United States Prevention, Pesticides EPA 738-R-94-024
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
4>EPA Reregistration
Eligibility Decision (RED)
Fenbutatin-oxide
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.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 which includes the
active ingredient fenbutatin-oxide. The enclosed Reregistration Eligibility Decision (RED)
contains the Agency's evaluation of the data base of this chemical, its conclusions of the
potential human health and environmental risks of the current product uses, and its decisions
and conditions under which these uses and products will be eligible for reregistration. The
RED includes the data and labeling requirements for products for reregistration. It may also
include requirements for additional data (generic) on the active ingredient to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. 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
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Susan Jennings at (703) 308-8021.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. Complete the two
response forms provided with each DCI letter by following the instructions contained in each
DCI. You must submit the response forms for each product and for each DCI within 90
days of the date you receive the RED; otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER 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 RED
issuance date (the cover letter date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in
item 5.
b. Five copies of draft labeling which complies with the RED and current
regulations and requirements. Only make labeling changes which are required by the
RED and current regulations (40 CFR 156.10) and policies. Submit any other
amendments (such as formulation changes, or labeling changes not related to
reregistration) separately. You may delete uses which the RED says are ineligible for
reregistration. For further labeling guidance, refer the labeling section of the EPA
publication "General Information on Applying for Registration in the U.S., Second
Edition, August 1992" (available from the National Technical Information Service,
publication #PB92-221811; 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the
EPA identifier (MRID) numbers. Before citing these studies, you must make sure
that they meet the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (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.
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e. Certification With Respect to Citation of Data. Complete and sign this form
(EPA form 8570-29) for each product. Cite-all is not a valid option for
reregistration.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE
Comments pertaining to the content of the RED may be submitted to the address shown
in the Federal Register Notice which announces the availability of this RED.
5. WHERE TO SEND ALL PCI RESPONSES (90-DAY) AND APPLICATIONS
FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-XXXX)* * XXXX = the
Office of Pesticide Programs (H7504C) case code for the
EPA, 401 M St. S.W. RED (see front
Washington, D.C. 20460-0001 cover of RED)
By express:
Document Processing Desk (RED-SRRD-XXXX)*
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Fenbutatin- Oxide
LIST A
CASE 0245
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
FENBUTATIN-OXIDE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 5
E. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Chronic Toxicity 8
d. Carcinogenicity 9
e. Developmental Toxicity 9
f. Reproductive Toxicity 10
g. Mutagenicity 10
h. Metabolism 11
i. Reference Dose 12
2. Exposure Assessment 12
a. Dietary Exposure 12
b. Occupational and Residential Exposure 14
3. Risk Assessment 16
a. Dietary 16
b. Occupational and Residential 17
C. Environmental Assessment 18
1. Environmental Chemistry, Fate and Transport 18
a. Hydrolysis 18
b. Photodegradation in Water 19
c. Photodegradation on Soil 19
d. Aerobic Soil Metabolism 19
e. Anaerobic Soil Metabolism 19
f. Leaching and Adsorption/Desorption 19
g. Soil Field Dissipation 20
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h. Long-Term Soil Field Dissipation 20
i. Accumulation in Fish 21
2. Environmental Fate Assessment 21
3. Ecological Effects 23
a. Acute Toxicity to Birds 24
b. Chronic Toxicity to Birds 24
c. Acute Toxicity to Freshwater Fish 25
d. Chronic Toxicity to Freshwater Fish 26
e. Acute Toxicity to Freshwater Invertebrates 26
f. Chronic Toxicity to Freshwater Invertebrates 26
g. Acute Toxicity to Estuarine and Marine Organisms 26
h. Chronic Toxicity to Estuarine and Marine Organisms ... 27
i. Non-Target Insects Data 27
j. Non-Target Plants Data 27
k. Other Non-Target Terrestrial Organisms 28
1. Field Residue Monitoring Studies 28
4. Ecological Effects Risk Assessment 29
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 39
A. Determination of Eligibility 39
1. Eligibility Decision 40
2. Eligible and Ineligible Uses 40
B. Regulatory Position 40
1. Risk Mitigation Measures 40
2. Restricted Use Classification 41
3. Tolerance Reassessment 42
4. Endangered Species Statement 48
5. Labeling Rationale 48
V. ACTIONS REQUIRED BY REGISTRANTS 51
A. Manufacturing-Use Products 51
1. Additional Generic Data Requirements 51
2. Labeling Requirements for Manufacturing-Use Products 51
B. End-Use Products 52
1. Additional Product-Specific Data Requirements 52
2. Labeling Requirements for End-Use Products 52
C. Existing Stocks 55
VI. APPENDICES 57
APPENDIX A. Table of Use Patterns Subject to Reregistration 59
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 71
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Fenbutatin-oxide 81
APPENDIX D. List of Available Related Documents 101
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APPENDIX E 105
PR Notice 86-5 107
PR Notice 91-2 125
APPENDIX F. Combined Generic and Product Specific Data Call-In 131
Attachment 1. Chemical Status Sheets 149
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions 153
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
159
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 167
Attachment 5. EPA Acceptance Criteria 171
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
185
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 187
APPENDIX G. FACT SHEET 197
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FENBUTATIN-OXIDE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Eric Maurer
Gabe Patrick
Doug Sutherland
Environmental Fate and Effects Division
Kathy Monk
Dana Spatz
Ron Parker
Allen Vaughan
Health Effects Division
Leung Cheng
Jeff Evans
Charles Frick
Joycelyn Stewart
Registration Division
Carl Andreason
Mary Waller
Special Review and Reregistration Division
Lawrence Schnaubelt
Susan Jennings
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemistry Branch II
Occupational and Residential Exposure Branch
Chemical Coordination Branch
Toxicology Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
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
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
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
LD
50
LDlo
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
PPE
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Analytical Method
Personal Protective Equipment
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration 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
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision Document (RED) addresses the reregistration
eligibility of the pesticide fenbutatin-oxide, Bis [tris (2-methyl-2-phenylpropyl)tin] oxide or
hexakis (2-methyl-2-phenylpropyl)-distannoxane. Fenbutatin-oxide is a foliarly applied
pesticide produced by E.I. DuPont de Nemours and Company for use on citrus, apples and
stone fruits for the control of mites. Fenbutatin-oxide formulations include wettable powder,
emulsifiable concentrate and soluble concentrate. Fenbutatin-oxide is applied aerially or
through airblast or groundboom equipment.
Fenbutatin-oxide was initially registered in the United States in October 1974 for use as
a miticide (acaricide) by Shell Chemical Company. The first end-use product was registered
in August 1975 for use on apples, pears and some citrus crops. Since that time, several other
food crops and outdoor and greenhouse ornamentals have been added to the label. The
registration was transferred to E.I. DuPont de Nemours and Company in October 1986. A
Registration Standard for fenbutatin-oxide was issued in March 1987 (NTIS #PB87-190690)
and evaluated the studies submitted to support the registration of the miticide. The
Registration Standard also required additional product chemistry, ecotoxicity, human toxicity,
occupational exposure, environmental fate and residue chemistry information. The Agency
has now completed its review of the fenbutatin-oxide data base including the data submitted in
response to the 1987 Registration Standard.
The Agency has determined that the uses of fenbutatin-oxide will not cause
unreasonable risk to humans or the environment and that these uses are eligible for
reregistration, provided certain risk mitigation measures are implemented and that the use of
fenbutatin-oxide is restricted to pesticide certified applicators. These actions and the
corresponding monitoring program are necessary due to fenbutatin-oxide's very high toxicity
to aquatic organisms. The Agency is requiring additional studies for product chemistry,
bioaccumulation in fish and spray drift. These data are confirmatory and are not expected to
change the regulatory decision on fenbutatin-oxide.
Based on the results of its reregistration review, the Agency classified fenbutatin-oxide
as a Group E carcinogen (signifies evidence of non-carcinogenicity in humans) and established
a reference dose of 0.05 mg/kg/day. The reference dose is based on a NOEL of 5.2
mg/kg/day for reduced body weight and food consumption in both sexes of pups of the first
and second generations at 17.4 and 20.3 mg/kg/day in a two-generation study in rats. The
dietary risk assessment is based on a worst-case scenario, assuming treatment of 100% of
acreage and highest legal residue values which result in an overestimation of exposure and
risk. However, when using anticipated residues, none of the population subgroups has an
exposure which exceeds 10% of the RfD. A reassessment of tolerances is included in this
document with recommended changes to some previously established tolerances.
Available data indicate that fenbutatin-oxide is practically non-toxic to birds on an
acute basis and extremely toxic to both freshwater and estuarine aquatic organisms. However,
VI
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because the chemical binds strongly to soil, it may be less available to fish in the water
column. The miticide presents some risk to birds and mammals and considerable risk to
aquatic organisms on a chronic basis. Fenbutatin-oxide is relatively immobile and persistent in
the environment, with no apparent major route of dissipation. To reduce the risks to aquatic
organisms, the Agency is reclassifying fenbutatin-oxide products to be used only by pesticide
certified applicators. The registrant has also agreed to a series of risk mitigation measures,
including an educational program for the applicators, application rate reductions and use
restrictions/limitations. The registrant will also institute a monitoring program, including
more accurate aquatic models and sediment sampling, to assess the adequacy of the mitigation
measures. These measures are discussed in more detail in the Risk Management and
Reregistration Decision section.
Before reregistering the products containing fenbutatin-oxide, the Agency is requiring
that product specific data, revised Confidential Statements of Formula (CSF) and revised
labeling be submitted within eight months of the issuance of this document. These data
include product chemistry for each registration and acute toxicity testing. 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 are
determined to be eligible for reregistration.
vn
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of fenbutatin-oxide. The document consists of six sections. Section I is the
introduction. Section II describes fenbutatin-oxide, 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 fenbutatin-oxide.
Section V discusses the reregistration requirements for fenbutatin-oxide. Finally, Section VI is
the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available upon request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
• Common Name: Fenbutatin-oxide
Chemical Name: Bis [tris (2-methyl-2-phenylpropyl)tin] oxide
or hexakis (2-methyl-2-phenylpropyl)-distannoxane
• Chemical Family: Organotin
• CAS Registry Number: 13356-08-6
• OPP Chemical Code: 104601
• Empirical Formula: C60H78OSn2
• Trade Name: Vendex
• Basic Manufacturer: E.I. DuPont de Nemours and Company
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 for fenbutatin-oxide is
in Appendix A.
For fenbutatin-oxide:
Type of Pesticide: non-systemic organotin acaricide
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Use Sites: greenhouse food/non-food crop, terrestrial food/non-food
crop
Target Pests: mites, aphids, thrips, mealybugs, white flies and scales
Formulation Types Registered: technical grade (98%), wettable powder
(50%), emulsifiable concentrate (42%),
soluble concentrate (less than 1%, 42%)
Method and Rates of Application:
Equipment - aerial, airblast and groundboom
Method and Rate - Foliar application is mostly by ground equipment,
with some aerial application. Maximum
application rate varies from 1.25 Ibs. a.i./A on
tree nuts to 2 Ibs. a.i./A on citrus and eggplant.
Timing - Application frequencies per year range from twice
(citrus, stone fruits and tree nuts) to four (pome
fruits and strawberries) to nine (papayas).
Use Practice Limitations: None
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
fenbutatin-oxide. These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and
site (crop) basis, reflect annual fluctuations in use patterns as well as the variability in
using data from various information sources.
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The table below summarizes fenbutatin-oxide's percent of U.S. crops treated
annually from 1989-1991:
Site1
Almonds
Apples
Cherries
Eggplant
Grapefruit
Grapes
Lemons
Oranges
Peaches
Pears
Plums/Prunes
Raspberries
Tangerines
Walnuts
Total
Acres
Grown2
(000)
401
482
98
5
144
741
63
622
186
71
131
11
17
180
3,152
Multiple
Acres Treated
(000)
15-30
5- 15
1 -2
1 -2
75-95
25-55
2-5
230-255
5- 10
1 -5
1 -2
1 -2
1 - 10
3-5
366 - 493
Percent
Crop
Treated
4-7
1 -3
1 -2
<1
52-66
3-7
3- <10
37-41
3-5
1 - <10
<1
<1
6-59
2-3
N/A
Pounds AI
Applied
(000)
10-30
1 - 10
1 -2
1 -2
70- 120
20-45
2-5
245 - 280
2-6
1 -5
1
1
5- 10
1 -5
361 -522
There are no known usage data available for Christmas trees, ornamentals, papaya, and
aquatic sites. There is no known usage on pecans and strawberries. Data based on
proprietary sources, DuPont, USDA, and state statistics.
1 Site identification based on EPA's Reference Files System.
2 1989 acreage was the most consistent source (USDA/NASS), although not the only one used.
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D. Data Requirements
Data requested in the March 31, 1987, Registration Standard for fenbutatin-
oxide included studies on product chemistry, residue chemistry, ecological effects,
environmental fate, toxicology, and occupational and residential exposure. These data
were required to support the uses listed in the Registration Standard. Appendix B
includes all data requirements identified by the Agency that are needed to support
reregistration of currently registered uses.
E. Regulatory History
Fenbutatin-oxide was registered in the United States in October 1974 for use as
a miticide (acaricide) by Shell Chemical Company. The first end-use product was
registered in August 1975 for use on apples, pears and some citrus crops. Since that
time, several other food crops and outdoor and greenhouse ornamentals have been
added to the labeling. The registration was transferred to E.I. DuPont de Nemours and
Company in October 1986. A Registration Standard for fenbutatin-oxide was issued in
March 1987 (NTIS #PB87-190690) which evaluated the studies submitted to support
the registration of the miticide. This Reregistration Eligibility Decision reflects a
reassessment of all data which were submitted in response to the Registration Standard.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Fenbutatin-oxide [hexakis(2-methyl-2-phenylpropyl)distannoxane] is a non-
systemic organotin acaricide with the following molecular structure:
Fenbutatin- Oxide
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The physical and chemical characteristics of the TGAI of fenbutatin-oxide
[hexakis(2-methyl-2-phenylpropyl)distannoxane] are described below (MRID's
00053791, 00113071, 40365801, 40506901, 40590501, 40696401, 40696402 and
40843601):
Color: White
Physical State: Crystalline solid
Odor: Odorless
Melting Point: 145° C
Density: 0.42g/cm3
Solubility: Soluble in water at only 12.7 ppb at 20° C.
Organic solvent solubilities range from 377 to 6
g/L, with solubility in dichloromethane > benzene
> xylene > octanol > acetone (23° C)
pH: Data Gap
The Agency has evaluated the product chemistry data base and has concluded
that available preliminary analysis data are not fully acceptable and additional data must
be submitted. Although data gaps exist for the formation of impurities and pH
(guidelines 61-2b and 63-12), the Agency considers the requirement of these studies as
confirmatory and not critical to the reregistration eligibility decision. The data
requirements and the data gaps are given in Appendix B.
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B. Human Health Assessment
1. Toxicology Assessment
The March 31, 1987, Registration Standard required the following
toxicology studies:
Acute Oral Toxicity
Acute Inhalation Toxicity - Rat
90-Day Feeding - Non-Rodent
21-Day Dermal - Rabbit
Chronic Toxicity - Non-Rodent
Oncogenicity - Mouse
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
The toxicological data base on fenbutatin-oxide is adequate and will
support reregistration eligibility. The data requirements are listed in Appendix
B and summaries of available studies are provided below.
a. Acute Toxicity
Technical fenbutatin-oxide (hexakis, Vendex) 98% a.i.
demonstrated an acute oral LD50 of 4400 mg/kg in rats. An acute
dermal toxicity study in rabbits demonstrated an LD50 of more than 2000
mg/kg, while the acute inhalation LC50 in rats was 0.074 mg/L.
Fenbutatin-oxide was a severe eye irritant when tested in rabbits' eyes
and produced only mild erythema and edema when a dose of 0.5 gram
was tested in rabbits' skin. Guinea pigs did not demonstrate dermal
sensitization when challenged with up to 10% fenbutatin-oxide solution.
The table below summarizes the values and categories for the
various acute toxicity studies.
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Test
Oral LD5n
Dermal LD50 - Rabbit
Inhalation LC50
Eye Irritation - Rabbit*
Dermal Irritation*
Dermal Sensitization*
Result
4400 mg/kg
> 2000 mg/kg
0.074 mg/kg
Severe
Mild
None
Category
3
3
2
1
4
N/A
MRID No.
40473504
00112990
40473502
40473503
00112990
00112990
00112990
Data pertaining to acute eye irritation, dermal irritation and dermal
sensitization are not required to support the reregistration of the TGAI.
These data are presented for informational purposes.
b. Subchronic Toxicity
When technical fenbutatin-oxide was administered by dermal
application to rabbits for three weeks at doses of up to 5 mg/kg/day no
systemic toxicity was demonstrated. Locally, erythema and edema were
observed at 0.5 mg/kg/day. (MRID 40641201)
c. Chronic Toxicity
When fenbutatin-oxide was administered to rats at dietary levels
of 0, 50, 100, 300 and 600 ppm (equivalent to 0,2.5, 5.0, 15 and 30
mg/kg/day) for two years, the NOEL for systemic toxicity was 100 ppm
and the LEL was 300 ppm. The LEL was based on decreased
leucocytes in female rats and reduced body weight in both sexes at all
reporting points (3, 6, 12 and 24 months). At the mid- and high-dose
levels, serum alkaline phosphatase was reduced and testes weight was
increased in males. There was no correlative testicular histopathology.
(MRID's 00037582, 00067049, 00113001)
A chronic dog study, in which fenbutatin-oxide was administered
in gelatin capsules for two years at doses ofO, 2.5, 5.0, 15, 30 and 60
mg/kg/day, did not demonstrate any toxicity other than clinical
observations of vomiting and diarrhea at doses of 15 mg/kg/day or
more. The NOEL was 5 mg/kg/day and the LEL was 15 mg/kg/day
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(MRID 00113002). Additional data submitted in response to the
Registration Standard substantiated these results (MRID's 40977001,
41192401).
d. Carcinogenicity
When fenbutatin-oxide was administered to rats at dietary levels
of 0, 50, 100, 300 and 600 ppm for two years, no increase in tumor
incidence was observed at any dosage. The chemical was tested at
adequate dose levels, since there was a significant decrease in body
weight for both sexes receiving 300 and 600 ppm of the chemical.
(MRID's 00037582, 00067049, 00113001)
Fenbutatin-oxide was tested in mice at dietary levels of 0, 50,
100, 300 and 600 ppm (equivalent to 0, 7.5, 15, 45 and 90 mg/kg/day).
No increase in tumor incidence was observed at the highest dose tested.
The study was conducted at adequate dosage, since there was a
significant decrease in body weight for animals administered 300 and
600 ppm. The NOEL and LEL were 100 and 300 ppm, respectively,
and were based on the body weight changes. (MRID's 00037581,
00067048, 00113000)
The Agency has classified fenbutatin-oxide as "Group E" for
carcinogenic potential, indicating evidence of non-carcinogenicity for
fenbutatin-oxide.
e. Developmental Toxicity
Mated female rats were administered fenbutatin-oxide (98.7%
a.i.) by gavage at doses of 0, 15, 30 and 60 mg/kg/day from the sixth
day through the fifteenth day of gestation. Aspirin (300 mg/kg) served
as the positive control compound. Significant dose-related body weight
reductions occurred at the mid- and high-dose levels in the treated rats.
The treated dams exhibited no compound related effects (e.g. numbers
of corpora lutea, implantation sites, resorptions, live and dead fetuses,
mean fetal weight, or the sex ratio of pups). The NOEL and LOEL for
maternal toxicity were 15 and 30 mg/kg/day, respectively, due to
reduced body weight. (MRID 00072693)
Groups of mated female New Zealand white rabbits were
administered fenbutatin-oxide in gelatin capsules at doses of 0, 1, 5 and
10 mg/kg/day from the sixth day through the eighteenth day of
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gestation. Thalidomide (150 mg/kg) served as the positive control on
gestation days 8 and 9. The NOEL for maternal toxicity was 1
mg/kg/day. The LEL was 5 mg/kg/day based on anorexia, gastric
lesions and abortions at that dose. The LEL was established due to an
increased incidence of abortions at 5 mg/kg and 10 mg/kg. (MRID's
00049230, 00069880, 00079319)
f. Reproductive Toxicity
Technical fenbutatin-oxide (94-99% a.i.) was tested in a 2-
generation rat reproductive study at dietary doses of 0, 40, 75, 250 and
500 ppm (equivalent to 0, 2.79, 5.20, 17.4 and 37.9 mg/kg/day in males
and 0, 3.22, 5.98, 20.3 and 43.9 mg/kg/day in females). The only
parental toxicity observed in both PI and Fl generations was decreased
body weight and food consumption at 250 ppm and 500 ppm. The
NOEL and LOEL were 75 ppm and 250 ppm, respectively.
