United States Prevention, Pesticides EPA 738-R-95-006
Environmental Protection And Toxic Substances April 1995
Agency (7508W)
4>EPA Re registration
Eligibility Decision (RED)
Metolachlor
-------
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 metolachlor which
includes the active ingredient metolachlor. The enclosed Reregistration Eligibility Decision
(RED) contains the Agency's evaluation of the data base of these chemicals, 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
ingredients 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
receipt of this letter. The 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
Veronica Dutch at (703) 308-8585. Address any questions on required generic data to the
Special Review and Reregistration Division representative, Jane Mitchell at (703) 308-8061.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
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. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of receipt of
this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS 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 REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
-------
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
-------
REREGISTRATION ELIGIBILITY DECISION
METOLACHLOR
LIST A
CASE 0001
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
-------
TABLE OF CONTENTS
METOLACHLOR REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 6
E. Regulatory History 6
III. SCIENCE ASSESSMENT 7
A. Product Chemistry 7
1. Identification of the Active Ingredient 7
2. Other Product Chemistry Considerations 8
B. Human Health Assessment 9
1. Toxicology Assessment 9
a. Acute Toxicity 9
b. Subchronic Toxicity 9
c. Chronic Toxicity 10
d. Carcinogenicity 10
e. Developmental Toxicity 11
f. Reproduction 11
g. Mutagenicity 11
h. Metabolism 12
i. Reference Dose (RfD) for Chronic Oral Exposure 12
j. Toxiocology Data Gaps 12
2. Exposure Assessment 12
a. Dietary Exposure 12
(1) Residue Information and Background 12
(2) Anticipated Residue Data 14
b. Occupational and Residential 16
(1) Use Summary 16
(2) Summary of Toxicity Concerns Impacting
Occupational and Residential Exposure 17
(3) Summary of Potential Occupational and Residential
Exposures 17
(4) Handler (Mixers, Loaders, Applicators, Etc.)
-------
Exposures 17
(5) Post Application Exposure to Workers 19
3. Risk Assessment 19
a. Dietary 19
b. Occupational and Residential 20
C. Environmental Assessment 23
1. Environmental Fate 23
a. Environmental Chemistry, Fate and Transport 23
b. Environmental Fate Assessment 27
2. Ecological Effects 29
a. Ecological Hazard 29
(1) Non-Target Birds 29
(2) Non-Target Freshwater Fish 30
(3) Non-Target Freshwater Invertebrates 30
(4) Non-Target Estuarine and Marine Organisms .... 31
(5) Non-Target Plants 31
b. Ecological Effects Risk Assessment 32
(1) Non-Endangered Species 33
(2) Endangered species 39
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 40
A. Determination of Eligibility 40
1. Eligibility Decision 40
2. Eligible and Ineligible Uses 41
B. Regulatory Position 41
1. Tolerance Reassessment 41
2. Rotational Crop Restriction 48
3. Reference Dose 48
4. Cancer Risk Assessment 48
5. Endangered Species Statement 49
6. Environmental Hazard Statements 49
7. Restricted Use Classification 49
8. State Management Plan Candidate 49
9. Groundwater Advisory 50
10. Surface Water Advisory 50
11. Spray Drift Advisory 50
12. Occupational/Residential Labeling Rationale/Risk Mitigation ... 50
13. Ground-Water Protection Requirements 55
V. ACTIONS REQUIRED BY REGISTRANTS 56
A. Manufacturing-Use Products 56
1. Additional Generic Data Requirements 56
2. Labeling Requirements for Manufacturing-Use Products 56
B. End-Use Products 57
1. Additional Product-Specific Data Requirements 57
-------
2. Labeling Requirements for End-Use Products 57
a. Occupational/Residential Labeling 57
(1) Personal Protective Equipment Requirements for
Pesticide Handlers (mixers, loaders, applicators, etc);
57
(2) Entry Restrictions; Labeling 59
(3) Other Labeling Requirements 61
b. Environmental Hazards Statements 62
c. Rotational Crops Restriction 63
d. Ground Water Labeling/Mitigation; Mixing/Loading ... 63
e. Ground Water Advisory 63
f. Surface Water Advisory 64
g. Spray Drift Labeling 64
C. Existing Stocks 67
VI. APPENDICES 69
APPENDIX A. Table of Use Patterns Subject to Reregistration
Appendix A is 63 pages long and is not being included. Copies of Appendix
A are available upon request per the instructions in Appendix D 71
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 73
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Metolachlor 93
APPENDIX D. List of Available Related Documents 137
APPENDIX E 141
PR Notice 86-5 143
PR Notice 91-2 165
APPENDIX F. Combined Generic and Product Specific Data Call-In 171
Attachment 1. Chemical Status Sheets 191
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms Plus Instructions 195
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms and Instructions 201
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 209
Attachment 5. EPA Acceptance Criteria 215
Attachment 6. List of All Registrants Sent This Data Call-In Notice . . 229
Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 231
APPENDIX G. FACT SHEET 241
-------
METOLACHLOR REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Art Grube
Neil Anderson
Environmental Fate and Effects Division
Kathy Monk
Concepcion Rodriguez
George Tompkins
Estella Waldman
Health Effects Division
Linda Kutney
Susan Hummel
Pat McLaughlin
Jeff Evans
Economic Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Chemistry Branch, Reregistration Support
Toxicology Branch II
Occupational and Residential Exposure Branch
Registration Division
Eugene Wilson Fungicide-Herbicide Branch
Special Review and Reregistration Division
Jane Mitchell Reregistration Branch
-------
11
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ADI Acceptable Daily Intake. A now defunct term for refernce dose (RfD).
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking water) lifetime
exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a
terrestrial ecosystem.
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
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other organizations when
emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death
in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed,
e.g., mg/L, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants in
drinking water under the Safe Drinking Water Act.
pg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin of Exposure
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
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
111
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
IV
-------
EXECUTIVE SUMMARY
Background
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide metolachlor, 2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-l-
methylethyl) acetamide.
Metolachlor, a broad spectrum herbicide, was first registered in 1976 for general weed
control in noncrop areas. Metolachlor is manufactured by Ciba-Geigy Corporation, the sole
producer and primary registrant. Since first registered for use on turf, it is now also
registered for use on corn, cotton, peanuts, pod crops, potatoes, safflowers, sorghum,
soybeans, stone fruits, tree nuts, nonbearing citrus, nonbearing grapes, cabbage, peppers (bell,
chili, Cubanelle, tabasco), buffalograss, guymon bermudagrass for seed production, nurseries,
hedgerows/fencerows and landscape plantings. Metolachlor's major use sites are corn,
soybeans, and sorghum. The emulsifiable concentrate formulation is the most commonly used
formulation on all sites. Ground application is the method of choice for all sites. Some
formulations may be applied by chemigation with special use directions.
The first registration standard for metolachlor was issued in 1980 and a second
standard was issued in 1987. The Agency has now completed its review of the metolachlor
target data base including data submitted in response to the 1987 standard.
Reregistration Eligibility
The Agency has determined that all uses of metolachlor with the exception of potatoes,
soybeans and peanuts as currently registered will not cause unreasonable risk to humans or the
environment and these uses are eligible for reregistration. An eligibility decision for use on
potatoes, soybeans, and peanuts cannot be made at this time because under current policies
section 409 tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA) are needed
because metolachlor concentrates in some of the processed fractions of these crops and such
tolerances may be barred by the Delaney Clause. The Agency has recently required additional
data to confirm this decision. (Data Call-in Notices dated 12/10/93, 2/15/94 and 5/10/94).
Also, additional confirmatory data (foliar soil dissipation and dermal passive dosimetry) are
required for residential lawn and turf uses.
Health Effects
The Agency's Office of Pesticide Program's Carcinogenicity Peer Review Committee
has classified metolachlor in Group C (possible human carcinogen) under EPA's Cancer
Assessment Guidelines with no cancer risk quantification. The Committee recommended that
chronic exposure to metolachlor be addressed by margin of exposure estimates. A RfD of 0.1
mg/kg body weight/day has been established based on a NOEL of 9.7 mg/kg/day and an
-------
uncertainty factor of 100. The NOEL was based on a one year feeding study in dogs that
demonstrated a decreased body weight gain.
A tolerance reassessment was performed and is included in this document. Data for
cottonseed, peanuts (EC formulation at layby), fresh corn and safflower processing are
required for the continued registration of metolachlor. Food additive tolerances are needed
for potato granules and feed additive tolerances are needed for potato dry peel, wet peel, and
waste from processing, soybean hulls and peanut meal. However, such tolerances may be
barred by the Delaney Clause of FFDCA which provides that a food/feed additive regulation
for a processed food may not be established for a pesticide which induces cancer in man or
animals. The Agency is unable to make a reregistration decision for these uses because EPA
is currently evaluating legal challenges related to the coordination of actions under FFDCA
section 409's Delaney Clause and FFDCA section 408 in FIFRA.
Occupational and Residential Exposure
No toxicological endpoints of concern for acute or short term exposure to metolachlor
through occupational or residential exposure have been identified.
Toxicological endpoints are of concern for workers exposed ten days or longer
(intermediate exposure). A 21-day rabbit dermal toxicity study demonstrated systemic
NOELS of 100 mg/kg/day for both sexes, based on increased bilirubin, increased liver
weights in males and increased kidney weights in females. Using the NOEL of 100
mg/kg/day, the corresponding margin of exposure (MOE) for intermediate duration of
occupational exposure was calculated. The MOEs range from 30 to 3890. The lower MOE's
represent exposure scenarios for aerial mixer/loaders using open pour systems. The Agency is
requiring that aerial mixer/loaders use closed systems. This requirement provides MOE's of
approximately 300 or greater.
Postapplication worker exposure and risk to residues from preemergent applications to
agricultural crops is likely to be minimal. Postapplication worker exposure and risk from
postemergent applications to agricultural crops is also likely to be minimal since the target
crops or weeds are small at the time of application, and harvesting or other maintenance
activities are likely to be limited. However, there is a greater potential for postapplication
exposure and risk following turf treatment. A foliar residue dissipation study and dermal
passive dosimetry study are required as confirmatory data to better refine the risk for
residential turf.
A foliar dissipation study submitted on weeds and ornamental turf grass gave exposure
estimates that do not pose an unreasonable risk to individuals reentering treated areas. These
estimates assume a 24-hour restricted entry interval (REI).
The Worker Protection Standard (WPS) for Agricultural Pesticides-40 CFR Parts 156
and 170—established an interim restricted-entry interval (REI) of 12 hours for metolachlor,
VI
-------
because the acute toxicity categories of metolachlor for acute dermal toxicity, skin irritation
potential, and eye irritation potential are Toxicity Category III and IV. However, since
metolachlor has been shown to have intermediate effects and is classified as a group C
carcinogen, a REI of 24 hours for all sites within the scope of the WPS is required.
Environmental Fate and Ecological Effects
Metolachlor appears to be moderately persistent to persistent and mobile to highly
mobile. Metolachlor is stable to hydrolysis under normal environmental conditions.
Metolachlor degradation appears to be dependent on microbially mediated and abiotic
processes. It appears to have a low potential to bioaccumulate in fish. Additional information
on terrestrial field dissipation is required to fully satisfy the guideline requirement; however
this additional information is not expected to change the overall fate assessment for
metolachlor. The additional information for terrestrial field dissipation will help determine the
efficiency and precision of extraction and analysis for metolachlor and several of its
metabolites. Five major degradates have been identified for metolachlor.
Metolachlor residues exceed the following levels of concern for ground water: (1)
Ground-water quality - Metolachlor has been detected in ground water in 20 states, although
generally below thresholds of concern for humans and animals. Considering the widespread
use of metolachlor, the Agency is concerned about the degradation of water quality in
metolachlor use areas. (2) Human health - Metolachlor residues have been detected in three
states above the lifetime Human Health Advisory (HAL) of 100 ppb. In five other states
detections exceeded 10% of the HAL; (3) Nontarget plants - No data are currently available to
assess the effect of metolachlor on aquatic or terrestrial plants. However, because metolachlor
is a herbicide, potential risk to non-target plants is likely. In areas where irrigation water is
contaminated with metolachlor, or where ground water discharges to surface water,
metolachlor residues could present a threat to non-target plants.
Substantial amounts of metolachlor could be available for runoff to surface water for
several months post-application. Metolachlor is among the top five pesticides in terms of
frequency of detection and greatest concentrations in samples of both raw and finished surface
water in the mid-western corn belt. It is detected in a high percentage of surface water
samples collected from numerous locations within the corn belt for several months post-
application. In streams and rivers of the corn belt, metolachlor concentrations typically
increase rapidly from pre-application concentrations of below one ppb to post-application peak
concentrations of typically several ppb.
Based upon the available results it appears highly unlikely that maximum or short term
average metolachlor concentrations in surface water will exceed the 1-10 day HALs of 2000
ppb or that annual average metolachlor concentrations will exceed the lifetime HAL
(potentially the MCL) of 100 ppb anywhere. Although not formally regulated by the Safe
Drinking Water Act, water supply systems are required to sample and analyze for
metolachlor. The Agency will review such data when they become available.
vn
-------
To address ground-water concerns, the registrant is conducting two small-scale
prospective ground water studies for metolachlor and its metabolites. The registrant has also
proposed additional labeling statements to mitigate point source contamination, i.e.
mixing/loading sites and precautionary label language which will reduce potential for off-
target movement due to spray drift, run-off or wind erosion. The registrant is presently
monitoring for metolachlor as part of the 19-state atrazine monitoring program. The wells
being monitored were selected by the states and are representative of vulnerable areas. The
registrant will provide the Agency with the metolachlor analyses from this program in 1995.
No chronic effects are expected for freshwater and estuarine/marine fish. The roadside
(rights-of-way) use pattern poses an acute risk for endangered freshwater fish in shallow
water.
The levels of concern for acute effects to non-endangered birds are not exceeded for
any application rate. At an application rate of 6 Ibs. ai/A the level of concern for acute risk
to endangered birds is exceeded for non-granular formulations. Based on a supplementary
study for waterfowl, the level of concern for chronic effects is exceeded at the 6 Ib. ai/A
application rate. Because this study is supplementary, new avian reproduction studies have
been required. These studies, which are due May 10, 1996, could result in changes in the
avian risk assessment.
A risk assessment using maximum and typical estimated environmental concentrations
(EECs) was done for acute effects to small mammals. The endangered species level of
concern is exceeded, using the maximum EEC, for small mammals eating short grass at an
application rate of 2 Ibs. ai/A. The endangered species level of concern is exceeded, using
typical EEC's, for small mammals eating short grass, at application rates of 4 Ibs. ai/A and
higher. The Agency is developing a program to identify all pesticides whose use may cause
adverse effects on endangered plants/animals. Any label changes or use modifications will be
implemented through the Endangered Species Program.
Because metolachlor is a herbicide, risk to non-target plants is expected. Toxicity data
for non-target plants were required on 12/10/93 in a Data Call-In Notice. Once these data
have been submitted, a risk assessment will be performed.
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices
and State Lead Agencies for pesticide regulation to develop the best spray drift management
practices. The Agency is now requiring interim measures that must be placed on product
labels/labeling as specified in Section V. Once the Spray Drift Task Force completes their
studies, submits data, and the Agency evaluation is completed, there may be further
refinements in spray drift management practices.
Before reregistering the products containing metolachlor, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
vin
-------
be submitted within eight months of the issuance of this document. These data include product
chemistry and acute toxicity testing for each registration. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will
be eligible for reregistration only when the other active ingredients subject to reregistration are
determined to be eligible for reregistration.
IX
-------
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 reregistration" before calling in
data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of metolachlor. The document consists of six sections. Section I is the
introduction. Section II describes metolachlor, 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 metolachlor.
Section V discusses the reregistration requirements for metolachlor. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
-------
II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration Eligibility
Document:
• Common Name: Metolachlor
Chemical Name: 2-chloro-N-(2-ethyl-6-methylphenyl)-N-2-
methoxy-1-methylethyl) acetamide
• Chemical Family: Chloroacetanilide
• CAS Registry Number: 51218452
• OPP Chemical Code: 108801
• Empirical Formula: C15H22C1N02
• Trade and Other Names: Dual
• Basic Manufacturer: Ciba-Geigy
B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of these uses of metolachlor is in
Appendix A.
Type of Pesticide: Herbicide
Mode of Action: Chloracetanilide inhibits seedling development.
Use Sites: Terrestrial Food Crops -cabbage, pepper (bell, chile, tabasco), radish,
stone fruits
Terrestrial Food and Feed Crops -corn (field, pop, sweet), cotton,
-------
legume vegetables, peanuts, peas, potato (white/Irish), safflower,
sorghum, soybeans, tree nuts
Terrestrial Feed Crops -alfalfa
Terrestrial Non-Food Crops -agricultural rights-of-
way/fencerows/hedgerows, airports/landing fields, Christmas tree
plantations, commercial/industrial lawns, golf course turf,
nonagricultural rights-of-way/fencerows/hedgerows, nonagricultural
uncultivated areas/soils, ornamental and/or shade trees, ornamental
lawns and turf, ornamental woody shrubs and vines, recreation area
lawns, recreational areas, nonbearing fruits (apples, cherries, citrus
fruits, crabapples, grapes, pears)
Terrestrial Non-Food and Outdoor Residential -ornamental and/or shade
trees, ornamental herbaceous plants, ornamental nonflowering plants,
ornamental woody shrubs and vines
Forestry -forest trees (softwoods, conifers)
Outdoor Residential -residential lawns
Pests:
Grass and Grasslike Weeds -barnyardgrass, browntop panicum,
crabgrass, crowfootgrass, fall panicum, giant foxtail, goosegrass, green
foxtail, red rice, signalgrass, southwestern cupgrass, witchgrass, yellow
foxtail, foxtail millet, prairie cupgrass, yellow nutsedge
Broadleaf Weeds -Eastern black nightshade, carpetweed, Florida pusley,
galinsoga, pigweed
-------
Formulation Types Registered:
Single Active Ingredient Products
Granular—5 to 25%
Emulsifiable concentrate-84.4 to 86.4%
Technical/liquid—95%
Multiple Active Ingredient (AI) Products
Granular-4% + 1 other AI
Emulsifiable concentrate—22 to 70% + 1 other AI
Methods and Rates of Application:
Granular - Use from 1.95 to 4.05 pounds active ingredient per acre as a band,
broadcast, soil incorporated, or no-till or minimum-till soil treatment. Apply with
either a granule or pneumatic compressed air applicator postemergence, post
transplant, layby, postplant, preemergence, preplant, ground crack, pre transplant, or
when needed.
Emulsifiable Concentrate - Use from 1.2 to 5 pounds active ingredient per acre as a
band, soil incorporated, broadcast, directed spray, or in-furrow soil treatment. Use
also as a no-till or minimum-till soil treatment and through chemigation. Apply with
ground, low volume ground, aircraft, center pivot irrigation, or sprinkler irrigation.
Application timings include preplant, preemergence, early postemergence,
postemergence, Fall, Spring, non-bearing, post-plant, layby, when needed, at-planting,
non-bearing nurserystock, post-transplant, pre-transplant, and containerized.
Use Practices Limitations:
• Do not use in greenhouses or other enclosed structures.
• Do not use on muck or peat soils.
• Do not use on sweet potatoes or yams.
• Do not apply to trees or vines transplanted less than 30 days and only after depressions
around the trees and vines have been filled in.
• Do not use on sand or loamy sand soils.
• Do not apply to trees or vines that will bear harvestable fruit within 12 months of
application.
• Do not graze livestock in treated areas.
• Do not apply to Taloka Silt Loam.
• Do not use on English peas in Northeastern U.S.
• Do not use on sorghum grown under dry-mulch tillage.
• Do not feed or graze cover crops grown in treated orchards.
• Do not graze or feed peanut forage or fodder to livestock for 30 days following
application.
C. Estimated Usage of Pesticide
-------
The best estimates available for the pesticide uses of metolachlor are derived from a
variety of published and proprietary sources available to the Agency. The data, reported
on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as
the variability in using data from various information sources.
The table below summarizes the pesticides use by site.
Estimated Metolachlor Usage
Based on data from 1987 to 1993
Lbs. Used
On Site
Use Site (000's)
Alfalfa < 10
Almonds < 10
Apples < 10
Barley < 10
Cole crops 20
Corn 41,000
Cotton 550
Cropland for pasture < 10
Crp acres-long term < 10
Cucurbits < 10
Dry Beans 320
Dry Peas < 10
Eggplant < 10
Green Beans 170
Green Peas 37
Melons < 10
Oats/Rye < 10
Onions < 10
Other hay < 10
Pasture & Rangeland
(Other) < 10
Peanuts 1,300
Pecans 0
Peppers < 10
Potatoes 690
Rice < 30
Safflower 100
Setaside acres < 20
Percent
Of Total Use
On This Site
<0.5
<0.5
<0.5
<0.5
<0.5
69
1
<0.5
<0.5
<0.5
1
<0.5
<0.5
<0.5
<0.5
<0.5
<0.5
<0.5
<0.5
<0.5
2
<0.5
<0.5
1
<0.5
<0.5
<0.5
Percent
Of Site
Treated
25-30
2-6
7-13
0
80-100
5-9
25-35
20-35
-------
Sorghum 3,000 5 15-19
Soybeans 11,000 19 5-10
Sugar beets < 10 <0.5
Summer fallow < 10 <0.5
Sunflowers < 10 <0.5
Sweet Corn 380 1 20-30
Tobacco < 10 < 0.5
Tomatoes < 10 <0.5
58,651 100
These are agricultural sites for which usage was reported. Misreporting may have occurred
and/or usage may have occurred on non-registered sites. Most numbers are rounded estimates
and actual usage may differ. Based on USD A, proprietary and Resources for the Future
(RFF) data from 1987 to 1993.
D. Data Requirements
Data requested in the 1987 Registration Standard for metolachlor included studies on
product chemistry, residue chemistry, toxicology, and environmental fate. These data were
required to support the uses listed in the Registration Standard. Also, two Data Call-In
Notices were issued on 12/10/93 and 5/10/94 which required data to be submitted for ground
water, phytoxicity, and ecotoxicity requirements. Appendix B includes all data requirements
identified by the Agency for currently registered uses needed to support reregistration.
E. Regulatory History
Metolachlor, a broad spectrum herbicide, was first registered in 1976 for general weed
control in noncrop areas. Metolachlor is manufactured by Ciba-Geigy Corporation, who is the
sole producer and primary registrant. Since first registered for use on turf, it is now
registered also for use on food/feed and non-food crops. Metolachlor's major use sites are
corn, soybeans, and sorghum.
Metolachlor was the first Registration Standard document issued by the EPA in March
1980. In Janaury 1987, a second standard was issued. Additional Data Call-In Notices were
issued in December 1993 and May 1994. The following data gaps were identified in these
standards and subsequent Data Call-In Notices:
-------
1980 and 1987 Standards
Toxicology
Mutagenicity
General metabolism
Effect on coagulation
Environmental Fate
Hydrolysis
Photodegradation
Metabolism
Mobility
Accumulation
Ground and Surface Water Monitoring
Product/Residue Chemistry
Product Chemistry
Plant Metabolism
Storage Stability
Crop Field Trials
1993 and 1994 Data Call-in Notices
Ecological Effects
Avian Reproduction
Phytotoxicity
Fish and Marine Organisms Toxicity
Ground Water
III. SCIENCE ASSESSMENT
A. Product Chemistry
1. Identification of the Active Ingredient
Metolachlor [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-l-methylethyl) acetamide] is
a chloracetanilide herbicide. The molecular structure of metolachlor is:
-------
Other identifying characteristics and codes are:
Empirical Formula: C15H22C1N02
Molecular Weight: 283.8
CAS Registry No.: 51218-45-2
Shaughnessy No.: 108801
Basic Manufacturer: Ciba-Geigy
Technical metolachlor is an odorless white to tan-colored liquid with a boiling point of
100 EC at 0.001 mm mercury. Its bulk density is 1.12 g/mL at 20 EC. Metolachlor's
solubility in water at 20 EC is 530 mg/L. Metolachlor technical is miscible in xylene, toluene,
ethylene dichloride, and cyclohexanone. It is classified as a Class Illb combustible liquid.
2. Other Product Chemistry Considerations
There is one technical product for metolachlor, the 95% technical (T) (EPA Reg. No.
100-587). All pertinent product chemistry data requirements for the metolachlor 95% T (EPA
Reg. No. 100-587) have been satisfied, with the exception of analytical methods to verify
certified limits (Guideline Ref. No. 62-3).
-------
B.
Human Health Assessment
1. Toxicology Assessment
a. Acute Toxicity
Table 1 summarizes acute toxicity results and categories for metolachlor.
Table 1: Acute Toxicity Results and Categories for metolachlor
TEST
MRID
Oral LD50 - Rat 00015523
Dermal LD50 - Rabbit 00015526
Inhalation LC50 - Rat 00015535
W44444444444444444444
Eye Irritation - Rabbit
Dermal Irritation - Rabbit
Dermal Sensitization -
Guinea Pig
00015528
00015530
00015631
RESULTS
2780 mg/kg
> 10 g/kg
>1.75mg/L
W4444444
Non-irritating
Non-irritating
Positive
CATEGORY
in
in
in
W44444U
IV
IV
Metolachlor displayed a low level of toxicity in acute tests. Studies using technical
metolachlor showed an oral LD50 of 2780 mg/kg in rats (Category III Toxicity) and a dermal
LD50 in excess of 10 g/kg in rabbits (Category III Toxicity). The inhalation LC50 in rats was
greater than 1.75 mg/L (Category III Toxicity). Neither eye nor dermal irritation was seen in
rabbits (Category IV Toxicities, Document No. 000428). Metolachlor was positive in a study
for dermal sensitization in guinea pigs (MRID 00015631).
b. Subchronic Toxicity
A three-month feeding study in beagle dogs displayed no effects at the doses of 500 and
1000 ppm; the NOEL for toxicity was equal to or greater than 1000 ppm (equivalent to 25
mg/kg/day) (guideline 82-1; MRID No. 00017690). Beagle dogs fed 0, 100, 300, or 1000
ppm for six months displayed a NOEL of 300 ppm (equivalent to 7.5 mg/kg/day) (MRID
00032174). The LOEL was 1000 ppm (equivalent to 25 mg/kg/day) based upon reduced body
weight gains and food consumption in the high dose dogs (Document Number 010251).
A 21-day dermal toxicity study was performed on New Zealand white rabbits with 0, 10,
100, or 1000 mg/kg/day of metolachlor (guideline 82-2, MRID 418331-01). The systemic
NOEL was 100 mg/kg/day for both sexes. The systemic LOELs was 1000 mg/kg/day based
-------
upon increased bilirubin in both sexes, increased relative and absolute liver weights in males
and increased kidney weights in females.
c. Chronic Toxicity
The requirement for a chronic feeding study in rodents is satisfied by the chronic
carcinogenicity study in rats (see discussion below).
Metolachlor was fed to beagle dogs at dose levels of 0, 100, 300, or 1000 ppm for up to
52 weeks (guideline 83-1; MRID 409807-01). The systemic NOEL for male dogs was 1000
ppm (32.7 mg/kg/day). The systemic NOEL for female dogs was 300 ppm (9.7 mg/kg/day)
and the LOEL was 1000 ppm (33 mg/kg/day) based on decreased body weight gain
(Document Number 010088).
d. Carcinogenicity
Metolachlor has been evaluated for carcinogenic activity in both rats and mice. No
treatment-related carcinogenic effects were observed in two acceptable chronic studies in mice.
Both Charles River CD-I mouse studies were two years in duration. One utilized dietary
concentrations of 0, 30, 1000, or 3000 ppm and the other used 0, 300, 1000, or 3000 ppm
(450 mg/kg/day) (Guideline 83-1, 83-2; 248722; MRID 000015634, 00042725, and
00084003, 00117597).
Metolachlor was fed to CD-Crl:CD (SD) BR albino rats from Charles River for 2 years at
0, 30, 300, or 3000 ppm (0, 1.5, 13.5 or 150 mg/kg/day) (MRID 00129377, Study 80030) as
part of a combined chronic toxicity and carcinogenity study. The NOEL was 300 ppm (15
mg/kg/day) for systemic toxicity. The LOEL was 3000 ppm (150 mg/kg/day) based on
decreased body weight gain and increased liver weights in high dose males. A significant
increase in liver neoplastic nodules was observed in females at the highest dose level
(equivalent to 150 mg/kg/day) (Guideline 83-1, -2; MRID 00129377). This study satisfies the
requirement for a chronic toxicity study in rats (MRID 00129377) (Guideline 83-la). Increases
of neoplastic modules and hepatocellular carcinomas were found in high dose females (MRID
00244166).
The 1991 HED Peer Review Committee recommended that metolachlor be classified as a
Group C (possible human) carcinogen, with a Qx* of 9.2 x 103 (mg/kg/day) *). The
classification of Group C was based on increases in liver tumors in the female rat, by both
pair-wise and trend analysis and the replication of the finding of tumors in the female rat in a
second study. However, the Peer Review conducted July 27, 1994, recommended an MOE
approach since there was no supportable mutagenicity concern and in light of new information
on the relative metabolism of metolachlor, quinone imine is presumed to be the ultimate
carcinogen for 2,6-dimethylaniline. Because of steric hindrance (provided by the additional
alkyl group about the nitrogen atom), the nitrogen atom is significantly less susceptible to
amide dealkylation and extremely stable to metobolic hydrolysis of the amide so that formation
10
-------
of the disubstituted aniline is presumably very low (if any).
e. Developmental Toxicity
Metolachlor was given to New Zealand white rabbits at 0, 36, 120, or 360 mg/kg/day by
gavage on gestation days 6-18. Under the conditions of the study, it was not a developmental
toxicant, with the NOEL for developmental toxicity equal to or greater than 360 mg/kg/day
(highest dose tested) (guideline 83-3; MRID 00041283). The NOEL for maternal toxicity was
120 mg/kg/day. The maternal LOEL was 360 mg/kg/day, based on lacrimation, miosis, and
reduced body weight gain.
In one developmental toxicity study in Sprague-Dawley rats, both the maternal and
developmental toxicity NOELs were greater than 360 mg/kg/day (highest dose tested). The
doses were 0, 60, 180, or 360 mg/kg/day, given by gavage on gestation days 6-15 (guideline
83-3; Ciba Geigy Report 227625). In a second study in CD rats, the gavage doses on
gestation days 6-15 were 0, 30, 100, 300, or 1000 mg/kg/day. The maternal and
developmental toxicity NOELs were 300 mg/kg/day (MRID 00151941). Both LOELs were
1000 mg/kg/day, and the LOEL for maternal toxicity was based on deaths, salivation,
lacrimation, convulsions, reduced body weight gain and food consumption. The LOEL for
developmental toxicity was based on reduced mean fetal body weight, reduced number of
implantations per dam with resulting decreased litter size, and a slight increase in resorption s
per dam with resulting increase in post-implantation loss (guideline 83-3, Document Number
009509).
f. Reproduction
A two-generation reproduction study in albino CD rats, with doses of 0, 30, 300 or 1000
ppm in the diet, revealed a reproductive NOEL of 300 ppm (23.5-26.0 mg/kg/day) (MRID
00080897). This NOEL was derived from reduced pup weights in the Fla and F2a litters at the
highest dose tested, i.e., 1000 ppm (75.8-85.7 mg/kg/day). The NOEL for parental toxicity
was 1000 ppm (Guideline 83-4; Document Number 010088).
g. Mutagenicity
Metolachlor was not found to be mutagenic in several tests. The tests for gene mutation
were the Salmonella assay and an L5178/TK+/ mouse lymphoma test (Accession Number
262712 and 262713). The tests for structural chromosome aberration were an in vivo
micronucleus assay in Chinese hamsters (Accession Numbers 26712 and 26713) and a
dominant lethal assay in mice (MRID 00015630). Tests for other genotoxic activity included
DNA damage/repair assays in rat hepatocytes and in human fibroblasts and an in vivo/in vitro
unscheduled DNA synthesis assay (MRID 43244003).
