 1
Appt &
Max Rau
2 per
yr.
Min. Interval
Between Appe. @
Max. Rate
(Dayal
not spec
Realticted
Entry
Interval
(Oeye)
•" See
REIat
end
Gsogiflphic
Limit ntions
Allowed
DiMllowed
Use UmitBlion*
Ornamental Nonflowaring Plants (Inc. ferns) Use Groups; Terrestrial Non-Food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
B/S
B/S
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
Yr.
2 per
Yr.
2 per
yr-
2 per
yr.
not spec
not spec
24 hr.
24 hr.
Ornamental Nonflowerlng Plants Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
B/S
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1.5lb Alper
Acre
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
*" See
REIat
end
Ornamental Nonflowering Plants Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
Spray, Foliar Stage, Ground
B/S
B/S
or G
PRL
WP
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
1 .5 Ib Al per
Acre
2 per
yr-
2 per
Yr.
not
spec
2 per
yr.
2 per
yr.
2 per
yr.
not
spec
2 per
yr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
"•See
REIat
end
•» See
REIat
end
* See
Limitation
at end
Ornamental Woody Shrubs and Vines Use Groups: Terrestrial Non-food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
B/S
B/S
na
na
.02 Ib Al per 2 per
1 ,000 sq. ft. 1 yr.
.02 Ib Al per 2 per
1 ,000 sq. ft. 1 yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
24 hr.
47
-------
APPENDIX A- Case 0577, [Methiocarb] Chemical 100501
SITE Application Type. Application riming. Application Equipment
Fotm
Minimum Application
R.I.
Minimum II Max. >
Application Rale II Appa.
M>». «
Appa e>
Max. Rat*
Min. Mafval
fx.lw.en Appa. fl
Mo. D.M
(Oaya)
Raattictad
Entry
htafval
(D.y.l
Geogtaphic
Limitations
Allowed
Disallowed
U*e Limitation*
Ornamental Woody Shrubs and Vines Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
BIS
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1 .5 Ib Al per
Acre
2 per
vr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
*" See
REIat
end
Ornamental Woody Shrubs and Vines Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
Spray, Foliar Stage, Ground
BIS
BIS
or G
PRL
WP
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
1.5 Ib Alper
Acre
2 per
Yr.
2 per
vr.
not
spec
2 per
yr.
2 per
yr.
2 per
yr. '
not
spec
2 per
yr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
••See
REIat
end
•• See
REIat
end
• See
Limitation
at end
Household/Domestic Dwellings Outdoor Premises Use Group: Outdoor Residential Only
Bait Application, When needed, Not on Label
BIS
or G
na
.02 Ib Al per I 2 per
1 ,000 sq. ft. || yr.
2 per
yr.
not spec
24 hr.
Ginseng (with 12 month Preharvest Interval) Use Group; Terrestrial Non-Food Crop
Bait Application, Spring, Ground
Bait Application, Spring, Hand-Held
BIS
BIS
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
Yr.
2 per
yr-
2 per
yr-
2 per
yr.
not spec
not spec
24 hr.
24 hr.
1 2 month
preharvest
interval
1 2 month
preharvest
interval
48
-------
APPENDIX A- Case 0577, [Methiocarb] Chemical 100501
SITE Application Type. Application liming. Application Equipment
Fo.m
Minimum Application
Rate
Maximum II Max. *
Application Rat* || Appt.
1
Max. *
Appa. @
Max. Rat*
Min. Interval
Batwe«n Appa. @
Max. Rata
(Daya)
Raatiictvd
Entry
(ntorval
(Oaya)
Gaogtaphic
Limitation*
Allowed
DiaallovMd
Ua* Limitation*
USES INELIGIBLE FOR REREGISTRATION: Includes Uses on Ornamental Lawns and Turf (Outdoor Residential Only) and all Food Crops including previously Registered Sites (Corn,
Avocado, and Citrus Fruits).
Abbreviations used
Header: max = maximum; min=minimum;apps = applications; not spec = not specified; na = not applicable
Form : G = Granular, BIS = Bait/Solid. WP = Wettable powder. PRL = Pressurized liquid
* Limitations for Greenhouse Use:
Do not enter treated areas without protective clothing until 24 hours after application.
* * Restricted Entry Interval (RED:
REI for Wettable Powder and Pressurized Liquid formulations: Do not enter or allow worker entry in treated areas during the restricted entry interval (RED of 25 days, except after 10 days,
workers may enter treated areas to perform tasks including hand labor tasks that involve contact with treated surfaces provided each worker spends no more than 3 hours in each 24 hour
period performing such tasks.
49
-------
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
51
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case covered by this Reregistration Eligibility Decision Document. It
contains generic data requirements that apply to 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.
53
-------
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT
61-1 Chemical Identity
61-2 Start. Mat. & Mnfg. Process
61-3 Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analtyical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
40686901
42389002
42389002
40619301, 40619302
40619301
40619301
40452101
40452101
40452101
40452101
N/A - TGAI is a solid at room temperature
40452101, 42389001
40452101
40452101
40452101
40452101
N/A - TGAI is not soluble enough in water
40452101, 42389001
55
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
64-1
Submittal of Samples
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary (LCSO) - Quail
71-2B Avian Dietary (LCSO) - Duck
71-3 Wild Mammal Toxicity
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
71-5A Simulated Field Study
71-5B Actual Field Study
72-1A Fish Acute (LCSO) - Bluegill
72-1B Fish Acute (LCSO) - Bluegill (TEP)
72-1C Fish Acute (LCSO) - Rainbow Trout
72-1D Fish Acute (LCSO) - Rainbow Trout
(TEP)
72-2A Aquatic Invertebrate (ECSO)
72-3A Estuarine/Marme Toxicity - Fish
72-3B Estuarine/Marine Toxicity -
Mollusk
CIK
CIK
CIK
CIK
C
CK
CK
CK
CK
CK
CK
CIK
CIK
CIK
CK
CK
RESERVED - If samples are required, the
Agency will request them
GS0577006, 00036482
00022923
00022923
N/A
00128119
00128119
40560001
40560001
00150628
00036484
00150628
00036484
00127638, 00150383
DATA GAP
DATA GAP
56
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
72-3C Estuarine/Marine Toxicity -
Shrimp
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
72-5 Life Cycle Fish
72-6 Aquatic Organism Accumulation
72-7A Simulated Field - Aquatic
Organisms
72-7B Actual Field - Aquatic Organisms
70-A-SS Special Test: Avian Repellency
70-B-SS Special Test: Aquatic Residue
Monitoring
141-1 Honey Bee Acute Contact Toxicity
141-2 Honey Bee Toxicity of Residues on
Foliage
141-4 Honey Bee Subacute Feeding Study
141-5 Field Testing for Pollinators
142-1 Acute Toxicity to Aquatic Insects
CK
CK
CK
CK
C
CK
C
C
C
DATA GAP
00155967 - DATA GAP
40628001 - DATA GAP
DATA GAP
N/A
RESERVED
RESERVED
40560001
WAIVED
0001999, 00036935
00060625
RESERVED - pending development of test
methodology.
N/A - data reviewed under RS does not
indicate need for this study.
RESERVED - pending Agency decision as to
whether data requirement should be
established.
57
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
142-2
142-3
143-1
thru
143-3
Aquatic Insect Life Cycle Study
Simulated or Actual Field Testing
for Aquatic Insects
NonTarget Insect Testing -
Predators and Parasites
RESERVED - pending Agency decision as to
whether data requirement should be
established.
RESERVED - pending Agency decision as to
whether data requirement should be
established.
RESERVED - pending Agency decision as to
whether data requirement should be
established.
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Eye Irritation
81-5 Dermal Irritation
81-6 Dermal Sensitization
81-7 Acute Delayed Neurotoxicity - Hen
82-1A 90-Day Feeding - Rodent
82-1B 90-Day Feeding - Non-rodent
CIK
CIK
CIK
CIK
CIK
CIK
CIK
00036477, 00083437
00036478
40404201
0055163
0055163
N/A - Not required for technical methiocarb.
N/A - Methiocarb is not an organophosphate.
N/A - Adequate chronic studies are available.
N/A - Adequate chronic studies are available.
58
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
82-2
82-3
82-4
82-5A
82-5B
82-A-SS
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
21-Day Dermal - Rabbit/Rat
CIK
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
30-Day Feeding - Non - Rodent
(Dog)
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)
CIK
CIK
CIK
CIK
CIK
CIK
CIK
41771701, 40922301 (Although these studies
were classified as supplemental, acceptable
chronic studies are available which satisfy this
guideline requirement.)
N/A - because of existing use patterns do not
result in repeated skin contact for an extended
period of time.
N/A - not required for current use patterns.
N/A - not required for current use patterns.
DATA GAP
N/A - not required for current use patterns.
00115226
00128939, 00149362
00115226
N/A - Not required for current use patterns.
00124617
00143213, 42496401, 42931901
N/A - Not required for current use patterns.
40508101
59
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
84-2 B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
85-2 Dermal Absorption
86-1 Domestic Animal Safety
REENTRY PROTECTION
132-1 A Foliar Residue Dissipation
132-1B Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
USE PATTERN CITATION(S)
CIK 40508102
CIK 40700801
N/A - Not required for current use patterns.
N/A - Not required for current use patterns.
N/A - Not required for current use patterns.
K DATA GAP
DATA GAP
K DATA GAP
I DATA GAP
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
CK
CI
C
DATA GAP
40624501
40622301
60
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
161-4 Photodegradation - Air
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/
Desorption
163-2 Volatility - Lab
163-3 Volatility - Field
164-1 Terrestrial Field Dissipation
164-2 Aquatic Field Dissipation
164-3 Forest Field Dissipation
164-4 Combination and Tank Mixes
164-5 Long-Term Soil Dissipation
CIK
CIK
CK
CK
N/A - Not required based on low vapor
pressure of methiocarb.