Ingestion of fenbutatin-oxide did not affect fertility, length of
gestation or pup viability. Pup body weight was reduced during
lactation. The NOEL and LOEL for reproductive toxicity were 75 and
250 ppm, based on the reduced pup body weight. (MRID 41540601)
g. Mutagenicity
Technical fenbutatin-oxide (98% a.i.) was evaluated in a
Salmonella typhimurium/Ames plate incorporation assay in tester strains
TA 1535, TA 97, TA 98 and TA 100, with and without metabolic
activation at concentrations of 5, 10, 50, 100 and 300 //g/plate. None of
the doses tested increased the number of revertant colonies. Preliminary
studies indicated that cytoxicity was induced at 1.2 //g/plate. Thus,
fenbutatin-oxide did not induce mutations in Salmonella typhimurium
strains when tested up to cytoxic levels. (MRID's 40473501, 40770601)
Technical fenbutatin-oxide did not increase the frequency of
mutation in Chinese Hamster ovary cells, when tested at up to cytoxic
levels both with and without metabolic activation. The 0, 0.025, 0.05,
1.0 and 1.5 //g/ml levels were tested without metabolic activation. The
0, 0.05, 0.5, 1.0, 2.5, 5.0 and 7.5//g/ml levels were tested with
metabolic activation. Cytoxicity was observed at 1 //g/ml without
metabolic activation and at 7.5 //g/ml with metabolic activation. (MRID
40590504)
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Technical fenbutatin-oxide did not induce chromosomal
aberrations in human lymphocytes obtained from the venous blood of
healthy male and female donors when tested at concentrations of 0.7,
1.0, 4.0 and 5.0 //g/ml with and without metabolic activation. The
chemical was tested up to cytoxic levels. (MRID 40590502)
Fenbutatin-oxide did not increase the micronucleated
polychromatic erythrocytes in the bone marrow of mice when
administered at dosage levels of 500, 2500 and 5000 mg/kg. (MRID
40590503)
Technical fenbutatin-oxide did not produce unscheduled DNA
synthesis in rat primary hepatocytes at concentrations of up to 1.0
//g/ml. (MRID 40590505)
h. Metabolism
The absorption, distribution, metabolism, and excretion of
fenbutatin-oxide was studied in male and female Sprague-Dawley rats.
The rats were treated with a single oral dose of 10 mg/kg of [119mSn]-
labelled fenbutatin-oxide, a single dose of 500 mg/kg of [119mSn]-
labelled fenbutatin-oxide or 14 repeated daily doses of unlabelled
fenbutatin-oxide at 10 mg/kg followed by a single labelled dose at 10
mg/kg. Fenbutatin-oxide was excreted virtually unchanged in the feces.
Over a 5-day period, 83-100% of the radioactivity was found in the
feces and urine. The amount of radioactivity was very low over a 5-7
day period, indicating that the potential for bioaccumulation of
fenbutatin-oxide is minimal. The highest radioactivity levels were found
in the liver, kidney, and heart. Thin layer chromatography analysis of
fecal extracts showed that unchanged fenbutatin-oxide accounted for 86-
96 percent of the radioactivity extracted from the feces, with two minor
metabolites comprising another 1-3%. One of these metabolites was
tentatively identified as IN-CG200, however, the other remained
unidentified. IN-CG200 [1,3-dihydroxy-l, 1,3,3-tetrakis(2-methyl-2-
phenylpropyl)distannoxane] is an impurity in the test compound.
(MRID 41069101)
The metabolism study demonstrates that approximately 1% of
fenbutatin-oxide is absorbed from the gastrointestinal tract when the
chemical is administered orally. This is based on the fact that at both
single and repeated low dose level, 98.8% and 100% of the administered
compound were recovered unchanged from the feces of treated rats, with
an additional 0.9% and 0.3% from the cage wash. In addition, the total
11
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radioactivity recovered in the carcasses, tissues and gastrointestinal tract
contents ranged from a mean of 0.1% to 1.1% of the administered dose
over all dosing groups, with only negligible quantities reported from the
males and females in the 500 mg/kg group. The Agency believes that
the skin will not absorb a larger percentage of the chemical than the
gastrointestinal tract, so that no more than 1% of a daily dose over a 14-
day period would be absorbed through the skin.
i. Reference Dose
The Agency's Reference Dose Committee determined the
reference dose (RfD) for systemic toxicity of fenbutatin-oxide to be 0.05
mg/kg/day. The reference dose was based on the NOEL of 5.2
mg/kg/day for reduced body weight and food consumption in both sexes
of pups of the first and second generations at 17.4 and 20.3 mg/kg/day
in a two-generation study in rats.
2. Exposure Assessment
a. Dietary Exposure
The March 31, 1987, Registration Standard required the
following dietary exposure studies:
Nature of the Residue in Livestock
Residue Analytical Methods for Plants
Residue Analytical Methods for Livestock
Storage Stability
Confined Rotational Crops
Magnitude of the Residue in Crop Field Trials
The data requirements are listed in Appendix B and summaries of
available studies are provided below.
The conclusions regarding the reregistration eligibility of
fenbutatin-oxide on the crops listed in Table A are based on the use
patterns registered by the basic producer, E. I. du Pont de Nemours &
Co., Inc., as reflected on the product labels for the 50% WP and the 4
Ib/gal EC formulations (EPA Reg. Nos. 352-480 and 352-493), which
are currently the only fenbutatin-oxide products registered for food or
feed uses.
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Plant Metabolism
The qualitative nature of the residue in plants is adequately
understood. Studies with apples and oranges indicate that residues are
primarily found on the fruits' surface. Since the parent compound
comprises the majority of the terminal residue in plants, only the parent
will be included in the tolerance expression for plant commodities.
(MRID00113018)
Animal Metabolism
The qualitative nature of the residue in animals is adequately
understood. Studies with goats and poultry revealed similar metabolic
profiles. The terminal residue to be regulated in livestock consists of
fenbutatin oxide and its metabolites dihydroxybis(2-methyl-2-
phenylpropyl) stannane (SD-31723) and 2-methyl-2-
phenylpropylstannoic acid (SD-33608). (MRID 41183801)
Residue Analytical Methods for Plants and Animals
An adequate enforcement method is available for fenbutatin-oxide
residues in plants and animals. The GLC/FPD method MMS-R-494-2
has successfully undergone Agency method validation for plants and
animals and has satisfied the requirements of PR Notice 88-5 concerning
independent laboratory validation. Method MMS-R-494-2 individually
quantifies each analyte to a detection limit of 0.05 ppm.
A spectrophotometric method for determining total organotin and
a GLC/EC method (MMS-R-391-1) for determining the parent
compound are published in PAM, Vol. II as Methods I and II,
respectively. These methods are inadequate for both data collection and
enforcement purposes. In addition, the TLC methods MMS-R-391-1,
published in PAM, Vol. II as Method A, and MMS-R-345-1 (the section
for SD-31723 analysis only), are adequate only for confirming GLC
results. (MRID's 41110901 and 41520701)
Storage Stability
Data have been submitted concerning the storage stability of
fenbutatin-oxide and its related metabolites in or on samples of almonds,
apples, cucumbers, eggplants, grapes, oranges, plums, and strawberries.
These data indicate that residues of fenbutatin oxide are stable in or on
almonds (28 months), apples (14 months), cucumbers (21 months),
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eggplants (8.5 months), grapes (13 months), oranges (12 months), plums
(12 months), and strawberries (28 months). The available storage
stability data adequately support the residue field trial data. (MRID
41110901 and 41520701)
Accumulation in Confined Rotational Crops
Uncharacterized fenbutatin-oxide residues (less than 0.09 ppm,
fresh weight) accumulated in turnip roots planted 30, 120, and 365 days
after [119mSn]fenbutatin-oxide was applied at a rate of 7.9 Ib a.i./A to
sandy loam soil. Uncharacterized fenbutatin-oxide residues (0.056 ppm,
fresh weight) also accumulated in mature wheat straw planted 30 days
after application. Residues did not accumulate in immature wheat straw,
mature lettuce, mature turnip foliage, or mature wheat grain at any
rotational interval. Total radioactive residues in soil samples taken at
treatment, planting, and harvest, varied from 4.4 ppm at treatment to
1.8 ppm at 453 days post-treatment. Fenbutatin-oxide was the only
component identified in all soil extracts analyzed and represented more
than 94% of the extractable radioactivity after 453 days. (MRID
41520702)
b. Occupational and Residential Exposure
The March 31, 1987, Registration Standard required an
occupational and residential exposure study on foliar dislodgeable
residues. This data requirement is listed in Appendix B and a summary
of the available study is provided below.
Occupational and residential exposure can be expected based on
the currently registered uses of products containing fenbutatin-oxide.
However, due to the lack of toxicological concerns additional occupation
and residential exposure data are not required. There are no special
toxicological concerns about fenbutatin-oxide that warrant the
establishment of active-ingredient-based personal protective equipment
(PPE) requirements for handlers. The Agency will base the PPE
requirements for pesticide handlers on the acute toxicity of the end-use
products.
Foliar Based Restricted Entry Interval (REI)
The foliar dislodgeable residue data consist of leaf disc samples
collected after four fenbutatin-oxide applications were applied to oranges
grown in California and Florida. In Florida, the 50% wettable powder
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formulation was applied, while in California both the 50% wettable
powder and the 4 Ib/gal EC formulation were applied. Due to the
similarity of the residues across formulation types and locations, the
registrant averaged all the data for statistical analysis. On the first day
after the final application of fenbutatin-oxide these averaged residues
peaked at 2.53 jig/cm2 and dissipated 56 days after the final application
to a level of 0.92 jjg/cm2.
Post Application Exposure
To conduct a post-application risk assessment, the Agency used a
dermal absorption factor of one percent. This factor was derived from
the metabolism study as discussed earlier in the metabolism summary.
Because foliar dislodgeable residue studies were conducted
without concurrent dermal exposure data, dermal exposure was
estimated using generic transfer coefficients (cm2/hr). These coefficients
assume worker exposure to treated foliage occurs at a constant rate
during reentry activities; and are based on the work of Zwieg,
Leffingwell, and Popendorf. To determine REI's for fenbutatin-oxide, a
transfer coefficient of 10,000 was used for orchard crops and 4,000 was
used for low growing/greenhouse crops. Reentry levels that provide an
acceptable margin of exposure of 100 (based on an 8 hour work day) are
11 jig/cm2 for orchard crops and 28 jig/cm2 for low growing and
greenhouse crops. Both levels are well above residue levels detected in
the field study.
Entry Restrictions for WPS Uses
The Worker Protection Standard for Agricultural Pesticides
(WPS) - 40 CFR Part 170 established the interim 48-hour REI based on
fenbutatin-oxide's Toxicity Category I eye irritation potential. The
Agency has determined that the 48-hour REI for all WPS sites should be
retained as a prudent measure to mitigate risk to workers entering
treated areas after application.
For occupational end-use products containing fenbutatin-oxide as
an active ingredient, the Agency has determined that a 48-hour
restricted-entry interval is required for each use of the product that is
within the scope of the Worker Protection Standard for Agricultural
Pesticides (WPS). The basis for this requirement is that fenbutatin-oxide
is categorized as toxicity category I (severe) for eye irritation potential.
The WPS REI in effect until now was 48 hours. The 48-hour interim
WPS REI was established through labeling modifications specified in PR
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Notice 93-7, which implemented the labeling requirements of the 1992
Worker Protection Standard for Agricultural Pesticides.
The PPE required for early entry is: coveralls, chemical-resistant
gloves, shoes, socks and protective eyewear. The clothing requirements
are based on fenbutatin-oxide's classification of category III for acute
dermal toxicity and category IV for skin irritation potential, as well as
EPA's lack of special concerns about other adverse effects. The
protective eyewear is required due to fenbutatin-oxide's category I
classification for eye irritation potential. The Agency will not require a
respirator for early-entry workers, since the WPS places very specific
restrictions on these workers. The Agency believes that existing WPS
protections are sufficient to mitigate post-application inhalation
exposures of workers.
Some registered uses of fenbutatin-oxide are outside the scope of
the Worker Protection Standard for Agricultural Pesticides (WPS). The
Agency has determined that, at this time, the entry restrictions discussed
in this section need not apply to uses of fenbutatin-oxide outside the
scope of the Worker Protection Standard for Agricultural Chemicals,
including out-of-scope commercial uses. The predicted frequency,
duration and degree of post-application exposure from these uses do not
warrant the risk mitigation measures being required for persons engaged
in the production of agricultural plants for commercial or research
purposes.
3. Risk Assessment
a. Dietary
Toxicological Endpoint
The chronic dietary risk estimate analysis used a Reference Dose
of 0.05 mg/kg body weight/day, based on a No Observed Effect Level
of 5.2 mg/kg bwt/day and an uncertainty factor of 100. The NOEL was
derived from a reproduction study in rats that demonstrated reduced
body weight and food intake in both sexes of pups of the first and second
generation.
Residue Information
Food uses in this analysis are the published and recommended
tolerances being supported in the reregistration of fenbutatin-oxide.
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Published tolerances for this chemical are listed in Tolerance Index
System (TIS) and 40 CFR §180.362, 185.3550 and 186.3550.
The analysis used anticipated residues for several commodities.
An anticipated residue value was derived for dried apples (26.9 ppm)
which is higher than the established tolerance for raw apples (15 ppm).
This occurs because the tolerance level is based on the raw agricultural
commodity (RAC) "apples" and no tolerance is set for "dried apples."
Separate anticipated residues are available for these two items.
Results
The Theoretical Maximum Residue Contribution (TMRC) for the
overall U.S. population, without any refinements was calculated to be
136% of the RfD. This value may overestimate the risk because the
TMRC assumes all crops have tolerance level residues and that 100% of
all crops are treated with fenbutatin-oxide.
The Anticipated Residue Contribution (ARC) for the overall U.S.
population from crops that may be treated with fenbutatin-oxide is
0.002132 mg/kg bwt/day, or 4% of the RfD. The subgroup most highly
exposed, children one to six years old, has an ARC from all uses of
0.004 mg/kg bwt/day, or 8% of the RfD. None of the subgroups in the
Dietary Risk Exposure System has an exposure which exceeds 10
percent of the RfD.
b. Occupational and Residential
Exposure by humans to fenbutatin-oxide may occur during
handling (mixing, loading, application, etc.) tasks and during post-
application exposures. Since fenbutatin-oxide is classified as toxicity
category I for eye irritation potential, eye irritation is a particular
concern.
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C. Environmental Assessment
1. Environmental Chemistry, Fate and Transport
The March 31, 1987, Registration Standard required the following
environmental fate studies:
Hydrolysis
Photodegradation in water
Photodegradation in soil
Aerobic soil metabolism
Anaerobic soil metabolism
Leaching/adsorption and desorption
Confined rotational crop
Lab volatility
Bioaccumulation in fish
Terrestrial field dissipation
Droplet size spectrum
Drift field evaluation
All of these data requirements have been fully satisfied, except for the
bioaccumulation in fish (165-4) and spray drift (201-1 and 202-1) requirements.
Although it has been shown that fenbutatin-oxide does accumulate in fish
tissues, a new fish accumulation study is required in order to determine the
actual extent of this accumulation. The additional information will be used as
confirmatory data and is not expected to change the overall environmental fate
assessment.
Due to concerns about the toxicity of fenbutatin-oxide to aquatic
organisms, the spray drift data requirements were imposed to assess the extent
of exposure of these organisms in nearby water bodies and canals to fenbutatin-
oxide as a result of its application to orchards. These studies are being reserved
pending the work currently being conducted by industry's Spray Drift Task
Force. Detailed information regarding the fate of fenbutatin-oxide in the
environment is presented below.
a. Hydrolysis
Fenbutatin-oxide was stable to hydrolysis at pH's 5,7, and 9 in
sterilized buffered aqueous solutions kept in darkness at approximately
25°C. After 30 days of incubation in each test solution, fenbutatin-
oxide comprised more than 90% of the originally applied radioactivity.
(MRID 40790901)
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b. Photodegradation in Water
Fenbutatin-oxide photodegraded in sterile water at pH 7 with a
half-life of 55 days under continuous irradiation. This half-life would
translate to a half-life of over 100 days if the chemical were exposed to
12 hours of irradiation alternated with 12 hours of darkness. The only
major photolytic degradation product was IN-CG200 (1,3-dihydroxy-
1,1,3,3-tetrakis (2-methyl-2-phenylpropyl) distannoxane). This
degradation product comprised 22.8% of total radioactivity by day 15 of
continuous exposure by a xenon lamp equipped with a filter to eliminate
wavelengths less than 290 nm. (MRID 40790902)
c. Photodegradation on Soil
Fenbutatin-oxide is relatively stable towards photodegradation on
soil. The half-life of fenbutatin-oxide was 128 days on sandy loam soil
irradiated on a 12-hour photoperiod with a xenon arc lamp for 31 days.
The major degradate was l,3-dihydroxy-l,l,3,3-tetrakis(2-methyl-2-
phenylpropyl)distannoxane (IN-CG200), comprising a maximum of
3.4% of the applied radioactivity at 31 days posttreatment. Fenbutatin-
oxide did not degrade in the dark controls. (MRID 40696403)
d. Aerobic Soil Metabolism
Fenbutatin-oxide was relatively stable in the three soils tested.
After 12 months under aerobic conditions in loamy sand, silty clay loam
and sandy clay loam soils, 80.0%, 76.5% and 79.7% of the applied
radioactivity was removed as undegraded fenbutatin-oxide, respectively.
(MRID 40257001)
e. Anaerobic Soil Metabolism
Fenbutatin-oxide was relatively stable in the three soils tested,
with 77.5%, 79.8% and 80.8% of the applied radioactivity being
recovered as undegraded fenbutatin-oxide after 60 days under anaerobic
conditions in loamy sand, silty clay loam, and sandy clay loam,
respectively. (MRID 40257002)
f. Leaching and Adsorption/Desorption
Unaged fenbutatin-oxide was immobile to slightly mobile in
columns of two loamy sand soils, a silty clay soil, and a sandy clay soil.
More than 90% of the 119Sn residues did not move out of the treated
layer. Fenbutatin-oxide residues aged 30 days were slightly mobile in a
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column of loamy sand soil. 119Sn residues were distributed throughout
the column (92% in the upper 6 cm) and 1% were recovered in the
leachate. 119Sn in fenbutatin-oxide comprised 98% of the recovered
extractable radioactivity in the soil. (MRID 40257003)
Fenbutatin-oxide with a 0.2% surfactant at 0.1, 1.0, and 10
ug/ml, was slightly mobile to immobile (Kads: 6.9-3587) in two loamy
sand soils, a silty clay soil and a sandy clay loam soil. Less than 5% of
the adsorbed pesticide desorbed from the soil. (MRID 40257004)
Fenbutatin-oxide with a 1% acetone co-solvent at 5, 1, 0.2 and
0.04 mg/ml was immobile (Kd: 1282 - 2333) in a loamy sand, sandy
loam and silty loam soil. Less than 0.5% of the adsorbed pesticide
desorbed from the soil. (MRID 43336401)
g. Soil Field Dissipation
Fenbutatin-oxide (Vendex 4L and Vendex 50WP) applied to
three separate soils at a rate of 8 Ibs a.i./acre was found to have a half-
life of greater than 1 year in the field. In addition to its persistence,
fenbutatin-oxide was also characterized as having low mobility. At the
Delaware and Washington sites, 99% of the residues were found in the
0-10 cm depth after 18 months. Throughout the study, the 0-10 cm
segment contained more than 94% of the total residues found. In
California, there were no significant residues deeper than 10 cm before
18 months. At no time were residues detected in the 30-90 cm soil
depths. The degradates l,3-dihydroxy-l,l,3,3-tetrakis(2-methyl-2-
phenylpropyl) distannoxane (SD31723) and 2-methyl-2-phenylpropyl
stannonic acid (SD33608) were found at low concentrations (less than
0.22 ppm). (MRID's 42074501 and 41608501)
h. Long-Term Soil Field Dissipation
Fenbutatin-oxide was persistent under field conditions. It
dissipated with half-lives between 271 and 1367 days from the upper 30
cm of bareground plots of silt loam soil located in Delaware, loam soil
located in Washington, and loam/sandy loam soil located in California.