However, metolachlor was positive in a test for induction of cell proliferation for
hepatocytes from male rats at one dose level (MRID 43244004).
11
-------
h. Metabolism
In a dermal penetration study, doses of 0.01, 0.1, and 1.0 mg/cm2 of metolachlor applied
to rat skin were found to be absorbed in relatively large amounts with significant
bioaccumulation observed in the carcass. The absorption at 24 hours was up to 62.8% of the
administered dose, with up to 30.1% of the dose remaining in the carcass (MRID 418331-02).
Dermal absorption is assumed to be 62.8% in the human, based on this study.
Several metabolism studies have been performed with metolachlor and the available data
indicate the compound is readily absorbed after oral dosing and excreted in approximately
equal amounts in urine and feces over 3 days (MRID 401144-01; Accession Number 262713).
A variety of metabolites were located in urine and feces and the proposed metabolic pathway
involves cleavage of metolachlor's ether bond and subsequent oxidation to carboxylic acid, as
well as hydrolytic removal of the chlorine atom. No conjugation was observed. (MRID Nos.
00015655, 00039193, 00015425).
i. Reference Dose (RfD) for Chronic Oral Exposure
The RfD for metolachlor was determined to be 0.10 mg/kg/day based upon the results of
the one-year toxicity study in dogs. The NOEL was 300 ppm, or 9.7 mg/kg/day, based on
decreased body weight gain at 1000 ppm (33 mg/kg/day). An uncertainty factor of 100 was
used to derive the RfD for metolachlor.
There is no acceptable daily intake (ADI) set by the Joint FAO/WHO Meeting on
Pesticide Residues (JMPR).
j. Toxiocology Data Gaps
There are no toxicological data gaps.
2. Exposure Assessment
a. Dietary Exposure
(1) Residue Information and Background
Tolerances for residues of metolachlor in or on food/feed commodities are currently
expressed in terms of the combined residues (free and bound) of the herbicide metolachlor [2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-l-methylethyl)acetamide] and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-l-propanol and
4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent
compound. Adequate enforcement methods are available for the determination of these
residues.
12
-------
The qualitative nature of the residue in plants is adequately understood. The Metolachlor
Registration Standard dated March, 1980, concluded that the qualitative nature of the residue
was adequately understood in corn and soybeans. Metabolism of metolachlor involves
conjugation with glutathione, breakage of this bond to form the mercaptan, conjugation of the
mercaptan with glucuronic acid, hydrolysis of the methyl ether, and conjugation of the
resultant alcohol with a neutral sugar. A minor pathway may involve sugar conjugation of
metolachlor directly to the corresponding oxo-compounds. Residues of concern in corn and
soybeans are metolachlor and its metabolites, determined as the derivatives CGA-37913 and
CGA-49751.
The Metolachlor Registration Standard dated March, 1980, concluded that the qualitative
nature of the residue in animals was adequately understood. Metolachlor is rapidly
metabolized and almost totally eliminated in the urine and feces of ruminants (goats), non-
ruminants (rats), and poultry. Metolachlor per se was not detected in any of the excreta or
tissues.
Adequate methods for purposes of data collection and enforcement of tolerances for
metolachlor residues are available. Methods for determining the combined residues of
metolachlor and its metabolites, as the derivatives CGA-37913 and CGA-49751, are described
in PAM, Vol. II, as Method I (plants; GC-NPD) and Method II (animals; GC-MS).
Storage stability studies have been conducted using fortified samples of beef muscle, beef
liver, milk, eggs, peanut nutmeats, potatoes, corn forage, corn grain, and corn oil. Residues
of CGA-37913 are stable in frozen storage (# -10 EC) in beef muscle for up to 52 days, in
corn oil for up to 102 days, and in or on the remaining animal and plant commodities for up to
1 year. Residues of CGA-49751 are stable in frozen storage (# -10 EC) in the animal
commodities for up to 1 year, and in or on the plant commodities for up to 2 years. The
registrant has reported the storage intervals for a sufficient number of the treated samples from
existing studies used to support proposed and established tolerances. The outstanding plant
and animal magnitude of residue studies must report the storage conditions and intervals for all
samples; samples should be stored under the conditions and analyzed within the intervals of
demonstrated residue stability.
Residue data are needed to support post-emergence uses of the new DF formulations.
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR §180.368(a) for: almonds, hulls; cabbage; corn, field, forage; corn, field, fodder;
corn, field, grain; peppers, bell; potatoes; sorghum, fodder (milo); sorghum, forage (milo);
sorghum, grain (milo); stone fruits group; peas and associated vine and hay commodities;
beans and associated forage and hay commodities; soybeans; soybeans, forage; and soybeans,
hay; tree nuts group, eggs; milk; the fat, kidney, liver, meat, and meat byproducts of cattle,
goats, hogs, horses, sheep; and the fat, liver, meat, and meat byproducts of poultry. The
dietary burden has been recalculated and the residues reported in the livestock feeding studies
adjusted for losses in frozen storage.
13
-------
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR §180.368(b) for: the straw, forage, and grain of barley, buckwheat, oats, rice,
rye, and wheat.
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR §180.368(c) for: peppers, chili; peppers, Cubanelle; and peppers, tabasco.
Food/feed additive tolerances are needed for the following processed commodities:
"potatoes, dry peel" (4.0ppm); "potatoes, wet peel" (0.5 ppm); "potatoes, granules" (0.5
ppm); and "potatoes, waste from processing" (4.0 ppm), soybean hulls (0.4 ppm) and
"peanuts, meal" (level cannot be determined). However, Delaney issues may prevent the
establishment of these tolerances.
Additional data are required to reassess other established tolerances (see tolerance
reassessment section, for details).
The confined rotational crop data indicate that [14C]Metolachlor residues accumulated in
lettuce, beets, and wheat planted 115 days after ring-labeled [14C]metolachlor (radiochemical
purity 99.1%) was applied at approximately 3.0 Ib ai/A to loamy sand soil subsequently
planted to potatoes. At mature harvest, total [14C]residues were 0.3 ppm in lettuce; 0.66 ppm
and 0.86 ppm in beet tops and roots; and 2.86, 0.14, an 1.17 ppm in wheat stalks, grain, and
hulls, respectively. In immature and mature crops, organosoluble residues ranged from 4.09
to 19.66% of the recovered radioactivity, water soluble residues ranged from 55.44 to
92.74%, and unextractable residues ranged from 1.82 to 28.52% Radioactive residues were
inadequately characterized. Additional data are required.
Because metolachlor is assessed as a Group C carcinogen, it is subject to the Delaney
clause of the FFDCA. See Section IV.B.I "Tolerance Reassessment."
Feeding studies are available for ruminants and poultry. These studies indicate that finite
residues will occur in milk, meat, poultry, and eggs. The tolerance reassessment summary for
these commodities is included in the Risk Managament Decision Section of this Reregistration
Eligibility Document.
(2) Anticipated Residue Data
In order to more accurately estimate dietary exposure to metolachlor, anticipated residues
for commodities which are major contributors to the dietary risk were determined using
available field trial data. Portions of the metolachlor residue database consist of Craven data.
Ciba-Geigy is in the process of generating replacement data for the Craven data. For this
anticipated residue assessment, Craven data were not used to generate average residues.
Tolerances previously established using Craven data were used provided sufficient other data
were available to support those tolerances on an interim basis.
14
-------
Cabbage
Potatoes
whole or pulp
granules
flakes
peel
chips
Peanuts
peanut oil
Milk
local
milksheds
Meat
Eggs
Poultry
Anticipated residues were:
0.055 ppm
0.09 ppm
0.18 ppm
0.18 ppm
0.14 ppm
0.09 ppm
0.27 ppm
0.054 ppm
0.0005 ppm
0.0021 ppm
0.0018 ppm beef, goat,
sheep, & pork MEAT
0.0013 ppm beef, goat,
sheep, & pork FAT
0.0044 ppm beef, goat,
sheep, & pork LIVER
0.007 ppm beef, goat,
sheep, & pork KIDNEY
0.006 ppm
0.006 ppm for poultry liver
(giblets)
0.0108 ppm poultry meat,
meat by-products
Tolerances:
1.0 ppm
0.2 ppm
0.5 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.05 ppm
0.2 ppm
0.02 ppm
0.05 ppm
0.02 ppm
15
-------
poultry fat
Field, corn grain
Corn Processed Products
Soybean
seed
meal
hulls
oil
0.006 ppm
0.04 ppm
0.04 ppm
0.10 ppm
0.10 ppm
0.14 ppm
0.03 ppm
Not established
Not established
0.2 ppm for grain
Not established, 0.4 ppm
tolerance needed
Not established, 0.4 ppm
tolerance needed
Not established, 0.4 ppm
tolerance
needed
b. Occupational and Residential
An occupational and/or residential exposure assessment is required for an active
ingredient if (1) certain toxicological criteria are triggered and (2) there is potential exposure
to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites
after application is complete.
(1) Use Summary
The emulsifiable concentrate formulation is the most commonly used formulation on all
sites. Ground application is the method of choice for all sites. Aerial applications are allowed
for some use sites.
Metolachlor is applied by chemigation, air or is broadcast. Rates of application vary from
0.75 Ib ai/A to 4.0 Ib ai/A. Maximum use rates on the major crops are: 4 Ib ai/A (nursery
turf), and 3 Ib ai/A (corn, soybeans, peanuts, potatoes, pod crops, sorghum and safflower).
Metolachlor is applied either immediately at or after planting (soybeans) or at a 14 to 45 day
pre-plant or post-emergent interval (dry beans and grapefruit). In the case of Tabasco or chili
peppers, directed post-emergent sprays can be made at mid-season.
At this time some products containing metolachlor are intended primarily for homeowner
use and some are intended primarily for occupational use.
16
-------
(2) Summary of Toxicity Concerns Impacting Occupational and
Residential Exposure
Metolachlor technical is in Toxicity Category III for acute dermal, oral, and inhalation
effects and is in Toxicity Category IV for dermal and eye irritation. These toxicity categories
do not trigger any requirement for evaluation of or reduction in, worker exposure.
Consequently, no worker exposure data were required by the Registration Standard (1980).
However, since the Standard was issued additional toxicological endpoints for worker
exposure have been identified. A 21-day dermal toxicity study was performed on New
Zealand white rabbits with 0, 10, 100 or 1000 mg/kg/day of metolachlor. The systemic
NOELS were 100 mg/kg/day for both sexes. The systemic LOEL was 1000 mg/kg/day based
on increased bilirubin in both sexes, absolute and relative liver weights for males, and in
relative kidney weights for females. In addition, metolachlor is classified as a Group C non-
quantified carcinogen. Quantification of risk is based on a NOEL of 15 mg/kg/day derived
from the chronic rat study.
(3) Summary of Potential Occupational and Residential
Exposures
Handler (Mixers, Loaders, Applicators, etc.) Exposures: EPA has determined that there
is an exposure potential for mixers, loaders, applicators, or other handlers during normal use
associated with metolachlor. Exposures to loaders, applicators, and loader-applicators is
likely when granular formulations are used. Exposures to mixer-loaders, applicators,
flaggers, and mixer-loader-applicators is likely when liquid formulations are used.
Post-Application Exposures: EPA has determined that there is an exposure potential for
persons entering treated sites after application is complete. For many uses of metolachlor, the
potential for post-application exposure is diminished since the herbicide is incorporated into
the soil following application. If metolachlor is appropriately incorporated, post-application
exposures should be limited to those situations where the task being performed disturbs the soil
sub-surface. There is more risk of exposure to metolachlor following post-emergent
applications, especially applications to turf.
(4) Handler (Mixers, Loaders, Applicators, Etc.) Exposures &
Assumptions
Mixer/loader/applicator (M/L/A) exposure data for metolachlor were not required during
the Registration Standard or Phase IV of the reregistration process, since no toxicological
criteria had been triggered at that time. However, handler exposure data for the emulsifiable
concentrate (EC) are available. A mixer/loader (MRID #40279809) was submitted. Data
from this study, combined with the Pesticide Handlers Exposure Database (PHED, ver 1.01)
were used to estimate worker exposure. The daily exposure estimates for the mixer/loader
(M/L), applicator (A), flagger (F), and combined job functions, mixer/loader/applicator
17
-------
(M/L/A) are shown in the attached tables. Surrogate exposure data for the granular
formulation are available using PHED. However, these data are deficient, since the surrogate
exposure data for exposure to granular formulations are based on an insufficient number of
data measurements (fewer than 15 replicates) that are of unacceptable quality. In addition,
there is no information on exposure when coveralls and gloves are used.
Based on the use patterns and potential exposures described above, four major exposure
scenarios were identified for metolachlor: (1) mixing/loading the liquid formulation to support
ground application, (2) applying the liquid formulation with a ground equipment, (3)
mixing/loading the liquid formulation to support aerial application, (4) applying the liquid with
aerial equipment, (5) flagging for aerial applications, (6) loading the dry (granular)
formulation, and (7) applying the dry formulation with ground equipment. The exposure
scenarios are presented in the attached Tables along with the corresponding exposure/risk
assessment. Footnotes to the tables list the actual clothing and equipment worn by persons
being monitored in the exposure studies.
Daily exposure (mg ai/kg bw/day)
= unit exposure (mg ai/lb ai) x use(lb ai/A) x Daily Acres Treated (A/day)
body wt (kg)
The following assumptions are made for the EC and granular use patterns:
•mixing/loading by ground application is done 1 day/year (Typical Private Rate)
•ground application is done 1 day/year (Typical Private Rate)
•aerial application is done 1 day/year (Typical Private Rate)
•M/L/A exposure is 10 days/year via ground equipment (Typical Commercial Rate)
•Aerial exposure is 10 days/year for turf uses (conservative estimate)
•Applications to rights of way, pastures, rangeland, very large farms are expected to be a
maximum of 10 d/yr (conservative estimate).
Mixer/loaders diluting large batches of metolachlor on a regular basis will be exposed to a
greater extent than those who prepare the pesticide for one application per year. Furthermore,
the label instructions specify a maximum use rate of 4.0 Ib ai/A for use on sod farms.
These calculations of daily exposure to metolachlor by handlers are used to assess the risk
to those handlers.
(5) Post Application Exposure to Workers
Post-application exposure data were not required during the Registration Standard or
Phase IV of the reregistration process, since, at that time, no toxicological criteria had been
triggered for metolachlor. A foliar dislodgeable residue study (MRID#410539-01) was
submitted in support of a registration for the use of metolachlor to control weeds on
ornamental turf grass.
18
-------
A rough estimate of the exposure to postapplication workers was made using foliar
dislodgeable residues from that study together with the Poppendorf transfer coefficient of
10,000 to estimate transfer of residues to the entire body surface. These calculations of daily
exposure to metolachlor by post-application workers are used to assess the risk to those
workers.
(6) Additional Occupational/Residential Exposure Studies
Two exposure studies are required as confirmatory data. A foliar
residue dissipation (132-la) and dermal passive dosimetry study (133-3) are required to better
refine the risk for residential turf.
3. Risk Assessment
a. Dietary
There was no evidence, based on the available data, that metolachlor is associated with
significant reproductive or developmental toxicity under the testing conditions. The data
available for review to address or characterize the hazard of a one-time or one-day exposure,
did not indicate that a one-day exposure to the chemical would be of such concern as to
warrant the need for an acute dietary risk assessment.
The DRES chronic exposure analysis used a Reference Dose (RfD) of 0.10 mg/kilogram
body weight/day, based on a No Observed Effect Level (NOEL) of 9.7 mg/kg bwt/day and an
uncertainty factor of 100. The NOEL was from a one year feeding study in dogs which
demonstrated decreased body weight gain as the effect of concern.
Metolachlor has been classified as a Group C (possible human) carcinogen by the HED
Carcinogenicity Peer Review Committee. As discussed under the Toxicology Assessment
(B)(l)(d) cancer risk assessments are based on a MOE approach. The MOE was calculated
from a NOEL of 15 mg/kg/day derived from the chronic rat study. However, because the
RfD is set on a NOEL of 9.7 mg/kg/day, dietary cancer concerns are adequately addressed by
the DRES chronic exposure analysis using the RfD.
Anticipated Residue/Dietary Risk Estimates
A DRES analysis using anticipated residue (AR) estimations and percent crop treated data
was performed to estimate dietary risk.
The ARC for the overall U.S. population from food uses of metolachlor being supported
through reregistration is 0.000199 mg/kg bwt/day, which represents less than 0.2% of the
RfD. If the pending use on celery is included, the ARC is raised to 0.000205 mg/kg bwt/day,
still less than 0.2% of the RfD. The subgroup most highly exposed through the diet, non-
nursing infants less than one year of age, has an ARC from recommended uses of 0.00641
19
-------
mg/kg bwt/day, or less than 0.6% of the RfD. If the pending use is included, the exposure is
raised to 0.000644 mg/kg bwt/day (less than 0.6% of the RfD). This low fraction of
allowable RfD is considered to be an acceptable dietary exposure risk. Tolerance
reassessments due to replacement of Craven data are not expected to significantly affect the
RED.
b. Occupational and Residential
The toxicological endpoints of concern for occupational and residential exposure are
Group C carcinogen classification and systemic toxicity resulting from exposure of one week
to several months (intermediate exposure). A NOEL of 100 mg/kg/day was used to estimate
MOEs, based on systemic toxicity from a 21-day dermal toxicity study in New Zealand white
rabbits. Because the effects discussed above are from a dermal study, a dermal absorption of
100% is assumed.
Intermediate Length Exposure MOE =
NOEL = 100 mg/kg/day
Dose Maximum Daily Exposure
Risk to Handlers (Mixers, Loaders, Applicators, etc.)
Margins of exposure (MOEs) for occupational exposure were calculated for handlers
using the NOEL (100 mg/kg/day) based on a risk concern for intermediate (one week to
several months) exposure. The calculated MOE's for subchronic toxicity are given presented
in the following Tables. The primary risk concern is for commercial handlers. Non-
commercial handlers are likely to be exposed only once per year.
The calculations indicate that MOEs for subchronic systemic effects are unacceptable
(less than 100) for mixer/loaders supporting aerial applications of metolachlor. The MOEs for
mixers/loaders supporting ground applications of liquid metolachlor formulations and for
applicators applying liquid metolachlor formulations using ground equipment are acceptable
only when certain personal protective equipment (gloves and coveralls) are worn by those
handlers.
The following risk mitigation measures for handlers, combined with generic worker
protection labeling, should mitigate these risks:
• mandatory use of a closed mixing and loading system by mixer/loaders who are
supporting aerial applications of metolachlor when using liquid formulations.
• requirement of chemical-resistant gloves and coveralls worn over short-sleeve shirt
and short pants for mixers/loaders supporting ground use applications of liquid
metolachlor formulations and for applicators applying liquid metolachlor
20
-------
formulations using ground equipment.
Risk From Post Application Exposures
Based on the rough post-application exposure estimates, the risk posed by post-application
exposure to metolachlor was estimated. Results of a turf dislodgeable residue study indicate
significant residue levels at 0 days post-application (at 16 micrograms/cm2). However,
residues rapidly decline by one day post application (0.269 micrograms/cm2). EPA has
determined that post-application exposures do not appear to pose an unreasonable risk to
individuals entering treated areas, provided entry is not permitted immediately following
application. Therefore, for all uses within the scope of the worker protection standards
(WPS), EPA is requiring a restricted-entry interval (REI) of 24 hours and personal protective
equipment for workers who enter the treated area before the REI is expired.
The 24-hour post-application entry restriction for metolachlor does not apply to uses
outside the scope of the Worker Protection Standard for Agricultural Chemicals, including
out-of-scope commercial uses and homeowner uses. The predicted frequency, duration, and
degree of exposure by such uses do not warrant the same risk mitigation measures required for
users covered by the WPS who are engaged in agriculture for commercial or research
purposes. For nonWPS occupational uses and homeowner uses, EPA is requiring:
• for liquid applications: a prohibition on entry until sprays have dried;
• for granular applications: a prohibition on entry until dusts have settled or, if the
granules must be watered-in, a prohibition on entry until the treated area is dry,
following the watering-in.
21
-------
The calculated MOE's for subchronic toxicity are given in the following Tables 2 and 3.
TABLE 2: ESTIMATED MOE'S FOR MIXER/LOADERS, APPLICATORS,
MIXER/LOADER/APPLICATORS, AND FLAGGERS FOR LIQUID FORMULATION
OF METOLACHLOR
SITE
VEGETABL
E
Corn,
Soybeans,
Sorghum,
Peanuts,
Potatoes, Pod
Crops,
Safflower
(Maximum
Rate, 3.0 Ib
ai/A)
TURF
Nursery and
Sod
(Maximum
Rate, 4.0 Ib
ai/A)
INDIVIDUAL
EXPOSED
M/L:
A:
M/L/ A:
F:
M/L :
A:
M/L/ A:
F:
GROUND
OPEN POUR
170
3890
170
130
2920
130
GROUND
CLOSED
SYSTEM
1670
3890
1170
1250
2920
880
AERIAL
OPEN
POUR
40
950
260
30
710
—
200
AERIAL
CLOSED
SYSTEM
380
950
260
290
710
—
200
M/L, A, and M/L/A wears Gloves and Coveralls
Aerial Applicator (pilot) wears No Gloves and Short Sleeves
Flaggers wear No Gloves, No Coveralls, Long pants and Long Sleeves
M/L = Mixer/Loader; A = Applicator; M/L/A = Mixer/Loader/Applicator;
F = Flagger
22
-------
TABLE 3: ESTIMATED MOE'S FOR MIXER/LOADERS, APPLICATORS AND
MIXER/LOADER/APPLICATORS FOR THE GRANULAR FORMULATION OF METOLACHLOR
SITE
VEGETABLE
Corn, Soybean, Sorghum,
Peanut, Potatoes, Pod Crops,
Safflower
(Maximum Rate, 3.0 Ib ai/A)
TURF
Nursery and Sod
(Maximum Rate, 4.0 Ib ai/A)
INDIVIDUAL
EXPOSED
M/L:
A:
M/L/ A:
M/L:
A:
M/L/A
GROUND OPEN POUR
4200
25000
3600
3100
19000
2700
M/L, A, and M/L/A wears Gloves and Coveralls
M/L = Mixer/Loader
A = Applicator
M/L/A = Mixer/Loader/Applicator
c.
Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
Metolachlor appears to be stable to hydrolysis at pH's of 5, 7, 9 without
significant degradation of parent material after 30 days.
The aqueous photolysis half-life was 70 days when exposed to natural sunlight
and 0.17 day when exposed to artificial sunlight (450 watt mercury arc lamp
with light intensity of 4500-4800 uW/cm2). After 30 days exposure to natural
sunlight the degradation products were CGA-41638 (3.63% of applied
radiocarbon), CGA-51202 (3.54%), CGA-46129 (3.42%), CGA-50720
23
-------
(3.20%), and parent metolachlor remaining was 62.92%.
The soil photolysis half-life of metolachlor when exposed to natural sunlight
was 8 days, and when exposed to artificial light conditions (mercury arc lamp
with intensity of 1600-2400 uW/cm2) the half-life was 37 days. The major
degradates reported after 21 days exposure to natural sunlight were CGA-51202
(maximum of 3.4% of applied radiocarbon), CGA-37735 (9.0%), CGA-41638
(5.7%), CGA-40172 (6.2%), and CGA-37913 (maximum of 7.3% of applied
radiocarbon).
Under aerobic soil conditions metolachlor degraded with a half-life of 67 days
in a sandy loam soil. The major metabolite was CGA-51202 (maximum of
28.09% of applied radioactivity at 90 days posttreatment). Other identified
metabolites were CGA-37735 (maximum of 14.85% at 272 days), CGA-41638
(maximum of 2.06% at 90 days), and CGA-13656 (maximum of 1.02%
immediately posttreatment). Other metabolites that were detected but not
quantified were CGA-40172, CGA-41507, CGA-40919, and CGA-37913.
The aerobic aquatic metabolism half-life of metolachlor was 47 days. The major
metabolites in the sediment were CGA-41507 (3.34% of applied radiocarbon at
29 days), CGA-50720 (1.17%), CGA-40172 (1.13%), CGA-46127 (1.54%)
and parent metolachlor was 34.56%. In the water fraction after 29 days
incubation parent metolachlor was 30.90% and the metabolite CGA-41507 was
1.21% and CGA-51202 was 1.99%.
Under anaerobic soil conditions metolachlor degraded with a half-life of 81
days in a sandy loam soil that was incubated under anaerobic conditions for 60
days at 25°C following 30 days of aerobic incubation. The major degradate in
both the soil and flood water was CGA-51202 (maximum of 23.33% of applied
radiocarbon at 29 days after anaerobic conditions were established); and other
reported degradates were CGA-37735 (1.25% at 29 days), CGA-41638 (8.30%
at 60 days), CGA-13656 (1.46% at 29 days), and CGA-50720 (maximum of
7.34% at 60 days).
The anaerobic aquatic metabolism half-life for metolachlor was 78 days. In the
anaerobic waters the major degradates were CGA-40172 (maximum of 5.64%
at 12 months), CGA-37913 (maximum of 4.28% at 6 months), CGA-46127
(maximum of 4.69% at 12 months) and CGA-41507 (maximum of 4.85% at 6
months). The major degradates in the sediment were CGA-41507 (maximum of
15.88% of applied radiocarbon at 12 months), CGA-40172 (maximum of
3.18% at 12 months), CGA-46127 (maximum of 13.02% at 12 months), CGA-
50720 (maximum of 1.67% at 29 days), and CGA-37913 (maximum of 2.33%
at 6 months), and after 12 months the sediment contained 1.47% parent
metolachlor.
24
-------
In the unaged portion of the leaching and adsorption and desorption study
metolachlor was shown to range from being highly mobile in a sand soil (Kd
value of 0.08) to being moderately mobile (Kd value of 4.81 in a sandy loam
soil) from column leaching studies using four soils. The leachate contained from
15.03% to 82.91% (comprised of 75.5% parent metolachlor, 1.14% of CGA-
51202, 3.69% of CGA-37735, and 2.26% CGA-41638) of the applied
radioactivity. In batch equilibrium studies employing the same four soils, the
Freundlich adsorption (Kad) values ranged from 0.108 to 2.157. These data
indicate that metolachlor has the potential to range from being a moderately
mobile material (clay soil and sandy loam soil) to being a highly mobile
material (loam soil and sand soil).
In the aged leaching portion of the leaching and adsorption and desorption study
the reported cumulative Kd for aged metolachlor and its degradates in columns
of an Iowa sandy loam soil was 2.01. This indicates that metolachlor and its
identified degradates (CGA-51202, CGA-37735, and CGA-41638) have the
potential to be mobile since in other studies it was shown that metolachlor and
its CGA-51202 degradate leached the slowest in the Iowa sandy loam soil
compared to their leaching rate in the other three soils tested. Batch equilibrium
studies showed that CGA-51202 has the potential to be extremely mobile with
reported Freundlich adsorption (Kad) values ranging from 0.04 in the Maryland
sand to 0.171 in the Iowa sandy loam soil.
Laboratory volatility studies indicated that volatility is not a significant mode of
dissipation for metolachlor from the soil. The maximum dissipation was 0.05%
of the metolachlor dose volatilizing per day.
In numerous terrestrial field dissipation studies using metolachlor (Dual 8E and
Dual 25G) both applied at 4 and 6 Ib ai/A the half-life of metolachlor in the 6-
12 inch soil layer ranged from 7 days (Iowa) to 292 days (California) with a
range of the total water applied ranging from 16.97 inches to > 40 inches
during the study period. Detections of metolachlor were made as far as the 36-
48 inch soil layer in some of the tests. The degradate CGA-40172 (0.07 ppm)
and CGA-40919 (0.21 ppm) were detected in the 36-48 inch soil layers in one
Iowa site. CGA-50720 was not detected (< 0.07 ppm) in any soil sampled at
any interval.
Metolachlor appears to have a low potential to bioaccumulate in fish with a
reported whole body bioconcentration factor of 69X and a whole body
elimination of 93% after 14 days depuration.
Substantial amounts of metolachlor could be available for runoff to surface
water for several months post-application. The low soil/water partitioning of
metolachlor indicates that most of the metolachlor runoff from soil will be in
25
-------
the form of dissolution in runoff water. A substantial amount of data on
metolachlor in the surface water of the mid-western corn belt are available.
Based upon these data along with a literature review submitted by Ciba-Geigy
(Tierney and Newby 1993), the Agency has reached and/or concurs with the
following conclusions with respect to metolachlor concentrations in surface
waters.
Metolachlor is among the top five pesticides in terms of frequency of detection
and greatest concentrations in samples of both raw and finished surface water in
the mid-western corn belt. It is detected in a high percentage of surface water
samples collected from numerous locations within the corn belt for several
months post-application. Detection percentages in early spring, before
application, and in late fall and winter, many months after application, are
lower than the first few months post-application, but are still relatively high due
presumably to its persistence.
Metolachlor concentrations typically increase rapidly from pre-application
concentrations of below one ppb to post-application peak concentrations of
typically several ppb. Peak concentrations sometimes exceed 10 ppb and
occasionally exceed 20 ppb. Peak concentrations exceeding 50 ppb appear to be
rare, but peak concentrations of metolachlor exceeding 50 ppb (up to 154 ppb)
have been reported. In areas where tile drainage and/or groundwater inflow
contribute substantially to the loading to surface waters, secondary peaks may
occur substantially after peak flow. Peak concentrations of metolachlor are
generally greater in surface waters draining small watersheds than in those
draining large watersheds.
Most of the available metolachlor data are for streams and rivers. Goolsby et al
(1993) reported detection percentages for metolachlor in 76 midwestern
reservoirs that were comparable to those for streams and rivers. The small
amount of metolachlor data for 10 lakes and reservoirs summarized by Tierney
and Newby (1993) indicate that elevated metolachlor concentrations sometimes
occur later and/or remain longer in some lakes and reservoirs than in streams or
rivers. However, the maximum metolachlor concentration reported for the 10
lakes and reservoirs listed in the Tierney and Newby review was only 6.8 ppb.
The study by Smith et al (1987) was the only study available in which finished
drinking water was sampled. However, metolachlor concentrations in raw and
finished water should generally be comparable because the primary treatment
processes employed by most surface water supply systems are not effective in
removing pesticides with low soil/water partitioning such as metolachlor.