41194601
41194601
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
40342201 - DATA GAP
N/A - Not required based on low vapor
pressure.
N/A - Not required based on low vapor
pressure.
DATA GAP
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
RESERVED
61
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT USE PATTERN CITATION(S)
165-1
165-2
165-3
165-4
165-5
Confined Rotational Crop
Field Rotational Crop
Irrigated Crops
Bioaccumulatin in Fish
Bioaccumulation - Aquatic
WAIVED
RESERVED
N/A - Not required
patterns.
WAIVED
N/A - Not required
because of current use
because of current use
Non-Target Organisms
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
patterns.
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
RESIDUE CHEMISTRY
*A11 of the Residue Chemistry data requirements are waived due to the dropped food uses. Residue Chemistry
references are listed in the Bibliography (Appendix C).
171-3 Directions for Use *
171-4A Nature of Residues - Plants *
171-4B Nature of Residues - Livestock *
171-4C Residue Analytical Method - Plants *
171-4D Residue Analytical Method - *
Animal
62
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/ Milk/Poultry
171-4K Cropfield Trials
Agricultural Crops
(Preplant Application)
Avocados
Blueberries
Cherries
Corn, Field
Cranberries
Deciduous Fruit Trees
(Nonbearing)
Grapefruit
Lemons
Oranges
Peaches
Peppers and Sunflowers
Grown for Seed
171-4L Processed Food
Citrus Group
171-5 Reduction of Residues
63
-------
-------
APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Methiocarb
65
-------
-------
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
67
-------
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.
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.
68
-------
BIBLIOGRAPHY
MRID
CITATION
00001999
00022923
00035520
00036477
00036478
00036482
Spagnoli, J. (1993) Typical Use of Methiocarb. (Letter to Karen Farmer,
U.S. EPA, dated July 22, 1993; submitted by Miles, Inc., Kansas City, Mo.)
Atkins, L., Jr.; Anderson, L.D. (1967) Toxicity of Pesticides and Other
Agricultural Chemicals to Honey Bees: laboratory Studies. (Unpublished
study received Jan 30, 1969 under 9G0802; prepared by Univ. of California-
Riverside, Dept. of Entomology, submitted by Hercules, Inc., Agricultural
Chemicals, Wilmington, Del.; CDL:093111-D)
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 Interior, Fish and Wildlife Service, Patuxent Wildlife
Research Center; unpublished report)
Strankowski, K.J.; Stanley, C.W. (1978) Determination of Residues of
Mesurol® and Its Toxic Metabolites in Crops: Report No. 45089.
(Unpublished study including report nos. 53015, 53701 and 62625, received
Jun 19, 1980 under OF2362; prepared in cooperation with International
Research & Development Corp. and others, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:099475-B)
Crawford, C.R.; Anderson, R.H. (1973) The Acute Oral Toxicity of Mesurol
Technical to Rats: Report No. 34008. Rev. (Unpublished study received Mar
26, 1975 under 5F1607; submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:094391-T)
Crawford, C.R.; Anderson, R.H. (1972) The Dermal Toxicity of Mesurol
Technical and Mesurol 75% Wettable Powder to Rabbits: Report No. 34477.
(Unpublished study received Mar 26, 1975 under 5F1607; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:094391-U)
Schafer, E.W., Jr.; Brunton, ? (1973) Toxicity and Repellency Tests of 9
Materials from Bayer and Chemagro: Report No. S-225; Report No. 36054.
(Unpublished study including report nos. S-223 and 36055, received Mar 26,
1975 under 5F1607; prepared in cooperation with U.S. Fish and Wildlife
Service, Denver Wildlife Research Center, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:094391-Z)
69
-------
BIBLIOGRAPHY
MRID
CITATION
00036484 Lamb, D.W.; Roney, D.J. (1973) Acute Toxicity of Mesurol 75% Wettable
Powder to Bluegill and Rainbow Trout: Report No. 36612. (Unpublished study
received Mar 26, 1975 under 5F1607; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:094391-AB)
00036491 Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N.F.; et al. (1973) The Chronic
Toxicity of Methiocarb to Crackles, Doves, and Quail and Reproductive
Effects in Quail: Report No. 39615. (U.S. Fish and Wildlife Service, Denver
Wildlife Research Center, unpublished study; CDL:094391-AJ)
00036496 Morgan, J.G.; Parton, K. (1974) Metabolism of Mesurol in Apples: Report
No. 40208. (Unpublished study received Mar 26, 1975 under 5F1607;
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:094391-AO)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides
and Other Agricultural chemicals to Honey Bees: Laboratory Studies. By
University of California, Dept. of Entomology. ?: UC, Cooperative
Extension. (Leaflet 2287; published study)
00037132 Chemagro Corporation (1971) Synopsis of Mesurol: Analytical and Residue
Information for Seed Treatment of Corn: (Unpublished study received Jul 2,
1975 under 6F1652; CDL:094636-A)
00037822 Cunningham, D.; Schafer, E.W., Jr. (1968) [Toxicity Studies on Birds]:
Report No. 23196. (U.S. Fish and Wildlife Service, Denver Wildlife
Research Center, unpublished study; CDL: 094390-AP)
00046448 Mobay Chemical Corporation (1978) Recovery of Mesurol from Blueberries
and Grapes: Report No. 65401. (Unpublished study received May 5, 1980
under 3125-288; prepared in cooperation with International Research and
Development Corp.; CDL:099423-B)
00046449 Mobay Chemical Corporation (1978) The Effect of Frozen Storage at 0 to
-10°=F on Mesurol Residues in Various Crops: Report No. 66101.
(Unpublished study received may 5, 1980 under 3125288; CDL:099423-C)
00046450 Stanley, C.W.; Kottman, R.F.; Bingman, K.J. (1979) Metabolism and
Excretion of Mesurol by Poultry: Report No. 66777. (Unpublished study
70
-------
BIBLIOGRAPHY
MRID
CITATION
received May 5, 1980 under 3125-288; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:099423-D)
00046451 Stanley, C.W.; Kottman, R.F.; Bingman, KJ. (1979) Radioactive Residues of
[14C]Mesurol in Poultry: Report No. 66778. Rev. (Unpublished study
received May 5, 1980 under 3125-288; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:099423-E)
00046453 Becker, B.D. (1979) Recovery of Mesurol from Grape Must: Report No.
68215. (Unpublished study received May 5, 1980 under 3125-288; prepared
in cooperation with International Research & Development Corp., submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL:099423-H)
00055163 Crawford, C.R.; Anderson, R.H. (1970) The Skin and Eye Irritating
Properties of Bay 37344 Technical to Rabbits: Report No. 28304.
(Unpublished study received May 20, 1971 under 3125-258; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:229102-A)
00056044 Mobay Chemical Corporation (1976) Synopsis of Mesurol Residue Chemistry
on Citrus. Summary of studies 095325-B through 095325-D. (Unpublished
study received Oct 15, 1976 under 3125234; CDL:095325-A)
00056045 Strankowski, K.J.; Stanley, C.W. (1975) Determination of Residues of
Mesurol and Its Toxic Metabolites in Crops: Report No. 45089. Method dated
Nov 21, 1975. (Unpublished study received Oct 15, 1976 under 3125-234;
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:095325-B)
00056047 Chemonics (1976) The Effect of Frozen Storage at 0 to -10° on Mesurol
Residues in Orange Peel and Pulp: Report No. 49580. (Unpublished study
received 3125-234; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:095325-D)
00060625 Johansen, C.; Hutt, R. (1962) Bee Poisoning Investigations, 1962: Report No.
10617. (Unpublished study received Mar 27, 1974 under 4F1485; prepared by
Washington State Univ., submitted by Chemagro Corp., Kansas City, Mo.;
CDL:092011-E)
00060635 Shellenberger, T.E. (1970) Letter sent to D.W. Lamb dated Dec 10, 1970:
Toxicological evaluations of three Chemagro chemicals with fish: GSRI
71
-------
BIBLIOGRAPHY
MRID
CITATION
Project No. NC-413; Report No. 29003. (Unpublished study received Mar
27, 1974 under 4F1485; prepared by Gulf South Research Institute, submitted
by Chemagro Corp., Kansas City, Mo.; CDL:092011-T)
00083437 Lamb, D.W.; Matzkanin, C.S. (1977) A Comparison of the Acute Oral
Toxicities of Mesurol Technical to Fasted and Non-fasted Rats: 51420.
(Unpublished study received Aug 30, 1979 under 3125-234; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:098990-A)
00083438 Thyssen, J.; Schilde, B. (1978) H 321 (Mesurol Active Ingredient):
Neurotoxicity Studies on Hens: Report No. 7637; 66482. (Unpublished study
received Aug 30, 1979 under 3125-234; prepared by Bayer AG, West
Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:098990-B)
00115224 Mobay Chemical Corp. (1982) Addition No. 2 to the Brochure Entitled:
Mesurol Residue Chemistry on Grapes: Document No. AS 821702.
(Compilation; unpublished study received Oct 4, 1982 under 3125-288;
CDL:071113-A)
00115226 Kroetlinger, F.; Loeser, E.; Vogel, O. (1981) H 321: (..., the Active
Ingredient of MESUROL)~Chronic Toxicity Study on Rats-(2-year Feeding
Experiment): Bayer Report No. 10039; Mobay ACD Report No. 69844.