These plots had been treated at 8 Ib a.i./A/year for 3 years with
fenbutatin-oxide (Vendex 4L Miticide, 4.0 Ib a.i./gallon F1C; or Vendex
50 WP Miticide, 50% WP). Fenbutatin-oxide and its metabolites
demonstrated low mobility at all of the test sites throughout the course of
the study. After the third application, approximately 90% of the
residues remained in the top 10 cm of soil at each of the sites. Of the
three sites, only California (2% of total residues) showed residues in soil
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at the 60-90 cm level. The degradates identified in the treated soil were
1,3-dihydroxy-l, 1,3,3-tetrakis(2-methyl-2-phenylpropyl) distannoxane
(SD 31723) and 2-methyl-2-phenylpropyl stannonic acid (SD 33608).
At the Delaware site, fenbutatin-oxide dissipated with a half-life
of 1367 days from the upper 30 cm of bareground plots of silt loam soil
that were treated in August 1988, 1989, and 1990. At the Washington
site, fenbutatin-oxide dissipated with a half-life of 714 days from the
upper 30 cm of bareground plots of loam soil that were treated in
August 1988, June 1989, and June 1990. At the California site,
fenbutatin-oxide dissipated with a half-life of 271 days (95% confidence
interval: 201-418 days) from the upper 30 cm of bareground plots of
loam/sandy loam soil that were treated in June 1988, 1989, and 1990.
These long half-lives caused residue levels to increase with
successive applications. Based on the half-life data, the maximum
expected concentrations found in the soils (0-30 cm depth) are 0.43 ppm
at Madera, CA; 4.15 ppm at Newark, DE; and 4.27 ppm at Wapato,
WA. (MRID 42896801)
i. Accumulation in Fish
To accurately define the bioaccumulation potential of fenbutatin-
oxide, a new study is needed. In the submitted study, the calculated
bioconcentration factors (BCF's) were not accurate. In this study the
accumulation of fenbutatin-oxide in the various tissue fractions did not
plateau during the 28-day exposure period so that the actual BCF's may
be significantly higher than those presented. The additional data are
confirmatory and are not expected to change the overall environmental
fate assessment. (MRID 40696404)
2. Environmental Fate Assessment
Fenbutatin-oxide is persistent in the environment, with no apparent
major route of dissipation. Chemical degradation studies have demonstrated
that fenbutatin-oxide is relatively unsusceptible to hydrolysis or
photodegradation in water or on soil. After 30 days of incubation in the
hydrolysis study, at least 90% of the applied radioactivity in each test solution
was undegraded parent. Estimated photolytic half-lives in water and on soil
were longer than 100 and 128 days, respectively. The degradate 1,3-
dihydroxy-1,1,3,3-tetrakis(2-methyl-2-phenylpropyl)distannoxane (SD31723)
was detected in both photodegradation studies, comprising a maximum of
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11.4% of the applied radioactivity in the photodegradation in water study and
3.4% in the photodegradation on soil study.
Microbial degradation of fenbutatin-oxide in soil is also very slow.
After 12 months in loamy sand, silty clay loam and sandy clay loam soils,
80.0%, 76.5% and 79.7%, respectively, of the applied radioactivity was
recovered as undegraded fenbutatin-oxide. Under anaerobic conditions, 77.5%,
79.8%, and 80.8% of the applied radioactivity was recovered as undegraded
fenbutatin-oxide after 60 days in the same three soils. Neither of the soil
metabolism studies was able to identify any extractable degradates.
Fenbutatin-oxide is relatively immobile in the environment. It is slightly
soluble in water (12.7 ppb at 20°C), has a low vapor pressure and binds
strongly to soil. Column leaching and batch equilibrium adsorption/desorption
studies have demonstrated that fenbutatin-oxide is not likely to move through
soil. In the column leaching studies, little downward movement of fenbutatin-
oxide was observed beyond the application site (top 3 cm) for all four soils
examined (two loamy sands, a silty clay loam, and a sandy clay loam).
Freundlich Kads values derived from a batch equilibrium study with fenbutatin-
oxide and a 0.2% Ortho X-77 surfactant ranged from 6.9 to 30.4 in two loamy
sand soils and a silty clay soil, and 3587.5 in sandy clay loam soil. In a second
batch equilibrium study using fenbutatin-oxide with a 1% acetone co-solvent, Kd
values ranged from 1282 to 2333 in loamy sand, sandy loam and silty loam
soils. These data suggest that fenbutatin-oxide binds strongly to soil and
therefore is not expected to leach.
Although fenbutatin-oxide is persistent, residues did not tend to
accumulate in crops planted in sandy loam soil that had been previously treated
with 7.9 Ibs a.i./A 30, 120, or 365 days prior to planting. This may be
partially due to fenbutatin-oxide's propensity to bind to soil. Residues did not
accumulate in immature wheat straw, mature lettuce, mature turnip foliage or
mature wheat grain at any rotational interval. However, residues were found in
turnip roots (less than 0.09 ppm) planted 30, 120, and 365 days after
application and in wheat straw (0.056 ppm) planted 30 days after application.
Fenbutatin-oxide does accumulate in fish tissues, as expected from its
high octanol-water partition coefficient (Kow = 1.4 x 105). Bioconcentration
factors of 340-500x for muscle tissue, 1100-1600x for visceral tissue, 450-640x
for the remaining carcass and 490-730x for whole fish were determined for
bluegill sunfish exposed to fenbutatin-oxide at 0.00013 mg/L or 0.00068 mg/L.
However, the lack of a plateau in the concentration of fenbutatin-oxide in the
various tissues could indicate that the actual BCF's are higher. The degradate
1,3-dihydroxy-l, 1,3,3-tetrakis(2-methyl-2-phenylpropyl) distannoxane
(SD31723) was identified in the muscle and visceral tissue (18-21% of the
22
-------
extractable residues). Depuration of accumulated residues was somewhat
limited, with only 51-75% of the accumulated residues being eliminated by day
14 of the depuration period.
In the field, fenbutatin-oxide exhibited the same characteristics of
persistence and immobility as in the laboratory. The calculated half-lives for
the dissipation of fenbutatin-oxide ranged from 271 days in California
loam/sandy loam soil to 714 days in Washington loam soil to 1367 days in
Delaware silt loam soil. These dissipation rates were measured from the upper
30 cm of bareground plots treated with 8 Ib a.i./A/year of fenbutatin-oxide for
3 years (Vendex 4L Miticide, 4.0 Ib a.i./gallon F1C; or Vendex 50 WP
Miticide, 50% WP). The long half-life caused residue levels to increase with
each successive application. Throughout the course of the study, fenbutatin-
oxide and its metabolites displayed low mobility at all of the test sites. After
the third application approximately 90% of the residues remained in the top 10
cm of soil at each of the sites. Madera was the only one of the three sites to
show residues (2% of the total) in soil at the 60-90 cm level. The degradates
identified in the treated soil were l,3-dihydroxy-l,l,3,3-tetrakis(2-methyl-2-
phenylpropyl) distannoxane (SD 31723), and 2-methyl-2-phenylpropyl
stannonic acid (SD 33608).
3. Ecological Effects
The March 31, 1987, Registration Standard required the following
ecological effects data:
Avian toxicity
Fish toxicity (TEP)
Invertebrate Toxicity
Estuarine/Marine acute fish toxicity
Estuarine/Marine acute mollusk toxicity
Estuarine/Marine acute shrimp toxicity
Early life stage fish
Life cycle invertebrate
Aquatic organism accumulation
The data submitted for the estuarine fish early life stage (guideline 72-
4a) and estuarine shrimp life cycle (guideline 72-4b) data requirements were
invalid largely due to difficulties with the saltwater medium required in the
estuarine tests. In the absence of the chronic estuarine testing, the chronic
freshwater results will be used for the chronic estuarine risk assessments. The
use of these estimates introduces uncertainty into the chronic assessment for
estuarine fish and invertebrates. Although data from the estuarine chronic
23
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studies would reduce this uncertainty, these studies are not being required at
this time.
The submitted avian reproduction studies provided No Observed Effect
Level's (NOEL's), but did not provide Lowest Effect Level's (LEL's). To
calculate the chronic risk, the Agency estimated the LEL to be equal to the
NOEL. This is a conservative estimate and introduces uncertainty into the
avian chronic assessment. Additional avian reproduction studies conducted at
higher dose levels could reduce this uncertainty, however, the Agency is not
requiring additional data at this time.
a. Acute Toxicity to Birds
Based on acute toxicity data, fenbutatin-oxide is practically
nontoxic to birds. An avian acute oral study performed on the bobwhite
quail resulted in an LD50 value of more than 2510 mg/kg. (MRID
00113073)
Fenbutatin-oxide is also practically nontoxic to birds on a
subacute dietary basis. Two studies, one on the mallard duck and one
on the bobwhite quail, produced LC50 values greater than 5620 ppm.
(MRID 00113074, 40473505)
b. Chronic Toxicity to Birds
Avian reproduction studies were required for fenbutatin-oxide,
since the product's persistence may cause birds to be repeatedly or
continually exposure to the pesticide.
Two avian reproduction studies, one on the mallard duck and one
on the bobwhite quail, showed no effect on reproduction at dietary levels
up to 150 ppm. (MRID's 41258902, 41258901)
24
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c. Acute Toxicity to Freshwater Fish
Species
Rainbow trout
Rainbow trout
Rainbow trout
Bluegill sunfish
Bluegill sunfish
% A.I.
95%
100%
98.6%
95%
100%
L^SO
1.7 ppb
1.7 ppb
6.6 ppb
4.8 ppb
4.8 ppb
MRID
00113075
40098001
40473506
00113076
40098001
The acute toxicity tests, listed above, show that fenbutatin-oxide
is very highly toxic to freshwater fish, with LC50 values ranging from
1.7 to 6.6 ppb. (MRID's 00113075, 40098001, 40473506, 00113076,
and 40098001)
In addition to testing on the technical product, formulated
product testing on fish was also required because the LC50 of the
technical fenbutatin-oxide was lower than the Expected Environmental
Concentration (EEC) in the aquatic environment. These data, listed
below, show that the formulated products of fenbutatin-oxide are highly
toxic to very highly toxic to freshwater fish. (MRID's 40098001,
40473507, 40473508, and 40098001)
Species
Rainbow trout3
Rainbow trout
Bluegill sunfish
Fathead minnow3
Channel catfish3
% A.I.
50%
42%
42%
50%
50%
Ll>5o
14 ppb
120 ppb
130 ppb
1.9 ppb
1.5 ppb
MRID
40098001
40473507
40473508
40098001
40098001
3 Studies are Supplemental due to inadequate detail in study reports.
25
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d. Chronic Toxicity to Freshwater Fish
A fish early life stage test was required because fenbutatin-oxide
is expected to be transported to aquatic sites, is relatively persistent in
water and has laboratory LC50 values of less than 1 mg/L.
An early life stage study performed with the rainbow trout shows
that growth and survival are impaired at concentrations of greater than
0.31 ppb. The Maximum Allowable Toxicant Concentration (MATC) is
between 0.31 ppb and 0.61 ppb. (MRID 40473512)
e. Acute Toxicity to Freshwater Invertebrates
The acute toxicity study performed on Daphnia magna with a
98.6% pure technical product showed that fenbutatin-oxide has an EC50
of 31 ppb and is very highly toxic to freshwater aquatic invertebrates.
(MRID 40473509)
Formulated product testing on aquatic invertebrates was required
for fenbutatin-oxide because the EC50 of the technical pesticide was
lower than the EEC in the aquatic environment.
The study, performed on a 42% pure formulated product,
showed that the formulated product has an EC50 of 10 ppb and is very
highly toxic to freshwater aquatic invertebrates. (MRID 40473511)
f. Chronic Toxicity to Freshwater Invertebrates
An aquatic invertebrate life cycle test was required because
fenbutatin-oxide is expected to be transported to aquatic sites, is
relatively persistent in water and has all laboratory EC50 values of less
than 1 mg/L.
A life-cycle study performed with Daphnia magna shows that
survival is impaired at concentrations greater than 0.016 ppm. The
MATC is between 0.016 ppm and 0.039 ppm. (MRID 40525901)
g. Acute Toxicity to Estuarine and Marine Organisms
Acute toxicity testing with estuarine/marine organisms was
required for fenbutatin-oxide because its use on citrus or apples could
result in exposure to the estuarine environment. These tests include an
acute LC50 for an estuarine fish, an acute LC50 for an estuarine shrimp,
and either an oyster embryolarvae study or an oyster shell deposition
26
-------
study.
The information in the following table characterizes fenbutatin-
oxide as very highly toxic to estuarine and marine fish and invertebrates.
(MRID's 41483301, 40590508, and 40590507)
Species
Sheepshead minnow
Mysid shrimp4
Eastern oyster5
(embryolarvae)
% A.I.
99%
98%
98%
Ll>5o
20.8 ppb
2.8ppb
0.4 ppb
MRID
41483301
40590508
40590507
h. Chronic Toxicity to Estuarine and Marine Organisms
Since fenbutatin-oxide is relatively persistent in water and has all
laboratory EC50 values of less than 1 mg/L, data from chronic tests were
required. Due to difficulties maintaining the required low
concentrations in saltwater, these tests are no longer required. Instead,
estimated MATC's will be used.
The MATC for estuarine fish is estimated to be between 0.31
ppb and 0.61 ppb, as determined in the chronic freshwater fish study.
The MATC for estuarine invertebrates is estimated to be the same as the
MATC in the freshwater invertebrate study (i.e. between 0.016 ppm and
0.039ppm).
i. Non-Target Insects Data
An acute contact LD50 study with technical fenbutatin-oxide to
establish the acute toxicity to honey bees resulted in an LD50 of 3982
//g/bee. This study shows that fenbutatin-oxide is practically nontoxic to
honey bees. (MRID 00036935)
j. Non-Target Plants Data
Non-target plant testing is not required to support currently
Study is supplemental because analytical detection limit and name of solvent were not reported.
Study is supplemental because analytical detection limit was not reported.
27
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registered uses of fenbutatin-oxide.
k. Other Non-Target Terrestrial Organisms
The available mammalian data indicate that fenbutatin-oxide is
practically nontoxic to mammals on an acute basis, since the rat LD50
was established at 4400 mg/kg. On a chronic basis, a two-generation
reproduction study with rats produced a reproductive NOEL of 75 ppm
and a LOEL of 250 ppm.
1. Field Residue Monitoring Studies
The Agency requires field monitoring studies on a case-by-case
basis when the use pattern of the chemical, the toxicity to nontarget
organisms, and the environmental fate characteristics of the chemical
indicate a potential for hazard to nontarget organisms. Fenbutatin-oxide
is extremely persistent in terrestrial and aquatic environments, and is
very highly toxic to aquatic organisms. The highest application rate is
for citrus in Florida. Use on Florida citrus also represents a situation
with high potential for contamination of aquatic habitats. For these
reasons, monitoring studies measuring residues in citrus groves and
adjacent waters were required.
The citrus residue monitoring study was conducted in central and
south Florida in 1991. Residues were measured in and around 5 citrus
groves that were each treated two times, at 60 day intervals with 2 Ib
a.i./A (Vendex 4L).
Under the conditions of this study, the major route of transport
was within-grove deposition on ditches and spray drift deposition to
perimeter/lateral canals. Maximum aquatic residues were 111 //g/L in
perimeter/lateral canals and 1.7 Mg/L in pond water. Sediment residues
were generally much greater than those in the water column, and
persisted from one year to the next.
For the purposes of calculating risk quotients for freshwater
organisms in flowing water, certain residue values from the monitoring
study were used. For acute risk quotients, the value used was 10 ppb,
the maximum level measured at a discharge point immediately following
application. For chronic risk quotients, the value used was 0.77 ppb,
the maximum level measured at a discharge point more than 7 days after
application. This value is greater than any 21-day average
concentration, but its use is justified by the often erratic timing of canal
discharges. Monitoring data from the flatwood region were used to
28
-------
generate a preliminary risk assessment. However, additional studies
conducted over multiple years are necessary to study the potential for
accumulation over multiple years. Computer model EEC's were used to
assess the risks to more static water because the Agency believes that the
conditions under which the pond study was conducted were less than
high exposure.
Maximum residue in/on citrus leaves was 260 ppm. The foliar
dissipation half-life was determined to be 42 days; measured foliar
residues as high as 29 ppm were present from the previous year's
applications.
The maximum measured soil residue level was 4.1 ppm (within
the grove). Very little degradation occurred in soil during the 60 days
between applications.
The study provides some usable data for assessing aquatic risks
from the use of fenbutatin-oxide in the freshwater to brackish flatwood
regions of Florida. However, the data may not reflect expected
accumulations over multiple-year use. In addition, the Agency believes
that the pond data reflect less than high exposure conditions. (MRID
42872101)
4. Ecological Effects Risk Assessment
This section consists of numerous risk assessments each covering a
different combination of endpoint and exposure scenarios. Each risk assessment
includes a risk quotient combining both 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). The generic risk quotients
and their respective LOC's for each risk assessment are provided in the table
below. Note that the same risk quotients are used for non-endangered and
endangered species, but the acute LOG is lower for endangered species.
29
-------
Established Levels of Concern (LOC's)
Endpoint/Scenario
Mammalian acute
Mammalian chronic
Avian acute
Avian chronic
Aquatic acute
Aquatic chronic
Non-Target insects
Risk
Quotient
EEC/LCsn
EEC/LEL
EEC/LC5n
EEC/LEL
EEC/LC5n
EEC/LEL
N/A
Non-Endangered
LOC
0.5
1.0
0.5
1.0
0.5
1.0
N/A
Endangered
LOC
0.1
1.0
0.1
1.0
0.05
1.0
N/A
Non-Endangered Terrestrial Organisms
Exposure of birds and mammals to fenbutatin-oxide is expected
through the consumption of insect and plant food material containing
fenbutatin-oxide residues and by direct exposure during application.
Acute Effects
No acute hazard to birds or mammals is expected following
direct application to vegetation at the maximum use rate. Expected
residue levels on terrestrial food items range from 14 to 480 ppm. The
risk quotient, using the highest residue level and the avian dietary LC50,
is 480/5620 = 0.1, which is well below the LOC of 0.5. The
mammalian LD50 value of 4400 mg/kg also results in no expected hazard
at the highest application rate.
Chronic Effects
Avian reproduction studies showed no adverse effects at 150
ppm, the highest rate tested. The no observed effect level (NOEL), 150
ppm, was used to calculate the chronic risk quotients for birds.
The use of fenbutatin-oxide at current rates presents the potential
for chronic hazard to birds and mammals. The following table outlines
the expected residue levels at various application rates. These expected
30
-------
environmental concentrations (EECs) are from the Kenaga nomograph.
Residues (ppm) and Risk Quotients (RQ's) for Avian Species:
Application
Rate
(Ib a.i./A)
1.00
1.25
1.50
2.00
Short
Grass
240
300,
360,
480
Short
Grass
RQ
k6
w
2,4
3,2
Long
Grass
110
138
J€5
,220
Long
Grass
RQ
0.7
0.9
1,1
1J
Leaves
/Leafy
Crops
125
156
188
250
Leaf
Crop
RQ
0.8
1.0
U
1
-------
Residues (ppm) and Risk Quotients (RQ's) for Mammals:
Application
Rate
(Ib a.i./A)
1.00
1.25
1.50
2.00
Short
Grass
240
300
3.80
480
Short
Grass
RQ
3,2
4,0
4,8
/6,4
Long
Grass
.,110
138
,115
,,220
Long
Grass
RQ
1,5
14
2.2
2,9
Leaves
/Leafy
Crops
125 '
1,56
188
250.
Leaf
Crop
RQ
14?
2,1
2 ,,5
3,3
Using the 75 ppm NOEL value, all of the risk quotients exceed
the established LOG of 1.0. The potential for chronic risk is again
increased by the persistence of fenbutatin-oxide and by desirability of
many of the use sites as habitat for small mammals.
Data from the field monitoring study support the conclusion of
chronic hazard. Based on the same set of foliage samples, residues in 19
of the 32 composite samples (59.4%) exceeded the chronic NOEL for
mammals. These residues ranged from 18.0 to 260.0 ppm.
Non-Endangered Aquatic Organisms
Fish and aquatic invertebrates are expected to be exposed to
fenbutatin-oxide through drift and runoff from treated areas.
Acute Effects
At current application rates, acute risk to freshwater fish can be
expected from all major uses. Acute hazard to freshwater invertebrates
can be expected for the citrus use. The major use sites for which
estuarine and marine organisms are a concern are citrus and apples.
Acute risk to estuarine fish and invertebrates is expected for the citrus
use. Acute risk to estuarine invertebrates is expected for the apple use.