The Agency computed annual and multiple year Time Weighted Mean
Concentrations (TWMCs) using the available data. All were less than 10 ppb,
26
-------
and most were less than 5 ppb. The computed annual TWMCs are probably
somewhat larger than the actual time integrated means, but are more accurate
approximations of the time integrated means than arithmetic means. Maximum
and seasonal-annual time weighted mean concentrations of metolachlor in
surface water at the same sampling location often vary substantially, sometimes
by greater than ten times, from year to year depending in part upon the
intensity, duration, and timing of post-application runoff events.
Metolachlor is not yet formally regulated under the Safe Drinking Water Act
(SDWA). Therefore, no enforcement MCL has been established for it.
However, it has relatively high drinking water health advisories (1-10 day HAs
of 2000 ppb and lifetime HA of 100 ppb). When pesticides become regulated,
their lifetime HA usually becomes their MCL.
Based upon the available results it appears highly unlikely that maximum or
short term average metolachlor concentrations will exceed the 1-10 day HAs of
2000 ppb or that annual average metolachlor concentrations will exceed the
lifetime HA (potentially the MCL) of 100 ppb anywhere. Although metolachlor
is not yet formally regulated by the SDWA, water supply systems are required
to sample and analyze for it. The Agency will review such data when they
become available.
b. Environmental Fate Assessment
Although the environmental fate data base is not complete, the information from
all acceptable and upgradeable environmental fate data from the 1980
Registration Standard to present indicate that parent metolachlor appears to be
moderately persistent to persistent. It also ranges from mobile to highly mobile
in different soils and it has been detected in ground water. Metolachlor is stable
to hydrolysis under normal environmental conditions of pH 5.0, 7.0, and 9.0.
Metolachlor degradation appears to be dependent on microbially mediated
(aerobic soil metabolism t1/2 = 67 days, anaerobic soil metabolism t1/2 = 81 days)
and abiotic processes (photodegradation in water t1/2 = 70 days under natural
sunlight and photodegradation on soil t1/2 = 8 days under natural sunlight). The
major degradates were identified as CGA-51202, CGA-50720, CGA-41638,
CGA-37735, and CGA-13656.
Depending on the soil characteristics metolachlor has the potential to range
from a moderately mobile to a highly mobile material (Kd values ranging from
0.08 to 4.81). Upgradeable field dissipation studies indicate that metolachlor is
persistent in the surface soil (t1/2 ranging from 7 days to 292 days the upper 6
inch soil layer). Metolachlor was reportedly detected as far as the 36 to 48 inch
soil layer in some of the studies. The degradate CGA-51202 was detected (0.11
ppm) as far as the 30-36 inch soil depth; CGA-40172 was detected as far as the
27
-------
36-48 inch depth; CGA-40919 was detected in the 36-48 inch depth (0.21 ppm),
and CGA-50720 was not detected (0.07 ppm) in any soil segment at any interval
(MRID 41335701 and 41309802).
Metolachlor appears to have a low potential to bioaccumulate in fish with a
reported whole body bioconcentration factor of 69 and a whole body
elimination of 93% after 14 days depuration.
The "Pesticides in Ground Water Data Base 1992" indicates that residues of
metolachlor have been detected in wells in 20 states. The lifetime Health
Advisory for metolachlor has been established at 100 ppb. Levels exceeded the
Health Advisory in a total of 3 wells located in Wisconsin, New York, and
Montana. In five other states concentrations in well water exceeded 10% of the
HAL. A recent 6 (a) (2) report submitted by the registrant indicates metolachlor
residues in one well that also exceeds the 100 ppb HAL. Because of these
detections the Agency is concerned about the degradation of water quality that
occurs in metolachlor use areas.
Metolachlor is among the top five pesticides in terms of frequency of detection
and greatest concentrations in samples of both raw and finished surface water in
the mid-western corn belt. It is detected in a high percentage of surface water
samples collected from numerous locations within the corn belt for several
months post-application. In streams and rivers of the corn belt, metolachlor
concentrations typically increase rapidly from pre-application concentrations of
below one ppb to post-application peak concentrations of typically several ppb.
Most of the available metolachlor data are for streams and rivers. However,
available detection percentages for metolachlor in 76 midwestern reservoirs
were comparable to those for streams and rivers. The data indicates that
elevated metolachlor concentrations sometimes occur later and/or remain longer
in some lakes and reservoirs than in streams or rivers.
Only one of the available studies involved finished drinking water. However,
metolachlor concentrations in raw and finished water should generally be
comparable because the primary treatment processes employed by most surface
water supply systems are not effective in removing pesticides with low
soil/water partitioning such as metolachlor.
Based upon the available results, it appears highly unlikely that maximum or
short term average metolachlor concentrations will exceed the 1-10 day HAs of
2000 ppb or that annual average metolachlor concentrations will exceed the
lifetime HA (potentially the MCL) of 100 ppb anywhere. Although metolachlor
is not yet formally regulated by the Safe Drinking Water Act, water supply
systems are required to sample and analyze for it. The Agency will review
28
-------
such data when they become available.
2. Ecological Effects
a. Ecological Hazard
(1) Non-Target Birds
Avian Acute
In order to establish the toxicity of metolachlor to birds, the minimum data
required on the technical material are: an avian single-dose LD50 test with
either one species of waterfowl, preferably the mallard, or one species of
upland game bird, preferably bobwhite; and two avian dietary LC50 tests, one
with a species of waterfowl, preferably the mallard, and one with a species of
upland game bird, preferably the bobwhite. The acceptable data are described
below.
Based on acute toxicity data, metolachlor is practically non-toxic to birds. An
avian acute oral study performed on the mallard duck resulted in an LD50 value
of 4640 mg/kg (MRID 00015547).
On a subacute dietary basis, metolachlor is practically non-toxic to birds. Two
studies one on the mallard duck and one on the bobwhite quail, produced LC50
values greater than 10,000 ppm (MRIDs 00016425, 00016426).
Avian Chronic
Avian reproduction studies are required because of repeat application to
peanuts, corn, and potatoes and because this is a persistent chemical (half life
ranging from 7 to 292 days). In order to establish the chronic toxicity of
metolachlor to birds, the data required on the technical material are: two avian
reproduction studies, one with a species of waterfowl, preferably the mallard;
and one with a species of upland game bird, preferably the bobwhite quail. The
available data are described below.
One supplemental avian reproduction study for the mallard duck shows that the
LOEL is 1000 ppm. A risk assessment was performed using this supplemental
study, but new avian reproduction studies are required to confirm the chronic
risk assessment. (MRID 00162292) The new avian reproduction studies have
been required in a Data Call-In Notice dated May 10, 1994.
(2) Non-Target Freshwater Fish
29
-------
Acute
The minimum data required for establishing the acute toxicity of metolachlor to
fish are two 96-hour studies with the technical product: one with cold water
species, preferably rainbow trout; the other with a warm water species,
preferably bluegill sunfish. The acceptable data are described below.
The test results show that technical metolachlor is moderately toxic to
freshwater fish in acute exposures. The LC50's ranged from 3.9 to 10 ppm
(MRID's 00018722, 00018723, 00015534).
Chronic
Chronic toxicity to fish is a concern because of repeat application to peanuts,
corn, and potatoes and because this is a persistent chemical (half life ranging
from 7 to 292 days). In order to establish the chronic toxicity of metolachlor to
fish, the data required on the technical material is a fish early life stage study
with one of the recommended species. The available study is described below.
The supplemental fish early life stage study gives an NOEC of 0.78 ppm and an
LOEC of 1.6 ppm. The geometric mean is 1.17 ppm.
(3) Non-Target Freshwater Invertebrates
Acute
The minimum data required for establishing the acute toxicity of metolachlor to
aquatic invertebrates is one 48-hour acute toxicity test with the technical
product. The acceptable study is described below.
The test results show that metolachlor is slightly toxic to aquatic invertebrates in
acute exposures. The EC50 is equal to 25.1 ppm (MRID 43044603).
Chronic
Chronic toxicity to invertebrates is a concern because of repeat application to
peanuts, corn, and potatoes and because this is a persistent chemical (half life
ranging from 7 to 292 days). In order to establish the chronic toxicity to
aquatic invertebrates the data required is an aquatic invertebrate reproduction
study with the water flea, Daphnia magna. No acceptable aquatic invertebrate
reproduction study is available.
However, based on the available data, the risk to freshwater invertebrates is not
expected to be substantially different than the risk to fish. The aquatic
30
-------
invertebrate reproduction study is required to confirm this assessment. This
study has been required in a Data Call-in Notice dated May 10, 1994.
(4) Non-Target Estuarine and Marine Organisms
Acute
Metolachlor is registered for uses which may expose estuarine organisms to the
pesticide. Such uses include cotton, corn, peanuts, turf, sorghum, soybeans,
and right-of-way. To establish the toxicity of metolachlor to non-target
estuarine/marine organisms, three studies are required: acute estuarine/marine
toxicity for the fish, mollusk and shrimp. The available data are described
below.
Technical metolachlor is slightly toxic to estuarine fish in acute exposures. The
LC50 is 7.9 ppm (MRID 43044303). No studies were available for the shrimp
and oyster. However, based on the available aquatic data, the toxicity to these
organisms is not expected to be substantially different than the toxicity to fish.
The shrimp and oyster studies have been recently required in a Data Call-In
Notice (December 10, 1993) to confirm the estuarine assessment for
metolachlor.
Chronic
To establish the chronic toxicity of metolachlor to estuarine fish, a chronic
toxicity study was submitted. The study provides an NOEC of 1.0 ppm and
LOEC of 2.2 ppm, based on length which was the most sensitive parameter
(MRID 43044602).
(5) Non-Target Plants
Non-target plant studies are required for any herbicide used on terrestrial food
and terrestrial non-food sites if, (1) ground application is used and the water
solubility is greater than 10 ppm (metolachlor solubility is 530 ppm) or the
vapor pressure is greater than 1.0 x 105 mmg Hg at 25 °C (metolachlor vapor
pressure is 1.3 x 105 mmg Hg at 25 °C); or (2) the typical end product (TEP) is
not thoroughly incorporated immediately after application (aerial application
and chemigation). To establish the toxicity of metolachlor to non-target plants,
the following studies are required: seed germination/seedling emergence; a
vegetative vigor; and an aquatic plant growth study.
Since metolachlor is a herbicide, potential risk to non-target plants is likely.
Non-target plant studies were recently required in a Data Call-In Notice
(December 10, 1993). These studies are being required to confirm the risk to
31
-------
non-target plants.
b. Ecological Effects Risk Assessment
The potential for ecological effects is presented in the following risk
assessments, each covering a different combination of endpoint and exposure
scenarios. Each risk assessment includes a risk quotient which combines the
toxicity and exposure information. For each risk quotient there is an
established value above which the risk is considered to be at a high level of
concern (LOG). In addition to these high risk values, restricted use is
considered when the risk quotient exceeds 0.1 for acute aquatic risk or 0.2 for
acute avian risk. The generic risk quotients and their respective LOC's for each
risk assessment are provided in the following table. Note that the same risk
quotients are used for non-endangered and endangered species, but the acute
LOG is lower for endangered species.
Established Levels of Concern (LOC's)
Endpoint/Scenario
Mammalian acute
Mammalian chronic
Avian acute
Avian chronic
Aquatic acute
Aquatic chronic
Non-target insects
and plants
Risk
Quotient
EEC/LCsn
EEC/LEL
EEC/LCsn
EEC/LEL
EEC/LC5n
EEC/LEL
NOT QUANTIFIED
Non-Endangered
LOG
0.5
1.0
0.5
1.0
0.5
1.0
N/A
Endangered
LOG
0.1
1.0
0.1
1.0
0.05
1.0
N/A
(1) Non-Endangered Species
Terrestrial Organisms (Avian)
Metolachlor is registered for numerous outdoor uses. Exposure to non-target
organisms can result from direct applications, spray drift from treated areas,
and runoff from treated areas. Such exposures can be both chronic as well as
acute.
32
-------
Acute Effects
Granular Products. The levels of concern for acute effects to avian species
are not exceeded for any application rate (Table 1). The maximum application
rate as a granular formulation is 4 Ib ai/acre. For broadcast application with no
incorporation the LD50/ft2 = 0.007. The same LD50/ft2 is assumed for
banding.
Table 1. Comparison of LD50/ft2 to the LOC for the highest
granular application rate of metolachlor. (LD50 = 4640}
Maximum Application
Rate
4 Ibs ai/acre
Method of Application
Broadcast (no incorporation)
LD50/ft2
0.007
LOC
High Risk $0.5
RU$0.2
ESS 0.1
RU = Restricted Use ES = Endangered Species
Non-Granular Products. The levels of concern for acute effects to non-
endangered avian species are not exceeded at any application rate (Table 2).
The LOC for endangered birds is exceeded at an application rate of 6 Ibs.
ai/acre.
Table 2. Risk Quotient and LOC for the lowest and highest
application rate of metolachlor. (LC50 > 10,000 ppm)
Use Site
Cabbage, Pepper Chili, Cotton,
Seed Radish
Corn, Peanuts, Alfalfa, Potatoes
Application Rate
2 Ibs ai/acre
6 Ibs ai/acre
Substrate (EEC)
Short Grass (480)
Short Grass (1440)
Risk Quotient
(EEC/LC50)
0.048
0.144
LOC
High Risk $0.5
RU$0.2
ESS 0.1
High Risk $0.5
RU$0.2
ES $ 0.1
RU = Restricted Use ES = Endangered Species
Chronic Effects
Preliminary chronic effects have been assessed based on a supplemental study
for waterfowl. Preliminary evaluation of the study shows that the LOEL is
1000 ppm. Based on that LOEL, the risk quotients do not exceed the LOCs at
the 2 Ib. application rate (Table 3). The LOC is eceeded for the 6 Ibs.
application rate for short grass. Since this risk assessment was based on a
supplementary study, the Agency has recently required two new avian
reproduction studies in a Data Call-in Notice (May 10, 1994) to confirm the
chronic risk assessment for birds.
33
-------
Table 3. Chronic Risk Quotient and LOG for the lowest and highest application rate of metolachlor, based on a LOEL of 1000 ppm.
Use Site
Cabbage, Pepper Chili, Cotton,
Seed Radish
Corn, Peanuts
Application Rate
2 Ib ai/acre
6 Ibs ai/acre
Substrate (EEC)
Short Grass(480)
Seeds (24)
Short Grass (1440)
Seeds (72)
Risk Quotient
(EEC/LOEL)
0.48
0.024
1.4
0.072
LOC
High Risk $ 1
Terrestrial Organisms (Small Mammals)
The endangered species level of concern is exceeded, using the maximum EEC,
for small mammals eating short grass at an application rate of 2 Ibs./acre. The
endangered species level of concern and restricted use level of concern are
exceeded, using typical and maximum EEC's, for small mammals eating short
grass, at application rates of 4 Ibs./acre and higher. The risk quotients range
from 0.1 to 0.3. (See table below) Small endangered grass eating mammals
that can be associated with agriculture (based on habitat and food) are the
following: in Utah the Utah prairie dog and in California the Giant Kangaroo
rat, the Fresno Kangaroo rat, and the Stephen's Kangaroo rat.
An acute rat study indicated that the LD50 for the rat is 2780 mg ai/kg. The
LC50 is estimated from the LD50, body weight of the organism in question,
and food consumption. A representative of an herbivore (meadow vole LC50
= 4567 ppm), a granivore (deer mouse LC50 = 17,209 ppm) and an
insectivore (least shrew LC50 = 2528) are used to estimate the risk to small
mammals.
34
-------
Table 4. Expected food items, typical and maximum estimated environmental concentrations and Acute LOC's for three small
mammals representing different food preferences. T=Typical EEC, M = Maximum EEC
Use Sites
Cabbage, Pepper,
Chili, Seed Radish
Soybeans, Corn,
Citrus, Stone Fruits,
Grapes
Corn, Peanuts
Application rate
2 Ibs ai/acre
4 Ibs ai/acre
6 Ibs ai/acre
Species (LC50)
Meadow Vole
(4567 ppm)
Least Shrew (2528
ppm)
Deer Mouse
(17,209 ppm)
Meadow Vole
(4567 ppm)
Least Shrew (2528
ppm)
Deer Mouse
(17,209 ppm)
Meadow Vole
(4567 ppm)
Least Shrew (2528
ppm)
Deer Mouse
(17,209 ppm)
Expected Food
(EEC ppm)
Grasses
T = 250
M = 480
Insects
T = 66
M = 116
Seeds
T = 6
M = 24
Grasses
T = 500
M = 960
Insects
T = 132
M = 232
Seeds
T = 12
M = 24
Grasses
T = 750
M = 1440
Insects
T = 198
M = 348
Seeds
T = 18
M = 72
Risk Quotient
(EEC/LC50)
T = 0.05
M = 0.11
T = 0.02
M = 0.04
T = 0.0003
M = 0.001
T = 0.1
M = 0.21
T = 0.05
M = 0.09
T = 0.0006
M = 0.0001
T = 0.16
M = 0.32
T = 0.04
M = 0.07
T = 0.001
M = 0.003
LOG
HR$0.5
RU$0.2
ES $0.1
HR$0.5
RU $0.2
ES $0.1
HR$0.5
RU $0.2
ES $0.1
Aquatic Organisms
Acute Effects
No acute effects to aquatic organisms (including freshwater invertebrates and
fish and estuarine fish) are expected as a result of the use of metolachlor when a
6 or 1 foot deep water body scenario is employed. However, for the roadside
use, a shallower scenario is considered to be more appropriate. The Agency
considers the roadside and rights-of-way use to be the same. Using the LC50 of
the most sensitive aquatic species, the freshwater fish, application of 1.25 Ib
ai/acre triggers the endangered species LOG for a water body of one foot deep
or less (Table 5).
35
-------
Table 5. Acute Risk Quotient and LOG for the lowest and highest application rate of metolachlor. (LC50 = 3.9 ppm)
Use Site
Cabbage, Pepper Chili, Cotton,
Seed Radish
Roadside
Corn, Peanuts, Alfalfa, Potatoes
Application Rate
2 Ibs ai/acre
1.25 Ibs ai/acre
6 Ibs ai/acre
Depth (EEC ppm)
6 ft (0.061)
6 ft
(0.038)
1 ft
(0.229)
6 inches
(0.458)
6 ft (0.186)
Risk Quotient
(EEC/LC50)
0.01
0.009
0.05
0.12
0.04
LOC
High Risk $0.5
RU$0.1
ES $ 0.05
High Risk $0.5
RU $ 0.1
ES $ 0.05
High Risk $0.5
RU$0.1
ES $ 0.05
RU = Restricted Use ES = Endangered Species
No data are available on acute effects for estuarine/marine invertebrates;
however, based on the available aquatic data, the risk to these organisms is not
expected to be substantially different than the risk to the estuarine fish. The
estuarine invertebrate data are being required to confirm the assessment for
these organisms.
Chronic Effects
No chronic effects to freshwater or estuarine/marine fish are expected from the
use of metolachlor (Table 6).
36
-------
Table 6. Chronic Risk Quotient and LOG for the lowest and highest a
Use Site
Cabbage, Pepper Chili, Cotton,
Seed Radish
Roadside
Corn, Peanuts, Alfalfa, Potatoes
Application Rate
2 Ibs ai/acre
1.25 Ibs ai/acre
6 Ibs ai/acre
oplication rate of metolachlor. ( Geometric Mean (GM)of NOEL and LOEL = 1.17 ppm
Depth (EEC ppm)
6 ft (0.061)
6ft
(0.38)
1 ft
(0.229)
6 inches
(0.458)
6 ft (0.186)
Risk Quotient
(EEC/CM)
0.05
0.32
0.19
0.39
0.15
LOC
High Risk $ 1
High Risk $ 1
High Risk $ 1
RU = Restricted Use ES = Endangered Species
No data are available on chronic effects for freshwater invertebrates. However,
based on the available aquatic data, the risk to these organisms is not expected
to be substantially different than the risk to freshwater fish. The invertebrate
data have recently been required in a Data Call-in Notice (May 10, 1994) to
confirm this assessment.
Non-Target Plants
There is no quantitative information available to conduct a risk assessment on
non-target terrestrial plants. However, because metolachlor is a herbicide, risk
to terrestrial non-target plants is expected. Non-target plant data are being
required to confirm the risk to non-target plants.
(2) Endangered species
The level of concern for acute effects to avian species eating short grass is
exceeded at an application rate of 6 Ibs./acre for non-granular formulations
using maximum EEC's (risk quotient = 0.1). Based on a supplemental study,
the level of concern for chronic effects to avian species is exceeded at an
application rate of 6 Ibs./acre (risk quotient = 1.4). The level of concern is
exceeded, using the maximum EEC, for small mammals eating short grass at an
application rate of 2 Ibs./acre (risk quotient =0.1). The level of concern is
exceeded, using typical and maximum EEC's, for small mammals eating short
grass, at application rates of 4 Ibs. ai and higher (risk quotients range from 0.1
to 0.3). The roadside use (application rate of 1.25 Ibs. ai/acre) exceeds the
level of concern for acute effects to endangered fish (risk quotient = 0.12).
37
-------
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for 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 metolachlor as an active ingredient. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing metolachlor except those
containing the three crops specified below. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregistration
eligibility of metolachlor, 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 metolachlor except potatoes, soybeans and peanuts and to determine that
all uses of metolachlor except potatoes, soybeans and peanuts can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products, except those registered for use on potatoes, soybeans and
peanuts, containing metolachlor as the active ingredient are eligible for reregistration.
EPA is unable to make an eligibility determination for the potato, soybean and peanut uses
at this time because under current policies these uses need section 409 tolerances and such
tolerances may be barred by the Delaney Clause. Additionally, EPA is in the process of
evaluating legal challenges to its policies related to the coordination of actions under
section 409's Delaney Clause and FFDCA section 408 and FIFRA. Refer to the
discussion under "Tolerance Reassessment." The reregistration of particular products is
addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data and the data identified in Appendix B. Although the Agency has found
that all uses of metolachlor except potatoes, soybeans, and peanuts, are eligible for
reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of
products containing metolachlor, if new information comes to the Agency's attention or if
the data requirements for registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient metolachlor, the
Agency has sufficient information on the health effects of metolachlor and on its potential
for causing adverse effects in aquatic organisms, wildlife and the environment. The
Agency concludes that products containing metolachlor for all uses except potatoes,
38
-------
soybeans and peanuts are eligible for reregistration.
The Agency has determined that metolachlor products, labeled and used as specified in
this Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects
to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of metolachlor except potatoes,
soybeans and peanuts are eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for metolachlor.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
Tolerances Listed Under 40 CFR section 180.368(a)
The tolerances listed in 40 CFR 180.368(a) are for the combined residues (free and
bound) of the herbicide metolachlor [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-l-
methylethyl)acetamide] and its metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-l-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound.
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR 180.368(a) for: almonds, hulls; cabbage; corn, field, forage; corn, field, fodder;
corn, field, grain; sunflower, seed; peppers, bell; potatoes; sorghum, fodder (milo); sorghum,
forage (milo); sorghum, grain (milo); stone fruits group; peas and associated vine and hay
commodities; beans and associated forage and hay commodities; soybeans; soybeans, forage;
and soybeans, hay; and tree nuts group.
Certain analytical data submitted to support the established tolerances listed in 40 CFR
180.368(a) were generated by Craven laboratories. The Agency has evaluated the impact of
these data and has determined that sufficient non-Craven data are available to support
extensions of the existing tolerances on an interim basis until the Craven data are replaced.
Craven replacement data are still needed for: corn, sweet (K + CWHR); cotton, seed
(postemergence use only); peanuts; peanuts, hay; peanuts, vines; peanuts, hulls (EC
formulation at layby); safflower, seed (processing data).
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR 180.368(a) for eggs; milk; the fat, kidney, liver, meat and meat byproducts of
39
-------
cattle, goats, hogs, horses, sheep; and the fat, liver, meat and meat byproducts of poultry.
The dietary burden to livestock has been recalculated based on the reassessed tolerances for
metolachlor in livestock feeds and the residues reported in the livestock feeding studies
adjusted for losses in frozen storage.
So that the commodity definitions listed in 40 CFR 180.368(a) will be in accordance with
the definitions in the Commodity Index Report dated 10/28/92, the tolerances should be
revoked for: "corn, forage and fodder; (8.0 ppm); "peanut, forage and hay" (30.0 ppm);
"sorghum, forage and fodder" (2.0 ppm), and "soybeans, forage and hay" (8.0 ppm).
Separate tolerances should be established in 40 CFR 180. 368(a) for: "corn, field, forage"
(8.0 ppm); "corn, field, fodder" (8.0 ppm); "peanuts, hay" (30.0 ppm); "sorghum, fodder
(milo)" (2.0 ppm); and "sorghum, forage (milo)" (2.0 ppm). The tolerances for "seed and
pod vegetables (except soybeans)" (0.3 ppm) should be revoked, and separate tolerances
should be established for "beans, dry" (0.1 ppm), "beans, succulent" (0.5 ppm); "peas, dry"
(0.1 ppm) and "peas, succulent" (0.5 ppm). In addition, tolerances for legume vegetable
group foliage (except soybean forage and soybean hay) should be replaced with tolerances of 3
ppm for beans, forage, and beans, hay; and with a tolerance of 15 ppm for peas, vines and 2
ppm for peas, hay.
Certain other commodity definitions listed in 40 CFR 180.368(a) are not in accordance
with the definitions in the Commodity Index Report dated 10/28/92; see summary table below
for additional modifications in commodity definitions.
Tolerances Listed Under 40 CFR 180.368(b)
The tolerances listed in 40 CFR 180.368(b) are for the combined residues (free and
bound) of the herbicide metolachlor [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-l-
methylethyl)acetamide] and its metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-l-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound, when present in the raw agricultural
commodities listed in 40 CFR 180.368(b) as a result of the application of metolachlor to
growing crops listed in 40 CFR 180.368(a). (Rotational crops)
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR 180.368(b) for: the straw, forage, and grain of barley, buckwheat, oats, rice, rye,
and wheat.
Certain analytical data submitted to support the established tolerances listed in 40 CFR
180.368(b) were generated by Craven laboratories. The Agency has evaluated the impact of
these data and has determined that sufficient non-Craven data are available to support
extensions of the existing tolerances on an interim basis until the Craven data are replaced for
non-grass animal feeds group. The non-Craven replacement data for alfalfa and clover (non-
grass animal feeds group) have been received and screened. The screen indicates that current
tolerances will not be exceeded.
40
-------
So that the commodity definitions listed in 40 CFR 180.368(b) will be in accordance with
the definitions in the Commodity Index Report dated 10/28/92, the tolerances should be
revoked for: "millet, fodder" (0.5 ppm); "millet, forage" (0.5 ppm); "milo, fodder" (0.5
ppm); "milo, forage" (0.5 ppm); and "milo, grain" (0.1 ppm). The definitions for millet
forage and fodder have been deleted from the Commodity Index Report, and do not appear in
Table II of Subdivision 0. The definitions for milo will be covered under 40 CFR 180.368(a)
as: "sorghum, fodder (milo)" (2.0 ppm); "sorghum, forage (milo)" (2.0 ppm); and
"sorghum, grain" (0.3 ppm).
Tolerances Listed Under 40 CFR 180.368(c):
The tolerances with regional registration as defined in section 180.1(n) listed in 40 CFR
180.368(c) are for the combined residues (free and bound) of the herbicide metolachlor [2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-l-methylethyl)acetamide] and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-l-propanol and
4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent
compound.
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR 180.368(c) for peppers, chili; peppers, Cubanelle; and peppers, tabasco.
The established tolerance listed in 40 CFR 180.368(c) for "peppers, tabasco" (.5 ppm),
should include a leading zero (0.5 ppm).
New Tolerances Needed:
Food/feed additive tolerances are needed for the following processed commodities:
"potatoes, dry peel" (4.0 ppm); "potatoes, wet peel" (0.5 ppm); "potatoes, granules" (0.5
ppm); and "potatoes, waste from processing" (4.0 ppm), and soybean hulls (0.4 ppm).
Peanuts will likely need a 409 tolerance once the Craven replacment data are submitted and
the data are reviewed.
These tolerances may be barred by the requirement in FFDCA section 409's Delaney
Clause barring the establishment of a tolerance for any substance found to induce cancer in
man or animal. EPA policies concerning when section 409 tolerances are necessary are being
reevaluated by the Agency in light of challenges questioning their legality. The Agency is
unable to make a reregistration eligibility decision on the potato, soybean and peanut uses of
metolachlor until a decision on these challenges has been reached.
41
-------
TOLERANCE REASSESSMENT SUMMARY
„ , Current r
Commodity ,
(PP
Almond hulls 0
Cabbage 1
"olerance Tolerance
m) Reassessment (ppm)
Tolerances listed under 180. 368 (a)
3 0.3
0 1.0
Comment/ Correct
Commodity Definition
Almonds, hulls
Cattle, fat 0.02 0.02
Cattle, kidney 0
2 0.2
Cattle, liver 0.05 0.05
Cattle, meat 0.02 0.05
Cattle, mbyp (except 0.02 0.05
kidney and liver)
Corn, fresh (inc. sweet K 0
+ CWHR)
Corn, forage and fodder 8
Corn, grain 0
Cottonseed 0
1 TBD
To be determined
0 Revoke and establish
separate tolerances at
8.0 ppm
1 0.1
1 TBD
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Cattle, mbyp (exc.
liver and kidney)
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Corn, sweet (K + CWHR)
Corn, field, forage
and
Corn, field, fodder
Corn, field, grain
Cotton, seed
Eggs 0.02 0.02
Goats, fat 0.02 0.02
Goats, kidney 0
2 0.2
Goats, liver 0.05 0.05
Goats, meat 0.02 0.05
Goats, mbyp (except 0.02 0.05
kidney and liver)
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Goats, mbyp (exc.
liver and kidney)
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Hogs, fat 0.02 0.02
Hogs, kidney 0
2 0.2
Hogs, liver 0.05 0.05
Hogs, meat 0.02 0.05
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
42
-------
1 Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct 1
Commodity Definition \
Hogs, mbyp (except kidney
and liver)
Horses, fat
Horses, kidney
Horses, liver
Horses, meat
Horses, mbyp (except
kidney and liver)
Legume vegetables group
foliage (except soybean
forage and soybean hay)
Milk
Peanuts
Peanut, forage and hay
0.02
0.05
0.02
0.2
0.05
0.02
0.02
15.0
0.02
0.5
30.0
0.02
0.2
0.05
0.05
0.05
Revoke and establish
separate tolerances at 3
ppm for beans, forage; 3
ppm beans, hay; 15 ppm
for peas, vines; and 2
ppm for beans, hay
0.02
TBD1
TBD1
Hogs, mbyp (exc.
liver and kidney)
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Horses, mbyp (exc.
liver and kidney)
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
beans, forage
beans, hay
peas, vines
peas, hay
Peanuts, hay
peanuts, vines and peanut forage
are no longer regulated
commodities
Peanut, hulls
Peppers, bell
Potatoes
Poultry, fat
Poultry, liver
Poultry, meat
Poultry, mbyp (except
liver)
Safflower seed
Seed and pod vegetables
(except soybeans)
6.0
0.1
0.2
0.02
0.05
0.02
0.02
0.1
0.3
TBD1
0.1
0.21
0.02
0.05
0.05
0.05
0.1
Revoke and establish
separate tolerances at
0.1 ppm beans, dry;
0.5 ppm for beans,
succulent; 0.1 ppm for
peas, dry; and 0.5 ppm
for pea, succulent
Peanuts, hulls
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Safflower, seed
Beans, dry;
Beans, succulent;
Peas, dry,
and
Peas, succulent
43
-------
1 Commodity
Sheep, fat
Sheep, kidney
Sheep, liver
Sheep, meat
Sheep, mbyp (except
kidney and liver)
Sorghum, forage and
fodder
Sorghum, grain
Soybeans
Soybeans, forage and hay
Stone fruits group
Tree nuts group
Current Tolerance
(ppm)
0.02
0.2
0.05
0.02
0.02
2.0
0.3
0.2
8.0
0.1
0.1
Tolerance
Reassessment (ppm)
0.02
0.2
0.05
0.05
0.05
Revoke and establish
separate tolerances at
2.0 ppm
0.3
0.21
8.01
0.1
0.1
Comment/Correct 1
Commodity Definition \
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Sheep, mbyp (exc.
liver and kidney)
Changes necessary to correct for
losses in frozen storage and 50%
radiovalidation in plants.