(Unpublished study received Oct 4, 1982 under 3125-288; prepared by Bayer
AG., W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071114-B)
00116555 Mobay Chemical Corp. (1970) Mesurol (Bay 37344): Metabolic, Analytical,
Residue, and Flavor Information (Apples and Pears). (Compilation;
unpublished study received Sep 9, 1971 under 1G1030; CDL:091909-A;
091907)
00123980 Mobay Chemical Corp. (1974) Mesurol: Metabolic, Analytical, Residue and
Flavor Information for Foliar Spray Applications on Apples, Cherries, Peaches
and Pears. (Compilation; unpublished study received Mar 26, 1975 under
5F1607; CDL:094388-A; 094387; 094386)
00124617 Lorke, D. (1971) Mesurol Active Ingredient (Bay 37 344): Studies on Rats for
Embryotoxic and Teratogenic Effects: Report No. 3133; 32142. (Unpublished
72
-------
BIBLIOGRAPHY
MRID
CITATION
study received Mar 26, 1975 under 5F1607; prepared by Farbenfabriken
Bayer, AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL: 094389-L)
00124968 Abdel-Wahab, A.; Kuhr, R.; Casida, J. (1966) Fate of C14-carbonyllabeled
aryl methylcarbamate insecticide chemicals in and on bean plants. J. Agr.
Food Chem. 14(3):290-297. (Submitter 18274; also In unpublished
submission received Jul 15, 1976 under 3125-EX-135; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:227756-E)
00125528 Mobay Chemical Corp. (1977) Addition No. 1, Mesurol Residue Chemistry on
Apples, Cherries, Peaches and Pears, to Brochure Entitled:
Mesurol-Metabolic, Analytical, Residue and Flavor Information for Foliar
Spray Applications on Apples, Cherries, Peaches and Pears: Document No.
AS77-1086. (Compilation; unpublished study received Jul 20, 1977 under
3125-288; CDL: 096264-A)
Mobay Chemical Corp. (1977) Mesurol: Residue Chemistry on Cole Crops:
Document No. AS77-559. (Compilation; unpublished study received May 5,
1977 under 3125-234; CDL:096118-A)
Mobay Chemical Corp. (1971) [Mesurol: Analytical and Residue Information
for Seed Treatment of Corn]. (Compilation; unpublished study received Feb
14, 1973 under unknown admin, no.; CDL: 126889-A)
Pfipharmecs (1957) Study of the Efficacy of Tetracycline and Terramycin on
Fish. (Compilation; unpublished study received Dec 5, 1956 under PP0111;
CDL092391-B).
Mobay Chemical Corp. (1977) Addition No. 1 to Brochure Entitled:
Mesurol-Residue Chemistry on Berries: Document No. AS77-259.
(Compilation; unpublished study received Feb 25, 1977 under 3125-EX-139-
CDL:096002-A)
00127630 Mobay Chemical Corp. (1977) Mesurol: Residue Chemistry on Grapes:
Document No. AS77-337. (Compilation; unpublished study received Mar 4,
1977 under 3125-EX-140; CDL:096017-A)
00125530
00125532
00125537
00127628
73
-------
BIBLIOGRAPHY
MRID
CITATION
00127634 Mobay Chemical Corp. (1976) Mesurol: Residue Chemistry on Beans:
Document No. AS77-565. (Compilation; unpublished study received May 5,
1977 under 3125-234; CDL:096117-A)
00127635 Mobay Chemical Corp. (1978) Addition No. 2 to Brochure Entitled: Mesurol:
Residue Chemistry on Berries (Dated Dec 1, 1976): AS19-1643.
(Compilation; unpublished study received Sep 14, 1979 under 3125-288;
CDL:098964-A)
00127638 Nelson, D.; Roney, D. (1979) Acute Toxicity of Mesurol Technical to
Daphnia magna: Report No. 67264. (Unpublished study received Sep 14,
1979 under 3125-288; submitted by Mobay Chemical Corp., Kansas City,
MO; CDL-.098965-D)
00128119 Lamb, D.; Carsel, M.; Mallicoat, D.; et al. (1982) Methiocarb Reproduction
Study with Bobwhite Quail: 82400. (Unpublished study received Feb 10, 1983
under 3125-234; submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071396-A)
00128121 Carlisle, L; Carsel, M.; Lamb, D.; et al. (1982) A Laboratory Study
Exposing Bobwhite Quail to Mesurol 2% Bait: 82399. (Unpublished study
received Feb 10, 1983 under 3125-234; submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:071396-C)
00128122 Carlisle, J.; Toll, P.; Lamb, D.; et al. (1982) Small Pen Field Study of
Mesurol 2% Bait Toxicity To Bobwhite Quail: 82674. (Unpublished study
received Feb 10, 1983 under 3125-234; submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:071396-D)
00128723 Mobay Chemical Corp. (19??) Summary of the Incidence of Nonneoplastic
Lesions in Male and Female Rats (Gross and Microscopic Observations):
Addendum to Bayer Report No. 10039: 69844. (Unpublished study received
Jun 22, 1983 under unknown admin, no.; CDL:250526-A)
00128939 Hoffman, K.; Schilde, B. (1980) H 321 (Mesurol Active Ingredient-
Mercaptodimethur): Chronic Toxicity Study on Dogs (Two-year Feeding
Experiment): Report No. 9626; 69364. (Unpublished study received Jun 15,
1983 under unknown admin, no.; prepared by Bayer AG, W. Ger., submitted
by Mobay Chemical Corp., Kansas City, MO; CDL:250497-A)
74
-------
BIBLIOGRAPHY
MRID
CITATION
00133477
00133480
00141660
00143213
00145802
00149362
00150383
00150628
00154537
Mobay Chemical Corp. (1983) Synopsis of Mesurol Toxicology: [Rats, Dogs
and Mice]. (Unpublished study received Dec 12, 1983 under OF2356;
CDL:072227-A)
Kroetlinger; Janda; Blass; et al. (1983) H 321 (Mercaptodimethur, the Active
Ingredient of Mesurol): Chronic Toxicity Study on Mice (Two-year Feeding
Experiment): Report No. 11908; 85950. (Unpublished study received Dec 12,
1983 under OF2356; prepared by Bayer AG, W. Ger., submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:072227-D)
Maddy, K.; Schneider, F.; Lowe, J.; et al. (1982) A Study of the Degradation
of Mesurol When Applied as a Foliar Spray to Grape Vineyards in Fresno and
San Luis Obispo Counties, California during August of 1981: HS-964.
Unpublished study prepared by California Dept. of Food and Agriculture,
Worker Health and Safety Unit. 6 p.
Tesh, J.; Ross, F.; Seeker, R. et al. (1981) H 321 : Effects of Oral
Administration upon Pregnancy in the Rabbit: 2. Main Study:
81/BAG013/598. Unpublished study prepared by Life Science Research.
P-
60
Atwell, S.; Murphy, J. (1978) Soil Absorption and Desorption of FCarbon
14cr Mesurol: Mobay report No. 66145. Unpublished study prepared by
Mobay Chemical Corp. 14 p.
Mobay Chemical Corporation (1985) pChronic Toxicity Study on Dogscr:
Report No. 69364: Addendum. Unpublished study. 42 p.
Marking, L.; Chandler, J. (1981) Toxicity of six bird control chemicals to
aquatic organisms. Bull. Environm. Contam. Toxicol. (26):705-716.
Lamb, D. (1981) Acute Toxicity of Technical Methiocarb (Mesurol) to
Bluegill and Rainbow Trout: Study Nos. 81-066-03 and 80-066-12: Mobay
Report No. 69407. Unpublished study prepared by Mobay Chemical Co. 9 p.
Mobay Chemical Corp. (1982) Mesurol: Residue Chemistry on Pecans.
Unpublished compilation. 92 p.
75
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BIBLIOGRAPHY
MRID
CITATION
00155042 Mobay Chemical Corporation (1981) Residue Data for Mesurol. Unpublished
compilation. 1059 p.
00155046 Strankowski, K.; Parker, G. (1981) Carbon-14 MESUROL® Rotational Crop
Study. Unpublished Mobay report 69270. 15 p.
00155055 Strankowski, K. (1979) Metabolism of MESUROL® in Rice: Report No.
66776. Unpublished study prepared by Mobay Chemical Corporation. 46 p.
00155057 Mobay Chemical Corporation (1981) Residue Data for MESUROL®.
Unpublished compilation. 793 p.
00155967 Carlisle, J. (1985) Toxicity of Methiocarb (Mesurol) Technical to Early Life
Stages of Rainbow Trout: Study No. 85-666-02: 90579. Unpublished study
prepared by Mobay Chemical Corp. 19 p.
00157781 Borderland Products Inc. (1986) Residue Data on Methiocarb in Paddy Canal
and Receiving Waters. Unpublished study prepared in cooperation with
Craven Laboratories, Inc. and Morse Laboratories, Inc. 71 p.
00157782 Borderland Products Inc. (1986) Aquatic Field Dissipation in Water.
Unpublished compilation prepared in cooperation with Craven Laboratories
Inc. and Morse Laboratories Inc. 74 p.
00158770 Mobay Chemical Corp. (1986) Mesurol: Residue Chemistry on Blueberries
and Cherries; March 13, 1986: Brochure No. 1444. Unpublished compilation.
280 p.
40342201 Ridlen, R. (1987) Soil Leaching of Aged Residues of Mesurol. Unpublished
Mobay Report 94872 prepared by Mobay Corp., Stanley Research Center. 40
P-
40404201 Shiotsuka, R. (1987) Acute Four-hour Inhalation Toxicity Study with Mesurol
Technical in Rats: Study No. 86-041-25; 94635. Unpublished study prepared
by Mobay Corp. 34 p.
40452101 Talbott, T. (1987) Product Chemistry of Mesurol Technical: Mobay Reports:
69950, 86787. Unpublished compilation prepared by Mobay Corp. 60 p.
76
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BIBLIOGRAPHY
MRID
CITATION
40508101 Herbold, B. (1986) H 321 c.n. Mercaptodimethur Salmonella/Microsome Test
to Evaluate for Point Mutagenic Effect: Report No. 14205. Unpublished
Mobay Study No. 91775 prepared by Bayer Ag, Germany . 33 p.