The aquatic acute hazard assessment calculates the risk quotient
as the EEC/LC50 and uses an LOG of 0.5. The assessment also uses
eco-toxicity values of the rainbow trout LC50 (1.7 ppb) and the Daphnia
magna EC50 (10 ppb). Computer-estimated instantaneous environmental
concentrations (EEC's) are provided in the following table. The EEC's
32
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for citrus, apples and grapes are based on the standard environmental
fate surface water models for a 10 hectare field draining into a 1
hectare, 2 meter deep pond using the one in ten-year maximum values
modeled over 36 years. The EEC's for almonds and stone fruits are
based on the values derived for the other three crops. In addition, actual
monitoring data were used to calculate the preliminary risk quotients for
flowing water associated with fenbutatin-oxide use on citrus in the
flatwood region of Florida.
Since two separate studies were submitted, each showing
different Kd values for sandy soil, the Agency has accepted a range of Kd
values for sandy soils. Use of the higher Kd values for the citrus EEC
calculations results in a lower aquatic EEC, as indicated in the table.
The differing Kd values for sandy soils affects the EEC calculations for
citrus only. The EEC's for apples, grapes, almonds and stone fruits are
static because these crops are generally grown in finer textured soils, for
which the Kd values are only addressed in one study. Both modelled
EEC values for citrus were used to calculate a range of risk quotients for
the citrus use.
Rather than use a calculated EEC value to estimate hazard to
aquatic organisms in flowing water, the assessment uses an actual
measured value from the citrus monitoring study.
Estimated Environmental Concentrations (Instantaneous):
Crop
Citrus
Apples
Grapes
Almonds
Stone
Fruits
Application
Rate
(Ib a.i./A)
2.00
1.50
1.25
1.25
1.00
EEC
Using
Lower Kd
Value
12.7
EEC Using
Higher Kd
Value
(ppb)
5.4
3.0
2.5
3.0
2.0
Flowing Water
EEC
(Monitoring
Study) (ppb)
10.0
Data from the citrus monitoring study support the above
estimates. Maximum residues in nearby aquatic environments ranged
from 1.7 ppb (pond) to as high as 111 ppb (lateral and perimeter
33
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canals). The flowing water EEC cited above (10 ppb) is the maximum
measured level at a discharge site immediately following application.
The following table shows the risk quotients for freshwater
fish/invertebrates using the above EEC's and the rainbow trout/Daphnia
magna LC50's (1.7 ppb/10.0 ppb).
Risk Quotients (RQ's) for Freshwater Fish/Invertebrates:
Crop
Citrus
Apples
Grapes
Almonds
Stone
Fruits
Application
Rate
(Ib a.i./A)
2.00
1.50
1.25
1.25
1.00
RQin
Static
H2Ow/
lower Kd*
7.5/1.3
RQin
Static H2O
w/ higher
K;
3.2/0.5
1.8/0.3
1.5/0.3
1.8/0.3
1.2/0.2
RQ in Flowing
H2Ow/
monitor study
K;
5.9/1.0
RQ's correspond to the EEC's divided by the rainbow trout/Daphnia magna LC50
for each instance
The risk quotients for freshwater fish range from 1.2 for stone
fruits to 7.5 for the citrus use. The freshwater fish LOG of 0.5 is
exceeded for all major uses. Acute risk to freshwater fish is expected
for all major uses at the current application rates. Acute risk to
freshwater invertebrates is only expected for the citrus use, where the
risk quotients range from 0.5 to 1.3.
The risk quotients calculated for freshwater fish with the citrus
use include three values: 3.2 for the modelled static water scenario
using the higher Kd value; 5.9 using the flowing water residue value
from the monitoring study; and 7.5 for the modelled static water
scenario using the lower Kd value. Despite the large differences in Kd
values, a risk quotient of 5.9 still results from the monitoring study,
causing the Agency to conclude that a significant potential for acute risk
to freshwater fish exists.
Since apple orchards and citrus groves are often located close to
34
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estuarine areas, the citrus and apple uses of fenbutatin-oxide generate
estuarine concerns. EEC's based on modeling are not yet available for
estuarine and marine environments, therefore, the analysis used
freshwater EEC's from the previous table to estimate exposure in these
environments. For citrus, the flowing water value from the citrus
monitoring study (10 ppb) was also used. Acute LC50 values for
estuarine organisms are:
Sheepshead minnow LC50
Mysid shrimp LC50
Oyster embryolarvae LC50
20.8 ppb;
2.8 ppb;
0.4 ppb.
Risk quotients for each of these organisms are shown in the table
below:
Risk Quotients (RQ's) for Sheepshead Minnow/Mysid
Shrimp/Oyster
Crop
Citrus
Apples
Application
Rate
(Ib a.i./A)
2.00
1.50
RQ in Static
H2Ow/
lower Kd
0.6/4.5/31.8
RQin
Static H2O
w/ higher
Kri
0.3/1.9/13.5
0.1/1.1/7.5
RQ in Flowing
H2Ow/
monitor study
Kri
0.5/3.6/25.0
Estuarine invertebrates are extremely sensitive to fenbutatin-
oxide. Acute risk to these organisms is expected from both the citrus
and apple uses. The risk quotients for the oyster range from 7.5 to 31.8
and for the mysid shrimp from 1.1 to 4.5, which far exceed the LOG of
0.5. The results of the citrus residue monitoring study indicate that
significant potential for acute risk to estuarine invertebrates exists.
For the estuarine fish, the LOG of 0.5 is exceeded for the citrus
use for the risk quotient based on static water modelled with the lower
K,.
35
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Chronic Effects
Chronic risk to freshwater and estuarine fish can be expected
from use on citrus, but is not anticipated for other major uses at the
current application rates. There is no chronic risk anticipated for
freshwater and estuarine invertebrates.
The aquatic chronic hazard assessment uses the geometric mean
of the No Observed Effect Level (NOEL) and the Lowest Observed
Effect Level (LOEL) to estimate the Lowest Effect Level (LEL). This
number is referred to as the Maximum Allowable Toxicant
Concentration (MATC). Eco-toxicity values for freshwater organisms
used in this assessment are the MATC for rainbow trout (0.435 ppb) and
Daphnia magna (24 ppb). Estimated chronic environmental
concentrations are provided in the following table. These estimates are
based on the standard environmental fate surface water models.
As in the acute assessment, the Agency is using a range of Kd
values for sandy soils. Use of the higher Kd values for the citrus EEC
calculations results in a lower aquatic EEC, as indicated in the table.
Ranges apply only to citrus, since apples, grapes, almonds and stone
fruits are generally grown in finer textured soils as discussed earlier.
Both modeled EEC values for citrus were used to calculate a range of
risk quotients for the citrus use. To estimate hazard to aquatic
organisms in flowing water, an actual EEC measured in the citrus
monitoring study was used instead of a calculated EEC.
Estimated Environmental Concentrations (Chronic):
Crop
Citrus*
Apples
Grapes
Application
Rate
(Ib ai/A)
2.00
1.50
1.25
21 -day
(ppb)
12.7/0.5
0.20
0.14
60-day
(ppb)
12.7/0.5
0.20
0.10
90-day
(ppb)
12.7/0.5
0.20
0.07
Flowing H2O
(Monitoring)
(ppb)
0.77**
For the 21-day, 60-day and 90-day intervals in citrus, the EEC's are presented as
calculations based on the lower Kd/higher Kd
Represents the maximum measured level at a discharge site more than 7 days after
application
The following table shows the chronic risk quotients, defined as
36
-------
the EEC divided by the MATC, for freshwater fish. These risk
quotients are based on the above EEC's and the MATC for rainbow
trout (0.435 ppb). The level of concern is 1.0.
Chronic Risk Quotients for Freshwater Fish:
Crop
Citrus
Apples
Grapes
Application
Rate
(Ib ai/A)
2.00
1.50
1.25
RQfor
lower Kd
(21/60/90-
days)
29.2
RQfor
higher Kd
(21/60/90-
days)
1.1/1.1/1.1
0.5/0.5/0.5
0.3/0.2/0.2
Flowing H2O
(Monitoring
Study)
1.8
Since EEC's based on modeling were not available for estuarine
and marine environments, freshwater EEC's were used to estimate such
exposure. Likewise since no estuarine chronic eco-toxicity data were
available, the estuarine risk assessments were based on the chronic
freshwater values only. The citrus and apple uses of fenbutatin-oxide
raise estuarine concerns as they are often closely associated with
estuarine areas.
The following table shows the chronic risk quotients for
freshwater invertebrates, based on the above EEC's and the MATC for
Daphnia magna (24 ppb). The level of concern for freshwater and
estuarine invertebrates is 1.0.
Chronic Risk Quotients for Freshwater Invertebrates:
Crop
Citrus
Apples
Grapes
Application
Rate
(Ib ai/A)
2.00
1.50
1.25
RQfor
lower Kd
(21/60/90-days)
0.5
RQfor
higher Kd
(21/60/90-days)
0.02/0.02/0.02
0.01/0.01/0.01
0.01/0/0
Flowing H2O
(Monitoring
Study)
0.03
There is significant potential for chronic risk to freshwater and
37
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estuarine fish from the use of fenbutatin-oxide on citrus. There are no
chronic concerns for freshwater and estuarine invertebrates. The
potential for chronic risk to fish is increased because fenbutatin-oxide is
very persistent in aquatic environments and may accumulate in fish. In
addition, citrus use sites are often in close proximity to estuarine
environments.
The chronic risk quotients calculated for fish for the citrus use
range from 1.1 to 29.2. Despite the large differences in Kd values, a
risk quotient of 1.8 results from the monitoring study, supporting the
Agency's conclusion that a significant potential for chronic risk to fish
exists, regardless of which Kd value is used.
Although the higher Kd values tend to indicate that fenbutatin-
oxide is expected to be associated more with the sediment than the water
column, it is possible that levels approaching the aqueous solubility of
approximately 12 ppb will be maintained in the water after several years
of continuous use due to high accumulation in the sediment and slow
release into the water. Measured residues in the field residue
monitoring study showed some tendency for partitioning into the
sediment.
Terrestrial Plants
Hazard to nontarget plants is not anticipated from the use of
fenbutatin-oxide.
Nontarget Insects
Hazard to bees is not anticipated from the use of fenbutatin-
oxide.
Endangered Terrestrial Organisms
Acute risk to endangered birds and mammals is not expected
from any of the current uses. There is a potential for chronic hazard to
these organisms from the use of fenbutatin-oxide at current rates.
Endangered Aquatic Organisms
Acute risk to endangered freshwater fish and invertebrates is
expected from all major uses. The endangered species LOG is 0.05.
The risk quotients for freshwater fish range from 1.2 to 7.5, while those
for invertebrates range from 0.2 to 1.3. There is acute hazard to
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endangered estuarine fish and invertebrates for both the citrus and the
apple uses. For the citrus use the fish risk quotients range from 0.3 to
0.6 and the invertebrate risk quotients range from 1.9 to 31.8. For the
apple use the fish risk quotient is 0.1 and the invertebrate risk quotients
range from 1.1 to 7.5.
The LOC's for chronic hazard are the same for both endangered
and non-endangered species. Fenbutatin-oxide on citrus at current rates
presents significant potential for chronic hazard to endangered
freshwater and estuarine fish.
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 fenbutatin-oxide
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 fenbutatin-oxide. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregistration eligibility of
fenbutatin-oxide, 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 fenbutatin-oxide and to determine whether fenbutatin-oxide can
be used without resulting in unreasonable adverse effects to humans and the
environment. To ensure that the potential risks of fenbutatin-oxide are not
unreasonable, the Agency is classifying fenbutatin-oxide as a Restricted Use pesticide
and requiring the registrant to implement certain risk mitigation measures. Provided
these measures are implemented, as discussed below, the Agency finds that all products
containing fenbutatin-oxide as an active ingredient are eligible for reregistration. The
reregistration of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that all uses of fenbutatin-oxide 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 fenbutatin-oxide following review of additional sampling data, if
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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
fenbutatin-oxide, the Agency has sufficient information on the health effects of
fenbutatin-oxide and on its potential for causing adverse effects in fish and
wildlife and the environment. Therefore, the Agency concludes that products
containing fenbutatin-oxide for all uses are eligible for reregistration.
The Agency has determined that fenbutatin-oxide 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
Although the Agency has determined that all uses of fenbutatin-oxide are
eligible for reregistration, the Agency is requiring additional risk mitigation
measures for the use of fenbutatin-oxide on citrus in Florida. These measures
are designed to mitigate the risk to both freshwater and estuarine aquatic
organisms that are found near Florida's citrus groves.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
fenbutatin-oxide. Where labeling revisions are required, specific language is set forth
in Section V of this document.
1. Risk Mitigation Measures
In order to reregister all uses of fenbutatin-oxide, the Agency is
classifying all fenbutatin-oxide products as Restricted Use pesticides for use by
certified applicators (or persons under their supervision) only. The Agency has
determined that the criteria set forth in 40 CFR 15.170(c)(iii) and 40 CFR
152.170(c)(iv) have been met. The Agency is also requiring additional
mitigation measures, including reduced application rates, label amendments
with instructions to minimize spray drift, development of more accurate aquatic
modeling, and monitoring to determine if fenbutatin-oxide levels accumulate
over multiple years of use.
The registrant is reducing the application rates of fenbutatin-oxide on
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most crops, including a 50% reduction in the use on citrus from a maximum of
4 pounds of active ingredient per acre, per season, to 2 pounds of active
ingredient.
The registrant is also eliminating the aerial application of fenbutatin-
oxide in the ecologically-sensitive flatwoods section of Florida and
implementing other restrictions on both aerial and airblast applications in
Florida. These restrictions are detailed in the Actions Required By Registrants
Section.
In addition, the Agency is requiring the registrant to evaluate the
mitigation measures through both a modeling and a sediment monitoring
program. The registrant will work closely with the Agency to develop a
modeling and sampling program that reflects the use of fenbutatin-oxide on
Florida citrus.
2. Restricted Use Classification
Because of its very high toxicity to aquatic organisms, the Agency is
requiring restricted use status for all uses of fenbutatin-oxide. Applicator
training will be required and only certified applicators will be able to apply
fenbutatin-oxide.
The Agency believes the Restricted Use classification is appropriate for
all uses of fenbutatin-oxide. Many of the use sites are located on or near bodies
of water and fenbutatin-oxide has been shown to be very highly toxic to
freshwater and estuarine aquatic organisms. In addition, fenbutatin-oxide
persists in the environment long after the initial application. The potential for
serious contamination of the eco-system is substantial.
The Agency is using the authority of FIFRA section 3(d)(l) to classify
fenbutatin-oxide as "Restricted Use". Fenbutatin-oxide meets the criteria for
restricted use by certified applicators for hazard to non-target species as stated
in CFR 152.170 because of its toxicity to freshwater and estuarine aquatic
organisms.
When the Agency classifies a use of a pesticide as Restricted, the
pesticide can only be used by or under the direct supervision of a certified
applicator who is certified for that use. State Lead Agencies for pesticide
programs carry out certification programs under cooperative agreement with the
Agency. Each state that conducts a certification program has had a plan
approved by the Agency to carry out that program. Within those plans, the
states identify categories of certification and standards of competency that must
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be met to become certified in each category. As required under FIFRA section
3(d)(l), the Agency will publish a notice of this proposed classification to
Restricted Use in the Federal Register. Registrants will need to amend their
registrations and product labels to incorporate the Restricted Use Statement, and
the other required language in this RED, to coincide with the certification
program.
3. Tolerance Reassessment
The tolerance expression for plants should include fenbutatin-oxide only.
The tolerance expression for meat, milk, poultry and eggs should include
fenbutatin-oxide and its metabolites dihydroxybis(2-methyl-2-phenylpropyl)
stannane (SD-31723) and 2-methyl-2-phenylpropylstannoic acid (SD-33608) as
well as the parent.
The following discussions address tolerance evaluations for each section
in the Code of Federal Regulations. A summary table follows these
discussions. A blank under the tolerance reassessment column in the summary
table indicates that the current tolerance is adequate.
Tolerances listed under 40 CFR §180.362(a)
The tolerances listed in 40 CFR §180.362(a) are for the residues of
fenbutatin-oxide. Sufficient data are available to ascertain the adequacy of the
established tolerances listed for: almonds; almonds, hulls; apples; cherries,
sour; cherries, sweet; citrus fruits; cucumbers; eggplant; grapes; papayas;
peaches; pears; pecans; plums; prunes; strawberries; and walnuts. Certain
commodity definitions of the above tolerances are not in accordance with the
definitions listed in the Commodity Index Report dated 10/28/92; see the table
and discussion below for modifications in commodity definitions.
The individual tolerances for "almonds" (0.5 ppm), "pecans" (0.5 ppm),
and "walnuts" (0.5 ppm) should be revoked, and a tolerance for residues in or
on "tree nuts group" should be established at 0.5 ppm. The available data from
almonds, pecans, and walnuts will support this crop group tolerance.
The separate tolerances for "cherries, sour" (6.0 ppm) and "cherries,
sweet" (6.0 ppm) should be combined into a single tolerance for residues in or
on "cherries" (6.0 ppm).
The commodity definition for "citrus fruits" should be changed to
"citrus fruits group."
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The commodity definition for "plums" (4.0 ppm) should be changed to
"plums (fresh prunes)," and the separate tolerance for prunes (4.0 ppm) should
be revoked.
Tolerances listed under 40 CFR §180.362(b)
The tolerances listed in 40 CFR § 180.362(b) are for the combined
residues of fenbutatin-oxide and its organotin metabolites calculated as the
parent. Sufficient data are available to ascertain the adequacy of the established
tolerances for: cattle, fat; cattle, mbyp; cattle, meat; eggs; goats, fat; goats,
mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses,
meat; horses, mbyp; milk fat; poultry, fat; poultry, mbyp; poultry, meat;
sheep, fat; sheep, mbyp; and sheep, meat. Certain commodity definitions of
the above tolerances are not in accordance with the definitions listed in the
Commodity Index Report dated 10/28/92; see the table and discussion below for
modifications in commodity definitions.
The commodity definition for "milk fat" should be changed to "milk,
fat."
Tolerances listed under 40 CFR §180.362(c)
The tolerance listed in 40 CFR § 180.362(c) is for residues of fenbutatin-
oxide. Sufficient data are available to ascertain the adequacy of the established
tolerance for: raspberries.
Tolerances listed under 40 CFR §185.3550
The tolerances listed in 40 CFR §185.3550 are for the residues of
fenbutatin-oxide. Sufficient data are available to ascertain the adequacy of the
established tolerances for: prunes, dried; and raisins. The commodity
definitions of the above tolerances are not in accordance with the definitions
listed in the Commodity Index Report dated 10/28/92; see the table below for
modifications in commodity definitions.
Tolerances listed under 40 CFR §186.3550
The tolerances listed in 40 CFR §186.3550 are for the residues of
fenbutatin-oxide. Sufficient data are available to ascertain the adequacy of the
established tolerance for: grape pomace, dried.
The commodity definitions of the feed additive tolerances are not in
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accordance with the definitions listed in the Commodity Index Report dated
10/28/92; see the table below for modifications in commodity definitions.
A feed additive tolerance has been proposed for "citrus, oil, refined"
(140 ppm). The available processing data indicate that fenbutatin-oxide
residues concentrate 6.9x in citrus oil.
The tolerance for "citrus pulp, dried" (35.0 ppm) has been proposed to
be increased to 100 ppm; available processing data indicate that fenbutatin-oxide
residues concentrate 4.8x in dried pulp.
The tolerance for "raisin waste" (20 ppm) has been proposed to be
increased to 80 ppm; available processing data indicate that fenbutatin-oxide
residues concentrate 1.7x in grape stems and 16.1x in stem waste.
Tolerance Reassessment Summary
Current
„ ,. Tolerance
Commodity , ,
(ppm)
Tolerances
Almonds 0.5
Pecans 0 . 5
Walnuts 0.5
Almonds, hulls 80.0
Apples 15.0
Cherries, sour 6.0
Cherries, sweet 6.0
Citrus fruits 20.0
Cucumbers 4 . 0
Eggplant 6.0
Grapes 5 . 0
Papayas 2 . 0
Peaches 10.0
Pears 15.0
Plums 4.0
Prunes 4.0
Tolerance
Reassessment Comment/ Correct
(ppm) Commodity Definition
listed under 180.362(a)
Revoke and
establish at 0 . 5 Tree nuts group
ppm
Combine into
one tolerance Cherries
at 6 ppm
Citrus fruits group
Plums (fresh prunes)
Revoke Covered under
"Plums (fresh prunes)"
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TABLE B.
(Continued).
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/ Correct
Commodity Definition
Strawberries
10.0
Tolerances listed under 180.362(b)
Cattle, fat
Cattle, mbyp
Cattle, meat
Eggs
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk fat
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
0.5
0.5
0.5
0.1
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.1 Milk, fat
0.1
0.1
0.1
0.5
0.5
0.5
Tolerances listed under 180.362(c)
Raspberries
10.0
Tolerances listed under 185.3550
Prunes, dried
20.0
Prunes
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TABLE B.