Sorghum, fodder (milo)
and
Sorghum, forage (milo)
Sorghum, grain (milo)
Soybeans, forage
and
Soybeans, hay
Tolerances listed under 180. 368(b)
Barley, fodder
Barley, forage
Barley, grain
Buckwheat, fodder
Buckwheat, forage
Buckwheat, grain
Millet, fodder
Millet, forage
Millet, grain
Milo, fodder
0.5
0.5
0.1
0.5
0.5
0.1
0.5
0.5
0.1
0.5
0.5
0.5
0.1
0.5
0.5
0.1
Revoke
Revoke
0.1
Revoke
Barley, straw
Buckwheat, straw
Commodity not listed in
Subdivision 0, Table II, and
deleted from Commodity Index
Report
Commodity not listed in
Subdivision 0, Table II, and
deleted from Commodity Index
Report
Covered under
Milo, forage
0.5
Revoke
"Sorghum, fodder (milo)"
Covered under
"Sorghum, forage (milo)"
44
-------
1 Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct 1
Commodity Definition \
Milo, grain
Nongrass animal feeds
(forage, fodder, straw, and
hay) group
Oats, fodder
Oats, forage
Oats, grain
Rice, fodder
Rice, forage
Rice, grain
Rye, fodder
Rye, forage
Rye, grain
Wheat, fodder
Wheat, forage
Wheat, grain
0.1
3.0
0.5
0.5
0.1
0.5
0.5
0.1
0.5
0.5
0.1
0.5
0.5
0.1
Revoke
TBD
0.5
0.5
0.1
0.5
0.5
0.1
0.5
0.5
0.1
0.5
0.5
0.1
Covered under
"Sorghum, grain (milo)"
Non-grass animal feeds group
Oats, straw
Rice, straw
Rye, straw
Wheat, straw
Tolerances listed under 180.368(c)
Peppers, chili
Peppers, Cubanelle
Peppers, tabasco
0.5
0.1
.5
0.5
0.1
0.5
Food and Feed Additive Tolerances Needed1
potatoes, dry peel
potatoes, granules
potatoes, waste from
processing
potatoes, wet peel
peanuts, meal
soybeans, hulls
4.0
0.5
4.0
0.5
cannot be determined,
additional data are
needed for peanuts, to
replace Craven data
0.4
Delaney issues may prevent establishment of these tolerances.
Codex Harmonization
45
-------
No maximum residue limits (MRLs) for metolachlor have been established by
Codex for any agricultural commodity. Therefore, no questions of compatibility exist
with respect to U.S. tolerances.
2. Rotational Crop Restriction
Metolachlor labels must prohibit planting any crop not specified on the label,
unless all appropriate rotational crop tolerances are established.
3. Reference Dose
The reference dose for metolachlor was determined to be 0.1 mg/kg /day based
on the chronic feeding study with dogs in which the NOEL was 9.7 mg/kg/day an
uncertainty factor of 100 was used.
4. Cancer Risk Assessment
The 1991 HED Peer Review Committee recommended that metolachlor be
classified as a Group C (possible human) carcinogen, with a Qx* of 9.2 x 103
(mg/kg/day) *). The classification of Group C was based on increases in liver tumors
in the female rat, by both pair-wise and trend analysis and the replication of the finding
of tumors in the female rat in a second study. However, the Peer Review conducted
July 27, 1994, recommended an MOE approach since there was no supportable
mutagenicity concern and in light of new information on the relative metabolism of
metolachlor, quinone imine is presumed to be the ultimate carcinogen for 2,6-
dimethylaniline.
5. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse impacts on
endangered and threatened species and to implement mitigation measures that will
eliminate the adverse impacts. The program would require use restrictions to protect
endangered and threatened species at the county level. Consultations with the Fish and
Wildlife Service may be necessary to assess risks to newly listed species or from
proposed new uses. In the future, the Agency plans to publish in the Federal Register
a description of the program and have available enforceable county-specific bulletins.
Because the Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through the RED. Rather,
any requirements for product use modifications will occur in the future under the
Endangered Species Protection Program.
6. Environmental Hazard Statements
46
-------
Certain environmental hazard statements are required for metolachlor products
because of the potential risk to non-target plants. Specific language is found in Section
V of this document.
7. Restricted Use Classification
Metolachlor is not currently classified as a restricted use pesticide. The Agency
has determined that metolachlor products should not be classified as "restricted use" at
this time. However, once the Restricted Use Rule for Ground Water is finalized,
metolachlor will be considered a candidate for classification as restricted use for
groundwater concerns. The eligibility determination made at this time is based upon a
presumption that registrations will conform to all applicable regulatory conditions
included in the final restricted use rule for groundwater.
8. State Management Plan Candidate
Since metolachlor has been detected in ground water as a result of normal
agricultural use, the Agency will consider metolachlor as a candidate for state
management plans when the State Management Plan rule is promulgated. EPA is
proposing regulations that currently: 1) designate five pesticides, one of which is
metolachlor, to be subject to EPA-approved State Management Plans (SMPs) as a
condition of their legal sale and use; and 2) establish these SMPs as an "other
regulatory restriction" by specifying procedures and criteria for SMP development,
review and approval, as provided under the Federal Insecticide, Rodenticide and
Fungicide Act (FIFRA) Section 3(d). In proposing these individual pesticides to be
subject to SMPs, EPA has determined that these pesticides may pose an unreasonable
adverse effect to the environment by their ground-water contamination potential, in the
absence of effective local management measures provided in a State plan. Any uses of
metolachlor allowed pursuant to the final rule will be predicated on a finding that such
uses will not pose unreasonable adverse effects on the environment when used pursuant
to the conditions contained in the rule. Upon promulgation of this rule, the labels for
pesticide products containing metolachlor may need to be changed to require use in
accordance with an EPA-approved SMP, and to prohibit sale and use in those States
without such an EPA-approved SMP, after a period (to be established in the rule)
allowed for development and approval of these State plans. The eligibility
determination made at this time is based upon a presumption that registrations will
conform to all applicable requirements of the final regulation addressing this issue.
9. Groundwater Advisory
Current metolachlor labels have a ground water advisory statement. This
statement must be modified to reflect current advisory language. Specific language is
found in Section V of this document.
47
-------
10. Surface Water Advisory
Since metolachlor can contaminate surface water through ground spray drift and
run-off, a surface water advisory is required. Specific language is found in Section V
of this document.
11. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional
Offices and State Lead Agencies for pesticide regulation to develop the best spray drift
management practices. The Agency is now requiring interim measures that must be
placed on product labels/labeling as specified in Section V. Once the Spray Drift Task
Force completes their studies, submits data, and the Agency evaluation is completed,
there may be further refinements in spray drift management practices.
12. Occupational/Residential Labeling Rationale/Risk Mitigation
a. Compliance with Worker Protection
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective equipment,
restricted entry intervals, etc.) to be specified on the label of all products that contain
uses within the scope of the WPS. Uses within the scope of the WPS include all
commercial (non-homeowner) and research uses on farms, forests, nurseries, and
greenhouses to produce agricultural plants (including food, feed, and fiber plants,
trees, turf grass, flowers, shrubs, ornamentals, and seedlings). Uses within scope
include not only uses on plants, but also uses on the soil or planting medium the plants
are (or will be) grown in.
At this time some of the registered uses of metolachlor are within the scope of
the Worker Protection Standard for Agricultural Pesticides (WPS) and some uses are
outside the scope of the WPS. Those that are outside the scope of the WPS include
use:
• on plants grown for other than commercial or research purposes, which
may include plants in habitations, home fruit and vegetable gardens, and
home greenhouses,
• on plants that are in ornamental gardens, parks, golf courses, and public
or private lawns and grounds and that are intended only for decorative
or environmental benefit. (However, pesticides used on sod farms ARE
covered by the WPS).
• in a manner not directly related to the production of agricultural plants,
48
-------
including, for example, control of vegetation along rights-of-way, in
hedgerows and fencerows and in other noncrop areas.
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with the
labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the Worker
Protection Standard (WPS), and PR Notice 93-11, "Supplemental Guidance for PR
Notice 93-7, which reflect the requirements of EPA's labeling regulations for worker
protection statements (40 CFR part 156, subpart K). These labeling revisions are
necessary to implement the Worker Protection Standard for Agricultural Pesticides (40
CFR part 170) and must be completed in accordance with, and within the deadlines
specified in, PR Notices 93-7 and 93-11. Unless otherwise specifically directed in this
RED, all statements required by PR Notices 93-7 and 93-11 are to be on the product
label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by the primary registrant or any
supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by any person.
Personal Protective Equipment (PPE) and Engineering Controls for Handlers (Mixer/
Loader/Applicators)
Occupational-Use Products (WPS and NonWPS Uses)
At this time some of the registered uses of metolachlor are within the scope of
the Worker Protection Standard for Agricultural Pesticides (WPS) and some are
outside the scope of the WPS. The PPE requirements will pertain to both the WPS and
nonWPS uses by occupational handlers, since the potential exposure to occupational
handlers is similar for WPS and nonWPS uses.
For each end-use product, PPE requirements for pesticide handlers will be set
during reregistration in one of two ways:
1. If the Agency has no special concerns regarding other adverse effects of an
active ingredient, the PPE for pesticide handlers will be established based on the acute
toxicity of the end-use product. For occupational-use products, PPE will be
established using the process described in PR Notice 93-7 or more recent EPA
guidelines.
49
-------
2. If the Agency has special concerns about an active ingredient due to very high
acute toxicity or certain adverse effects, such as allergic effects or other effects
(cancer, developmental toxicity, reproductive effects, etc):
• In the RED document for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE requirements that pertain
to all or most occupational end-use products containing that active
ingredient.
• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of each end-use
product.
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product acute toxicity of each end-use product.
For granular metolachlor formulations, the MOE's were calculated as being
acceptable for loaders and applicators without additional active-ingredient-based
personal protective equipment.
For liquid (emulsifiable concentrate) there are special risk concerns (Group C
carcinogen and systemic toxicity for intermediate exposure) that warrant the
establishment of active-ingredient-based minimum PPE requirements for handlers of
liquid (emulsifiable concentrate) metolachlor formulations. The MOE's were
calculated as being acceptable for (1) occupational mixers/loaders of liquid
formulations to support ground application and (2) occupational applicators and
flaggers exposed during applications of the liquid formulation using the assumption that
coveralls over a short-sleeved shirt and short pants and chemical-resistant gloves were
worn. The use of PPE was not sufficient to reduce the MOE's to an acceptable level
for mixers and loaders using open mixing systems to support aerial applications.
Those MOE's were acceptable only with the use of closed mixing systems.
Handler PPE for Homeowner-Use Products
At this time some products containing metolachlor are intended primarily for
homeowner use. EPA is not establishing minimum (baseline) handler PPE for
metolachlor end-use products that are intended primarily for homeowner use, since the
Agency anticipates that the frequency, duration, and degree of exposure by such users
do not warrant the risk mitigation measures imposed for occupational handlers.
Personal protective equipment, if appropriate, will be established based on the acute
toxicity of the end-use product.
Postapplication/Entry Restrictions
50
-------
Occupational-Use Products (WPS Uses)
Restricted-Entry Interval: Under the Worker Protection Standard (WPS),
interim restricted entry intervals (REI) for all uses within the scope of the WPS are
established on the basis of the acute toxicity of the active ingredient. The toxicity
categories of the active ingredient for acute dermal toxicity, eye irritation potential,
and skin irritation potential are used to determine the interim WPS REI. If one or
more of the three acute toxicity effects are in toxicity category I, the interim WPS REI
is established at 48 hours. If none of the acute toxicity effects are in category I, but
one or more of the three is classified as category II, the interim WPS REI is established
at 24 hours. If none of the three acute toxicity effects are in category I or II, the
interim WPS REI is established at 12 hours. A 48-hour REI is increased to 72 hours
when an organophosphate pesticide is applied outdoors in arid areas. In addition, the
WPS specifically retains two types of REI's established by the Agency prior to the
promulgation of the WPS: product-specific REI's established on the basis of adequate
data and interim REI's that are longer than those that would be established under the
WPS.
For occupational end-use products containing metolachlor as an active
ingredient, EPA is establishing a 24-hour restricted-entry interval for each use of the
product that is within the scope of the Worker Protection Standard for Agricultural
Pesticides (WPS). The basis for this recommendation is that metolachlor has a
toxicological endpoint of concern for systemic toxicity for intermediate exposures and
also is classified as a Group C carcinogen. EPA notes that the WPS places very
specific restrictions on entry during restricted-entry intervals when that entry involves
contact with treated surfaces. EPA believes that these existing WPS protections are
sufficient to mitigate post-application exposures of workers who contact surfaces
treated with metolachlor.
The WPS REI in effect until now was 12 hours. The WPS REI was established
through labeling modifications specified in PR Notice 93-7, which implemented the
labeling requirements of the 1992 Worker Protection Standard for Agricultural
Pesticides.
For those uses of metolachlor that are incorporated into the soil, EPA notes that
if metolachlor has been correctly incorporated, the WPS permits workers to enter the
treated area during the restricted-entry interval without personal protective equipment
or any other restriction if they are performing tasks that do not involve contact with the
soil subsurface.
Early Entry PPE: The WPS establishes very specific restrictions on entry by
workers to areas that remain under a restricted-entry by workers if the entry involves
contact with treated surfaces. Among those restrictions are a prohibition of routine
entry to perform hand labor tasks and requirement that personal protective equipment
51
-------
be worn. Personal protective equipment requirements for persons who must enter
areas that remain under a restricted-entry interval are based on the toxicity concerns
about the active ingredient. The requirements are set in one of two ways.
1. If the Agency has no special concerns about the acute or other adverse
effects of an active ingredient, it establishes the early-entry PPE requirements
based on the acute dermal toxicity, skin irritation potential, and eye irritation
potential of the active ingredient.
2. If the Agency has special concerns about an active ingredient due to very
high acute toxicity or to certain other adverse effects, such as allergic effects,
cancer, developmental toxicity, or reproductive effects, it may establish early-
entry PPE requirements that are more stringent than would be established
otherwise.
EC Formulations: There are special concerns about emulsifiable concentrate
formulations of metolachlor (Group C carcinogen and systemic toxicity) and the
MOE's for handlers were marginal. Therefore, for early entry following applications
of the emulsifiable concentrate, EPA is establishing PPE for dermal protection that is
more stringent than the PPE that would otherwise be established based on the acute
toxicity of the active ingredient. Since metolachlor is classified as category IV for eye
irritation potential, protective eyewear is not required.
Granular Formulations There are no special concerns about the granular
formulation of metolachlor, since the MOE's for handlers were high. The PPE
required for early entry following applications of granular formulation is the minimum
early-entry PPE allowed by the Worker Protection Standard for Agricultural
Pesticides. Since metolachlor is classified as category IV for eye irritation potential,
protective eyewear is not required.
Occupational Use Products (nonWPS Uses)
At this time some registered uses of metolachlor are outside the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS). The Agency is
establishing entry restrictions for all nonWPS occupational uses of metolachlor end-use
products. For specific language refer to Section V of this document.
Homeowner Use Products (nonWPS Uses)
At this time some products containing metolachlor are intended primarily for
homeowner use. EPA is concerned about post-application exposures to homeowners
following application of metolachlor. For specific language, refer to Section V of this
document.
52
-------
Additional Labeling Requirements
The Agency is requiring additional labeling statements to be located on all end-
use products containing metolachlor that are primarily for occupational use. For the
specific labeling statements, refer to Section V of this document.
13. Ground-Water Protection Requirements
The "Pesticides in Ground Water Data Base 1992" indicates that residues of
metolachlor have been detected in wells in 20 states. Levels exceeded the Health
Advisory level of 100 ppb in a total of 3 wells located in Wisconsin, New York, and
Montana. In five other states concentrations in well water exceeded 10% of the HAL.
A recent 6 (a) (2) report submitted by the registrant indicates metolachlor residues in one
well that also exceed the HAL. Because of these detections, the Agency is concerned
about the degradation of water quality that may occur in metolachlor use areas.
Because of the widespread use of metolachlor and the detections in many states, the
Agency is requiring two small scale prospective ground-water studies to determine
metolachlor's impact on ground-water quality. In addition, metolachlor is part of a 19-
state atrazine monitoring program. Data on metolachlor from this program have and
are being made available to the Agency. The registrant will submit a full report of all
metolachlor analyses from this program which is scheduled for completion in 1995.
The Agency is also requiring label statements to further reduce the risk of
contamination posed by practices involved in the mixing and loading of metolachlor.
These label statements are already found on some metolachlor labels. These
statements are found in Section V.
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 metolachlor for the above
eligible uses has been reviewed and determined to be substantially complete for all uses.
As noted, additional data have been recently required in Data Call-In Notices (12/10/93,
2/15/94 and 5/10/94). Also, additional confirmatory data are needed to fulfill
requirements for the studies listed below:
Foliar Residue Dissipation (132-la) - for use on residential turf
Dermal Passive Dosimetry Exposure (133-3) - for use on residential turf
53
-------
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP) labeling
must be revised to comply with all current EPA regulations, PR Notices and applicable
policies. The MP labeling must bear the following statement under Directions for Use:
"Only for formulation into a herbicide for the following uses(s):
(fill blank only with those uses that are being supported by MP registrant)."
An MP registrant may, at his/her discretion, add one of the following statements
to an MP label under "Directions for Use" to permit the reformulation of the product
for a specific use or all additional uses supported by a formulator or user group:
(a) "This product may be used to formulate products for specific use(s) not listed
on the MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding the support of such uses(s)."
(b) "This product may be used to formulate products for any additional use(s) not
listed on the MP label if the formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding the support of such uses(s)."
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.
2. Labeling Requirements for End-Use Products
a. Occupational/Residential Labeling
(1) Personal Protective Equipment Requirements for Pesticide
54
-------
Handlers (mixers, loaders, applicators, etc);
Sole-active-ingredient end-use products that contain metolachlor must be revised to adopt
the handler personal protective equipment requirements set forth in this section. Any
conflicting PPE requirements on their current labeling must be removed.
Multiple-active-ingredient end-use products that contain metolachlor must compare the
handler personal protective equipment requirements set forth in this section to the PPE
requirements on their current labeling and retain the more protective. For guidance on which
PPE is considered more protective, see PR Notice 93-7.
• Handler PPE for Occupational-Use Products (products NOT
intended primarily for home use — (see tests in PR Notice 93-7 and 93-11):
Minimum (Baseline) Personal Protective Equipment Requirements:
Some of the registered uses of metolachlor are within the scope of the Worker Protection
Standard for Agricultural Pesticides (WPS) and some are outside the scope of the WPS. The
minimum (baseline) PPE requirements pertain to both the WPS and nonWPS uses by
occupational handlers, since the potential exposure to occupational handlers is similar for
WPS and nonWPS uses.
Granular Formulations: The Agency is establishing no minimum (baseline) PPE
for WPS and nonWPS uses of metolachlor end-use products that are formulated as
granules.
EC Formulations: The minimum (baseline) PPE for all WPS and nonWPS
occupational uses of metolachlor end-use products formulated as a liquid is:
• Products NOT Intended Primarily For Home Use: The personal
protective equipment (PPE) requirement for pesticide handlers on all end-use products, except
products intended primarily for home use (see tests in PR Notice 93-7 and 93-11), is:
"Applicators and other handlers must wear:
—Coveralls over short-sleeved shirt and short pants
—Chemical-resistant gloves (see instructions * below)
—Chemical-resistant footwear plus socks
—Chemical-resistant headgear for overhead exposure
—Chemical-resistant apron when cleaning equipment, mixing, or loading" (see instructions
** below)
* The glove statement for metolachlor is the statement established through the instructions
in Supplement Three of PR Notice 93-7.
** The words "mixing, or loading" may be removed if the product is formulated as "ready-
to-use."
55
-------
Actual End-Use Product Personal Protective Equipment Requirements: The PPE that would
otherwise be established based on the acute toxicity of each end-use product must be
compared to the minimum (baseline) personal protective equipment, if any, specified above.
The more protective PPE must be placed on the product labeling. For guidance on which
PPE is considered more protective, see PR Notice 93-7.
Placement in Labeling: The personal protective equipment must be placed on the end-use
product labeling in the location specified in PR Notice 93-7 and the format and language of
the PPE requirements must be the same as is specified in PR Notice 93-7.
• Products Intended Primarily for Homeowner Use: EPA is not
establishing minimum (baseline) handler PPE for metolachlor end-use products that are intended
primarily for homeowner use. Personal protective equipment, if appropriate, will be established
based on the acute toxicity of the end-use product.
Placement in Labeling: The personal protective equipment requirements, if any, must be
placed on the end-use product labeling immediately following the precautionary statements in the
labeling section "Hazards to Humans (and domestic animals)."
(2) Entry Restrictions; Labeling
Sole-active-ingredient end-use products that contain metolachlor must be revised to adopt
the entry restrictions set forth in this section. Any conflicting entry restrictions on their
current labeling must be removed.
Multiple-active-ingredient end-use products that contain metolachlor 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."
• Occupational-Use Products (Products NOT Intended Primarily
For Home Use):
-Uses Within the Scope of the WPS:
Restricted-Entry Interval: A 24-hour restricted entry interval (REI) is required for uses
within the scope of the WPS (see PR Notice 93-7) on all end-use products (see tests in PR
Notices 93-7 and 93-11). This REI must be inserted into the standardized REI statement
required by Supplement Three of PR Notice 93-7.
Early-Entry Personal Protective Equipment (PPE):
EC Formulations: The PPE required for early entry following applications of the
emulsifiable concentrate is:
56
-------
—coveralls over short-sleeve shirt and short pants,
—chemical-/resistant gloves,
—chemical-resistant footwear plus socks,
—chemical-resistant headgear for overhead exposures.
Granular Formulations: The PPE required for early entry following applications
of granular formulation is:
—coveralls,
—chemical-resistant gloves,
—shoes plus socks.
Placement in Labeling: The REI must be inserted into the standardized REI statement
required by Supplement Three of PR Notice 93-7. The PPE required for early entry must
be inserted into the standardized early entry PPE statement required by Supplement Three
of PR Notice 93-7.
-Uses Not Within the Scope of the WPS:
For liquid applications:
"Do not enter or allow others to enter the treated area until sprays have dried."
For granular applications:
"Do not enter or allow others to enter the treated area until dusts have settled. If
soil incorporation is required following the application, do not enter or allow
others to enter the treated area (except those persons involved in the incorporation)
until the incorporation is complete. If the incorporation is accomplished by
watering-in, do not enter or allow others to enter the treated area until the surface
is dry following the watering-in."
Placement in Labeling:
If WPS uses are also on label: Follow the instructions in PR Notice 93-7 for establishing
a Non-Agricultural Use Requirements box and place the appropriate nonWPS entry
restriction in that box.
If no WPS uses are on label: Add the appropriate nonWPS entry restriction to the labels
of all end-use products, except products primarily intended for homeowner use, in a
section in the Directions For Use with the heading: "Entry Restrictions:"
Products Primarily Intended for Home Use:
For liquid applications:
57
-------
"Do not enter or allow others to enter the treated area until sprays have dried."
For granular applications:
"Do not enter or allow others to enter the treated area until dusts have settled. If
soil incorporation is required following the application, do not enter or allow
others to enter the treated area (except those persons involved in the incorporation)
until the incorporation is complete. If the incorporation is accomplished by
watering-in, do not enter or allow others to enter the treated area until the surface
is dry following the watering-in."
Placement in Labeling: Add the entry restriction to the labels of products primarily
intended for homeowner use in a section in the Directions For Use with the heading:
"Entry Restrictions:"
(3) Other Labeling Requirements
The Agency is requiring the following statements to be located on all
metolachlor end-use product labeling intended primarily for occupational use:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area during
application."
Engineering Controls:
"Mixers and loaders supporting aerial applications are required to use closed
systems. The closed system must be used in a manner that meets the requirements
listed in the Worker Protection Standard (WPS) for agricultural pesticides (40 CFR
170.240(d)(4). When using the closed system, the mixers' and loaders' PPE
requirements may be reduced or modified as specified in the WPS."
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that
meets the requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides (40 CFR 170.240(d) (4-6), the handler PPE requirements
may be reduced or modified as specified in the WPS."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables, use detergent and hot water. Keep and wash PPE
separately from other laundry."
58
-------
User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
• "Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Skin Sensitizer Statement:
In addition, because metolachlor is classified as a skin sensitizer, EPA is requiring
the following statement in the "Hazards to Humans (and Domestic Animals)"
section of the Precautionary Statements on the labeling of all end-use products
containing metolachlor:
"This product may cause skin sensitization reactions in some people."
Soil Incorporation Statement:
Registrants may add the following statement to their labeling in the Agricultural
Use Requirements box immediately following the restricted entry interval:
"Exception: if the product is soil-incorporated, the Worker Protection Standard,
under certain circumstances, allows workers to enter the treated area if there will
be no contact with anything that has been treated."
b. Environmental Hazards Statements
Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high-water mark. Do not contaminate water when
disposing of equipment wash water or rinsate.
General information section of label:
"Do not apply under conditions which favor runoff or wind erosion of soil
containing this product to non-target areas."
To prevent off-site movement due to run-off or wind erosion:
59
-------
"Avoid treating powdery dry or light sand soils when conditions are
favorable for wind erosion. Under these conditions, the soil surface should
first be settled by rainfall or irrigation."
"Do not apply to impervious substrates such as paved or highly compacted
surfaces."
"Do not use tailwater from the first flood or furrow irrigation of treated
fields to treat non-target crops unless at least 1/2 inch of rainfall has
occurred between application and the first irrigation."
c. Rotational Crops Restriction
Do not rotate to food or feed crops other than those listed on this label.
d. Ground Water Labeling/Mitigation; Mixing/Loading
The following label language regarding mixing/loading setbacks must appear in
Precautionary Statements in the Environmental Hazards section of the label:
This product may not be mixed or loaded within 50 ft. of perennial or intermittent
streams and rivers, natural or impounded lakes and reservoirs. This product may not be
mixed/loaded or used within 50 ft. of all wells, including abandoned wells, drainage wells,
and sink holes. Operations that involve mixing, loading, rinsing, or washing of this
product into or from pesticide handling or application equipment or containers within 50
ft. of any well are prohibited unless conducted on an impervious pad constructed to
withstand the weight of the heaviest load that may be positioned on or moved across the
pad. Such a pad shall be designed and maintained to contain any product spills or
equipment leaks, container or equipment rinse or wash-water, and rain water that may fall
on the pad. Surface water shall not be allowed to either flow over or from the pad, which
means the pad must be self-contained. The pad shall be sloped to facilitate material
removal. An unroofed pad shall be of sufficient capacity to contain at a minimum 110%
of the capacity of the largest pesticide container or application equipment on the pad. A
pad that is covered by a roof of sufficient size to completely exclude precipitation from
contact with the pad shall have a minimum containment capacity of 100% of the capacity
of the largest pesticide container or application equipment on the pad. Containment
capacities as described above shall be maintained at all times. The above-specified
minimum containment capacities do not apply to vehicles when delivering pesticide
shipments to the mixing/loading site.
e. Ground Water Advisory
The following ground water advisory language must be placed on all
60
-------
metolachlor labels:
"This chemical is known to leach through soil into ground water under
certain conditions as a result of agricultural use. Use of this chemical in areas
where soils are permeable, particularly where the water table is shallow, may
result in ground-water contamination."
f. Surface Water Advisory
The following surface water advisory language must be placed on all
metolachlor labels:
"Metolachlor can contaminate surface water through ground spray drift.
Under some conditions, metolachlor may also have a high potential for
runoff into surface water (primarily via dissolution in runoff water), for
several months post-application. These include poorly draining or wet soils
with readily visible slopes toward adjacent surface waters, frequently
flooded areas, areas over-laying extremely shallow ground water, areas
with in-field canals or ditches that drain to surface water, areas not
separated from adjacent surface waters with vegetated filter strips, and
areas over-laying tile drainage systems that drain to surface water."
g. Spray Drift Labeling
The following language must be placed on each product label that can be applied
aerially:
Avoiding spray drift at the application site is the responsibility of the applicator.
The interaction of many equipment-and-weather-related factors determine the
potential for spray drift. The applicator and the grower are responsible for
considering all these factors when making decisions.
The following drift management requirements must be followed to avoid off-target
drift movement from aerial applications to agricultural field crops. These
requirements do not apply to forestry applications, public health uses or to
applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not exceed 3/4 the
length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never
be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
61
-------
The applicator should be familiar with and take into account the information
covered in the Aerial Drift Reduction Advisory Information.
The following aerial drift reduction advisory information must be contained in the
product labeling:
[This section is advisory in nature and does not supersede the mandatory label
requirements.]
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The
best drift management strategy is to apply the largest droplets that provide
sufficient coverage and control. Applying larger droplets reduces drift potential,
but will not prevent drift if applications are made improperly, or under
unfavorable environmental conditions (see Wind, Temperature and Humidity, and
Temperature Inversions).
CONTROLLING DROPLET SIZE
• Volume - Use high flow rate nozzles to apply the highest practical spray
volume. Nozzles with higher rated flows produce larger droplets.
• Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets. When
higher flow rates are needed, use higher flow rate nozzles instead of increasing
pressure.
• Number of nozzles - Use the minimum number of nozzles that provide
uniform coverage.
• Nozzle Orientation - Orienting nozzles so that the spray is released parallel
to the airstream produces larger droplets than other orientations and is the
recommended practice. Significant deflection from horizontal will reduce droplet
size and increase drift potential.
• Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce larger
droplets. Consider using low-drift nozzles. Solid stream nozzles oriented straight
back produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of the
62
-------
wingspan or rotor length may further reduce drift without reducing swath width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top of
the largest plants unless a greater height is required for aircraft safety. Making
applications at the lowest height that is safe reduces exposure of droplets to
evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be displaced
downward. Therefore, on the up and downwind edges of the field, the applicator
must compensate for this displacement by adjusting the path of the aircraft upwind.