40508102 Putman, D. (1986) Sister Chromatid Exchange Assay in Chinese Hamster
Ovary (CHO) Cells: Laboratory Study No. T4522.334. Unpublished Mobay
Study No. 91334 prepared by Mocrobiological Associates, Inc. 25 p.
40560001 Dolbeer, R.; Avery, M.; Tobin, M. (1988) Assessment of Field Hazards to
Birds and Mammals from Methiocarb Applications to Fruit Crops: Report No.
87266. Unpublished compilation. 1198 p .
40615001 Greig-Smith, P.; Hardy, A.; Brown, P. et al. (1981) Assessment of the
Hazard to Wildlife from the Use of Methiocarb To Protect Ripening Cherries:
Project No. C/88/0127. Unpublished study prepared by ADAS Tolworth
Laboratory. 214 p.
40619301 Talbott, T. (1988) Product Chemistry of Mesurol Technical: 86256: 95644.
Unpublished study prepared by Mobay Corp. 214 p.
40619302 Talbott, T. (1988) Product Chemistry of Mesurol 75% Concentrate: 88839:
95644. Unpublished study prepared by Mobay Corp. 213 p.
40622201 Carlisle, J. (1985) Supplemental Submission to EPA Accession No. 262626:
Toxicity of Methiocarb (Mesurol) Technical to Early Life Stages of Rainbow
Trout: Study Report No. 85-666-02. Unpublished Mobay report No. 90579-1.
6 p.
40622301 Jackson, S.; Kesterson, A.; Lawrence, L. (1988) Soil Surface Photolysis of
[Carbon 14]Mesurol in Natural Sunlight: Report No. 1148: Project No. 220.
Unpublished study prepared by Pharmacology and Toxicology Research
Laboratory. 71 p.
40624501 Kesterson, A.; Marsh, J.; Lawrence, B.; et al. (1988) Photochemical
Degradation of [Carbon 14]Mesurol in Aqueous Solutions: Project No. 214;
Report No. 1147. Unpublished study prepared by Pharmacology and
Toxicology Research Laboratory. 78 p.
77
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BIBLIOGRAPHY
MRID
CITATION
40624502 Saakvitne, J.; Gustafson, D.; Wilkes, L.; et al. (1981) Mesurol Hydrolysis in
Sterile Buffers: Proj. No. 443. Unpublished Mobay study 69272 prepared by
Analytical Development Corp. 32 p.
40628001 Forbis, A. (1988) Chronic Toxicity of [Carbon 14]-Mesurol to Daphnia magna
Under Flow-through Test Conditions: Final Report No. 35249. Unpublished
Mobay study no. 96731 prepared by Analytical Bio-Chemistry Laboratories,
Inc. 34 p.
40686901 Talbott, T. (1988) Supplement 1: Product Chemistry of Mesurol Technical:
Doc. Reg. No. 2017. Unpublished study prepared by Mobay Corp. 10 p.
40700801 Curren, R. (1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
Test Article Mesurol: Study No. T5391.380. Unpublished study prepared by
Microbiological Associates, Inc. 41 p.
40922301 Procter, B. (1988) A 21-Day Dermal Toxicity Study of Mesurol Technical in
Albino Rabbits: Bio-Research Laboratory 51901. Unpublished Mobay report
no. 98369 prepared by Bio-Research Laboratories, Ltd. 259 p.
40994801 Murphy, J. (1989) Field Dissipation of Mesurol in Sand and Sandy Loam:
Proj. ID ME092101. Unpublished Mobay report no. 98512 prepared in
cooperation with Wilbur-Ellis Co., and EPL BioAnalytical Services, Inc. 300
P-
41015101 Gronberg, R.; Lemke, V. (1989) Validation of the Analytical Residue Method
for Methiocarb and Metabolites Using Field Weathered Residues in [Carbon
14] Mesurol 75 WP Treated Cherries: Report No. 98524. Unpublished study
prepared by Mobay Corporation. 71 p.
41015102 Gronberg, R.; Lemke, V. (1989) Validation of the Analytical Residue Method
for Methiocarb and Metabolites Using Greenhouse Weathered Residues in
[Carbon 14] Mesurol 75 WP Treated Blueberries: Report No. 98525.
Unpublished study prepared by Mobay Corp. 70 p.
41194601 Minor, R.; Freeseman, P. (1989) Fate of Methiocarb under Aerobic and
Anaerobic Soil Conditions: Project ID 99206. Unpublished study prepared by
Mobay Corp. 71 p.
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BIBLIOGRAPHY
MRID
CITATION
41771701 Procter, B. (1989) A 21-Day Dermal Toxicity Study of Mesurol Technical in
Albino Rabbits: Lab Project Number: 51925. Unpublished Study prepared by
Bio-Research Laboratories Ltd. 190 p.
42389001 Fontaine, L. (1992) Supplement to MRID 40452101: Product Chemistry of
Mesurol Technical: Lab Project Number: 34049: BR1807. Unpublished study
prepared by Miles Inc. 18 p.
42389002 Fontaine, L. (1992) Supplement to MRID 40404401: Product Chemistry of
Mesurol Technical: Lab Project Number: PN 97210-00: BR 1806.
Unpublished study prepared by Miles Inc. 14 p.
42481001 Proctor, B. (1992) A 21-day Dermal Toxicity Study of Mesurol Technical in
Albino Rabbits: [Supplement to MRID 41771701]: Lab Project Number:
98369. Unpublished study prepared by Bio-Research Labs, Ltd. 59 p.
42496401 Dotti, A.; Biedermann, K. (1992) Embryotoxicity Study (Including
Teratogenicity) with H 321 (c.n. Methiocarb) in the Rabbit (Dermal
Application): Lab Project Number: 103271. Unpublished study prepared by
RCC, Research and Consulting Co. Ltd. 294 p.
42758401 Dotti, A. (1993) Embryotoxicity Study (Including Teratogenicity) with H 321
(c.n. Methiocarb) in the Rabbit (Dermal Application): First Amendment to
Report: Lab Project Number: 297900: 297898: 103271-1. Unpublished study
prepared by Research and Consulting Co. Ltd. 99 p.
42931901 Dotti, A. (1993) Embryotoxicity Study (Including Teratogenicity) with H 321
(c. n. Methiocarb) in the Rabbit (Dermal Application): Supplement to: Second
Amendment to: Lab Project Number: 297900: 297898: R 5627. Unpublished
study prepared by RCC, Research and Consulting Co., Ltd. 15 p.
GS0577001 Watts, R.R. (1975) Method Trial for Mesurol on Corn Grain. Located in
Section D of PP# 6F1652.
GS0577002 Mahijani, G.P. (1977) Results of Method Tryout for Mesurol and its Sulfoxide
Metabolite in Milk and Beef Liver. Submitted under PP# 7F1988.
GS0577003 Mobay Chemical Corp. (1978) Chemagro Agricultural Division Experiment:
661-1609-77D. Report No. 66573. Located in Section D of PP# OF2362.
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BIBLIOGRAPHY
MRID
CITATION
GS0577004 Mobay Chemical Corp. (1981) Addition No. 2 to "Mesurol, the Effects on the
Environment - Environmental Chemistry"; Vol. I. Received May 29, 1981
under PP# OF2362. (EPA Accession Number 070111).
GS0577005 Mobay Chemical Corp. (1981) Addition No. 2 to "Mesurol, the Effects on the
Environment - Environmental Chemistry"; Vol. II. Received May 29, 1981
under PP# OF2362. (EPA Accession Number 070112).
GS0577006 Hudson, R.H.; Tucker, R.K.; Haegele, M.A. (1984) Handbook of Toxicity of
Pesticides to Wildlife. USDI Publication 153, Washington, D.C.
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APPENDIX D. List of Available Related Documents
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The following is a list of available documents related to methiocarb. It's purpose is
to provide a path to more detailed information if it is needed. These accompanying
documents are part of the Administrative Record for and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Methiocarb RED Fact Sheet (included in this RED)
4. PR Notice 91-2 (included in this RED) pertains to the Label Ingredient
Statement
Federal publications on methiocarb are available and may be purchased from the
National Technical Information Service (NTIS), 5825 Port Royal Road, Springfield, VA
22161.
1. Guidance for the Reregistration of Pesticide Products Containing Methiocarb
as the Active Ingredient (The 1987 Registration Standard): NTIS Stock No.
PB87-190898
2. Pesticide Fact Sheet (No. 120) for Methiocarb: NTIS Stock No. PB87-191920
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APPENDIX E. PR Notice 91-2
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
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certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(C)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(l)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July l, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
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level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
Ann* E. tiftdaay, Director
Registration Division (H-7505
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
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 7; 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 UI-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 6).
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 information is authorized under the Paperwork Reduction Act by OMB
Approval No. 2070-0107 and 2070-0057 (expiration date 3-31-96).
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at toast 50% recycled fiber
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This Notice is divided into six sections and seven 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 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 Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
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 safety 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 ingredients.
SECTION H. 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: Attachment 3 (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 (Attachment 3) within
the timeframes 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: 703-487-4650).
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(cV2^ 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-Inte). 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 ffl. 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 Form, and the Requirements Status and Registrant's Response Form.
(contained in Attachments 2 and 3, respectively).
The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms 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 Forms and the Requirements Status and
Registrant's Response Forms (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 completed Generic and Product Specific
Data Call-In Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Formfsl If you
choose this option, these are the only forms that you are required to complete.
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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 (Attachment
3), 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. You must also complete a Data Call-in Response Form 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.
To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form. Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-In Response Form. If you claim a generic
data exemption you are not required to complete the Requirements Status and Registrant's
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Response Form. 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 HI-C.1. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to
satisfy the generic data requirements), you must submit the Data Call-In Response Form and
the Requirements Status and Registrant's Response Form 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 Form. 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.