(Continued).
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/ Correct
Commodity Definition
Raisins
20.0
Grapes, raisins
Tolerances listed under 186.3550
Apple pomace,
dried
Citrus oil
Citrus pulp, dried
Grape pomace,
dried
Raisin waste
75
35.0
100.0
20.0
30
140
100
80
Apples, pomace, wet
Citrus, oil, refined
Citrus, pulp, dried
Grapes, pomace, wet and dried
Grapes, raisin, waste
Codex Harmonization
Several maximum residue limits (MRLs) for fenbutatin-oxide have been
established by Codex in various commodities. The Codex MRLs (currently
expressed in terms of fenbutatin-oxide) and applicable U.S. tolerances
(currently expressed in terms of the combined residues of fenbutatin-oxide and
its organotin metabolites) are listed in the table below. The tolerance
expression for plants should include fenbutatin-oxide only. The tolerance
expression for meat, milk, poultry and eggs should include metabolites
dihydroxybis(2-methyl-2-phenylpropyl)stannane (SD-31723) and 2-methyl-
2-phenylpropyl stannoic acid (SD-33608) as well as the parent.
Because of the differences between the Codex and the current and
recommended U.S. tolerance expressions for animal commodities, compatibility
is not achievable. Furthermore, with the exception of the tolerance levels for
grapes (5 ppm and 5 mg/kg), U.S. tolerance levels are higher than the
corresponding Codex MRLs. The established or reassessed U.S. tolerances for
citrus pulp, dried; eggplant; and meat of cattle, goats, hogs, horses, and sheep
exceed the corresponding codex MRLs by factors greater than 5x. Available
data indicate that U.S. agricultural practices involving applications of
fenbutatin-oxide can result in residues that exceed the Codex MRLs, making it
unlikely that U.S. tolerance levels could be lowered to achieve compatibility
with Codex MRLs.
No questions of compatibility exist with respect to commodities where:
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(i) no codex MRL's have been established but U.S. tolerances exist; and (ii)
Codex MRLs have been established but U.S. tolerances do not exist.
Codex MRL's and Applicable U.S. Tolerances
Commodity
Apple
Apple pomace, wet
Cherries
Citrus fruits
Citrus pulp, dry
Cucumber
Eggplant
Gherkin
Grapes
Horse kidney
Horse liver
Kidney of cattle, goats, pigs, and sheep
Liver of cattle, goats, pigs, and sheep
Meat of cattle, goats, horses, pigs, and
sheep
Melons, except Watermelon
Milks
Peach
Pear
Peppers, Sweet
Plums (including Prunes)
Strawberry
Tomato
Codex MRL
(mg/kg)
5
20
5
5
7
1
1
1
5
0.2
0.2
0.2
0.2
0.02
1
0.02
7
5
1
3
3
1
Reassessed U.S. Tolerance
(ppm) ||
15 (Apples)
30 (Apples, pomace, wet)
6 (Cherries)
20 (Citrus fruits group)
100 (Citrus, pulp, dried)
4 (Cucumbers)
6 (Eggplant)
4 (Cucumbers)
5 (Grapes)
0.5 (Horses, mbyp)
0.5 (Horses, mbyp)
0.5 (Cattle, mbyp)
0.5 (Goats, mbyp)
0.5 (Hogs, mbyp)
0.5 (Sheep, mbyp)
0.5 (Cattle, meat)
0.5 (Goats, meat)
0.5 (Horses, meat)
0.5 (Hogs, meat)
0.5 (Sheep, meat)
N/A
0.1 (Milk, fat)
10 (Peaches)
15 (Pears)
N/A
4 [Plums (fresh prunes)]
20 (Prunes)
10 (Strawberries)
N/A
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4. Endangered Species Statement
Acute hazard to endangered birds and mammals is not expected from
any current use. There is significant potential for chronic hazard to these
organisms from the use of fenbutatin-oxide at current rates.
There is significant acute hazard to endangered freshwater aquatic
organisms from all major uses at current application rates. For the two use
sites, citrus and apples, that raise estuarine concerns due to their close
proximity to estuarine areas, there is significant acute hazard to endangered
aquatic organisms. There is also significant potential for chronic hazard to
freshwater and estuarine fish from the citrus use.
EPA is currently working with the U.S. Fish and Wildlife Service and
other federal and state agencies to develop a program to avoid jeopardizing the
continued existence of listed species from the use of pesticides. When this
program goes into effect, endangered species precautionary labeling will be
required.
5. Labeling Rationale
Due to fenbutatin-oxide's toxicity to aquatic organisms, all
manufacturing-use products are required to bear a statement on the toxicity of
the pesticide to fish and aquatic invertebrates. Please see the Actions Required
by Registrants section for further details.
Due to the potential for chronic hazard to birds, mammals and aquatic
organisms, all labels for end-use products containing fenbutatin-oxide must be
amended to bear a statement on the toxicity of the pesticide and some
application mitigation measures. Please see the Actions Required by Registrants
section for further details.
Worker Protection Requirements
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
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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) for Handlers
For each end-use product, PPE requirements for pesticide handlers will
be set during reregistration in one of two ways:
1. If EPA has no special concerns about the acute or other adverse effects
of an active ingredient, the PPE for pesticide handlers will be 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.
2. If EPA has special concerns about an active ingredient due to very high
acute toxicity or to certain other adverse effects, such as allergic effects
or delayed effects (cancer, developmental toxicity, reproductive effects,
etc):
In the RED for that active ingredient, EPA 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.
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There are no special toxicological concerns about fenbutatin-oxide that
warrant the establishment of active-ingredient-based PPE requirements for
handlers.
Early Entry PPE Requirements
The WPS establishes very specific restrictions on entry by workers to
areas that remain under a restricted-entry interval 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 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 EPA 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 EPA 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.
For products containing fenbutatin-oxide, the PPE required for early
entry is coveralls, chemical-resistant gloves, shoes plus socks, and protective
eyewear.
Entry Restrictions for non-WPS Uses
Some registered uses of fenbutatin-oxide are outside the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS). The Agency
has determined that, at this time, the entry restrictions discussed in this section
need not apply to uses of fenbutatin-oxide outside the scope of the Worker
Protection Standard for Agricultural Chemicals, including out-of-scope
commercial uses. The predicted frequency, duration and degree of post-
application exposure from these uses do not warrant the risk mitigation
measures being required for persons engaged in the production of agricultural
plants for commercial or research purposes.
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All non-WPS occupational uses of fenbutatin-oxide end-use products
must bear the following entry restriction, "Do not enter or allow others to enter
the treated area until sprays have dried."
Entry Restrictions for Residential Products
The Agency is concerned about post-application exposures to
homeowners following application of fenbutatin-oxide, therefore, residential
products must contain the following requirement, "Do not allow persons or pets
to enter the treated area until sprays have dried."
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 fenbutatin-oxide
for the above eligible uses has been reviewed and determined to be substantially
complete. However, the following additional generic data are required at this
time:
61-2(b) Discussion of formation impurities
63-12 pH
165-4 Bioaccumulation in fish
201-1 Droplet size spectrum
202-1 Drift field evaluation
2. Labeling Requirements for Manufacturing-Use Products
Toxicity Statement
Due to the toxicity of fenbutatin-oxide to birds, mammals and aquatic
organisms, all manufacturing-use products must bear the following statement:
"This pesticide is toxic to birds, mammals, fish, and aquatic
invertebrates."
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA requires 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
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10.
Use Directions
In this RED document, all the uses of fenbutatin-oxide are being
declared Restricted. For products being reregistered under this RED
document, a restricted use legend must appear at the top of the front
panel of the label. No other wording or symbols may appear above the
legend and it must begin with the heading "RESTRICTED USE
PESTICIDE," followed by a brief statement of the reason for the
restricted use classification (i.e., "DUE TO VERY HIGH TOXICITY
TO AQUATIC ORGANISMS"). Following this, the terms of the
restriction must be stated as, "For retail sale to and use only by Certified
Applicators or persons under their direct supervision and only for those
uses covered by the Certified Applicator's certification."
Worker Protection Standard
Personal Protective Equipment for Handlers
There are no special toxicological concerns about fenbutatin-
oxide that warrant the establishment of active-ingredient-based PPE
requirements for handlers. The PPE for pesticide handlers will be based
on the acute toxicity of the end-use product.
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Entry Restrictions
For occupational end-use products containing fenbutatin-oxide as
an active ingredient, the Agency is establishing a 48-hour restricted-
entry interval for each use of the product that is within the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS). For
products containing fenbutatin-oxide, the PPE required for early entry
permitted by the WPS is coveralls, chemical-resistant gloves, shoes plus
socks, and protective eyewear.
All non-WPS occupational uses of fenbutatin-oxide end-use
products must bear the following entry restriction: "Do not enter or
allow others to enter the treated area until sprays have dried."
All residential products must bear the following entry restriction:
"Do not allow persons or pets to enter the treated area until sprays have
dried."
Other Labeling Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing fenbutatin-oxide that are
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:
"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."
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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."
Type of Respirator: If the acute inhalation toxicity of the end-use
product is in category I or II, then a respirator is required for pesticide
handlers. A dust/mist filtering respirator (MSHA/NIOSH approval
number prefix TC-21C) is the only type of respirator that is appropriate
to mitigate fenbutatin-oxide inhalation concerns.
Toxicity Statement
Due to the toxicity of fenbutatin-oxide to birds, mammals and aquatic
organisms, all end-use product labels must bear the following statement:
"This pesticide is toxic to birds, mammals, fish, and aquatic
invertebrates. Do not apply directly to water, or to areas where surface
water is present or to intertidal areas below the mean high-water mark.
Drift and runoff may be hazardous to aquatic organisms in neighboring
areas. Do not contaminate water when disposing of equipment
washwater or rinsate."
Drift Reductions
To mitigate the risks posed by fenbutatin-oxide's high toxicity to aquatic
organisms, all end-use product labels with aerial applications must bear the
following statements for citrus use in Florida:
1) Do not apply within 125 feet of bodies of water such as lakes,
reservoirs, rivers, permanent streams, natural ponds, marshes or
estuaries.
2) Do not apply when gusts or sustained winds exceed 8 mph.
3) The boom length must not exceed 3/4 of the wing or rotor length
(i.e. The distance of the outer-most nozzles on the boom must
not exceed 3/4 of the length of the wingspan or rotor).
4) Do not apply at a height greater than 10 feet above the top of the
54
-------
target plants unless a greater height is required for aircraft safety.
5) Nozzles must always point backward and never be pointed
downwards more than 45 degrees.
6) Do not apply in less than 10 gallons of final spray per acre.
7) Do not apply east of US Highway #1, south and east of State
Road #846 or south of West Palm Beach Canal.
All end-use products using airblast applications must bear the following
statements for citrus use in Florida:
1) Citrus groves may be planted close to bodies of water. Do not
apply within 25 feet of bodies of water such as lakes, reservoirs,
rivers, permanent streams, natural ponds, marshes or estuaries.
2) For all plantings within 75 feet of bodies of water as described
above, spray trees only from outside the planting away from the
bodies of water.
3) Shut off the sprayer when turning at row ends.
4) Do not apply when gusts or sustained winds exceed 12 mph.
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 fenbutatin-
oxide 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.
55
-------
56
-------
VI. APPENDICES
57
-------
58
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
59
-------
60
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page 1
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
ALMOND
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
APPLE
High volume spray (dilute) . , Prebloom EC NA
through foliar., High volume ground.
WP NA
Low volume spray (concentrate) . , Prebloom EC NA
through foliar., Low volume ground.
WP NA
CHERRY
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
CITRUS FRUITS
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Use Group
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
Use Group
1.5 Ib A *
1.5 Ib A *
1.5 Ib A *
1.5 Ib A *
Use Group
1.5 Ib A *
1.5 Ib A *
1.5 Ib A *
1.5 Ib A *
Use Group
4 Ib A *
4 Ib A *
2 Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL
2
2
2
2
NS
NS
NS
NS
: TERRESTRIAL
4
4
4
4
NS
NS
NS
NS
: TERRESTRIAL
NS
2
NS
2
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
2/1 yr
2/1 yr
2/1 yr
FOOD+FEED
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
CROP
NS AN 1
NS AN 1
NS AN 1
NS AN 1
CROP
NS AN 1
NS AN 1
NS AN 1
NS AN 1
NS AN 1
NS AN 1
NS AN 1
NS AN 1
CROP
NS 60 1
NS 60 1
NS 60 1
Limitations Use
Disallowed Limitations
Codes
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
H01(14)
HOI (14)
H01(14)
HOI (14)
H01(14)
HOI (14)
H01(14)
HOI (14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(7)
H01(7)
H01(7)
Low volume ground.
Ib A
NS 2/1 yr
C46, G20, H01(7)
-------
Date 09/06/94 _ Time 10:42
APPENDIX A _ CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
EGGPLANT
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
GRAPES
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
NECTARINE
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
PAPAYA
High volume spray (dilute) ., Foliar., High WP NA
volume ground.
PEACH
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Use Group:
2 Ib A *
2 Ib A *
Use Group:
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
Use Group:
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
Use Group:
1 Ib A *
Use Group:
1 Ib A *
1 Ib A *
1 Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
TERRESTRIAL
3
3
NS
NS
TERRESTRIAL
2
2
2
2
NS
NS
NS
NS
TERRESTRIAL
2
2
2
2
NS
NS
NS
NS
TERRESTRIAL
9
NS
TERRESTRIAL
2
2
2
NS
NS
NS
FOOD CROP
NS 6 Ib AN 1
NS 6 Ib AN 1
FOOD+FEED CROP
NS NS 21 1
NS NS 21 1
NS NS 21 1
NS NS 21 1
FOOD CROP
NS NS AN 1
NS NS AN 1
NS NS AN 1
NS NS AN 1
FOOD CROP
NS NS 30 1
FOOD CROP
NS NS AN 1
NS NS AN 1
NS NS AN 1
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
CA C46, G20,
C46, G06,
C46, G20,
C46, G06,
H01(3)
H01(3)
HOI (28)
HOI (28)
HOI (28)
HOI (28)
HOI (14)
HOI (14)
HOI (14)
HOI (14)
H01(7)
H01(14)
HOI (14)
H01(14)
Low volume ground.
1 Ib A
C46, G20, H01(14)
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page 3
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEAR
High volume spray (dilute) . , Prebloom EC NA
through foliar., High volume ground.
WP NA
Low volume spray (concentrate) . , Prebloom EC NA
through foliar., Low volume ground.
WP NA
PECAN
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
PLUM
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Low volume ground.
WP NA
PRUNE
High volume spray (dilute) ., Foliar., High EC NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., EC NA
Use Group:
1.5 Ib A *
1.5 Ib A *
1.5 Ib A *
1.5 Ib A *
Use Group:
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
Use Group:
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
Use Group:
1 Ib A *
1 Ib A *
1 Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
TERRESTRIAL
4
4
4
4
NS
NS
NS
NS
TERRESTRIAL
2
2
2
2
NS
NS
NS
NS
TERRESTRIAL
2
2
2
2
NS
NS
NS
NS
TERRESTRIAL
2
2
2
NS
NS
NS
FOOD CROP
NS NS AN 1
NS NS AN 1
NS NS AN 1
NS NS AN 1
FOOD CROP
NS NS AN 1
NS NS AN 1
NS NS AN 1
NS NS AN 1
FOOD CROP
NS NS AN 1
NS NS AN 1
NS NS AN 1
NS NS AN 1
FOOD CROP
NS NS AN 1
NS NS AN 1
NS NS AN 1
Limitations Use
Disallowed Limitations
Codes
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
C46, G20,
C46, G06,
H01(14)
HOI (14)
H01(14)
HOI (14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
H01(14)
Low volume ground.
1 Ib A
C46, G20, H01(14)
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page 4
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
RASPBERRY (BLACK, RED)
High volume spray (dilute) ., Postharvest . ,
High volume ground.
High volume spray (dilute) ., Preharvest . ,
High volume ground.
STRAWBERRY
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
WALNUT (ENGLISH/BLACK)
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
EC
EC
WP
WP
EC
EC
WP
WP
EC
WP
EC
WP
EC
WP
EC
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group:
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
Use Group:
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
Use Group:
1.25 Ib A *
1.25 Ib A *
1.25 Ib A *
Max. # Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
TERRESTRIAL
2
2
2
2
3
3
3
3
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
4
4
4
4
NS
NS
NS
NS
TERRESTRIAL
2
2
2
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
21
21
21
21
21
21
21
21
AN
AN
AN
AN
AN
AN
AN
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
NS OR
NS WA
NS OR
NS WA
NS OR
NS WA
NS OR
NS WA
1
1
1
1
1
1
1
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
HOI (7)
HOI (7)
HOI (7)
HOI (7)
HOI (7)
HOI (7)
HOI (7)
HOI (7)
G06, H01(l)
G20, H01(l)
G06, H01(l)
G20, H01(l)
G06, HOI (14)
G20, HOI (14)
G06, HOI (14)
Low volume ground.
1.25 Ib A
C46, G20, HOI(14)
NON- FOOD/NON- FEED
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page 5
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CHRISTMAS TREE PLANTATIONS
Low volume spray (concentrate) ., Foliar.,
Aircraft.
Spray., Foliar., Airblast.
Use Group
EC
EC
EC
EC
NA
NA
NA
NA
1
1
1
1
Ib
Ib
Ib
Ib
A *
A *
A *
A *
: TERRESTRIAL
1
1
1
1
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
OR
WA
OR
WA
C46
C46
C46
C46
ORNAMENTAL AND/OR SHADE TREES
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
Soil treatment., Foliar., Hose-end sprayer
Soil treatment., Foliar., Power sprayer.
Soil treatment., Foliar., Tank-type sprayer. EC
Spray., Foliar., Hose-end sprayer.
Spray., Foliar., Power sprayer.
Spray., Foliar., Tank-type sprayer.
High volume spray (dilute)., Foliar., High WP NA
volume ground.
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS AN
UC
NS
NS
NS
NS AN
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS AN 1
WP
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
Use
UC
UC
UC
UC
UC
UC
* NS
* NS
4/1 yr
NS
Group: TERRESTRIAL
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON - FOOD +OUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
1
1
RESIDENTIAL
21
21
21
7
7
7
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS AN 1
C46, G06
C46, G06
C46, G06
C46, G20
C46, G06
C46, G20
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL AND/OR SHADE TREES (con't)
High volume spray (dilute)., Nurserystock., WP NA
High volume ground.
ORNAMENTAL HERBACEOUS PLANTS
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
Soil treatment., Foliar., Hose-end sprayer
Soil treatment., Foliar., Power sprayer.
Soil treatment., Foliar., Tank-type sprayer. EC
Spray., Foliar., Hose-end sprayer.
Spray., Foliar., Power sprayer.
Spray., Foliar., Tank-type sprayer.
High volume spray (dilute)., Foliar., High WP NA
volume ground.
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS AN 1
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS AN 1
UC
NS
NS
NS
NS AN
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS AN 1
WP
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
Use
UC
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
4/1 yr
NS
Group: TERRESTRIAL
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON - FOOD +OUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
1
1
RESIDENTIAL
21
21
21
7
AN
7
AN
7
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL+GREENHOUSE NON-POOD CROP
UC * NS NS NS NS AN 1
C46, G20
C46, G06
C46, G06
C46, G06
C46, G20
C46, G06
C46, G20
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page 7
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
High volume spray (dilute)., Nurserystock., WP NA
High volume ground.
ORNAMENTAL NONFLOWERING PLANTS
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
Soil treatment., Foliar., Hose-end sprayer
Soil treatment., Foliar., Power sprayer.
Soil treatment., Foliar., Tank-type sprayer. EC
Spray., Foliar., Hose-end sprayer.
Spray., Foliar., Power sprayer.
Spray., Foliar., Tank-type sprayer.
High volume spray (dilute)., Foliar., High WP NA
volume ground.
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS AN 1
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS AN 1
UC
NS
NS
NS
NS AN
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS AN 1
WP
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
Use
UC
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
4/1 yr
NS
Group: TERRESTRIAL
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON - FOOD +OUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
1
1
RESIDENTIAL
21
21
21
7
AN
7
AN
7
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL+GREENHOUSE NON-POOD CROP
UC * NS NS NS NS AN 1
C46, G20
C46, G06
C46, G06
C46, G06
C46, G20
C46, G06
C46, G20
-------
Date 09/06/94
Time 10:42
APPENDIX A
CASE 0245, [Vendex] Chemical 104601 [Hexakis]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL NONFLOWERING PLANTS (con't)
High volume spray (dilute)., Nurserystock., WP NA
High volume ground.