Swath adjustment distance should increase, with increasing drift potential (higher
wind, smaller drops, etc.)
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many
factors, including droplet size and equipment type determine drift potential at any
given speed. Application should be avoided below 2 mph due to variable wind
direction and high inversion potential. NOTE: Local terrain can influence wind
patterns. Every applicator should be familiar with local wind patterns and how
they affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to produce
larger droplets to compensate for evaporation. Droplet evaporation is most severe
when conditions are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because drift
potential is high. Temperature inversions restrict vertical air mixing, which causes
small suspended droplets to remain in a concentrated cloud. This cloud can move
in unpredictable directions due to the light variable winds common during
inversions. Temperature inversions are characterized by increasing temperatures
with altitude and are common on nights with limited cloud cover and light to no
wind. They begin to form as the sun sets and often continue into the morning.
Their presence can be indicated by ground fog; however, if fog is not present,
inversions can also be identified by the movement of smoke from a ground source
or an aircraft smoke generator. Smoke that layers and moves laterally in a
63
-------
concentrated cloud (under low wind conditions) indicates an inversion, while
smoke that moves upward and rapidly dissipates indicates good vertical air mixing.
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adjacent
sensitive areas (e.g. residential areas, bodies of water, known habitat for
threatened or endangered species, non-target crops) is minimal (e.g. when wind
is blowing away from the sensitive areas).
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 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 metolachlor products
bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons
other than the registrant may distribute or sell such products for 50 months from the date of
the issuance of this RED. Registrants and persons other than registrants remain obligated to
meet pre-existing Agency imposed label changes and existing stocks requirements applicable
to products they sell or distribute.
64
-------
VI. APPENDICES
65
-------
66
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
Appendix A is 63 pages long and is not being included. Copies of Appendix A
are available upon request per the instructions in Appendix D
67
-------
68
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
69
-------
70
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Metolachlor covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Metolachlor 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
0 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.
71
-------
72
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
Oxidizing/Reducing Action
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
40276601
40276601
40276601
40276601
40276601
DATA GAP
40276602
40276602
40276602
N/A
40276602
40276602
40276602
40276602
40276602
40276602
40276602
40276602
40276602
73
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
63-15
63-16
63-17
63-18
63-19
63-20
63-21
64-1
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
Dielectric breakdown volt
Submittal of Samples
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
40276602
40276602
40276602
40276602
40276602
40276602
N/A
N/A
ECOLOGICAL EFFECTS
71-1A
71-1B
71-2A
71-2B
71-3
71-4A
71-4B
71-5A
71-5B
72-1A
72-1B
Acute Avian Oral - Quail/Duck
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Quail
Avian Dietary - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Simulated Field Study
Actual Field Study
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
A,B,C
A,B,C
A,B,C
A,B,C
00062465
N/A
00016425
00016426
N/A
DATA GAP
DATA GAP
N/A
N/A
00018722
N/A
74
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
USE PATTERN
CITATION(S)
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
72-3C
72-3D
72-3E
72-3F
72-4A
72-4B
72-5
72-6
72-7A
72-7B
122-1A
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Estuarine/Marine Toxicity Fish-
TEP
Estuarine/Marine Toxicity Mollusk
-TEP
Estuarine/Marine Toxicity Shrimp
-TEP
Early Life Stage Fish
Life Cycle Invertebrate
Life Cycle Fish
Aquatic Organism Accumulation
Simulated Field - Aquatic
Organisms
Actual Field - Aquatic Organisms
Seed Germination/Seedling
Emergence
A,B,C 00018723
N/A
A,B,C 00015546
N/A
A,B,C 43044602
IN REVIEW
IN REVIEW
N/A
N/A
N/A
A,B,C 47025723
DATA GAP
N/A
N/A
N/A
N/A
N/A
75
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
12 2- IB Vegetative Vigor
122-2 Aquatic Plant Growth
123-1A Seed Germination/Seedling
Emergence
123- IB Vegetative Vigor
123-2 Aquatic Plant Growth
124-1 Terrestrial Field
124-2 Aquatic Field
141-1 Honey Bee Acute Contact
141-2 Honey Bee Residue on Foliage
141-5 Field Test for Pollinators
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-7 Acute Delayed Neurotoxicity - Hen
82-1A 90-Day Feeding - Rodent
82- IB 90-Day Feeding - Non-rodent
USE PATTERN CITATION(S)
N/A
N/A
IN REVIEW
IN REVIEW
IN REVIEW
N/A
N/A
N/A
N/A
N/A
ALL 00015523
ALL 00015526
ALL 00015535
ALL 00015528
ALL 00015530
ALL 00015631
N/A
N/A
A,B 00017690,00032174
76
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
USE PATTERN
CITATION(S)
82-2 21-Day Dermal - Rabbit/Rat
82-3 90-Day Dermal - Rodent A,B
82-4 90-Day Inhalation - Rat
82-5A 90-Day Neurotoxicity - Hen
82-5B 90-Day Neurotoxicity - Mammal
83-1A Chronic Feeding Toxicity - Rodent A,B
83-IB Chronic Feeding Toxicity - Non- A,B
Rodent
83-2A Oncogenicity - Rat A,B
83-2B Oncogenicity - Mouse A,B
83-3A Developmental Toxicity - Rat A,B
83-3B Developmental Toxicity - Rabbit A,B
83-4 2-Generation Reproduction - Rat A,B
84-2A Gene Mutation (Ames Test) ALL
84-2B Structural Chromosomal ALL
Aberration
84-4 Other Genotoxic Effects ALL
85-1 General Metabolism A,B
85-2 Dermal Penetration ALL
86-1 Domestic Animal Safety
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation ALL
41833101
N/A
N/A
N/A
00001563,00042725,00084003,00117597
40980701
00129377,244166
000015634,00042725,00117597
00151941
00041283
00080897
00026712,00026713
00026712,00026713
43244003
40114401
41833102
N/A
41053901
77
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
132- IB Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
231 Estimation of Dermal Exposure at
Outdoor Sites
232 Estimation of Inhalation Exposure
at Outdoor Sites
233 Estimation of Dermal Exposure at
Indoor Sites
234 Estimation of Inhalation Exposure
at Indoor Sites
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
161-4 Photodegradation - Air
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
USE PATTERN CITATION(S)
N/A
DATA GAP
N/A
N/A
N/A
N/A
N/A
N/A
A,B,C 40430201
A,B,C 40430202
A,B,C 40430203
N/A
A,B,C 41309801
A,C 41309801
A,B,C 41185701
N/A
78
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
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
164-5 L°ng Term Soil Dissipation
165-1 Confined Rotational Crop
165-2 Field Rotational Crop
165-3 Accumulation - Irrigated Crop
165-4 Bioaccumulation in Fish
165-5 Bioaccumulation - Aquatic
NonTarget
166-1 Ground Water - Small Prospective
166-2 Ground Water - Small
Retrospective
166-3 Ground Water - Irrigated
Retrospective
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
RESIDUE CHEMISTRY
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
171-4A
Nature of Residue - Plants
A,B
40494602,40494603,40494604,40494605
40494606
N/A
41309802,4148420106,413357016
N/A
N/A
N/A
41470601
N/A
N/A
41154201
N/A
DATA GAP
N/A
RESERVED
RESERVED
42664302
79
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
171-4B
Nature of Residue - Livestock
171-4C Residue Analytical Method - Plants
B
A,B
00015423,00015424,
00015652,00015653,
00022872,00022873,
00022874,00022879,
00022880,00074898,
00074900,40766601
42644301,42652101
00015432,00015466,
00015543,00015698,
00016306,00039176,
00111693,00125227
171-4D Residue Analytical Method -
Animal
A,B
00015432,00015466,
00015543,00015698,
00016306,00039176,
00111693,00125227
171-4E Storage Stability
171-4F Magnitude of Residues - Potable
H2O
171-4G Magnitude of Residues in Fish
171-4H Magnitude of Residues - Irrigated
Crop
171-41 Magnitude of Residues - Food
Handling
A,B
42810601,41506501,41506491,40980702,40980
703
N/A
N/A
N/A
N/A
80
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
N/A
Root and Tuber Vegetables Group
- Potatoes
- Radishes grown for seed
Bulb Vegetables (Allium spp.)
Group
- Onions
Leafy Vegetables (except Brassica
vegetables) Group
- Celery
Brassica (cole) Leafy Vegetables
Group
- Cabbage
Legume Vegetables (succulent or
dried) Group
- Beans (succulent and dried)
- Peas (succulent and dried)
A
A
A
A
A
00105957, 00106191,
00109613
none
43000101
41551201
40644901
00064182, 00128731, 43295701
00064182, 00128731, 43295701
81
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
- Soybeans
- Lupine
Foliage of Legume Vegetables
- Bean vines and hay
- Pea vines and straw
- Soybean forage and hay
A
A
A
A
00015399,
00015401,
00015405,
00015409,
00015541,
00015721,
00015726,
00015735,
00015761,
00015765,
00015769,
00015773,
00015779,
00016604,
00015400,
00015402,
00015406,
00015410,
00015542,
00015722,
00015727,
00015736,
00015762,
00015766,
00015770,
00015774,
00015780,
00039174,
00015403,
00015407,
00015411,
00015706,
00015723,
00015728,
00015737,
00015763,
00015767,
00015771,
00015777,
00016248,
43178401
00015404,
00015408,
00015540,
00015719,
00015725,
00015729,
00015760,
00015764,
00015768,
00015772,
00015778,
00016427,
00128731,
00128731,
00015399,
00015403,
00015542,
00015722,
00015728,
00015733,
00015760,
00015764,
00015768,
00015772,
00015777,
43295701
43295701
00015400,
00015408,
00015706,
00015725,
00015729,
00015734,
00015761,
00015765,
00015769,
00015773,
00039174,
00015401,
00015540,
00015719,
00015726,
00015731,
00015736,
00015762,
00015766,
00015770,
00015774,
43178403
00015402,
00015541,
00015721,
00015727,
00015732,
00015737,
00015763,
00015767,
00015771,
00015775,
82
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
Fruiting Vegetables (except
cucurbits)
Group
- Peppers
Stone Fruits Group
Tree Nuts Group
- Almonds, hulls
Cereal Grains Group
- Barley
- Buckwheat
A
A
A
00150180, 00156573,
40557301
40899301
00131376
00078297
00078297
83
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
- Corn, field and fresh
A
00015428, 00015429, 00015430, 00015570,
00015571, 00015572, 00015586, 00015587,
00015588, 00015589, 00015590, 00015591,
00015592, 00015593, 00015594, 00015595,
00015597, 00015598, 00015599, 00015600,
00015601, 00015602, 00015676, 00015677,
00015678, 00015679, 00015680, 00015681,
00015682, 00015683, 00015684, 00015685,
00015686, 00015687, 00015688, 00015689,
00015690, 00015691, 00015692, 00015693,
00015694, 00015704, 00015705, 00015707,
00015708, 00015709, 00015710, 00015711,
00015712, 00015713, 00015714, 00015715,
00015716, 00015717, 00015718, 00015739,
00015740, 00015741, 00015742, 00015743,
00015744, 00015745, 00015746,
00015747,00015748, 00015749, 00015750,
00015751, 00015752, 00015753, 00015754,
00015755, 00015756, 00015757, 00015786,
00015787, 00015950, 00015954, 00015955,
00016392, 00016393, 00016394, 00016395,
00016396, 00016397, 00016398, 00016399,
00016435, 00016436, 00016437, 43178401
84
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
USE PATTERN
CITATION(S)
- Corn, field and fresh, continued
- Millet
-Milo
- Oats
-Rice
-Rye
- Sorghum
- Wheat
Forage, Fodder, and Straw of
Cereal
Grains Group
- Barley, forage and straw
- Buckwheat, forage and straw
- Corn, forage and fodder
- Millet, forage and straw
- Milo, forage and straw
- Oats, forage and straw
- Rice, forage and straw
- Rye, forage and straw
- Sorghum, forage and fodder
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
43178401
00078297
00078297
00078297
00078297
00078297
00015548, 00015549, 00015550, 00015551,
00015552, 00016607, 00016608, 00016609,
00016610, 00016990, 00016991, 00016992,
00111693
00078297
00078297
00078297
identical to corn grain
00078297
00078297
00078297
00078297
00078297
identical to sorghum grain
85
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT
USE PATTERN
CITATION(S)
171-4L
- Wheat, forage and straw
Grass forage, fodder, and hay
Group
Non-grass Animal Feeds (forage,
fodder, straw, and hay) Group
Miscellaneous Commodities
- Cotton, seed
- Peanuts
- Peanuts, forage and hay
- Peanuts, hulls
- Safflower, seed
Magnitude of the
Residue in Processed Food/Feed
- Beans (succulent and dried)
- Corn, field
- Corn, fresh
- Cotton
- Peanuts
- Potato
- Safflower
- Sorghum, grain
- Sorghum, sweet
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
00078297
43367101
00065048, 00129058, 40980707, 43178402
00015553, 00015554, 00015555, 00015556,
00015557, 43263101
40980705
40980705
40980707
40980708
40980704
86
-------
Data Supporting Guideline Requirements for the Reregistration of METOLACHLOR
REQUIREMENT USE PATTERN CITATION(S)
- Soybeans A 40980706, 41506501
87
-------
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Metolachlor
89
-------
90
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
91
-------
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.
92
-------
BIBLIOGRAPHY
MRID
CITATION
00001563 Parks, W.L.; Miller, W. (1975) Final Report: Evaluation of a Urea Terrazole
Fertilizer at Several Rates on Corn: Report No. 3068. (Unpublished study
received Feb 4, 1977 under 1258-812; prepared by Univ. of Tennessee, Plant
Science Dept., submitted by Olin Corp., Agricultural Div., Little Rock, Ark.;
CDL:095799-I)
00001663 Iwan, G.R. (1976) 01in-14C Terrazole Channel Catfish, Ictalurus
punctatus(Rafinesque), Static Bioaccumulation Study. (Unpublished study
received Oct 20, 1976 under 1258-812; prepared by Union Carbide Corp.,
Aquatic Environmental Sciences, submitted by Olin Corp., Agricultural Div.,
Little Rock, Ark.; CDL:228143-AB)
00015399 Seim, V. (1975) Residue Report: Soybeans: AG-A No. 3268 I,II,III.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:095747-A)
00015400 Peek, J.; Stahlberg, L. (1975) Residue Report: Soybeans: AG-A No. 3466 I,II.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 095747-B)
00015401 Roper, J. (1975) Residue Report: Soybeans: AG-A No. 3523 I,II,III.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:095747-C)
00015402 Juby, M. (1975) Residue Report: Soybeans: AG-A No. 3570 I,II,III.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:095747-D)
00015403 Pruss, S.; Ross, R.H. (1976) Residue Report: Soybeans: AG-A No. 3650 III.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 095747-E)
00015404 Peek, J.; Stahlberg, L. (1976) Residue Report: Soybeans: AG-A No. 3702 III.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 095747-F)
00015405 Shriver, J.; Wendling, C. (1976) Residue Report: Soybeans: AG-A No. 3724
III. (Unpublished study including AG-A nos. 3742 II, 3743 II and 3747 II,
received Jan 19, 1977 under 100-583; prepared in cooperation with Chemagro
93
-------
BIBLIOGRAPHY
MRID
CITATION
and E.I. du Pont de Nemours and Co., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 095747-G)
00015406 Gaspard, J. (1976) Residue Report: Soybeans: AG-A No. 3758 II.
(Unpublished study received Jan 19, 1977 under 100-583; prepared in
cooperation with Chemagro, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:095747-K)
00015407 Westmoreland, W.G. (1976) Residue Report: Soybeans: AG-A No. 3764 II.
(Unpublished study received Jan 19, 1977 under 100-583; prepared in
cooperation with Chemagro, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:095747-L)
00015408 Pruss, S.W.; Schnappinger, M.G. (1976) Residue Report: Soybeans: AG-A
No. 3775 II. (Unpublished study including AG-A no. 3776 II, received Jan
19, 1977 under 100-583; prepared in cooperation with E.I. du Pont de
Nemours and Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:095747-M)
00015409 Peek, J.; Stahlberg, L. (1976) Residue Report: Soybeans: AG-A No. 3778 II.
(Unpublished study including AG-A nos. 3780 II and 3782 II, received Jan 19,
1977 under 100-583; prepared in cooperation with Chemagro and E.I. du Pont
de Nemours and Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:095747-0)
00015410 Thomas, J.; Herman, D. (1976) Residue Report: Soybeans: AG-A No. 3803
II. (Unpublished study including AG-A no. 3812 II, re- ceived Jan 19, 1977
under 100-583; prepared in cooperation with E.I. du Pont de Nemours & Co.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095747-R)
00015411 Pruss, S.W.; Luke, J.E. (1976) Residue Report: Soybeans: AG-A No. 3885.
(Unpublished study received Jan 19, 1977 under 100- 583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 095747-T)
00015423 Sumner, D.D.; Thomas, R.D.; Cassidy, J.E. (1975) Structure Elucidation of
the Metabolites of CGA-24705 in Corn: M4-68-2Y: Report No. GAAC-75012.
(Unpublished study received Mar 26, 1975 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094378-F)
94
-------
BIBLIOGRAPHY
MRID
CITATION
00015424 Gross, D. (1974) Uptake, Translocation annd Degradation of CGA 24 705 in
Corn Grown Under Controlled Conditions: Project Report No. 13/74:
Addendum to Project Report No. 8/74. (Unpublished study received Mar 26,
1975 under 5F1606; prepared by Ciba-Geigy, Ltd., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:094378-H)
00015428 Kincaid, L. (1975) Residue Report: Field Corn: AG-A No. 3383. (Un-
published study received Mar 26, 1975 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094379-0)
00015429 Thomas, J.; Herman, D. (1975) Residue Report: Field Corn: AG-A No. 3501
I,II. (Unpublished study received Mar 26, 1975 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094379-P)
00015430 Kincaid, L. (1975) Residue Report: Sweet Corn: AG-A No. 3446. (Un-
published study received Mar 26, 1975 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094379-T)
00015432 Ramsteiner, K.; Karlhuber, B. (1975) CGA 24705: Determination of Total
Residue in Material of Animal Origin. Method no. REM 2/75 dated Feb 6,
1975. (Unpublished study received Mar 26, 1975 under 5F1606; prepared by
Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:094379-AJ)
00015466 Aziz, S.A.; Ross, J.A. (1975) Analytical Method for the Determination of
Residues of CGA-24705 Soybean Metabolites as CGA-37913 and CGA-49751
by Acid Hydrolysis. Method no. AG-286 dated Jun 10,1975. (Unpublished
study received Nov 25, 1975 under 6G1708; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 094877-S)
00015523 Bathe, R. (1973) Acute Oral LD50 of Technical CGA-24705 in the Rat: Project
No. Siss 2979. (Unpublished study received Mar 1, 1974 under 5G1553;
prepared by Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:094220-B)
00015526 Bach, K.J. (1974) Acute Dermal LD50 Test in Rabbits: Contract No.
120-2255-34. (Unpublished study received on unknown date under 5G1553;
prepared by Affiliated Medical Research, Inc., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:094220-E)
95
-------
BIBLIOGRAPHY
MRID
CITATION
00015528 Sachsse, K. (1973) Irritation of Technical CGA-24705 in the Rabbit Eye:
Project No. Siss 2979. (Unpublished study received Mar 1, 1974 under
5G1553; prepared by Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:094220-G)
00015530 Sachsse, K. (1973) Skin Irritation in the Rabbit after Single Application of
Technical CGA-24705: Project No. Siss 2979. (Unpublished study received
Mar 1, 1974 under 5G1553; prepared by Ciba-Geigy, Ltd., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094220-I)
00015535 Sachsse, K.; Ullmann, L. (1974) Acute Inhalation Toxicity of Technical
CGA-24705 in the Rat: Project No. Siss 3516. (Unpublished study received
on unknown date under 5G1553; prepared by Ciba-Geigy, Ltd., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094220-N)
00015540 Ross, R.H. (1979) Metolachlor (Dual 8E); Chloramben (Amiben 2E): AG-A
No. 5173 I,II. (Unpublished study including letter dated May 8, 1979 from
S.L. Harrison to Warren A. Davis, received Jun 20, 1979 under 100-583;
prepared in cooperation with AM-CHEM Products, Inc. and Union Carbide
Agricultural Products Co., Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:238677-B)
00015541 Kern, C.L. (1979) Metolachlor (Dual 8E); Chloramben (Amiben 2SL): AG-A
No. 5218 I,II. (Unpublished study including letter dated May 8, 1979 from
S.L. Harrison to Warren A. Davis, re- ceived Jun 20, 1979 under 100-583;
prepared in cooperation with AM-CHEM Products, Inc. and Union Carbide
Agricultural Products Co., Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL: 238677-C)
00015542 Rose, W.; Clapp, T.; Clapp, G. (1979) Metolachlor (Dual 8E); Chloramben
(Amiben 2E): AG-A No. 5341. (Unpublished study including letter dated May
8, 1979 from S.L. Harrison to Warren A. Davis, received Jun 20, 1979 under
100-583; prepared in cooperation with AM-CHEM Products, Inc. and Union
Carbide Agricultural Products Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:238677-D)
00015543 Cargile, N.L.; Ross, J.A. (1979) Analytical Method for Residues of
Metolachlor Plant Metabolites Determined as CGA-37913 and CGA- 49751
after Acid Hydrolysis. Method no. AG-338 dated Apr 23, 1979.
96
-------
BIBLIOGRAPHY
MRID
CITATION
(Unpublished study received Jun 20, 1979 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:238677-F)
00015546 Vilkas, A.G. (1976) Acute Toxicity of CGA-24705 Technical to the Water
Flea,Daphnia magnaStraus. (Unpublished study received Nov 24, 1976 under
100-587; prepared by Union Carbide Corp., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:226955-E)
00015548 Houseworth, L.D.; Rolla, H. (1977) Residues of Metolachlor in or on
Sorghum Resulting from Preplant Incorporated and Preemergence
Applications: Report No. ABR-77086. (Unpublished study received Nov 14,
1977 under 8G2019; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:096625-A)
00015549 Ragsdale, D.; Peek, J. (1977) Residue Report: Sorghum: AG-A No. 4413
Third Report. (Unpublished study received Nov 14, 1977 under 8G2019;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:096626-A)
00015550 Thomas, J.; Herman, D. (1977) Residue Report: Sorghum: AG-A No. 4418
Third Report. (Unpublished study received Nov 14, 1977 under 8G2019;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:096626-B)
00015551 Turner, W.E. (1977) Residue Report: Sorghum: AG-A No. 4503 Third
Report. (Unpublished study received Nov 14, 1977 under 8G2019; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:096626-C)
00015552 Holt, B.E. (1977) Residue Report: AG-A No. 4753. (Unpublished study
received Nov 14, 1977 under 8G2019; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:096626-D)
00015553 Kahrs, R.A. (1979) Residues of Metolachlor in Peanuts Resulting from
Preplant Incorporated or Preemergence Applications: Report No. ABR-79059.
Summary of studies 098298-B, 098298-C, 098298-F, 098298-1 and 098298-J.
(Unpublished study received May 18, 1979 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098298-A)
97
-------
BIBLIOGRAPHY
MRID
CITATION
00015554 Rose, W.; Coble, H. (1979) Metolachlor (Dual 8E), Naptalam + DNBP
(Dyanap 3E): AG-A No. 4715 I,II. (Unpublished study received May 18,
1979 under 100-583; prepared in cooperation with IRDC, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098298-B)
00015555 Dill, R. (1979) Residue Report: Peanuts: AG-A No. 4742 II. (Unpublished
study received May 18, 1979 under 100-583; prepared in cooperation with
IRDC, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098298-C)
00015556 McMahon, A. (1979) Residue Report: Peanuts: AG-A No. 4840 II. (Un-
published study received May 18, 1979 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098298-F)
00015557 McMahon, A. (1979) Metolachlor (Dual 8E): AG-A No. 4841 I,II.
(Unpublished study received May 18, 1979 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098298-I)
00015570 Taylor, D.; Shriver, J.; Guthrie, C. (1976) Residue Report: Field Corn: AG-A
No. 3372 II. (Unpublished study received Jun 20, 1977 under 100-590;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:230685-E)
00015571 Seim, V. (1976) Residue Report: Field Corn: AG-A No. 3674 II,III.
(Unpublished study received Jun 20, 1977 under 100-590; submitted by
Ciba-Geigy Coorp., Greensboro, N.C.; CDL:230685-G)
00015572 Chamberlain, E.; Shriver, J.; Wendling, C. (1976) Residue Report: Field
Corn: AG-A NO. 3745 I,II,III. (Unpublished study received
00015572 Jun 20, 1977 under 100-590; submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:230685-H)
00015586 Houseworth, L.D. (1978) Residues of Metolachlor and Atrazine in or on Corn
Resulting from the Application of Metolachlor, Metola- chlor/Atrazine Tank
Mixes or a Metolachlor/Atrazine Pre-pack through Center Pivot Irrigation
Systems: Report No. ABR-78074. Summary of studies 235358-B through
235358-J. (Unpublished study received Oct 20, 1978 under 100-583;
submitted by Ciba- Geigy Corp., Greensboro, N.C.; CDL:235358-A)
98
-------
BIBLIOGRAPHY
MRID
CITATION
00015587 Stahlberg, L. (1978) Metolachlor (Dual 8E): AG-A No. 4870 I, II.
(Unpublished study received Oct 20, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:235358-B)
00015588 Turner, W.E.; Wiese, A.F. (1978) Metolachlor (Dual 8E): AG-A No. 4908
I,II. (Unpublished study received Oct 20, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 235358-C)
00015589 Threewitt, T. (1978) Metolachlor (Dual 8E): AG-A No. 4929 I, II.
(Unpublished study received Oct 20, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:235358-D)
00015590 Stahlberg, L. (1978) Metolachlor + Atrazine; Dual 8E + Aa- trex 4L: AG-A
No. 4871 I,II. (Unpublished study received Oct 20, 1978 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:235358-E)
00015591 Stahlberg, L. (1978) Metolachlor + Atrazine (Bicep 4.5L): AG-A No. 4872
I,II. (Unpublished study received Oct 20, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 235358-F)
00015592 Turner, W.E.; Wiese, A.F. (1978) Metolachlor + Atrazine, Dual 8E +
Aatrex 4L: AG-A No. 4909 I,II. (Unpublished study re- ceived Oct 20, 1978
under 100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:235358-G)
00015593 Turner, W.E.; Wiese, A.F. (1978) Metolachlor + Atrazine (Bicep 4.5L):
AG-A No. 4910 I,II. (Unpublished study received Oct 20, 1978 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:235358-H)
00015594 Threewitt, T. (1978) Metolachlor + Atrazine (Dual 8E + Aa- trex SOW):
AG-A No. 4930 I,II. (Unpublished study received Oct 20, 1978 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:235358-I)
00015595 Threewitt, T. (1978) Metolachlor + Atrazine (Bicep 4.5L): AG-A No. 4931
I,II. (Unpublished study received Oct 20, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 235358-J)
99
-------
BIBLIOGRAPHY
MRID
CITATION
00015597 Buchholz, C. (1978) Metolachlor (Dual 8E); Cyanazine (Bladex SOW): AG-A
No. 4752 I,II. (Unpublished study received Oct 20, 1978 under 100-583;
prepared in cooperation with Shell Chemical Co., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:235359-B)
00015598 Rose, W.; Monaco, T. (1978) Metolachlor (Dual 8E); Cyanazine (Bladex
4WDS): AG-A No. 4810. (Unpublished study received Oct 20, 1978 under
100-583; prepared in cooperation with Shell Chemical Co., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:235359-C)
00015599 Turner, W. (1978) Metolachlor (Dual 8E); Cyanazine (Bladex SOW);
Cyanazine (Bladex 4WDS): AG-A No. 4864 I,II. (Unpublished study received
Oct 20, 1978 under 100-583; prepared in coopera- tion with Shell Chemical
Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:235359-D)
00015600 Stahlberg, L. (1978) Metolachlor (Dual 8E); Cyanazine (Bladex SOW): AG-A
No. 4875 I,II. (Unpublished study received Oct 20, 1978 under 100-583;
prepared in cooperation with Shell Chemical Co., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:235359-E)
00015601 Clarkson, V. (1978) Metolachlor (Dual 8E); Cyanazine (Bladex SOW): AG-A
No. 4972 I,II. (Unpublished study received Oct 20, 1978 under 100-583;
prepared in cooperation with Shell Chemical Co., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:235359-F)
00015602 Wustner, D.A. (1978) Metolachlor (Dual 8E); Cyanazine (Bladex 4L): AG-A
No. 6013. (Unpublished study received Oct 20, 1978 under 100-583; prepared
in cooperation with Shell Oil Co., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 235359-G)
00015631 Sachsse, K.; Ullmann, L. (1977) Skin Sensitizing (Contact Allergenic) Effect in
Guinea Pigs of Technical CGA 24705: Project No. Siss 5726. (Unpublished
study received Jan 18, 1978 under 100-583; prepared by Ciba-Geigy, Ltd.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:096717-F)
00015652 Sumner, D.D.; Cassidy, J.E. (1974) The Metabolism of CGA-24705 in Corn:
Report No. GAAC-74050. (Unpublished study received Sep 26, 1974 under
5G1553; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094217-D)
100
-------
BIBLIOGRAPHY
MRID
CITATION
00015653 Gross, D. (1974) Uptake, Translocation and Degradation of CGA 24 705 in
Corn Grown under Controlled Conditions: Project Report No. 8/74.