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 Form, and the Requirements Status and Registrant's Response Form.
for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-In
Response Form must be submitted as part of every response to this Notice. In addition, one
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copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form 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 Form and Requirements Status and
Registrant's Response Form (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
Form, indicating your election of this option. Voluntary cancellation is item number 5 on
both the Generic and Product Specific Data Call-In Response Forms. 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.2. 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 Form 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 Form. 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 Response Form. If you choose this option, you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form 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.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-in Response Form 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 Form
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
deadlines 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 Form 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.
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
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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 Form 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.
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,
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you may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do 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 EPA Form 8570-32, Certification of Offer to Cost Share in the Development of
Data, Attachment 7. 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
Form and a Requirements Status and Registrant's Response Form 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.
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly Met:
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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 "'[r]aw 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 also 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 submitting 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
Reregistration 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 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.
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.
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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 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.
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.
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 "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.
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If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In Response Form 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 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 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 HI.C.I, 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.I, 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.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section IH.C.I., Option 3) apply to this option. This option only applies to
acute toxicity and certain efficacy data as described in option 2 above.
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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 Form and the
Requirements Status and Registrant's Response Form, 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
Form. 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 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:
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(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 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
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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. 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 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.
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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 EI-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:
i. Inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form.
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ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. 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
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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 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.
Ill
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All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (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 Forms need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Prevention, Pesticides
and Toxic Substances (OPPTS), EPA, will be monitoring the data being generated in
response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration 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 Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
112
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Attachment 1. Chemical Status Sheet
113
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Generic and Product Specific Data Call-In
Chemical Status Sheet
for
Methiocarb
INTRODUCTION
You have been sent this combined Generic and Product Specific Data Call-In
Notice because you have product(s) containing methiocarb.
This combined Generic and Product Specific Data Call-In Chemical Status Sheet
contains an overview of data required by this combined notice, and points of contact for
inquiries pertaining to the reregistration of methiocarb. This attachment is to be used in
conjunction with:
• The Combined Generic and Product Specific Data Call-In Notice (Appendix
E),
• The Generic Data Call-In and Product Specific Data Call-In Response Forms
with Instructions (Attachment 2)
• The Generic Data Call-In and Product Specific Data Call-In Requirements
Status and Registrant's Response Forms with Instructions (Attachment 3),
• EPA's Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration (Attachment 4),
• The EPA Acceptance Criteria (Attachment 5),
• List of registrants receiving this combined DCI (Attachment 6), and
• The Confidential Statement of Formulat, Cost Share and Data Compensation
Forms (Attachment 7)
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the data base for methiocarb are
contained in the Requirements Status and Registrant's Response Forms. (Attachment 3).
The Agency has concluded that additional data on methiocarb 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 methiocarb
products.
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INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of methiocarb, please contact
Ms. Karen Jones at (703) 308-8047.
All responses to this Notice for the generic data requirements should be submitted to:
Ms. Karen Jones, Chemical Review Manager
Reregistration Branch
Special Review and Reregistration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC 20460
RE: Methiocarb
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Mr. Franklin Gee at (703) 308-8008.
All responses to this Notice for the product specific data requirements should be
submitted to:
Ms. Emily Mitchell
Special Review and Reregistration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Methiocarb
116
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
117
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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" and are to be used by registrants to respond to generic and product specific Data
Call-Ins as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide,
and Rodenticide Act. The type of data call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response"
forms must be completed.
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 2136, 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
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.
Item 3. 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.
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
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
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.
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 Form 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
Generic and Product Specific Data Call-In
Item 8. 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 initialled 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 not fit on this form in a signed
letter that accompanies your response. For example, you may wish to report that
your product has already been transferred to another company or that you have
already voluntarily cancelled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
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DRAFT
COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1. Comnany name and Address 2. Case # and Name
SAMPLE COMPANY 0577 Methiocarb
NO STREET ADDRESS Chemical # and Name 100501
NO CITY, XX 00000 Methiocarb
4. EPA Product
Registration
NNNNNN-NN'NNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
GENERIC
7. Product Specific Data
7a. My product is an HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11.
Phone Number
123
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DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460
^ ' OMB Mo. 2070-0107
DATA CALL-IN RESPONSE 2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name 3. Date and Type of DC I
SAMPLE COMPANY 0577 Methiocarb PRODUCT SPECIFIC
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification 9. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number
125
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
127
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Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
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 reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be completed.
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 2136, 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.
129
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
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, Subpart c.
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 Form.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
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
131
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
TEP/MET Typical End-Use Product and Metabolites
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.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORMS"
Generic and Product Specific Data Call-In
Option 2. ON BOTH FORMS: (Agreement to Cost Share) 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.
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 Share) 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
133
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INSTRUCTIONS FOR COMPLETING THE "REOUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
existing data outlined in the Data Call-In Notice and I have attached the
needed supporting information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study) 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 Study) I am citing an existing study
that has been previously classified by EPA as acceptable, core, core
minimum, 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" 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.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
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" 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 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.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 10. ON BOTH FORMS:
Item 11. ON BOTH FORMS:
Item 12. ON BOTH FORMS:
Item 13. 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.
Enter the date of signature.
Enter the name of the person EPA should contact
with questions regarding your response.
Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this your response. For example, you may wish
to report that your product has already been transferred to another company or
that you have already voluntarily cancelled this product. For these cases,
please supply all relevant details so that the Agency can ensure that its records
are correct.
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COPY
Page 1 of
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1 . Comoanv name 'and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
it. Guideline
Requi rement
Number
72-3 (a) *
72-3 (b) *
72-3 (C) *
72-4(a) *
72-4 (b) *
72-5 *
82-5(b) *
132-1 (a) *
132-l(b) *
133-3 *
133-4 *
161-1 *
163-1 *
164-1 *
233 *
234 *
81-8-SS *
5. Study Title
Estu/mari tox. fish
Estu/marl tox. mollusk
Estu/mari tox. shrimp
Early life stage fish
Life cycle invertebrate
Life cycle fish
90-day neurotox-mammal
Foliar residue dissipation
Soil residue dissipation
Dermal passive dosimetry expo
Inhal. passive dosimetry expo
Hydrolysis
Leach/adsorp/desorpt i on
Terrestrial field dissipation
Estimation of Dermal Exposure at Indo
Estimation of Inhalation Exposure at
Acute Neurotoxicity - Rat
6
I
f
/
2. Case # and Name
0577 Methiocarb
Chemical # and Name 100501
Methiocarb
Progress
Reports
1
Y
Y
Y
Y
Y
Y
Y
2
3
6. Use
Pattern
CK
CK
CK
CK
CK
CK
CIK
K
CIK
CIK
I
CK
CK
CK
CIK
7. Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
TGAI/PAIRA
TGAI
TEP
TEP
TEP
TGAI
10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
8.
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
GENERIC
Time
Frame
12
12
12
12
12
24
24
24
24
24
24
12
12
24
12
12
12
3
11.
13.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
fflos —
9. Registrant
Response
'
:
Date
Phone Number
137
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DRAFT
COPY
Page 2 of 2
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi rement
Number
90-1-SS *
5. Study Title
Usage Data
I
2. Case n and Name
0577 Methiocarb
Chemical # and Name 100501
Methiocarb
Progress
Reports
1
2
3
6. Use
Pattern
CK
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
GENERIC
8. Time
Frame
3
mos.
9. Registrant
Response
Date
138
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Page 1 of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case it and Name
0577 Methiocarb
Chemical # and Name
100501 Methiocarb
GUIDELINE
COMMENT
72-3(a)The Agency reviewed the estuarine/marine organisms data (MRIDs 155937, 155970) submitted
by the registrant in response to the Registration Standard for methiocarb. These data
contained summary information only and therefore are classified as unacceptable for use
in the ecological risk assessment for methiocarb. Testing of technical methiocarb on
estuarine/marine species is required since methiocarb is registered for use on lawns and
turf in coastal counties. The 96-hour LC50 study on an estuarine/marine species of fish
should be performed using technical methiocarb. These data are considered confirmatory
for supporting the lawns and turf uses of methiocarb.
72-3(b) The 48-hour EC50 study with oyster embryolarvae or a 96-hour EC50 oyster shell
disposition study should be performed using technical methiocarb. See comment for
guideline for 72-3(a).
72-3(c) The 96-hour LC50 study on an estuarine/marine species of shrimp should be performed
using technical methiocarb. See comment for guideline 72-3(a).
72-4(a) The submitted data (MRID 00155967) partially satisfies this guideline requirement
because of a technical problem in the control tank had occurred. The Agency is
requiring data which describes the water temperature in each tank to ensure that no
significant variance of temperature occurred in any of the tanks. If these data are
submitted, the study (MRID 00155967) may be upgraded to fulfill this guideline
requirement. These data are considered confirmatory to support the reregistration of
methiocarb for lawn and turf uses.
72-4(b) The submitted data (MRID 40628001) was deemed supplemental because raw data was not
available. The Agency is requiring this study to support the reregistration of
methiocarb on lawns and turf. These data are considered confirmatory.
139
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Page 2 of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0577 Methiocarb
Chemical # and Name
100501 Methiocarb
GUIDELINE
COMMENT
72-5 Data from fish life cycle tests are required to support the reregistration of an end-use
product that is expected to be transported to water from the intended use site when any
of the following conditions apply:
* If the estimated EEC is > 1/10 of the no effect level in the fish early life stage
or invertebrate life cycle test.
* If studies of other organisms indicate that the reproductive physiology of the fish
may be affected.
The Agency is requiring this study based on the fish early life stage study results.
These data are considered confirmatory for supporting the lawns and turf uses of
methiocarb.
82-5(b) The acute and neurotoxicity studies are now required for all carbamate pesticides.
These studies are not part of the target data set for this reregistration review;
however, the Agency is requiring these studies because methiocarb is a carbamate. These
studies must be performed with the methiocarb technical in order to support the
continued registration of methiocarb.