ORNAMENTAL WOODY SHRUBS AND VINES
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
High volume spray (dilute)., Foliar., High EC NA
volume ground.
High volume spray (dilute)., Nurserystock., EC NA
High volume ground.
Soil treatment., Foliar., Hose-end sprayer
Soil treatment., Foliar., Power sprayer.
Soil treatment., Foliar., Tank-type sprayer. EC
Spray., Foliar., Hose-end sprayer.
Spray., Foliar., Power sprayer.
Spray., Foliar., Tank-type sprayer.
High volume spray (dilute)., Foliar., High WP NA
volume ground.
High volume spray (dilute)., Nurserystock., WP NA
High volume ground.
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS AN 1
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS AN 1
UC
NS
NS
NS
NS AN
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS AN 1
WP
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
Use
UC
UC
UC
UC
UC
UC
* NS
* NS
4/1 yr
NS
Group: TERRESTRIAL
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON - FOOD +OUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
1
1
RESIDENTIAL
21
21
21
7
7
7
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL+GREENHOUSE NON-POOD CROP
UC * NS NS NS NS AN 1
UC
NS
NS
NS
NS AN
C46, G20
C46, G06
C46, G06
C46, G06
C46, G20
C46, G06
C46, G20
C46, G20
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Date 09/06/94 _ Time 10:42 APPENDIX A _ CASE 0245, [Vendex] Chemical 104601 [Hexakis] LUIS 1.5 _ Page 9
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
EC : EMULSIFIABLE CONCENTRATE
WP : WETTABLE POWDER
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C46 : Do not apply through any type of irrigation system.
G06 : Do not feed or graze livestock on cover crops in treated areas.
G20 : Do not feed or graze animals on cover crops in treated areas.
HOI : day(s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
CA : California
OR : Oregon
WA : Washington
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70
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
71
-------
72
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Fenbutatin-oxide covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Fenbutatin-oxide 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.
73
-------
74
-------
REQUIREMENT
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Fenbutatin-Oxide
CITATION(S)
USE PATTERN
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
40365801
00113071, 40365801, 40843601
00113071, 40365801
40590501
40590501
00053791, 00113071, 00113078, 40590501
00113071, 40365801
00113071, 40365801, 40560901
00113071,40365801
00113071, 40365801
N/A
40365801
00113071,40365801,40696401
40365801
N/A
40696402
40365801
00113071, 40365801
75
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Data Supporting Guideline Requirements for the Reregistration of Fenbutatin-Oxide
REQUIREMENT USE PATTERN CITATION(S)
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
72-1A Fish Toxicity Bluegill
72-IB Fish Toxicity Bluegill - TEP
72-1C Fish Toxicity Rainbow Trout
72-ID Fish Toxicity Rainbow Trout- TEP
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
72-3A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity -
Shrimp
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
72-5 Life Cycle Fish
72-6 Aquatic Organism Accumulation
72-7B Actual Field - Aquatic Organisms
A, B, C, I, K
A, B, C, I, K
A, B, C, K
A, B, C
A, B, C
A, B, C, K
A, B, C
A, B, C, I, K
A, B, C, K
A, B, C, I, K
A, B, C, K
A, B, C
A, B, C
A, B, C
00113073
40473505
00113074
41258901
41258902
00113076, 40098001
40473508
00113075; 40098001; 40473506
40473507
40473509
40473511
41483301
40590507
40590508
A, B, C
A, B, C
A, B, C
A, B, C
A, B
40473512
41551401
40525901
41551402
42872101
76
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Data Supporting Guideline Requirements for the Reregistration of Fenbutatin-Oxide
REQUIREMENT
141-1
Honey Bee Acute Contact
USE PATTERN
A, B, C
00036935
CITATION(S)
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
40709901
40709902
40473502, 40473503
40709803, 40709805
40709803, 40709905
40709804, 40709806
00037582, 00067049,
00113002, 40977001,
40641201
00037582, 00067049,
00113002, 40977001,
00037582, 00067049,
00037581, 00067048,
00072693
00049230, 00069880,
41540601
40473501, 40770601
00113001
41192401
00113001
41192401
00113001
00113000
00079319
77
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Data Supporting Guideline Requirements for the Reregistration of Fenbutatin-Oxide
REQUIREMENT USE PATTERN CITATION(S)
84-2B Structural Chromosomal
Aberration
A
84-4 Other Genotoxic Effects A
85-1 General Metabolism A
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching/Adsorption/Desorption
164-1 Terrestrial Field Dissipation
164-5 Long Term Soil Dissipation
165-1 Confined Rotational Crop
RESIDUE CHEMISTRY
171 -4 A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
A
A, C, I, K
A, C
A, C
A, C, I, K
A, C
A, C, I, K
A, C, K
A, C, K
A
A
A
40590502, 40590504
40590503, 40590505
41069101
40083802
40790901
40790902
40790903
40257001
40257002
40257003, 40257004
41608501, 42074501
42896801
41520702
00113018
00113018, 00113020, 00113029, 00113078,
41183801
78
-------
Data Supporting Guideline Requirements for the Reregistration of Fenbutatin-Oxide
REQUIREMENT USE PATTERN CITATION(S)
171-4C
Residue Analytical Methods
Plants/Livestock
A
00026038,
00069881,
00105161,
00112902,
00130837,
00148257,
40750603,
41110803,
41520701,
00030349,
00070506,
00105203,
00113018,
00143694,
00148733,
40750604,
41110804,
42106801
00045869,
00077245,
00105204,
00113063,
00145444,
40750601,
41110801,
41110901,
00045870,
00093721,
00109280,
00113078,
00146038,
40750602,
41110802,
41110902,
171-4E
171-4J
Storage Stability
Magnitude of Residues -
Meat/Milk/Poultry/Egg
A
A
00113063, 00113078, 00146308, 41110801,
41110901, 41520701, 42568701
00113078
171-4K Crop Field Trials
A 00026038,
00071183,
00105203,
00113018,
00148257,
41110802,
00030349,
00077245,
00105204,
00113063,
00148733,
41110803,
00045869,
00093721,
00109280,
00145444,
00109280,
41110804,
00069881,
00105161,
00112902,
00146038,
41110801,
41110902
79
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80
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Fenbutatin-oxide
81
-------
82
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
83
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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.
84
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BIBLIOGRAPHY
MRID
CITATION
00026038 Nugent, K.D.; Zwick, B.; Matsuyama, H.; et al. (1978) Residue Data
Developed from the Use of Vendex-• (R)ae Miticide on Cherries. (Unpublished
study received Dec 11, 1979 under 201-369; prepared in cooperation with
Univ. of Oregon, Mid-Columbia Experiment Station and others, submitted by
Shell Chemical Co., Washington, D.C.; CDL:099140-I)
00030349 Nugent, K.D.; Howitt, A.J.; Simkover, H.G. (1979) Residue Data Developed
from the Use of Vendex-• (R)aeMiticide (4 Lb/Gallon Liquid) on Apples, Pears
and Citrus. (Unpublished study received Jan 10, 1980 under 201-412; prepared
in cooperation with Michigan State Univ., Dept. of Entomology and others,
submitted by Shell Chemical Co., Washington, D.C.; CDL:241616-I)
00036935 Atkins, E.L.; Greywood, E.A.; MacDonald, R.L. (1975) Toxicity of Pesticides
and Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By
University of California, Dept. of Entomology. ?: UC, Cooperative Extension.
(Leaflet 2287; published study.)
00037581 Granville, G.C.; Simpson, B.J.; Doak, S.M.; et al. (1973) Toxicity Studies on
the Pesticide SD 14114: An 18 Month Feeding Study in Mice: TLGR.0036.73.
(Unpublished study received on unknown date under 4F1492; prepared by Shell
Research, Ltd., submitted by Shell Chemical Co., Washington, D.C.;
CDL:093941-H)
00037582 Simpson, B.J.; Granville, G.; Doak, S.M.; et al. (1973) Toxicity Studies on
the Pesticide SD 14114: Two Year Oral Experiment in Rats: TLGR.0034.73.
(Unpublished study received on unknown date under 4F1492; prepared by Shell
Research, Ltd., submitted by Shell Chemical Co., Washington, D.C.;
CDL:093941-I)
00045869 University of Hawaii (1979) The Results of Tests on the Amount of Vendex and
It's Metabolite Residues Remaining in or on Papaya Including a Description of
the Analytical Method Used. Summary of study 099547-B. (Compilation;
unpublished study received Aug 15, 1980 under OE2397; submitted by
Interregional Research Project No. 4, New Brunswick, N.J.; CDL:099547-A)
00045870 University of Hawaii (1976) Analytical Procedure for Vendex (R), in Papaya.
85
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BIBLIOGRAPHY
MRID
CITATION
Undated method. (Unpublished study received Aug 15, 1980 under OE2397;
prepared by Agricultural Biochemistry Dept., Pesticide Laboratory, submitted
by Interregional Research Project No. 4, New Brunswick, N.J.;
CDL:099547-B)
00049230 Dix, K.M.; Wilson, A.B.; Stevenson, D.E. (1973) Toxicity Studies with SD
14114: Teratological Studies in Rabbits Given SD 14114 Orally: Group
Research Report TLGR.0052.72. (Unpublished study received May 4, 1976
under 201-367; prepared by Shell Research, Ltd., England, submitted by Shell
Chemical Co., Washington, D.C.; CDL:224065-A)
00053791 Shell Development Company (1977) Estimation of Fiber Contamination in
Triazine Herbicides and Vendex-" (R)ae Miticide and Their Formulations.
Method MMS-C-378-3 dated Jan, 1977. (Unpublished study received Mar 30,
1978 under 201-403; CDL:233494-L)
00067048 Granville, G.C.; Simpson, B.J.; Doak, S.M.; et al. (1973) Toxicity Studies on
the Pesticide SD 14114: An 18 Month Feeding Study in Mice: Group Research
Report TLGR.0036.73. (Unpublished study received Jun 25, 1974 under
4F1492; prepared by Shell Research, Ltd., England in cooperation with
Sittingbourne Laboratories, England, submitted by Shell Chemical Co.,
Washington, D.C.; CDL: 094758-A)
00067049 Simpson, B.J.; Granville, G.; Doak, S.M.; et al. (1973) Toxicity Studies on
the Pesticide SD 14114: Two Year Oral Experiment in Rats: Group Research
Report TLGR.0034.73. (Unpublished study received Jun 25, 1974 under
4F1492; prepared by Shell Research, Ltd., England in cooperation with
Sittingbourne Laboratories, England, submitted by Shell Chemical Co.,
Washington, D.C.; CDL: 094756-A)
00069880 Dix, K.M.; Wilson, A.B.; Stevenson, D.E. (1973) Toxicity Studies with SD
14114: Teratological Studies in Rabbits Given SD 14114 Orally: Group
Research Report TLGR.0052.72. (Unpublished study received Apr 13, 1976
under 201-369; prepared by Shell Research, Ltd., England, submitted by Shell
Chemical Co., Washington, D.C.; CDL:097032-A)
00069881 Shell Chemical Company (1975) Summary of Information Regarding Residues
of Vendex-i (R)ae on Strawberries. (Compilation; unpublished study, including
86
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BIBLIOGRAPHY
MRID
CITATION
TIR-24-140-74, TIR-24-706-73, TIR-24-707-73, ..., received Apr 13, 1976
under 201-369; CDL:097032-B)
00070506 Potter, J.C. (1980) 1979-Residue Data for Vendex- (R)ae Miticide and Its
Organotin Metabolites SD 31723 and SD 33608, in Filberts following Three
Applications of Vendex-" (R)ae to Filbert Trees, an Oregon Study:
RIR-24-273-79. (Unpublished study received Feb 17, 1981 under 201-412;
submitted by Shell Chemical Co., Washington, D.C.; CDL:244429-A)
00071183 Shell Chemical Company (1979) Residue Data Developed from the Use of
Vendex-i (R)ae Miticide on Strawberries. (Compilation; unpublished study
received Sep 3, 1980 under 201-369; CDL:099580-A)
00071955 Ross, D.B.; Roberts, N.L.; Cameron, M.M.; etal. (1977) Examination of
Permethrin (PP 557) for Neurotoxicity in the Domestic Hen: ICI/157-
NT/77468. (Unpublished study received Jan 27, 1978 under 10182-18;
prepared by Huntingdon Research Centre, England, submitted by ICI
Americas, Inc., Wilmington, DE; CDL:096768-H)
00072693 Dix, K.M.; Cassidy, S.L.; Hend, R.W.; et al. (1981) Teratology Study in Rats
Given SD 14114 by Gavage: Group Research Report TLGR.80.145.
(Unpublished study received Apr 27, 1981 under 201-369; prepared by Shell,
Ltd., England, submitted by Shell Chemical Co., Washington, D.C.;
CDL:244935-A)
00077245 Shell Chemical Company (1981) Residue Data Developed from the Use of
Vendex-i (R)ae Miticide on Grapes and Grape Products. (Compilation;
unpublished study received Jun 25, 1981 under 201-369; CDL:245469-A)
00079319 Dix, K.M.; Cassidy, S.L.; Vilkauls, J.; et al. (1981) Teratology Study in New
Zealand White Rabbits Given SD 14114: SBGR.18.055. (Unpublished study
received Jul 23, 1981 under 201-369; prepared by Shell Research, Ltd.,
England, submitted by Shell Chemical Co., Washington, D.C.;
CDL:245605-A)
00093721 Shell Oil Company (1980) Summary of Information Regarding Residues of
Vendex-i (R)ae Miticide on Apples, Pears, and Citrus. Includes method
MMS-R-494-2 dated Dec 1979. (Compilation; unpublished study received Jan
19, 1982 under 2F2631; CDL:070602-A)
87
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BIBLIOGRAPHY
MRID
CITATION
00105161 Reinsfelder, R.; Simkover, H.; Collins, R.; et al. (1982) The Results of Tests
on the Amount of Residues Remaining, Including a Description of the
Analytical Methods Used: Vendex. (Unpublished study received Jun 24, 1982
under 201-369; prepared in cooperation with Louisiana State Univ., Pecan
Station and Henry Agri-Scientific, submitted by Shell Chemical Co.,
Washington, DC; CDL:070967-A)
00105203 Shell Chemical Co. (1982) Summary of Vendex Miticide Residue Data-Grapes
(4L). (Compilation; unpublished study received Jun 17, 1982 under 201-412;
CDL:247721-A)
00105204 Shell Chemical Co. (1982) Summary of Corridor Residue Data for Apples,
Pears, and Citrus Which Had Received Applications of Vendex 50WP or 4L
Miticide. (Compilation; unpublished study received Jun 17, 1982 under
201-412; CDL:247722-A)
00109280 Shell Oil Co. (1982) Summary: CEvendex 4L Miticide. (Compilation;
unpublished study received Jul 20, 1982 under 201-412; CDL: 247906-A)
00112902 Shell Chemical Co. (1982) Residue Data Developed from the Use of Vendex 4L
Miticide on Cherries, Plums and Prunes. (Compilation; unpublished study
received Aug 25, 1982 under 201-412; CDL: 071061-A)
00113000 Simpson, B.; Stevenson, D. (1972) Toxicity Studies on the Pesticide SD 14114:
Two Year Oral Experiment in Mice; Interim Report after One Year: Group
Research Report TLGR.0040.72. (Unpublished study received on unknown
date under 3G1354; prepared by Shell Research, Ltd., Eng., submitted by Shell
Chemical Co., Washington, DC; CDL:093620-Q)
00113001 Simpson, B.; Stevenson, D. (1972) Toxicity Studies on the Pesticide SD 14114:
Two Year Oral Experiment in Rats; Interim Report after One Year: Group
Research Report TLGR.0039.72. (Unpublished study received on unknown
date under 3G1354; prepared by Shell Research, Ltd., Eng., submitted by Shell
Chemical Co., Washington, DC; CDL:093620-R)
00113002 Wilson, A.; Stevenson, D. (1972) Toxicity Studies on the Pesticide SD 14114:
Two Year Oral Toxicity Test in Dogs; Interim Report After One Year: Group
Research Report TLGR.0053.72. (Unpublished study received on unknown
88
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BIBLIOGRAPHY
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date under 3G1354; prepared by Shell Research, Ltd., Eng., submitted by Shell
Chemical Co., Washington, DC; CDL:093620-S)
00113018 Shell Chemical Co. (1974) CSD 14114 Residues in Apples, Pears, Citrus, Milk
and Tissues from Cows. (Compilation; unpublished study received on unknown
date under 4F1492; CDL:093938-B)
00113020 Potter, J. (1974) Characterization of the 1195n Residues in the Kidney and
Liver of Cows Fed SD 14114-1195n: TIR-22-112-74. (Unpublished study
received on unknown date under 4F1492; submitted by Shell Chemical Co.,
Washington, DC; CDL:094515-A)
00113029 Loeffler, J. (19??) The Fate of Ingested 119Sn-SD 14114 in Rats:
TIR-22-117-72. (Unpublished study received Jun 25, 1974 under 4F1492;
submitted by Shell Chemical Co., Washington, DC; CDL: 094519-H)
00113063 Shell Chemical Co. (1976) The Results of Tests on the Amount of CVendex
Residues Remaining, Including a Description of the Analytical Methods Used.
(Compilation; unpublished study received Apr 15, 1977 under 7G1947;
CDL:096090-C)
00113071 Shell Oil Co. (1976) The Name, Chemical Identity, and Composition of the
Pesticide Chemical: CVendex. (Compilation; unpublished study received Apr
2, 1979 under 201-369; CDL:098036-A)
00113073 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Acute Oral LD50-Bobwhite
Quail: SD 14114: Project No. 109-119. Final rept. (Unpublished study
received Apr 2, 1979 under 201-369; prepared by Wildlife International, Ltd.,
submitted by Shell Oil Co., Washington, DC; CDL:098036-C)
00113074 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Eight-day Dietary
LC50-Mallard Duck: SD-14114: Project No. 109-120. Final rept.
(Unpublished study received Apr 2, 1979 under 201-369; prepared by Wildlife
International, Ltd., submitted by Shell Oil Co., Washington, DC;
CDL:098036-D)
00113075 Johnson, W. (1972) Acute Toxicity of Technical SD 14114 to Rainbow Trout.
(U.S. Fish and Wildlife Service, Fish-pesticide Research Laboratory;
unpublished study; CDL:098036-H)
89
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00113076 Johnson, W.; Jones, T. (1971) Static Acute Toxicity of SD 14114 to Bluegill.
(U.S. Fish and Wildlife Service, Fish-pesticide Research Laboratory;
unpublished study; CDL:098036-I)
00113078 Shell Oil Co. (1979) The Results of Tests on the Amount of Residues
Remaining, Including a Description of the Analytical Methods Used: C Vendex.
(Compilation; unpublished study received Apr 2, 1979 under 201-369;
CDL:098036-K)
00130837 Interregional Research Project No. 4 (1983) The Results of Tests on the
Amount of Fenbutatin-oxide Residues Remaining in or on Eggplant, Including a
Description of the Analytical Method Used. (Compilation; unpublished study
received Sep 21, 1983 under 201369; CDL:071955-A)
00143694 Interregional Research Project No. 4 (19??) The Results of Tests on the
Amount of Fenbutatin-Oxide Residues Remaining in or on Avocado Including a
Dsecription of the Analytical Method Used. Unpublished compilation. 43 p.
00145444 Interregional Research Project No. 4. (19??) The Results of Tests on the
Amount of Fenbutatin-Oxide Residues Remaining in or on Raspberries
Including a Description of the Analytical Method Used. Unpublished
compilation. 49 p.
00146038 Interregional Research Project No. 4 (19??) The Results of Tests on the
Amount of Fenbutatin-oxice Residues Remaining in or on Cucumbers Including
a Description of the Analytical Method Used. Unpublished compilation. 18 P.
00148257 Shell Oil Company (1982) Residue Data Developed from the Use of Vendex 4L
Miticide on Peaches and Strawberries. Unpublished study. 116 p.
00148733 Shell Oil Co. (1985) Vendex 4L Miticide: Vendex 50WP Water Soluble Bag
Miticide: Amendment to Strawberries: ?Residue Data in Strawberries*.
Unpublished compilation. 40 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and
Data Base 410 Chemicals and 66 Species of Freshwater Animals. US Fish &
Wildlife Service; Resource Publication (160): 579 p.
40257001 Lee, P. (1980) Aerobic Soil Metabolism of 119Sn-SD-14114: Shell Report No.
90
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TIR-22-002-80. Unpublished study prepared by Shell Development Co. 30 p.