(Unpublished study received Sep 26, 1974 under 5G1553; prepared by
Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:094217-F)
00015676 Tharrington, W.H. (1974) Residue Report: Field Corn: AG-A No. 2967.
(Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-B)
00015677 Thetford, L.; Snow, J.G. (1974) Residue Report: Field Corn: AG-A No.
2972. (Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094216-C)
00015678 Roper, J. (1974) Residue Report: Field Corn: AG-A No. 2982. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-D)
00015679 Schnappinger, M.G. (1974) Residue Report: Sweet Corn: AG-A No. 3005.
(Unpublished study received Sep 26, 1974 under
00015679 5G1553; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094216-E)
00015680 Anliker, W. (1974) Residue Report: Sweet Corn: AG-A No. 3083. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-G)
00015681 Davidson, W.E. (1974) Residue Report: Field Corn: AG-A No. 3103.
(Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-H)
00015682 Shriver, J.; Conterio, W.A. (1974) Residue Report: Field Corn: AG-A No.
3132. (Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094216-1)
00015683 Shriver, J.; Guthrie, C.A. (1974) Residue Report: Field Corn: AG-A No.
3137. (Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094216-J)
101
-------
BIBLIOGRAPHY
MRID
CITATION
00015684 Fickle, J. (1974) Residue Report: Field Corn: AG-A No. 3141. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-K)
00015685 Kincaid, L. (1974) Residue Report: Sweet Corn: AG-A No. 3153. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-L)
00015686 Ross, R.H. (1974) Residue Report: Field Corn: AG-A No. 3255. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-M)
00015687 Snow, J.G. (1974) Residue Report: Sweet Corn: AG-A No. 2974. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-N)
00015688 Westmoreland, W.G. (1974) Residue Report: Field Corn: AG-A No. 3070.
(Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094216-P)
00015689 Snow, J.G. (1974) Residue Report: Field Corn: AG-A No. 3288. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-Q)
00015690 Stahlberg, L.; Peek, J. (1974) Residue Report: Field Corn: AG-A No. 3289.
(Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094216-R)
00015691 Roper, J.; Thomas, J.; Herman, D. (1974) Residue Report: Field Corn: AG-A
No. 3298. (Unpublished study received Sep 26, 1974 under 5G1553;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-S)
00015692 Roper, J.; Thomas, J.; Herman, D. (1974) Residue Report: Field Corn: AG-A
No. 3299. (Unpublished study received Sep 26, 1974 under 5G1553;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-T)
00015693 Kern, C.L. (1974) Residue Report: Field Corn: AG-A No. 3325. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-U)
102
-------
BIBLIOGRAPHY
MRID
CITATION
00015694 Juby, M. (1974) Residue Report: Field Corn: AG-A No. 3327. (Unpub-
lished study received Sep 26, 1974 under 5G1553; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:094216-V)
00015698 Hormann, W.D.; Guth, J.A.; Formica, G.; et al. (1974) CGA 24705: Gas
Chromatographic Determination of Total Residues in Material of Animal
Origin (Provisional). Method no. REM 5/74 dated Jun 26, 1974.
(Unpublished study received Sep 26, 1974 under 5G1553; prepared by
Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:094216-Z)
00015704 Juby, M. (1974) Residue Report: Field Corn: AG-A No. 3328. (Unpub-
lished study received Sep 26, 1974 under 5G1553; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:094216-AK)
00015705 Kern, C.L. (1974) Residue Report: Field Corn: AG-A No. 3326. (Un-
published study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-AL)
00015706 Kahrs, R.A. (1978) Summary: Residue Chemistry Data to Establish Tolerances
for Residues of Metolachlor in Corn Forage and Fodder, Soybean Forage and
Fodder, and Fresh Corn, including Sweet Corn (Kernels plus Cobs, Husks
Removed): Report No. ABR- 78028. Summary of studies 094216-B,
094216-C, 094216-E through 094216-K, 094216-M, 094216-N, 094216-P
through 094216-V, 094216-AK, 094216-AL, 094379-D, 094379-0, 094379-P,
094379-T, 094379-AB, 097134-Q, 097134-S, 097134-X, 097134-AE through
097134-AI, 097134-AO through 097134-AT, 228126-E through 228126-H,
228126-J, 230685-G, and 230685-H. (Unpublished study received May 11,
1978 under 100-583; submitted by Ciba-Geigy Corp., greensboro, N.C.;
CDL:097133-A)
00015707 Snow, J.G.; Tinklepaugh, ? (1976) Residue Report: Field Corn: AG-A No.
3799 II,III. (Unpublished study received May 11, 1978 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097134-S)
00015708 Ross, R.H. (1978) Metolachlor (Dual 8E): AG-A No. 4855 I,II, Second
Report. (Unpublished study received May 11, 1978 under 100-583; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097134-AE)
103
-------
BIBLIOGRAPHY
MRID
CITATION
00015709 Turner, W.E. (1978) Metolachlor (Dual 8E): AG-A No. 4860 I,II Second
Report. (Unpublished study received May 11, 1978 under 100-583; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097134-AF)
00015710 Stahlberg, L. (1978) Metolachlor (Dual 8E): AG-A No. 4873 I, II, 2nd
Report. (Unpublished study received May 11, 1978 under 100-583; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097134-AG)
00015711 Turner, W.E. (1978) Metolachlor + Atrazine (Dual 8E + AAtrex 4L): AG-A
No. 4861 I,II Second Report. (Unpublished study received May 11, 1978
under 100-583; submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:097134-AH)
00015712 Stahlberg, L. (1978) Metolachlor + Atrazine (Dual 8E + AAtrex 4L): AG-A
No. 4874 I,II Second Report. (Unpublished study received May 11, 1978
under 100-583; submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:097134-AI)
00015713 Buchholz, C. (1978) Metolachlor (Dual 8E): AG-A No. 4749 I, II.
(Unpublished study received May 11, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:097134-AO)
00015714 Rose, W.E.; Monaco, T. (1978) Metolachlor (Dual 8E): AG-A No. 4806.
(Unpublished study received May 11, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097134-AP)
00015715 Clarkson, V. (1978) Metolachlor (Dual 8E): AG-A No. 4974. (Unpublished
study received May 11, 1978 under 100-583; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:097134-AQ)
00015716 Buchholz, C. (1978) Metolachlor + Atrazine (Dual 8E) + (AAtrex SOW):
AG-A No. 4748 I, II. (Unpublished study received May 11, 1978 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097134-AR)
00015717 Rose, W.; Monaco, T. (1978) Metolachlor + Atrazine (Dual 8E) + (AAtrex
4L): AG-A No. 4807. (Unpublished study received May 11, 1978 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097134-AS)
104
-------
BIBLIOGRAPHY
MRID
CITATION
00015718 Clarkson, V. (1978) Metolachlor, Atrazine (Dual 8E, AA- trey SOW): AG-A
No. 4975. (Unpublished study received May 11, 1978 under 100-583;
submitted by Ciba-Geigy Corp., Greens- boro, N.C.; CDL:097134-AT)
00015719 Ross, R.H.; Pruss, S. (1976) Residue Report: Soybeans: AG-A No. 3650 I,II.
(Unpublished study received May 11, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097135-A)
00015721 Shriver, J.; Wendling, C. (1976) Residue Report: Soybeans: AG-A No. 3747
II. 2nd Report. (Unpublished study received May 11, 1978 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-D)
00015722 Pruss, S.; Schnappinger, M.G. (1976) Residue Report: Soybeans: AG-A No.
3775 II. 2nd report. (Unpublished study received May 11, 1978 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-E)
00015723 Peek, J.; Stahlberg, L. (1976) Residue Report: Soybeans: AG-A No. 3782.
(Unpublished study received May 11, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-F)
00015725 Pruss, S.W.; Luke, J.E. (1976) Residue Report: Soybeans: AG-A No. 3885.
2nd Report. (Unpublished study received May 11, 1978 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-H)
00015726 Richards, R.F. (1976) Residue Report: Soybeans: AG-A No. 3948. 2nd
Report. (Unpublished study received May 11, 1978 under 100-583; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-1)
00015727 Shriver, J.; Wendling, C. (1976) Residue Report: Soybeans: AG-A No. 3743.
(Unpublished study received May 11, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-J)
105
-------
BIBLIOGRAPHY
MRID
CITATION
00015728 Schnappinger, M.G.; Pruss, S.W. (1976) Residue Report: Soybeans: AG-A
No. 3776. (Unpublished study received May 11, 1978 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:097135-K)
00015729 Peek, J.; Stahlberg, L. (1976) Residue Report: Soybeans: AG-A No. 3780.
(Unpublished study received May 11, 1978 under 100- 583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097135-L)
00015731 Shriver, J.; Wendling, C. (1977) Residue Report: Soybeans: AG-A No. 3742.
(Unpublished study received May 11, 1978 under 100- 583; prepared in
cooperation with Mobay Chemical Corp. and Analytical Biochemistry
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097135-0)
00015732 Gaspard, J.T. (1977) Residue Report: Soybeans: AG-A No. 3758.
(Unpublished study received May 11, 1978 under 100-583; prepared in
cooperation with Mobay Chemical Corp. and Analytical Biochemistry
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097135-P)
00015733 Westmoreland, W.G. (1977) Residue Report: Soybeans: AG-A No. 3764.
(Unpublished study received May 11, 1978 under 100-583; prepared in
cooperation with Mobay Chemical Corp. and Analytical Biochemistry
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097135-Q)
00015734 Peek, J.; Stahlberg, L. (1977) Residue Report: Soybeans: AG-A No. 3778.
(Unpublished study received May 11, 1978 under 100- 583; prepared in
cooperation with Mobay Chemical Corp. and Ana- lytical Biochemistry
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097135-R)
00015735 Luke, J. (1978) Metolachlor (Dual 8E): AG-A No. 4737 I,II. (Unpublished
study received May 11, 1978 under 100-583; sub- mitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:097135-T)
00015736 Kern, C. (1978) Metolachlor (Dual 8E): AG-A No. 4781 I,II. (Unpublished
study received May 11, 1978 under 100-583; sub- mitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:097135-U)
106
-------
BIBLIOGRAPHY
MRID
CITATION
00015737 Herman, D. (1978) Metolachlor (Dual 8E): AG-A No. 4986 I,II. (Unpublished
study received May 11, 1978 under 100-583; sub- mitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:097135-V)
00015739 Chamberlain, E.; Stahlberg, L. (1978) Metolachlor (Dual 8E); Atrazine
(AAtrex SOW & 4L): AG-A No. 4790 I,II,III. (Unpublished study received
Mar 16, 1979 under 100-583; prepared in coopera- tion with EN-CAS
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237817-B)
00015740 Luke, J.E. (1978) Metolachlor (Dual 8E); Atrazine (AAtrex SOW +4L): AG-A
No. 4811 I,II,III. (Unpublished study received Mar 16, 1979 under 100-583;
prepared in cooperation with EN-CAS An- alytical Laboratories, submitted by
Ciba-Geigy Corp., Greens- boro, N.C.; CDL:237817-C)
00015741 Turner, W.E. (1978) Metolachlor (DualSE); Atrazine (AAtrex 4L): AG-A No.
4862 I,II. (Unpublished study received Mar 16, 1979 under 100-583; prepared
in cooperation with Texas Agricultural Experiment Station and EN-CAS
Analytical Laborato- ries, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL: 237817-D)
00015742 Dorr, J.; Buchholz, C. (1978) Metolachlor (Dual 6E); Atrazine (AAtrex 4L):
AG-A No. 4750 I,II. (Unpublished study received Mar 16, 1979 under
100-583; prepared in cooperation with EN-CAS An- alytical Laboratories,
submitted by Ciba-Geigy Corp., Greens- boro, N.C.; CDL:237817-E)
00015743 Chamberlain, E.; Stahlberg, L. (1978) Metolachlor (Dual 8E); Atrazine
(AAtrexSOW): AG-A No. 4791. (Unpublished study received Mar 16, 1979
under 100-583; prepared in cooperation with EN-CAS Analytical Laboratories,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237817-F)
00015744 Rose, W.; Monaco, T. (1978) Metolachlor (Dual 8E); Atrazine (AAtrex 4L):
AG-A No. 4808. (Unpublished study received Mar 16, 1979 under 100-583;
prepared in cooperation with EN-CAS Analyti- cal Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237817-G)
00015745 Chamberlain, E.; Stahlberg, L. (1978) Metolachlor + Atrazine (Bicep 4.5L):
AG-A No. 4792 I,II,III. (Unpublished study received Mar 16, 1979 under
100-583; prepared in cooperation with EN-CAS Analytical Laboratories,
107
-------
BIBLIOGRAPHY
MRID
CITATION
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237817-H)
00015746 Luke, J.E. (1978) Metolachlor + Atrazine (Bicep 4.5L): AG-A No. 4812
I,II,III. (Unpublished study received Mar 16, 1979 under 100-583; prepared
in cooperation with EN-CAS Analytical Laboratories, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:237817-I)
00015747 Turner, W.E. (1978) Metolachlor + Atrazine (Bicep 4.5L): AG-A No. 4863
I,II. (Unpublished study received Mar 16, 1979 under 100-583; prepared in
cooperation with Texas Agricultural Experiment Station and EN-CAS
Analytical Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237817-J)
00015748 Dorr, J.; Buchholz, C. (1978) Metolachlor + Atrazine (Bicep 4.5L): AG-A
No. 4751 I,II. (Unpublished study received Mar 16, 1979 under 100-583;
prepared in cooperation with EN-CAS Analytical Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237817-K)
00015749 Chamberlain, E.; Stahlberg, L. (1979) Metolachlor + Atrazine (Bicep 4.5L):
AG-A No. 4793 A. (Unpublished study received Mar 16, 1979 under
100-583; prepared in cooperation with EN-CAS Analytical Laboratories,
submitted by Ciba-Geigy Corp., Greens- boro, N.C.; CDL:237817-L)
00015750 Rose, W.; Monaco, T. (1978) Metolachlor + Atrazine (Bicep 4.5L): AG-A
No. 4809. (Unpublished study received Mar 16, 1979 under 100-583;
prepared in cooperation with EN-CAS Analytical Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 237817-M)
00015751 Rose, W.; Worsham, D.; Slagowski, J.L. (1978) Metolachlor (Dual 8E);
Atrazine (AAtrex SOW); Paraquat (Paraquat CL): AG-A No. 4959 I,II.
(Unpublished study received Mar 16, 1979 under 100-583; prepared in
cooperation with EN-CAS Labora- tories and Chevron Chemical Co.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237819-F)
00015752 Kern, C.L.; Staniforth, D.; Slagowski, J.L. (1978) Metolachlor (Dual 8E);
Atrazine (AAtrex SOW or 4L); Paraquat (Paraquat CL): AG-A No. 5000 I,II.
(Unpublished study received Mar 16, 1979 under 100-583; prepared in
cooperation with Iowa State Univ., EN-CAS Laboratories and Chevron
Chemical Co., sub- mitted by Ciba-Geigy Corp., Greensboro, N.C.;
108
-------
BIBLIOGRAPHY
MRID
CITATION
CDL:237819-H)
00015753 Schnappinger, M.G. (1979) Metolachlor (Dual 8E); Atrazine (AAtrex SOW);
Glyphosate (Roundup 4E): AG-A No. 4888 I,II. (Unpublished study received
Mar 16, 1979 under 100-583; prepared in cooperation with EN-CAS
Laboratories and ADC Laboratories, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 237819-1)
00015754 Rose, W.; Worsham, D. (1979) Metolachlor (Dual 8E); Atrazine (AAtrex
SOW); Glyphosate (Roundup 4E): AG-A No. 4960 I, II. (Unpublished study
received Mar 16, 1979 under 100-583; prepared in cooperation with EN-CAS
Laboratories and ADC Laboratories, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 237819-J)
00015755 Searcy, S.; Herman, D. (1979) Metolachlor (Dual 8E); Atrazine (AAtrex 4L);
Glyphosate (Roundup 4E): AG-A No. 4983 I, II. (Unpublished study received
Mar 16, 1979 under 100-583; prepared in cooperation with EN-CAS
Laboratories and ADC Laboratories, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 237819-K)
00015756 Kern, C.L.; Staniforth, D. (1979) Metolachlor (Dual 8E); Atrazine (AAtrex
SOW or 4L); Glyphosate (Roundup 4E): AG-A No. 4999 I, II. (Unpublished
study received Mar 16, 1979 under 100-583; prepared in cooperation with
Iowa State Univ., EN-CAS Labora- tories and ADC Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237819-L)
00015757 Dorr, J.; Buchholz, C. (1979) Metolachlor (Dual 8E); Atrazine (AAtrex 4L);
Glyphosate (Roundup 4E): AG-A No. 5004. (Unpublished study received Mar
16, 1979 under 100-583; prepared in cooperation with EN-CAS Laboratories
and ADC Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237819-M)
00015760 Kincaid, L. (1979) Metolachlor + Glyphosate + Linuron; Dual 8E +
Roundup 4E + Lorox SOW: AG-A No. 4763 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Robert A. Kahrs,
received Mar 16, 1979 under 100-583; prepared in cooperation with E.I. du
Pont de Nemours & Co., Inc. and ADC Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-B)
109
-------
BIBLIOGRAPHY
MRID
CITATION
00015761 Schnappinger, M.G. (1979) Metolachlor + Glyphosate + Linuron; Dual 8E +
Roundup 4E + Lorox SOW: AG-A No. 4886 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Robert A. Kahrs,
received Mar 16, 1979 under 100-583; prepared in cooperation with E.I. du
Pont de Nemours & Co., Inc. and ADC Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.: CDL:237821-C)
00015762 Searcy, V.; Herman, D. (1979) Metolachlor + Glyphosate + Linuron; Dual
8E + Roundup 4E + Lorox SOW: AG-A No. 4893 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Rig- gleman to Robert A.
Kahrs, received Mar 16, 1979 under 100-583; prepared in cooperation with
E.I. du Pont de Nemours & Co., Inc. and ADC Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-D)
00015763 Rose, W.; Worsham, D. (1979) Metolachlor + Glyphosate + Linuron; Dual
8E + Roundup 4E + Lorox SOW: AG-A No. 4956 I,II A. (Unpublished study
including letter dated May 23, 1978 from J.D. Rig- gleman to Robert A.
Kahrs, received Mar 16, 1979 under 100-583; prepared in cooperation with
Rocky Mount Experiment Station, ADC Laboratories and E.I. du Pont de
Nemours & Co., Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237821-E)
00015764 Kincaid, L. (1979) Metolachlor (Dual 8E); Glyphosate (Roundup 4E);
Metribuzin (Sencor SOW): AG-A No. 4765 I,II. (Unpublished study including
letter dated May 23, 1978 from J.D. Riggleman to Robert A. Kahrs, received
Mar 16, 1979 under 100-583; prepared in cooperation with ADC Laboratories
and E.I. du Pont de Nemours & Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237821-F)
00015765 Schnappinger, M.G. (1978) Metolachlor (Dual 8E); Glyphosate (Round- up
4E); Metribuzin (Sencor SOW): AG-A No. 4887 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Robert Kahrs,
received Mar 16, 1979 under 100-583; prepared in cooperation with ADC
Laboratories and E.I. du Pont de Nemours & Co., Inc., submitted by
Ciba-Geigy Corp., Greens- boro, N.C.; CDL:237821-G)
00015766 Searcy, S.; Herman, D. (1979) Metolachlor (Dual 8E); Glyphosate (Roundup
4E); Metribuzin (Sencor SOW): AG-A No. 4895 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Robert A. Kahrs,
110
-------
BIBLIOGRAPHY
MRID
CITATION
received Mar 16, 1979 under 100- 583; prepared in cooperation with ADC
Laboratories and E.I. du Pont de Nemours & Co., Inc., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-H)
00015767 Rose, W.; Worsham, D. (1979) Metolachlor (Dual 8E); Glyphosate (Roundup
4E); Metribuzin (Sencor SOW): AG-A No. 4958 I,II A. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Robert A. Kahrs,
received Mar 16, 1979 under 100- 583; prepared in cooperation with ADC
Laboratories and E.I. du Pont de Nemours & Co., Inc., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-I)
00015768 Kincaid, L.; Slagowski, J.L. (1978) Metolachlor + Linuron + Para- quat;
Dual 8E + Lorox SOW + Paraquat 2CL: AG-A No. 4762 I,II. (Unpublished
study including letter dated May 23, 1978 from J.D. Riggleman to Robert A.
Kahrs, received Mar 16, 1979 under 100- 583; prepared in cooperation with
Chevron Chemical Co. and E.I. du Pont de Nemours & Co., Inc., submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-J)
00015769 Searcy, V.; Herman, D.; Slagowski, J.L. (1978) Metolachlor + Linuron +
Paraquat: Dual 8E + Lorox SOW + Paraquat 2CL: AG-A No. 4892 I,II.
(Unpublished study including letter dated May 23, 1978 from J.D. Riggleman
to Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepared in
cooperation with Chevron Chemical Co. and E.I. du Pont de Nemours & Co.,
Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-L)
00015770 Schnappinger, M.G.; Slagowski, J.L. (1978) Metolachlor + Linuron +
Paraquat (Dual 8E + Lorox SOW + Paraquat 2CL): AG-A No. 4915 I, II.
(Unpublished study including letter dated May 23, 1978 from J.D. Riggleman
to Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepared in
cooperation with Chevron Chemical Co. and E.I. du Pont de Nemours & Co.,
Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-L)
00015771 Rose, W.; Worsham, D.; Slagowski, J.L. (1978) Metolachlor + Linuron +
Paraquat: Dual 8E + Lorox SOW + Paraquat 2CL: AG-A No. 4955 I,II.
(Unpublished study including letter dated May 23, 1978 from J.D. Riggleman
to Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepared in
cooperation with Rocky Mount Experiment Station, Chevron Chemical Co.
and E.I. du Pont de Nemours & Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237821-M)
111
-------
BIBLIOGRAPHY
MRID
CITATION
00015772 Kincaid, L.; Slagowski, J.L. (1978) Metolachlor (Dual 8E); Metribuzin
(Sencor SOW); Paraquat (2C1): AG-A No. 4764 I,II. (Unpublished study
including letter dated May 23, 1978 from J.D. Riggleman to Robert A. Kahrs,
received Mar 16, 1979 under 100-583; prepared in cooperation with E.I. du
Pont de Nemours & Co., Inc. and Chevron Chemical Co., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-M)
00015773 Searcy, S.; Herman, D.; Slagowski, J.L. (1978) Metolachlor (Dual 8E);
Metribuzin (Sencor SOW); Paraquat (2C1): AG-A No. 4894 I,II. (Unpublished
study including letter dated May 23, 1978 from J.D. Riggleman to Robert A.
Kahrs, received Mar 16, 1979 under 100-583; prepared in cooperation with
E.I. du Pont de Nemours & Co., Inc. and Chevron Chemical Co., submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-0)
00015774 Schnappinger, M.G.; Slagowski, J.L. (1978) Metolachlor (Dual 8E);
Metribuzin (Sencor SOW); Paraquat (2 Cl): AG-A No. 4916 I, II.
(Unpublished study including letter dated May 23, 1978 from J.D. Riggleman
to Robert A. Kahrs, received Mar 16, 1979 under 100-583; prepared in
cooperation with E.I. du Pont de Nemours & Co., Inc. and Chevron Chemical
Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-P)
00015775 Rose, W.; Worsham, D.; Slagowski, J.L. (1978) Metolachlor (Dual 8E);
Metribuzin (Sencor SOW); Paraquat (Cl): AG-A No. 4957 I,II. (Unpublished
study including letter dated May 23, 1978 from J.D. Riggleman to Robert A.
Kahrs, received Mar 16, 1979 under 100-583; prepared in cooperation with
E.I. du Pont de Nemours & Co., Inc. and Chevron Chemical Co., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-Q)
00015777 Stahlberg, L. (1978) Metolachlor (Dual 8E); Naptalam + DNBP (Dya nap 3E):
AG-A No. 4728 I,II. (Unpublished study received Mar 16, 1979 under
100-583; prepared in cooperation with Biospher- ics, Inc. for Uniroyal
Chemical Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237822-B)
00015778 Herman, D. (1978) Metolachlor (Dual 8E); Naptalam + DNBP (Dyanap 3E):
AG-A No. 4896 I,II. (Unpublished study received Mar 16, 1979 under
100-583; prepared in cooperation with Biospherics, Inc. for Uniroyal Chemical
Co., submitted by Ciba- Geigy Corp., Greensboro, N.C.; CDL:237822-C)
112
-------
BIBLIOGRAPHY
MRID
CITATION
00015779 Schnappinger, M.G. (1978) Metolachlor (Dual 8E); Naptalam + DNBP
(Dyanap 3E): AG-A No. 4934 I,II. (Unpublished study received Mar 16, 1979
under 100-583; prepared in cooperation with Biospherics, Inc. for Uniroyal
Chemical Co., submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:237822-D)
00015780 Dill, R. (1978) Metolachlor (Dual 8E); Naptalam + DNBP (Dyanap 3E):
AG-A No. 5053. (Unpublished study received Mar 16, 1979 under 100-583;
prepared in cooperation with Biospherics, Inc. for Uniroyal Chemical Co.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237822-E)
00015786 Chamberlain, E.; Taylor, T.D. (1978) Metolachlor, Dual 8E; Dicamba,
Banvel: AG-A No. 4865 I, II. (Unpublished study received Mar 16, 1979
under 100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:237818-E)
00015787 Chamberlain, E.; Kern, C.L. (1978) Metolachlor, Dual 8E; Dicamba, Banvel:
AG-A No. 4948 I,II. (Unpublished study received Mar 16, 1979 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237818-F)
00015950 Shriver, J.; Guthrie, C. (1975) Residue Report: Field Corn: AG-A No. 3406
II. (Unpublished study received Mar 26, 1975 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094379-AB)
00015954 Turner, W.E. (1974) Residue Report: Field Corn: AG-A No. 3057.
(Unpublished study received Sep 26, 1974 under 5G1553; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:094216-F)
00015955 Luke, J.E.; Slagowski, J.L. (1978) Metolachlor (Dual 8E); Atrazine (AAtrex
SOW); Paraquat (Paraquat CL): AG-A No. 4964. (Unpublished study received
Mar 16, 1979 under 100- 583; prepared in cooperation with EN-CAS
Laboratories and Chev- ron Chemical Co., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237819-G)
00016248 Richards, R.F. (1976) Residue Report: Soybeans: AG-A No. 3948.
(Unpublished study received Jan 19, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:095747-U)
00016306 Hermes, P. (1972) Biphasic Extraction of Radioactive Metabolites from
113
-------
BIBLIOGRAPHY
MRID
CITATION
Treated Biological Material. Method no. AG-214 dated Aug 15, 1972.
(Unpublished study received Sep 26, 1974 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094385-Q)
00016392 Houseworth, L.D.; Rolla, H. (1977) Residues of Metolachlor and Atrazine in
or on Corn Grain Resulting from Tank Mix Applications with and without
Liquid Fertilizer—Preplant Incorporated and Preemergence Applications:
Report No. ABR-77017. (Unpub- lished study received Feb 18, 1977 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-A)
00016393 Seim, V. (1976) Residue Report: Field Corn: AG-A No. 3672 II-III.
(Unpublished study received Feb 18, 1977 under 100-583; sub- mitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-D)
00016394 Seim, V. (1976) Residue Report: Field Corn: AG-A No. 3673 I,II,III.
(Unpublished study received Feb 18, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-E)
00016395 Ragsdale, D.; Stahlberg, L. (1976) Residue Report: Field Corn: AG-A No.
3704 I,II. (Unpublished study received Feb 18, 1977 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-F)
00016396 Taylor, T.D.; Shriver, J.; Wendling, C. (1976) Residue Report: Field Corn:
AG-A No. 3734 I,II,III. (Unpublished study received Feb 18, 1977 under
100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-G)
00016397 Shriver, J.; Wendling, C. (1976) Residue Report: Field Corn: AG-A No. 3735
I,II,III. (Unpublished study received Feb 18, 1977 under 100-583; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-H)
00016398 Snow, J.G.; Tinklepaugh, ? (1976) Residue Report: Field Corn: AG-A No.
3799 II,III. (Unpublished study received Feb 18, 1977 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 228126-1)
00016399 Thetford, L.; Snow, J.G.; Tinklepaugh, ? (1976) Residue Report: Sweet Corn:
AG-A No. 3858. (Unpublished study received Feb 18, 1977 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-J)
00016425 Fink, R. (1974) Final Report: Eight-Day Dietary LC50-Mallard Ducks:
114
-------
BIBLIOGRAPHY
MRID
CITATION
Project No. 108-111. (Unpublished study received on unknown date under
5G1553; prepared by Truslow Farms, Inc. in cooperation with Maryland, Dept.
of Agriculture, Div. of Inspection and Regulation, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:094220-0)
00016426 Fink, R. (1974) Final Report: Eight-Day Dietary LC50-Bobwhite Quail:
Project No. 108-110. (Unpublished study received on unknown date under
5G1553; prepared by Truslow Farms, Inc. in cooperation with Maryland, Dept.
of Agriculture, Div. of Inspection and Regulation, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:094220-P)
00016427 Kahrs, R.A. (1979) Residues of Metolachlor and Chloramben in Soybeans
Resulting from Preemergence or Preplant Incorporated Applications: Report
No. ABR-79068. Summary of studies 238677-B through 238677-D.
(Unpublished study received Jun 20, 1979 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:238677-A)
00016435 Houseworth, L.D. (1977) Residues of Metolachlor and Dicamba in or on Corn
Grain Resulting from Preemergence Tank Mix Applications: Report No.
ABR-77071. Summary of studies 232192-B through 232192-D. (Unpublished
study received Nov 10, 1977 under 100- EX-59; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL: 232192-A)
00016436 Chamberlain, E.; Coan, R.M. (1977) Residue Report: Field Corn: AG-A No.
4253 II. (Unpublished study received Nov 10, 1977 under 100-EX-59;
prepared in cooperation with Velsicol Chemical Corp., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:232192-B)
00016437 Chamberlain, E.; Kern, C.L. (1977) Residue Report: Field Corn: AG-A No.
4264 II. (Unpublished study received Nov 10, 1977 under 100-EX-59;
prepared in cooperation with Velsicol Chemical Corp. and Craven
Laboratories, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:232192-C)
00016604 Shriver, J.; Wendling, C. (1976) Residue Report: Soybeans: AG-A No. 3724.
(Unpublished study received May 11, 1978 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 097135-C)
00016607 Cheung, M.W.; Kahrs, R.A. (1979) Residues in Sorghum Resulting from
115
-------
BIBLIOGRAPHY
MRID
CITATION
Applications of Milocep 5L—Preplan! Incorporated and Preemergence
Applications: Report No. ABR-79015. Summary of studies 237815-B through
237815-F. (Unpublished study received Mar 16, 1979 under 100-604;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237815-A)
00016608 Davidson, W.E. (1979) Metolachlor-Propazine (Milocep 5L): AG-A No. 5159
I-II A. (Unpublished study received Mar 16, 1979 under 100-604; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 237815-B)
00016609 Dill, R. (1978) Metolachlor + Propazine (Milocep 5L): AG-A No. 5176 A.
(Unpublished study received Mar 16, 1979 under 100- 604; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 237815-C)
00016610 Dill, R. (1978) Metolachlor-Propazine (Milocep 5L): AG-A No. 5176 II.
(Unpublished study received Mar 16, 1979 under 100-604; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 237815-D)
00016990 Davidson, W.E. (1978) Metolachlor + Propazine; Dual 8E + Milo- gard 4L:
Grain Sorghum: AG-A No. 4883 II A. (Unpublished study received Nov 24,
1978 under 100-EX-62; submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:235981-B)
00016991 Chamberlain, E.; Threewitt, T. (1978) Metolachlor + Propazine; Dual 8E +
Milogard SOW: Grain Sorghum: AG-A No. 4926 II B. (Unpublished study
received Nov 24, 1978 under 100-EX-62; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:235981-C)
00016992 Turner, W.E. (1978) Metolachlor + Propazine; Dual 8E + Milogard SOW:
Grain Sorghum: AG-A No. 4995 A. (Unpublished study received Nov 24,
1978 under 100-EX-62; submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:235981-D)
00018722 Buccafusco, R.J.; Stiefel, C.; Sullivan, D.M.; etal. (1978) Acute Toxicity of
CGA-24705 to Rainbow Trout (jjSalmo gairdneri): Report #BW-78-6-186.