132-1(a) The Agency is requiring postapplication/reentry data on foliar residue dissipation to
support the homeowner use of methiocarb on lawns and turf. This study must be conducted
concurrently with the dermal passive dosimetry study (GL 133-3).
132-1(b) The Agency is requiring the soil residue dissipation study to support the granular
formulation use of methiocarb on ornamentals. This study is required to assess the
exposure to persons entering treated ornamental planting areas. This study is
considered confirmatory.
140
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Page 3 of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0577 Methiocarb
Chemical # and Name
100501 Methiocarb
GUIDELINE
COMMENT
133-3
133-4
The Agency is requiring postapplication/reentry data on dermal passive dosimetry
exposure to support the homeowner use of methiocarb on lawns and turf. This study must
be conducted concurrently with the foliar dislodgeable residue dissipation study (GL
132-la). The dermal passive dosimetry study is also required to support the granular
formulation use of methiocarb on ornamentals. This study is considered confirmatory for
the granular formulation use on ornamentals.
There is a potential for inhalation exposure following the application of the
pressurized liquid formulation of methiocarb. The Agency is retaining the 24-hour
reentry interval and ventilation requirements for entering greenhouses following an
application using the pressurized liquid formulation. The Agency is also requiring
postapplication inhalation monitoring data in order to support the reregistration of the
pressurized liquid formulation of methiocarb. These data are considered confirmatory.
161-1 The Agency is requiring this study because it is the baseline used to assess abiotic
degradation of methiocarb in soil and aquatic environments. This study is required for
all outdoor uses and it will be considered confirmatory data.
163-1 The unaged portion of this study was previously satisfied using a single loam textured
soil. The Agency believes that additional batch equilibrium are necessary on 3 soils
with different textures to assess more completely the mobility of methiocarb. As per
Subdivision N guidelines, one of the test soils should have a sand or loamy sand texture
with a low organic matter coontent (<1% OM). Also, the batch equilibrium data on any
single soil (e.g., loam) may not adequately represent pesticide partitioning in other-
soils (e.g., sand and loamy sand). This study is required for all outdoor uses and it
will be considered confirmatory data.
141
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Page 4 of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0577 Methiocarb
Chemical # and Name
100501 Methiocarb
GUIDELINE COMMENT
164-1 The submitted data (MRIDs 00155781, 00155782, and 40994801) were found unacceptable
because sampling depth increments were too broad (or wide) across soil depth; broad
sampling increments may dilute soil pesticide concentrations and hence mask possible
detection of pesticide movement. At this time the field dissipation data cannot be used
to assess leaching at soil depths greater than 30 cm. The Agency is requiring
additional field studies with greater sampling depths and appropriate soil sampling
increments to assess leaching of methiocarb below 30 cm. This study is required on a
confirmatory basis to support the lawns and turf uses.
233 The Agency is requiring this study to support the reregistration of methiocarb for
commercial application of the wettable powder formulation to greenhouse/nursery grown
ornamentals.
234 See comment for guideline 233.
81-8-SS See comment for guideline 82-5(b).
90-1-SS The Agency has determined that the outdoor uses of methiocarb is likely to have adverse
effects on aquatic and terrestrial species. The Agency is requiring usage data to
estimate how much of methiocarb's use is outdoors and the geographical areas of the
outdoor uses.
142
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DRAFT COPY
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi rement
Number
61-1
61-2 (a)
61-2 (b)
62-1
62-2
62-3
63-3
63-7
63-12
63-13
63-14
63-15
5. Study Title
Prod Gum - Regular Chemcal
Product identity & composition (1)
Desert ptn starting materials, (1,2)
productn & formulatn
process
Discussion of formation of (1,3)
impurities
Preliminary analysis (1,4)
Certification of limits (1,5)
Analytical method (1)
Physical state :
Density
pH (9)
Stability
Oxidiiinfl or reducing action (10)
Flammability (11)
10. Certification
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
the attached instructions and supply the information requested on this form.
2. Case # and Name 3. Date and Type of DC I
0577 Methiocarb PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
EPA Reg. NO. NNNNNN-NNNNN
|
5
Q
n
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEffGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Substance
MP/EP
MP/EP and TGAI
MP/EP and TGAI
TGAI
MP/EP
TGAI
MP/EP and TGAI
MP/EP and TGAI
MP/EP and TGAI
MP/EP
MP/EP
MP/EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
11. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
be punishable by fine, imprisonment
13. Phone Number
144
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DRAFT COPY
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
81-6
the attached instructions and supply the information requested
2. Case # and Name
0577 Methiocarb
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
ExplodabHity (12)
Storage stability (50)
Viscosity (15)
Miscibility (14)
Corrosion characteristics
Dielectric breakdown voltage (15)
Acute Toxic - Regular Chemical
Acute oral toxi city- rat (1,37)
Acute dermal (1,2,3?)
toxicity-rabbit/rat
Acute inhalation toxi city- rat (3)
Primary eye irri tat ion- rabbit (2)
Primary dermal irritation (1,2)
Dermal sensitization (4)
k
I
C
?
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
and TGAI
and TGAI
and TGAI
V
8. Time
Frame
8 mos*
8 mos.
8 inos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos*
8 mos.
8 raos.
8 mos.
9. Registrant
Response
Date
145
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DRAFT COPY Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case t and Name: 0577 Methiocarb
Key: MP - manufacturing-use product; EP « end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Qum - Regular Cheaical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); "158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 To support registration of an MP or EP, whether produced by an integrated system or not, the technical grade of Active Ingredient must be analyzed. If the technical
grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade of Active Ingredient must be submitted.
Data on EPs or MPs will be required on a case-by-case basis.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
H Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
50 Required but need not be submitted unless requested.
Acute Toxic - Regular CheMical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
Ufi
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DRAFT COPY Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0577 Nethiocarb
Footnotes (cont.):
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
147
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Attachment 4. EPA Grouping of End-Use Products for
Meeting Data Requirements for Reregistration
149
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-------
EPA'S DECISION ON BATCHING PRODUCTS CONTAINING METHIOCARB FOR
PURPOSES OF 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 reregistration of products containing the active ingredient
Methiocarb, the Agency considered batching products. This process involves grouping similar
products for purposes of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition and biological activity), type
of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products within
a batch may not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the information described above as available.
Acute toxicity data on individual products has been found to be incomplete. 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. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or 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
rely upon previously submitted acute toxicity data, he/she may do so provided that the data base
is complete and valid by today's standards (see acceptance criteria attached), 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. Regardless of
whether new data is generated or existing data is cited, the registrant must clearly identify the
material tested by its EPA registration number.
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/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/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/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant 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/her studies and offering to cost share (Option 3) those studies.
151
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Table I lists 5 batches containing a total of 14 products.
Table I.
Batch No.
1
2
3
4
5
EPA Reg. No.
70-247
2393-241
NC86000300
WI92000400
3125-234
3125-387
7401-342
56644-20
5481-189
5481-333
5481-195
5481-332
802-500
802-566
% of Methiocarb
& other Active ingredients
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
1.0
2.0 Meta Metaldehyde
1.0
2.0 Meta Metaldehyde
2.0
2.0
Formulation
Type
granular
pellet
pellet
pellet
granular
pellet
granular
pellet
granular
granular
granular
granular
pellet
granular
Table II lists the products which could not be batched. These products were not
considered similar for purposes of acute toxicity. The registrants of these products are
responsible for meeting the acute toxicity data requirements specified in the data matrix for end-
use products.
Table II
EPA Reg. No.
239-2416
499-276
3125-258
7001-283
769-706
769-707
3125-288
3125-257
WI92000300
% of Methiocarb
2.0
1.0
95.0
2.0
2.0
2.0
75.0
75.0
2.0
Formulation Type |
granular
liquid !
technical
granular
pellet
granular
wetable powder
powder
pellet
152
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Attachment 5. EPA Acceptance Criteria
153
-------
-------
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
155
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at >_ 0.1% by
weight and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at .>. 0.1 % or was found at J>. 0.1 % by product analyses and (2) certain
lexicologically significant impurities (see #3).
156
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient bebg reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1%.
2. Degree of accountability or closure >_ ca 98 %.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
case of products containing dinitroanilines or containing secondary or tertiary arnines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
fresh and stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at J>. 0.1% and for certain lexicologically
significant impurities at <0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
157
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
with reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3
or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
158
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63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
159
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dennal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
161
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
or contains particles of inhalable size for man (aerodynamic diameter 15 jam or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or ^.11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
164
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <2 or >11.S.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with noninitating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
days (whichever is shorter).
11 .* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >.11.5.
3. One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
166
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
167
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List of All Registrants Sent This Data Call-in Notice
Case # and Name
0577 Methiocarb
Chemical # and Name
100501 Methylthio)-3,5-xylyl methylcarbamate
Company Number Company Name
Additional Name
Address
City & State
Zip
000070
000239
000499
000769
000802
002393
003125
005481
007001
007401
WILBUR-ELLIS COMPANY
SOLARIS GROUP. THE
WHITNIRE RESEARCH LABORATORIES, IN
H.R. MCLANE, INC.
CHAS H. LILLY CO.
HACO, INC
MILES INC
AMVAC CHEMICAL CORP
J.R. SIMPLOT CO.
VOLUNTARY PURCHASING GROUP, INC.
A D1V OF THE AGRICULTURAL GROUP OF
AGENT FOR: SURECO, INC.