40257002 Lee, P. (1980) Anaerobic Soil Metabolism of 119Sn-SD-14114: Shell Report
No. TIR-22-110-79. Unpublished study prepared by Shell Development Co.
76 p.
40257003 Lee, P. (1980) Leaching Study of SD-14114 by Soil Column Chromatography:
Shell Report No. TIR-22-108-79. Unpublished study prepared by Shell
Development Co. 23 p.
40257004 Lee, P. (1980) Adsorption and Desorption of SD-14114 on Soil-0.2% Ortho
X-77 Water Suspension: Shell Report No. TIR-22-124-79. Unpublished study
prepared by Shell Development Co. 18 p.
40365801 Chang, W. (1987) Vendex (Fenbutatin Oxide): Product Identity and
Composition: Laboratory Project ID: Y4332.A (ES). Unpublished study
prepared by E. I. du Pont de Nemours and Co. 91 p.
40459301 Brenner, W. (1987) Vendex (Fenbutatin Oxide): Product Chemistry: Physical
and Chemical Characteristics: Laboratory Project ID Y4332.B (ES).
Unpublished study prepared by E.I. du Pont de Nemours and Co., Inc. 6 p.
40473501 Arce, G. (1987) Mutagenicity Testing of Vendex Technical in the Salmonella
typhimurium Plate Incorporation Assay: Haskell Laboratory Report No.
740-87: Medical Research No. 4581-545. Unpublished study prepared by
Dupont Haskell Laboratory for Toxicology and Industrial Medicine. 19 p.
40473502 Valentine, R. (1987) Acute Inhalation Toxicity Study with IN Y4332-6 in Rats:
Haskell Laboratory Report No. 701-87: Medical Research No. 4581-555.
Unpublished study prepared by Dupont Haskell Laboratory for Toxicology and
Industrial Medicine. 44 p.
40473503 Coate, W. (1981) Acute Rat Dust Inhalation Study of Technical Vendex:
Laboratory Project ID 776-135. Unpublished study prepared by Hazleton
Laboratories America, Inc. 45 p.
91
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40473505 Johnson, M.; Grimes, J.; Jaber, M. (1987) H # 16,849: A Dietary LC50 Study
with the Bobwhite: Wildlife International Ltd. Project No. 112-183: Dupont
HLO #733-87. Unpublished study prepared by Wildlife International Ltd. 26
P-
40473506 Hutton, D. (1987) Static Acute 96-hour LC50 of Technical Vendex to Rainbow
Trout (Salmo gairdneri): Haskell Laboratory Report No. 327-87: MR
4581-472. Unpublished study prepared by Haskell Laboratory for Toxicology
and Industrial Medicine. 10 p.
40473507 Hutton, D. (1988) Static Acute 96-hour LC50 of Vendex 4L to Rainbow Trout:
Haskell Laboratory Report No. 707-87: MR 4581-540. Unpublished study
prepared by Hasekll Laboratory for Toxicology
40473508 Hutton, D. (1988) Static Acute 96-hour LC50 of Vendex to Bluegill Sunfish:
Haskell Laboratory Report No. 13-88: MR 4581-540. Unpublished study
prepared by Dupont Haskell Laboratory for Toxicology and Industrial
Medicine. 14 p.
40473509 Hutton, D. (1987) Daphnia magna Static Acute 48-hour EC50 of Technical
Vendex: Haskell Laboratory Report No. 316-87: MR 4581501. Unpublished
study prepared by Dupont Haskell Laboratory for Toxicology and Industrial
Medicine. 10 p.
40473511 Hutton, D. (1988) Daphnia magna Static Acute 48-hour EC50 of Vendex 4L:
Haskell Laboratory Report No. 12-88: MR 4581-540. Unpublished study
prepared by Dupont Haskell Laboratory for Toxicology and Industrial
Medicine. 13 p.
40473512 Hutton, D. (1987) Early Life Stage Toxicity of Technical Vendex to Rainbow
Trout (Salmo gairdneri): Haskell Laboratory Report No. 460-87: MR
4581-472. Unpublished study prepared by Dupont Haskell Laboratory for
Toxicology and Industrial Medicine. 19 p.
40506901 Brenner, W. (1988) Vendex (Fenbutatin Oxide) Product Chemistry: Physical
and Chemical Characteristics: Laboratory Project ID Y4332.C (ES).
Unpublished study prepared by E.I. du Pont de Nemours and Company, Inc. 7
P-
92
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BIBLIOGRAPHY
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40525901 Hutton, D. (1988) Chronic Toxicity of Technical Vendex to Daphnia magna:
Rept. No. 94-88. Unpublished study prepared by E.I. du Pont de Nemours and
Co., Inc. 20 p.
40590501 Chang, W. (1988) Vendex Product Chemistry: Analysis and Certification of
Product Ingredients: Project ID: Y4332.F. Unpublished study prepared by E.I.
du Pont de Nemours and Co., Inc. 14 p.
40590502 Vlachos, D. (1988) In vitro Evaluation of Vendex Technical (in Y 4332-5) for
Chromosome Abberrations in Human Lymphocytes: Report No. 69-88; Medical
Research No. 4581-545. Unpublished study prepared by E.I.du Pont de
Nemours and Co., Inc. 26 p.
40590503 Vlachos, D. (1988) Mouse Bone Marrow Micronucleus Assay of Vendex
Technical: Report No. 71-88; Medical Research No. 4581-545. Unpublished
study prepared by E.I. du Pont de Nemours and Co., Inc. 19 p.
40590504 Stahl, R. (1988) Mutagenicity Evaluation of Vendex Technical in the
CHO/HPRT Assay: Report No. 128-88; Medical Research No. 4581-545.
Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc. 20 p.
40590505 Bentley, K. (1988) Assessment of Vendex Technical in the in vitro Unscheduled
DNA Synthesis Assay in Rat Primary Hepatocytes: Report No. 130-88.
Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc. 18 p.
40590507 Boeri, R. (1988) Static Acute Toxicity of Haskell Sample No. 16,879 to
Embryos and Larvae of the Eastern Oyster Crassostrea virginica: Project No.
D0787. Unpublished study prepared by Enseco Inc. 21 p.
40590508 Boeri, R. (1987) Static Acute Toxicity of Haskell Sample No. 16,879 to the
Mysid, Mysidopsis bahia: Project No. D0987. Unpublished study prepared by
Enseco Inc. 22 p.
40641201 Brock, W. (1988) Repeated Dose Dermal Toxicity: 21-day Study with IN
Y4332-5 (Vendex Technical) in Rabbits: Haskell Laboratory Report No.
173-88. Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc.
260 p.
40696401 Simmons, R. (1988) Determination of the Water Solubility of Vendex (Fenbutin
93
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Oxide), Y4332: Rept. No. Y4332.D. Unpublished study prepared by E.I. Du
Pont de Nemours and Co., Inc. lip.
40696402 Melander, W. (1988) n-Octanol/Water Partition Coefficient of Fenbutatin
Oxide: Proj. ID AMR-1108-88. Unpublished study prepared by E.I. du Pont
de Nemours & CO., Inc. 25 p.
40696403 Mucha, C.; Koeppe, M. (1988) Photodegradation of CTin 119-Fenbutatin Oxide
on soil: Proj. ID AMR-925-87. Unpublished study prepared by E.I. du Pont de
Nemours & Co., Inc. 43 p.
40696404 Hutton, D. (1988) Dynamic Bluegill Sunfish Bioconcentration Study with
Fenbutatin Oxide: Rept. No. 336-88. Unpublished study prepared by E.I. du
Pont de Nemours & Co., Inc. 61 p.
40709802 Bagos, A.; Griffis, L. (1988) The Acute Inhalation Toxicity of CC-16244
(SX-1786) in Rats: Proj. ID CEHC 2875. Unpublished study prepared by
Chevron Environmental Health Center, Inc. 80 p.
40709803 Dougherty, K. (1988) The Four-Hour Skin Irritation Potential of CC-16244
(SX-1786) in Adult Albino Rabbits: Proj. ID CEHC 2873. Unpublished study
prepared by Chevron Environmental Health Center, Inc. 25 p.
40709804 Dougherty, K. (1988) Modified Buehler Test for the Skin Sensitization
Potential of CC-16244 (SX-1786): Proj. ID CEHC 2876. Unpublished study
prepared by Chevron Environmental Health Center, Inc. 38 p.
40709901 Dougherty, K. (1988) The Acute Oral Toxicty of CC-16243 (SX-1793) in Adult
Male and Female Rats: Project ID: CEHC 2878; S-3090. Unpublished study
prepared by Chevron Environmental Health Center, Inc. 43 p.
40709902 Dougherty, K. (1988) The Acute Dermal Toxicity of CC-16243 (SX-1793) in
Adult Male and Female Rabbits: Project ID: CEHC 2879; S-3091.
Unpublished study prepared by Chevron Environmental Health Center, Inc. 33
P-
94
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BIBLIOGRAPHY
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CITATION
40709905 Dougherty, K. (1988) The Four-Hour Skin Irrtation Potential of CC-16243
(SX-1793) in Adult Albino Rabbits: Project ID: CEHC 2880; S-3092.
Unpublished study prepared by Chevron Environmental Health Center, Inc.
23 p.
40750601 Fomenko, J.; Olinger, C.; Cargile, N. (1988) Testing of SD 14114 through
FDA Multi-residue Protocol I: DuPont Study AMR 987-87-1: Biospherics
Study No. 87-017. Unpublished study prepared by Biospherics Inc. 17 p.
40750602 Fomenko, J.; Olinger, C.; Cargile, N. (1988) Testing of SD 14114 through
FDA Multi-residue Protocol II: DuPont Study AMR 987-872: Biospherics
Study No. 87-017. Unpublished study prepared by Biospherics Inc. 21 p.
40750603 Fomenko, J.; Olinger, C.; Cargile, N. (1988) Testing of SD 14114 through
FDA Multi-residue Protocol III: DuPont Study AMR 987-873: Biospherics
Study No. 87-017. Unpublished study prepared by Biospherics Inc. 16 p.
40750604 Fomenko, J.; Olinger, C.; Cargile, N. (1988) Testing of SD 14114 through
FDA Multi-residue Protocol IV: DuPont Study AMR 987-874: Biospherics
Study No. 87-017. Unpublished study prepared by Biospherics Inc. 16 p.
40770601 Arce, G.; Rickard, L. (1985) Mutagenicity Testing of Vendex Technical in the
Salmonella typhimurium Plate Incorporated Assay: Supplemental 1 to: Report
No. 740-87. Unpublished study prepared by E.I. du Pont de Nemours & Co.,
Inc. 128 p.
40790901 Home, P. (1988) Hydrolysis of CTin 119-Fenbutatin Oxide in Buffer Solutions
of pH 5, 7 and 9: Laboratory Project ID AMR-923-87. Unpublished study
prepared by E. I. du Pont de Nemours & Co. 35 p.
40790902 Home, P. (1988) Photodegradation of CTin 119-Fenbutatin Oxide in Water:
Laboratory Project ID AMR-924-87. Unpublished study prepared by E. I. du
Pont de Nemours & Co., Inc. 34 p.
40843601 Kauder, 0. (1988) Vendex (Fenbutatin Oxide): Product Identity and
Composition: Second Response to Review of DuPont Study Y4332.A ES
10/8/87 MRID 40365801: Project ID: Y4332.I. Unpublished study prepared
by Witco Corp. 27 p.
95
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40977001 Granville, J.; Dix, K. (1989) Toxicity Studies on the Pesticide SD14114: Two
Year Oral Toxicity Test in Dogs: Proj. ID TLGR 0035.73. Unpublished
supplemental study prepared by Shell Research Limited. 280 p.
41069101 Reynolds, V. (1989) Metabolism of (119mSn)Fenbutatin Oxide by the
Laboratory Rat: Project ID: Haskell Report No. 66-89; Du Pont Amr No.
928-87. Unpublished study prepared by E.I. du Pont de Nemours and Co.,
Inc. 54 p.
41110801 Marxmiller, R. (1989) Magnitude of Residues of Fenbutatin Oxide and
Metabolites in Citrus and Citrus Processed Products following Application of
Vendex at the Maximum Labeled Rate: Project No. AMR-943-87.
Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc. 68 p.
41110802 Eble, J. (1989) Magnitude of Residues of Fenbutatin Oxide in Apples and Their
Processed Fractions: Project No. AMR-1125-88. Unpublished study prepared
by The National Food Laboratory in cooperation with McKenzie Laboratories,
Inc. 61 p.
41110803 Eble, J. (1989) Magnitude of Residues of Fenbutatin Oxide and Its Metabolites
in Plums and Processed Plums (Prunes) after Application of Vendex Miticide:
Project No. AMR-1127-88. Unpublished study prepared by The National Food
Laboratory, Inc. in cooperation with McKenzie Laboratories, Inc. 50 p.
41110804 Eble, J. (1989) Magnitude of Residues of Fenbutatin Oxide and Two
Metabolites in Grapes...after Application of Vendex Miticide: Project No.
AMR-1126-88. Unpublished study prepared by The National Food Laboratory,
Inc. in cooperation with McKenzie Laboratories, Inc. 54 p.
41110901 Barber, G. (1989) Freezer Storage Stability Study of Fenbutatin Oxide and
Metabolites in Strawberries, Eggplants, and Almonds: Proj. ID AMR-991-87.
Unpublished study prepared by McKenzie Laboratory. 41 p.
41110902 Marxmiller, R. (1989) Magnitude of Residues of Fenbutatin Oxide and
Metabolites in Cocumbers Treated with Vendex Miticide: Proj. ID
AMR-1138-88. Unpublished study prepared by E.I. du Pont de Nemours &
Co., Inc. 104 p.
96
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BIBLIOGRAPHY
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41183801 Hawkins, D.; Mayo, B.; Jackson, A.; et al (1989) The Metabolism of Mass
119 Sn°- Fenbutatin Oxide in Laying Hens: Project ID HRC/-DPT 185/89231
and AMR-922-87. Unpublished study prepared by Huntingdon Research
Centre. 63 p.
41183802 Ravitz, S.; Baugher, D. (1989) Dislodgeable Foliar Residues of Vendex
Miticide Applied to Citrus in California and Florida, 1988: OAI Project No.
26587: Du Pont Study No. AMR-981-87-I. Unpublished study prepared by
Orius Associates in association with McKenzie Research. 107 p.
41192401 Smith, R. (1989) Toxicity Studies on the Pesticide SD14114: Two Year Oral
Toxicity Test in Dogs: Supplement 2: Laboratory Project ID TLGR 0035.73.
Unpublished study prepared by Shell Research Ltd. 33 p.
41258901 Beavers, J.; Hoxter, K.; Corbitt, A.; et al. (1989) Vendex Technical: A
One-generation Reproduction Study with the Bobwhite (Colinus virginianus):
Wildlife International Ltd. Project No. 112-201. Unpublished study prepared
by Dupont Haskell Laboratory. 155 p.
41258902 Beavers, J.; Hoxter, K.; Corbitt, A.; et al. (1989) Vendex Technical: A
One-generation Reproduction Study with the Mallard (Anas platyrhynchos):
Wildlife International Ltd. Project No. 112-202. Unpublished study prepared by
Dupont Haskell Laboratory. 152 p.
41483301 Boeri, R.; Ward, T. (1990) Acute Flow-through Toxicity of Vendex to the
Sheepshead Minnow, Cyprinodon variegatus: Lab Project No.: HLO-78-90.
Unpublished study prepared by Resource Analysts, Inc., EnviroSystems Div.
30 p.
41520701 McClory, J. (1990) Freezer Storage Stability Study of Fenbutatin Oxide in
Cucumbers, Oranges, Plums, Apples, and Grapes: Lab Project I.D.:
AMR-1495-89. Unpublished study prepared by E.I. du Pont de Nemours and
Co., Inc. in association with McKenzie Laboratories, Inc. 22 p.
41520702 Home, P. (1990) Confined Accumulation Study of (tll9mSn-Fenbutatin Oxide
on Rotational Crops: Lab Project I.D.: AMR-926-87. Unpublished study
prepared by E.I. du Pont de Nemours and Co., Inc. 41 p.
97
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BIBLIOGRAPHY
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41540601 Bentley, K. (1990) Reproductive and Fertility Effects with Vendex Technical
(IN Y4332-5) Multigeneration Reproduction Study in Rats: Lab Project
Number: 128-90: 8388-001. Unpublished study prepared by E. I. du Pont de
Nemours and Co./Haskell Laboratory. 1262 p.
41551401 Boeri, R.; Ward, T. (1990) Early Life Stage Toxicity of Vendex to the
Sheepshead Minnow, Cyprinodon variegatus: Lab Project No.: HLO 303-90.
Unpublished study prepared by EnviroSystems Div. 182 p.
41551402 Boeri, R.; Ward, T. (1990) Life-cycle Toxicity of Vendex Technical to the
Mysid, Mysidopsis bahia: Lab Project Number: HLO 304-90. Unpublished
study prepared by EnviroSystems Div. 318 p.
41608501 Marxmiller, R.; McClory, J. (1990) Field Soil Dissipation of Vendex Miticide:
Lab Project Number: AMR-1152-88. Unpublished study prepared by
McKenzie Laboratories, Inc. 97 p.
42074501 Marxmiller, R.; McClory, J.; Stanley, B. (1991) Field Soil Dissipation of
Vendex Miticide: Lab Project Number: AMR 1152-88. Unpulished study
prepared by McKenzie Laboratories, Inc. 136 p.
42106801 Barber, G. (1990) Method Validation Study for Fenbutatin-Oxide and
Metabolites in Agricultural Crops: Lab Project No: AMR/992/87. Unpublished
study prepared by McKenzie Labs. 75 p.
42568701 McClory, J. (1992) Freezer Storage Stability Study of Fenbutatin Oxide and
Metabolites in Strawberries, Eggplants, and Almonds: Supplement No. 1: Lab
Project Number: AMR 991-88. Unpublished study prepared by E.I. DuPont de
Nemours and Co. 37 p.
42721001 Amoo, J.; Walker, D. (1993) Solubility of Fenbutatin Oxide in n-Octanol and
Dimethylformamide: Lab Project Number: AMR 2605-93. Unpublished study
prepared by E.I. du Pont de Nemours and Co. 22 p.
42872101 Wallace, M.; Jenkins, J.; Sutherland, C.; et al. (1993) An Aquatic Residue
Monitoring Study of Vendex 4L in Florida Citrus Groves: Amended Report I:
Lab Project Number: 112-194: AMR 1165-88. Unpublished study prepared by
McKenzie Labs, Inc. and Wildlife International Ltd. 764 p.
98
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BIBLIOGRAPHY
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42896801 McClory, J.; Freeman, C.; Wetherington, J. (1993) Field Soil Dissipation of
Vendex Miticide: Fenbutatin-Oxide: Lab Project Number: AMR 1152-88.
Unpublished study prepared by E. I. du Pont de Nemours and Co.; Mckenzie
Lab., Inc. 222 p.
43336401 Goodyear, A. (1993) (Carbon 14) Fenbutatin-Oxide: Adsorption/Desorption
in Three Soils: Final Report: Lab Project Number: 579/127/1015: 579/127.
Unpublished study prepared by Hazelton UK. 83 p.
99
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100
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APPENDIX D. List of Available Related Documents
101
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102
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The following is a list of available documents related to Fenbutatin-oxide. 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 Fenbutatin-oxide and are included in the
EPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Fenbutatin-oxide RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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104
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APPENDIX E. PR Notices 86-5 and 91-2
105
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106
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PR Notice 86-5
107
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108
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tpno1 WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns 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)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
Ill. 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 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. 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
109
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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
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 C9mpatible 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 C9sts 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 applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 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 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r 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
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f 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
110
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 8 14
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 f9r 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 admin-
istrative material must be gr9uped 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 trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline 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
111
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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 petiti9n and
an application for a 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 complete-
ness. A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding 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 V9lumes 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.1 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 C9ntrol data, and the like are often assoc-
iated 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
112
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional 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
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld 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)(1)(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,
h9wever, of limiting a study to the report of a single inves-
tigation 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 C9mmodities 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
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports Iaborat9ry Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
113
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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 C9ntent 9f 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 IdentificatJ9n. 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 if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly 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 pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
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)(1)(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. 09 not make CBI
claims with respect to analytical methods associated with pet-
114
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itions for tolerances or emergency exemptions (see NOTE Pg 13).
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 9f 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 t9 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)(1) 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 of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential 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. Sam-
ples 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 t9 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 pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorp9rated into the statement of
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 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
115
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instructions bef9re 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 prop9sed regulati9ns 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 Stan-
dard 9r Special Review must be provided in four C9pies, fr9m 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 of 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)(1)(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 phrase "Public Docket Material -
contains no information claimed as confidential".