(Unpublished study received Jul 13, 1978 under 100-597; prepared by EG&G,
Bionomics, submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:234396-B)
00018723 Buccafusco, R.J.; Stiefel, C.; Sullivan, D.M. (1978) Acute Toxicity of
116
-------
BIBLIOGRAPHY
MRID
CITATION
CGA-24705 to Bluegill (Lepomis macrochirus): Report #BW- 78-6-181.
(Unpublished study received Jul 13, 1978 under 100-597; prepared by EG&G,
Bionomics, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:234396-C)
00022872 Sumner, D.D.; Cassidy, J.E. (1975) The Uptake and Distribution of
Phenyl-14C-CGA-24705 from Soil in Greenhouse Grown Soybeans: Report
No. GAAC 75039. (Unpublished study received Jan 19, 1977 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095750-F)
00022873 Sumner, D.; Cassidy, J. (1974) The Uptake and Distribution of Phen-
yl-14C-CGA-24705 from Soil in Greenhouse Grown Corn: Report No.
GAAC-74015. (Unpublished study received Sep 26, 1974 under 5F1606;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL: 094385-B)
00022874 Sumner, D.; Cassidy, J. (1974) The Uptake and Distribution of Phen-
yl-14C-CGA-24705 in Field Grown Corn: Report No. GAAC-74022.
(Unpublished study received Sep 26, 1974 under 5F1606; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:093485-C)
00022879 Szolics, I.M.; Cassidy, J.E. (1978) The Uptake and Balance of Phen-
yl-14C-Metolachlor in Field Rotation Lettuce Planted in the Fall: Report No.
ABR-78085. (Unpublished study received Aug 1, 1979 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:238899-C)
00022880 Szolics, I.M.; Cassidy, J.E. (1978) The Uptake and Balance of Phenyl
14C-Metolachlor in Field Rotation Lettuce Planted in the Spring: Report No.
ABR-78086. (Unpublished study received Aug 1, 1979 under 100-583;
submitted by Ciba-Geigy Corp., Greens- boro, N.C.; CDL:238899-D)
00026712 Bruhl, ? (1979) SN 66 752 Residues in Tobacco Plants, Cured Leaves, and
Cigarette Smoke. (Unpublished study received Dec 13, 1979 under
2139-EX-24; prepared by Schering, AG, submitted by Nor-Am Agricultural
Products, Inc., Naperville, 111.; CDL:241517-D)
00026713 Pitblado, R.; Hawf, L.R.; Glaze, N.; et al. (1975) Analysis of Lima Beans for
Possible Residues of Chloramben. (Unpublished study received May 23, 1975
under 264-266; prepared by Ridgetown Col- lege of Agriculture & Technology
and others, submitted by Union Carbide Agricultural Products Co., Ambler,
117
-------
BIBLIOGRAPHY
MRID
CITATION
Pa.; CDL:195120-B)
00032174 Jessup, D.C.; Arceo, R.J.; Estes, F.L.; et al. (1980) 6-Month Chronic Oral
Toxicity Study in Beagle Dogs: IRDC No. 382-054. (Unpublished study
received Jun 5, 1980 under 100-587; prepared by International Research and
Development Corp., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:242672-A)
00039174 Seim, V.; Peek, J.; Stahlberg, L.; et al. (1975) Residue Report: Soybeans:
AG-A No. 3268 I,II,III. (Unpublished study including AG-A nos. 3466 I,II,
3523 I,II,III, 3570 I,II,III..., received Nov 25, 1975 under 6G1708; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094878-A)
00039176 Ciba-Geigy, Limited (19??) CGA 24 705 Feeding Study in Milk Cows:
Methods. (Unpublished study received Nov 25, 1975 under 6G1708;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094878-D)
00041283 Lightkep, G.E.; Christian, M.S.; Christian, G.D.; et al. (1980) Teratogenic
Potential of CGA-24705 in New Zealand White Rabbits: Segment II
Evaluation—Project 203-001. (Unpublished study received Sep 15, 1980 under
100-597; prepared by Argus Research Laboratories, Inc., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:099630-A)
00042725 Marias, A.J.; Gesme, J.; Albanese, E.; et al. (1977) Report to Ciba-Geigy
Corporation: Carcinogenicity Study with CGA-24705 Technical in Albino
Mice: IBT No. 622-07925 (8532-07925). (Unpublished study including
submitter summary, received Jan 18, 1978 under 100-583; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 096719-A; 096720)
00062465 Fink, R.; Beavers, J.B.; Brown, R.; et al. (1981) Final Report: Acute Oral
LD50~Mallard Duck: Project No. 108-200. (Unpublished study received Mar
31, 1981 under 100-587; prepared by Wildlife International, Ltd. and
Washington College, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:244691-B)
00064182 Ciba-Geigy Corporation (1980) [Residue of Dual 8E and Eptam 6E on Kidney
Beans and Various Other Beans]. (Compilation; unpub- lished study received
Mar 31, 1981 under 100-597; CDL:099988-B)
118
-------
BIBLIOGRAPHY
MRID
CITATION
00065048 Ciba-Geigy Corporation (1981) [Residue Tests with Cotton]. (Compilation;
unpublished study received Apr 28, 1981 under 100-597; CDL:070049-B)
00074898 Szolics, I.M.; Simoneaux, B.J.; Cassidy, J.E. (1981) The Uptake and
Distribution of Phenyl-14C-metolachlor from Soil in Greenhouse Grown
Potatoes: ABR-81023. (Unpublished study received Jul 15, 1981 under
100-597; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070182-B)
00074900 Szolics, I.M.; Simoneaux, B.J.; Cassidy, J.E. (1981) The Uptake and
Distribution of Phenyl-14C-metolachlor from Soil in Greenhouse Grown
Lettuce: ABR-81021. (Unpublished study received Jul 15, 1981 under
100-597; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070182-D)
00078297 Ciba-Geigy Corporation (1981) [Tests for Residues in Various Crops and Soil].
(Compilation; unpublished study received Jul 23, 1981 under 100-587;
CDL:245628-A)
00080897 Smith, S.H.; O'Loughlin, C.K.; Salamon, C.M.; et al. (1981) Two-generation
Reproduction Study in Albino Rats with Metolachlor Technical: Study No.
450-0272. Final rept. (Unpublished study received Sep 30, 1981 under
100-597; prepared by Whittaker Corp., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:245959-A; 245960; 245961)
00084003 Marias, A.J.; Gesme, J.; Albanese, E.; et al. (1977) Revised Final Report to
Ciba-Geigy Corporation: Carcinogenicity Study with CGA-24705 Technical in
Albino Mice: IBT No. 622-07925 (8532- 07925). (Unpublished study received
Jul 7, 1978 under 100-583; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:097169-A; 097170)
00105957 Ciba-Geigy Corp. (1982) Residues in or on Potato Tubers Resulting from 4.0
Lbs. AI/A Preemergence Applications of Dual 8E or Sequential Applications of
Dual 8E + Sencor/Lexone Tank Mix Preemergence Followed by Dual 8E at
Layby. (Compilation; unpublished study received Jun 25, 1982 under 100-597;
CDL:247756-A)
00106191 Houseworth, L. (1979) Residues of Metolachlor and Metribuzin in Potato
Tubers Resulting from the Use of Metolachlor and Metolachlor/Metribuzin
Tank Mixes for Weed Control in Potato Cu ture: Report No.: ABR-79040.
(Unpublished study received Apr 25, 1979 under 100-583; submitted by
119
-------
BIBLIOGRAPHY
MRID
CITATION
Ciba-Geigy Corp., Greens- boro, NC; CDL:098227-A)
00109613 Ciba-Geigy Corp. (1982) Metolachlor Residues Resulting from the Application
of Dual 15G to Potatoes: Report # ABR-82036. (Compilation; unpublished
study received Aug 12, 1982 under 100-638; CDL:248087-A)
00111693 Ciba-Geigy Corp. (1979) Summary of Metolachlor Residues in Sorghum
Milling Fractions: Report No. ABR-79036. (Compilation; unpublished study
received Mar 16, 1979 under 8F2098; CDL:098010-A)
00117597 Tisdel, M.; MacWilliams, P.; Dahlgren, R.; et al. (1982) Carcinogenicity
Study with Metolachlor in Albino Mice: Study No. 79020. (Unpublished study
received Nov 2, 1982 under 100-587; prepared by Hazleton Laboratories
America, Inc., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:248722-A; 248723; 248724; 248725)
00125227 Ciba-Geigy Corp. (1975) Procyazine-Corn: Tank Mixes with CGA-24705
with and without Fertilizers: Preemergence and Preplant Incorporated
Applications: Procyazine Plus CGA-24705~15% Granule: Summary of
Residue Data. (Compilation; unpublished study received Nov 6, 1975 under
4G1469; CDL:095190-A)
00128731 Ciba-Geigy Corp. (1983) Residues in Forage and Fodder of Vegetable Pod
Crops Resulting from Preplant Incorporated or Preemergence Applications of
Dual 8E, Dual 8E + Premerge 3 or Dual 8E + Eptam 7E. (Compilation;
unpublished study received Jun 16, 1983 under 100-597; CDL:071705-A)
00129058 Cargile, N. (1983) Letter sent to C. Brinkley dated Mar 7, 1983: Dual/cotton
24 (C) supportive data. (Unpublished study received Jun 24, 1983 under AZ
83/5; prepared by Ciba-Geigy Corp., submitted by State of Arizona, Phoenix,
AZ; CDL:250597-A)
00129377 Tisdel, M.; Jackson, T.; MacWilliams, P.; et al. (1983) Two-year Chronic
Oral Toxicity and Oncogenicity Study with Metolachlor in Albino Rats: Study
No. 80030. Final rept. (Unpublished study received May 24, 1983 under
100-587; prepared by Hazleton Raltech, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL: 250369-A; 250370; 250371; 250372; 250373;
250374; 250375)
120
-------
BIBLIOGRAPHY
MRID
CITATION
00131376 Ciba-Geigy Corp. (1983) Residues in or on Stone Fruit Resulting from
Applications of Dual 8E Alone, or in Tank Mixture with Princep SOW or
Princep Caliber 90. (Compilation; unpublished study received Sep 7, 1983
under 100-597; CDL:071927-A)
00150180 Interregional Research Project No. 4 (1984) The Results of Tests on the
Amount of Metolachlor Residues Remaining in or on Chili Peppers.
Unpublished compilation. 36 p.
00151941 Lochry, E. (1985) Embryo/Fetal Toxicity and Teratogenic Potential Study of
CGA-24705 (...) Administered Orally Via Gavage to (...) Presumed Pregnant
Rats: Final Report: Project No. 203-004. Unpublished study prepared by
Argus Research Laboratories, Inc. 178 p.
00156573 Interregional Research Project No. 4 (1986) Petition Proposing a Tolerance for
Metolachlor for Use in Tabasco Pepper Production in Louisiana. Unpublished
study. 122 p. study. 122 p.
40114401 Orr, G. (1987) Disposition of Metolachlor in the Rat: (General Metabolism):
Laboratory/Study No. ABR-86111. Unpublished study prepared by
Ciba-Geigy Corp. 78 p.
40276601 Brown, R.; Lail, L. (1987) Technical Metolachlor: Product Chemistry Data:
Study No. PC-87-019. Unpublished compilation prepared by Ciba-Geigy
Corp. 80 p.
40276602 Brown, R.; Lail, L. (1987) Technical Metolachlor: Product Chemistry Data:
Study No. PC-87-019. Unpublished compilation prepared by Ciba-Geigy
Corp. 115 p.
40430201 Spare, W. (1987) Determination of the Hydrolysis Rate Constants of
Metolachlor: Agrisearch Project No. 1263. Unpublished study prepared by
Agrisearch Inc. 41 p.
40430202 Spare, W. (1987) Determination of the Solution Photolysis Rate Constants and
Photodegradation Products of Metolachlor Under Natural and Artificial Light:
Laboratory Study No. 1261. Unpublished study prepared by Agrisearch Inc.
63 p.
121
-------
BIBLIOGRAPHY
MRID
CITATION
40430203 Spare, W. (1987) Soil Photolysis of Metolachlor Under Natural and Artifical
Light: Laboratory Study No. 1262. Unpublished study prepared by Agrisearch
Inc. 77 p.
40494602 Spare, W. (1987) Leaching Characteristics of Parent Metolachlor: Laboratory
Study No. 1234. Unpublished study prepared by Agrisearch, Inc. 77 p.
40494603 Spare, W. (1987) Leaching Characteristics of Aged Metolachlor: Laboratory
Study No. 1233. Unpublished study prepared by Agrisearch, Inc. 53 p.
40494604 Spare, W. (1987) Determination of Adsorption/Desorption Constants of
Metolachlor: Agrisearch Project No. 1235. Unpublished study prepared by
Agrisearch, Inc. 79 p.
40494605 Spare, W. (1988) Determinations of Adsorption/Desorption Constants of
CGA-51202: Agrisearch Project No. 1266. Unpublished study prepared by
Agrisearch, Inc. 66 p.
40494606 Spare, W. (1987) The Volatilization of Metolachlor from Soil (A Laboratory
Study): Agrisearch Project No. 1260. Unpublished study prepared by
Agrisearch, Inc. 60 p.
40557301 Baron, J. (1988) Metolachlor-Magnitude of Residue on Bell Pepper: Project
ID: PR 1524. Unpublished study prepared by USDA Analytical Laboratories.
201 p.
40644901 Baron, J. (1988) Metolachlor-Magnitude of Residue on Cabbage: Project ID:
IR-4 PR 1527. Unpublished study prepared by USDA Analytical Laboratory.
277 p.
40766601 Simoneaux, B. (1988) Uptake and Characterization of Metolachlor and its
Metabolites in Field and Greenhouse Grown Potatoes: Laborat ory Study No.
ABR-88110. Unpublished study prepared by Ciba-Geigy Corp. 104 p.
40899301 Baron, J. (1988?) Metolachlor-Magnitude of Residue on Cubanelle Peppers:
Project ID: IR-4 Project 3829. Unpublished study prepared by USDA
Environmental Chemistry Laboratory. 77 p.
40980701 Hazelette, J. (1989) Metolachlor Technical: Chronic Toxicity Study in Dogs:
122
-------
BIBLIOGRAPHY
MRID
CITATION
Study No. 862253. Unpublished study prepared by Ciba-Geigy Corp. 758 p.
40980703 Cheung, M. (1989) Residue Stability Study of CGA-37913 and CGA- 49751
(Metolachlor Metabolites) in Beef Muscle, Beef Liver, Dairy Milk, and
Poultry Eggs Under Freezer Storage Conditions (One-Year Interim Report):
Project ID: ABR-88166. Unpublished study prepared by Ciba-Geigy Corp.
65 p.
40980704 Cheung, M. (1989) Residue Summary-Metolachlor Potato Processed
Fractions: Project ID: ABR-88167. Unpublished study prepared by
Ciba-Geigy Corp. 74 p.
40980705 Cheung, M. (1989) Residue Summary—Metolachlor Corn Processed Fractions
(Dry and Wet Milling): Project ID: ABR-88168. Unpublished study prepared
by Ciba-Geigy Corp. 87 p.
40980706 Cheung, M. (1989) Residue Summary—Metolachlor Soybean Processed
Fractions: Project ID: ABR-88169. Unpublished study prepared by
Ciba-Geigy Corp. 71 p.
40980707 Cheung, M. (1989) Residue Summary-Metolachlor Cotton Processed
Fractions: Project ID: ABR-88170. Unpublished study prepared by
Ciba-Geigy Corp. 73 p.
40980708 Cheung, M. (1989) Residue Summary-Metolachlor Peanut Processed
Fractions: Project ID: ABR-88171. Unpublished study prepared by
Ciba-Geigy Corp. 72 p.
41053901 Merricks, D. (1988) Pennant Dislodgeable Residue Study in Southern Turf
Grass: Metolachlor: Final Report: Agrisearch Project No. 12102.
Unpublished study prepared by Agrisearch, Inc. 82 p.
41154201 Fackler, P. (1989) Bioconcentration and Elimination of [Carbon 14] Residues
by Bluegill (Lepomis macrochirus) Exposed to Metolachlor: Laboratory Report
No. 87-9-2505. Unpublished study pre- pared by Springborn Life Sciences,
Inc. 188 p.
41185701 Spare, W. (1989) Aerobic and Anaerobic Aquatic Metabolism of Meta-
lachlor: Final Report: Study No. 1259. Unpublished study prepared by
123
-------
BIBLIOGRAPHY
MRID
CITATION
Agrisearch Inc. 140 p.
41309801 Spare, W. (1989) Soil Metabolism of Metolachlor under Aerobic,
Aerobic/Anaerobic, and Sterile Conditions: Lab Project Number: 1258.
Unpublished study prepared by Agrisearch Inc. in association with Ciba-Geigy
Corp. 130 p.
41309802 Spare, W. (1989) Soil Metabolism of Metalochlor under Aerobic,
Aerobic/Anaerobic, and Sterile Conditions: Lab Project Number: 1258.
Unpublished study prepared by Agrisearch, Inc. 130 p.
41335701 Merricks, D. (1989) Metolachlor Field Dissipation Study in Iowa-Site B:
Final Report: Lab Project Nos. 1264-B; 1264. Unpublished study prepared by
Agrisearch Inc. 300 p.
41470601 Thede, B. (1990) Uptake of [Carbon 14]-Metolachlor in Rotational Crops
grown in Soil which has been Previosly Used for Growing Potatoes: Lab Study
No.: ABR-90037. Unpublished study prepared by Ciba-Geigy Corp. 74 p.
41484201 Merricks, D. (1989) Metolachlor Field Dissipation Study in Iowa- Site A:
Amendment to Final Report: Unpublished study prepared by Ciba-Geigy
Corp. 6 p.
41506501 Cheung, M. (1990) Metolachlor: Response to EPA Deb Review of Residue
Chemistry Data Submitted Under the Metolachlor Frstr: Lab Project Number:
ABR-90045. Unpublished study prepared by Ciba-Geigy Corp. 20 p.
41551201 Baron, J. (1990) Metalochlor: Magnitude of Residue on Celery: Lab Project
Number: IR-4 1337. Unpublished study prepared by USDA- ARS/Beltsville
Agriculture Research Center. 162 p.
41833101 Mastrocco, F.; Huber, K.; Schiavo, D.; et al. (1987) Metolachlor Technical:
21-Day Dermal Toxicity Study in Rabbits: Lab Project Number: 862012.
Unpublished study prepared by Ciba-Geigy Corp. 173 p.
41833102 Murphy, T. (1987) Dermal Absorption of Metolachlor in Rats: Lab Project
Number: ABR-87051. Unpublished study prepared by Ciba- Geigy Corp. in
coop, with WIL Research, Inc. 120 p.
124
-------
BIBLIOGRAPHY
MRID
CITATION
42644301 Wurz, R. (1993) Metolachlor: Validation of Analytical Method AG-338,
Analytical Method for the Residues of Metolachlor Plant Metabolites
Determined as CGA-37913 and CGA-49751 after Acid Hydrolysis with
Modifications for the Determination of Residues of Metolachlor in (carbon
14)-treated Corn and Potatoes from
42644301 Metabolism Studies: Lab Project Number: ABR-92088. Unpublished study
prepared by CIBA-GEIGY Corp. 72 p.
42652101 Fleischmann, T. (1993) Uptake and Metabolism of (carbon 14)-Metolachlor in
Greenhouse Grown Potatoes and Corn: Lab Project Number: ABR-92090:
93-90. Unpublished study prepared by Ciba-Geigy Corp. 170 p.
42810601 Cheung, M. (1993) Metolachlor: Response to EPA Review of Metolachlor
Storage Stability Data Reported in ABR-88168 (Supplement) (MRID No.
42384401) and ABR-92042 (MRID No. 42502901): Lab Project Number:
ABR-88168: ABR-92042. Unpublished study prepared by Ciba-Geigy Corp.,
Residue Chemistry Department. 97 p.
43000101 Kunkel, D. (1993) Metolachlor: Magnitude of Residue on Onion (Dry Bulb):
Lab Project Number: 1520. Unpublished study prepared by USDA. 288 p.
43044000 Industry Task Force II on MCPA Research (1993) Submission of Summary
Hazard Evaluation Data in Support of FIFRA 6(a) (2) for MCPA Acid, DMA
Salt, and 2-EH Ester. Transmittal of 1 Study.
43178401 Grunenwald, M. (1994) Metolachlor: Magnitude of the Residues of
Metolachlor as CGA-37913 and CGA-49751 in or on Field Corn Following
Preplant Incorporated (PPI) and Layby Application of Dual 8E and Dual 25G:
Lab Project Number: ABR/93065: 130377: 42-91. Unpublished study
prepared by Ciba-Geigy Corp. 483 p.
43178402 Grunenwald, M. (1994) Metolachlor: Magnitude of the Residues of
Metolachlor as CGA-37913 and CGA-49751 in Soybeans Following PPI
Application of Dual 25G: Lab Project Number: ABR/93063: 130375: 38-91.
Unpublished study prepared by Ciba-Geigy Corp. 212 p.
43178403 Grunenwald, M. (1994) Metolachlor: Magnitude of the Residues in Cottonseed
Following PRE or PPI Application of Dual 8E to Cotton: Lab Project Number:
125
-------
BIBLIOGRAPHY
MRID
CITATION
ABR/93061: 130373: 36-91. Unpublished study prepared by Ciba-Geigy Corp.
258 p.
43244003 Ham, A. (1994) Metolachlor: Test for Other Genotoxic Effects in the in vivo/
in vitro Assay for Unscheduled DNA Synthesis in Rat Primary Hepatocytes
with Two Timepoints: Final Report: Lab Project Number: 15881/0/494.
Unpublished study prepared by Hazleton Washington, Inc. 46 p.
43263101 Grunenwald, M. (1994) Metolachlor-Magnitude of Residues in Peanuts
Following Application of Dual 25G or 8E: (Data submitted as alternate to
Craven Laboratories generated data): Lab Project Number: ABR-92076.
Unpublished study prepared by Ciba-Geigy Co. 480 p.
43295701 Grunenwald, M. (1994) Metolachlor-Magnitude of the Residues of
Metolachlor as CGA-37913 and CGA-49751 in Succulent and Dried
43295701 Legumes Following Preplant Incorporated (PPI) Application of Dual 8E: (Data
Submitted as Alternate to Craven Laboratories Generated Data): Lab Project
Number: ABR-93084: 39-91: 130376. Unpublished study prepared by
Ciba-Geigy Corp. 355 p.
43367101 Grunenwald, M. (1994) Metolachlor: Magnitude of the Residues in Rotational
Alfalfa and Clover Following PPI Application of Dual 8E to Field Corn: Lab
Project Number: ABR/93-62. Unpublished study prepared by Ciba-Geigy
Corp. 534 p.
126
-------
APPENDIX D. List of Available Related Documents
127
-------
128
-------
The following is a list of available documents related to Metolachlor. 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 Metolachlor and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Appendix A
2. Health and Environmental Effects Science Chapters
3. Detailed Label Usage Information System (LUIS) Report
4. Metolachlor RED Fact Sheet
5. PR Notice 86-5 (included in this appendix)
6. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
129
-------
130
-------
APPENDIX E. PR Notices 86-5 and 91-2
131
-------
132
-------
PR Notice 86-5
133
-------
134
-------
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/""Pno1t° WASHINGTON, B.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of pesticides.
Subject: Standard format for data submitted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental Protection Agency (EPA) in a
standard format. This Notice also provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
requirements for granting or maintaining pesticide registrations, experimental use permits,
tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
are defined in FIFRA §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to be, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice.
OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
135
-------
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8 14
136
-------
D. 5 Good Laboratory Practice Compliance Statement 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then be bound separately.
Submitters sometimes provide additional materials that are intended to clarify,
emphasize, or otherwise comment to help Product Managers and reviewers better understand
the submittal.
- If such materials relate to one study, they should be included as an appendix to that
study.
- If such materials relate to more than one study (as for example a summary of all
studies in a discipline) or to the submittal in general, they must be included in the
submittal package as a separate study (with title page and statement of confidentiality
claims).
B. Transmittal Document
The first item in each submittal package must be a transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted--i.e., a registration application, petition, experimental
use permit (EUPj, §3(c)(2j(B) data call-in, §6(aj(2) submittal, or a special review; the
transmittal date; and a list of all individual studies included in the package in the order of their
appearance, showing (usually by Guideline reference number) the data requirement(s)
addressed by each one. The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be included in the transmittal
document as well, if it is known to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data submittal package supporting a
registration application should be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data submittal package supporting a
petition for tolerance or an application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and an application for a
137
-------
registration or an EUP, list the petition studies first, then the balance of the studies. Within
these two groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range for biorational pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,
151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
138
-------
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely
broad in scope; studies addressing residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Required
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
I, (B).or(C)
Example
Page 12
Page 13
Page 16
If CBI is claimed under FIFRA
§10(d)(l)(A), (B),or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
Page 15
Page 14
139
-------
D.I. Title Page
A title page is always required for each submitted study, published or unpublished.
The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance (s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
b. Data requirement addressed. Include on the title page the Guideline number (s) of the
specific requirement (s) addressed by the study.
c. Author (s). Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or it it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant tacts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
140
-------
D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachment
must be associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list of the points to address in such a statement is included in Attachment 4
on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims must be signed and dated
and must include the typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory work subject to GLP
requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
141
-------
microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies Required - All submittal packages except those associated with a
Registration Standard or Special Review (See Part G below) must be provided In three
complete, identical copies. (The proposed regulations specified two copies; three are now
being required to expedite and reduce the cost of processing data into the OPP Pesticide
Document Management System and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard or Special Review
must be provided in four copies, from one of which all material claimed as CBI has been
excised. This fourth copy will become part of the public docket for the RS or SR case. If no
claims of confidentiality are made for the study, the fourth copy should be identical to the
other three. When portions of a study submitted in support or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
Mark the fourth copy plainly on both its cover and its title page with the phi
"Public Docket Material - contains no information claimed as confidential".
ihrase
142
-------
V. For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
143
-------
ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+ Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+ Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official:
Signature Name
Company Name
Company Contact:
Name Phone
144
-------
ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
145
-------
ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method, can be approved unless the applicant waives all claims of
confidentiality for the analytical method. These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
146
-------
ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
• Identify specifically by page and line number (s) each portion of the study for
which you claim confidentiality.
• Cite the reasons why the cited passage qualifies for confidential treatment.
• Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
• Identify the measures taken to guard against undesired disclosure of this
information.
• Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
• Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
• If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
• If you assert that the information in voluntarily submitted, indicate whether you
believe disclosure of this information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
147
-------
ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PARAGRAPH(S) :
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process § 1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10 (d) (1) (A)
148
-------
ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
149
-------
ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
• Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
:—"]' _. :""; . Supplemental Statement
i...-r--''' i of Confidentiality Claims
• " * When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
150
-------
PR Notice 91-2
151
-------
152
-------
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 or 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
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 158.1/5. 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
153
-------
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes or 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 1, 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 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.
154
-------
(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1557, 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.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
155
-------
156
-------
APPENDIX F. Combined Generic and Product Specific
Data Call-In
157
-------
158
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
0
f WASHINGTON, D.C. 20460
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 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 III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 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).
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:
159
-------
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 - 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 II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: 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.
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).
160
-------
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-ln(s), or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).
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-CalHn Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2 and 3, respectively).
161
-------
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^). 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 Form(s). If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (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) ~~-~
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;
162
-------
(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 compiete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option tor 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^) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
no longer in compliance with this Data Call-In Notice, the Agency will consider that both they
and you are not compliance and will normally initiate proceedings to suspend the registrations
of both your and their product(s), unless you commit to submit and do submit the required
data within the specified time. In such cases the Agency generally will not grant a time
extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
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 weii 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.
163
-------
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 Z and 3, respectively). 1 he Data CallTn
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Caii-ln Response Form uniess 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. 1 he 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 b 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.
164
-------
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)
I have made offers to cost-share (Offers to Cost Share)
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
-i-i.-i. Oj_1\ OJVO
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
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.
165
-------
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing tor 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, 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^) 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)(Bj(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.
166
-------
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:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements or 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
167
-------
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.
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 nurriber 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
168
-------
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.
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 Ya or Yb), 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)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.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 lll.C.l., Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section lll.C.l" Option 4) apply to this option for product specific data.
169
-------
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
llI.C.l., Option b) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section 111.0.17, 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 (lll.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:
(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.
170
-------
(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 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
171
-------
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 Tor your product(s) you must choose a ~~
method or meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days or your receipt or 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.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
JMUTICE
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).
172
-------
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for a generic data exemption either
to:
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.
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.
173
-------
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3 (c) (2) (B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your product (s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of 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
LJJMREASONABLE 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(sj listed in Attachment 1, the Data Call-in Chemical Status
Sheet.
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
174
-------
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 (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Caii-ln and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula, Cost Share and Data Compensation Forms
175
-------
176
-------
Attachment 1. Chemical Status Sheets
177
-------
178
-------
METOLACHLOR DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Metolachlor.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point or contact tor inquiries pertaining to the reregistration of
Metolachlor. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Metolachlor Generic Data Callln (Attachment
F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Metolachlor are contained in the Requirements Status and Registrant's Response, Attachment
C. The Agency has concluded that additional occupational and residential exposure data on
Metolachlor are needed. These data are needed to fully complete the reregistration of all
eligible Metolachlor products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Jane Mitchell at (703) 308-8061.
All responses to this Notice for the generic data requirements should be submitted to:
Jane Mitchell, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Metolachlor
179
-------
METOLACHLOR DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Metolachlor.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact tor inquiries pertaining to the reregistration of
Metolachlor. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Metolachlor Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Metolachlor are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on Metolachlor are needed tor 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 Metolachlor products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Metolachlor, please contact
Jane Mitchell at (703) 308-8061.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Veronica Dutch at (703) 308-8585.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Veronica Dutch
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Metolachlor
180
-------
Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms Plus Instructions
181
-------
182
-------
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 213o, 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.
183
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item l.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
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Caii-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.
184
-------
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."
April 3, 1995
Item Tb.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.
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.
185
-------
186
-------
Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms and Instructions
187
-------
188
-------
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 213TH 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.
189
-------
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.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE HJRMS"
Generic and Product Specific Data Caii-ln
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
190
-------
Item 7.
Item 8.
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
0 Indoor residential
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
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
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
191
-------
date of receipt. However, your response to the Data Call-in itself is due 90
days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of
each code follow. The Data Call-In Notice contains a fuller description of each
of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study and
submit it within the time frames specified in item 8 above. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-In Notice and that I will provide the protocols
and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost 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 existing data outlined in the Data CalHn Notice and I have
attached the needea supporting information along with this response.
192
-------
Options. 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 U) 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.
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.
193
-------
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 tor 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.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that 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
194
-------
Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
195
-------
196
-------
EPA'S BATCHING OF METOLACHLOR PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing the active ingredient
metolachlor, the Agency has batched products which can be considered similar 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.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. 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
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/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 referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the
Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/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 5j 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.
197
-------
The table below shows six batches of registrations.
BATCH NO.
1
2
3
4
5
EPA REG. NO.
&
SLN REG. No.