AGRICULTURE DIVISION
BOX 16458
BOX 5006
3568 TREE CT INDUSTRIAL BLVD
7210 RED ROAD, SUITE 206
7737 N.E. KILLINGSWORTH
BOX 7190
8400 HAUTHORN RD BOX 4913
4100 EAST WASHINGTON BLVD
BOX 198
P. 0. BOX 460
FRESNO CA
SAN RAMON CA
ST LOUIS MO
MIAMI FL
PORTLAND OR
MADISON WI
KANSAS CITY MO
LOS ANGELES CA
LATHROPE CA
BONHAM TX
93755
94583
63122
33143
97218
53707
64120
90023
95330
75418
169
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Attachment 7. Confidential Statement of Formula, Cost Share and
Data Compensation Forms
171
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Confidential Business In formation: Does Not Contain National Security Information (E.O. 12065)
United Stele* Environmental Protection Agency A. __.
Office of Pesticide Programs (TS-767) LJ Basic Formulation
f\ e~ pj yy Washmgttn, DC 20460 r— ,
*& El IT f\ Confidential Statement of Formula L-l Alternate Formulation
i . Name and Address of Applicam/Reflistrant (Include ZIP Code) 2. Nama and Address of Producer
3. Product Mams
EPA USE ONLY
10. Components in Formulation ILut u actutlly introduced
into r/M formulation. Gift commonlf tcctpttd ctttmictt
ritmt. trtatnamt. indCAS numbtt.)
4. Registration No./File Symbol
7. Pounds/Gal or Bulk Density
1 1 . Supplier Name & Address
-
Form Approved OMB No 2070-0060. Approval Expires 2/28/941
Page
ol
See nfitruciions on Back
5 EPA Product Mgr/Team No
8.pH
12. EPA Reg No.
16. Typed Name of Approving Official
18. Signature of Approving Official
in Formulation
S. Amount <>.%hrWiitii
1 7. Total
19. Title
EPA Form 8670-4 (Rev. 12-90) Previous editions are obsolete. If you can photocopy this, please submit an additional copy. White • EPA
Weight
100%
9. Flash Point/flame Extension
%br Weight
UM*r Li"M b Icwtr Imit
formulation
i 20. Phone No. jlnclude Area Cede)
21- Date
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
175
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approve! Expires 3-31-96
Public reporting burden for this coflection 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 bunlen estimate or any other
aspect of this collection of Information, Including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106). Washington, DC 20503.
Please fill In blanks below.
Company Name
Product >«nc
Company Number
KPA Kff. No.
! Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentteide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2}(B){iu) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name gf FIrm(»>
Date of Offer
Certification:
I certify that 1 am duly authorized to represent the company named above, and that the statements that I have made on
this form and afl attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Mama and
of Company's Authorized Reprwentiflve
D»le
TUI« (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580. which is ubuilctc
177
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United State* Environmental Protection Agency FW» tmnvu
^\ P^nji Washington, DC 20480
^VHK/A CERTIFICATION WITH RESPECT TO "" "* SSSffi
^^ •"> * » DATA COMPENSATION REQUIREMENTS AW**** am*. "«•*
Public reporting burden for this colection 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 reflection of information. Send comments regarding the burden estimate or any other
aspect of this coilection of information, inducing suggestions for reducing this burden, to Chid. Information Policy
Branch. PM-223, U.S. Environmental Protection Agency. 401 M St., S.W., Washington, DC 20460: and to the Office
of Management and Budget, Papeiworic Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Name
Product M«M
1 Certify that:
1. For each study cited in support of registration or registration under the Federal In
Rodentfcjde Aa (FIFRA) that is an exclusive use study, 1 am the original data submit
written permission of the original data submitter to cite that study.
2. That for each study died in support of registration or reregistration under FIFRA tha
study. 1 am the original data submitter, or I have obtained the wrtten permission el tt
have notified in writing the companyfies} that submtted data 1 have died and have c
compensation for those data In accordance with sections 3(c)(l)(D] and 3(c){2)(D) o
negotiation w oewrnvne wncn ana ere subject to tne compensation recjwremeni c
compensation due, I any. The companies 1 have notified are: (check one)
ine companies wno nave submitted tne stuoes listed on the back of tras term
sheets, or irxficaied on the attached "Requirements Status and Registrants' F
3. That i nave prevwusJyconplitdwttwctJon3(cHlXD) of FIFRA for the studies I ha
registration or wtgtttrnon unotf r IFRA.
Signature
Nam w* Tin* (PIMM Tree «r Print)
GENERAL OFFER TO PAY: 1 hereby offer and agree to pay compensation to other pi
registration or reregistration of my products, to the extent required by RFRA sections i
Signature
HUM and TUto (PtMM TyM «r Prinl)
Coffipuny Number
KPA X*g. MO.
sedicide, Fungicide and
ner. or I have obtained the
t is NOT an exclusive use
» original data submitter, or 1
iHeredio: (a) Pay
1 F1FRA; and (b) Commence
rf FIFRA and the amount of
or attached
Response Form,"
ve cited in support of
l>a»
irsons. wRh regard o the
KcKi)(D)and3(0(2)(0).
Datr
EPA Form U70>n
179
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APPENDIX G. RED Fact Sheet
181
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United States Prevention. Pesticides EPA-738-F-94-002
Environmental Protection And Toxic Substances February 1994
Agency (7508W)
R.E.D. FACTS
Methiocarb
Pesticide AU pesticides sold or distributed in the United States must be
Reregistration registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED for methiocarb.
Use Profile Methiocarb is an insecticide, acaricide and molluscicide. It is used to
control snails, slugs, spider mites and insects on lawns, turf and
ornamentals, around building foundations, and in ginseng gardens.
Methiocarb has no remaining food uses; the use on ginseng has a 12-month
preharvest interval and therefore is not considered a food use.
Methiocarb end-use products formulated as granulars and
pellets/tablets are used on residential and commercially grown lawns,
turfgrass and ornamentals, in commercial greenhouses and nurseries,
around building foundations, and in ginseng gardens. A wettable powder
formulation is used as a foliar spray for nursery and greenhouse
ornamentals. A pressurized liquid is applied as a total release aerosol
spray in commercial greenhouses.
Although the total volume of use is relatively low, methiocarb is
considered an important tool for controlling slugs and snails in nurseries
and greenhouses.
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Regulatory Methiocarb was first registered as a pesticide in the U.S. in 1972.
History EPA issued a Registration Standard for methiocarb in March 1987 (NTIS
#PB87-190898), requiring additional product chemistry, residue chemistry,
ecological effects, environmental fete, toxicology, and occupational and
residential exposure data. The methiocarb producers deleted all food uses
from their product labels between 1989-92, so residue chemistry studies
are no longer required. The technical producer is no longer supporting the
commercial turf use of methiocarb. If end-use registrants do not support
this use, it will have to be removed from product labels.
Currently, 22 pesticide products are registered which contain the
active ingredient methiocarb. All methiocarb products for outdoor use
except products with homeowner uses are classified as Restricted Use
Pesticides, and may be applied only by or under the direct supervision of
certified applicators.
Human Health Toxicity
Assessment Methiocarb is among the carbamate family of chemicals; that is, it
has the ability to inhibit the body's production of cholinesterase, an enzyme
necessary for accurate transmission of nerve impulses.
In acute toxicity studies using laboratory animals, methiocarb has
been shown to be highly toxic by the oral route and has been placed in
Toxicity Category I (the highest of four levels) for acute oral effects. It is
moderately toxic by the inhalation route and slightly toxic by the dermal
route, and has been placed in Toxicity Categories n and ffl for these
effects. Methiocarb is not an eye or skin irritant, and it does not cause
delayed neurotoxicity.
Subchronic dermal toxicity studies using rabbits showed inconsistent
results, but the range-finding study resulted in treatment-related deaths at
the higher doses. In chronic feeding studies using rats and beagle dogs,
methiocarb caused inhibition of red blood cell and plasma cholinesterase,
but not brain cholinesterase. In the dog study, hind limb weakness and
tremor occurred in the high dose group. Methiocarb is not carcinogenic in
rats, and does not appear to have any mutagenicity potential. Administered
by the dermal route, methiocarb is associated with developmental toxicity
in rabbits. By the oral route, it is associated only with maternal toxicity in
both rats and rabbits.
Although they are not part of the target data base for reregistration,
acute and chronic neurotoxicity studies in rodents, now required for all
carbamate pesticides, must be performed for methiocarb.
Dietary Exposure
Dietary exposure to methiocarb is not expected to occur since there
are no remaining food uses. Ginseng is not considered a food use since
current methiocarb labels require a 12-month preharvest interval. The
184
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Agency will revoke all existing methiocarb tolerances (maximum food
residue limits) set forth in 40 CFR 180.320.
Occupational and Residential Exposure
Methiocarb wettable powder products applied as foliar sprays can
result in dermal and inhalation exposure to mixers, loaders and applicators.
Use of the granular and total release aerosol products is expected to result
in less applicator exposure than use of the foliar sprays.
Post-application exposure also may occur following most methiocarb
applications. Examples include dermal exposure to residues on treated
lawns, turf and soil following the granular applications, dermal exposure to
foliage of commercially grown ornamentals following the wettable powder
and pressurized liquid formulations, and inhalation exposure following
application of total release aerosol sprays.
Methiocarb meets both the toxicity and the exposure criteria requiring
mixer/loader/applicator exposure data and post-application reentry data.
These studies will be required for reregistration of the commercial use of
the wettable powder formulation to greenhouse- and nursery-grown
ornamentals.
The Worker Protection Standard (WPS) converted the previous 24-
hour worker reentry interval (where reentry with protective clothing is
allowed) to a 24-hour restricted entry interval or REI (where entry is
limited to performance of short term activities as defined in the WPS).
Considering the lexicological concerns with methiocarb, EPA considers
these additional protections essential to its decision that REIs will
sufficiently mitigate risks to workers.
Human Risk Assessment
Since no food uses are registered, methiocarb poses no human dietary
risks. Regarding acute toxicity, methiocarb is extremely toxic by the oral
route but is moderately to slightly toxic by other routes of exposure.
Methiocarb is a developmental toxicant, and workers and homeowners may
be at risk for developmental effects from exposure to methiocarb during or
after application.