116
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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 G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
117
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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 J9int 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:
Name Signature
Company Name
Company Contact:
Name Phone
118
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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
January 5, 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)
119
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(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)(1)(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
Meth9ds 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.
120
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion 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 con-
nection with those disclosures.
• Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe th9se harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informati9n in voluntarily sub-
mitted, 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.
121
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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)
122
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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
123
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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
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
124
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PR Notice 91-2
125
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126
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.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 P^gram's P9licy 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(1). 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
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d 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
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(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
127
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(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 C9ncentrati9n 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. C9pies 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 pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i. e., upper limit(s) 9nly) 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 C9ntrol 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.
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(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
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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:
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
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Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - FPA Grouping or End-Use Products for Meeting Acute Toxicology Data
Requirements tor Reregistration
5 - FPA Acceptance Criteria
6 - List or 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).
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
C"ECD 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
1JY THE AGENCY
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Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-in (s), or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-in you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).
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).
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.
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If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application for amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-In Response Form by signing the certification, item
number 8. Application forms for amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) ~~-~
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
all of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current " Confidential Statement
of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form, Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-in Response Form. If you claim a generic data exemption
you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific
data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant^) 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.
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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. or 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.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
for product specific data (contained in Attachments 2 and 3, respectively). 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. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person (s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product (s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,
indicating your election of this option. Voluntary cancellation is item number 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.
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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 tor 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.
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
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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.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
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 N otice.
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
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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
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.
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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
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 (a 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
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(Cost Sharing)
1 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.
Option 5 .Upgrading a Study — The same requirements described for generic data (see Section
lll.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 lll.C.l" Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (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
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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.
(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.
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(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
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your product(s) you must choose a ~~
method of meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days of your receipt of the Agency's written decision, you must
submit a revised Requirements Status and Registrant s Response Form indicating the
option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements tor product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted~without adequate
supporting rationale will be denied and the original due date will remain in force.
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SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
JNUTHJK
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant
to FIFRA section 3 (c) (2) (B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for a generic data exemption either
to:
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 Reqistrant'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.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3 (c) (2) (B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your product (s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of 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
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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
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,
Louis P. True, Jr., Acting 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 Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula, Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
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Fenbutatin-oxide DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Fenbutatin-oxide.
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
Fenbutatin-oxide. 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 2j, (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 Fenbutatin-oxide 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
Fenbutatin-oxide are contained in the Requirements Status and Registrant's Response,
Attachment C. The Agency has concluded that additional product chemistry data on
Fenbutatin-oxide are needed. These data are needed to fully complete the reregistration of all
eligible Fenbutatin-oxide 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 Susan Jennings at (703) 308-8021.
All responses to this Notice for the generic data requirements should be submitted to:
Susan Jennings, 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: Fenbutatin-oxide
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FENBUTATIN-OXIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Fenbutatin-oxide.
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
Fenbutatin-oxide. 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), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Fenbutatin-oxide
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 Fenbutatin-oxide
are contained in the Requirements Status and Registrant's Response, Attachment 3. The
Agency has concluded that additional data on Fenbutatin-oxide are needed for specific
products. These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible Fenbutatin-oxide
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Fenbutatin-oxide, please
contact Susan Jennings at (703) 308-8021.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 308-8583.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Emily Mitchell
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: Fenbutatin-oxide
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
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Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
and are to be used By registrants to respond to generic and product specific Data Call-Ins as
part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. The type of data call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response" forms
must be completed.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out
the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by
the registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 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.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
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Item 7a.ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy the data
requirements by responding "yes."
Item 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 7 a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Caii-ln
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
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
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Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be completed.
Although the form is the same for both product specific and generic data, instructions
for completing the forms differ slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average
30 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 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.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
of Data Call-In. The date of issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This ID number must be used
in the transmittal document for any data submissions in response to this Data
Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-in Notice, govern the conduct of the required studies. Note that
series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section III of the Data Call-In Notice, 90-day progress reports are required for
all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's
Response Form.
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
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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
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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.
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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.
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.
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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
this product. For these cases, please supply all relevant details so that the Agency can ensure that its records are correct.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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EPA'S BATCHING OF FENBUTATIN-OXIDE 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 fenbutatin-
oxide, 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 lexicological 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 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6).
If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However,
a registrant should know that choosing not to participate in a batch does not preclude other
registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
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The table below shows the two EPA registrations and six Special Local Need (SLN) registrations
which were placed into two batches.
BATCH NO.
1
2
EPA REG. NO.
&
SLN REG. No.
352-480
OR880005
WA880009
352-493
OR880004
OR9 10001
WA880010
WA9 10001
% of Fenbutatin-Oxide
50.00% - Fenbutatin-Oxide
50.00% - Fenbutatin-Oxide
50.00% - Fenbutatin Oxide
42.00% - Fenbutatin-Oxide
42.00% - Fenbutatin-Oxide
42.00% - Fenbutatin-Oxide
42.00% - Fenbutatin-Oxide
42.00% - Fenbutatin-Oxide
Formulation Type
Wettable Powder
Wettable Powder
Wettable Powder
Emulsifiable Concentrate
Emulsifiable Concentrate
Emulsifiable Concentrate
Emulsifiable Concentrate
Emulsifiable Concentrate
The table below shows three EPA registrations which were not batched for various reasons
such as additional active ingredients, significant differences in the inert ingredients, and significant
differences in the concentrations of active and inert ingredients.
EPA REG. NO.
239-2594
239-2595
352-479
% of Fenbutatin-Oxide &
Other Active Ingredients
0.75% - Fenbutatin-Oxide
4.00% - Acephate
3.25%-Tnfonne
0.50% -Fenbutatin-Oxide
8.00% - Acephate
98.40% - Fenbutatin-Oxide
Formulation Type
Soluble Concentrate
Soluble Concentrate
Technical
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Attachment 5. EPA Acceptance Criteria
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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
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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).
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > ff. 1%.
2. Degree of accountability or closure _>^ ca 98%.
3. Analyses conducted for certain trace toxicTmpurities 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 how the limits were determined.
8. Upper certified limit proposed for each impurity present at j>_ 0.1% and for certain lexicologically significant
impurities at < 0.1% along with explanation of how linnTdetermined.
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.
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in ° C
Any observed decomposition reported
63-6 Boiling Point
Reported in ° C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
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
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SUBDIVISION F
Guideline Study Tide
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
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.r 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.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.~ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oerore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
or contains particles of inhalable size for man (aerodynamic diameter 15 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.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of < 2 or > 11.5.
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 shorter).
11 .^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One offhe 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.
G.~ 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.
183
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184
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
185
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186
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
187
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188
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190
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric system
units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow
the 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.
191
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192
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
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 Firm(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
Name and
of Company's Authorized Representative
Date
Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
193
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194
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OUI N*. 2070-0107
2070-0057
Approval Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, includina
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 20S03.
Please fill In blanks below.
Company Numb«r
SPA Reg. He.
I Certify that:
1.
For each study cited in support of registration or ^registration 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.
That for each study cited in support of registration or ^registration 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 company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due. if any. The companies I have notified are: (check one)
[ ] 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)(i )(D) of FIFRA for the studies I have cited in support of
registration or ^registration under FIFRA.
Signature
Name and Till* (Plrnaa Type or Print)
Date
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to me
registration or reregistration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
Signature
Nam* and Tltta (Plaaaa Typ* or Print)
EPA Form 1570-11 (4-90
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196
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APPENDIX G. FACT SHEET
197
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198
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-021
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Fenbutatin-oxide
All pesticides sold or distributed in the United States must be
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 reregi strati on, 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 reregi strati on, EPA announces this
and explains why in a Reregi strati on Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 0245, fenbutatin-oxide or Vendex.
Use Profile
Fenbutatin-oxide is a miticide or acaricide used to control mites,
aphids, thrips, mealybugs, whiteflies and scale on citrus, apples, stone
fruits, nut trees, several other food crops and ornamentals. Marketed under
the trade name Vendex, fenbutatin-oxide is used in the U.S. primarily on
orange and grapefruit crops.
Fenbutatin-oxide is formulated as a wettable powder, emulsifiable
concentrate and soluble concentrate. It is applied aerially or through
airblast or groundboom equipment two to nine times per year, depending
on the site.
Regulatory
History
Fenbutatin-oxide was first registered as a pesticide in the U.S. in
1974. The first end-use product was registered in August 1975. EPA
issued a Registration Standard for fenbutatin-oxide in March 1987 (NTIS
#PB87-190690). Currently, 10 pesticide products containing this active
ingredient are registered.
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Human Health
Assessment
Toxicity
Fenbutatin-oxide generally is of low acute toxicity. However, it is a
severe eye irritant in rabbits and has been placed in Toxicity Category I,
indicating the highest degree of acute toxicity, for eye irritation effects.
In a subchronic dermal toxicity study using rabbits, fenbutatin-oxide
caused redness of the skin and swelling at a low dosage but did not cause
systemic toxicity.
Fenbutatin-oxide does not cause chronic toxicity and has been
classified as a "Group E" carcinogen—a chemical showing evidence of non-
carcinogenicity for humans.
In a developmental toxicity study using rats, fenbutatin-oxide caused
no compound-related effects in treated dams. A similar study using rabbits
resulted in anorexia, gastric lesions and abortions. In a reproductive
toxicity study using rats, decreased body weight and food consumption
were observed in parents, and pup body weights also were reduced during
lactation. Fenbutatin-oxide is not mutagenic.
Metabolism studies indicate that the potential for bioaccumulation of
fenbutatin-oxide is minimal. Approximately 1% of the pesticide is
absorbed from the gastrointestinal tract when it is administered orally.
A reference dose (RfD), or amount believed not to cause adverse
effects if consumed daily over a 70-year lifetime, has been established for
fenbutatin-oxide at 0.05 mg/kg/day (milligrams per kilogram per day).
This RfD is based on the reproductive toxicity study which caused reduced
body weight and food consumption in both generations of rats.
Dietary Exposure
People may be exposed to residues of fenbutatin-oxide through the
diet. Tolerances or maximum residue limits have been established for
citrus, apples, many stone and other fruits, tree nuts and several vegetables
(please see 40 CFR 180.362(a) and (c)); for milk fat, eggs and the meat, fat
and meat byproducts of cattle, goats, hogs, horses, poultry and sheep
(please see 40 CFR 180.362(b); for dried prunes and raisins (please see 40
CFR 185.3550); and for apple and grape pommace, citrus oil and pulp, and
raisin waste (please see 40 CFR 186.3550). EPA has reassessed these
fenbutatin-oxide tolerances and found that a number of changes are
needed, as detailed in the RED document.
International maximum residue limits (MRLs) have been established
by Codex for many food commodities. However, because of the
differences in tolerance expression between the MRLs and U.S tolerances,
compatibility between the two is not achievable. In addition, the U.S.
tolerances are higher than the corresponding Codex MRLs. Established
U.S. agricultural practices for application of fenbutatin-oxide are unlikely
to be changed. Therefore, U.S. tolerance levels probably cannot be
lowered to achieve compatibility with Codex MRLs.
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EPA has assessed the dietary risk posed by fenbutatin-oxide. For the
overall U.S. population, exposure from all current tolerances represents
136% of the Reference Dose (RfD), or amount believed not to cause
adverse effects if consumed daily over a 70-year lifetime. This value
likely overstates the risk, however, because it assumes all crops have
tolerance-level residues and 100% of all crops with tolerances are treated.
Information on actual anticipated residue levels and percent of crop
treated with fenbutatin-oxide was included to more accurately estimate
dietary exposure. The resulting Anticipated Residue Contribution (ARC)
for the overall U.S. population represents 4% of the RfD, and the ARC for
the most highly exposed subgroup, children age one to six, is 8% of the
RfD. Chronic dietary risk from exposure to fenbutatin-oxide is believed to
be minimal.
Occupational and Residential Exposure
Occupational and residential exposure can be expected based on the
use patterns of currently registered products containing fenbutatin-oxide.
The Worker Protection Standard for Agricultural Pesticides (WPS)
established an interim 48-hour restricted entry interval (REI) based on
fenbutatin-oxide's Toxicity Category I eye irritation potential. EPA has
determined that the 48-hour REI should be retained for all WPS sites as a
prudent measure to mitigate risk to workers entering treated areas after
application. The personal protective equipment (PPE) required for early
entry includes coveralls, chemical-resistant gloves, shoes, socks and
protective eyewear.
Uses of fenbutatin-oxide that are outside the scope of the WPS
including occupational and residential use products are required to add
strengthened entry restrictions to their labels.
Human Risk Assessment
Fenbutatin-oxide generally is of low acute toxicity but is a severe eye
irritant. It poses no significant chronic health risks and is classified as a
Group E carcinogen, indicating that it poses no known cancer risk for
humans.
Although people may be exposed to residues of fenbutatin-oxide in
many fruits and other foods, the chronic dietary risk from such exposure is
minimal. Workers and other users may be exposed to fenbutatin-oxide
during and after application to food crops and ornamentals. To mitigate
the risk of eye irritation during these activities, EPA is requiring a 48-hour
REI and use of PPE including protective eyewear for all agricultural uses
within the scope of the WPS, and more stringent entry restrictions for non-
WPS occupational and residential uses.
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Environmental Environmental Fate
AsSGSSniGnt Fenbutatin-oxide is persistent in the environment, with no major
route of dissipation. It is relatively unsusceptible to hydrolysis or
photodegradation in water or on soil. Microbial degradation of fenbutatin-
oxide in soil also is very slow.
Fenbutatin-oxide is relatively immobile in the environment. It is
slightly soluble in water, has a low vapor pressure and binds strongly to
soil. Therefore, it is not expected to leach.
Although fenbutatin-oxide is persistent, residues do not tend to
accumulate in crops planted in previously treated soil. Fenbutatin-oxide
does accumulate in fish tissues.
In the field, fenbutatin-oxide exhibits the same characteristics of
persistence and immobility as in the laboratory. Calculated half-lives
range from 271 days to 1367 days in different States and soils. This long
half-life causes residue levels to increase with each successive application.
Ecological Effects
Fenbutatin-oxide is practically nontoxic to birds on an acute and
subacute dietary basis, and has no effect on their reproduction. It also is
practically nontoxic to mammals and honey bees. However, fenbutatin-
oxide is very highly toxic to freshwater, estuarine and marine fish and
invertebrates.
Ecological Effects Risk Assessment
Although no acute hazard is expected, use of fenbutatin-oxide at
current rates does present the potential for chronic hazard to birds and
mammals. Hazards to bees and nontarget plants are not anticipated.
Acute risk to freshwater fish is expected for all major uses of
fenbutatin-oxide at current application rates. Acute risk to freshwater
invertebrates is only expected for the citrus use, and acute risk to estuarine
invertebrates is expected from both the citrus and the apple uses.
A significant potential for chronic risk to fish exists from the use of
fenbutatin-oxide on citrus. No chronic risk is anticipated for freshwater
and estuarine invertebrates.
Acute risk to endangered birds and mammals is not expected, but
there is a potential for chronic hazard to these organisms. Acute risk to
endangered freshwater fish and invertebrates is expected from all major
uses. Use of fenbutatin-oxide on citrus presents significant potential for
chronic hazard to endangered freshwater and estuarine fish.
Additional Data EPA 1S requiring the following additional generic data for fenbutatin-
Rpnuirpri oxide to confirm its regulatory assessments and conclusions: Discussion of
formation impurities, Ph, bioaccumulation in fish, droplet size spectrum,
and drift field evaluation.
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Product Labeling
Changes Required
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 reregi strati on.
All fenbutatin-oxide end-use products must comply with EPA's
current pesticide product labeling requirements, and with the following:
Use Directions (Restricted Use Classification)
All uses of fenbutatin-oxide are declared Restricted, and products
reregistered under this RED must bear a restricted use legend at the top of
the front panel of the label. No other wording or symbols may appear
above the legend and it must begin with the heading,"RESTRICTED USE
PESTICIDE," followed by a brief statement of the reason for the
restricted use classification (ie, "DUE TO VERY HIGH TOXICITY TO
AQUATIC ORGANISMS"). Following this, the terms of the restriction
must be stated as, "For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only for those uses covered
by the Certified Applicator's certification."
Entry Restrictions and Personal Protective Equipment (PPE)
For occupational end-use products, EPA is establishing a 48-hour
restricted entry interval (REI) for each use that is within the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS). The PPE
required for early entry permitted by the WPS is coveralls, chemical-
resistant gloves, shoes plus socks, and protective eyewear.
All end-use products with non-WPS occupational uses must bear the
following entry restriction:
"Do not enter or allow others to enter the treated area until sprays
have dried."
All residential use products must bear the following entry
restriction:
"Do not allow persons or pets to enter the treated area until sprays
have dried."
Other Labeling Restrictions
EPA is requiring the following labeling statements on all 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: "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."
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User Safety Requirements: "Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions exist 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."
Type of Respirator: If the acute inhalation toxicity of the end-use
product is in category I or II, then a respirator is required for
pesticide handlers. A dust/mist filtering respirator (MSHA/NIOSH
approval number prefix TC-21C) is the only type of respirator that
is appropriate to mitigate fenbutatin-oxide inhalation concerns.
Toxicity Statement
Due to the toxicity of fenbutatin-oxide to birds, mammals and
aquatic organisms, all end-use product labels must bear the following
statement:
"This pesticide is toxic to birds, mammals, fish, and aquatic
invertebrates. Do not apply directly to water, or to areas where
surface water is present or to intertidal areas below the mean high-
water mark. Drift and runoff may be hazardous to aquatic organisms
in neighboring areas. Do not contaminate water when disposing of
equipment washwater or rinsate."
Drift Reductions
To mitigate risks posed due to fenbutatin-oxide's high toxicity to
aquatic organisms, all end-use product labels with aerial applications must
bear the following statements for citrus use in Florida:
1) Do not apply within 125 feet of bodies of water such as lakes,
reservoirs, rivers, permanent streams, natural ponds, marshes or
estuaries.
2) Do not apply when gusts or sustained winds exceed 8 mph.
3) The boom length must not exceed 3/4 of the wing or rotor length
(ie, the distance of the outer-most nozzles on the boom must not
exceed 3/4 or the length of the wingspan or rotor).
4) Do not apply at a height greater than 10 feet above the top of the
target plants unless a greater height is required for aircraft safety.
5) Nozzles must always point backward and never be pointed
downwards more than 45 degrees.
6) Do not apply in less than 10 gallons of final spray per acre.
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Regulatory
Conclusion
7) Do not apply east of US Highway #1, south and east of State
Road #846 or south of West Palm Beach Canal.
All end-use products using airblast applications must bear the
following statements for citrus use in Florida:
1) Citrus groves may be planted close to bodies of water. Do not
apply within 25 feet of bodies of water such as lakes, reservoirs,
rivers, permanent streams, natural ponds, marshes or estuaries.
2) For all plantings within 75 feet of bodies of water as described
above, spray trees only form outside the planting away form the
bodies of water.
3) Shut off the sprayer when turning at row ends.
4) Do not apply when gusts or sustained winds exceed 12 mph.
To ensure that the potential risks of this pesticide are not
unreasonable, EPA is classifying fenbutatin-oxide as a Restricted Use
Pesticide and is requiring the registrant to implement certain risk
mitigation measures. Provided that these measures are implemented, all
products containing fenbutatin-oxide as an active ingredient are eligible for
reregi strati on.
The Restricted Use Pesticide classification is appropriate for all uses
of fenbutatin-oxide because many of its use sites are located on or near
bodies of water, and this pesticide is very highly toxic to freshwater and
estuarine aquatic organisms. Fenbutatin-oxide persists in the environment
long after initial application. The potential for serious contamination of
the ecosystem is substantial.
The required risk mitigation measures are designed to reduce the risk
to freshwater and estuarine aquatic organisms found near Florida's citrus
groves. Measures include reduced application rates, label amendments
with instructions to minimize spray drift, development of more accurate
aquatic modeling, and monitoring to determine if fenbutatin-oxide levels
accumulate over multiple years of use.
Fenbutatin-oxide products will be reregistered once the confirmatory
generic data, product-specific data, revised Confidential Statements of
Formula and revised labeling (including the Restricted Use Pesticide
classification) are received and accepted by EPA, assuming that the
required risk mitigation measures also are implemented.
For More
EPA is requesting public comments on the Reregi strati on Eligibility
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Information Decision (RED) document for fenbutatin-oxide during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Following the comment period, the fenbutatin-oxide RED document
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 reregi strati on program,
the fenbutatin-oxide RED, or reregi strati on of individual products
containing fenbutatin-oxide, 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-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.
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