100-645
100-710
NE 930003
3125-366
ID 900002
62719-239
62719-240
100-627
100-638
100-712
100-597
100-688
100-691
100-711
AZ 830005
FL 900002
% OF METOLACHLOR & OTHER
ACTIVE INGREDIENTS
35.6% - Metolachlor
27.4% - Atrazine
34.8% - Metolachlor
27.4% - Atrazine
35.6% - Metolachlor
27.4% - Atrazine
70.0% - Metolachlor
15.0% - Metribuzin
70.0% - Metolachlor
15.0% - Metribuzin
79.9% - Metolachlor
2.1% - Flumetsulam
79.9% - Metolachlor
2.6% - Flumetsulam
15.0% -Metolachlor
25.0% - Metolachlor
25.0% - Metolachlor
86.4% - Metolachlor
85.1% -Metolachlor
85.1% -Metolachlor
84.4% - Metolachlor
86.4% - Metolachlor
85.1% -Metolachlor
FORMULATION TYPE
Emulsiflable Concentrate
Soluble Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Granular
Granular
Granular
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
BATCH NO.
5
(cont.)
EPA REG. NO.
&
SLN REG. No.
FL 930001
LA 880005
NC 920005
NM 850004
NM 860004
NY 900001
OK 860003
% OF METOLACHLOR & OTHER
ACTIVE INGREDIENTS
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
FORMULATION TYPE
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
198
-------
BATCH NO.
6
EPA REG. NO.
&
SLN REG. No.
OR 910007
OR 930022
TX 830011
VA 920004
WI 890002
WI 940001
100-673
NC 920004
VA 920005
WA 910004
% OF METOLACHLOR & OTHER
ACTIVE INGREDIENTS
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
86.4% - Metolachlor
FORMULATION TYPE
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
Emulsiflable Concentrate
The following two tables show registrations which were not batched for various
reasons such as additional active ingredients not found in any other registrations, significant
differences in the inert ingredients, and significant differences in the concentrations of active
and inert ingredients.
EPA REG. NO.
&
SLN REG. No.
100-587
100-590
100-665
% OF METOLACHLOR & OTHER ACTIVE
INGREDIENTS
95.0% - Metolachlor
27.5% -Metolachlor
20.8% - Atrazine
0.5% - Metolachlor
FORMULATION TYPE
Technical
Emulsiflable Concentrate
Granular
EPA REG. NO.
&
SLN REG. No.
100-715
100-716
100-731
100-747
100-748
% OF METOLACHLOR & OTHER ACTIVE
INGREDIENTS
4.0% - Metolachlor
1 . 0% - Simazine
22.0% - Metolachlor
22.0% - Cyanazine
36.6% - Metolachlor
17.4% - Atrazine
55.0% - Metolachlor
30.6% - Metolachlor
23.2% -Atrazine
FORMULATION TYPE
Granular
Emulsiflable Concentrate
Emulsiflable Concentrate
Water Dispersible Granular
Water Dispersible Granular
199
-------
EPA REG. NO.
&
SLN REG. No.
241-328
10182-134
% OF METOLACHLOR & OTHER ACTIVE
INGREDIENTS
68.5%-Metolachlor
2.74% - Imazethapyr
22.70%-Metolachlor
7.84% - Paraquat Dichloride
FORMULATION TYPE
Soluble Concentrate
Emulsiflable Concentrate
200
-------
Attachment 5. EPA Acceptance Criteria
201
-------
202
-------
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
203
-------
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 < 0.1%.
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 _>_ 0.1% by product analyses and (2) certain lexicologically significant impurities
(see #3).
204
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the information
in items 6, T, 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 tdxTcTmpurities at lower than 0.1% (examples, nitrosamines in the case of products
containing dinitroanilines or containing secondary or tertiary amines/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 now the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant impurities
at < 0.1% along with explanation of how limit determine!!.
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.
205
-------
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 MeltingPoint
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
20-2B°C)
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
206
-------
SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal 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
207
-------
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.
208
-------
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.
7.1 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 oefore 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.
Lj\J\J
-------
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 pm 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.
210
-------
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 particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24nours.
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.
-------
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 <7. or > 11.5.
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 nonirritating 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 snorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
Lj i Lj
-------
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 <2of >11.5.
3. une oflhe 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.
6C 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.
Lj i O
-------
214
-------
Attachment 6. List of All Registrants Sent This Data Call-In Notice
215
-------
216
-------
Attachment 7. Cost Share, Data Compensation Forms, Confidential Statement of
Formula Form and Instructions
217
-------
218
-------
s
s
8
•g.
UJ
5
2
a.
^
o
s
9
h~
8
6
z
CO
O
_^
?
o
Q.
Q.
|
O
11
.^^
10
(0
^J
«N
•
O
uj
1
«
1
"*
'C
3
u
CO
"5
1
j
u
(U
m
c
0
VI
c.
o
3
. E
c »-
•— 1?
to
ir- •*:
-00 O
Environmental Protec
Pesticide Programs (T
Washington, DC 2046O
1 Statement
So* (D
2| ~
•go 0)
£ ."2
3 1^
c
o
o
D.
LJJ
4cff^
^*^^
•fi
0
o
a.
N
1
§
o
u
•a
o
ct
0
CO
tfi
CD
•o
•o
c
(D
E
(0
cvi
I
Q
Q.
N
5
c
(D
W
?
S
CC
~
1
^-
"o
%
0)
•o
c
(D
(D
Z
^
i
E
o
LL
V
^
5
^
c
0
u
CD
b
z
e
(0
0)
\
o>
2
^J
1
i
LU
X)
1
>•
CO
[£
\
b
z
c
o
a
1
a:
*
i
a
z
s
1
a.
m
c
o
U)
c
(D
LU
0)
(Q
\
C
"o
a.
^:
(D
LL,
CT)
X
a.
GO
S
c
ID
Q
J£
OQ
O
. Pounds/Ga
^
- c
o
3
|
|
£
c |
£"*
5"°
•^^
^ s
^ a
n>
"»
1
c *
(D If
00°
E »
O 3
o e_
tsi
igU.0
u_t i— C
UJ C fc
f>
*~ (D
b
Z
0?
(C
<
LU
e & Address
E
z
^
a
3
U)
^
II
./if as actually introdL
nonly accepted chem
tar./
~~KC
irmulatior
G/Ve coi
•dCASnu
"• § "
»3i |
11*
1-2 1
£«•".
3«g-
• o t
2.£g
z
0
UJ
co
<
0.
UJ
O
O
"
£
G)
>
>
2
o
K
•-
"5
u
0
a
c
>
o
Q.
Q
O
E
a
•a
o
a.
(b
2
Q
01
•%
tj
^
•o
-g
§
6
c
o
a.
Q
CM
9
jH
O)
"ra
^
?
i
1
"o
c
CO
219
-------
220
-------
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 4CI 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.
221
-------
222
-------
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
Approval Expires 3-31-96
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, 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 Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide 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)(iii) 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 of Flrm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all 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 of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete-
223
-------
224
-------
United States Environmental Protection Agency -ceo ST**
Washington, DC 20460 ^ _g*J
f S3EZ *
CERTIFICATION WITH RESPECT TO % HiaJIUPi .|-
DATA COMPENSATION REQUIREMENTS **»< mot«>°
Form Approved
OMB No. 2070-01 07,
2070-0057
Approval Expires
3-31-96
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 th
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 Cnief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 40TM 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 Name
Company Number
EPA Reg. No.
I Certify that:
1 . For each study cited in support of registration or reregistratiion under the Federal Insecticide Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
companv(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with section
3(c)(1 )(F) and 3(c](2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FlFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
f ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration
or reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
225
-------
226
-------
APPENDIX G. FACT SHEET
227
-------
228
-------
United States Prevention, Pesticides EPA-738-F-95-007
Environmental Protection And Toxic Substances April 1995
Agency (7508W)
R.E.D. FACTS
Metolachlor
PGStJCJdG All pesticides sold or distributed in the United States must be
RGTGClistration 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 document for
reregistration case 0001, metolachlor.
USG ProfilG Metolachlor is a broad spectrum herbicide used for general weed
control in many agricultural food and feed crops (primarily corn, soybeans
and sorghum), and on lawns and turf, ornamental plants, trees, shrubs and
vines, rights of way, fencerows and hedgerows, and in forestry. The
emulsifiable concentrate formulation is most commonly used, but granular
formulations also are available. Ground application is the use method of
choice for all sites, although aerial, irrigation, and chemigation application
methods also are permitted.
Use practice limitations prohibit applying metolachlor in greenhouses
or other enclosed structures, on muck or peat soils, on sweet potatoes or
yams, to trees or vines transplanted less than 30 days (and only after
depressions around the trees and vines have been filled in), on sand or
loamy sand soils, to trees or vines that will bear harvestable fruit within 12
months, to Taloka Silt Loam, on English peas in Northeastern U.S., and on
sorghum grown under dry-mulch tillage. They also prohibit grazing
livestock in treated areas, feeding or grazing cover crops grown in treated
orchards, and grazing or feeding peanut forage or fodder to livestock for 30
days following application.
-------
Regulatory
History
Human Health
Assessment
Metolachlor was first registered in the U.S. in 1976 for general weed
control on turf. This pesticide was the subject of EPA's first Registration
Standard, in March 1980. The Agency issued a second Registration
Standard for metolachlor in January 1987, and Data Call-In notices in
December 1993 and May 1994.
Toxicity
Metolachlor displayed a low level of toxicity in acute tests. It is
slightly toxic by the oral, dermal, and inhalation routes, and has been placed
in Toxicity Category III (the second-lowest of four categories) for these
effects. It is non-irritating to the eyes and skin (Toxicity Category IV), but
is positive for skin sensitization in guinea pigs.
While a three-month subchronic feeding study in beagle dogs
produced no effects, a six-month study resulted in reduced body weight
gains and food consumption in the high dose dogs. A dermal toxicity study
using New Zealand white rabbits resulted in increased bilirubin, increased
liver weights in males, and increased kidney weights in females. In a
chronic feeding study using beagle dogs, metolachlor caused decreased body
weight gain.
Metolachlor has been evaluated for carcinogenic activity in both rats
and mice. No treatment-related cancer effects were observed in two studies
using mice. In studies using rats, metolachlor caused a significant increase
in liver nodules and carcinomas in high dose females. In 1991, the
Agency's HED Peer Review Committee recommended that metolachlor be
classified as a Group C possible human carcinogen, based on increases in
liver tumors in the female rat. However, a Peer Review conducted in July
1994 recommended a margin of exposure (MOE) approach to assessing
chronic risk since there was no supportable mutagenicity concern, and in
light of new information on the relative metabolism of metolachlor
indicating that formation of the derivative presumed to be the ultimate
carcinogen actually is very low.
Metolachlor shows some evidence of causing developmental toxicity
effects in rats but none in rabbits. It was not mutagenic in several tests.
Dietary Exposure
People may be exposed to residues of metolachlor through the diet.
Tolerances or maximum residue limits have been established for residues
in/on a variety of food and feed commodities including corn, cotton,
peanuts, pod crops, potatoes, safflower, sorghum, soybeans, stone fruits,
tree nuts, nonbearing citrus and grapes, and cabbage; straw, forage and
grain of barley, buckwheat, oats, rice, rye, and wheat; several types of
peppers; and eggs, milk, and the fat, meat and meat byproducts of poultry,
cattle, goats, hogs, horses, and sheep (please see 40 CFR 180.368(a),(b)
and (c)).
-------
Sufficient data are available to determine the adequacy of most
established tolerances. (Certain studies generated by Craven Laboratories
are being replaced.) However, some tolerances need to be revoked, some
need to be replaced, and some separate ones need to be established to bring
them up to date with current commodity definitions.
New food/feed additive tolerances are needed for processed potatoes
(dry peel, wet peel, granules, and waste from processing) and soybean
hulls, and, based on some replacement studies, will likely be needed for
peanuts. Under the Delaney clause of the Federal Food, Drug, and
Cosmetic Act (FFDCA), however, food and feed additive tolerances may
not be established for pesticides that induce cancer in man or animals.
Although its cancer-causing potential in humans is weak, EPA still considers
metolachlor to be a chemical that "induces cancer" within the meaning of
the Delaney clause. Therefore, under current policy EPA would not issue
these food and feed additive tolerances, and would not continue in effect
tolerances for the associated raw agricultural commodities potatoes,
soybeans, and peanuts.
EPA currently is evaluating its policies regarding pesticide tolerances,
registrations, and the Delaney clause in light of ongoing legal challenges.
Because of these issues, the Agency is unable to make a reregistration
eligibility decision at this time regarding the potato, soybean, and peanut
uses of metolachlor.
EPA has assessed the dietary risk posed by metolachlor. The
Anticipated Residue Concentration (ARC) for the overall U.S. population
represents less than 0.2% of the Reference Dose (RfD), or amount believed
not to cause adverse effects if consumed daily over a 70-year lifetime. The
most highly exposed subgroup, non-nursing infants less than one year old,
has an ARC which represents less than 0.6% of the RfD. This low fraction
of the allowable RfD is considered to be an acceptable dietary exposure risk.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders and
applicators) may be exposed to metolachlor during normal use of both
granular and liquid formulations. The potential for post-application
exposure also exists for people entering treated sites. For many uses of
metolachlor, however, this potential is diminished since the herbicide is
incorporated into the soil following application. For post-emergent
applications, especially applications to turf, there is more of a risk of post-
application exposure.
Because metolachlor is a possible human carcinogen and systemic
toxicity may result from intermediate exposure (one week to several
months), EPA assessed exposure and risk to workers using several major
exposure scenarios. Margins of Exposure (MOEs) for subchronic systemic
effects are unacceptable (less than 100) for mixers/loaders during aerial
applications of liquid metolachlor. In addition, MOEs for
-------
mixers/loaders/applicators during ground applications of liquid metolachlor
are acceptable only when certain personal protective equipment (PPE)
(gloves and coveralls) is worn by those handlers.
To mitigate these risks to metolachlor handlers, EPA is requiring use
of a closed mixing and loading system by mixers/loaders supporting aerial
applications of liquid formulations. In addition, mixers/loader/applicators
must wear appropriate PPE--chemical-resistant gloves and coveralls over
short-sleeved shirts and short pants—during/supporting ground applications
of liquid metolachlor formulations.
Post-application exposures do not appear to pose an unreasonable risk
to people entering treated areas, as long as they do not reenter immediately
after application. Therefore, for all uses within the scope of the Worker
Protection Standard (WPS), EPA is requiring a 24-hour restricted entry
interval (REI), strengthening the interim 12-hour REI in place until now, as
well as PPE for workers who enter treated areas before the REI has
expired.
For uses outside the scope of the WPS, EPA is requiring, for liquid
applications, a prohibition on entry until sprays have dried, and for granular
applications, a prohibition on entry until dusts have settled or the treated
area is dry following watering-in.
Human Risk Assessment
Metolachlor is of low acute toxicity but can cause dermal sensitization.
It is classified as a "Group C," possible human carcinogen based on
increases in liver tumors in the female rat. Metolachlor also shows some
evidence of causing developmental toxicity in rats.
Although people may be exposed to residues of metolachlor through
the diet, dietary risks appear to be minimal. Systemic toxicity risks to
certain handlers (mixers/loaders/applicators) are of concern from
intermediate exposure to metolachlor, but will be mitigated by requiring use
of closed mixing and loading systems for aerial applications of liquid
formulations, and use of certain minimum, baseline PPE (gloves and
coveralls) for all handlers during ground use of liquid formulations. To
reduce post-application exposure and risk, a more stringent 24-hour REI is
being imposed, as is early entry PPE.
Environmental Environmental Fate
AsSGSSITIGnt Parent metolachlor appears to be moderately persistent to persistent.
It ranges from mobile to highly mobile in different soils, and has been
detected in ground water. Metolachlor is stable to hydrolysis under normal
environmental conditions. Degradation is dependent on microbially
mediated and abiotic processes. Five major degradates have been identified.
Metolachlor has the potential to range from a moderately mobile to a
highly mobile material in different types of soil. It is persistent in surface
soil with a half-life in the 6-12 inch soil layer ranging from 7 to 292 days.
-------
Detections were made as far as the 36-48 inch soil layer in some tests.
Metolachlor has a low potential to bioaccumulate in fish.
Residues of metolachlor have been detected in ground water in 20
states. Detections in three states have been found to contain residues that
exceed the lifetime Health Advisory of 100 ppb for metolachlor. In five
other states, concentrations in well water exceed 10% of the Health
Advisory Level (HAL). Because of these detections, EPA is concerned
about the degradation of water quality that occurs in metolachlor use areas.
Metolachlor is among the top five pesticides found in surface water in
the mid-western corn belt. It is detected in a high percentage of surface
water samples collected from numerous locations within the corn belt for
several months post-application. Comparable levels are found in streams,
rivers, and reservoirs.
It appears unlikely that metolachlor concentrations will exceed the 1-
10 day or lifetime Health Advisory levels. Although metolachlor is not yet
formally regulated by the Safe Drinking Water Act, water supply systems
are required to sample and analyze for it. EPA will review these data when
they become available.
Ecological Effects
Metolachlor is practically nontoxic to birds on both an acute and a
subacute dietary basis. New avian reproduction studies are required to
determine its chronic toxicity to birds. Metolachlor is moderately toxic to
freshwater fish on an acute basis. It is slightly toxic to aquatic invertebrates
on an acute basis. A reproduction study is required to confirm that chronic
risks to aquatic invertebrates are similar to risks to fish. Metolachlor is
slightly toxic to estuarine fish in acute exposures. Since metolachlor is a
herbicide, potential risk to nontarget plants is likely.
Ecological Effects Risk Assessment
Metolachlor is registered for many outdoor uses. Acute as well as
chronic exposures to nontarget organisms can result from direct
applications, spray drift, and runoff from treated areas.
The level of concern (LOG) for endangered birds is exceeded at an
application rate of 6 Ibs active ingredient (ai) per acre. In addition, the
LOG is exceeded for waterfowl at 6 Ibs. ai/acre in short grass.
In addition, the endangered species LOG is exceeded for small
mammals eating short grass at an application rate of 2 Ibs/acre. The
endangered species and restricted use LOCs are exceeded for small
mammals eating short grass at an application rate of 4 Ibs./acre and higher.
Although no acute effects to aquatic organisms are expected as a result
of exposure to metolachlor in deeper water, freshwater fish (the most
sensitive aquatic species) trigger the endangered species LOG in a shallow
water body one foot deep or less. Risk to non-target plants also is expected.
In summary, endangered species levels of concern are exceeded in
some circumstances for birds, small mammals, and endangered fish.
-------
Risk Mitigation
Additional Data
Required
Limitations may be imposed on the use of metolachlor in the future to
protect threatened and endangered species when EPA implements the
Endangered Species Protection Program.
EPA is requiring the following risk mitigation measures for
metolachlor, as discussed earlier:
° An environmental hazard statement is required on product labeling to
protect endangered plants.
° Metolachlor will be considered a candidate for classification as a
restricted use pesticide for groundwater concerns when the Restricted Use
Rule for Ground Water goes into effect.
° Since metolachlor has been detected in ground water as a result of normal
agricultural use, EPA will consider metolachlor as a candidate for state
management plans when the State Management Plan rule is promulgated.
0 The ground water advisory on existing product labels must be modified
to reflect current advisory language.
° A surface water advisory also is required since metolachlor can
contaminate surface water through ground spray drift and run-off.
° Interim spray drift advisory language must be placed on product labels.
° Metolachlor products applied as liquids that have uses within the scope of
the WPS warrant the establishment of minimum PPE requirements for
handlers. In addition, mixers and loaders must use closed mixing systems to
support aerial applications (see discussion above).
° EPA also is requiring a strengthened 24-hour REI for uses that are within
the scope of the WPS.
° Early entry PPE for dermal protection also is required for emulsifiable
concentrate formulations.
° Certain entry restrictions also are required for uses outside the scope of
the WPS and for homeowner use products.
° To protect ground water, EPA is requiring two small-scale prospective
ground water studies on metolachlor, as well as a report on the results of a
19-state monitoring program.
Label statements also are required to reduce mixing and loading risks.
EPA is requiring the following generic studies for metolachlor to
confirm its regulatory assessments and conclusions: a Foliar Residue
Dissipation study and a Dermal Passive Dosimetry Exposure study for use
on residential turf. The Agency also is requiring product-specific data
including product chemistry and acute toxicity studies, revised Confidential
Statements of Formula (CSFs), and revised labeling for reregistration.
Product Labeling
All metolachlor end-use products must comply with EPA's current
-------
ChangGS pesticide product labeling requirements, and with the following (for detailed
RGCjUJrGd labeling instructions, please see the metolachlor RED):
Personal Protective Equipment (PPE) Requirements for Pesticide
Handlers
Sole-active-ingredient products must be revised to adopt the PPE
requirements set forth in this section. Any conflicting PPE requirements on
current labeling must be removed. Multiple-active-ingredient products must
compare these handler PPE requirements to those on current labeling and
retain the more protective.
Handler PPE for Occupational-Use Products (products NOT
intended primarily for home use):
Minimum (Baseline) Personal Protective Equipment Requirements: Some
uses of metolachlor are within the scope of the Worker Protection Standard
(WPS) and some are outside its scope. The minimum (baseline) PPE
requirements pertain to both the WPS and nonWPS uses by occupational
handlers, since potential exposure is similar.
Granular Formulations: The Agency is establishing no minimum
(baseline) PPE for WPS and nonWPS uses of metolachlor products
formulated as granules.
EC Formulations: The minimum (baseline) PPE for all WPS and
nonWPS occupational uses of metolachlor products formulated as liquids is:
"Applicators and other handlers must wear:
—Coveralls over short-sleeved shirt and short pants
—Chemical-resistant gloves (see instructions * below)
—Chemical-resistant footwear plus socks
—Chemical-resistant headgear for overhead exposure
—Chemical-resistant apron when cleaning equipment, mixing, or
loading" (see instructions ** below)
* The glove statement for metolachlor is the statement established
through instructions in Supplement Three of PR Notice 93-7.
** The words "mixing, or loading" may be removed if the product is
formulated as "ready-to-use."
Actual End-Use Product Personal Protective Equipment Requirements: The
PPE that would otherwise be established based on the acute toxicity of each
end-use product must be compared to the minimum (baseline) PPE specified
above, and the more protective must be placed on product labeling.
Placement in Labeling: The PPE must be placed on end-use product
labeling in the location specified in PR Notice 93-7, and the format and
language of the PPE requirements must be the same as specified there.
Products Intended Primarily for Homeowner Use:
-------
EPA is not establishing minimum (baseline) handler PPE for metolachlor
end-use products intended primarily for homeowner use. Any necessary
PPE will be established based on the acute toxicity of the end-use product.
Placement in Labeling: PPE requirements, if any, must be placed on end-
use product labeling immediately following the precautionary statements in
"Hazards to Humans (and domestic animals)."
Entry Restrictions
Sole-active-ingredient products must be revised to adopt the entry
restrictions set forth in this section. Any conflicting entry restrictions on
current labeling must be removed. Multiple-active-ingredient products must
compare the entry restrictions set forth in this section to those on 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."
Occupational-Use Products (products NOT intended primarily for
home use):
-Uses Within the Scope of the WPS:
Restricted-Entry Interval: A 24-hour restricted entry interval (REI) is
required for uses within the scope of the WPS on all end-use products.
Early-Entry Personal Protective Equipment (PPE):
EC Formulations: The PPE required for early entry following
applications of the emulsifiable concentrate is:
—coveralls over short-sleeve shirt and short pants,
—chemical-/resistant gloves,
—chemical-resistant footwear plus socks,
—chemical-resistant headgear for overhead exposures.
Granular Formulations: The PPE required for early entry following
applications of granular formulation is:
—coveralls,
—chemical-resistant gloves,
—shoes plus socks.
Placement in Labeling: The REI must be inserted into the standardized REI
statement and the PPE required for early entry must be inserted into the
standardized early entry PPE statement required by Supplement Three of PR
Notice 93-7.
-Uses Not Within the Scope of the WPS:
For liquid applications:
"Do not enter or allow others to enter the treated area until
sprays have dried."
For granular applications:
-------
"Do not enter or allow others to enter the treated area until dusts
have settled. If soil incorporation is required following the
application, do not enter or allow others to enter the treated area
(except those persons involved in the incorporation) until the
incorporation is complete. If the incorporation is accomplished
by watering-in, do not enter or allow others to enter the treated
area until the surface is dry following the watering-in."
Placement in Labeling:
If WPS uses also are on label: Follow instructions in PR Notice 93-7
for establishing Non-Agricultural Use Requirements box and place
appropriate nonWPS entry restriction in that box.
If no WPS uses are on label: Add appropriate nonWPS entry
restriction to labels of all end-use products, except products primarily
intended for homeowner use, in a section in the Directions For Use with the
heading: "Entry Restrictions:"
Products Primarily Intended for Home Use:
For liquid applications:
"Do not enter or allow others to enter the treated area until
sprays have dried."
For granular applications:
"Do not enter or allow others to enter the treated area until dusts
have settled. If soil incorporation is required following the
application, do not enter or allow others to enter the treated area
(except those persons involved in the incorporation) until the
incorporation is complete. If the incorporation is accomplished
by watering-in, do not enter or allow others to enter the treated
area until the surface is dry following the watering-in."
Placement in Labeling: Add entry restriction to labels of products primarily
intended for homeowner use in section in Directions For Use with the
heading: "Entry Restrictions:"
Other Labeling Requirements
The Agency is requiring the following labeling statements on all
metolachlor end-use products intended primarily for occupational use:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
Engineering Controls:
"Mixers and loaders supporting aerial applications are required to use
closed systems. The closed system must be used in a manner that
meets the requirements listed in the Worker Protection Standard
(WPS) for agricultural pesticides (40 CFR 170.240(d) (4). When
-------
using the closed system, the mixers' and loaders' PPE requirements
may be reduced or modified as specified in the WPS."
"When handlers use closed systems, enclosed cabs, or aircraft in a
manner that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides (40 CFR 170.240(d) (4-6),
the handler PPE requirements may be reduced or modified as
specified in the WPS."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible,
wash thoroughly and change into clean clothing."
Skin Sensitizer Statement:
Because metolachlor is classified as a skin sensitizer, EPA is requiring
the following statement in the "Hazards to Humans (and Domestic
Animals)" section of the Precautionary Statements on the labeling of
all end-use products:
"This product may cause skin sensitization reactions in some people."
Soil Incorporation Statement:
Registrants may add the following statement to their labeling in the
Agricultural Use Requirements box immediately following the restricted
entry interval:
"Exception: if the product is soil-incorporated, the Worker Protection
Standard, under certain circumstances, allows workers to enter the
treated area if there will be no contact with anything that has been
treated."
Environmental Hazard Statement
"Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high-water mark. Do not
contaminate water when disposing of equipment wash water or
rinsate."
Rotational Crops Restriction
"Do not rotate to food or feed crops other than those listed on this
label."
Ground Water Labeling/Mitigation; Mixing/Loading
10
-------
The following language regarding mixing/loading setbacks must
appear in Precautionary Statements in the Environmental Hazards section of
the label:
"This product may not be mixed or loaded within 50 ft. of perennial
or intermittent streams and rivers, natural or impounded lakes and
reservoirs. This product may not be mixed/loaded or used within 50
ft. of all wells, including abandoned wells, drainage wells, and sink
holes. Operations that involve mixing, loading, rinsing, or washing of
this product into or from pesticide handling or application equipment
or containers within 50 ft. of any well are prohibited unless conducted
on an impervious pad constructed to withstand the weight of the
heaviest load that may be positioned on or moved across the pad.
Such a pad shall be designed and maintained to contain any product
spills or equipment leaks, container or equipment rinse or wash-water,
and rain water that may fall on the pad. Surface water shall not be
allowed to either flow over or from the pad, which means the pad
must be self-contained. The pad shall be sloped to facilitate material
removal. An unroofed pad shall be of sufficient capacity to contain at
a minimum 110% of the capacity of the largest pesticide container or
application equipment on the pad. A pad that is covered by a roof of
sufficient size to completely exclude precipitation from contact with
the pad shall have a minimum containment capacity of 100% of the
capacity of the largest pesticide container or application equipment on
the pad. Containment capacities as described above shall be
maintained at all times. The above-specified minimum containment
capacities do not apply to vehicles when delivering pesticide shipments
to the mixing/loading site."
Ground Water Advisory
The following ground water advisory language must be placed on all
metolachlor labels:
"This chemical is known to leach through soil into ground water under
certain conditions as a result of agricultural use. Use of this chemical
in areas where soils are permeable, particularly where the water table
is shallow, may result in ground-water contamination."
Surface Water Advisory
The following surface water advisory language must be placed on all
metolachlor labels:
"Metolachlor can contaminate surface water through ground spray
drift. Under some conditions, metolachlor may also have a high
potential for runoff into surface water (primarily via dissolution in
runoff water), for several months post-application. These include
poorly draining or wet soils with readily visible slopes toward adjacent
11
-------
surface waters, frequently flooded areas, areas over-laying extremely
shallow ground water, areas with in-field canals or ditches that drain
to surface water, areas not separated from adjacent surface waters
with vegetated filter strips, and areas over-laying tile drainage systems
that drain to surface water."
Endangered Plants Labeling
The following is required in the general information section of label:
"Do not apply under conditions which favor runoff or wind erosion of
soil containing this product to non-target areas."
To prevent off-site movement due to run-off or wind erosion:
"Avoid treating powdery dry or light sand soils when conditions are
favorable for wind erosion. Under these conditions, the soil surface
should first be settled by rainfall or irrigation."
"Do not apply to impervious substrates such as paved or highly
compacted surfaces."
"Do not use tailwater from the first flood or furrow irrigation of
treated fields to treat non-target crops unless at least 1/2 inch of
rainfall has occurred between application and the first irrigation."
Spray Drift Labeling
The following language must be placed on the label of each product
that can be applied aerially:
"Avoiding spray drift at the application site is the responsibility of the
applicator. The interaction of many equipment-and-weather-related
factors determine the potential for spray drift. The applicator and the
grower are responsible for considering all these factors when making
decisions.
"The following drift management requirements must be followed to
avoid off-target drift movement from aerial applications to agricultural
field crops. These requirements do not apply to forestry applications,
public health uses or to applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not
exceed 3/4 the length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream
and never be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be
observed.
"The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory
Information."
Aerial drift reduction advisory information must be contained in
product labeling. See the metolachlor RED document for this additional
required labeling.
12
-------
Regulatory
Conclusion
For More
Information
The use of currently registered products containing metolachlor, in
accordance with labeling amended to reflect the risk mitigation measures
imposed by this RED, generally will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products,
except on potatoes, soybeans, and peanuts, are eligible for reregistration.
EPA is unable to make a reregistration eligibility decision regarding
the potato, soybean, and peanut uses because, under current policy, the food
and feed additive tolerances needed to support these uses appear to be barred
by the Delaney clause in the FFDCA.
Metolachlor products with eligible uses will be reregistered once the
required product-specific data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for metolachlor 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.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA. GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the metolachlor RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the metolachlor RED, or reregistration of individual products containing
metolachlor, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, 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-
is
-------
free 1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard
Time, Monday through Friday.
14
------- |