For handlers of the wettable powder/foliar spray formulation of
methiocarb using currently-required personal protective equipment (PPE),
the estimated margin of exposure (MOE) for dermal and inhalation toxicity
is estimated to be less than 100, the commonly accepted margin.
However, with the use of additional PPE (coveralls), the MOE increases to
well over 100. To achieve an acceptable MOE, therefore, EPA is
requiring use of additional PPE.
EPA also is concerned about workers entering treated areas following
application of methiocarb. To protect workers, the Agency is requiring a
25-day restricted entry interval (REI) following foliar applications of the
wettable powder and pressurized liquid (total release aerosol) formulations
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to ornamental plants. After 10 days, workers may enter treated areas to
perform tasks, including hand labor tasks that involve contact with treated
surfaces, provided each worker spends no more than 3 hours in each 24-
hour period performing such tasks. PPE is not required during the 3-hour
work period.
Because methiocarb has been identified as a developmental toxicant,
EPA is requiring use of extra PPE by all applicators, handlers and early
entry workers. These PPE requirements will not apply to homeowner
users of methiocarb since their frequency and duration of exposure is less
than that of occupationally exposed users.
Environmental Environmental Fate
Assessment Methiocarb appears to be moderately persistent and relatively
immobile in soil, and is not likely to contaminate ground water. A full
assessment will be possible only when confirmatory hydrolysis, adsorption-
desorption/leaching and terrestrial field dissipation studies are submitted.
Ecological Effects
Methiocarb is toxic to terrestrial mammals. It is very highly toxic to
birds on an acute oral basis. In subacute studies, it is slightly toxic to
waterfowl and practically non-toxic to upland game birds. Methiocarb is
highly toxic to coldwater and warmwater fish, and very highly toxic to
aquatic invertebrates. It also is very highly toxic to honey bees.
Ecological Effects Risk Assessment
Outdoor use of methiocarb is likely to have adverse effects on aquatic
and terrestrial species. For all formulations of methiocarb used on all
outdoor sites, acute and/or chronic levels of concern are exceeded for avian
and mammalian species, aquatic invertebrates and other aquatic organisms.
Although methiocarb is used in low volumes compared to other pesticides,
it still could have major impacts in areas where there is concentrated
outdoor use.
Methiocarb may pose a hazard to endangered species including many
listed birds, mammals, insects, and aquatic organisms. The U.S. Fish and
Wildlife Service will be consulted and a generic label statement may be
required when EPA's Endangered Species Program is implemented.
EPA is requiring additional use precautions and maximum application
rates on product labels, requiring additional confirmatory data, and
negotiating with the registrants to maintain a production cap in an effort to
decrease the environmental risks of methiocarb.
Additional Data EPA is requiring the following additional generic data to confirm its
Required risk assessment for methiocarb: estimation of dermal exposure for
wettable powder formulation use in greenhouses and nurseries; estimation
of inhalation exposure for wettable powder formulation use in greenhouses
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and nurseries; inhalation passive dosimetry for pressurized liquid
formulation use in greenhouses; estimation of dermal exposure and soil
dissipation for granular formulations used on ornamentals; aquatic and
estuarine organisms (fish/mollusk/shrimp) for all lawn and turf uses;
aquatic invertebrate life cycle for all lawn and turf uses; fish early life
stage for all lawn and turf uses; fish life cycle for all lawn and turf uses;
hydrolysis for all outdoor uses; adsorption/desorption/leaching for all
outdoor uses; terrestrial field dissipation for all lawn and turf uses; outdoor
usage data (pounds used per year by site); foliar dislodgeable dissipation
and dermal passive dosimetry for residential lawns and turf; and acute and
subchronic neurotoxicity data (which are not part of the target data base for
reregistration).
EPA is requiring product-specific data including product chemistry
and acute toxicity studies, as well as revised labeling, for reregistration of
pesticide products containing methiocarb.
Product Labeling All methiocarb end-use products must comply with EPA's current
Changes Required pesticide product labeling requirements. In addition:
Worker Protection Standard (WPS) - Any product whose labeling
permits use in the production of an agricultural plant on any agricultural
establishment (farm, forest, nursery or greenhouse) must comply with the
labeling requirements of EPA's Worker Protection Standard (WPS). See
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." Unless specifically directed in the RED, all statements
required by the WPS and reflected in these two PR Notices must be
included on product labeling.
Entry Restrictions - [See the RED for detailed instructions.] For uses
within the scope of the WPS and products not primarily intended for home
use:
• Wettable Powder Formulations - A 25-day restricted entry interval (REI)
is required:
"Do not enter or allow worker entry in treated areas during the
restricted entry interval (REI) of 25 days, except, after 10 days,
workers may enter treated areas to perform tasks including
hand labor tasks that involve contact with treated surfaces
provided each worker spends no more than 3 hours in each 24
hour period performing such tasks."
• Pressurized Liquid Formulations - A 25-day REI is required: (see
statement above).
• Granular Formulations - A 24-hour REI is required, except for products
intended primarily for home use.
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Personal Protective Equipment (PPE) Requirements
[See the RED for detailed instructions.]
• For Products Not Primarily Intended for Home Use - The minimum
PPE requirement is:
"Applicators and other handlers must wear:
-Coveralls over short-sleeved shirt and short pants
-Chemical-resistant or waterproof gloves...
—Chemical-resistant footwear plus socks
-Chemical-resistant headgear for overhead exposure
-Chemical-resistant apron when cleaning equipment, mixing, or
loading..."
In addition, handlers must wear a respirator with an organic vapor
cartridge TC-23C during early entry to greenhouses following treatment
with the pressurized liquid for those tasks associated with ventilating the
greenhouse. A dust mask must be worn while mixing/loading the wettable
powder formulation.
Compare the PPE requirements set forth in the RED to the PPE
requirements, if any, on current labeling and retain the more protective.
• For Products Intended for Home Use - Do not add any additional PPE
requirements but retain any requirements already on current product
labeling.
• For Entry During the Restricted Entry Period - See the RED for
detailed instructions.
• For Uses Not Within the Scope of the WPS, and For Products Primarily
Intended for Home Use - Do not add any new entry restrictions but retain
any on current product labeling.
Lawn and Turf Uses
• If a registrant chooses to support lawn and turf uses, he must submit the
data required in the RED.
• If a registrant chooses to support the residential lawn uses only, he must
add the following statement to his product labels to remove the site from
the scope of the WPS:
"Not for use on turf being grown for sale or other commercial
use as sod, or for commercial seed production, or for research
purposes."
• If a registrant does not support the residential lawn uses, he must delete
the use from the product label and add the following statement:
"Do not use on turfgrass around residences or dwellings."
Restricted Use Pesticide - The following statement must appear on the
labels of all end-use products for outdoor uses except products intended for
use by homeowners:
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"Restricted Use Pesticide
Due to Toxicity to Fish, Birds, and Aquatic Organisms
For retail sale to and use only by certified applicators or
persons under their direct supervision and only for those uses
covered by the certified applicator's certification."
Use Kates and Number of Applications - The following number of
applications must appear as the maximum application rate in the Directions
for Use section of the label, to decrease aquatic risks:
• 75% Wetteble Powder -
"2 Ibs 75 % wettable powder per 50 gallons of water applied up
to 2 times a year."
• Granular or Pelletized Bait -
"Should not be applied more than twice a year."
Rsh and Wildlife Protection - The following statements must appear on
products for the following uses:
• Granular or Pelletized Bait for Snails and Slugs -
"This product is toxic to fish and very highly toxic to birds and
mammals. Do not apply directly to water, wetlands (swamps,
bogs, marshes, and potholes). Runoff from treated area may be
hazardous to aquatic organisms in adjacent aquatic sites. Do
not contaminate water when disposing of equipment washwaters
and rinsates."
• 75% Wettable Powder Formulation -
"This pesticide is toxic to fish and very highly toxic to birds
and mammals. Do not apply directly to water, or to areas
below the mean high water mark. Runoff from treated area
may be hazardous to aquatic organisms in adjacent aquatic
sites. Do not contaminate water when disposing of equipment
washwaters and rinsates.
"This product is very highly toxic to honey bees exposed to
direct treatment or residues on blooming shrubs, flowers,
weeds and trees. Do not apply this product or allow it to drift
to blooming shrubs, flowers, weeds, or trees if bees are visiting
the treatment area."
Regulatory The use of most currently registered pesticide products containing
Conclusion methiocarb in accordance with approved labeling, except the use of
granular and pelletized formulations on residential lawns and turf, and
except products for use by homeowners on ornamentals marketed in 20-25
pound bags, will not pose unreasonable risks or adverse effects to humans
or the environment. Therefore, uses of methiocarb on residential and
commercial ornamentals (except large size products for use by homeowners
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on ornamentals), by homeowners around building foundations, in
greenhouses, on commercially grown turfgrass, and on ginseng are eligible
for reregistration.
These products will be reregistered once the required confirmatory
generic data, product specific data and revised labeling are received and
accepted by EPA. Products which also contain other active ingredients
will be reregistered after the other active ingredients are determined to be
eligible for reregistration.
EPA cannot make a reregistration eligibility decision regarding the
residential lawn and turf use of methiocarb until appropriate postapplication
reentry exposure, ecological effects and environmental fate data are
submitted and evaluated.
The Agency similarly cannot make a reregistration eligibility decision
regarding large size methiocarb products for use by homeowners on
ornamentals, marketed in 20-25 pound bags, until soil dissipation and
dermal exposure data are received and evaluated.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for methiocarb during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register.
To obtain a copy of the RED document or to submit written comments,
please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Following the comment period, the methiocarb RED document will
be available from the National Technical Information Service (NTTS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the methiocarb RED, or reregistration of individual products containing
methiocarb, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Vfashington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, from 8:00 am to 6:00 pm Central
Time, Monday through Friday.
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